Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: Rotator cuff syndrome; Vaccination site pain; Fatigue; Sinus pain; Psoriasis flare-up; Headache; Flu like symptoms; Pain; Nausea; MARKETTING PROGRAME NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not aplicable). The reporter is the patient. Other Case identifier(s): 21K-163-4133697-00 (Agency).  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20May2021 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single and intramuscular, administration date 20Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) for psoriatic arthropathy, psoriasis. The patient's relevant medical history was not reported. Concomitant medication(s) included: MODERNA COVID-19 VACCINE taken for covid-19 immunisation, start date: 02Jan2022, stop date: 02Jan2022. The following information was reported: ROTATOR CUFF SYNDROME (medically significant) with onset 2021, outcome "unknown", described as "Rotator cuff syndrome"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Vaccination site pain"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; SINUS PAIN (non-serious) with onset 2021, outcome "unknown", described as "Sinus pain"; PSORIASIS (non-serious) with onset 2021, outcome "not recovered", described as "Psoriasis flare-up"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Headache"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Flu like symptoms"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Pain"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Nausea". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of rotator cuff syndrome.  Clinical information: The patient had flu like symptoms of achiness, nausea, headaches for seven to ten days, fatigue and sinus pain caused by Pfizer vaccine second dose. On 21Oct2021, she had right rotor cuff surgery which was recovering with the causality of no reasonable possibility. The cold, dry weather caused scalp to be itchy and dry. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for HUMIRA (ADALIMUMAB) Causality: Rotator cuff syndrome: Causality as per reporter (Drug/Vaccine)-Not reported, Causality as per Mfr (Drug/Vaccine)- No reasonable possibility, Dechallenge-N/A, Vaccination site pain: Causality per reporter (Drug/Vaccine)  No reasonable possibility, Causality as per Mfr (Drug/Vaccine)- No reasonable possibility, Dechallenge-NA, Fatigue: Causality as per reporter (Drug/Vaccine)- No reasonable possibility, Causality as per Mfr (Drug/Vaccine) - No reasonable possibility, Dechallenge-N/A, Sinus pain, Causality as per reporter (Drug/Vaccine)  No reasonable possibility, Causality as per Mfr (Drug/Vaccine) - No reasonable possibility, Dechallenge NA, Psoriasis flare up: Causality as per reporter (Drug/Vaccine) - reasonable possibility, Causality as per Mfr (Drug/Vaccine) - No reasonable possibility, Dechallenge -NA, Headache: Causality as per reporter (Drug/Vaccine)  No reasonable possibility, Causality as per Mfr (Drug/Vaccine) - No reasonable possibility, Dechallenge -NA, Flu like symptoms: Causality as per reporter (Drug/Vaccine)  No reasonable possibility, Causality as per Mfr (Drug/Vaccine) - No reasonable possibility, Dechallenge -NA, Pain: Causality as per reporter (Drug/Vaccine)  No reasonable possibility, Causality as per Mfr (Drug/Vaccine) - No reasonable possibility, Dechallenge NA, Nausea, Causality as per reporter (Drug/Vaccine)  No reasonable possibility, Causality as per Mfr (Drug/Vaccine) - No reasonable possibility, Dechallenge NA.  Causality of PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN): Rotator Cuff syndrome: Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A, Vaccination site pain: Causality as per reporter (Drug/Vaccine): Not related, Dechallenge: N/A, Fatigue, Causality as per reporter (Drug/Vaccine): Not related, Dechallenge: N/A, Sinus pain: Causality as per reporter (Drug/Vaccine): Not related, Dechallenge: N/A, Psoriasis flare-up: Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A, Headache: Causality as per reporter (Drug/Vaccine): Not related, Dechallenge: N/A, Flu like symptoms, Causality as per reporter (Drug/Vaccine): Not related, Dechallenge: N/A, Pain: Causality as per reporter (Drug/Vaccine): Not related, Dechallenge: N/A, Nausea: Causality as per reporter (Drug/Vaccine): Not related, Dechallenge: N/A, Headache, 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 events  and suspect drug BNT162B2 cannot be excluded. 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.