- Staat
- -
- Alter
- 32,0
- Geschlecht
- M
- Eingang
- 10.01.2023
- Impfdatum
- 16.02.2022
- Beginn
- 16.02.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
C-reactive protein increased
Catheterisation cardiac normal
Cellulitis
Dyspnoea
Injection site rash
Pericarditis
Red blood cell sedimentation rate increased
Symptomtext
Narrative: Patient received Tdap and PPSV23 on 2/16/22 and developed rash on right arm where PPSV23 was administered the next day then on second day began to be SOB and was advised to go to ED outside the facility. Patient was treated for pericarditis and cellulitis. CRP and Sed rate were elevated but heart cath normal. Patient was treated with colchicine with good benefit and for cellulitis was treated with Keflex. Pt was hospitalized from 2/19 to 2/21 and on d/c was doing well, recovered, and no complications.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pericarditis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 81,0
- Geschlecht
- F
- Eingang
- 30.12.2022
- Impfdatum
- 28.12.2022
- Beginn
- 28.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Erythema
Injected limb mobility decreased
Injection site pain
Skin warm
Swelling
Symptomtext
CAUSING LOTS PAIN IN INJECTION SITE UP INTO SHOULDER, CANT RAISE ARM OR LIFT ANYTHING, HOT, SWOLLEN, RED. GOTTEN WORSE SINCE DATE OF VACCINE UNTIL TODAY 12/30. TRIED APAP (DID NOTHING), TAKING 1/2 OF HER HYRDOCODONE TO HELP WITH PAIN. TOLD HER TO WATCH AND CALL BACK TOMORROW TO UPDATE ME.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injected limb mobility decreased
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- patient got a colonoscopy day before vaccine
- Vorgeschichte
- Hypothyroidism, Insomnia, Gout, High cholesterol, Acid reflux, High blood pressure
- Andere Medikamente
- patient took tylenol for the pain and it did not help so she is taking 1/2 of her hydrocodone for the pain.
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- 68,0
- Geschlecht
- F
- Eingang
- 09.10.2022
- Impfdatum
- 02.10.2022
- Beginn
- 02.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Abdominal pain
Asthenia
Cellulitis
Chest discomfort
Chest pain
Chills
Dizziness
Dysphagia
Fatigue
Injection site erythema
Injection site pain
Injection site pruritus
Injection site swelling
Lethargy
Nausea
Pruritus
Rash
Throat tightness
Symptomtext
Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Abdominal Pain-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Medium, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Medium, Additional Details: Patient is still only currently dealing with rash/itchiness. She was seen by MD today and diagnosed with cellulitus. Patient is starting treatment today. She has had no reaction to previous year's flu vaccine of same brand, no previous reactions to Pfizer Covid-19 injection. Patient thinks this reaction was caused by her Pneumonia vaccination. This completed her Pneumonia vaccine series. All recieved same day.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Chest pain
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 68,0
- Geschlecht
- M
- Eingang
- 12.09.2022
- Impfdatum
- 10.09.2022
- Beginn
- 10.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Injected limb mobility decreased
Injection site discomfort
Injection site erythema
Injection site pain
Injection site swelling
Injection site warmth
Insomnia
Pain
Pain in extremity
Peripheral swelling
Symptomtext
Patient described burning upon injection of Pneumovax. Patient contacted us the following day, on September 11, 2022 to let us know he was concerned about swelling and pain in his right arm. He described only being able to lift his arm to 90 degrees, suffered insomnia due to pain throughout the night, warmth in the area, and swelling approximately 2 inches larger circumference of arm. He described that this started shortly after getting vaccines. I advised the patient to seek medical attention if he thought it was necessary but the symptoms sounded like normal side effects. The patient stated that the injections were not given near the shoulder joint. I also recommended an ice pack at the area to reduce swelling and discomfort. The patient opted to wait 24 hours and follow up with us to let us know how he was doing. He did contact us again on September 12th and stated that although his arm was now red, the swelling had gone down, his mobility had improved and he felt he was going to be fine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injected limb mobility decreased
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 28,0
- Geschlecht
- F
- Eingang
- 06.04.2022
- Impfdatum
- 22.03.2022
- Beginn
- 22.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cellulitis
Erythema
Injected limb mobility decreased
Insomnia
Pain
Pain in extremity
Peripheral swelling
Symptomtext
cause of reaction is unknow, pt also received Flucelvax Quadrivalent lot# 308467 at the same time in the same arm, and Boostrix lot#3A745 in the other (right) arm. Patient called the pharmacy on 3/25/22 to report a red swollen arm that was very painful and was difficult to move. She had been taking 800 mg Ibuprofen for the last 2 days without relief. The pain began several hours after recieving the vaccinations and persisted through the night, which kept her from sleeping. She described a red swollen area going from the shoulder almost to the elbow. She complained about the arm being painful and difficult to move and questioned if the shot had been given "too high". A discription was given about how the placement of the shots had been determined, about 2 inches down from the top of the shoulder and 1 to 1&1/2 inches horizontal to each other. By the following Monday, 3/28 she said the arm was feeling "a little better". She had taken some Keflex for a suspected cellulitus and wasn't sure if it had helped but was going to continue taking it for a few more days.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injected limb mobility decreased
- Hospital-Tage
- -
- Labordaten
- Pt did not have any lab test done nor did she get examined by a medical professional. She had called Tele-doc and was referred to a clinic but she did not go to one. Pt is a medical school student preparing for her clinicals, which is why she was getting the vaccination and felt the condition would be self-limiting based on her own research.
- Aktuelle Erkrankungen
- none reported
- Vorgeschichte
- none reported
- Andere Medikamente
- unknown
- Allergien
- none reported
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- 66,0
- Geschlecht
- F
- Eingang
- 05.04.2022
- Impfdatum
- 04.04.2022
- Beginn
- 04.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injected limb mobility decreased
Injection site pain
Musculoskeletal pain
Pain in extremity
Symptomtext
SIGNIFICANT PAIN FROM LEFT SHOULDER BLADE DOWN TO WRIST. LIMITED RANGE OF MOTION.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injected limb mobility decreased
- Hospital-Tage
- -
- Labordaten
- I AM CURRENTLY LESS THAN 24 HOURS POST VACCINE INJECTION AND WILL WAIT TO SEE IF CONDITION IMPROVES / RESOLVES PRIOR TO PROCEEDING WITH A CLINICAL EVALUATION.
- Aktuelle Erkrankungen
- NONE
- Vorgeschichte
- OSTEOPOROSIS
- Andere Medikamente
- DAILY (CENTRUM) VITAMIN DAILY (CALTRATE) CALCIUM
- Allergien
- PENICILLIN (ITCHING)
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 67,0
- Geschlecht
- F
- Eingang
- 02.04.2022
- Impfdatum
- 29.03.2022
- Beginn
- 29.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Dizziness
Flushing
Hyperhidrosis
Tremor
Symptomtext
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Tremor
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NH
- Alter
- 53,0
- Geschlecht
- F
- Eingang
- 25.02.2022
- Impfdatum
- 22.02.2022
- Beginn
- 23.02.2022
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cellulitis
Injected limb mobility decreased
Injection site erythema
Injection site induration
Injection site swelling
Injection site warmth
Pain in extremity
Tenderness
Symptomtext
On 2/23/22 the patient developed right arm soreness , which got gradually worse and became severe. The arm if tender to touch. Tylenol and Ibuprofen did not help with the pain. There is decreased range of motion. BP 185/96 (usually 112/68. HR 140 (usually 99). On exam Right deltoid area is red, warm and swollen/. indurated. Diagnosed with cellulitis of the right arm, Rxd Cephalexin 500 mg po four times a day for 7 days, Oxycodone as needed for pain.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injected limb mobility decreased
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- IDDM type 1, PTSD, Major depression, migraine, hypertension, anxiety
- Andere Medikamente
- Promethazine, Insulin, Clonazepam, Zolpidem, Aubra EQ, Amlodipine, Trazodone, Prednicarbate ointment, meclizine, insulin NPH, Humulin N
- Allergien
- Escitalopram, Fish, Codeine Sulfate, Erythromycin, Lisinopril, Losartan, Norco (Hydrocone- Acetaminophen
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 66,0
- Geschlecht
- F
- Eingang
- 15.02.2022
- Impfdatum
- 11.02.2022
- Beginn
- 15.02.2022
- Tage bis Beginn
- 4,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Hypoaesthesia
Injected limb mobility decreased
Injection site hypoaesthesia
Injection site pain
Pain
Pain in extremity
Screaming
Symptomtext
Patient reported intense pain and intermittent "numbness" in the injected arm all the way from her shoulders to her fingertips. Described the pain as the "worst in her entire life," and claimed she screamed when someone accidentally touched her. Reported inability to move arm without severe pain. Unclear whether extreme pain due to administration error or bad reaction to vaccine. Pharmacist recommended seeking care from primary care physician for evaluation and treatment. Will follow-up with patient to determine outcome
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injected limb mobility decreased
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- 42,0
- Geschlecht
- M
- Eingang
- 20.01.2022
- Impfdatum
- 17.01.2022
- Beginn
- 17.01.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Dehydration
Diarrhoea
Nausea
Vomiting
Symptomtext
Patient developed nausea, vomiting, and diarrhea 6 hours after his vaccination. He was seen at the emergency department at 06:00am on 1/18/2022 due to dehydration. He was treated with Zofran for nausea and was given oral fluids which he tolerated. Advised to follow up with his primary care provider.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dehydration
- Hospital-Tage
- -
- Labordaten
- Vitals taken at ED Temperature 36.4C Pulse 106 Respiratory Rate 16 Blood Pressure 109/87 O2 Sat 96%
- Aktuelle Erkrankungen
- Post COVID Pneumonia COVID-19 (10/2021)
- Vorgeschichte
- Generalize Anxiety Disorder
- Andere Medikamente
- Vitamin C, Multi-vitamin
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 66,0
- Geschlecht
- F
- Eingang
- 09.01.2023
- Impfdatum
- 06.01.2023
- Beginn
- 07.01.2023
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Pain
Pruritus
Rash
Swelling
Symptomtext
localized swelling , rash , itchy, sore
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pain
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- osteopenia carpal tunnel hyperlipidemia insomnia hematuria
- Andere Medikamente
- atorvastatin vitamin d 3 calcium citrate multivitamin melatonin
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- 66,0
- Geschlecht
- F
- Eingang
- 29.09.2022
- Impfdatum
- 26.09.2022
- Beginn
- 27.09.2022
- Tage bis Beginn
- 1,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Pain in extremity
Peripheral swelling
Rash
Symptomtext
Patient has rash, pain and swelling in the arm
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pain in extremity
- Hospital-Tage
- -
- Labordaten
- NONE
- Aktuelle Erkrankungen
- NONE
- Vorgeschichte
- NO
- Andere Medikamente
- NONE
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- 59,0
- Geschlecht
- M
- Eingang
- 05.08.2022
- Impfdatum
- 04.08.2022
- Beginn
- 05.08.2022
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Erythema
Pain
Pain in extremity
Peripheral swelling
Symptomtext
Patient describes swelling and redness in the left arm. Also, very sore to move around. Started in the evening of 08/04/22. Improved after ibuprofen given on 08/05/22 and ice. Still sore after a couple hours on ibuprofen.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pain
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NC
- Alter
- 48,0
- Geschlecht
- F
- Eingang
- 03.08.2022
- Impfdatum
- 02.08.2022
- Beginn
- 02.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Pain in extremity
Peripheral swelling
Skin warm
Tenderness
Symptomtext
Patient states that left arm began swelling and becoming sore the night of the vaccination. She states that it is warm, tender and swollen. She went to PCP and they gave her a tordal injection to relieve the pain. Instructed to take benadryl and pepcid by PCP.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pain in extremity
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- Shingles (07/28/2022)
- Vorgeschichte
- Sarcoidosis Hypertension Seasonal Allergies IBS
- Andere Medikamente
- Lisinopril 5mg Linzess 290mg OTC Pre Probiotic Claritin 10mg
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 65,0
- Geschlecht
- F
- Eingang
- 24.07.2022
- Impfdatum
- 22.07.2022
- Beginn
- 22.07.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site erythema
Injection site induration
Injection site pain
Injection site pruritus
Injection site swelling
Symptomtext
Patient called pharmacy when we were closed and left a voicemail on 7/23/22 at 919 pm reporting the adverse event from the vaccine she received on 7/22/22 around 4 pm. I listened/received her voicemail on the next business day 7/24/22 around 835am. She said 4-5 hours after receiving Pneumovax 23 her deltoid muscle became red, painful, itchy, hard, and swollen about the size of a softball. She put ice on it and took Ibuprofen and benadryl. She says it seems a little better today (7/23/22 when she called) but it is still sore and the redness extends under her arm. She is going to let her doctor know about it.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- Unknown
- Aktuelle Erkrankungen
- Unknown
- Vorgeschichte
- Patient has MS (multiple sclerosis) - patient put this on her vaccine screening questionnare and consent form
- Andere Medikamente
- Unknown
- Allergien
- Unknown
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 2,0
- Geschlecht
- F
- Eingang
- 28.06.2022
- Impfdatum
- 15.04.2022
- Beginn
- 17.04.2022
- Tage bis Beginn
- 2,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Cellulitis
Cough
Injection site erythema
Injection site pain
Injection site swelling
Injection site cellulitis
Pyrexia
Rash macular
Laboratory test
Otitis media
Respiratory tract congestion
Restlessness
Sinusitis
Screaming
Somnolence
Vomiting
Upper respiratory tract infection
X-ray
Symptomtext
03/15/2022 Patient came in for vomiting out of nowhere for a couple of days, had water and milk and threw it up . Recurrent vomiting, cough and congestion. Patient was sent for labs and x-rays Diagnoses: Severe OM, URI and cough 03/19/2022 Patient was assessed over telemedicine for labs and x-ray Diagnoses: sinusitis and cough Medication: Augmentin 600/5ml (5ml PO BID x 8 days 04/15/2022 Patient came in for sinus infection was given the pneumococcal 23 IM on the left thigh Diagnoses: sinusitis and low pneumococcal titers 04/17/2022 Patient was assessed over telemedicine for pain and redness to injection site, vomiting, restless x 1 day @13:30 per mom size grew Diagnoses: Cellulitis Medication: Clindamycin 75mg/5 ml (10ml TID x 7 days) 04/19/2022 Follow up on pcv 23 has cellulitis from vaccine. Site still red and swollen Diagnoses: Left thigh cellulites 04/ 21/2022 Follow up on injection site and cellulites Diagnoses: improved
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site cellulitis
- Hospital-Tage
- -
- Labordaten
- 03/15/2022 labs and Xray 04/15/2022 repeat Xray
- Aktuelle Erkrankungen
- Sinusitis- Augmentin
- Vorgeschichte
- Recurrent Infections Possible immunization deficiency
- Andere Medikamente
- None
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- IA
- Alter
- -
- Geschlecht
- U
- Eingang
- 17.06.2022
- Impfdatum
- 02.06.2022
- Beginn
- 02.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Exposure via skin contact
Incorrect dose administered
Injection site extravasation
No adverse event
Symptomtext
Pharmacist stated she gave the patient a second dose (same lot/exp) due to partial dose being administered; during an injection of PNEUMOVAX 23 yesterday some of the medication leaked out and was running down the patient's arm; Leaking During Use / attached a needle securely to the end and once giving the injection/pushing the plunger forward, liquid; during an injection of PNEUMOVAX 23 yesterday some of the medication leaked out and was running down the patient's arm; Caller was initially pharmacy technician (listed as healthcare prof-other, since pharmacy technician is not an option) who reported that during an injection of PNEUMOVAX 23 yesterday some of the medication leaked out and was running down the patient' s arm. Caller then put the pharmacist on the line who actually gave the injection and stated that she used the prefilled syringe that appeared to not be damaged and attached a needle securely to the end and once giving the injection/ pushing the plunger forward, liquid appeared to leak from or near the end. The pharmacist stated she disposed of the syringe in the sharps container and therefore is not able to provide pictures or return to Merck for investigation. Pharmacist stated she gave the patient a second dose (same lot/exp) due to partial dose being administered initially and is inquiring about credit. No further information provided. No other adverse events or product quality complaints reported. QUESTION SECTION: High Risk: Leaking Prior to Opening High Risk: Leaking during use from a site other than the product dispensing point Medium Risk: Leaking during use from the product dispensing point NOTE: Most MERCK prefilled syringes require a syringe needle to be attached to the hub or tip of the syringe using a Luer Lock attachment by the healthcare provider, which allows the needle to be twisted onto the tip and then locked in place. NOTE: Confirm that the syringe is not cracked or broken, including a broken or loose Luer Lock adaptor. If there is any sign of breakage, refer to the appropriate broken/cracked syringe article. Additionally, if there was difficulty attaching the syringe needle, and the leakage occurred at the syringe tip and syringe needle area of attachment, also refer to the Prefilled Syringe: Broken/Cracked Article. For syringes when the customer must attach a needle: Was the syringe needle attached to the syringe tip before the leaking occurred? YES If a needle was attached, was the needle able to be attached securely to the syringe? YES If no, describe what issue was encountered while attaching the needle? From where did the leaking occur? (Select one) From the tip of the Syringe Needle? NO From the tip of the Syringe? MAYBE Between the syringe hub/Luer lock and syringe needle? YES, POTENTIALLY, THE SYRINGE WAS SECURELY ATTACHED AND THE LIQUID WAS COMING OUT AS THE PLUNGER WAS BEING PUSHED Base of syringe where the plunger rod/stopper is located? NO Under what situation was this defect noticed: (select one) While the syringe was still in the tray? NO If yes, is there still product (liquid or residue) in the blister tray? NA After removing the syringe from the tray? NO While trying to attach the needle to the syringe? NO While pulling back on the plunger rod? NO While the plunger rod was being pushed forward? YES, WHILE GIVING INJECTION Did the plunger rod/stopper come completely or partially out of the syringe barrel while pulling back on the plunger rod? NO While giving the injection? YES After the injection was given? NO Is there anything that is visible that could explain why the leaking occurred? (e.g. cracked barrel, malformed stopper?etc.?) COULD NOT SEE CRACK OR ANY OTHER DEFECT AT TIME THAT WOULD INDICATE WHY THIS HAPPENED, SYRINGE WAS DISPOSED. Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES If photos are available, ask the customer to send them Retrieval Information: Expedited Return Obtain product (& tray if possible) NOTE: Vaccine Prefilled Syringes may be returned even if biohazardous. Sample Tracking Number: User's Experience: Repeat User Insertion Difficulty: Not Applicable Insertion Difficulty Details: Not Applicable Doubt About Presence: Not Applicable Doubt Details: Not Applicable Migration: Not Applicable Migration Details: Not Applicable Removal Problem: Not Applicable Removal Problem Details: Not Applicable 03-JUN-2022 15:30 PM: Attachment added to Service Cloud. Complaint Description Summary Caller is reporting some of the medication leaked out and was running down the patient's arm.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site extravasation
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 76,0
- Geschlecht
- F
- Eingang
- 18.04.2022
- Impfdatum
- 13.04.2022
- Beginn
- 13.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
C-reactive protein
Cellulitis
Differential white blood cell count
Erythema
Full blood count
Injection site erythema
Injection site pain
Injection site swelling
Metabolic function test
Pain
Pain in extremity
Peripheral swelling
Red blood cell sedimentation rate
Ultrasound Doppler
Symptomtext
11 p.m. 4/13: Itching; Pain; Swollen upper left arm muscle where vaccine was administered gradually symptoms spreading to include opposite side of upper arm; Red skin. 4/14: entire upper left arm swollen, red, with extreme pain in muscle when moving arm; 4/15: All previous symptoms now have spread several inches below left elbow and I go to the ER; DISGNOSED AT ER AS CELLULITIS AND GIVEN IV antibiotic prior to discharge.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- 4/15: C-reactive protein; CBC with Differential; comprehensive metabolic panel; Sed rate; Vascular Ult venous duplex
- Aktuelle Erkrankungen
- Ductal carcinoma (cancerous mass surgically removed on 3/1/22)
- Vorgeschichte
- Chronic Sacro-iliac pain; low back pain; osteoporosis
- Andere Medikamente
- Gabapentin; duloxetine; B vitamins; Calcium; D3; coQ10; vit. K; iron
- Allergien
- Opiate-related drugs; Darvon; Ultram; Codeine, etc.
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- F
- Eingang
- 14.03.2022
- Impfdatum
- 03.03.2022
- Beginn
- 07.03.2022
- Tage bis Beginn
- 4,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Injection site erythema
Injection site pruritus
Injection site warmth
Symptomtext
L UPPER ARM RED, ITCHY, WARM TO TOUCH
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- NO
- Aktuelle Erkrankungen
- NONE
- Vorgeschichte
- NONE
- Andere Medikamente
- NONE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AR
- Alter
- 69,0
- Geschlecht
- F
- Eingang
- 07.02.2022
- Impfdatum
- 07.02.2022
- Beginn
- 07.02.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Erythema
Pain in extremity
Skin warm
Swelling
Symptomtext
swelling, warm to the touch with red streaking down her arm, area painful
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pain in extremity
- Hospital-Tage
- -
- Labordaten
- ER visit 2/3/22
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- hypothyroidism depression prediabetes
- Andere Medikamente
- none
- Allergien
- Sulfa
- Vorherige Impfungen
- -
- Staat
- MN
- Alter
- 66,0
- Geschlecht
- M
- Eingang
- 17.12.2021
- Impfdatum
- 11.12.2021
- Beginn
- 11.12.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Fatigue
Malaise
Vaccination site erythema
Vaccination site pain
Vaccination site swelling
Symptomtext
Approx 8 hours after vaccination arm became red, swollen, painful to the touch from mid deltoid muscle down to the elbow. Systemic affects were fatigue and malaise for 24 hours. Arm Reaction reached is worse about 18 hours after vaccination and then gradually subsided and completely gone after 7 days.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Fatigue
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 59,0
- Geschlecht
- F
- Eingang
- 12.12.2021
- Impfdatum
- 07.12.2021
- Beginn
- 08.12.2021
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Hypersensitivity
Injection site erythema
Injection site inflammation
Injection site irritation
Symptomtext
pt came to pharmacy with redand irritated injection site from pneumovax 23 vaccination 12/7/21. it was healing and looking better per pt but states red and inflamed almost like allergic reaction.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- na
- Vorgeschichte
- na
- Andere Medikamente
- omeprazole, escitalopram, bupropion, trazodone, lamotrigine, tramadol, metoprolol
- Allergien
- sulfa ( bactrim)
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 3,0
- Geschlecht
- F
- Eingang
- 13.02.2023
- Impfdatum
- 09.02.2023
- Beginn
- 09.02.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Expired product administered
No adverse event
Symptomtext
Patient was given a dose that had expired on 01/14/2023
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- No adverse event
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- -
- Geschlecht
- U
- Eingang
- 25.01.2023
- Impfdatum
- 18.01.2023
- Beginn
- 18.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
No additional AEs/no PQCs; HCP reporting that a patient was administered an expired dose of PNEUMOVAX 23 on 01/18/2023. No further information was provided. Consent to contact HCP was provided. No additional AEs/no PQCs.; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concomitant medications, previous drug reactions, and allergies were not provided. On 18-JAN-2023, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) injection as prophylaxis (lot number U022819 has been verified to be valid; expiration date reported and established as 14-JAN-2023) (expired product administered) (strength, dose, route of administration, and anatomical location were not provided). No additional adverse event was reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- SC
- Alter
- 55,0
- Geschlecht
- M
- Eingang
- 23.01.2023
- Impfdatum
- 19.01.2023
- Beginn
- 19.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Expired product administered
Symptomtext
Vaccine given on 1/19/23, vaccine expired 1/14/23
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- Clindamycin Bactrim
- Vorherige Impfungen
- -
- Staat
- MS
- Alter
- 65,0
- Geschlecht
- F
- Eingang
- 19.10.2022
- Impfdatum
- 30.09.2022
- Beginn
- 05.10.2022
- Tage bis Beginn
- 5,0
- Dosis
- N/A
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
No adverse event
Symptomtext
None at this time have been reported
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- No known allergies
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- -
- Geschlecht
- U
- Eingang
- 18.07.2022
- Impfdatum
- 17.03.2022
- Beginn
- 17.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
No additional AE reported; PNEUMOVAX 23 was administered to the patient after the excursion occured; This spontaneous report was received from a registered nurse and referred to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 17-MAR-2022, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot #U022819, expiration date: 14-JAN-2023) for prophylaxis (strength, dose and route of administration were not provided) (product storage error). It was reported that the suspect vaccine was exposure to a temperature of 0.8 degree Celsius for a time frame of 24 hours. There was previous temperature excursion. No additional adverse event was reported. This is one of the several reports reported by the same reporter. ; Sender's Comments: US-009507513-2206USA006770: US-009507513-2206USA006587: US-009507513-2206USA007094: US-009507513-2206USA006674: US-009507513-2206USA007098: US-009507513-2206USA007068:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.07.2022
- Impfdatum
- 22.03.2022
- Beginn
- 22.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
No additional AE reported; PNEUMOVAX 23 was administered to the patient after the excursion occured; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 22-MAR-2022, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot number U022819 with expiration date 14-JAN-2023 (dose, route, and anatomical location were not reported) for prophylaxis. The vaccination occurred after the temperature excursion occurred (product storage error). The pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was exposed to 1.4 degrees Celsius during 48 hours and it was reported that there were a previous temperature excursion. No additional adverse events were reported. ; Sender's Comments: US-009507513-2206USA006587: US-009507513-2206USA006770: US-009507513-2206USA007094: US-009507513-2206USA006674: US-009507513-2206USA007098: US-009507513-2206USA007068:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.07.2022
- Impfdatum
- 09.06.2022
- Beginn
- 09.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE; Caller is a HCP calling to report a TE for PNEUMOVAX 23.; This spontaneous report was received from a Registered nurse referring to a patient of an unknown age and gender. The patient's pertinent medical history, current conditions, drugs reactions or allergies and concomitant medication were not provided. On 09-JUN-2022, the patient was vaccinated with an improperly stored dose pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #U022819 with expiration date on 14-JAN-2023, administered for prophylaxis (strength, vaccination scheme frequency and , dose, route of administration and anatomical location were not provided). The administered vaccine experienced the temperature excursion of 0.2 degrees Celsius (C) for a time frame of 24 hours. There was a previous temperature excursion. No adverse events were reported. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-2206USA006587: US-009507513-2206USA006770: US-009507513-2206USA007094: US-009507513-2206USA007068: US-009507513-2206USA007098: US-009507513-2206USA006670: US-009507513-2206USA006731: US-009507513-2206USA007090: US-009507513-2206USA007045: US-009507513-2206USA006852: US-009507513-2206USA006952: US-009507513-2206USA007098: US-009507513-2206USA007059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.07.2022
- Impfdatum
- 11.04.2022
- Beginn
- 11.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE details.; Inbound call from HBP who stated PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion. No additional AE details or PQC. Names of vaccines involved (including lot/exp) PNEUMOVAX 23 U022819 01/14/2023; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies or concomitant therapies was provided. On 11-APR-2022, the patient was inadvertently administered pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #U022819, expiration date: 14-JAN-2023, strength, dose and route of administration were not provided) for prophylaxis after a non-supported temperature excursion (Incorrect product storage). The vaccine involved was stored at 7 degrees Fahrenheit (F) for 96 hours. There was no previous temperature excursion reported. No additional adverse event.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 09.07.2022
- Impfdatum
- 13.04.2022
- Beginn
- 13.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No adverse event; Inbound call from HBP who stated PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion. No additional AE details or PQC.; This spontaneous report was received from a office manager, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided. On 13-APR-2022, the patient was inadvertently administered pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# U022819, expiration date 14-JAN-2023; formulation, strength, dose, frequency and route were not provided) for prophylaxis after a non-supported temperature excursion (product storage error). The storage temperature of the vaccine was 70 degrees Fahrenheit for a time frame of 96 hours. There was no previous temperature excursions. No additional adverse events (AEs) or product quality complaint (PQC) reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- -
- Geschlecht
- U
- Eingang
- 06.07.2022
- Impfdatum
- 09.03.2022
- Beginn
- 09.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE reported; During the evaluation the customer reported that the PNEUMOVAX 23 was administered to the patient after the excursion occured.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, past drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 09-MAR-2022, the patient was vaccinated with improperly stored and administered dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, (valid lot #U022819, expiration date: 14-JAN-2023) (strength, dose, frequency and route of administration were not reported) for prophylaxis. The temperature was 0.1 Celsius degrees during 24 hours. Additionally, a previous temperature excursion was reported. No additional adverse events (AE) were reported. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-2206USA006587: US-009507513-2206USA007068: US-009507513-2206USA007098: US-009507513-2206USA007094:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- -
- Geschlecht
- U
- Eingang
- 03.07.2022
- Impfdatum
- 18.03.2022
- Beginn
- 18.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
PNEUMOVAX 23 was administered to the patient after the excursion occured; No additional Adverse Event reported; This spontaneous report has been received from a registered nurse, concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided. On 18-MAR-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot number U022819 which was determined to be valid with expiration date 14-JAN-2023, for prophylaxis, after a temperature excursion of 0 degrees Celsius (C) for a time frame of 24 hours (product storage error) (dose, vaccination scheme, and frequency were not provided). Additionally, a previous temperature excursion was reported. No additional adverse events (AE) were reported. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-2206USA006770: US-009507513-2206USA006587: US-009507513-2206USA007068: US-009507513-2206USA007098:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- -
- Geschlecht
- U
- Eingang
- 03.07.2022
- Impfdatum
- 11.04.2022
- Beginn
- 11.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
No additional AE reported; Caller is a HCP calling to report a TE for PNEUMOVAX 23.; This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided. On 11-APR-2022, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot number U021995 has been verified to be a valid lot number, expiration date: 13-JAN-2023) (strength, dose, frequency, and vaccination scheme were not provided) (product storage error) administered for prophylaxis. The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was stored at a temperature of 0.7 Celsius (C) for a time frame of 24 hours. There was a previous temperature excursion. No additional adverse events were reported. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-2206USA007094: US-009507513-2206USA006587: US-009507513-2206USA006674: US-009507513-2206USA006670: US-009507513-2206USA006731: US-009507513-2206USA007090: US-009507513-2206USA006981: US-009507513-2206USA007045: US-009507513-2206USA006852: US-009507513-2206USA007070: US-009507513-2206USA007098: US-009507513-2206USA006952: US-009507513-2206USA007059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- -
- Geschlecht
- U
- Eingang
- 03.07.2022
- Impfdatum
- 23.03.2022
- Beginn
- 23.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE reported; Caller is a HCP calling to report a TE for PNEUMOVAX 23. During the evaluation the customer reported that the PNEUMOVAX 23 was administered to the patient after the excursion occured. Additional AE filed in 02190216, 02190130, 02190106, 02190106, 021; This spontaneous report has been received from a healthcare worker regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported. On 23-MAR-2022, the patient was vaccinated with improperly stored doses of pneumococcal vaccine, polyvalent (23-valent) lot number U022819 with expiration date on 14-JAN-2023 for prophylaxis (dose, route of administration, strength and anatomical location not reported). The pneumococcal vaccine, polyvalent (23-valent) was stored at a temperature of 1.4 degrees Celsius (?C) for the time frame of 24 hours. No additional adverse effects reported. ; Sender's Comments: US-009507513-2206USA006770: US-009507513-2206USA007068: US-009507513-2206USA007098:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 79,0
- Geschlecht
- F
- Eingang
- 30.06.2022
- Impfdatum
- 28.06.2022
- Beginn
- 29.06.2022
- Tage bis Beginn
- 1,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Erythema
Peripheral swelling
Skin warm
Symptomtext
Patient received Pneumovax23 on 6/28/22, she states that her arm became swollen, red, and hot starting on the morning of 6/29/22 (the next day). On 6/30/22 she saw her doctor and was prescribed Sulfamethoxazole/trimethoprim to treat the symptoms, which she picked up and is currently taking.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- Penicillin, Ciprofloxacin
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.06.2022
- Impfdatum
- 15.03.2022
- Beginn
- 15.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
No additional AE reported; the PNEUMOVAX 23 was administered to the patient after the excursion occurred; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported. On 15-MAR-2022, the patient was vaccinated with improper stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot #U022819, expiration date: 14-JAN-2023 (dose, and route of administration were not provided), administered for prophylaxis (Product storage error). The administered dose of the vaccine experienced a temperature excursion in 1.7 degrees Celsius for 24 hours. There was previous temperature excursion. No additional adverse event (AE) reported. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-2206USA006587: US-009507513-2206USA006432: US-009507513-2206USA006670: US-009507513-2206USA006674: US-009507513-2206USA006731: US-009507513-2206USA006852: US-009507513-2206USA006952: US-009507513-2206USA006981: US-009507513-2206USA007045: US-009507513-2206USA007059: US-009507513-2206USA007068: US-009507513-2206USA007070: US-009507513-2206USA007090: US-009507513-2206USA007094: US-009507513-2206USA007098:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.06.2022
- Impfdatum
- 11.04.2022
- Beginn
- 11.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
No additional AE details or PQC.; PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion; This spontaneous report as received from a healthcare business, referring to a patient of unknown age and gender. The patient's pertinent medical history, current condition, previous drug reaction or allergy, and concomitant medication were not reported. On 11-APR-2022, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection (strength, dose, route of administration and anatomical site of vaccination were not reported, lot number U022819, expiration date reported and validated as 14-JAN-2024) for prophylaxis (product storage error). The vaccine was exposed to the temperature excursions: 70 degrees Fahrenheit for 96 hours. There was no previous temperature excursion. No additional adverse event details.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- -
- Geschlecht
- U
- Eingang
- 25.06.2022
- Impfdatum
- 08.03.2022
- Beginn
- 08.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE; Caller is a HCP calling to report a TE for PNEUMOVAX 23.; This spontaneous report has been received from a registered nurse, concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided. On 08-MAR-2022, the patient was administered vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (valid lot number U022819 [expiration date 14-JAN-2023]) for prophylaxis, after a temperature excursion of 0.5 degrees Celsius (C) for 24 hours (product storage error) (dose, vaccination scheme, and frequency were not provided). Additionally, a previous temperature excursion was reported. No additional adverse events (AE) were reported. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-2206USA007070: US-009507513-2206USA006852: US-009507513-2206USA007090: US-009507513-2206USA006674: US-009507513-2206USA006674: US-009507513-2206USA006670: US-009507513-2206USA006731: US-009507513-2206USA006770: US-009507513-2206USA006952: US-009507513-2206USA006981: US-009507513-2206USA007045:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- -
- Geschlecht
- U
- Eingang
- 25.06.2022
- Impfdatum
- 07.03.2022
- Beginn
- 07.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
No additional AE reported; During the evaluation the customer reported that the PNEUMOVAX 23 was administered to the patient after the excursion occured.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided. On 07-MAR-2022, the patient was vaccinated with improperly stored (product storage error) dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis. Temperature excursion information: temperature 1.5 degree Celsius, timeframe 24 hours. There was no previous temperature excursion. There was no additional adverse event reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 25.06.2022
- Impfdatum
- 11.04.2022
- Beginn
- 11.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
No additional AE details; PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 11-APR-2022, the patient was inadvertently vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #U022819, expiration date: 14-JAN-2023 (strength, dose, site, and route of administration were not provided) administered for prophylaxis, after a non-supported temperature excursion (product storage error). Vaccine was improperly stored for 96 hours in temperature of 70 Fahrenheit degrees. There were no previous excursions. It was not reported whether the digital data logger was involved to capture the temperature excursion. No additional adverse events details or product quality complaints were reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 22.06.2022
- Impfdatum
- -
- Beginn
- 11.04.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE details are available; Inbound call from HBP who stated PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion. No additional AE details or PQC. Names of vaccines involved (including lot/exp) PNEUMOVAX 23 U022819 01/14/2023; This spontaneous report was received from a non health professional and refers to a patient of unknown age and gender. The patient's pertinent medical history, previous drug allergies or reactions, concurrent conditions, and concomitant medications were not provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot number U022819, expiration date reported as 14-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided), after a non-supported temperature excursion (product storage error). No additional adverse event was reported.The temperature excursion reported was of 70 degrees Fahrenheit for 90 hours. No previous temperature excursion.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 17.06.2022
- Impfdatum
- 13.04.2022
- Beginn
- 13.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE details; PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion; This spontaneous report was received from a healthcare business professional (HBP, also reported as office manager) and refers to a patient of unknown gender and age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 13-APR-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe, lot number: U022819, expiration date: 14-JAN-2023, administered for prophylaxis (dose, strength, and route of administration were not provided). Vaccine was improperly stored in temperature of 70 F for 96 hours (product storage error). There was no previous temperature excursion. No additional adverse event was reported (no adverse event).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 14.06.2022
- Impfdatum
- 12.04.2022
- Beginn
- 12.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
No additional AE details or PQC.; Inbound call from HBP who stated PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion; This spontaneous report was received from a healthcare business professional (HBP) referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concomitant medications, concurrent conditions and drug reactions/ allergies was not provided. On 12-APR-2022, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) pre-filled syringe, lot number: U022819, expiration date: 14-JAN-2023 (dose, dose number, route of administration and anatomical location was not reported) for prophylaxis (product storage error). No additional adverse event (AE) details or product quality complaint (PQC) was reported (no adverse event). The administered dose of the vaccine experienced a non-supported temperature excursion of 70 degrees Fahrenheit for 96 hours. There were no previous reported temperature excursions. It was unknown, whether a digital data logger was involved.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 14.06.2022
- Impfdatum
- 11.04.2022
- Beginn
- 11.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE details or PQC; PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion; This spontaneous report was received from a healthcare business professional (HBP) and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided. On 11-APR-2022, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe, lot # U022819, expiration date 14-JAN-2023, for prophylaxis (exact dose, route of administration and anatomical site were not provided). Vaccine was improperly stored for 96 hours in temperature of 70 F (Product storage error). Data logger was not used to capture the temperature excursion. There was no previous temperature excursion. No additional adverse event or product quality complaint was provided (No adverse event).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 82,0
- Geschlecht
- F
- Eingang
- 31.05.2022
- Impfdatum
- 31.05.2022
- Beginn
- 31.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Wrong patient
Symptomtext
When I called the right Pt's name, the wrong Pt came and when I asked if her birthdate was the right Pt's, wrong patient responded yes. I gave her the immunization. Then realized it was the wrong Pt when the desk person told me the right Pt was still waiting in the lobby. Error was reported to my immediate supervisor, spoke with Pt's physician, Health Department was called, and Pt was called. Pt reported no problems/health issues.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong patient
- Hospital-Tage
- -
- Labordaten
- None required. As Health Department RN stated, "Patient now has extra protection."
- Aktuelle Erkrankungen
- no other illness at time of vaccine, Pt in clinic for weight check.
- Vorgeschichte
- HTN, A-fib, glaucoma, bilateral tinnitus, abnormal WBC, thyroid disease, Leukocytosis, hyperlipidemia
- Andere Medikamente
- atenolol, antivert, ASA, metforman, zocor, losartan potassium, etc.
- Allergien
- codeine sulfate, sulfacetamide sodium
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 67,0
- Geschlecht
- F
- Eingang
- 16.02.2022
- Impfdatum
- 31.01.2022
- Beginn
- 31.01.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Inappropriate schedule of product administration
Symptomtext
First pneumovax 23 given in 2020, re-administration of a second dose on 1/31/2022
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- hypertension, hyperlipidemia, hypothyroid, obesity
- Andere Medikamente
- -
- Allergien
- nkda
- Vorherige Impfungen
- -