Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Biopsy, Blood testosterone, Body temperature, Chest X-ray
Clinical narrative: booster; arm was immobilized; pain; bad pain in back; Swollen back; body felt torn; can't walk; body messed up; Back curls up; This is a spontaneous report received from contactable reporter (Consumer).   A 37-year-old male patient received bnt162b2 (BNT162B2), administration date 13Dec2021 (Lot number: FE3594) at the age of 37 years as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid-19 illness in 2006/had some kind of corona virus or sars type illness", start date: 2006 (not ongoing), notes: Covid-19 illness in 2006/had some kind of corona virus or sars type illness; "Allergic to psychological Drugs" (ongoing); "Allergic to psychological Drugs: Seizures" (unspecified if ongoing); "Smoker" (ongoing), notes: smoke 3-4 cigarettes per day; "Non-Alcohol user" (ongoing); "Fever" (ongoing), notes: patient was ill at the time of vaccination; "Body ache" (ongoing), notes: patient was ill at the time of vaccination; "Headache" (unspecified if ongoing), notes: patient was ill at the time of vaccination. Concomitant medications included: SEROQUEL, start date: 2002; METHADONE, start date: 2009. Vaccination history included: Covid-19 vaccine ad26.cov2. s (dose 1; batch number: 1805022 at 12:00 on left arm), administration date: 22Mar2021, when the patient was 37 years old, for prophylactic vaccination, reaction(s): "inappropriate route of administration", "Kidney failure", "Blood clot in the leg", "Liver infection", "Staph infection in spine that eating away bone marrow", "Kidney Infection / Kidney Inflammation", "Discitis", "can't move/ barely get out of bed/bedridden in hospital/cannot move legs/cant walk/ not been able to walk at all/ unable to walk", "severe back pain", "blood clot in the femoral artery", "infection in the arm that spread to the hips/infection in disc of the back", "confirmed COVID-19 Infection", "calcification in cerebral artery", "confirmed inflammation", "bottom part of body weighing down", "oversized artery", "Lungs filled with fluid", "Appendix messed up", "Gall Bladder messed up", "Pancreatic pain", "Abdominal swelling", "losing weight", "Loss appetite", "pain to left and right flank area", "left side of body numb/ both hands numb and cold", "Low testosterone", "leg and feet pain worsening/chronic pain", "vein inside left hip is protruding and bulging", "Loss of voice", "gasteritis in back"; Flu vaccine, reaction(s): "got nauseated once". The following information was reported: IMMUNISATION (medically significant) with onset 13Dec2021, outcome "unknown", described as "booster"; IMMOBILE (medically significant) with onset 13Dec2021, outcome "not recovered", described as "arm was immobilized"; PAIN (non-serious) with onset 13Dec2021, outcome "unknown", described as "pain"; BACK PAIN (non-serious) with onset 13Dec2021, outcome "not recovered", described as "bad pain in back"; SWELLING (non-serious) with onset 13Dec2021, outcome "unknown", described as "Swollen back"; MUSCLE STRAIN (non-serious) with onset 13Dec2021, outcome "unknown", described as "body felt torn"; GAIT INABILITY (non-serious) with onset 13Dec2021, outcome "not recovered", described as "can't walk"; FEELING ABNORMAL (non-serious) with onset 13Dec2021, outcome "unknown", described as "body messed up"; SPINAL DEFORMITY (non-serious) with onset 13Dec2021, outcome "unknown", described as "Back curls up". The event "bad pain in back" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: biopsy: (unspecified date) unknown results, notes: Classification: unk; (04Jun2021) results awaiting, notes: Classification: unk; blood testosterone: (unspecified date) low, notes: Classification: unk; body temperature: (23Mar2021) 102 Fahrenheit, notes: Classification: unk; chest x-ray: (unspecified date) unknown results, notes: Classification: unk; computerised tomogram: (unspecified date) unknown results, notes: Classification: unk; computerised tomogram abdomen: (unspecified date) clear, notes: Classification: unk; lumbar puncture: (unspecified date) unknown results, notes: Classification: unk; (03Jun2021) results not mentioned, notes: Classification: unk; magnetic resonance imaging: (unspecified date) staph infection, notes: Classification: unk; (unspecified date) unknown results, notes: Classification: unk; sars-cov-2 test: (unspecified date) positive; ultrasound scan: (unspecified date) unknown results, notes: Classification: unk. Additional information: on 13Dec2021, the patient was experiencing similar symptoms like the first time when he received the Covid-19 vaccine ad26. cov2 (Janssen). Following vaccination with BNT162 (13Dec2021), the patient experienced pain, body felt torn, back curled up, body was messed up, arm was immobilized, can't walk, bad pain in back and swollen back (dose number in series 2).   Company (Janssen) Remarks: These events are considered unassessable. The events have a compatible/ suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. These events are labeled per RA and are therefore considered potentially related.