Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor
Clinical narrative: Temperature up to 102.2; Numbness in fingertips; Chills; Nausea; Soreness in arm; Shaking too badly; This is a spontaneous report from a contactable Registered Nurse (patient) and Consumer (Patient's husband). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot# EK5730), via an unspecified route of administration in Left deltoid on 17Dec2020 14:00 at single dose for COVID-19 immunization.  Vaccination Facility Type: Hospital. Vaccine administered at site: No. Medical history included cervical dystonia. The patient had COVID back in Mar2020.  Symptoms were similar but she doesn't remember having the numbness in her fingertips. Family medical history: None. The patient's concomitant medications were not reported.  Additional vaccines administered on same date of Pfizer suspect: None. The patient previously took povidone-iodine (BETADINE) and experienced allergy to betadine.  Prior Vaccinations within 4 Weeks: None. AES follow prior vaccinations: None. The patient experienced temperature up to 102.2 on 18Dec2020 11:00, chills on 18Dec2020 10:00, numbness in fingertips on 18Dec2020 10:45, nausea on 18Dec2020, soreness in arm on 17Dec2020, shaking too badly in Dec2020.  No AES require a visit. Relevant tests: None. The patient received shot at 2PM. Had a little soreness in arm and took paracetamol (TYLENOL, Acetaminophen 500mg, Product strength and count size dispensed: 500mg caplets; quantity 100,  Provided 0CE3259A above date of Jan2022, Provided 484782EF17 from bottle, NDC: 49035-308-78, Manufacturer is Unknown) as pain reliever before bed, Dose: 1000mg on 17Dec2020 at 9PM. Took Ibuprofen (Product strength and count size dispensed: 200mg tablets; quantity 100, Provided 0DE2612A above date of Feb2022, Provided 604782EF8 from bottle, NDC: 49035-308-78, Manufacturer is Unknown) at dose: 400mg on 18Dec2020 at 4AM this morning. Having chills, temperature up to 102.2, numbness in fingertips and a little nausea. Clarified she is referring to the COVID Vaccine. The patient was shaking too badly. Symptoms started with Chills around 10AM 18Dec2020. Temperature was checked at 11AM Central time 18Dec2020 and checked now during report. Temperature was the same. Numbness in fingertips began 10:45AM 18Dec2020. Nausea had been on and on due to chills. Chills were aggravating the nausea. Had not thrown up. Temperature was going up and she was worried about getting dehydrated. Clarified EK5730 is from CDC Patient Card. Indication: Front line worker; lead nurse in Intensive Care and is in front of COVID all day long. A sample of the product is available to be returned, if requested, notified of mailer. Packaging is sealed and intact. The patient underwent lab tests and procedures which included temperature: 102.2 in Dec2020 and on 18Dec2020. The outcome of all the events was unknown. Serious: Yes, Seriousness criteria-Other medically important condition: No (as reported). Reporter seriousness for Temperature up to 102.2, Chills, Numbness in fingertips, Nausea: Medically significant. Relatedness of drug to reactions/events: Reaction assessed: Temperature up to 102.2, Chills, Numbness in fingertips, Nausea; Source of assessment: Primary Source Reporter; Source of assessment: Global Introspection; Drug result: Related. Verbatim event relatedness: COVID-19 Vaccine: Temperature up to 102.2, Numbness in fingertips-Related.; Sender's Comments: Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events, temperature up to 102.2, chills, numbness in fingertips, nausea, soreness in arm, shaking, are related to BNT162 vaccine. 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.