Received Jun 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
everything is immunocompromised/getting infections easily; she experienced palpitations; shortness of breath; she has been getting infections easily; she has an Allergic stomach; she has an Allergic stomach; ended up in a car accident because of low energy; ended up in a car accident because of low energy; her skin color was fading; she collapsed/Caller states she collapsed and at that time/collapses, she collapsed multiple times; her adrenal gland was not working; This is a spontaneous report received from a Nurse from medical information team. A 60-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown), in hand for covid-19 immunisation. The patient's relevant medical history included: "NSAIDS" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Drug allergy: Morphine"; Hydrocodone, reaction(s): "Drug allergy: hydrocodone". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for COVID-19 Immunisation. The following information was reported: ADRENAL INSUFFICIENCY (medically significant) with onset 2022, outcome "not recovered", described as "her adrenal gland was not working"; SKIN DISCOLOURATION (non-serious) with onset Oct2022, outcome "unknown", described as "her skin color was fading"; CIRCULATORY COLLAPSE (medically significant) with onset Oct2022, outcome "unknown", described as "she collapsed/Caller states she collapsed and at that time/collapses, she collapsed multiple times"; ROAD TRAFFIC ACCIDENT (non-serious) with onset 19Feb2026, outcome "unknown", ASTHENIA (non-serious), outcome "unknown" and all described as "ended up in a car accident because of low energy"; IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "everything is immunocompromised/getting infections easily"; PALPITATIONS (non-serious), outcome "unknown", described as "she experienced palpitations"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; INFECTION SUSCEPTIBILITY INCREASED (non-serious), outcome "unknown", described as "she has been getting infections easily"; GASTROINTESTINAL DISORDER (non-serious), HYPERSENSITIVITY (non-serious), outcome "unknown" and all described as "she has an Allergic stomach". The events "her adrenal gland was not working" and "she collapsed/caller states she collapsed and at that time/collapses, she collapsed multiple times" required physician office visit. Therapeutic measures were taken as a result of adrenal insufficiency, immunodeficiency. Clinical course: Caller was a patient who received the Pfizer COVID vaccine in 2021 and had a "serious health problem" and patient wants to knew to whom does she have to file a report. Patient was on the line, reporting on Pfizer covid vaccine, patient got the vaccine back in 2021 since then patient experienced a serious health problem. Patient Details: Started event state: 2022 was diagnosis with adrenal gland stopped working. When queried if that was the first time reporting to safety, caller stated that she called maybe the wrong place before and this is the first time she got a chance to talk. Caller stated she collapsed and at that time she found out her adrenal glad was not working. She was getting, caller clarifies she was very active, very healthy person, there was no history of any diagnosis of any hypertension, diabetic or any thing or arthritis and states she didnt have any history of anything. Caller states after the vaccine she experienced palpitations, repeats, she started having palpitations, these palpitations started maybe 3 to 4 months after the second shot. Caller states the first shot she only had elevated temperature. It was the second shot where patient was started that these palpitations and shortness of breath and her skin color was fading, and clarified her skin color was fading and then she collapsed in Oct2022 and then find out; caller paused and stated that she was with severe gastric pain she was having severe gastric pain and vomiting and the pain and then after all the investigation they found out patient adrenal gland was not function. Now, patient is on a steroid since then. Because of her adrenal gland not functioning she had a work injury and nothing is healing, everything is immunocompromised. She was not able to work now. Patient could not be doing anything normal, she is walking slowly and cannot function properly, patient gets palpitations if get anything normally it makes her collapse. Call handler asked her to clarify what she just said and she stated, only with the help of steroid she is tolerating and states only with help of steroid she is living. Caller states, she is taking hydrocortisone, initially when hydrocortisone started she was taking 100mg and now it is 30mg daily now. 30mg is hardly doing anything, if patient is working, she cannot work in 2022 she was working barely. She used to call out and if she works anything normal she collapses, she collapsed multiple times. She can not drive, because if she drives it makes her sleep because of the adrenal gland. Caller states she ended up in a car accident because of low energy, the car accident was on 19Feb2026. Seriousness Criteria: When queried caller about seriousness patient stated that her energy the way it is she was working at that time continuously and after maximum of two days she can work but then has to get off, her employee made her work Monday through Friday, 5 days. That is when she had to stop working continuously, she was getting sick frequently. After two days working her energy is gone. Her work is not considering her health condition. They are not giving her restrictions according to the doctor which are to work two days on and two days off. Outcome: That was life time condition. Only could manage with rest. Management, she had to take the steroid in order be alive. She has to stay away from stress, stressful situations and infection. Caller states she has been getting infections easily. AE required a visit to the. Inquired any other diagnosed illnesses/medical history/chronic health conditions to report. Responded that nothing prior, but added she has an Allergic stomach, immunosuppressed and easily getting infections. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on the known product safety profile, known pathophysiology of the events and the available information, a causal association between the suspect product BNT162b2 (BNT162B2) and the reported events adrenal insufficiency, immunodeficiency, circulatory collapse, palpitations, dyspnea, skin discoloration, infection susceptibility increased, road traffic accident, gastrointestinal disorder, hypersensitivity and asthenia cannot be made there is not enough evidence to attribute the events and most likely related to intercurrent conditions and/or underlying medical conditions, hence assessed as unrelated. 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.
Medical History/Concurrent Conditions: Allergy to NSAIDs