Age: 49.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: digestive system problem; not had period in over a year; hot flashes; sweating; sore arm after both dose of covid vaccination; seizure; FACILITATED COLLECT  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): 21K-163-4168054-00 (RA).  A 48 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Jul2021 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single and intramuscular, administration date 22Jul2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1153085) at citrate free for hidradenitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant) with onset 2020, outcome "not recovered", described as "seizure"; GASTROINTESTINAL DISORDER (medically significant), outcome "not recovered", described as "digestive system problem"; AMENORRHOEA (medically significant), outcome "unknown", described as "not had period in over a year"; VACCINATION SITE PAIN (medically significant) with onset Jul2021, outcome "unknown", described as "sore arm after both dose of covid vaccination"; HOT FLUSH (medically significant), outcome "unknown", described as "hot flashes"; HYPERHIDROSIS (medically significant), outcome "unknown", described as "sweating". The action taken for bnt162b2 and adalimumab was unknown.  The reporter considered "sore arm after both dose of covid vaccination" related to bnt162b2.  Additional information: On unknown dates, the patient experienced non-serious three lumps on leg after got covid boost shot, sore throat and slight cough with Humira (Adalimumab). Pfizer Biontech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 09Feb2021, she received first dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 02Mar2021, she received second dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. In 2021, she received booster dose COVID-19 Vaccine manufactured by Pfizer/BioNTech.  Causality for Humira(Adalimumab) The reporter's causality for the event(s) of three lumps on leg after got Covid boost shot, sore throat and slight cough with Humira (Adalimumab) was no reasonable possibility.  Suspect Drug(s)  Product-Reaction level Seq.No. 1 Drug: HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB), 1153085 Daily Dose: Citrate Free Route of administration: Subcutaneous Indication for use: Moderate to Severe Hidradenitis Suppurativa Therapy Dates(From/To): UNK Causality:  1)) Seizure (Seizure) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr.(Drug/Vaccine): Not assessable Dechallenge: N/A  2) Gastrointestinal disorder (Gastrointestinal disorder) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr.(Drug/Vaccine): Not assessable Dechallenge: N/A  3) Menses lack of (Amenorrhoea) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr.(Drug/Vaccine): No reasonable possibility Dechallenge: N/A  4) Vaccination site pain (Vaccination site pain) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr.(Drug/Vaccine): No reasonable possibility Dechallenge: N/A  5) Hot flashes (Hot flush) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr.(Drug/Vaccine): No reasonable possibility Dechallenge: N/A  5) Sweating (Hyperhidrosis) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr.(Drug/Vaccine): No reasonable possibility Dechallenge: N/A  Seq.No. 2 Drug: Pfizer Biontech Covid-19 Vaccine(Tozinameran)(Tozinameran), Unknown, Unknown, Unknown Daily dose: First dose (1 in 1 Once) Second dose (1 in 1 Once) Route of admin: Intramuscular Intramuscular Therapy Dates/Duration :  1) 01Jul2021 - 01Jul2021  2) 22Jul2021 - 22Jul2021  Indication for use: Covid-19 Vaccination  Causality:  1)) Seizure (Seizure) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Related Dechallenge: N/A  2) Gastrointestinal disorder (Gastrointestinal disorder) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Related Dechallenge: N/A  3) Menses lack of (Amenorrhoea) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Related Dechallenge: N/A  4) Vaccination site pain (Vaccination site pain) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Probable Dechallenge: N/A  5) Hot flashes (Hot flush) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Related Dechallenge: N/A  5) Sweating (Hyperhidrosis) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Related Dechallenge: N/A  Did Event Abate After Stopping Drug? NA Concomitant drugs and dates of administration (exclude those used to treat event): Concomitant Drugs Not Reported Other relevant history: Not reported.  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 provided in the narrative, a causal association between the event "Vaccination site pain" and the suspect drug cannot be completely excluded. However, the relationship between the events Seizure, gastrointestinal disorder, Amenorrhoea, hot flashes and sweating and the suspect drug is considered unrelated. 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.