Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Peripheral swelling
Clinical narrative: swelling in her feet and legs; couldn't even raise her head from the dizziness; nausea/ raising her head up it made her nauseous; This is a spontaneous report from a contactable Consumer. This (Age: 75, Units: Unspecified) female consumer reported that:  Originating AE Request: REQ-# Attachments: 1 Patient Age: 75 Reporter Subtype: Patient PQC Present: No AE Present: Yes PQC Details:  Request Name: REQ-# Product: Pfizer-Biontech Covid-19 Vaccine Question: E-transmitting possible duplicate AE (this report may contain additional information not shared during the warm-transfer). Call transferred, ID/ Report ID. Caller reported extreme dizziness and nausea. It hit her 3 hours after the 1st dose. She was 'flat on (her) back' for 6 hours and couldn't even raise her head from the dizziness and was nauseated when she did.  She also reported her aunt could not take more than 1/4 aspirin if not she got overwhelmed. Caller would like to know if she should get the 2nd dose of the covid vaccine with her history of side effects. Request Name: REQ-# Product: Pfizer-Biontech Covid-19 Vaccine Question: Caller would like to know if I have heard of any reports of swollen feet and legs after the covid vaccine. Also, referenced EUA Fact sheet for recipients under section WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE?  LAB-#-# Revised: Dec2020 Request Name: REQ-# Product: Pfizer-Biontech Covid-19 Vaccine Question: Caller would like to know if the dose of the covid vaccine is based on weight. She weighs 110 lbs. Referenced EUA Fact sheet for HCPs under Summary Of Instructions For Covid-19 Vaccination Providers section: The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection administered as a series of two doses (0.3 mL each) 3 weeks apart. LAB-#-# Revised: Jan2021 Request Name: REQ-# Product: Pfizer-Biontech Covid-19 Vaccine Question: Caller does not think the covid vaccine dose should be the same for everyone. Request Name: REQ-# Product: Pfizer-Biontech Covid-19 Vaccine Question: 'Thank you for helping me'  Follow-up (08Feb2021): This is a follow-up spontaneous report from a contactable Consumer. This consumer reported that: Patient characteristics: Sex: Female  Reaction(s)/Event(s): Reaction/event as reported by primary source: extreme dizziness    Reaction(s)/Event(s): Reaction/event as reported by primary source: raising her head up it made her nauseous    Reaction(s)/Event(s): Reaction/event as reported by primary source:  swelling in feet and legs    Reaction(s)/Event(s): Reaction/event as reported by primary source: feet always freezing, but have been warm due to the swelling    Reaction(s)/Event(s): Reaction/event as reported by primary source: went to see the doctor    Reaction(s)/Event(s): Reaction/event as reported by primary source: given water pills     Drug(s) Information: Characterization of drug role:  (Suspect)   Proprietary medicinal product name: Covid vaccine    Action(s) taken with drug: Unknown  Drug(s) Information: Characterization of drug role:  (Suspect)   Proprietary medicinal product name: unspecified water pills    Batch/lot number:  ELD9261    Action(s) taken with drug: Unknown  Narrative case summary and further information Case Narrative  Selected Report Type: Initial Is the patient also the reporter? Yes Reporter type: Consumer or other non health professional Reporter telephone: # Reporter alternative telephone: # Reporter email: (email id) Primary / Prescribing Healthcare Professional Info HCP postal address:  Dates for extreme dizziness: (From: Unspecified To: Unspecified) Dates for raising her head up it made her nauseous: (From: Unspecified To: Unspecified) Dates for swelling in feet and legs: (From: Unspecified To: Unspecified) Dates for feet always freezing, but have been warm due to the swelling: (From: Unspecified To: Unspecified) Dates for went to see the doctor: (From: Unspecified To: Unspecified) Dates for given water pills: (From: Unspecified To: Unspecified) Is Covid vaccine a Pfizer product? Yes Covid vaccine manufacturer: Unspecified Dates for Covid vaccine: (Start: Unspecified Stop: Unspecified) NDC number of Covid vaccine: Not Provided Expiry Date of Covid vaccine: Not Provided Is unspecified water pills a Pfizer product? Unspecified unspecified water pills manufacturer: Unspecified Dates for unspecified water pills: (Start: Unspecified Stop: Unspecified) NDC number of unspecified water pills: Not Provided Expiry Date of unspecified water pills: Not Provided  Other Products: Not Provided Patient History: Not Provided Investigation Assessment: Not Provided  Additional Context: Caller reports she had the first Covid shot about 2 weeks ago and is due for it again this Friday. Had no reactions afterwards except 3 hours afterwards she had a reaction in the severe list, it was extreme dizziness and when raising her head up it made her nauseous and that lasted about 6 hours.   Is not sure if anyone has said anything else about swelling in the feet and has never had swelling in her feet or legs in her life. Since after the shot she has had the swelling in her feet and she went to see the doctor. The doctor gave her water pills and she is a little concerned because her feet are always freezing and she has never had warm feet in her life, but since they are swollen they are warm. Does not know what to do about the second shot because she heard you are more likely to have side effects worsen. Doesn't know if she wants worsening side effects and doesn't understand now the same shout is given to someone that weighs 110 pounds as a person who weighs more than 110 pounds. Are medications based on weight.  When clarifying which vaccine, caller provides lot number from card. No further details provided. Declines to provide an address, but provides email address. Declines report and would like questions answered.