Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Chills, Endoscopy, Pain in extremity, Syncope
Clinical narrative: Left arm got sore; Shivering and shaking; Shivering and shaking; weak; her body just collapsed to floor; This is a spontaneous report from a contactable nurse (patient herself, retired LPN). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 04Jun2021 at 13:00 at the age of 72 years old (Batch/Lot Number: FE8F37, Expiration date: unknown) as dose 1, single for COVID-19 immunization. The vaccination facility type was a pharmacy/drug store; the vaccine was not administered at military facility. The patient weighed the odds of getting COVID-19 versus getting the vaccine. Relevant medical history included allergies and asthma, both from an unknown date and unknown if ongoing and tightness in her chest and maybe she had caught a bug with congestion treated with antibiotics, both from Feb2021 to an unspecified date. The patient's concomitant medications were not reported. The patient previously used her beclometasone dipropionate (QVAR inhaler). The patient had no family medical history relevant to adverse events (AEs). The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were administered on same date of the Pfizer suspect. The patient had no prior vaccinations (within 4 weeks). The patient stated she got the Pfizer vaccine last Friday, 04Jun2021 at 13:00, and at 23:00 she started shivering and shaking. She stated she took 1 acetaminophen (TYLENOL) and went to bed and first Tylenol helped. The patient stated she woke up and didn't know what time it was, but she was shivering and shaking again. She stated she had the Tylenol bottle in her hand and a cup of water and her body just collapsed to the floor on an unspecified date in Jun2021. She didn't know if her whole body shook or collapsed her to floor. She said that it seemed like her whole body shook a little bit, but she was not sure. The patient stated she could not get up. She tried to get up and waited for a bit and then was able to get herself up. The patient stated she did some research the day prior reporting and didn't see anything about the collapsing, but she knew the shivering and shaking were to be expected. She stated this was very scary and she couldn't control it. The patient was scared to death to get the second one. The patient stated she worked in a nursing home until it closed, and then they moved her to assisted living. The patient stated that by her research, she knew this was common side effect. She hoped she could be told more information to see if its safe to get the second vaccine. For the events shivering and shaking, the patient stated that sometimes she would stay up to watch a movie. She woke up and it had started again. She wasn't sure if it was after midnight on 04Jun2021 or if it was 05Jun2021 when it resolved. She stated she came in to get the Tylenol and she collapsed on her way back to bed and she was lucky she didn't hit her head. She knew at 2300, she got it to stop and as far as she remembered, the second time she went off to sleep. The patient said that the Tylenol got it under control. She was not shivering and shaking by the next morning. For the event collapse, the patient stated it could have been 05Jun2021. She stated she didn't faint at all and thought her body shook all over. She stated it took her whole body down and the bottle of Tylenol and water flew everywhere. She said that it was very scary. The patient had allergies and asthma and heard if you have COPD or lung issues that it could be much worse. The patient stated she told the pharmacist this before she received her first shot. She stated she had an endoscopy on 15Feb2021 and woke up and everything went fine, everything was negative. Later, on an unspecified date in Feb2021 she had tightness in her chest after she woke up. She called the GI doctor and they said she did so well through the endoscopy, that maybe she had caught a bug. She stated she later did some research and found that 5 percent of people got sick afterwards. She did end up taking 4 bottles of antibiotics and the congestion and everything came back. She stated she told the pharmacist the date of last pill and said everything was ok to get the shot. She stated she took her last pill on 17May2021. The patient mentioned taking her QVAR inhaler. The patient wanted to know if someone could tell her if its safe to get her second dose. The patient said that she was weak all day the day after she collapsed on an unspecified date in Jun2021. On an unspecified date, left arm got sore. The AEs did not require a visit to emergency room or a physician office. Therapeutic measures were taken as a result of shivering and shaking. The patient recovered from shivering and shaking on an unspecified date in Jun2021; she recovered from the event "her body just collapsed to floor" on an unspecified date; while the outcome of the rest of the events was unknown.; Sender's Comments: Based on temporal association and profile of the product, the contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) to reported events is possibly related.