Sex: M
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Injection site nodule, Injection site pain, Musculoskeletal disorder, Night sweats
Clinical narrative: Rheumatoid arthritis flare up; cold weather bothers rheumatoid arthritis; Musculoskeletal disorder/could not sit long; Vaccination site pain/reaction to COVID 19 vaccine was left arm sore; Night sweats; Injection site nodule/OCASSIONAL KNOTS AT INJECTION SITE; Injection site bleeding; pain/stinging at injection site with HUMIRA (ADALIMUMAB); This is a solicited report based on the information from a non-Pfizer sponsored program  received by Pfizer (Mfr. Control No. : 21K-163-3819205-00) from a 65-year-old male non-contactable consumer(patient).  Solicited report from the USA by a consumer of a 65-year-old elderly male with events of non-serious COULD NOT SIT LONG, REACTION TO COVID 19 VACCINE WAS LEFT ARM SORE, NIGHT SWEATS, OCASSIONAL KNOTS AT INJECTION SITE, BLEEDING AT INJECTION SITE, RHEUMATOID ARTHRITIS FLARE UP/COLD WEATHER BOTHERS RHEUMATOID ARTHRITIS and PAIN/STINGING AT  INJECTION SITE with HUMIRA (ADALIMUMAB). There was no reported medical history.  On unknown dates, the patient experienced COULD NOT SIT LONG, REACTION TO COVID 19 VACCINE WAS LEFT ARM SORE, NIGHT SWEATS, OCASSIONAL KNOTS AT INJECTION SITE, BLEEDING AT INJECTION SITE, RHEUMATOID ARTHRITIS FLARE UP/COLD WEATHER BOTHERS RHEUMATOID ARTHRITIS and PAIN/STINGING AT INJECTION SITE. PFIZER BIONTECH COVID-19VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown, expiration date unknown.  Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of COULD NOT SIT LONG, OCASSIONAL KNOTS AT INJECTION SITE, BLEEDING AT INJECTION SITE, RHEUMATOID ARTHRITIS FLARE UP/COLD WEATHER BOTHERS RHEUMATOID ARTHRITIS and PAIN/STINGING AT INJECTION SITE with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of REACTION TO COVID 19 VACCINE WAS LEFT ARM SORE and NIGHT SWEATS with HUMIRA(ADALIMUMAB) was no reasonable possibility.  Change History. On 28May2021, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. The events of "COULD NOT SIT LONG", "REACTION TO COVID 19 VACCINE WAS LEFT ARM  SORE" and "OCASSIONAL KNOTS AT INJECTION SITE" were added. The event of "COLD WEATHER BOTHERS RHEUMATOID  ARTHRITIS" was amended to "RHEUMATOID ARTHRITIS FLARE UP/COLD WEATHER BOTHERS RHEUMATOID ARTHRITIS". The event of "STINGING AT INJECTION SITE" was amended to "PAIN/STINGING AT INJECTION SITE".  The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment  Amendment: This follow-up report is being submitted to amend previously reported information: event "Rheumatoid arthritis flare up" upgraded as serious for medically significant.; Sender's Comments: Based on the limited information, a possible contributory role of the product, BNT162B2 vaccine, cannot be completely excluded for the reported events of Rheumatoid arthritis flare up/ cold weather bothers rheumatoid arthritis, could not sit long, reaction to COVID-19 vaccine/ left arm sore, night sweats, occasional knots at injection site, bleeding at injection site. However, due to direct role of co-suspect product Humira for the event of Injection site stinging and pain as per the report, the role of , BNT162B2 vaccine for this event is assessed to be 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.