Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Drug ineffective, Intervertebral disc protrusion, Suspected COVID-19, Vaccination complication
Clinical narrative: Drug ineffective; Suspected COVID-19; herniated disc a little worse; herniated disc a little worse; Covid vaccination was a lot worse; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): ABBVIE-4190685.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Batch/Lot number: unknown), on 29Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 11Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown), subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown"; INTERVERTEBRAL DISC PROTRUSION (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "herniated disc a little worse"; VACCINATION COMPLICATION (non-serious), outcome "unknown", described as "Covid vaccination was a lot worse". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "drug ineffective", "suspected covid-19", "herniated disc a little worse" and "covid vaccination was a lot worse" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Clinical information: Solicited report from PRIVATE by a consumer of a 58.000 years old male with events of and non-serious herniated disc a little worse, Covid, and Covid vaccination was a lot worse with Adalimumab Solution for Injection, Single Dose Pen. There was no reported medical history. On unknown date(s), the patient experienced Covid vaccination was a lot worse, Covid, herniated disc a little worse. Pfizer covid-19 vaccination was also considered suspect. Primary reporter contact for lot number information was unsuccessful.  The reporter's causality for the event(s) of Covid and herniated disc a little worse with Adalimumab Solution for Injection was Not Provided.  The reporter's causality for the event(s) of Covid vaccination was a lot worse with Adalimumab Solution for Injection was Reasonable Possibility.  The reporter's causality for the event(s) of Covid, Covid vaccination was a lot worse and herniated disc a little worse with Pfizer BioNTech Covid-19 vaccine (Tozinameran) was Not Provided.  Regulatory Authority opinion was that the causality for the event(s) of Covid, Covid vaccination was a lot worse and herniated disc a little worse with Adalimumab Solution for Injection was Not Provided.  Regulatory Authority opinion was that the causality for the event(s) of Covid, Covid vaccination was a lot worse and herniated disc a little worse with Pfizer BioNTech Covid-19 vaccine (Tozinameran) was Not Provided.  Assessment Results - Humira-Covid-19, Non-Health Care Professional, Not Reported - Humira-Herniated disc, Non-Health Care Professional, Not Reported - Humira-Vaccination complication, Market Authorization Holder (MAH) - Humira-Vaccination complication, Non-Health Care Professional, Possible - Pfizer covid-19 vaccination-Vaccination complication, Market Authorization Holder (MAH) - Pfizer covid-19 vaccination-Vaccination complication, Non-Health Care Professional, Not Reported - Pfizer covid-19 vaccination-Covid-19, Market Authorization Holder (MAH) - Pfizer covid-19 vaccination-Covid-19, Non-Health Care Professional, Not Reported - Pfizer covid-19 vaccination-Herniated disc, Market Authorization Holder (MAH) - Pfizer covid-19 vaccination-Herniated disc, Non-Health Care Professional, Not Reported - Humira-Covid-19, Market Authorization Holder (MAH) - Humira-Herniated disc, Market Authorization Holder (MAH)  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events .Case will be reviewed on receipt of FU information.