Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Pain
Clinical narrative: extremely dizzy; extremely sweaty; Passed out; body aches; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on [15Sep2021], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable nurse (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19) dose 1 via an unspecified route of administration in left arm on 14Sep2021 (at the age of 30-year-old) as single dose for COVID-19 immunization. The patient medical history included COVID about 4 months ago (May2021). The patient had none family medical history. The patient concomitant medications were none. The patient had no other vaccines within 4 weeks. The patient had no other vaccines on the same day as the suspect product. The adverse event was she got up with body aches, which she knows is totally normal, so she was going to get paracetamol (TYLENOL) and was extremely dizzy. She was very dizzy and had to lean against cabinet. She felt a little better and was walking back to her bedroom and she passed out. All this happened while walking to get the paracetamol. At the same time, she was extremely sweaty. The patient took 2 regular paracetamol (TYLENOL, lot number: AAA012, expiry: Sep2024, NDC: 5058049698. Strength: 325mg). The onset date of the event body aches on 14Sep2021 7AM. The onset date of the event extremely dizzy and extremely sweaty on 15Sep2021 7AM. The onset date of the event passed out on 15Sep2021 8PM or 9PM. The adverse events did not require a visit to emergency room, physician office. The seriousness criterion of the event extremely dizzy was reported as disabling. The seriousness criterion of the event extremely sweaty was reported as medically significant. The reporter assessed the event body aches non-serious. The reporter commented for the event passed out asshe didn't go to the hospital, but if she had injured herself with the fall she would have. Extremely sweaty was coming and going. Extremely Dizzy was gone and better. Her head was a little funny so she would say she had recovered with lasting effects. The patient was recovering from the event body aches. The patient recovered from the event extremely dizzy with sequel on 15Sep2021. The patient recovered from the event passed out on 15Sep2021. The patient did not recover from the event extremely sweaty. The reporter assessed the events extremely dizzy and sweaty related to the vaccine.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events cannot be 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.