Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Weight
Clinical narrative: she had a scratchy throat; On Saturday morning, she had a scratchy throat, and she has been coughing more; headache; eyes were itching and burning; eyes were itching and burning; she was so cold; bone-racking chills/ shivering; really high fever of 103.4F; pretty dehydrated; This is a spontaneous report received from a contactable consumer (patient). This 63-year-old female received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0169; Expiry date UNKNOWN), via intramuscular route of administration, in Arm left, on 07May2021 at 13:30 (at the age of 63-year-old), as a single dose, for Covid-19 immunization. The patient medical history included arthritis. The patient's concomitant medications included Tylenol for arthritis. Patient was previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0169; Expiry date UNKNOWN), via intramuscular route of administration, in Arm left, on 16Apr2021 13:30 (at the age of 63-year-old), as a single dose, for Covid-19 immunization; and Shingrix (She received the first dose of Shingrix about a month before in Feb2021 and 2nd She received the second dose of Shingrix on 18Mar2021). The patient did not receive additional vaccines on same date of the Pfizer Suspect. On 05Jun2021, the patient had really high fever reached up to 103.4 degrees Fahrenheit and she had bone-racking chills and was shivering which lasted whole Saturday night through Tuesday, 08Jun 2021. She could not take a shower because she was so cold. She had to crank up the air conditioning in her room up to 73 degrees, and she thought that was really odd. At home, she normally Kept her air on 68 degrees. She was hot natured. She went to bed that night and woke up late the next morning with a headache on 06Jun2021, and her eyes were itching and burning. She thought it was because of seasonal allergies, and all of the pollen in the air. On the same day (on sunday afternoon), she was so cold. She was sitting in her chair with a heating pad on her back, and two blankets on top of her. Her temperature at that point was 97.7 degrees Fahrenheit. She felt so hot that she kicked everything off, and she still felt hot. She rechecked her temperature, and it was 102.2 degrees Fahrenheit. She took a Tylenol for arthritis and she took that anyways, but she took an extra dose in the middle of the day for her fever. The fever lasted for a while. She checked her temperature a couple of hours later, and her temperature was 103.4 degrees Fahrenheit and clarified that this was on 06Jun2021. It was a pretty quick spike, by that same evening, her temperature was 99.9 degrees Fahrenheit. But that was still feverish for her, normal for her was 96.8-97.2 degrees Fahrenheit. 97.7 degrees Fahrenheit was on the higher range for her. She was freezing all night and woke up in the middle of the night with shivering chills. This was not normal for her. On 06Jun2021, she had headache which lasted all day Tuesday till 08Jun2021. On Monday, 07 Jun 2021, she was in bed bundled up. Her temperature the rest of the time was 98.7 degrees Fahrenheit or 98.9 degrees Fahrenheit. Seriousness criteria: Unknown, she states that is why she called today. She woke up on Wednesday, 09Jun2021, and still had a headache. But once she got to moving around, the headache went away. She thinks she got a headache because she was pretty dehydrated on an unspecified date in Jun2021, and the fever dried her out. The reporter (patient) stated that her husband had Ankylosing Spondylitis, and took an immunosuppressant, so he was a very vulnerable person hence her husband wanted her to get the vaccine, so she went with it. Her and her husband got it at the same time. On an unspecified date in Jun2021, she went to get tested for covid this week. On 12Jun2021 (Saturday morning), she had a scratchy throat, had cough and she had been coughing more. This was infrequent with other symptoms, and she was attributing them to allergies. She thought, she was getting her annual case of bronchitis. The patient stared that her weight was 188.2 pounds and had recently lost 88 pounds and she was happy to say she was under 200 pounds and stated that she had more weight to lose. There was no emergency room and physician Office visits for the events. The patient received treatment for the fever only with Tylenol. The patient underwent lab tests and procedures which included Really high fever showing body temperature at 103.4 Fahrenheit, on 05Jun2021, 97.7 degrees Fahrenheit on 06Jun2021, 102.2 and rest of the time was in between 98.7 to 98.9 on an unspecified date in Jun2021; Covid test got negative for both rapid test and PCR test, on an unspecified date in Jun2021; and weight showed under 200 pounds as recently lost 88 pounds on an unspecified date in Jun2021. The outcome of the events fever of 103.4f (pyrexia) and chills was resolved on 08Jun2021, the outcome for headache was resolved on 09Jun2021, the outcome for cough resolved on an unspecified date in 2021, for throat irritation was resolving while the outcome for eyes were itching and burning, pretty dehydrated, and feeling cold was unknown.; Sender's Comments: The causal association between the event Pyrexia and Cough and the suspect drug BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) 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.