Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back pain, Body temperature, Medical device site erythema, Medical device site warmth, Nerve injury
Clinical narrative: nerve in back was crushed/had three rods put in rod turned bright red and hot/had to sleep on ice machine/thought in midst of having surgery some nerves were affected; nerve in back was crushed/had three rods put in rod turned bright red and hot/had to sleep on ice machine/thought in midst of having surgery some nerves were affected; nerve in back was crushed/had three rods put in rod turned bright red and hot/had to sleep on ice machine/thought in midst of having surgery some nerves were affected; nerve in back was crushed/had three rods put in rod turned bright red and hot/had to sleep on ice machine/thought in midst of having surgery some nerves were affected; Back pain; High temperature; weird sensation in back of head with Humira; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4470408-00 (Agency).  A 61-year-old female patient received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Batch/Lot number: unknown), on 26Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 30Sep2021 as dose 3 (booster),single (Batch/Lot number: unknown) at the age of 60 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as unk (citrate free) (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis, uveitis. The patient's relevant medical history included: "Moderate To Severe Rheumatoid Arthritis" (unspecified if ongoing); "Non-Infectious Intermediate Posterior and Panuveitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NERVE INJURY (medically significant), MEDICAL DEVICE SITE ERYTHEMA (medically significant), MEDICAL DEVICE SITE WARMTH (medically significant), NEUROLOGICAL PROCEDURAL COMPLICATION (medically significant), outcome "unknown" and all described as "nerve in back was crushed/had three rods put in rod turned bright red and hot/had to sleep on ice machine/thought in midst of having surgery some nerves were affected"; BACK PAIN (medically significant), outcome "not recovered"; PYREXIA (medically significant), outcome "not recovered", described as "High temperature"; SENSORY DISTURBANCE (medically significant), outcome "unknown", described as "weird sensation in back of head with Humira". The patient underwent the following laboratory tests and procedures: Body temperature: High, notes: High temperature (Pyrexia). The action taken for adalimumab was unknown.  Causality for Pfizer BioNTech Covid-19 Vaccine: The reporter's causality for the event(s) of Crushed nerve (Nerve injury), Medical device site erythema (Medical device site erythema), Medical device site warmth (Medical device site warmth), Intraoperative neurological injury (Neurological procedural complication), Back pain (Back pain), High temperature (Pyrexia) & Abnormal physical sensation (Sensory disturbance) was probable.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of nerve in back was crushed/had three rods put in rod turned bright red and hot/had to sleep on ice machine/thought in midst of having surgery some nerves were affected unknown onset, nerve in back was crushed/had three rods put in rod turned bright red and hot/had to sleep on ice machine/thought in midst of having surgery some nerves were affected unknown onset, nerve in back was crushed/had three rods put in rod turned bright red and hot/had to sleep on ice machine/thought in midst of having surgery some nerves were affected unknown onset, nerve in back was crushed/had three rods put in rod turned bright red and hot/had to sleep on ice machine/thought in midst of having surgery some nerves were affected unknown onset, back pain, high temperature and weird sensation in back of head was not provided(Not Reported). Agency's opinion was that there was no reasonable possibility that the events of nerve in back was crushed/had three rods put in rod turned bright red and hot/had to sleep on ice machine/thought in midst of having surgery some nerves were affected unknown onset: Crushed nerve (Nerve injury), nerve in back was crushed/had three rods put in rod turned bright red and hot/had to sleep on ice machine/thought in midst of having surgery some nerves were affected unknown onset: Medical device site erythema (Medical device site erythema), nerve in back was crushed/had three rods put in rod turned bright red and hot/had to sleep on ice machine/thought in midst of having surgery some nerves were affected unknown onset: Medical device site warmth (Medical device site warmth), nerve in back was Crushed/had three rods put in rod turned bright red and hot/had to sleep on ice machine/thought in midst of having surgery some nerves were affected unknown onset: Intraoperative neurological injury (Neurological procedural complication), back pain and high temperature are related to Humira (Adalimumab). Agency's opinion was that there was a reasonable possibility that the event of Weird Sensation In Back Of Head: Abnormal physical sensation (Sensory disturbance) Is Related To Humira (Adalimumab).  Clinical information: The patient experienced back pain, she said nerve in back was crushed and had to have corrective surgery. She had three rods put in, she said the rod turned bright red and hot and she had to sleep on ice machine. The physician thought in the midst of surgery some nerves were affected. She had weird sensation in the back of head after taking her last Humira shot although she was not sure if it was from Humira. She experienced high temperature after each vaccine injection. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Nerve injury, Medical device site erythema, Medical device site warmth, Neurological procedural complication, Back pain, Pyrexia, Sensory disturbance 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.