Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Fatigue, Malaise, Pain, Therapeutic product effect decreased
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4299082-00 (RA), 20220427755. A 31-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), from 17Dec2021 (Batch/Lot number: unknown) to 25Mar2022 at 40 mg (citrate free (40 mg,1 in 2 wk.)), subcutaneous for ankylosing spondylitis. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing); "Ankylosing Spondylitis" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Glycopyrrolate, reaction(s): "Glycopyrrolate Allergy"; Benadryl, reaction(s): "Benadryl allergy"; Dye free Benadryl, reaction(s): "Dye Free Benadryl Allergy". Vaccination history included: Janssen CoviD-19 vaccine (JANSSEN COVID-19 VACCINE, Dose 1, Intramuscular), administration date: 01Apr2021, when the patient was 30-year-old, for Covid-19 immunization; Janssen CoviD-19 vaccine (JANSSEN COVID-19 VACCINE, Dose 2, Intramuscular), administration date: 16Oct2021, when the patient was 31-year-old, for Covid-19 immunization. The following information was reported: ASTHMA (medically significant) with onset 17Dec2021, outcome "recovered" (25Mar2022), described as "Asthma aggravated"; THERAPEUTIC PRODUCT EFFECT DECREASED (medically significant) with onset 17Dec2021, outcome "recovered" (25Mar2022), described as "Lack of drug effect"; FATIGUE (medically significant), outcome "not recovered", described as "Fatigue extreme"; MALAISE (medically significant), outcome "unknown", described as "Feeling unwell"; PAIN (medically significant), outcome "unknown". The action taken for adalimumab was dosage permanently withdrawn on 25Mar2022. The reporter's assessment of the causal relationship of "lack of drug effect", "fatigue extreme", "feeling unwell", "asthma aggravated" and "pain" 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. Additional information: Solicited report by consumer of a 31 year old male with events of non-serious Fatigue /Tried/Extremely drained more than usual/ Fatigue was extreme, Felt poorly, felt that asthma issues got worse /Severe side effects regarding asthma/asthma would flare up, Lack of effect and pain with Humira (Adalimumab). On unknown dates, the patient experienced fatigue/tired/extremely drained more than usual/fatigue was extreme, felt poorly and pain. On 17Dec2021, the patient experienced felt that asthma issues got worse/severe side effects regarding asthma/asthma would flare up and lack of effect. On 25Mar2022, the felt that asthma issues got worse/severe side effects regarding asthma/asthma would flare up and lack of effect resolved. Janssen Covid-19 vaccine (Covid-19 vaccine NRVV ad26 (injection #) and Pfizer BioNTech Covid-19 vaccine (Tozinameran) were also considered suspect. The patient's past medications include: Glycopyrrolate for unknown indication and Benadryl for unknown indication. Causality for Humira(Adalimumab): The reporter's causality for the event(s) of fatigue/tired/extremely drained more than usual/fatigue was extreme, felt poorly and pain was not provided. The reporter's causality for the event(s) of felt that asthma issues got worse/severe side effects regarding asthma/asthma would flare up and lack of effect with Humira (adalimumab) was a reasonable possibility. On 08Apr2022, received updates to medical history, event information, reporter opinion of causality, suspect drug information, past drug information and narrative description. The events of "felt poorly", "lack of effect" and "pain" were added. The event of "fatigue/tired/extremely drained more that usual" was amended to "fatigue/tired/extremely drained more than usual/fatigue was extreme". The event of "feels that asthma issues were getting worse" was amended to "felt that asthma issues got worse/severe side effects regarding asthma/asthma would flare up". The event of "extremely shortness of breath/hard time breathing" was removed. Causality for PFIZER BIONTECH COVID-19 VACCINE: Fatigue extreme (Fatigue), Feeling unwell (Malaise), Asthma aggravated (Asthma), Lack of drug effect (Drug ineffective), Pain (Pain) Causality as per reporter (Drug/Vaccine) was Possible. Causality for Janssen Covid-19 Vaccine: Fatigue extreme (Fatigue), Feeling unwell (Malaise), Asthma aggravated (Asthma), Lack of drug effect (Drug ineffective), Pain (Pain) Causality as per reporter (Drug/Vaccine) was Possible. Company Remarks (sender's comments) VO:20220427755-Covid-19 vaccine ad26.cov2.s-lack of drug effect. The event (s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically special satiation, therefore, this event(s) is considered not related. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (26Apr2022): This is a spontaneous follow-up report based on the information received by Pfizer (Mfr. Control No. 20220427755(0)). A contactable 31-year-old male consumer (Patient) reported that Updated information included: RMH was added seriousness criteria. 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 Limited information available therapeutic product effect is assessed unlisted. Possible contributory role of events fatigue, malaise, asthma, pain and the suspect BNT162B2 cannot be excluded for the reported events. 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.