Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Glomerular filtration rate, Glomerular filtration rate decreased, Illness, Renal failure
Clinical narrative: her hands are clubbing and curling in; episodes of severe vomiting; magnesium is low; GFR is down to 13% in which 90 is normal; she could not hold potassium; creatinine was 3.6 which was 3 times the normal, the other day and goes really high; her BUN is high; Swelling whole entire body like three times the size; CHF; she got really sick; kidney failure; patient did get Covid virus a couple of weeks ago; patient did get Covid virus a couple of weeks ago; This is a spontaneous report received from a contactable other HCP (parent).  This 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unknown route, on unknown date in 2021 (at the age of 41-year-old) at single dose for COVID-19 immunisation and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route, on 12Apr2021 (at the age of 41-year-old) at single dose for COVID-19 immunisation, administered at hospital. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) administered in 2021 and developed headache. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No problems with vaccines in past. The patient did not have a medical history and family history. The patient did not have known allergies. The patient did not have concomitant medications. In Jun2021, the patient had episodes of severe vomiting, crazy numbers of Glomerular Filtration Rate (GFR), blood urea (BUN) and creatinine: GFR was down to 13% in which 90 is normal (this is indicative of a kidney transplant), her BUN is high, and creatinine was 3.6 which was 3 times the normal, the other day and goes really high; her magnesium was low.  She was taking daily infusions of potassium. She can't hold potassium (as reported).  She had swelling whole entire body like three times the size. On unknown date in 2021, after second dose, she got really sick. She went to the emergency room via ambulance and it's a mix between congestive heart failure (CHF) and kidney failure. There were no other changes besides her getting the vaccine. She had a PICC line infusion every day and they had to take it out because it got infected. Unable to provide any details about the PICC line. On 20Oct2021 (today, as reported), her hands are clubbing and curling in. She has spent about 30 days in the hospital now since June off and on. She did get a port today, but unable to provide any further details. Was a healthy person up until now. She has been several times to the emergency room, about 10 times. She has been admitted to withheld hospital and to second hospital and now she is in the emergency room at second hospital withheld but they are going to send her home because they can't figure out what's going on with her so she will not be admitted. The patient did get COVID virus a couple of weeks ago, on 22Sep2021, she had a breakthrough case around 22Sep2021. Did not have any treatment and stayed at home. She went to the lab every 2 days for lab draw and has been having crazy labs and its indicative of kidney failure, but no one can diagnose anything, and they can't find a doctor to find out what is wrong with her. It makes her wonder if it's the shot because that was the only thing that was different. She had a PICC line. She had a port put in yesterday. The patient had not recovered from vomiting, magnesium low, BUN high, and creatinine high. The outcome of the remaining events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.,Linked Report(s) : US-PFIZER INC-202101411905 same reproter/drug/pt, different dose (first dose)/event