Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Fluid intake reduced, Hypersomnia, Joint stiffness, Loss of personal independence in daily activities
Clinical narrative: Nausea; Vomiting; Feeling unwell; Severe fatigue/Fatigue extreme; she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day; like she had arthritis; Her hair has been falling out/Hair loss; Joint pain; Fingers were frozen; Couldn't eat; barely hydrated; Pain she had in her fingers/ Her toes hurt when she walks; It was hard for her to cook, wash clothes, and do anything; This is a spontaneous report from a contactable Nurse (Patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, intramuscular, administered in Deltoid Left on 16Feb2021, 13:15 (Batch/Lot Number: elg267) as SINGLE DOSE for covid-19 immunisation, at 65 years old. Medical history included ongoing Irritable bowel syndrome, she was diagnosed with IBS (irritable bowel syndrome) 15 years ago (unspecified date); Blood pressure high from 2000 and ongoing, High cholesterol from an unknown date (she has had high cholesterol for about 4-5 years or longer), depression from an unknown date (she was diagnosed with depression in her 30s after a car accident. She said she has had post-traumatic stress and depression for years); type 2 diabetes mellitus from an unknown date (she has had Type 2 Diabetes for a while. She said she couldn't take the diabetes medicine. She said she didn't say much to her doctor about the diabetes medicine. She said she tried all different medicines for her diabetes. She said her current doctor had been treating her Type 2 Diabetes for almost 4 years now); post-traumatic stress from an unknown date. Patient received the first dose of BNT162B2 on 29Jan2021 13:15, 65 years old, (lot number el9262) for covid-19 immunisation and experienced back pain, fatigue, alopecia, malaise, arthralgia, nausea, vomiting, feeling abnormal, musculoskeletal stiffness, arthritis, illness, hypersomnia and fluid intake reduced. There were no concomitant medications. The patient had her second COVID-19 vaccine on 23Feb2021. On 23Feb2021, patient experienced feeling unwell. She has never been so sick; and severe fatigue/fatigue extreme. She got her second COVID-19 Vaccine shot her tiredness was worse. Reported with the regular flu vaccine she had felt bad for maybe 3-4 days, but nothing like how she felt after getting the COVID-19 Vaccine. Reported after she received her second COVID-19 Vaccine on 23Feb2021, she didn't feel good. She said she had such severe fatigue that she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. Reported it had been 10-12 days since she had her second COVID-19 Vaccine, and she was still so tired. She is tired all of the time. Her tiredness was worse. She was tired and went to bed. She said the next morning she was tired, and then the next day she was really tired. She said the following day got so bad; she was in bed for 2 weeks. She said she only got out of bed to go to the bathroom and get something to drink and a few crackers to nibble on. She said she had such severe fatigue that she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. She said she had gone to her doctor yesterday and was exhausted when she got home. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed. She said she woke up at 5:30AM today. She said she was exhausted from just going to a doctor's appointment. On 25Feb2021, patient experienced nausea and vomiting. She said she had severe nausea and vomiting, clarifying that the nausea and vomiting lasted 2 weeks. Treatment was Phenergan Syrup 6.25mg/5ml every 6 hours, as needed. She said the Phenergan was originally prescribed for IBS. She said the Phenergan Syrup was dispensed in a pharmacy bottle, and didn't have a NDC, Lot, and Expiration Date. She said the Phenergan prescription label only had a printed barcode. Zofran 4mg tablet, as needed, three times a day. On an unspecified date in Feb2021, the patient experienced her hair has been falling out / Hair loss. She reported that her symptoms while a little better she is still tired all of the time, her hair is still falling out reporting, "If I roll it up in a clump its the size of a golf ball". She said after she got her second COVID-19 Vaccine on 23Feb2021, her hair loss was really bad. Hair Loss Treatment: She said the first thing she started taking was 1 Vitafusion Extra Strength Biotin 5000mcg Hair, Skin, and Nails Support. She stated she also took 2 Vitafusion Vitamin C 282mg Gummies a day. She said the product label said to take 3 Vitafusion Vitamin C 282mg Gummies per day, but she only takes 2 Gummies; Reported she was taking a multivitamin with Biotin and antioxidants every day. She said her doctor knew she was taking more than one vitamin and supplement and told her to watch out because she may be taking more than what was recommended. She said she stopped taking the multivitamin and now takes a regular vitamin. She said she also takes D3. She said her Fingers were frozen in a half closed position when she woke up in the morning. She said she had to work to open her fingers up. She said her fingers were sore, and she had to massage her fingers to get her fingers to unstick; Couldn't eat and was barely hydrated. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed; Pain she had in her fingers/ Her toes hurt when she walks, she never hand been like this before. She said every joint in her body ached like she had arthritis. She said her toes, ankles, knees, fingers, and arms ached. She said she still has the joint pain happening. She said her fingers were sore. Treatment: Reported when she was at her doctor appointment yesterday, she asked her doctor for a Prednisone prescription for her joint pain. She said her doctor gave her a 6 day prescription of Prednisone 50mg tablets. She said she was dispensed 6 Prednisone 50mg tablets and is to take 1 Prednisone 50mg tablet a day for 6 days; It was hard for her to cook, ash clothes, and do anything. She said she was just laying bed with an ice pack, or a heat pack, and taking pain pills. She said she told her doctor she had called the Health Department, and the CDC. She said the Health Department didn't want to tell her anything, and the CDC will only talk with someone who has had an anaphylactic reaction to the COVID-19 Vaccine. She said she asked her doctor how long she was going to have the side effects. She said her doctor said that all of her patients who had any reaction to the COVID-19 Vaccine, had mostly had called into her office to ask about the COVID-19 Vaccine side effects, and most of the patients COVID-19 Vaccine side effects resolved in a week. She said her doctor said not one of her other patients had ever told her about the kind of side effects she was having. She said her doctor told her she must be in the 2% group and to call Pfizer to report her side effects. She asked how long the events would last and what can she take. The patient underwent lab tests and procedures which included cardiac stress test: all was good right now (unspecified date).  Therapeutic measures were taken as a result of her hair has been falling out/hair loss, like she had arthritis, nausea, vomiting, joint pain (arthralgia). Events did not require visit to emergency room. Outcome of the event hair loss was not recovered; outcome of feeling unwell, severe fatigue/exhausted, joint pain was recovering; nausea and vomiting was recovered on an unspecified date; and outcome of all other events was unknown. The patient considered the events as related. The reporter considered the events as serious - medically significant.; Sender's Comments: Based on a temporal association and known drug safety profile, the causal association between the events and the suspect drug BNT162B2 cannot be totally excluded. Possible contribution from patient's underlying medical condition is also considered.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.