Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adrenocortical insufficiency acute, Arthralgia, Dizziness, Extra dose administered, Flank pain
Clinical narrative: received her third dose of the Pfizer COVID-19 Vaccine; received her third dose of the Pfizer COVID-19 Vaccine; experienced symptoms she relates to Adrenal Crisis; not be able to go back to sleep.; light headedness/feeling like she is going to pass out; severe muscle and joint pain; severe muscle and joint pain; bilateral flank pain; headache; has had nightly nightmares; Nausea; near syncope; This is a spontaneous report from a contactable other hcp.   A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), dose 3 via an unspecified route of administration on 13Aug2021 (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunization. Medical history included addison's disease from an unknown date and unknown if ongoing (she has a history of underlying Addison Disease), ongoing adrenocortical insufficiency acute (has had adrenal crisis before last night). The patient concomitant medications were not reported. The patient previously took first dose of bnt162b2 via an unspecified route of administration, on unspecified date (Batch/Lot Number: not reported) as for covid-19 immunization and experienced no symptoms, second dose of bnt162b2 via an unspecified route of administration, on unspecified date (Batch/Lot Number: not reported) as for covid-19 immunization and experienced as she did have a medicine taste in her mouth and then had weakness for about three weeks because of her Addisons, but did not have any pain, no fever, no chills, just weakness. She could tell her body was fighting it. On Aug2021, after receiving that booster she experienced symptoms she relates to Adrenal Crisis including sever light headedness, feeling like she is going to pass out, severe muscle and joint pain, bilateral flank pain, sever headache and has had nightly nightmares after that, which began the night of the injection and are still persisting, she has never had them before, they are pretty life like and medically debilitating because she cannot sleep , she will wake up at 2 am and not be able to go back to sleep. So she has had sever light headedness, feeling like passing out, severe muscle and joint pain, bilateral flank pain, sever headache and nightly nightmares. Do we have anything in our literature about Adrenal Crisis as far as Side effects. She says caller states she has had Addisons and has had adrenal crisis before and then she started getting these symptoms she felt like she was going into adrenal crisis. She did not get care at the emergency department because they were so packed with COVID-19 Patients, so she went home and treated herself, had she not been a medical person and knew who to treat herself, she felt like she would have been in full blown adrenal crisis and could have died. She feels like for future or other Addison Patients or adrenal insufficiency patients this needs to be researched, this is an SAE for her, she knows how to code she has worked in research for 30 years, so this was defiantly SAE. She gave herself a truck load of steroids last night/this morning States she was hypotensive as well which is a sing of adrenal crisis. And nausea, near syncope. The outcome of events received her third dose of the Pfizer COVID-19 Vaccine was unknown. The outcome of all the rest events was not recovered.  Information on the lot/batch number has been requested.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event adrenal crisis cannot be totally excluded.   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.