Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: passed out from exhaustion; Fever; was unable to stand unassisted.; writhing in pain/so much pain; in and out of consciousness/passed out; tongue swelled up, making it hard to breathe and impossible to speak; tongue swelled up, making it hard to breathe and impossible to speak; tongue swelled up, making it hard to breathe and impossible to speak; sweating profusely; couldn't support her own body without tipping over.; seizure; lymph nodes in her left armpit swelled up so much that she couldn't put her arm down without extreme pain; lymph nodes in her left armpit swelled up so much that she couldn't put her arm down without extreme pain; chills; extreme muscle pain; spasms; This is a spontaneous report from a non-contactable consumer (patient herself). A 29-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm on 02Apr2021 13:15 (Batch/Lot Number: ER8737) as single dose, for COVID-19 immunisation.  Medical history was reported as no. Patient did not have COVID-19 prior to vaccination. Patient did not receive other vaccines within 4 weeks prior to COVID-19 vaccine. Patient's concomitant medication includes omeprazole, ethinylestradiol, levonorgestrel (MARLISSA), venlafaxine and gabapentin from unspecified dates, received within 2 weeks of vaccination, for unspecified indication. Patient historically took first dose of Pfizer BNT162B2 (Lot number: EN6204) on 13Mar2021 at 11:00 AM on the left arm for COVID-19 immunisation. Patient previously took hydrocodone bitartrate, paracetamol (VICODIN) on an unspecified date and indication and had allergy. On 02Apr2021, around 10pm, patient began having chills and extreme muscle pain and spasms, and the lymph nodes in her left armpit swelled up so much that she couldn't put her arm down without extreme pain.  By midnight (03Apr2021 00:00), patient had a fever and was unable to stand unassisted. She was writhing in pain and arching uncontrollably off the bed.  She believed in hindsight that this was a seizure as she went in and out of consciousness and her tongue swelled up, making it hard to breathe and impossible to speak. She was sweating profusely, and had to drink water constantly.  Her husband had to help her get to the bathroom because she couldn't support her own body without tipping over.  The chills and fever alternated all night, and she finally passed out from exhaustion at 03Apr2021 at 7am. The next 2 days, she was in a cycle of fever and chills again, and the fever got so bad that she seized twice more on Saturday (03Apr2021).  She had to take the day off work on Monday (05Apr2021) as she was still in so much pain that she could barely leave bed except to use the bathroom. Events were reported as life-threatening, immediate risk of death from the events. Patient was not hospitalized. Treatment for the adverse events were cool baths, naproxen (ALEVE) for fever and pain, and PEDIALYTE. COVID-19 was not tested post vaccination. Vaccination facility type was at a hospital. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.