Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Fatigue, Headache, Illness, Myalgia
Clinical narrative: throbbing headache; exhausted; muscle aches; sick; fatigue; hands had tremors; body aches; This is a spontaneous report from a contactable consumer. This 68-years-old Female consumer reported herself that:  Country: Report about covid vaccine: Yes. Reporting type: AE. Reporter type: Non-healthcare Professional reporting for a patient. Patient name: (name). DOB: ## Age group: Elderly (65+ Years). Current age: 68. Current age unit: Years. Gender: Female. Is pregnant: No. Race: (race). Address street: (address). City: (city). State: (state). Zipcode: ### Phone no.: ## Email: (mail id).  Covid vaccine details:  Product=COVID 19 Brand=Prizer. Lot number= EN6198. Lot unknown= False Administration date=03Mar2021 Administration time=10:15 AM Vaccine location= Right arm. Dose number=1  Facility type vaccine: (name) Facility name: (name) Facility address street: (address) Facility city: (city)  Facility state: (state)  Facility zipcode: ### Facility country:  If other vaccine in four weeks: No. Other medications in two weeks: Albuterol Inhaler.  Adverse event: I had a throbbing headache in the back of my head that has lasted 12 days. It was the worst headache I have ever had and had terrible fatigue. My hands had tremors and I had body aches for 3 days. Headache so bad I had to get a CT scan Adverse event start date: 05Mar2021 Adverse event start time: 12:00 AM Adverse event country:   Ae resulted in: Doctor or other healthcare professional office/clinic visit. If patient recovered: Recovering If treatment ae: Yes. Ae treatment: CT scan, Blood work.  If covid prior vaccination: No. If Covid tested post vaccination: Yes. Covid test post vaccination: Covid test type post vaccination=Nasal Swab Covid test name post vaccination=Rapid Test Covid test date=12Mar2021 Covid test result=Negative.  Known allergies: No. Other medical history: Cancer in remission for 6 years.  Follow-up (23Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that included:  Patient Details: Initials: (name). Sex: Female. Is the patient also the reporter? Yes Date of birth: ### Country of Incidence:   Reporter Details: Reporter type: Consumer or other non health professional. Reporter type details: self. First name: (name). Surname: (name). Address line:  (address). Town / City: (city). County / State: (state). Post code / ZIP code: ## Country:  Telephone: ## Email address: (mail).  Primary / Prescribing Healthcare Professional Info: Country:  Event Details:  Company aware date: 23Mar2021 Report type: Follow-up Report no new event   Products: Suspect products: COVID Vaccine: NDC number: Not Provided. Lot Number: Not Provided. Reason for no lot number: Other: follow up report and she previously provided it. Expiry date: Not Provided.  History: Concomitant Products: Other Products Not Provided. Other conditions: Other Conditions Not Provided.  Investigations: Investigations Not Provided.  Additional Context: Other Reference(s): No Transfer to agency Required.  Additional Context: She had her first shot three weeks ago tomorrow. She is scheduled to get second one tomorrow. She was sick for 13 days after the first one. She was so sick. The headache was so bad the doctor sent her for a CT scan of her head. The headache was at the crown of the head and down into the back of the head. She never had a headache in the back of her head like that before. Her doctor wanted to make sure no bleed. It started lightly for two days and got worse and worse. It was 13 days before it went away. On top of that she had muscle aches in the beginning, but those went away. She was exhausted. She has already sent this in to Pfizer. She is questioning if she should get the second dose. She did get a COVID test and that was negative. She has done what she was supposed to do. Reference Number: she doesn't have a reference number. She has been on hold for two hours. She held because she feels this is very important. She really don't want to end up in trouble because she gets the second vaccine. Her doctor said it is a tough call. When she has to go get a shot and walk in with an EpiPen it gives her an ugly feeling. Her doctor is really not thrilled. She is darned if she does and darned if she doesn't. She knows one lady that died two days later and another one that died a couple of days later. They were both in another place. One was the wife of a surgeon. She thinks it has been reported. One was a community leader. They are waiting on the autopsies. Caller declined to proceed with a report for the two women that died after receiving the COVID vaccine. One died in the bathroom on the second day. The other is a doctor's wife and she passed one to two days after the shot. Neither was expected. Caller doesn't have their health records. She doesn't live in the same town. She is sure they are aware at Pfizer that this happened. She can't find anything. She didn't get a reference number from Pfizer. She gave the lot number when she reported it before because she remembered she had to get the card. She also reported it through (name). (name) gave her a confirmation number of ## on 13Mar2021. She think she would have filed them at the same time, so she probably reported it to Pfizer on 13Mar2021. Caller is going to delay the second shot. She knows she has up to 42 days. to get it.  Is there a product complaint to report: No. Is there a medical information request: Yes. Please describe the medical information request: She is questioning if she should get the second dose. Is this an Other report: No Site: Call Centre # Contact Centre Ref: ##,  ##  Follow-up (23Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that included:  Primary source(s) of information: Reporter title: (title). Reporter given name: (name). Reporter family name: (name). Reporter's postcode: ### Reporter country code: Qualification: Consumer or other professional. Reporter Phone Number: ###  Patient characteristics: Patient: PRIVACY.  Sex: male. Patient First Name: (name). Patient Last Name: (name).  Drug(s) Information: Characterization of drug role: suspect. Proprietary medicinal product name: Pfizer-Biotech COVID-19 Vaccine. Identification of the country where the drug was obtained:  Country of authorization/application:   Active Substance Information: Active Drug substance names: Pfizer-Biotech COVID-19 Vaccine.  Narrative case summary and further information: Case narrative: Originating AE Request: REQ-# Attachments: 1 Reporter Subtype: Patient. PQC Present: No. AE Present: Yes.  PQC Details:   Request Name: REQ-# Product: Pfizer-Biotech COVID-19 Vaccine. Question: Potential Duplicate case: Caller stated she reported this online to Pfizer safety on 13Mar. Caller received the first dose of the Pfizer covid vaccine on 03Mar and it made her sick for 13 days. She had a really bad headache for 9 days and had a CT scan done for the headache, she was in the hospital, was exhausted. Caller is scheduled for second dose tomorrow. caller wanted to know if the side effects lasted that long after the first dose with other people. caller is a 68 years old female. Caller stated she is not sure about if the 2 females who received the covid vaccine were Pfizer covid vaccine or not but they died in (place name). Caller refused to provide any other information including age of the patients. Caller stated that one of them was a Doctor's wife.  Request Name: REQ-# Product: Pfizer-Biotech COVID-19 Vaccine. Question: Question: Caller wanted to know how many people experienced severe headache and were they given the second dose.