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Reporte zur Charge U028164

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

27Reporte angezeigt
0Todesfaelle
1Hospitalisiert
1Lebensbedrohlich
0Bleibende Schaeden
CA 5 NY 3 WA 2 MI 2 NJ 2 AZ 2 MT 1 SC 1 WY 1 MN 1 ID 1 KY 1

VAERS 2444847

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

schwer
Staat
MT
Alter
1,0
Geschlecht
F
Eingang
14.09.2022
Impfdatum
24.05.2022
Beginn
25.05.2022
Tage bis Beginn
1,0
Dosis
1
Route/Site
UN / RL
Tod: unbekannt Lebensbedrohlich: ja Hospital: ja Disable: unbekannt ER: ja Erholt: nein
Blood test Electroencephalogram abnormal Lethargy Pyrexia Rash Seizure

Symptomtext

5/25/22 at 3:30am first witnessed seizure, fever 106 -> parents took private vehicle to Emergency room. 4:00am patient received Tylenol in ER and still lethargic and discharged home. 5:00am patient home. Motrin given 7:00am, 7:15am second seizure witnessed. 7:45 ambulance arrived and transported patient back to the emergency room. Patient had another seizure in route to the hospital witnessed by parent. Patient had fever 104.6 in ER and lethargic. Patient sent by private vehicle to hospital for an EEG. Then patient returned back and was observed overnight at ER. 5/26/2022 a rash appeared all over patients abdomen, face, partial down legs. 5/27/2022 another doctor appointment and no fever present. 5/30-31/2022 Rash started to resolve. Referred to Pediatric neurologist. Another EEG was preformed.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Seizure
Hospital-Tage
1,0
Labordaten
5/25/22 - EEG (abnormal) and blood work Second EEG - unknown date was within normal range
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 2558742

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

mild
Staat
SC
Alter
1,3
Geschlecht
M
Eingang
12.01.2023
Impfdatum
09.01.2023
Beginn
10.01.2023
Tage bis Beginn
1,0
Dosis
UNK
Route/Site
SC / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site erythema Injection site pain Injection site swelling

Symptomtext

Patient had to get vaccines 3 on left thigh and 3 on right thigh on 1/9/2023. Pt was getting 6 vaccines due to missing the 12 month vaccines. Had reaction on 1/10/2023 was seen again on 1/10/23. Reaction on both right and left thigh consisted of redness swelling and pain. Treatment on 1/10/2023 to give ibuprofen as needed and apply warm compresses. Mom called again on 1/11/20233 said reaction getting worse on both thighs. There is more redness and swelling. Provider ordered antibiotic and child will be seen again on 1/13/2023. Unknown which vaccines reacted due to patient having 6.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2426550

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

mild
Staat
WY
Alter
42,0
Geschlecht
F
Eingang
01.09.2022
Impfdatum
30.08.2022
Beginn
31.08.2022
Tage bis Beginn
1,0
Dosis
2
Route/Site
SC / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site erythema Injection site pain Injection site pruritus Injection site swelling Urticaria

Symptomtext

Redness, swelling, welt at injection site that appeared about 24 hours after injection. Welt is hot to touch and itchy and painful.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2405756

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

mild
Staat
MN
Alter
1,0
Geschlecht
F
Eingang
09.08.2022
Impfdatum
09.08.2022
Beginn
09.08.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
SC / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Injection site erythema Injection site swelling Laboratory test

Symptomtext

swelling/redness at sight was in lab they sent her over to the ER. Dr who she had seen for a well child that day was notified and went and checked on patient as well as the RN. Patient and mother were brought back up to clinic and monitored for about 30 mins longer. RN drew labs. Provider said patient was just fine and well. Patient left with mother.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
n/a
Aktuelle Erkrankungen
n/a
Vorgeschichte
n/a
Andere Medikamente
Patient had Fluoride Varnish 5% administered on teeth prior to vaccinations
Allergien
n/a
Vorherige Impfungen
-

VAERS 2369505

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge u028164

mild
Staat
WA
Alter
1,0
Geschlecht
F
Eingang
14.07.2022
Impfdatum
13.07.2022
Beginn
14.07.2022
Tage bis Beginn
1,0
Dosis
1
Route/Site
SC / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Rash

Symptomtext

Developed rash on the morning of 7/14 that spread all over body throughtout the day.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Rash
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
41 days in NICU- 31 6/7 weeker w/ IUGR and ASD Eye conditions/corrective lenses: 7/2021- ROP stage 1, no PLUS disease Macrocephaly
Andere Medikamente
none noted on chart
Allergien
none noted on chart
Vorherige Impfungen
-

VAERS 2347514

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

mild
Staat
MI
Alter
1,0
Geschlecht
M
Eingang
01.07.2022
Impfdatum
20.06.2022
Beginn
28.06.2022
Tage bis Beginn
8,0
Dosis
1
Route/Site
SC / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Pyrexia

Symptomtext

>>MESSAGE (06/30/22 09:50 AM): >> Mom called and stated pt. received vaccines last week. He developed a fever on Tuesday. Tmax 104.4, but stays around 100-101 with motrin and tylenol. She was wondering whether the MMR would cause this. I spoke w/ Dr. and reviewed this online and per website "around 7 to 11 days after the injection, babies or young children may feel a bit unwell or develop a high temperature for about 2 or 3 days." Dr. recommended a covid test to be sure and to monitor for other symptoms in case it is not a vaccine reaction. Relayed this to mom and advised her to call us tomorrow if the fever has not broken. I spoke w/ mom on 7/1/22 and she stated pt.'s fever has come down to 100.3 without Tylenol or Motrin. Advised to continue to monitor. If his fever resumes or he begins not feeling well over the weekend, advised to contact our after-hours line for further instruction.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
-
Labordaten
Requested patient's mother administer a covid test to be sure this wasn't the source of the fever. Unsure if she completed this.
Aktuelle Erkrankungen
Ear pain and penile adhesions
Vorgeschichte
None
Andere Medikamente
None
Allergien
NKA
Vorherige Impfungen
-

VAERS 2318853

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

mild
Staat
WA
Alter
4,0
Geschlecht
M
Eingang
14.06.2022
Impfdatum
13.06.2022
Beginn
13.06.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
SC / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Urticaria

Symptomtext

Hives started within minutes of patient receiving the vaccines. Patient was given prednisone in office and monitored before being sent home.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Urticaria
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 2667833

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

gering
Staat
ID
Alter
0,6
Geschlecht
M
Eingang
08.08.2023
Impfdatum
14.06.2023
Beginn
14.06.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product storage error

Symptomtext

No further AE details provided; VARIVAX was administered after a TE; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported. On 20-JUN-2023, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliters once as prophylaxis (W024552, which was determined to be valid, with an expiration date on 31-JAN-2024) (strength, route of administration and anatomical location of administration were not reported), in combination with a sterile diluent. The administered dose underwent a temperature excursion via digital data logger of 12.84 degrees Fahrenheit for 25 minutes. There was a no previous temperature excursion reported. No further adverse event details provided. Follow-up information has been received from the nurse on 25-JUL-2023. This case has been become valid as concerns to a 7-month-old male patient. On 22-MAY-2023, the freezer door was opened for scraping ice off-sides, but the door was left open too long. Then, temperature excursion occurred and was improperly stored. Consequently, it was confirmed that the 7-month-old child was vaccinated on 14-JUN-2023, with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U028164 with expiration date 09-SEP-2023) administered subcutaneously in the left tight for prophylaxis. The vaccine was used according to the instruction leaflet. It was reported that the patient was given the vaccinate without reporting to the manufacturer to verify if the vaccine was safe to use. On 11-JUL-2023, the vaccine was properly reported to the manufacturer with temperature excursion; however. The vaccine was no available for return/evaluation. Manufacturer reported that the vaccine was safe to use. The child received the last dose of the vaccine in stock at that time and no other stock was administered. The patient had not had medical events occurred due to the administered vaccine. This temperature excursion did not occur as a result of a reading from a digital data logger. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-2307USA002368: US-009507513-2307USA002154: US-009507513-2308USA001000:

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2479161

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

gering
Staat
NJ
Alter
-
Geschlecht
U
Eingang
15.10.2022
Impfdatum
12.08.2022
Beginn
12.08.2022
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 adverse event reported; Caller is a pharmacist calling to report that improperly stored doses of RECOMBIVAX HB and VARIVAX were administered to the patient on 12AUG2022. No additional information provided. No additional AE reported. No PQC reported. RECOMBIVAX HB- lot U; This spontaneous report has been received from a pharmacist, concerning a patient of unknown age and gender. The patient{s medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided. On 12-AUG-2022, the patient was vaccinated with an improperly stored hepatitis B vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) (lot number U008328 has been verified to be valid; expiration date reported and established as 16-DEC-2022), and varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U028164 has been verified to be valid; expiration date reported and established as 09-SEP-2023) for prophylaxis (doses, vaccination schemes, routes of administration, and anatomical locations were not provided). The administered dose of hepatitis B vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) was stored at a temperature of 48.79 degrees Fahrenheit (F), during a time frame of 2 hours and 43 minutes (conflicting information also reported as 22.87 F during a time frame of 3 hours and 36 minutes), and for varicella virus vaccine live (Oka/Merck) (VARIVAX) a temperature of 33.13 F was reported during a time frame of 14 hours and 55 minutes. No additional temperature excursion were reported for neither of the vaccines. No additional adverse event was reported.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2474321

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

gering
Staat
NJ
Alter
-
Geschlecht
U
Eingang
11.10.2022
Impfdatum
05.08.2022
Beginn
05.08.2022
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.; Improperly stored doses of RECOMBIVAX HB and VARIVAX were administered to the patient.; This spontaneous report has been received from a pharmacist referring a patient of unknown age and gender. The patient's concurrent conditions, medical history,drugs reactions or allergies and concomitant medications not reported. On 05-AUG-2022, the patient was vaccinated with improperly stored doses of hepatitis B vaccine (recombinant)thimerosal-free (RECOMBIVAX HB) intramuscular injection, vial, lot number U008328 with expiration date: 16-DEC-2022 and with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous Injection, lot number U028164 with expiration date: 09-SEP-2023, both of them administered for prophylaxis (strengths,doses, frequencies, routes of administration and anatomical sites of application were not provided) (product storage error). The hepatitis B vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) had temperature excursion between 48.79 F for 2 hours and 43 minutes and 22.87 F for 3 hours and 36 minutes. Also, varicella virus vaccine live (oka/merck) (VARIVAX) had temperature excursion between 33.13 F for 14 hours and 55 minutes. It was reported that there were no previous temperature excursions. No additional adverse event reported.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product storage error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2472984

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

gering
Staat
AZ
Alter
-
Geschlecht
M
Eingang
10.10.2022
Impfdatum
28.07.2022
Beginn
28.07.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Inappropriate schedule of product administration No adverse event Overdose

Symptomtext

No additional AE reported.; concomitant administration of PROQUAD and VARIVAX to a patient on 7/28/2022; concomitant administration of PROQUAD and VARIVAX to a patient on 7/28/2022; This spontaneous report was received from a nurse and referred to a 12-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-JUL-2022, the patient was administered concomitantly with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot #U028164, expiration date: 09-SEP-2023; dose, strength and route were unknown) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (lot #U028178, expiration date: 08-MAR-2023; dose, strength and route were unknown) for prophylaxis (Overdose; Inappropriate schedule of product administration). No additional AE reported. No product quality compliant (PQC) reported.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Inappropriate schedule of product administration
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2455525

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

gering
Staat
NY
Alter
-
Geschlecht
U
Eingang
23.09.2022
Impfdatum
-
Beginn
31.08.2022
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

Confirmed with caller no other AE occurred; Customer reported an AE for VARIVAX and MMRII. The caller said these products were administered to the patient after two temperature excursions occurred; This spontaneous report has been received from a consumer concerning a patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, two temperature excursions occurred for varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) with a temperature of 5.9 and 8.8 degrees Celsius, for a time frame of 10 and 8 hours. No previous temperature excursions were reported. On 31-AUG-2022, the patient was administered varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot # U028164, expiration date 09-SEP-2023; and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) 1 dose, lot # U019291 expiration date 18-JUN-2023 (route of administration and anatomical location were not provided) both as prophylaxis (product storage error). No other events were reported (no adverse event).; Sender's Comments: US-009507513-2209USA003954: US-009507513-2209USA004005:

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2452932

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

gering
Staat
NY
Alter
-
Geschlecht
U
Eingang
21.09.2022
Impfdatum
02.09.2022
Beginn
02.09.2022
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 other adverse events occurred; The caller said these products were administered to the patient after two temperature excursions occurred.; This spontaneous report was received from a consumer concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-SEP-2022, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, lot #U019291, expiration date: 18-JUN-2023 (strength, and route of administration were not provided); and 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U028164, expiration date: 09-SEP-2023 (strength, and route of administration were not provided), both administered as prophylaxis. The reporter stated that the vaccines experienced two temperature excursions at a temperature of 5.9 Celsius degrees (C) for 10 hours and 8.8C for 8 hours (Product storage error). There were no previous temperature excursions and no other adverse events reported. This is one of three reports received from the same source.; Sender's Comments: US-009507513-2209USA003954: US-009507513-2209USA004041:

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2451754

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

gering
Staat
NY
Alter
-
Geschlecht
U
Eingang
20.09.2022
Impfdatum
02.09.2022
Beginn
02.09.2022
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 other adverse event occurred; Customer reported an AE for VARIVAX and MMRII. The caller said these products were administered to the patient after two temperature excursions occurred. Confirmed with caller no other AE occurred. Caller did not specify if she could be contacted. AE; This spontaneous report was received from a consumer concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-SEP-2022, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, lot #U019291, expiration date: 18-JUN-2023, (strength, and route of administration were not provided); and 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U028164, expiration date: 09-SEP-2023, (strength, and route of administration were not provided), both administered as prophylaxis. The reporter stated that the vaccines were administered to the patient after two temperature excursions at a temperature of 5.9 Celsius degrees (C) for 10 hours, and 8.8C for 8 hours (product storage error). There were no previous temperature excursions and no other adverse events reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-2209USA004041:

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2447834

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

gering
Staat
AZ
Alter
1,0
Geschlecht
M
Eingang
16.09.2022
Impfdatum
28.07.2022
Beginn
01.07.2022
Tage bis Beginn
-
Dosis
1
Route/Site
SC / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Extra dose administered No adverse event Product administration error

Symptomtext

The child was accidently given 2 doses of Varicella. Proquad and a dose of Varicella was inadvertently administered to the patient during the well child visit. The error was discovered during a audit by pharmacy

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
N/A the parent does not report any effects from the extra dose.
Aktuelle Erkrankungen
N/A
Vorgeschichte
N/A
Andere Medikamente
None
Allergien
N/A
Vorherige Impfungen
-

VAERS 2439320

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

gering
Staat
CA
Alter
-
Geschlecht
U
Eingang
10.09.2022
Impfdatum
-
Beginn
19.08.2022
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect route of product administration No adverse event Product storage error

Symptomtext

No additional AEs; Caller reported vaccines administered after temperature excursio; the vaccines were administered IM (instead of SQ}.; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 19-AUG-2022, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot #U028164, expiration date: 09-SEP-2023; and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, 0.5 ml, lot #U006596, expiration date: 01-MAR-2023 (vaccination schedules were not provided) both administered intramuscularly for prophylaxis (Product storage error, Incorrect route of product administration). The vaccines were stored in 32.9 Fahrenheit degrees (F) in a time frame of 28 hours and 39 minutes. It was reported the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was stored within recommended range for this reported excursion. The vaccines had undergone previous excursion in 20.7 F in a time frame of 32 hours and 10 minutes. No additional adverse events were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2208USA008668:dpoc# 02231010 US-009507513-2208USA010122:dpoc# 02231010 US-009507513-2208USA009718:dpoc# 02231010 US-009507513-2208USA008558:dpoc# 02231010

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect route of product administration
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2426122

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

gering
Staat
CA
Alter
-
Geschlecht
U
Eingang
10.09.2022
Impfdatum
16.08.2022
Beginn
16.08.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect route of product administration No adverse event Product storage error

Symptomtext

No additional AEs; Caller reported vaccines administered after temperature excursion. Caller also unable to provide information on prior temperature excursions. During data collection- Caller reported the vaccines were administered IM (instead of SQ). No additional; Vaccines were administered IM (instead of SQ); This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not reported. On 16-AUG-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX)at a dose of 0.5 ml lot #U028164, expiration date: 09-SEP-2023, administered intramuscularly instead of subcutaneously (incorrect route of administration) for prophylaxis following a temperature excursion of 32.9 degrees Fahrenheit for 28 hours and 39 minutes (product storage error), it was stated that previous temperature excursions did occurred. No additional adverse event was reported. This is one of several case from the same reporter.; Sender's Comments: US-009507513-2208USA008668: US-009507513-2208USA010122: US-009507513-2208USA008558:

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect route of product administration
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2426119

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

gering
Staat
CA
Alter
-
Geschlecht
U
Eingang
01.09.2022
Impfdatum
17.08.2022
Beginn
17.08.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect route of product administration No adverse event Product storage error

Symptomtext

No additional AEs; the vaccines were administered IM (instead of SQ).; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender. Information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies was not provided. On 17-AUG-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) as prophylaxis (lot number U006596 has been verified to be valid, expiration date reported and established as 01-MAR-2023) 0.5 milliliters (ml) administered intramuscularly (IM) instead of subcutaneously (incorrect route of product administration). It was reported that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) was stored within recommended temperature range. No additional adverse events were reported (no adverse event). The patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (case # 2208USA008558). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2208USA008668: US-009507513-2208USA009718: US-009507513-2208USA008558: US-009507513-2208USA008497: US-009507513-2208USA008503: US-009507513-2208USA008699:

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect route of product administration
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2421804

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

gering
Staat
CA
Alter
-
Geschlecht
U
Eingang
27.08.2022
Impfdatum
15.08.2022
Beginn
15.08.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect route of product administration Product storage error

Symptomtext

no adverse event; vaccines administered after temperature excursion.; es were administered IM (instead of SQ).; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unspecified date in 2022, doses of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U028164, expiration date: 09-SEP-2023; and doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) lot #U006596, expiration date: 01-MAR-2023 underwent a temperature excursion of 32.9 fahrenheit degrees during 28 hours and 39 minutes with previous temperature excursions. On 15-AUG-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #U028164, expiration date: 09-SEP-2023, administered intramuscularly (Subcutaneous injection formulation administered by other route) (strength, dosage regimen, and anatomical location were not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) 0.5 milliliter, lot #U006596, expiration date: 01-MAR-2023, administered intramuscularly (Subcutaneous injection formulation administered by other route) (strength , dosage regimen, and anatomical location were not provided) as prophylaxis. No adverse event was reported. This is one of several cases reported by the same reporter.; Sender's Comments: US-009507513-2208USA008558: US-009507513-2208USA008497: US-009507513-2208USA008503: US-009507513-2208USA008699:

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect route of product administration
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2421802

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

gering
Staat
CA
Alter
-
Geschlecht
U
Eingang
27.08.2022
Impfdatum
16.08.2022
Beginn
16.08.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect route of product administration No adverse event Product storage error

Symptomtext

No additional AEs; Caller reported vaccines administered after temperature excursio; the vaccines were administered IM (instead of SQ); This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 16-AUG-2022, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot #U028164, expiration date: 09-SEP-2023 (vaccination schedule was not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, 0.5 ml, lot #U006596, expiration date: 01-MAR-2023 (vaccination schedule was not provided), both administered intramuscularly instead of subcutaneously for prophylaxis (Product storage error, Incorrect route of product administration). The vaccines underwent temperature excursion in 32.9 degrees Fahrenheit (F) in a time frame of 28 hours and 39 minutes. It was reported measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) was stored within recommended temperature range, however the vaccines underwent previous temperature excursion, for which reporter was unable to provide data. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2208USA008668:dpoc# 02230999 US-009507513-2208USA008497: US-009507513-2208USA008558: US-009507513-2208USA008699:

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect route of product administration
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2416620

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

gering
Staat
KY
Alter
1,0
Geschlecht
U
Eingang
20.08.2022
Impfdatum
25.07.2022
Beginn
25.07.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Inappropriate schedule of product administration No adverse event

Symptomtext

No other issues or concerns noted.; Customer calling to report that PROQUAD and VARIVAX were administered at the same time. No PQC. No other information provided. No other issues or concerns noted. PROQUAD: LOT: W007748 EXP: 7/4/2022 VARIVAX: LOT: U028164 EXP: 9/9/2023 ADMIN ON:; This spontaneous report was received from a medical assistant concerning to a 12-month-old patient with unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The reporter calling to report that on 25-JUL-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot # W007748, and expiration date: 04-SEP-2023, since it matched the autopopulated expiration date (strength and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U028164 and expiration date: 09-SEP-2023, since it matched the autopopulated expiration date (strength and route of administration were not provided) at the same time as a prophylaxis. No other information provided. No other issues or concerns noted.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Inappropriate schedule of product administration
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2364318

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (OTHER) · Charge U028164

gering
Staat
-
Alter
1,0
Geschlecht
M
Eingang
11.07.2022
Impfdatum
21.06.2022
Beginn
21.06.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Wrong product administered

Symptomtext

Patient was in for his 12 month well exam with Dr. He was to be given MMR, Varicella, and HIB per Dr. CMA got a Proquad, Varicella, and HIB. She did not follow the correct process to pre document prior to giving vaccines and administered the incorrect vaccines. Because of this patient received two doses of the Varicella vaccine. Proquad was also given and has increased risk for fever and seizures in this age group.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2359158

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

gering
Staat
HI
Alter
1,0
Geschlecht
U
Eingang
06.07.2022
Impfdatum
22.06.2022
Beginn
22.06.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Accidental overdose No adverse event

Symptomtext

No additional AE reported; Student medical assistant reports that a 12 month old patient was accidently administered both VARIVAX and PROQUAD on Jun 22. 2022.; This spontaneous report has been received from a student medical assistant concerning a 12-month-old patient of unknown gender. The concomitant medications, medical history, drug reactions or allergies, and concurrent conditions were not reported. On 22-JUN-2022, the patient was accidently administered both measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) lot # U030590, expiration date 29-MAR-2023 (strength, dose, route of administration and anatomical location were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) lot # U028164, expiration date 09-SEP-2023 (strength, dose, route of administration and anatomical location were not provided) for prophylaxis (accidental overdose). No further information was provided. Healthcare professional (HCP) provided consent to be followed up with, and stated if she was not there, could talk to anyone at the doctors' office. No additional adverse event (AE) was reported. No product quality complaints (PQC) was reported.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Accidental overdose
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2342490

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge u028164

gering
Staat
OR
Alter
1,0
Geschlecht
M
Eingang
29.06.2022
Impfdatum
29.06.2022
Beginn
29.06.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
SC / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered

Symptomtext

MMR and Varicella Vaccine ordered today. MA gave MMRV and Varicella vaccine. Patient received double dose of varicella. Error was discovered after patient left clinic. CDC Vaccine Information Line contacted to discuss/learn of any possible complications of which none where identified. Contacted mom to inform of error.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
No
Vorgeschichte
No
Andere Medikamente
None
Allergien
Milk Protein Sensitivity
Vorherige Impfungen
-

VAERS 2299552

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

gering
Staat
MI
Alter
-
Geschlecht
U
Eingang
28.05.2022
Impfdatum
25.05.2022
Beginn
25.05.2022
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; Customer calling for TE evaluation of VARIVAX. Customer states she called yesterday 5/24/2022 to report a TE but they just found out they had another TE 1 week ago and they need to report that at this time. VARIVAX has been administered to one patien; This spontaneous report was received from a customer referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided. On 25-MAY-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number U028164, expiration date 09-SEP-2023 (dose and route of administration not provided) for prophylaxis and that was reconstituted with a sterile diluent (product storage error). No adverse event was reported. the excursion was between -14 degrees Celsius (?C) to 10 ?C for 2 hours and 5 minutes and between -10?C to 8?C with an average of -0.4?C for 1 hour and 25 minutes. A previous temperature excursion was deteceted and was between -14?C to -10?C with an average of -12?C for 50 minutes.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product storage error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
STERILE DILUENT
Allergien
-
Vorherige Impfungen
-

VAERS 2270763

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

gering
Staat
VA
Alter
2,0
Geschlecht
M
Eingang
11.05.2022
Impfdatum
10.05.2022
Beginn
10.05.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
SC / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Inappropriate schedule of product administration

Symptomtext

Pentacel was given too early. Patient needed a plain Polio and a plain Haemophilus Influenzae.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Inappropriate schedule of product administration
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
nkda
Vorherige Impfungen
-

VAERS 2265561

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U028164

gering
Staat
IA
Alter
4,0
Geschlecht
U
Eingang
06.05.2022
Impfdatum
19.04.2022
Beginn
19.04.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product storage error

Symptomtext

No adverse event; Nurse reporting improperly stored MMR II and VARIVAX in freezer; This spontaneous report was received from a nurse, referring to a 4-year-old child. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, it was reported that a nurse improperly stored measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (OKA/MERCK) (VARIVAX) in the freezer (Product storage error). On 19-APR-2022 at 13:30, the patient received the first dose of measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (albumin status of rHA (recombinant human albumin)) (M-M-R II), valid lot #U007684 with expiration date on 09-MAR-2023 (strength, and route of administration not provided); and varicella virus vaccine live (OKA/MERCK) (VARIVAX), valid lot #U028164, with expiration date on 09-SEP-2023 (strength, and route of administration not provided). Both vaccines were administered as prophylaxis. No adverse events were reported. No additional information was provided. The causal assessment between the vaccines and the event were not reported.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-