Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral coldness, Throat irritation
Clinical narrative: numbness/numbness in arms and legs, like ice in her veins; tingling/tingling in arm and legs and feet; a cold sensation in her arms and feet; blood pressure was high/Blood pressure increased; her throat became itchy; lightheaded/dizzy; hot flash with her head; felt crappy; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received BNT162B2, via an unspecified route of administration, administered in Arm Right on 24Aug2021 10:00 (Lot Number: EW0177; Expiration Date: 14Sep2021), at the age of 35-years-old, as dose 1, single for COVID-19 immunization. Medical history included ongoing High cholesterol and COVID-19 from Oct2020 to an unknown date. Concomitant medications included atorvastatin taken for High cholesterol from Mar2021 and ongoing. The patient previously had Flu shot (her last shot was in Sept or Oct2020) for immunization. The patient experienced numbness/numbness in arms and legs, like ice in her veins, tingling/tingling in arm and legs and feet, a cold sensation in her arms and feet, blood pressure was high/blood pressure increased, her throat became itchy and lightheaded/dizzy on 24Aug2021 10:10; and hot flash with her head and felt crappy on 24Aug2021. The events ('numbness/numbness in arms and legs, like ice in her veins', 'tingling/tingling in arm and legs and feet', 'a cold sensation in her arms and feet' and 'hot flash with her head') were assessed as serious- medically significant. The events ('blood pressure was high/blood pressure increased' and 'her throat became itchy') were assessed as serious- disability. The event ('lightheaded/dizzy') was assessed as serious- disability, medically significant. The event ('felt crappy') was assessed as serious- non-serious. The clinical course was reported as follows: She is a registered nurse, but is calling as the patient. She is 35 years old. She received first dose of Pfizer COVID19 vaccine on 24Aug2021. She had a reaction and spoke to her healthcare practitioner. She experienced numbness, tingling, numbness and tingling in arms and legs and feet, states it felt like there was ice in her veins, cold sensation in her arms and in her feet, her throat became itchy, and her blood pressure was high/went up after they measured it. All of this occurred 10 minutes after receiving the injection. She confirmed details provided by transfer agent and wanted to add that within 10 minutes she got lightheaded and dizzy as well. Blood Pressure was High: it was 143/78 and then another time it was 142/80. It started to go down and then it was 131/78 thirty minutes after the vaccine. She had got a hot flash with her head and that is why they took the last blood pressure reading. The hot flash was only in her head and her head got really hot. Throat was Itchy: she has been taking antihistamines and the itchy throat has gone away. This morning without medication her throat was itchy. It felt like it wanted to come back. She was able to drink water and it felt better. The antihistamines were generic Zyrtec 10mg (lot number: PY920025, expiry: Apr2022) and generic Claritin 10mg (lot number is LVE24488 or 1VE24488. Expiry: Jan2021). She clarified that the itchy throat did go away with the medications. This morning she had not taken either one and she felt it a little bit and then the sensation went away after a few hours. Tingling: she has never had that happen before. It was bizarre. The throat being itchy worried her the most. She would say it was disabling because she didn't know what would happen. She didn't know if it would get worse or better. She saw her nurse practitioner for an appointment at 11:15 that morning. The vaccine was given at 10AM. Blood pressure was high: she would say disabling because if it went over a certain amount it could have caused a stroke. Outcome of Events: It all has resolved. Later in the day she didn't feel quite right. She kind of assumed it was normal because she had COVID before. She thought it was a reaction. She had antibody test before the vaccine and it showed no antibodies. She clarified that she had COVID in Oct 2020. She clarified for the events numbness, tingling, cold sensation in her arms and in her feet, blood pressure was high, dizzy, and lightheaded the stop date would have been 25Aug2021. Tuesday she woke up better, but felt crappy. Investigations: they tested her blood pressure and vitals. Her blood pressure was 127/78. Her pulse was fine and her sats were fine. The nurse practitioner did a physical assessment and felt caller's throat and looked in her throat. It wasn't growing, so she said unfortunately there was nothing she could do to undo the vaccine. She wants to know if she should get the second dose, and if she should she report to VAERS. States her blood pressure went up to 142/80 which she says is high for her. States she was treated with Benadryl, states she did not take any antihistamines today and she feels fine. She states her blood pressure returned to normal, her symptoms all resolved that same day but the itchy throat lingered, states it is improving today. States she has never had a reaction to anything before. States that during the event her O2 was 100%, her heart rate was normal and her blood pressure came down to 120/70 after about 30 minutes. Caller states she has had Covid before so she anticipated an immune response but had an antibody test and did not show any antibodies which is why she went ahead and felt more comfortable getting the vaccine. The patient underwent lab tests and procedures which included antibody test: no antibodies on an unknown date; blood pressure: 143/78, 142/80, 131/78, 127/78 and 120/70 all on 24Aug2021; Pulse/Heart rate: normal (Fine) on an unknown date, sats/O2: normal (Fine) % on an unknown date; and Vitals: unknown result on an unknown date. Therapeutic measures were taken as a result of tingling/tingling in arm and legs and feet , a cold sensation in her arms and feet, blood pressure was high/blood pressure increased, her throat became itchy, lightheaded/dizzy and hot flash with her head. The outcome of the event 'felt crappy' was unknown; event 'her throat became itch' was recovering; events 'a cold sensation in her arms and feet' and 'hot flash with her head' was recovered in Aug2021 and outcome of the other events was recovered on 25Aug2021.  Relatedness of drug to reactions/events: Reaction assessed: Numbness, Tingling, cold sensation in her arms and in her feet, throat became itchy, blood pressure was high, Dizzy and lightheaded; Source of assessment: Primary Source Reporter, Drug result: Related.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely 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.