Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Ear inflammation, Ear pain, Interchange of vaccine products, Off label use, Otorrhoea
Clinical narrative: 1st dose covid-19 vaccine manufactured by Johnson and Johnson.; Stomach pain; Ear inflammation; Ear pain; Ear discharge; COVID-19 virus test positive; drug ineffective; Joint pain; Low back pain; Interchange of vaccine products; Describe reaction(s) (include relevant test/lab data): Solicited report by a consumer of a 25 year old female with events of non-serious tested positive for covid 19, joint pain, lower back pain, ears inflamed/hurt/ had some discharge, off label use in unapproved indication and stomach hurting with rinvoq (upadacitinib). There was no reported medical history.  On unknown dates, the patient experienced ears inflamed/hurt/ had some discharge, off label use in unapproved indication and stomach hurting. On 28dec2021, the patient experienced joint pain and lower back pain. In Jan2022, the patient experienced tested positive for covid 19. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. A day after receiving pfizer booster shot, the patient had been having joint pain that has heightened and her lower back pain increased. Her stomach had been hurting. She tested positive for covid in Jan2022. Her ears were inflamed, hurt and had some discharge. Her physician put her on ear drops. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 27Dec2021, patient received 3rd dose (booster dose) covid-19 vaccine manufactured by pfizer biontech.  Causality for rinvoq(upadacitinib): The reporter's causality for the event(s) of tested positive for covid 19, joint pain, lower back pain, ears inflamed/hurt/ had some discharge unknown onset, off label use in unapproved indication and stomach hurting with rinvoq(upadacitinib) was a reasonable possibility. The reporter's causality for the event(s) of ears inflamed/hurt/ had some discharge unknown onset and ears inflamed/hurt/ had some discharge unknown onset was not provided.  Did event abate after stopping drug?: NA Concomitant drugs and history: Concomitant drugs and dates of administration (exclude those used to treat event): Other relevant history: No known allergies. Date received by manufacturer: 13Jan2022 Report source: study Report type: initial  Product-Reaction level: Seq.No.: 1 Drug: RINVOQ(UPADACITINIB), Route of Admin: 1) Oral Indication for use: 2) rheumatoid arthritis with lupus and or sjogren's disease 3) rheumatoid arthritis with lupus and or sjogren's disease Continuation Sheet for report: 1) COVID-19 virus test positive  (SARS-CoV-2 test positive) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Reasonable possibility Dechallenge: N/A 2) Joint pain  (Arthralgia) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Reasonable possibility Dechallenge: N/A 3) Low back pain (Back pain) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Reasonable possibility Dechallenge: N/A 4) Ear inflammation  (Ear inflammation) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Reasonable possibility Dechallenge: N/A 5) Off label use in unapproved indication  (Off label use) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Reasonable possibility Dechallenge: N/A 6) Ear pain  (Ear pain) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A 7) Ear discharge  (Otorrhea ) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A 8) Stomach pain  (Abdominal pain upper  Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Reasonable possibility Dechallenge: N/A Seq.No.: 2 Drug: PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN),UNKNOWN 1) COVID-19 virus test positive  (SARS-CoV-2 test positive  Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Possible Dechallenge: N/A 2) Joint pain  (Arthralgia) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Possible Dechallenge: N/A 3) Low back pain  (Back pain) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Possible Dechallenge: N/A 4) Ear inflammation  (Ear inflammation) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not reported Dechallenge: N/A 5) Off label use in unapproved indication  (Off label use) Action(s) taken with drug: Not applicable  Causality as per reporter (Drug/Vaccine): Not reported  Dechallenge: N/A 6) Ear pain  (Ear pain) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A 7) Ear discharge  (Otorrhea) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A 8) Stomach pain  (Abdominal pain upper  Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Reasonable possibility Dechallenge: N/A; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.