Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Diarrhoea, Myalgia, Pain in extremity
Clinical narrative: Diarrhea; back aches; lower body aches; left hip aches; Muscle aches in lower back and left hip; This is a spontaneous report from a regulatory authority. A contactable 82-year-old Female consumer (patient) reported that. An 82-years-old female patient received (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: ER8737; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Arm Left on 01Apr2021 (age at vaccine 82-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included glucose tolerance impaired from an unknown date and unknown if ongoing diagnosed 16-18 years ago with prediabetes and started Metformin about 8 years ago, hip arthroplasty from 15Oct2004 to an unknown date The left hip was 15Oct2004, hip arthroplasty from 26Jul2012 to an unknown date The right hip was 26Jul2012, spinal operation from 2002 to an unknown date, blood pressure abnormal, gastrooesophageal reflux disease, had reflux longer because she was quite young when she had that, around 70, surgery and colonoscopy all from an unknown date and unknown if ongoing. patient previously received historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6207 Expiration Date: Jul2021), via intramuscular route of administration, administered Both were in the left arm, upper arm on 11Mar2021 as dose 1, single for COVID-19 immunization, shingles shot VARICELLA ZOSTER VACCINE second shingle shots, immunisation Her arm, upper, swelled up 2 inches wide and 4 inches long, shingles shot VARICELLA ZOSTER VACCINE immunisation her arm had a fever, It was before 2018 because that was before she started keeping a journal. Concomitant medications included metformin (METFORMIN) taken for glucose tolerance impaired, hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for blood pressure abnormal, amlodipine besilate (NORVASC) taken for blood pressure abnormal, pantoprazole (PANTOPRAZOLE) taken for gastrooesophageal reflux disease, all from on start and stop date were not reported; simvastatin (ZOCOR) taken for an unspecified indication, start and stop date were not reported. it was reported asks where call handler is located, because she was in the Philippines and she enjoys knowing where people are located that she speaks with. She states that she has to find her cell phone which has a locator thing and her car keys on there. That was the first thing she had. She clarifies that her vaccine was 01Apr2021 and on 02Apr2021 she had diarrhea all day and then it went away and the next day she was okay. She clarifies that she does not have vision issues, but the stuff is really fine print, really really really small print on the bottle but at least she found it and can read it. She states that she heard that the Pfizer BioNTech Vaccines are all proven now.  She just heard that the vaccine is approved. She asks if call handler has heard that. She adds she is going to get a magnifying glass so she can read with certainty. She also states because she is old and asks if that is a motivation. She has three daughters that are 60, 59, and 48 that have not gotten the vaccine and she does not know why. One was at 10 am, and she knew she could not leave until 10:38 am with the first one. The second one, she does not remember. The second one was in the morning, on April Fools Day. AEs following prior vaccinations: Yes, she received the second shingles shot and she cannot remember when it was but she had a reaction to the second shingle shots. Her arm, upper, swelled up two inches wide and four inches long. It had a fever in it. she clarifies that she did not have an increased body temperature, but that her arm had a fever. She did not get the Moderna because she heard it had a reaction like this, like the fever her arm had. She does not know NDC, EXP, LOT, or manufacturer for the shingles vaccine. She was trying to figure out when she got her shingles shot. She thought she could find it but she cannot. it was before 2018 because that was before she started keeping a journal. She adds that is everything, she just has to and wants to report it. she adds it will go away before she dies. she adds that it is just a good day, every day is a good day. She figures if she can get up and walk around it is a good day. Description of complaint: While reporting that Advil cause constipation, she states the writing on the bottle is tiny. Advil: liquid gel. 200 mg. She thought Advil was Ibuprofen but it says it is an NSAID which is different and is like Aleve. she adds, anyhow, it is helping.  she adds she does not have any NDC, UPC, LOT, expiration, or additional details because they were on the box and she threw away the box.  There are a lot of directions on it. she adds that the box states it is distributed by Pfizer and that she does see that the LOT is R85563 and expiration Jan2023. She stated, she did call in on 05May and reported side effects from the Pfizer Vaccine. And so, you should have a record for me for calling in. It was the 05May and she definitely know now that it was a side effect she was having pain in my left hip and my back because on the 17May I woke up in the morning and my pain was gone. So, I know it definitely was. She thought maybe it was just some other problem. But I thought. she called in anyhow on the 5th. she had my vaccine on the first and then on the second she had diarrhea all day and then she started developing the pain in my back and my hip. Then she waited she saw my Doctor and he told me to take Tylenol not Tylenol he told me to take Advil (treatment) and finally she called on the 05May to report it and now she was calling to report it and then she was calling to tell whoever can put this in my record that she woke up on the 17th, two weeks later and she had no pain. So, she do definitely know that it was from the vaccine. The patient experienced muscle aches in lower back and left hip, back aches, lower body aches and left hip aches all from on Apr2021, diarrhea on 02Apr2021. The clinical outcome of the events muscle aches in lower back and left hip, back aches, lower body aches and left hip aches was recovered on2021, diarrhea recovered on 02Apr2021 and lower body aches was unknown.  No follow-up attempts are possible. No further information is expected.