Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: heaviness that feels like he needs to cough/Kind of heaviness on my chest like I have to cough or something; every joint hurts and aches; He also has headache, nausea which was on and off; He also has headache, nausea which was on and off; trouble sleeping because of the neck and joint pain; having trouble sleeping because when he lays his head on the pillow, because his neck is hurting, it's very uncomfortable to sleep at night; he was in so much pain that he can't work; feeling awful/miserable; its like every joint and muscle in his body, he literally feels everything and it aches; cough; that his muscles just kind of tense up from lack of sleep; he's so tired; unable to work; This is a spontaneous report from a contactable consumer (patient) and nurses via Medical Information Team. A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 11Jun2021 13:00 (Batch/Lot Number: EW0167) (at the age of 48-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient had no prior vaccinations in 4 weeks. Medical history included high blood pressure for years and high cholesterol about 2, maybe 3 years ago. Family history also includes high blood pressure and high cholesterol, both on his dad's side and also reported that diabetes was really high on his dad's side of the family. Ongoing concomitant medications included lisinopril taken for blood pressure and atorvastatin taken for cholesterol. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER8736) administered in left arm on 21May2021 (at the age of 48-year-old) as DOSE 1, SINGLE for covid-19 immunization where patient experienced arm just got a little swollen from 22May2021 to May2021; also received flu shots and pneumonia shots for immunisation and never had any problems. He received the second dose of the bnt162b2 on 11Jun2021 and the next day or 12Jun2021, he said that every joint hurts and aches. He also has headache, nausea which was on and off, heaviness that feels like he needs to cough, and trouble sleeping because of the neck and joint pain. He said that he was unable to work. He had COVID pay for the first 2 weeks but in the third week he's not getting paid. Starting on Sunday he stop getting paid. He wanted to know what he needs to do and how long the symptoms will last. He already contacted his doctor and was advised to call Pfizer because his doctor doesn't know what to do either. He was asking if his doctor can call Pfizer. Additionally, patient reported that he has been seeing his doctor for about 3 weeks now and his doctor does not know what to do, so he advised the caller to contact Pfizer. Patient reported that he got his first dose of the Covid-19 vaccine back in May2021 and then 3 weeks later, he came in on 11Jun2021 and got the number two shot. Patient got the number two Covid-19 shot on 11Jun2021. Patient reported that he came home, everything was fine, he woke up the next morning, and he's been feeling god awful for 3 weeks. Patient stated that basically what was happening was, its like every joint and muscle in his body, he literally feels everything and it aches. He stated that every joint and muscle in his body he literally feel everything and it aches: patient reported that the only way he can describe it was when you've been in a car ride for many hours and you get the leg jerks. That's what his entire body feels like. Patient reported that his shoulder are and then going up his neck, that's where the aggravation was so bad that it actually hurts. Patient reported that he was having trouble sleeping because when he lays his head on the pillow, because his neck was hurting, it's very uncomfortable to sleep at night. Also, patient has had a mild headache this entire time. Patient reported that every once in awhile, the headache will actually get worse. When the headache gets worse, he can literally feel the blood pumping in his temples. That's how bad it gets. The headache getting worse has only happened a couple of times. He has had a mild headache for 3 weeks now. The patient also reported that he has had nausea and a kind of heaviness on his chest like he has to cough or something. Patient reported that from talking to his doctor, the first thing that he had the patient do was take another Covid test. Patient reported the Covid test came back negative. Patient reported that his doctor then turned around and had him to see the practices urgent care. Patient reported that the doctor from urgent care said that, most likely from the way it was sounding, most side effects of the Covid-19 vaccine either happen immediately or within 12 hours. Patient reported that the urgent care physician informed him that the patient going to bed the night of 11Jun2021 and waking up the next morning and feeling awful, that coincides with possible side effects to the Covid-19 vaccine. The urgent care physician informed the patient that the side effects were going to last roughly 2 weeks. Patient reported that its been past 2 weeks and he's still feeling miserable so he went back to the doctor Monday, 28Jun2021, and his physician ran some blood tests. Patient reported that his physician did a complete blood count (CBC), sedimentation (sed) rate, and also did an electrocardiogram (EKG). Patient reported that his sed rate was elevated but all his other stuff looked pretty decent. Patient reported that he called his physician's nurse and asked what they do now because the caller was still in a lot of pain. Patient reported that his physician's nurse stated that he had not heard of anyone having these kinds of side effects and stuff, and recommended that the patient contact Pfizer. Patient reported that his physician's nurse gave him the number for Pfizer and instructed the caller to call and ask what Pfizer thinks he should do. Patient reported that he only got Covid pay for 2 weeks at work, and since this is his third week off, he was not getting paid. Patient stated that whatever he needs to do to get better because he needs to go back to work as he has a wife and child to support. Patient reported that right now he was in so much pain that he can't work. Caller stated so we've got to figure something out. Furthermore, patient reported that he has been experiencing nausea off and on. Patient reported that his physician gave him these pills that dissolve in your mouth. When he talked to the doctor about it, he said they're nasty but they give those to people that are recovering from cancer. His physician instructed him not to be alarmed, but it was just the best medicine they could give him to get rid of the nausea. The medication instructions state not to take the medication with water and let it dissolve in your mouth, but it just tastes nasty so he takes it with water. Patient reported that the nausea was getting slightly better. Patient reported that at first, he was so nauseous that he was afraid to eat anything. Patient reported that now he gets a little nauseous when its time to eat but as soon as he eats he feels better, so he's not having to take those dissolving pills as much anymore. Patient reported that he was prescribed Ondansetron 8 mg. Patient reported that the urgent care physician also prescribed him Fluticasone 50 mcg spray, 16 count. The patient also reported that he was having trouble sleeping because when he lays his head down on his pillow, it puts pressure on his neck and it hurts. Patient reported that he was only averaging 5-6 hours of sleep per night. Patient reported that his trouble sleeping was basically the same. Patient reported that since he's not working, he has been sleeping on and off all day long. Patient reported that he has been having some car trouble and needs to get new tires and brakes on his car, but he hasn't been able to do it because he's so tired. The patient also reported that the heaviness on his chest was why his doctor did an EKG. Patient reported that he tried telling his doctor that for years, every time his chest gets tight its normally because of lack of sleep. Patient reported that his muscles just kind of tense up from lack of sleep. Patient reported that his doctor informed him that they just wanted to check him out anyway. Furthermore, patient reported that his physician ran a CBC and there was one thing that was slightly above the green. Patient reported that the way his physician was acting with all the others, he was not concerned about it. Patient reported that his sed rate was 28 and the normal was 0-15. Patient reported that his physician instructed him not to be concerned about the result. Patient reported that he asked if his physician was sure the result was ok as his sed rate was almost double the normal range and his physician instructed him not to freak out and informed the patient that he was not concerned. CBC on 28Jun2021 showed the following results: white blood cell (WBC): 9.3, red blood cell (RBC): Within green range; Hemoglobin: Normal; Hematocrit: Normal; mean corpuscular volume (MCV): Normal, patient reported it was lower on the green scale; mean corpuscular hemoglobin (MCH): normal; mean cell hemoglobin concentration (MCHC): Normal; red distribution width (RDW): patient reported that between 11 and 15 was normal and his was 15.7, so it was slightly up; Platelets: 253; mean platelet volume (MPV): 8.1; Neutrophils: 68; Lymphocytes: 24; Monocytes: 6; Eosinophils: 2; Basophils: 0; Absolute (Abs.) Neutrophil count: 6.31; Abs. Lymphocyte count: 2.2; Abs. Monocyte count: 0.51; Abs. eosinophil count: 0.2; and Abs. basophil count: 0.03. The patient also reported that his Covid-19 test was collected on 15Jun2021 and he got the results on 17Jun2021. Patient reported that the results stated SARS Cov-2 not detected. Patient reported that he had a Zoom call with his physician and his physician instructed the patient to go get tested for Covid. Patient reported that the test results came back negative and his physician instructed him to come into the office, but it was Thursday night and there were no appointments for the next day. Patient reported that his physician instructed him to go to urgent care. Patient reported that when he went to urgent care, the physician informed the patient that him getting the Covid-19 vaccine and waking up the next day coincides with what they've seen with side effects. Patient reported that the physician informed him that he would be miserable for 2 weeks, some people feel better sooner and some people it takes longer, but the average length of time for side effects was 2 weeks. The events "every joint and muscle in my body I literally feel everything and it aches, headache, nausea, heaviness on chest" did not require emergency room visit, but did require physician office visit. Additionally, the nurse reported that the patient said that they have the ongoing symptoms and patient was frustrated and he wanted to know what was causing the patients symptoms. He has ongoing joint aches, Headache, nausea on and off, neck pain, and cough. The doctor has run tests and labs, showing nothing and was asking. The outcome of the event nausea was recovering; outcome of feeling awful/miserable and tiredness was unknown, while outcome of the rest of the events was not yet recovered.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as 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.