Age: 69.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Feeling hot, Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: On 14Aug2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer BioNtech. On 28Nov2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNtech; Vaccination site pain; Feeling hot; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4231234-00 (AbbVie).  A 69 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 28Nov2021 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1154341) for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Daily Dose: 1) (1 in 1 Once), Route of Admin: 1)Intra-muscular), administration date: 14Aug2021, when the patient was 69 years old, for Covid-19 immunization, reaction(s): "Back surgery", "pain on left side of his back", "COVID-19", "COVID-19". It was unknown if patient was enrolled in a covid-19 vaccine trial.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (medically significant), outcome "unknown", described as "On 14Aug2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer BioNtech. On 28Nov2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNtech"; VACCINATION SITE PAIN (medically significant) with onset 2021, outcome "recovered" (2021), described as "Vaccination site pain"; FEELING HOT (medically significant) with onset 2021, outcome "recovered" (2021), described as "Feeling hot". The action taken for adalimumab was unknown.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of back surgery but had pain on left side of back unknown onset, back surgery but had pain on left side of back unknown onset, arm hurt after second Covid vaccine, felt hot after second Covid vaccine and Covid was not provided.  There opinion is that there is no reasonable possibility that the events of back surgery but had pain on left side of back unknown onset, back surgery but had pain on left side of back unknown onset, arm hurt after second Covid vaccine, felt hot after second Covid vaccine and Covid are related to Humira (Adalimumab).  Causality for Pfizer Biontech Covid-19 Vaccine (Tozinameran): Causality assessment from reporting person and from reporting unit was being Possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the events Vaccination Site pain, Feeling Hot and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION  the suspect drug BNT162B2. 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