Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Oxygen saturation, Oxygen saturation decreased, Skin discolouration, Tremor
Clinical narrative: Passed out; Stopped breathing/hard to breathe; Turned purple; Felt really tired; Sweating; Could hardly talk; Leg was shaking; Her oxygen was not 100 percent/ oxygen level was low; had an allergic reaction; This is a spontaneous report from a Pfizer sponsored program. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0198), dose 1 via an unspecified route of administration, administered in arm right on 24Jul2021 as (at the age of 36-year-old) DOSE 1, SINGLE for covid-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Concomitant medication included adalimumab (HUMIRA) taken for rheumatoid arthritis, start and stop date were not reported. No History of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations within 4 weeks. No AE following prior vaccinations. No Patient's Medical History including any illness at time of vaccination. No Family Medical History Relevant to AE.   On 24Jul2021 at 10:40 the patient experienced passed out, stopped breathing/hard to breathe, turned purple, felt really tired, sweating, could hardly talk, leg was shaking, her oxygen was not 100 percent/ oxygen level was low, had an allergic reaction. It was reported that Caller had the first dose of the Pfizer vaccine 24Jul2021. A few minutes later, she stopped breathing, turned purple and passed out. She ended up in the emergency room and is now reporting this. She had an allergic reaction to the Pfizer vaccine. Clarified with the caller the details previously provided. Stated that she ended up in the emergency room. Clarified that she is referring to the Pfizer Covid 19 vaccine. States that this happened Saturday. Today is the day she feels normal again. It was reported that Event Details: Not even 3 minutes after, she stopped breathing and her face turned purple. They gave her an Epi Pen and she passed out and woke up in the ambulance. The ambulance rushed her to the hospital because her oxygen was not 100 percent. She couldn't breathe, so they gave her the Epi pen. She couldn't even make it. She remembers sitting there and she started sweating and couldn't really talk or breathe. Her face turned purple, and her leg was shaking. Stated it was there, right after she got the shot, that they had given her the Epi pen. She last remembers waking up in the ambulance. Does not have a clue how long she was out for. It wasn't too long because her 12-year-old daughter was with her, yelling at her to wake up. She was not admitted to the hospital. It was just to the emergency room. Once she was at the emergency room, they gave her a steroid, Benadryl, IV and oxygen. Later that night, into the next day, she was released. They told her not to get the second one. Treatment: Nothing other than the Epi Pen, the Benadryl, IV, oxygen and steroid that were previously mentioned. It was reported that she is currently taking Humira for rheumatoid arthritis. On the information card, they had asked that. It was reported that She just felt really tired, and it was just hard to breathe. Sunday and yesterday, was better and today she feels like herself. Caller clarified that it had been 2 or 3 weeks since taking the Humira. She had wanted to wait on taking it before getting the vaccine. Tests: just had blood work not that long ago and everything was normal. The patient underwent lab tests and procedures which included oxygen saturation was not 100% on 24Jul2021. The outcome of events stopped breathing/hard to breathe and felt really tired was unknown, and outcome of all other events was recovering.  Follow-up attempts are completed. No further information is expected.