Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tremor, Ultrasound Doppler
Clinical narrative: She was freezing; Shaking; She cannot sleep; Her blood pressure was sky high; Internal Tremors; Aches and pains; Chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 10Feb2021 14:30 (Lot number: EL9266) at the age of 77 years as single dose for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing); "Compromised immune status" (unspecified if ongoing); "Respiratory illness" (unspecified if ongoing), notes: Verbatim: Respiratory illness; "Genetic /chromosomal abnormalities" (unspecified if ongoing), notes: Verbatim: Genetic /chromosomal abnormalities; "Diabetes" (unspecified if ongoing), notes: Verbatim: Endocrine abnormalities; "Obesity" (unspecified if ongoing), notes: Verbatim: Endocrine abnormalities. Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol increased; LISINOPRIL taken for hypertension; SOTALOL taken for atrial fibrillation; XARELTO; ALLOPURINOL taken for gout. Past drug history included: B-12 shot, start date: 12Feb2021, notes: It was in shoulder and she thinks it was in the right arm. Vaccination history included: Bnt162b2 (Dose:1, First Pfizer COVID vaccine 29Jan2021, Lot EL3248, Expiration is unknown.  Injected intramuscularly on left shoulder. , Time the vaccination was given: 1st one at 13:30), administration date: 29Jan2021, for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 11Feb2021 03:00, outcome "recovered" (12Feb2021), described as "Aches and pains"; CHILLS (non-serious) with onset 11Feb2021 03:00, outcome "recovering", described as "Chills"; TREMOR (non-serious) with onset 15Feb2021 03:00, outcome "not recovered", described as "Internal Tremors"; FEELING COLD (non-serious), outcome "unknown", described as "She was freezing"; TREMOR (non-serious), outcome "unknown", described as "Shaking"; INSOMNIA (non-serious), outcome "unknown", described as "She cannot sleep"; HYPERTENSION (non-serious), outcome "unknown", described as "Her blood pressure was sky high". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Received call from consumer regarding the Pfizer COVID vaccine. She had the second shot on 10Feb2021.  She is not certain if  her symptoms are due to the Pfizer COVID vaccine or not. She is trying to find out and has been talking to people. The first day after she received the second shot, she was fine. The second day, she got up in the morning and had aches and pains and chills, lots of chills. She still gets chilly a bit. Everything else went away after 24 hours. About 5 days later, and is ongoing, she has what they call an internal tremor. She has seen every doctor. She saw her heart doctor, neurologist, and nephrologist. She said it is an internal shaking that is like a tremor. She was talking to people and they said they had that a couple of hours after getting it and it went away. Hers did not go away. She does not have any information on any others that experienced that to report on.  It is terrible at night because she cannot sleep. She wanted to know if there have been any reports of anyone else experiencing this.  It is very frightening and very costly to go to these various doctors.  You don't know what is going on. On 12Feb2021, the aches and pains were gone. During the time she had chills, she had 3 blankets on her and she was freezing. It improved but on and off she gets chills. It could be 70 degrees outside and she is inside freezing. It is not constant. Internal tremors were described as being like you are sitting in a car with a constant shimmer and an idle in her abdomen.  It started in her abdomen and went to her butt and legs. On 15Feb2021 is when she first noticed. It was not until that night that she noticed it. She keeps a daily log for years and she noted it that she was shaking that night. She said in her journal that she had a bad night and was shaking all night. You can't see any shaking visibly though. She is 77 years old and she wanted to get the vaccine and is still glad she did.  She was hesitant about calling.  She has done too many testing and they say they don't know what is wrong with her.  She doesn't think she is going crazy and then said she sure hopes not. Everything test wise has been cleared.  She wore a 7 day heart monitor through Biotel. They just took it off a month ago. That is fine. CT head scan which was done on 13Apr2021 and that was fine. CT Abdomen and Pelvis on 13Apr2021 and that was fine.  Ultrasound of Carotid Artery on 25Mar2021 and that was fine.   ER or physician's office required:  She saw her cardiologist and thought it was maybe her heart.  Cardiologist put her on the 7 day heart monitor and everything checked out ok.  Her blood pressure was sky high because she could not sleep because of shaking.  They did not treat the blood pressure and said she needs to see her nephrology doctor.  That is (withheld) Nephrology.  She took her on and off of blood pressure medication.  She is susceptible to change of medications.  They took her off of medication because kidney function went really high.  She is not on anything now.  That medication that caused her BUN and creatine to almost double in one month was Hydrochlorothiazide.   She gets from pharmacist and does not have a lot or expiration.  It is in a pharmacy vial.  She was only on Furosemide 20 mg, no lot or expiration, for 2 days. It is also in a pharmacy vial.  The dose for Hydrochlorothiazide was 12.5 mg once daily.  She was on it for a month.  She has been taking Lisinopril for years.  From the 20 mg of Lisinopril that she was taking once daily, they upped to 40mg, or 20mg twice a day out of the same bottle. They supplemented it with the Hydrochlorothiazide 12.5mg for a month.  It is a diuretic.  She cannot take that and it caused her BUN and Creatinine to go up.  Then she took for 2 days, Furosemide 20mg.  The Lisinopril is in a pharmacy vial and does not have a lot or expiration.  She then saw (withheld) Neurology, Unknown address and phone.  They also performed Carotid Artery Doppler and that was fine.  She saw her via Skype and talked to her on the telephone and that is her trying to diagnose by skype and telephone.   She suggested she go to a psych place.  They are closed until Jun2021. She had a B-12 shot given on 12Feb2021. No manufacturer, lot or expiration. It was given at Medical Center. It was in shoulder and she thinks it was in the right arm. She said that the Lisinopril she was taking at the time that her blood pressure went up is not the same bottle she is taking now.  She does not know if it was the same manufacturer. She no longer has the previous bottle. She has had previous reactions to blood pressure medication 5-6 years ago.  She had hives, leg swelling, and red legs and arm.  It was just a reaction to whatever was in the medication. She tried 20-30 different medications for blood pressure before they put her on Lisinopril.  She does not have the names of those medications that caused that, and does not have lots or expirations for any of them. PSCC Communication:  PC Filed. Attempted to warm transfer caller to Pfizer Medical Information, however, due to extended hold time, caller opted to be transferred to hold place in the queue.  Provided caller with websites of www.cvdvaccine.com and www.pfizermedinfo.com, along with phone of #, option 3, with hours of 8a-8p, Monday-Friday, 9a-3p, Saturday and Sunday, prior to transfer, in the event of disconnection. Description of complaint: She was taking Lisinopril 20 mg once daily and when this shaking started and she was having trouble sleeping, her blood pressure went up, so they increased her to 20 mg twice day out of the same bottle. They supplemented it with Hydrochlorothiazide 12.5mg for a month.  It is a diuretic.  She cannot take that and it caused her BUN and Creatinine to go up.  Then she took for 2 days, Furosemide 20mg.  All of them are in a pharmacy vial and she does not have a lot or expiration. She said that the Lisinopril she was taking at the time that her blood pressure went up is not the same bottle she is taking now.  She does not know if it was the same manufacturer.  She no longer has the previous bottle.  Product strength and count size dispensed: Lisinopril 20 mg 30 count Additional lot numbers: none Is a sample of the product available to be returned, if requested (Y/N): No. She is not sure if the one she has now is the same manufacturer as when her blood pressure originally started going up.  Packaging sealed and intact: No No follow-up attempts are possible. No further information is expected.