Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Arthritis flare up/My thumbs would not even work; Most severe were my hands; My feet, everything, my neck, everything; It was unbelievable; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 19Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritic flare up" (unspecified if ongoing), notes: maybe 46 years ago when she was pregnant something similar to it in severity; "blood clotting disorder" (ongoing); "blood pressure" (ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure management (ongoing). Vaccination history included: Comirnaty (DOSE 1, SINGLE), for COVID-19 Immunization; Comirnaty (DOSE 2, SINGLE), for COVID-19 Immunization; Comirnaty (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 Immunization; Influenza vaccine, administration date: Oct2024, for Immunization. The following information was reported: ARTHRITIS (non-serious) with onset 2024, outcome "recovering", described as "Arthritis flare up/My thumbs would not even work; Most severe were my hands; My feet, everything, my neck, everything; It was unbelievable". Therapeutic measures were taken as a result of arthritis.  Additional information: Transferring agent stated, "They have a consumer on the line that wants to report a side effect on a shot she received from (Pharmacy name withheld), a COVID shot (Later clarified as Comirnaty)." When probed for the side effects, consumer stated, "The side effect was, an Arthritis flare up, 10 to 14 days after receiving the immunization. Patient could, her thumbs would not even work since even now a week and a half later. She cannot even pull up the blinds in her house, the shades and she had to ice, She had to wear a brace above to her feet, her hips. It was unbelievable. she was getting better, but it was truly an Arthritic flare up that she had maybe 46 years ago when she was pregnant something similar to it in severity." When clarified the name of the vaccine, consumer stated, "(Pharmacy name withheld) and it was the Comirnaty 12 plus and it was at (Pharmacy name withheld)." When clarified the concern, consumer stated, "She guess, She did not had any questions. Maybe it was, should she ever get the Pfizer COVID Vaccine again based on her arthritis flared-up this time?". When paraphrased the above concern, consumer stated, "Her hands, most severe were her hands, her thumbs would not even work and her feet, everything, her neck, everything, it was unbelievable." Consumer stated, "Okay, the purpose of her call taking time out from her busy day to do this, was just so that you have, when evaluating the med and she had got many Pfizer vaccines before she had always got the COVID shot but this one was different. In all her past COVID initial set and then the subsequent boosters have always been Pfizer, but this was different and she felt that it needed to be reported, so that action could be taken for me or for people in the future." Consumer stated, "The date was 19Oct2024 around noon." Anatomical location: Right arm. Treatment: Consumer stated, "Tylenol, She cannot take any other drugs besides Tylenol because she had a blood clotting disorder and she iced her joints and a brace on her thumb and rest." Other medical conditions and concomitant medication: Consumer stated, "Losartan for blood pressure. She had taken that forever so with all her other COVID shots." Consumer stated, "No, she had no lab work." When probed if any same date vaccination with Comirnaty, consumer stated, "No." When probed if any 4 weeks prior vaccination, consumer stated, "Yes, exactly two weeks prior she had her Flu vaccination." When probed if vaccination card handy and name of the Flu vaccine, consumer stated, "she had Influenza, it looks like she did not know if it was an IIV3 high dose, Influenza IIV3 high dose on 09Oct2024.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.