Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, SARS-CoV-2 test negative, Sleep disorder
Clinical narrative: fatigue; pain on arms; Nausea; Dry heaves; it's been hard for her to walk because her legs are heavy and stiff; it's been hard for her to walk because her legs are heavy and stiff; it's been hard for her to walk because her legs are heavy and; headache; joint and muscle pain/shoulder pain; joint and muscle pain; flu-like symptoms; pain in her neck; pain in her neck and of course at the site of the injection; This is a spontaneous report from a contactable female consumer (patient) received from a Pfizer-sponsored program. A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN9581, NDC number: Unknown, Expiry Date: Unknown), intramuscularly, administered in Left arm, very high up on 12Feb2021 16:45 at the age of 65-years-old as dose 1, single for covid-19 immunisation. Medical history included Allergy to yellow dye, stomach acid from an unknown date, she sometimes takes Famotidine for her stomach acid. She stated that she sees a gastrologist for a colonoscopy and endoscopy from time to time. The patient was not pregnant at the time of vaccination. The patient had no other conditions. Concomitant medications included famotidine (FAMOTIDINE) 20mg, tablet taken by mouth as needed taken for stomach acid from an unspecified date. she doesn't take it every day, it as needed; Extra strength tylenol (paracetamol) (TYLENOL) taken for an unspecified indication from an unspecified date; bismuth subsalicylate, calcium carbonate (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) taken for an unspecified indication from an unspecified date; curcumin (CURCUMIN) taken for an unspecified indication from an unspecified date received within 2 weeks of vaccination. The patient previously took percocet [oxycodone hydrochloride;paracetamol] and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Facility type vaccine was hospital. Additional vaccines administered on same date of the pfizer suspect were none. It was reported that 1st Shot was on 12Feb, Friday. Severe symptoms of fatigue, pain on arms on an unspecified date. The reporter mentions she is a personal care worker. She went online and filled something out and she tried calling last night. She was on hold for a while, and she assumed the department was closed because she never spoke to anyone. She explains she just got back from urgent care. She received her first COVID-19 vaccine on Friday, 12Feb2021, around quarter to five. They kept her 15 minutes afterwards. Around 2 hours later, around quarter to 7, she started to get pain in her neck and of course at the site of the injection. She started to have some joint pain and pain in the left side of her neck. She was in so much pain they told her to take Tylenol. She eventually fell asleep but woke up at 4 am and had a terrible headache on 13Feb2021 and joint and muscle pain. The pain got worse last night and is gradually edging up. She put in 3 hours of work Saturday and the previous day. She believes the Tylenol is edging the pain. She was not used to taking pills. She thought she needed more but it wasn't time and then it all just really snowballed. She clarifies she is taking the Pharmacy's Brand Acetaminophen (compared to Tylenol). It's extra strength. Lot: P119012 Expiry date: Jan2022 Above the barcode, she sees #. On her vaccine record care, she mentions she doesn't know if she can read it. It's terrible. In the beginning, she sees BioNTech/Pfizer. She has a question from urgent care. The doctor is not sure she should get the second round on 05Mar. She was not sure if she should get the next one. She guesses she will see how long it takes to weather this. Healthcare Professional: The caller explains since she did go to urgent care and wasn't seen by her family doctor, she will provide the urgent care doctor for the product. If she is not any better by Thursday, she is supposed to go see her family doctor. She is out of work until Thursday. She confirms Dr. (name) is her family doctor. She explains she did file something online but didn't get a case number or anything. No further details were provided. She was not sure if she should get the next dose of the COVID-19 Vaccine. She wanted to know what is the risk of not getting the second vaccine? Would she just not get covered? She explains she had pain in both arms over the shoulders, and also the pain at the injection site. She went to get up to go relax in the recliner and she felt like she had cinder blocks on her legs. The pain went from her neck all the way to her shoulder blades. It was reported that the vaccine just brought on nausea and dry heaves on an unspecified date, it's nothing gastric related. She received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 12Feb2021, she is scheduled to receive the second dose of the vaccine on 15Mar2021. It was reported that two hours after she received the injection, she started experiencing some side-effects, flu-like symptoms, a lot of pain at the injection site in her shoulder (she could hardly move her arm), joint pain and muscle pain, she also had some headaches the next morning on 13Feb2021; she tested negative for Covid-19 and she took Tylenol, Benadryl and medication for nausea. The headaches disappeared and were not severe, however the joint and muscle pain kept getting worse, she's being trying to do her daily routine but it's been hard for her to walk because her legs are heavy and stiff on an unspecified date, she should go back to work by Thursday. She would like to know what would happen if she decides not to take the second dose of the vaccine because she was scared. The adverse events did not require a visit to Emergency Room or Physician Office. It was reported that morning at her 8:30 AM visit, they did a COVID test and flu test. The patient underwent lab tests and procedures which included Flu test (influenza virus test): negative on 15Feb2021, COVID-19 Test (sars-cov-2 test): negative on 15Feb2021. The reporter assessed events as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The outcome of event, headache was recovered on an unspecified date in 2021 and Neck pain, Arthralgia, Muscle pain were not recovered while for other events was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.