Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Investigation, Rash, Weight increased
Clinical narrative: Very sick; gained 20 pounds; Coughing and coughing; rash on her chest; Has asthma; Inflammation; Allergies; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Mar2021 15:00 (Lot number: EN6198) at the age of 80 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN taken for hypercholesterolaemia (ongoing); VALSARTAN taken for hypertension (ongoing); GABAPENTIN taken for arthralgia (ongoing); METOPROLOL taken for hypertension (ongoing); OMEPRAZOLE taken for oesophageal disorder (ongoing). Vaccination history included: Covid-19 vaccine (Patient had the first dose of the Pfizer COVID 19 vaccine on at 16: 00PM in the right arm, lot number  EL9269), administration date: 15Feb2021, when the patient was 81 years old, for Covid-19 immunization, reaction(s): "Cough", "Gained 20 pounds", "Rash on her chest", "Inflammation", "Allergies". The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "not recovered", described as "Very sick"; WEIGHT INCREASED (non-serious) with onset 2021, outcome "unknown", described as "gained 20 pounds"; COUGH (non-serious) with onset 2021, outcome "not recovered", described as "Coughing and coughing"; RASH (non-serious) with onset 2021, outcome "unknown", described as "rash on her chest"; ASTHMA (non-serious) with onset 2021, outcome "unknown", described as "Has asthma"; INFLAMMATION (non-serious) with onset 2021, outcome "unknown", described as "Inflammation"; HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "Allergies". The events "very sick", "gained 20 pounds", "coughing and coughing", "rash on her chest", "has asthma", "inflammation" and "allergies" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of cough, rash, inflammation, hypersensitivity.  No follow-up attempts are possible. No further information is expected.  Additional information: The patient did not have any other vaccines 4 weeks prior to Vaccination. Family Medical History Relevant to AE(s): none.The patient asked regarding the first dose of the Pfizer Covid 19 vaccine. Patient had the first dose of the Pfizer COVID 19 vaccine on  15Feb2021 at 1600PM in the right arm, lot number  EL9269; and received the second dose on 05Mar2021 at 1500PM in the right arm, lot number EN6198. She would like to know what is in it because she is very sick, coughing and coughing. Added she has been to her pulmonary doctor and has changed the medications and she still has the cough. It comes and goes every few minutes and sometimes it keeps her awake until four in the morning. She has taken all kinds of cough medications and has gained 20 pounds. She is also taking codeine and it is helping but not much. Stated nothing helps, her nothing at all. They gave something for allergies, nose drops for inflammation and other pills. She has to go to the pulmonary doctor tomorrow. Three weeks ago she gave her several medication and nothing is working. They are talking about a third dose for people over sixty, she is asking about a recommendation for the third dose. the The patient started to experience the cough within a day or so of the first vaccination. Reported the medications they have given her for her cough include: Promethazine with codeine esyp; no NDC, lot or expiration date seen on product dispensed in a pharmacy vial, Delsym; UPC is #; Lot 290321; Expiration Aug2023.  Zyrtec Alert Allergy; UPC 5200042; Lot AC12273; Exp Dec2022, Ipratropium 0.06% Atrovent Spray, 15mi, by (withheld) caller does not see NDC, lot or expiration date on manufacturers package with a pharmacy label over it. Provided bar code #, Expiration date 29Jun2029, Inhaler Bredrin 3 AstraZeneca; Provides bar code ,# NDC # Expiration date Sep2022; Lot 6100194D00, Inhaler Combivent; caller does not see NDC, lot or expiration date on manufacturers package with a pharmacy label over it. Provides # barcode.  Fluticasone Propionate 30mg; NDC #; lot 372771; Expiration Mar2022. Provides # from the bar code.  Mentioned the doctor advised her to continue Gabapentin 300mg take two daily which she has been taking for 10 years.  The patient also stated she has rash on her chest, doesnt know what is going on. She went to an infection doctor who gave her a cream to put on the rash and it is not really helping Ketoconazole 2% lot AB44114; exp Mar2023, caller does not see NDC on manufacturers package with a pharmacy label over it. Tests: chest x-rays a lot of them all good; two breathing tests two weeks ago, normal. Patient Age at Time of Vaccination in Months: or Years: 81  Adverse Event: coughing, rash. Time of Onset: (24-hour clock): Feb2021. The patient visited to the Physician office. Is there a Product Complaint: Yes. Description of complaint: Patient reporting an AE for the Pfizer COVID 19 vaccine mentioned she has been to her pulmonary doctor and has changed the medications and she still had the cough, she has taken all kinds of cough medications. She is also taking codeine and it is helping but not much. Stated nothing helped, her nothing at all. Also stated she has rash on her chest, an infection doctor who gave her a cream to put on the rash and it is not really helping Ketoconazole 2% lot AB44114; exp Mar2023; caller does not see NDC on manufacturers package with a pharmacy label over it. Relayed that she would like to know if there is a way that someone like her who is over 65 and having problems can receive a third dose of the vaccine. She states that she has been more sick than ever since receiving the vaccine and she cannot stop coughing. She stated that she has asthma and has been to many doctors appointments. She stated that she has been on 4 different medications for this cough and that they just gave her a new one the last time she went back. She relays that she is having to take 40 things of cough syrup with codeine in it and that she has gained 20 lbs from the medication they have given her. They want to put her on a CPAP machine as well. She relayed that the vaccine as to be what is causing her to be sick and not be able to stop coughing because its the only thing that has changes and she states that they don't go anywhere or do anything. She would like to know if she can have a third shot of the vaccine, and if we know when it will be approved.