Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Musculoskeletal disorder, Pain
Clinical narrative: Pain; fingers were getting worse; she was not able to walk for very long; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4157623-00.  A 64-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 12Mar2021 (Batch/Lot number: unknown) at the age of 64 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization. The following information was reported: PAIN (hospitalization) with onset May2021, outcome "not recovered", described as "Pain"; MUSCULOSKELETAL DISORDER (hospitalization) with onset May2021, outcome "unknown", described as "fingers were getting worse"; GAIT DISTURBANCE (hospitalization) with onset May2021, outcome "unknown", described as "she was not able to walk for very long". The patient was hospitalized for pain, musculoskeletal disorder, gait disturbance (start date: May2021). On unknown dates, the patient experienced pain, fingers were getting worse and not able to go shopping because not able to walk for very long. in May2021, the patient experienced hospitalized. in May2021, the hospitalized resolved. PFIZER BIONTECH (TOZINAMERAN) was also considered suspect. In May2021, patent was hospitalized after second covid shot for little bit over than 24 hours. She Was not saying Humira was working but she was thinking long term and was hoping to try alternative medicine. She was Still experienced pains but admits it was even worse without the Humira. Her fingers were getting worse every year. She also was not able to go for shopping because she was not able to walk for very long. Patient was not enrolled in a COVID-19 Vaccine Trial. On unknown, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer BioNTech. On 12Mar2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNTech. The action taken for adalimumab was unknown. The reporter's causality for the event(s) of hospitalised with Humira(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of pain with Humira(adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of fingers were getting worse and not able to go shopping because not able to walk for very long was not provided. # opinion is that there is no reasonable possibility that the events of hospitalised, pain, fingers were getting worse and not able to go shopping because not able to walk for very long are related to Humira (ADALIMUMAB). Causality for HUMIRA(ADALIMUMAB): Hospitalisation, Causality as per reporter (Drug/Vaccine): No reasonable possibility, Causality as per Mfr.(Drug/Vaccine): No reasonable possibility, Pain, Causality as per reporter (Drug/Vaccine): Reasonable possibility, Causality as per Mfr.(Drug/Vaccine): No reasonable possibility. Musculoskeletal disorder, Causality as per reporter (Drug/Vaccine): Not Reported, Causality as per Mfr.(Drug/Vaccine): No reasonable possibility. Walking difficulty (Gait disturbance), Causality as per reporter (Drug/Vaccine): Not Reported, Causality as per Mfr.(Drug/Vaccine): No reasonable possibility. For PFIZER BIONTECH COVID-19 VACCINE: Hospitalisation, Causality as per reporter (Drug/Vaccine): Not Related, Pain Causality as per reporter (Drug/Vaccine): Not Reported, Musculoskeletal disorder Causality as per reporter (Drug/Vaccine): Not Reported, Walking difficulty Causality as per reporter (Drug/Vaccine): Not Reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The information provided is very limited to make a meaningful medical evaluation of the case. However, based on the current information available a possible contributory role of the suspect BNT162B2 for the reported events of Pain, Musculoskeletal disorder and Gait disturbance cannot be completely excluded. The case will be reassessed further upon receipt of additional information. 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.