Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Allergic respiratory symptom, Bell's palsy, Device issue, Dyspepsia
Clinical narrative: Bell's palsy; Rheumatoid arthritis flare up; Numbness in toes; Fatigue; Heartburn; airborne allergies; Fibromyalgia; restricted in movement; misfire with a pen exploded; sprayed the in the eyes and face; This is a solicited report based on the information received by Pfizer (Manufacturer Control No: 21K-163-4062444-00). A contactable consumer (patient) reported A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), intramuscular, first dose on 23Jul2021 (at age of 49 years old), second dose on 13Aug2021 (at age of 50 years old), both as single dose for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date at unspecified dose for Moderate to Severe Rheumatoid Arthritis. The patient medical history and concomitant medications were not reported. A 50-year-old female with events of non-serious misfire with a pen exploded and sprayed the in the eyes and face, bell's palsy, numbness in the toes, fatigue, rheumatoid arthritis flare, heartburn, airborne allergies, fibromyalgia and restricted in movement with humira (adalimumab). On unknown dates, the patient experienced bell's palsy, numbness in the toes, fatigue, rheumatoid arthritis flare, heartburn, airborne allergies, fibromyalgia and restricted in movement. In 2021, the patient experienced misfire with a pen exploded and sprayed the in the eyes and face. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 23Jul2021, patient received 1st dose COVID-19 vaccine manufactured by Pfizer. On 13Aug2021, patient received 2nd dose COVID-19 vaccine manufactured by Pfizer. The action taken in response to the events for adalimumab was not applicable. The Outcome of the event Rheumatoid arthritis flare up was recovered on unknown date, misfire with a pen exploded and sprayed the in the eyes and face was recovered in 2021, for fatigue was recovering, for restricted in movement was unknown, for other events was not recovered. Causality for HUMIRA (adalimumab): The reporter's causality for the events of misfire with a pen exploded and sprayed the in the eyes and face onset in 2021, rheumatoid arthritis flare and misfire with a pen exploded and sprayed the in the eyes and face onset in 2021 with humira (adalimumab) was a reasonable possibility. The reporter's causality for the events of bell's palsy, numbness in the toes, fatigue, heartburn, airborne allergies and fibromyalgia with humira (adalimumab) was no reasonable possibility. The reporter's causality for the events of restricted in movement was not provided. For Humira: Accidental contact of product with eye Causality as per reporter (Drug/Vaccine): Reasonable possibility; Bell's palsy Causality as per reporter (Drug/Vaccine): No reasonable possibility; Numbness in toes, Causality as per reporter (Drug/Vaccine): No reasonable possibility; Fatigue, Causality as per reporter (Drug/Vaccine): No reasonable possibility; Rheumatoid arthritis flare up, Causality as per reporter (Drug/Vaccine): Reasonable possibility; Device issue Causality as per reporter (Drug/Vaccine): Reasonable possibility; Heartburn Causality as per reporter (Drug/Vaccine): No reasonable possibility; Allergic respiratory symptom, Causality as per reporter (Drug/Vaccine): No reasonable possibility; Fibromyalgia Causality as per reporter (Drug/Vaccine): No reasonable possibility; Mobility decreased Causality as per reporter (Drug/Vaccine): Not Reported. For PFIZER BIONTECH COVID-19 vaccine, Accidental contact of product with eye Causality as per reporter (Drug/Vaccine): Not Related; Bell's palsy Causality as per reporter (Drug/Vaccine): Not Related; Numbness in toes Causality as per reporter (Drug/Vaccine): Not Related; Fatigue Causality as per reporter (Drug/Vaccine): Not Related; Rheumatoid arthritis flare up Causality as per reporter (Drug/Vaccine): Not Related; Device issue Causality as per reporter (Drug/Vaccine): Not Related; Heartburn Causality as per reporter (Drug/Vaccine): Not Related; Allergic respiratory symptom Causality as per reporter (Drug/Vaccine): Not Related; Fibromyalgia Causality as per reporter (Drug/Vaccine): Not Related; Mobility decreased Causality as per reporter (Drug/Vaccine): Not Related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, the reported events were assessed as probably unrelated to the suspect product BNT162B2 and more likely due to the concomitant medications.