Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Product administered at inappropriate site, Weight
Clinical narrative: Administered in left shoulder; has been having dizziness stating "my equilibrium is off"; This is a spontaneous report from a contactable consumer. This 65-year-old male consumer reported that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EL9269; expiry date: unknown) via an unspecified route of administration in the left shoulder as an unknown, single dose for COVID-19 immunization. The patients past medical history included in NOV 2020, the patient had COVID and he came close to not being able to speak to loved ones anymore. He wanted to get the vaccination and be protected. Mentioned he got the Flu Shot, Pneumonia shot, and figured he would get this one and try it. Hopefully nothing from it will kill him. Patient had Coronary artery disease (From: Unspecified To: Ongoing) Additional Information for Other Conditions: Diagnosed in 2002 sometime when had first bypass, open heart surgery. NDC number of COVID 19 Vaccine was Unknown. On unknown dates, the patient had Open heart surgery, Diabetes which was ongoing, cardiac patient, pain in back and back, bad back, nerves in back. The concomitant medications included sacubitril valsartan sodium hydrate (ENTRESTO) 2x/day (49mg/51mg tablet twice a day) for heart medication, ranolazine (RANOLAZINE) 1000 mg, 2x/day, (Lot #17200838 Exp; May2022), apixaban (ELIQUIS) 5 mg, 2x/day Placed on when had COVID because found out had a clot behind right knee and was ongoing, digoxin (DIGOXIN) for heart 125 ug, 1x/day was ongoing, rosuvastatin (ROSUVASTATIN) for Cholesterol as 20 mg, 1x/day was ongoing, clopidogrel (CLOPIDOGREL) for Blood thinner as 75 mg, 1x/day was ongoing, isosorbide (ISOSORBIDE) for the heart as 120 mg, 1x/day was ongoing, pregabalin (PREGABALIN) for Nervous system and back, bad back, nerves in back as 200 mg, 2x/day, amlodipine (AMLODIPINE) for Blood pressure as 10 mg, 2x/day was ongoing, metoprolol (METOPROLOL) for Blood pressure as 100 mg, 2x/day, fenofibrate (FENOFIBRATE) for Cholesterol as 145 mg, 1x/day was ongoing, pantoprazole (PANTOPRAZOLE) for the stomach as 40 mg, 1x/day was ongoing, glipizide (GLIPIZIDE) for Sugar as 10 mg, 2x/day was ongoing, metformin hcl (METFORMIN HCL) for For Sugar as 500 mg, 2x/day was ongoing, ropinirole HCL (ROPINIROLE HCL) for Restless leg syndrome as 1 mg, 1x/day, furosemide (FUROSEMIDE) for to how feel with bloated as 40 mg, 1x/day (40mg tablet one a day; can take up to two a day according to how feel with bloated) was ongoing, codeine phosphate, paracetamol (ACETAMINOPHEN AND CODEINE) for pain in back as 2 DF, 2x/day (average about 2 twice a day), zinc (ZINC) 50 mg, 1x/day, magnesium (MAGNESIUM) as 500 mg, 1x/day, vitamin c [ascorbic acid] VITAMIN C [ASCORBIC ACID] as 1000 mg, 1x/day was ongoing, VITAMIN D3 as 50 ug, 1x/day (50mcg 2000IU once a day) was ongoing, vitamin b complex (VITAMIN B) as 100 mg was ongoing. On 14Feb2021, the patient said that has been having dizziness stating "my equilibrium is off" and was asking how long the dizziness is expected to last. Additional Information for Other Conditions: Has had two open heart surgeries. Not sure exactly when the first one was. Believes it was 2002 or 2004. The second one was five years ago, so sometime in 2016. Patient history: Coronary artery disease (From: Unspecified To: Ongoing) Additional Information for Other Conditions: Diagnosed in 2002 sometime when had first bypass, open heart surgery. Investigation Assessment: No. The patient stated nothing has been done yet. He just felt that he is not 100 percent balanced. Having the dizziness. The patient did not require visit to Emergency Room and Physician's office. The patient did not had a vaccine since Oct last year. AE(s) following prior vaccinations: None. He can take all medications and has no reactions or anything to what is prescribed. There was a Product Complaint: description of Product Complaint: Description of complaint: While reporting an AE on the COVID19 Vaccine caller mentioned details about a concomitant product. He mentioned he could not see the name of the product. He initially provided it as Ranexa, but later clarified it was the generic, Ranolazine ER. He confirmed it was in a manufacturer bottle. Ranolazine ER- Lot #17200838 Exp; May2022.  Follow-up (15Feb2021): This is a follow up spontaneous from a contactable consumer. This 65-year-old consumer reported that: Dates for Dizziness was Ongoing. Additional Information for Concomitant Products, Product Complaint, medical history. The clinical outcome for the event was not recovered and was ongoing.