Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Chills
Clinical narrative: having arthritis in his hands, bones and joints; chills; After second dose it was worse/The second shot make this arthritis pain unbearable/The chills got worse he still has them even in 80 degrees; After second dose it was worse/The second shot make this arthritis pain unbearable/The chills got worse he still has them even in 80 degrees; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 24Mar2021 at around 3:30 or 4:00 (at the age of 57-year-old) as dose 1, single; again received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0162) via an unspecified route of administration, administered in left arm on 12Apr2021 at 4:30 as dose 2, single, both doses for COVID-19 immunization. Medical history included severely allergic to bee stings from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior vaccinations. There was no History of previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer Suspect. On 27Mar2021, 3-days after first dose, the patient began having arthritis in his hands, bones, and joints along with chills; after second dose it was worse/the second shot make this arthritis pain unbearable//the chills got worse he still has them even in 80 degrees on an unspecified date in 2021. Adverse events resulted in physician office visit on an unspecified date. The second shot make this arthritis pain unbearable. Patient couldn't hold a coffee cup after the second. Patient had to use both hands. After the second shot, a day later, the arthritis nailed him big time. Patient could have lived with the pain after the first shot. The chills set in at the same time. Patient reports HCP who told him it may be immune response and for him to call Pfizer. The doctor prescribed methotrexate and prednisone. If he were to stop it the swelling comes back in his joints again. No further details about the prednisone or methotrexate were provided. If he doesn't take the prednisone or methotrexate, he wouldn't be able to use his hands at all. The chills are worse but constant. Patient stated that it has been 3 months now since getting vaccine. The events were serious (medically significant). Patient wants to know if arthritis is associated with vaccine and how long will side effects last. Patient had no relevant tests but, there was a set up for blood work for immune response but has not had blood drawn yet. The patient received methotrexate and prednisone as treatment medication for the events. The outcome of the events arthritis, chills was not recovered; arthritis aggravated, chills worsened was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on plausible dose-event relationship  and increased severity the causal role  of BNT162B2 cannot be excluded for the reported events. .  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.