Reporte zur Charge NN6206

Symptomtext

developed acute delirium; redness in arm; Right arm swelling; After that very wild, I was screaming. Very scary. My memory was gone; she passed out at home; she is very depressed has anxiety; she is very depressed has anxiety; panic attack; gained 16 pounds; vomited; loss of appetite; body ache/pain; This is a spontaneous report from a contactable Other HCP (patient). A 58-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: NN6206 and expiration date: Not available), via an unspecified route of administration in the right arm on 04Mar2021 12:00 as a single dose for COVID-19 immunisation. Medical history included removed brain tumor, she has sciatic nerve damage on left arm and left leg and is paralyzed, coma, chronic body aches, seizures, bad vision, high blood pressure and three brain surgery, short term memory. The patients historical vaccine included Flu vaccine injection in right arm deltoid muscle. The patient's concomitant medications included Oxycodone (5mg three times a day tablet) been taking for 3 years since she has brain tumor removed and for chronic body aches and Lyrica. On an unknown date, the patient gained 16 pounds. In Mar2021, the patient experienced she passed out at home and she was very depressed, anxiety, panic attack, body ache/pain, vomited and loss of appetite. On 04Mar2021, the patient experienced right arm swelling, screaming, scary, memory was gone. On an unknown date, she experienced developed acute delirium. On 06Mar2021, the patient had redness in arm. The patient was in the hospital for 4 days and was admitted on 14Mar2021. Her memory came back little by little and side effect of vaccine it says that if she had side effects from first one do not take second dose because it is worse and she is scared to be admitted to the hospital and does not want to experience that again. She was taking pain medication and did not tell her she cannot take Tylenol of course with body aches they did not tell her. It was not specific acute delirium it is a psychiatric disorder and she was wild and has never been like that before, she was tied up to the bed. The reporter states that she is disabled. She has bad vision and she is by herself at home. She is 5 1/2 already going down. She is not going to get the second one until get report results because it is ridiculous, and she is very nervous as she was admitted at night to the hospital. Body ache happened 24 to 36 hours after vaccine not that severely unusual as it went away, and she has a chronic illness and is in a wheelchair from chronic pain. Reporter stated she could not swallow liquid or eat food and she was scheduled for a cat scan, but she could not go since she has been on the phone with Pfizer to get truth and fairness. Reporter stated yesterday this started getting better. Reporter stated was discharged from hospital last Tuesday but had pain at home. Developed acute delirium: stated when she woke up in the ER the next day in few hours she was admitted and in the ER she was crazy and tried running even though she cannot run because she is paralyzed and she did not remember nothing. Reporter stated no she did not get it that when she was discharged, it had been 48 hours. Pain started 48 hours after the vaccine. She has chronic pain the pain is not that excruciating, and it has stopped. She could not remember what happened but just knew it was redness and hurt a lot. Her memory and everything came back. States she had MMR (as provided by Reporter ) done, because of pain in her whole body and everything came back negative. She had terrible pain, she asked to be given pain medication, and was given pain medication. Reporter stated it disappeared about one week now it disappeared and has recovered completely. Reporter stated black and blue inflammation and it does not hurt and the pain it went away. She was discharged from the hospital and discharge paper said second vaccine on 26Mar2021. She has been taking Oxycodone pain medication, reporter thinks she even got a higher dose since the pain was excruciating. The patient did not take any vaccines with 4 weeks. No Relevant Tests were performed. While providing an AE for the COVID vaccine she took Tylenol and Motrin as treatment, on top of it, but the pain didn't go away. She has been taking Oxycodone pain medication, reporter thinks she even got a higher dose since the pain was excruciating. The clinical outcome of events gained 16 pounds, passed out at home, depressed, anxiety, panic attack, body ache/pain, vomited and loss of appetite, right arm swelling, screaming, scary, developed acute delirium, redness in arm was unknown whereas of memory gone it was recovering/resolving.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events peripheral swelling, amnesia, delirium, loss of consciousness, depression, anxiety, panic attack, and erythema and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.