Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pruritus
Clinical narrative: The 1st dose was given on 24 Jan 2021/The 2nd dose was given on 10 Feb 2021; When she had first two Pfizer COVID vaccine shots in Feb 2021, it was just an itchy arm.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 10Feb2021 (Lot number: EN5318, Expiration Date: May2021) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus", start date: 1995 (unspecified if ongoing); "Irregular heart beat" (unspecified if ongoing); "blood thinner" (unspecified if ongoing), notes: blood thinner; "upper respiratory nasal drip" (unspecified if ongoing), notes: last 5 years, she has developed the upper respiratory nasal drip; "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure measurement, start date: 2006; ASPIRIN [ACETYLSALICYLIC ACID] taken for blood disorder, start date: 1995; EZETIMIBE taken for blood pressure measurement, start date: 2006; PRAVASTINE taken for blood pressure measurement, start date: 2006; AMLODIPINE taken for heart rate irregular; METFORMIN taken for diabetes mellitus, start date: 2001; HUMALOG taken for diabetes mellitus, start date: 2013. Vaccination history included: Bnt162b2 (DOSE 1, Lot Number: EL8982, Expiration Mar2021, Anatomical location: upper Left arm), administration date: 24Jan2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "When she had first two Pfizer COVID vaccine shots in Feb 2021, it was just an itchy arm."; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "The 1st dose was given on 24 Jan 2021/The 2nd dose was given on 10 Feb 2021".  Additional Information: Concomitant Products Humalog: Started 8 years. Concomitant Products Metformin: Taking for 20 years. Concomitant Products Pravastin: Taking 15 years. Concomitant Products Amlodipine: Given by heart physician. Taking for a half a year. The patient was taking Concomitant Products Amlodipine for irregular heart beat. Concomitant Products Ezetimibe: Taking for 15 years. Concomitant Products Aspirin: Taking since 1995-1999 since she found out she has diabetes. The patient was taking Concomitant Products Aspirin : blood thinner. Concomitant Products Losartan: Started taking 15 years. Received call from consumer who provided her middle initial as Withheld. She had her Booster shot of the Pfizer Covid vaccine last Wednesday, 20Oct2021. She had the two previous ones in February and then space and got another one. She had no effects from the others at all except an itchy arm. This time it has been worse. She said her voice is still hoarse, but later said that she always has a hoarseness when she wakes up. She felt ok on Wednesday and. She woke up Thursday and felt totally different. She has an itchy arm and soreness, and everyone has had that. She did not have anyone specific to report on except two ladies that live in the same senior community. They had an itchy arm and soreness. Other than that, they were fine and did not have any lethargy, sore throat, and did not have the feeling that they were not going to be able to make it that she had. She did not wish to complete a report for them. Separate report completed for them. She had a sore throat and was nauseous and lethargic. She felt out of it and felt like she would faint when she went to the bathroom. She lied down all day Thursday. She took two Tylenol. She was lethargic, dragging, and had low energy. She is not sleepy, but just wakes up and makes breakfast, then gets heaviness in legs and sits down. She also has loose bowels. Whenever she eats, an hour to two later, she has to go the bathroom and it is usually loose. In the morning, she is usually hoarse because of a constant sinus drip, but this occurred prior to the vaccine. The hoarseness now is not different. Her voice will clear when she gets up. It sounds better when she is up for a while. She has a raspy voice anyway. The postnasal drip and hoarseness is not attributed to the vaccine. It was there before. She cannot understand the consistent lethargy and tiredness. She had no energy. She has never had that when she took the other shots. When she had first two Pfizer Covid vaccine shots in Feb2021, it was just an itchy arm. It was not even sore. Her son also had the same booster shot and had no reaction at all. He is 42-43 and she is 75. No further details provided. Dizziness was on and off on Friday, and when she stands up, she does not know if it is the fluids, but it is still there. There is almost like there is something else going on. The 1st dose was given on 24Jan2021. She said she needs to get glasses and she needed them before the vaccine. The 3rd dose was given 20Oct2021, Lot FF8841, Expiration unknown. This was injected in the right arm. The needle was long, and she thinks it was given in the muscle, but she was not looking and cannot confirm, but it was given in the upper part of her right arm. She is diabetic, so all three times was given for prevention. She did not want to get sick. She had a 10:15 appt, so that morning, she took Humalog. When providing her other medications, she said she is a medicine cabinet. Over the last 5 years, she has developed the upper respiratory nasal drip. She was on CPAP machine, but that was recalled, so she is waiting on an approval for another method they will use. Right arm itchy and sore - 10:30 -11:00She felt herself rubbing it and when she reached up, it was sore. Sore throat - When she woke up 06:00-06:30. Nauseous - 7:00 or a little after that. She immediately when she stood up to stand and go to the bathroom. When she got to the bathroom, she felt she would faint or throw up. Lethargic - 08:00, then she said 07:30. When she came and lied back in bed, she got that overall feeling of doom and gloom. She tried to get up throughout the day and just lied in bed and could not get up. Loose bowels - Thursday evening when she ate 19:00-19:30. She had soup and half of a sandwich, like peanut butter and a cup of tea. Dizziness - 07:30. She really thought she was going to faint, and she started to tell her son to call the ambulance because she did not want to fall out, but she did not. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): She had Flu Shot on 04Oct2021, which was about 3 weeks before this Booster shot. She does not have the manufacturer, lot, or expiration. AE(s) following prior vaccinations: She had an itchy arm with the flu vaccine above. No lot or expiration. Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Mother had diabetes and it seems to run in family. Sister who is still living also has diabetes and young son is pre-diabetic. There is also her niece. She called her doctor and said she should probably have a nose culture, but not for COVID, but to see if anything viral is going on. She has not had anything done yet. List other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebra-spinal fluid culture, pleural fluid culture, urine culture, diagnostic imaging, (e.g., chest X-ray, MRI).She just thought maybe others have had conditions like her. She would like to know if these symptoms are a reaction from the booster.  Follow-up attempts are completed. No follow-up attempts are possible. No further information is expected.