Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Nausea, Vertigo, Vomiting
Clinical narrative: dizziness; nausea; I was so dizzy, flopped down to the chair wasn't able to walk; wasn't able to walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "dizziness"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "nausea"; FALL (non-serious) with onset 2021, outcome "recovered" (2021), described as "I was so dizzy, flopped down to the chair wasn't able to walk"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "recovered" (2021), described as "wasn't able to walk".   Additional information: Event details: Question: Caller is a 85 year old female patient, she expressed her concerns on receiving second dose (in 2 weeks, on 23Apr2021) of Pfizer Covid vaccine, first dose was received on 26Mar2021 and she experienced: "I didn't find until the 6th day in the morning at 7 am with dizziness and nausea, I was so dizzy, flopped down to the chair wasn't able to walk, had to call someone to help me, it lasted for 6 hours from 7 am to 2pm. Then went away. I read everything I can about this vaccine, the usual side effects people have experienced; fever and aches and so on and so forth, all of that, it says they appear 24 or 48 hours later. Vertigo and dizziness are not listed. I read those happen within 30 minutes after the administration. Did I have an allergic reaction. should I take second dose. One encouraging factor is, I was googling Pfizer it talks about there have been over 2 thousand deaths over certain period of time but were not determined to be directly related to the vaccine, the encouraging factor to me is I'm not gonna die from a severe allergic reaction. Have anybody else called you regarding dizziness after 6 days." E-transmitted possible duplicate AE. Caller stated: "called the Pfizer phone number they took all the information, I believe this was already documented but you may report it again". Response: Responded per documents attached and referred back to her HCP for medical advice. Responded per Fact Sheet for Recipients and Caregivers, section: WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE? Revised: 06 April 2021. Responded per FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE Section Adverse Reactions- Adverse Reactions in Post Authorization Experience. Revised: 06 April 2021. Responded per Full EUA Section 6 OVERALL SAFETY SUMMARY. Revised: 06 April 2021. As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.