Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Meniscus injury, Pain in extremity, Vaccination site pain
Clinical narrative: 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): 21K-163-4168674-00 (RA). A 64 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 26Feb2021 (Batch/Lot number: unknown) as dose 1, single, intramuscular, administration date 15Mar2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 17Aug2021 (Batch/Lot number: unknown) as dose 3, (booster) single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease, rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENISCUS INJURY (medically significant) with onset 2021, outcome "recovering", described as "Meniscus tear of knee"; VACCINATION SITE PAIN (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "Vaccination site pain"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "Sore arm". The action taken for adalimumab was unknown.  Clinical Course: Solicited report by a consumer of a 64 year old male with events of two torn meniscus in knee and non-serious sore arm with covid vaccine with Humira (Adalimumab). There was no reported medical history. In 2021, the patient experienced two torn meniscus in knee. in oct2021, the patient experienced sore arm with covid vaccine. In Oct2021, the sore arm with covid vaccine resolved. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. The patient had right knee surgery on 22Sep2021 for two torn meniscus and was now in recovery as of 18Nov2021. It was unknown if he was enrolled in a COVID-19 Vaccine Trial. On 26Feb2021, he received first dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 15Mar2021, he received second dose COVID-19 Vaccine manufactured  by Pfizer/BioNTech. On 17Aug2021, he received booster COVID-19 Vaccine manufactured by Pfizer/BioNTech. Causality for Humira (Adalimumab)The reporters causality for the event(s) of two torn meniscus in knee was not provided. The reporters causality for the event(s) of sore arm with covid vaccine with Humira(Adalimumab) was no reasonable possibility. Regulatory Authority opinion is that there is no reasonable possibility that the events of two torn meniscus in knee and sore arm with covid vaccine are related to Humira (Adalimumab).  Seq.No.: 1 Humira (Solution for injection in pre-filled pen) (Adalimumab), Causality 1) Meniscus tear of knee(Meniscus injury) Action(s) taken with drug : Unknown Causality as per reporter (Drug/Vaccine) : Not reported Causality as per Mfr.(Drug/Vaccine) :  No reasonable possibility Dechallenge : N/A 2) Vaccination site pain(Vaccination site pain) Action(s) taken with drug : Unknown Causality as per reporter (Drug/Vaccine) : No reasonable possibility Causality as per Mfr.(Drug/Vaccine) :  No reasonable possibility Dechallenge : N/A   Seq.No. : 2 Drug : Pfizer Biontech Covid-19 Vaccine(Tozinameran) Causality 1) Meniscus tear of knee(Meniscus injury) Action(s) taken with drug : Unknown Causality as per reporter (Drug/Vaccine) :Not reported Dechallenge : N/A 2) Vaccination site pain(Vaccination site pain) Action(s) taken with drug : Unknown Causality as per reporter (Drug/Vaccine) :Probable Dechallenge : N/A  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 known safety profile of the vaccine BNT162B2, a Causal relation between the events  Vaccination site pain, Pain in extremity and the administration of the vaccine cannot be excluded. A Causal relation between the event Meniscus injury and  the administration of the vaccine is unlikely.