Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Device issue, Headache, Influenza like illness, Lethargy
Clinical narrative: Flu like symptoms; Lethargy; chills; Headache; Injection site pain/tenderness; Device issue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4182651-00.  A 36 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 22May2021 (Lot number: EW0178) at the age of 36 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous since 18Mar2021 (ongoing) (Batch/Lot number: unknown) at 40 mg for hidradenitis. Relevant medical history included: "Trigeminal neuralgia" (unspecified if ongoing); "Birth control" (unspecified if ongoing). Concomitant medication(s) included: DIAMOX [ACETAZOLAMIDE]; TOPAMAX taken for trigeminal neuralgia; TEGRETOL taken for trigeminal neuralgia; FOLIC ACID; METRONIDAZOLE; JUNEL FE taken for contraception; LAMICTAL taken for trigeminal neuralgia. Past drug history included: Dilaudid, reaction(s): "Severe itching"; Tetracycline, reaction(s): "Impaired vision". The following information was reported: DEVICE ISSUE (non-serious) with onset 2021, outcome "unknown", described as "Device issue"; INFLUENZA LIKE ILLNESS (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "Flu like symptoms"; LETHARGY (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "Lethargy"; CHILLS (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "chills"; HEADACHE (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "Headache"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Injection site pain/tenderness". The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of influenza like illness, lethargy, chills, headache, vaccination site pain.  Additional information: The patient experienced injection site raised circle mark, recurring, and issue with humira pen/received needlestick/ medicine pooled under skin but eventually went out, rolled down skin to the bed with humira 40mg/0.4ml (adalimumab). On an unknown date, the patient experienced issue with humira pen/received needlestick/medicine pooled under skin but eventually went out, rolled down skin to the bed. On 18Mar2021, the patient experienced recurring. On 30Nov2021, the patient experienced injection site raised circle mark. On 30Nov2021, the recurring. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 08Jun2021, patient received 2nd dose of covid-19 vaccine manufactured by pfizer/biontech, lot number EW0178. The patient was treated with ibuprofen.   The reporter's causality for the event(s) of injection site raised circle mark with humira 40mg/0.4ml(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of recurring injection site pain/tenderness with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of flu like symptoms, headache, chills, lethargy, issue with humira pen/received needlestick/medicine pooled under skin but eventually went out, rolled down skin to the bed unknown onset and issue with humira pen/received needlestick/medicine, rolled down skin to the bed unknown onset was not provided with injection site papule was probable, injection site pain was not related, flu like symptoms (influenza like illness), headache was not assessable and with device issue (device issue) was not reported.  Causality of Drug: Pfizer biontech covid-19 vaccine (tozinameran) EW0178, with Injection site pain was not reported, for Flu like symptoms (influenza like illness), Headache, Chills, Lethargy, Device issue was not assessable.  No follow-up attempts are possible. No further information is expected.