Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Chills, Fall, Tremor
Clinical narrative: This is a spontaneous report from a contactable Nurse (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as first dose, single dose for covid-19 immunisation. Medical history included asthma, hashimoto's, and allergy (she takes allergies shots). The patient's concomitant medications were not reported. The patient previously took QVAR for asthma. Patient got the shot at 1:00 PM on an unspecified date and at 11:00 PM starting shivering and shaking so she took one Tylenol in water and that seemed to start to get it under control. She woke up again, but she was not sure what time, and the shivering a shaking started again. She got up to go to the kitchen to get another Tylenol but she didn't make it back to bed. She stated, her whole body, not for sure about this, maybe it was shaking all over (not like the shivering and shaking), but whole body collapsed and she went to the floor and had no control over it. She did not pass out. She had not taken the second Tylenol yet at that point. She could not get back up for a few minutes and finally got back to bed and took a Tylenol. She did not see any information about someone collapsing like she did. It was a scary experience. She is scared to death to get the second shot. After the verbal response she stated that her muscles were not hurting or anything. She said she saw nothing about anyone collapsing when she was researching it. She does not think the collapsing had anything to do with the shaking and shivering. She stated she had taken allergies shots before and she knows what anaphylaxis is and that was not what she was experienced. She stated she had an endoscopy on "15Feb2021" and the next morning her chest was tight and everything was negative that she had checked. They thought maybe she picked up a bug. She had to take 4 bottles on antibiotics (ended on 17May2021) and after each one she would still get the congestion again. She stated she was out of the QVAR for asthma and that medication has really helped again. They told her after all of this it was okay to get the vaccine. The patient underwent lab test and procedure that includes endoscopy: negative on 15Feb2021. The outcome of event whole body collapsed and she went to the floor and had no control over it/ could not get back up for a few minutes was recovered; outcome of events chest was tight/ congestion, shivering and shaking all over was not recovered; and outcome of other events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; 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 events chest discomfort, illness, disability, fear of death, chills, tremor and shock like symptom 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.