Age: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back pain, Bladder dysfunction, Feeling abnormal, Kidney infection, Lower respiratory tract infection
Clinical narrative: strained muscle in wrist; not able to feel bladder; pain in back; feels like was getting worse; Chest cold; Kidney infection; Rash; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4261657-00 (Agency).  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Jun2021 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single and intramuscular, administration date 30Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Lot number: 1155993) at citrate free and second regimen subcutaneous (Lot number: 1159670) at citrate free for hidradenitis. Relevant medical history included: "COVID-19", start date: Dec2020 (unspecified if ongoing), notes: The patient experienced COVID-19. The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The following information was reported: KIDNEY INFECTION (medically significant) with onset Jan2022, outcome "unknown", described as "Kidney infection"; RASH (non-serious) with onset Jan2022, outcome "unknown", described as "Rash"; MUSCLE STRAIN (non-serious), outcome "unknown", described as "strained muscle in wrist"; BLADDER DYSFUNCTION (non-serious), outcome "unknown", described as "not able to feel bladder"; LOWER RESPIRATORY TRACT INFECTION (non-serious) with onset Jan2022, outcome "not recovered", described as "Chest cold"; BACK PAIN (non-serious), outcome "unknown", described as "pain in back"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feels like was getting worse". The action taken for adalimumab was unknown. Pfizer BioNTech covid-19 vaccine (tozinameran) was also considered suspect. The events were assessed as non-serious.  The reporter considered "kidney infection", "rash", "strained muscle in wrist", "not able to feel bladder", "chest cold", "pain in back" and "feels like was getting worse" not related to bnt162b2.   Causality for Humira (Adalimumab) The reporter's causality for the event(s) of kidney infection with a rash onset in Jan2022, strained muscle in wrist, not able to feel bladder and covid with Humira (Adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of kidney infection with a rash onset in Jan2022, chest cold, pain in back and feels like was getting worse was not provided.   Causality for drug: Humira (Adalimumab)  1) Kidney infection (10023424) (Kidney infection (10023424)) [v.24.1] Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): No reasonable possibility Dechallenge: N/A  2) Rash Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  3) Muscle strain  Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): No reasonable possibility Dechallenge: N/A  4) Bladder dysfunction  Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): No reasonable possibility Dechallenge: N/A  5) Chest cold Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  6) Back pain Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  7) Feeling abnormal  Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  Causality for drug: Pfizer BioNTech Covid-19 Vaccine (Tozinameran)   1) Kidney infection (10023424) (Kidney infection (10023424)) [v.24.1] Causality as per reporter (Drug/Vaccine): Not related  Dechallenge: N/A  2) Rash Causality as per reporter (Drug/Vaccine): Not related  Dechallenge: N/A  3) Muscle strain  Causality as per reporter (Drug/Vaccine): Not related  Dechallenge: N/A  4) Bladder dysfunction  Causality as per reporter (Drug/Vaccine): Not related  Dechallenge: N/A  5) Chest cold Causality as per reporter (Drug/Vaccine): Not related  Dechallenge: N/A  6) Back pain Causality as per reporter (Drug/Vaccine): Not related  Dechallenge: N/A  7) Feeling abnormal  Causality as per reporter (Drug/Vaccine): Not related  Dechallenge: N/A  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the reported events and the suspect drug BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.