Pfizer

Psychological symptom reports

Male, 40 - 59 years

Age Reported Symptoms Notes
40 2021-01-04 sleep disorder, restlessness COVID vaccine Tuesday. Some soreness at the site that resolved over 2 days. Over the past 24 hours... Read more
COVID vaccine Tuesday. Some soreness at the site that resolved over 2 days. Over the past 24 hours, developed some mild parasthesias [nonspecific]. Aren't painful, but tingling is annoying, contributed to restless night last night. Response 12/26: Acetaminophen, Start B-complex with Fe, report if not already done Chart 12/26: Reported. A bit better this am but will start vitamins Chart 12/29 [excerpt] Still having same symptoms of parasthesias. Started multivitamin as well as acetaminophen. I've noticed it affects only the right side of my body, and that it's purely sensory, no motor changes. Still mild, but not been sleeping well Responded, scheduled appt.   Vaccinated in L deltoid. Describes R side of body feels 'Cold' [dysesthesia] on R side of body and extremities. No weakness, no change in ROM. No joint swelling. No rash. Sensation feels less on R but still sense of touch. Thinks this is about the same- notices more when lies down in bed than in daytime. Symptoms persist 1/5/2021: Referred to Neurology at his request
40 2021-01-06 feeling abnormal, anxiety Employee returned to vaccination area at 13:45, reported mild intermittent tingling in hands and fee... Read more
Employee returned to vaccination area at 13:45, reported mild intermittent tingling in hands and feet bilat; primarily feet and primarily when he sat down. Also reported mild brief blotchiness to bilat lower forearms. Narrative: Mildly anxious, mild reactions to which he was unsure if he should return to vaccination site or not. Denied dizziness, light-headedness, palpitations. Reported mild feeling of a 'rush' "kind of feeling, like, stimulated". VS: at 13:46: BP 14977. O2 99%, P 79, T 36.3. Reported he had been continuing doing his duties without difficulty but didn't know if he should be concerned. Noted blotchiness on forearms under different lighting when he went to restroom. Blotchiness mild to moderate and mostly resolved before he left. VS at 14:02: BP 136/69, O2 99%, P 80, T 36.7. Reported tingling mostly resolved if he stretches his legs out some. Reported anxiety over "the whole thing. It's just weird and I've been excited about the vaccine". Reviewed S/S to be aware of, when to seek medical attention and that he was feeling completely stable and comfortable before he left. Positively reactive to increased information and seeing improvement in blotchiness. Left at 14:08.
40 2021-01-08 confusional state Symptoms began on 1/2/21 Self isolating Start of symptoms similar to a cold with mild discombobulati... Read more
Symptoms began on 1/2/21 Self isolating Start of symptoms similar to a cold with mild discombobulation Symptoms are mild with a loss of taste and smell continuing
40 2021-01-12 impaired work ability Significant chills for 5 hours, fever, body aches, headache significant enough to impair my ability ... Read more
Significant chills for 5 hours, fever, body aches, headache significant enough to impair my ability to work the following day. No reaction occurred after first dose. Reaction began with several hours of chills.
40 2021-01-13 impaired work ability Per reporter: "I received the COVID vaccine on 12/29/2020 (first dose). The first couple days I had ... Read more
Per reporter: "I received the COVID vaccine on 12/29/2020 (first dose). The first couple days I had a really sore left arm, but didn?t feel any ?side effects? until about Wednesday, 1/6 (about a week later). I remember waking up to a sore left side of my upper body. The left side of my neck, chest, arm, and lymph node (under my left arm) felt weird. It was until about Saturday night, 1/9, that I felt my left under arm lymph node noticeably swollen. I had a bad headache and loss of energy, and overall feeling unwell. No fever or night sweats to report. I was absent from work on 1/11 and 1/12, as a result. 1/13 was my first day back and feel better. The swollen left lymph node is no longer present, but still slightly tired. I did not seek Medical Care for my symptoms.
40 2021-01-18 loss of personal independence in daily activities Experienced severe shaking chills, necessitating I leave work. Also experienced mild myalgias, heada... Read more
Experienced severe shaking chills, necessitating I leave work. Also experienced mild myalgias, headache. Treated with acetaminophen 1000mg and ibuprofen 400mg.
40 2021-01-20 loss of personal independence in daily activities general ache/pains, headache woke me up ~3:30am. movement hurt, pain progressed, headaches got worse... Read more
general ache/pains, headache woke me up ~3:30am. movement hurt, pain progressed, headaches got worse, never went away. nausea, fever throughout the day, general tiredness and increased join point all day. swollen glands in arm pits. headache pain completely impaired daily activity. Tylenol in the afternoon for fever, dramamine for nausea Effects lasted 24 hours... headaches persisted 5+days
40 2021-01-25 feeling abnormal Body ache, chills diarrhea, fatigue, mild fever, muscle pain, brain foggy
40 2021-02-01 confusional state About 2 to 3 minutes after receiving the injection I felt light headed and passed out. My wife said ... Read more
About 2 to 3 minutes after receiving the injection I felt light headed and passed out. My wife said my eyes were open but glazed over. I also started shaking. When I woke up I was confused and felt nauseated. A few minutes after I woke up the EMTs ran my vitals. My heart rate was in the 40s and my blood pressure was in the 90s. I have never had a reaction like this to any other shot/vaccines.
40 2021-02-01 confusional state Systemic: Other- Patient said he suffered from confusion, fatigue, and had a hypertensive emergency ... Read more
Systemic: Other- Patient said he suffered from confusion, fatigue, and had a hypertensive emergency in which he had to increase his amount of blood pressure medication. Highest reading was 198/116.-Severe; symptoms lasted 2 days
40 2021-02-04 anxiety Headache, "Feels like I need to run." pain in back of shoulder blades, anxious
40 2021-02-05 anger Rage for no apparent reason. It subsided a day later.
40 2021-02-12 sleep disorder Violent tremors or chills in the middle of the night for half an hour, followed by a burning electri... Read more
Violent tremors or chills in the middle of the night for half an hour, followed by a burning electric feeling in my muscles. Not able to sleep afterwards. Woke up and muscles in body are very tight and tense.
40 2021-02-28 anxiety fainted with preceding anxiety after getting the vaccine
40 2021-03-02 disorientation After waiting 15 minutes I was released and felt fine. About 3-5 minutes after leaving the site my t... Read more
After waiting 15 minutes I was released and felt fine. About 3-5 minutes after leaving the site my tongue became numb and felt s=slightly swollen, throat became extremely dry, pulse rate increased from low 50 BPM to 100 BPM. Drove to a nearby store and stopped, felt a bit disoriented when trying to call my wife. Drank water and waited at a store for approximately 15 minutes until I felt better. This was about 40 minutes after the vaccine was administered. When driving home still some discomfort/numbing of the tongue and throat. Ate at 1:30 and symptoms had stopped.
40 2021-03-02 mental impairment Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presents to urgent care one day after vaccination with... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presents to urgent care one day after vaccination with fatigue, chest tightness, back pain, myalgias, headaches, right arm soreness, and decreased concentration. Patient states had COVID-19 illness in October 2020 and current symptoms are similar. Patient denies facial/throat swelling, palpitations, rash, or lesions and reports some symptom improvement with acetaminophen. Vitals within normal ranges except blood pressure 141/84 attributed to white coat syndrome. Advised to continue acetaminophen and discharged to home stable.
40 2021-03-08 sleep disorder began with dehydration - frequent urination, low fever - up all night due to stomach issues very tir... Read more
began with dehydration - frequent urination, low fever - up all night due to stomach issues very tired all of the time, drinking unreal amounts of water developed dangerously high blood sugar over the next week - diagnosed with diabetes on March 1
40 2021-03-09 depression Following 1 week of the normal symptoms, 2 weeks of weakness, muscle pain and mild depression.
40 2021-03-11 nervousness patient waited his 15 minutes for observation. he walked out of the vaccination clinic about 12:23 ... Read more
patient waited his 15 minutes for observation. he walked out of the vaccination clinic about 12:23 & returned at 12:25 due to feeling like his tongue was numb. he also felt shaky & dizzy
40 2021-03-15 disturbance in attention Starting 3/15/21 and continuing today, 3/16/21 (the time this was authored), I have noticed that I c... Read more
Starting 3/15/21 and continuing today, 3/16/21 (the time this was authored), I have noticed that I continue to have brain-fog after the second COVID vaccine. Not sure if this is normal or will go away.
40 2021-03-19 disturbance in attention I had difficulty concentrating and focusing on Wednesday evening, a little over a day after getting ... Read more
I had difficulty concentrating and focusing on Wednesday evening, a little over a day after getting my first shot. The focusing/concentration issues went away by the next morning when I woke up, however I have been feeling very tired physically since then. I'm yawning all day and have very little energy or interest in doing things I need to be doing. I'm not certain that this is vaccine related, and I'm not super concerned about it yet as I'm on Spring break from school, but I start virtual classes again on Monday and will be concerned if I'm still super tired. If it doesn't go away by next weekend, I will likely resubmit/add on to this report if that is an option. It is not a serious concern yet so I haven't contacted medical professionals yet, but I thought it might be a good idea to at least report that this has been going on to VAERS
40 2021-03-22 anxiety Anxiety
40 2021-03-24 loss of personal independence in daily activities, disorientation Starting at 8pm on vaccination day I got loopy and disoriented, and had a hard time speaking intelli... Read more
Starting at 8pm on vaccination day I got loopy and disoriented, and had a hard time speaking intelligibly. I also had trouble with balance and fine motor skills. Had some personality changes too: became very moody with erratic mood swings. The next day I slept all day because of exhaustion and aches. When I woke up on Wednesday (36hrs later) I was literally screaming in pain because of how bad my arm and shoulder hurt. It hurt to move it, and hurt not to move it. It was excruciating and ibuprofen didn't seem to help at all. Throughout Wednesday I could hardly move my left arm. Getting dressed or washing my hair was very difficult and very painful. I was also still very uncoordinated. My left armpits lymph nodes were so swollen that (1) it filled in my entire armpit so there was no more pit, just a very soft bulge, and (2) the fluid extended all the way to my chest and it looked like I had one breast and one pec.
40 2021-03-26 incoherent, loss of personal independence in daily activities, disorientation 8 hours after shot extreme nausea. In one instant, extreme feeling of an instant blow to the head, ... Read more
8 hours after shot extreme nausea. In one instant, extreme feeling of an instant blow to the head, extreme ringing in ears, unable to hear, disoriented, unable to speak, incoherent, rapid fever that quickly reduced. Symptoms disappeared quickly and were gone within an hour. Afterwards mild headache, fatigue, nausea persisted for 2-3 days.
40 2021-03-27 loss of personal independence in daily activities Pfizer-BioNTech COVID-19 Vaccine EUA Got vaccinated on 8/24/21, starting 8/26/21 I have severe pain ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Got vaccinated on 8/24/21, starting 8/26/21 I have severe pain and decreased movement in my right shoulder. I cannot perform daily tasks or use my right arm.
40 2021-03-30 confusional state Client got lightheaded when changing position from sitting to standing. SN noted client kneeled on a... Read more
Client got lightheaded when changing position from sitting to standing. SN noted client kneeled on all fours and laid on floor. He become confused and verbally non responsive. His breathing was irregular on our assessment. On arousal patient started to respond after 30-40 seconds. His speech was garbled and delayed and patient was aware that he had fainted. He admits to a history of fainting in the past at work. He was able to walk to observation bay to lay down for approximately an hour. Paramedics were called at the beginning of episode. Bp 129/78, Pulse 78 Resp16, O2 sat 98% temp 32 C temporal He rested in bay about a hour and was transported home via car by wife after refusing transfer to hospital by paramedics
40 2021-04-01 insomnia Body ache and difficulty sleeping beginning overnight after shot, increasingly unpleasant body aches... Read more
Body ache and difficulty sleeping beginning overnight after shot, increasingly unpleasant body aches, weakness, tiredness throughout following day.
40 2021-04-07 disturbance in attention, confusional state Whole body Numbness and tingling, loss of feeling of lower right arm and lower right leg. Loss of co... Read more
Whole body Numbness and tingling, loss of feeling of lower right arm and lower right leg. Loss of control of lower right arm. Extreme fatigue unable to get up and move at times. Very light headed and on the verge of blacking out.. possibly Loss of consciousness. Extreme tightness in chest. Increase work of breathing. Confusion. Unable to keep eyes open and maintain alertness. Extremely tired Symptoms have gotten a little better throughout the day of april 8th with lots of rest and very little physical activity. I still have slight tightness in chest. Increase work of breathing. Still have tingling throughout body and am lightheaded. When doing any physical activity I become fatigued and lightheaded very fast and must stop after 5-10 minutes. Tongue is still tingling and metallic taste in moutg
40 2021-04-09 feeling abnormal patient stated he was feeling cold and a tingling in his throat and started to have tunnel vision w... Read more
patient stated he was feeling cold and a tingling in his throat and started to have tunnel vision with a weird feeling. patient was assessed for vitals times 3 every 10minutes patient later after third set of vitals stated he was feeling back to normal patient was escorted back out to the exit of the building with his son also accompany him. patient was encouraged to encourage fluids, and to make sure to rest. patient vitals were as follows 9:19a b/p 135/92 p 93 r 18 o2 99% 9:25a b/p 134/84 p 83 r 18 o2 99% 9:30ab/p121/87 p86 r18 o2 98% patient was released and escorted to the car.
40 2021-04-10 feeling abnormal, impaired work ability 4 days of fever, headache, body aches, fatigue, "brain zaps", brain fog. Most symptoms have resolve... Read more
4 days of fever, headache, body aches, fatigue, "brain zaps", brain fog. Most symptoms have resolved but fever and brain fog persist as of day 6. Sleeping 14+ hours per day, unable to work due to symptoms.
40 2021-04-13 disturbance in attention I had already completed my menstrual cycle before the vaccine. I started a extremely heavy menstrual... Read more
I had already completed my menstrual cycle before the vaccine. I started a extremely heavy menstrual flow the day after vaccination and it went on for 8 days. I had body aches on my left side only. Was not able to stay awake an entire hour. Slept 3/4 of the day away for the first 4 days. It was hard to focus or read any information.
40 2021-04-17 feeling abnormal, confusional state, abnormal dreams, panic attack Vivid/lucid dreaming with bright lights; Vivid/lucid dreaming with bright lights; light headiness a ... Read more
Vivid/lucid dreaming with bright lights; Vivid/lucid dreaming with bright lights; light headiness a feeling that i would pass out or die and tingling and shakimg; tingling and shaking throughout his body; tingling and shaking throughout his body; As he remained in a confused mental state; received bnt162b2 first dose on 10Mar2021, second dose on 24Mar2021; received bnt162b2 first dose on 10Mar2021, second dose on 24Mar2021; nocturnal panic attack with unknown trigger; Occasinally elevated blood pressure; slight markings of dehydration; hangover; This is a spontaneous report from a Contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, brand: Pfizer), second dose via an unspecified route of administration, administered in arm left on 24Mar2021 11:30 at age of 40-year-old (Lot Number: ER8733) at single dose for COVID-19 immunization. The most recent COVID-19 vaccine was administered at Facility of Doctor's office/urgent care. Medical history included gout, anxiety, gastrooesophageal reflux disease, 'espoghutis'. The patient did not have allergies to medications, food, or other products. Concomitant medication within 2 weeks of vaccination included omeprazole; allopurinol; escitalopram. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 via an unspecified route of administration, administered in arm left on 10Mar2021 11:30 at age of 40-year-old (Lot Number: En6206) at single dose for COVID-19 immunization. On 02Apr2021, the patient had vivid/lucid dreaming with bright lights and unusual feelings as he initially fell asleep. He was able to wake himself up but remained in between sleep and awake. This was accompanied by light headiness a feeling that he would pass out or die and tingling and shaking throughout his body as he remained in a confused mental state while his wife called an ambulance. In 2021, his vitals were fine with occasionally elevated blood pressure and slight markings of dehydration ( during the day following his second dose he felt like he had a bad hangover). The ER doctor thought the most likely explanation is sometime of nocturnal panic attack with unknown trigger. He had not previously sufferer anything like it. The events were reported as non-serious. The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the adverse events which included: drugs to calm, fluids. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events light headiness, tingling and shaking throughout his body, confused mental state, nocturnal panic attack with unknown trigger, vivid/lucid dreaming with bright lights, elevated blood pressure, slight markings of dehydration, hangover were resolving. Information on lot/batch number obtained. Further information is expected.
40 2021-04-18 disorientation Shortness of breath. Disorientation, Dizziness, Gastrointestinal issues, urinary tract discomfort, b... Read more
Shortness of breath. Disorientation, Dizziness, Gastrointestinal issues, urinary tract discomfort, blurred vision for extended periods of time during multiple days.
40 2021-04-18 disturbance in attention Bruising on upper back and left arm. Blurred Vision. Gastrointestinal issues. Shortness of Breath. ... Read more
Bruising on upper back and left arm. Blurred Vision. Gastrointestinal issues. Shortness of Breath. Dizziness. Eyes being extremely sore. Fatigue. Difficulty concentrating.
40 2021-04-20 depression, anxiety I believed vaccine caused anxiety attacks and depression. I could not leave the house without fear. ... Read more
I believed vaccine caused anxiety attacks and depression. I could not leave the house without fear. I needed multiple therapy sessions and multiple medications to help overcome illness.
40 2021-04-23 feeling abnormal Fatigue, body aches, brain fog, loss of muscle tone and headache.
40 2021-04-24 anxiety Fever - Unverified by Medical Treatment Facility Dizziness Sitting & Standing Vomiting Psychosis - I... Read more
Fever - Unverified by Medical Treatment Facility Dizziness Sitting & Standing Vomiting Psychosis - Inability to Communicate Properly Major Anxiety Allergic Reaction - Unverified by Hospital CT - Scan Not Performed Psychological Evaluation Not Performed
40 2021-04-24 irritability Irritable; was fatigued; Patient has tenderness at the injection site; This is a spontaneous report ... Read more
Irritable; was fatigued; Patient has tenderness at the injection site; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received BNT162B2 first dose on 30Mar2021 17:15 (Age at vaccination was 40 Years old) on left arm at single dose for COVID-19 immunization. Medical history included Pencillin Allergy. Concomitant medications in two weeks included SSRI. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient has tenderness at the injection site, and was fatigued and irritable beginning approximately 24 hours after vaccination (31Mar202105:00 PM). Symptoms lasted for approximately 12 hours. At the end of that 12 hour period all symptoms ceased. The outcome of the events was recovered in 2021. No treatment for the events. No covid tested post vaccination. No follow up attempts are possible. Information on lot/batch number cannot be obtained.
40 2021-04-26 confusional state Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Fainting / Un... Read more
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Medium
40 2021-04-26 nervousness Patient DOB: 11/18/1980. Received his first dose Pfizer (LOT#: EW0179 EXP: 8/2021) at 1108 on 4/27/2... Read more
Patient DOB: 11/18/1980. Received his first dose Pfizer (LOT#: EW0179 EXP: 8/2021) at 1108 on 4/27/21. Patient alerted EMT. Patient stated that she was sweating a lot and felt like his vision went blurry/dark for about 3 minutes. Patient stated that he also felt nervous. EMT alerted PHN. PHN suggested to move patient to zero gravity chair. Patient walked with assistance from EMT to gravity chair. Patient walked over and sat down safely on gravity chair. EMT took patients vital signs. BP: 118/60, pulse: 65, O2: 97%. Patient was given water. PHN recommended that patient stay an extra 30 minutes. Patient agreed. EMT re-assessed patient. Patient stated that he was feeling a lot better and that his vision was completely fine now. Patient left vaccination site unassisted and with a steady gait at 1150.
40 2021-04-28 feeling abnormal Brain fog; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 40-year-... Read more
Brain fog; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 05Apr2021 (10:30) as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), allopurinol, omeprazole (PRILOSEC) and lorazepam. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 15Mar2021 (when the patient was 40 years old) for COVID-19 immunization. On 05Apr2021 (14:00), the patient had brain fog and dizziness. The events had resulted into doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care, and were reported to be serious (causing disability or permanent damage). The patient did not receive any treatment for the reported events. The outcome of the events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.
40 2021-05-01 feeling abnormal Nausea Foggy brain Fatigue
40 2021-05-03 insomnia, nervousness Since shot last Thursday April 29 at 930 am I cannot sleep at all and have a hard time breathing. Bo... Read more
Since shot last Thursday April 29 at 930 am I cannot sleep at all and have a hard time breathing. Body will not let me fall asleep. I get a rush of nervous or anxious energy and hot flashes
40 2021-05-06 confusional state, feeling abnormal, abnormal dreams Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Se... Read more
Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Severe, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: vivid dreams-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Mild, Additional Details: general feeling of increased inflammation of joint pain
40 2021-05-07 sleep disorder I developed sudden-onset, severe, crushing pain in my left shoulder, radiating down my left arm. Th... Read more
I developed sudden-onset, severe, crushing pain in my left shoulder, radiating down my left arm. This is the location where I received my vaccine one month prior. The pain was 8/10 and lasted approximately 7 hours. It woke me from sleep. I also experienced nausea. I tried Tylenol 1000mg, ice, and heat. Nothing helped. I went to the Urgent Care. They did multiple EKGs and lab tests. They ruled out a heart attack and pulmonary embolism. There was no injury. They were unable to find any cause for the pain. They administered aspirin, protonix, and nitroglycerin. The pain resolved after the third dose of nitroglycerin. (I was told by the cardiology PA that this was probably a coincidence.)
40 2021-05-09 confusional state Chills, dizziness, vax fog (confusion, disorientation), fatigue, headaches. Took a 3 hour nap and wo... Read more
Chills, dizziness, vax fog (confusion, disorientation), fatigue, headaches. Took a 3 hour nap and woke up with just a headache, which went away in the evening.
40 2021-05-09 disturbance in attention Fatigue, nausea, dizzyness, headache, difficulty concentrating, generally feeling like I have a conc... Read more
Fatigue, nausea, dizzyness, headache, difficulty concentrating, generally feeling like I have a concussion
40 2021-05-11 insomnia, feeling abnormal Body aches, severe chills/shaking, mild to moderate headache, sleeplessness. I took Advil and put o... Read more
Body aches, severe chills/shaking, mild to moderate headache, sleeplessness. I took Advil and put on pants, a sweatshirt, a a beanie and got underneath 3 blankets (for the chills). I fell asleep about 2 hours later. Now, it is 11:23 am on 5/12/2021 and I still feel moderate to severe fatigue, mild chills and my headache is gone. My head does feel a bit foggy though. I took Advil again at 6:45 am. At noon, I'm going to take Aspirin.
40 2021-05-12 nightmare Bad dreams.
40 2021-05-17 feeling abnormal, disorientation, confusional state 40 Y/O M 15 mins post vaccine- A/Ox0, presented disoriented with a confused daze followed by complai... Read more
40 Y/O M 15 mins post vaccine- A/Ox0, presented disoriented with a confused daze followed by complaint of dizziness and general feeling of "not right". v/s within normal limits. PT given emesis bag for episode of nausea. PT A/Ox3 w/in 2 minutes post-episode. W/in 10 minutes still feels "cloudy". EMS called for evaluation.
40 2021-05-17 panic attack Started 5/11 in the morning with headache and dizziness. Left arm started feeling heavy and numb als... Read more
Started 5/11 in the morning with headache and dizziness. Left arm started feeling heavy and numb also finger tips got tingling. Started to get sharp chest pains near my heart then started to feel fatigue. Then my tongue started to get swollen/numb and I couldn't really talk. Went to urgent care and due to my condition they called the ambulance and went to hospital. They did an EKG/chest x-rays and blood work. Couple hours later they send me home with no diagnosis just to see primary doctor. Symptoms were mild for 2 days then again on 5/14 symptoms came back and went back to urgent care. They did an EKG/Covid test/ only and doctor just said it was a panic attack. I disagree I still don't feel completely right.
40 2021-05-18 anxiety After about 5 minutes of vaccine administration, patient complained of "feeling of passing out", swe... Read more
After about 5 minutes of vaccine administration, patient complained of "feeling of passing out", sweating hands and face, racing heart rate. Called 911. After EMT arrived, and checked patient for any issues. From EMT, patient had known history of "fear of needles" and had anxiety attack after the vaccine. After about 20 minutes, patient was stabled and got release by EMT.
40 2021-05-19 sleep disorder Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: ... Read more
Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Nausea-Severe, Systemic: Unable to Sleep-Severe, Additional Details: He was covered in red spots, terrible itching. Couldn't sleep or eat for 3-4 weeks. He has taken mostly steroids to treat. Finally cleared on about May 14th. He said the itching was intense, could not eat or sleep. Ready to jump out of his skin. Just wanted to call someone to let them know and document.
40 2021-05-21 thinking abnormal Shortly after I received the shot, I had minor soreness in the spot of the injection. This was the o... Read more
Shortly after I received the shot, I had minor soreness in the spot of the injection. This was the only symptom for about 12 hours. At the twelve hour mark, about, I almost immediately started shivering uncontrollably. I was very cold ad sweating. I wasnt able to think clearly. My wife said I had a fever. Also, I had a headache. This occurred for about 6 hours. I was still cold and sweating, with a headache, for about another 4 hours, but it wasn't as extreme. I was still unable to think well. I had a desire to drink gatorade, not water, at this time. This was unusual. I drank about 2L of gatorade. I began to not feel cold, and only had a minor fever. Not sure how correlated these are. Over the next 10hrs or so, I slowly improved and was able to carryon daily activities.
40 2021-05-26 loss of personal independence in daily activities 50% loss of vision; Tingling on one side of body; Experienced Transient Ischemic Attack 1 week after... Read more
50% loss of vision; Tingling on one side of body; Experienced Transient Ischemic Attack 1 week after vaccine 2nd dose (April 27, 2021).; Strong pressure in head; loss of ability to support body in RL; Slurred speech; Difficulty in breathing; Cognitive difficulties; Extreme headache; This is a spontaneous report from a contactable consumer (patient) reported for himself that a 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL7533) via an unspecified route of administration, administered in Arm Left on 20Apr2021 14:00 as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (Lot number EL8727) in the Left arm on 29Mar2021 16:00 at the age of 40 years for covid-19 immunisation. No known allergies. No vaccines were received within 4 weeks prior to the COVID vaccine. Healthy and no prior adverse event history. The patient experienced transient ischemic attack 1 week after vaccine 2nd dose, strong pressure in head, loss of ability to support body in RL, slurred speech, difficulty breathing, cognitive difficulties, extreme headache on 27Apr2021 16:30; visited emergency department. 2nd incident 02May2021- 50% loss of vision, tingling on one side of body, slurred speech, cognitive difficulties, extreme headache. The adverse events resulted in emergency room and healthcare professional office visit. Patient was treated with headache medications. It was reported that patient was recovered from events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered in 2021. Information on Lot/Batch number was available. Additional information has been requested.
40 2021-05-28 confusional state, feeling abnormal, amnesia Walking to the observation room approximately 2 minutes post shot I felt extreme dizziness. Felt li... Read more
Walking to the observation room approximately 2 minutes post shot I felt extreme dizziness. Felt like I could potentially pass out so I waited 30 minutes in the observation room before leaving. After I was fairly confident I would not pass out I left the facility. When I made it outside it felt like the right side of my brain was "not there," like a portion of my brain was dead. While driving home approximately 45 minutes post shot I felt numbness and tingling on the right side of my face. Mental confusion also started. I don't recall the numbness and tingling in my face continuing at this time. Proceeded home, laid down on the couch to relax and about 3 hours post shot felt my heart racing. Checked heart rate with pulse oximeter and heart rate was 120 w/98 oxygen. 5 minutes later the heart rate went down to around 90 but blood oxygen went to 90. I sat up, drank water and pulse/oxygen returned to normal. The next day the mental confusion continued. Approx. 24 hours post shot tingling and numbness felt on right side of face. Couldn't move lips properly, communicate to my facial muscles. This lasted around an hour or two. 30 hrs post shot short term memory loss caused confusion when typing texts, following conversation, etc. Symptoms improved greatly over the next couple of days. Tiredness/general unwell feeling approximately 48hrs post shot but unremarkable. By the time I went to a GP 84hours post shot I felt 95%. Went to a neurologist 108hrs post shot who performed standard tests and all was well. 1 week post shot got into an argument and felt tingling and numbness on right side which lasted approximately 10 seconds.
40 2021-05-29 depression, anger From the patient I participated in phase 3 randomized, Double-Blind, placebo controlled Center stud... Read more
From the patient I participated in phase 3 randomized, Double-Blind, placebo controlled Center study for Clinical Research back in December of 2020 to determine the safety and efficacy of AstraZenecas, a combination of 2 of their monoclonal antibodies (AZD8895 and AZD1061) to preexposure prophylaxis in COVID-19 I was told to wait at 90 days before I got my vaccine and I think I should have waited much longer. Not long after I received the monoclonal antibody treatment I started to have really bad depression issues and anger problems that seemed to last up to around mid April of 2021. I also had my hepatitis viral load go from 180,000 to 580,000 in just a few months so a massive jump in hep c viral load. I reported all of this to them and they assured me that I was fine and the promised I?d be ok. I recently got the Pfizer vaccine with my second dose being on May the 7th 2021. My first dose on April the 16th was felt within minutes and I thought I was going to have to ask a staff worker with help getting out to the car. I was very sick for a day or so and it made me very frightened to get the second one. So much that I contacted The council about it. Everyone was extremely polite and very helpful. I got my second dose and it was not as bad to go through but now I have a constant fungal infection that I can not get rid of and if I eat sweets it gets really bad. My concern is not for anyone getting just the vaccine but for the people who have had the monoclonal antibodies and then getting the vaccine within 3 months. The second dose seemed to make me angry but it did not last as long. I?m worried about the effects other people may have had by combining the 2 or maybe not waiting longer before getting the actual vaccine. I don?t know but I can?t get rid of this fungus and I?m not sure else who to report it to. I?ve obviously shown it to my doctor. He gave me anti fungal creams but it turns out I have an allergy to fungal creams. I did let the drug trial site know what happened as well. I do not think it?s a Pfizer thing but a combination of it with the AstraZeneca monoclonal antibodies and the vaccine.
40 2021-06-06 disorientation Within about 5 minutes of patient of patient receiving the vaccine, he had a seizure in the lobby of... Read more
Within about 5 minutes of patient of patient receiving the vaccine, he had a seizure in the lobby of the pharmacy. The seizure was not witnessed by any employee, but by his companion and a customer. I immediately had a technician call 911 and ran out with our emergency kit when I heard the patient's companion screaming for help. When I got to the patient he was in a seated position in a chair in the lobby and was coming to. He was disoriented and looking around. I asked if he knew his name and what day it was, he did know. I asked if he knew where he was and he responded correctly. He said he felt week and hot, he appeared sweaty. I checked his blood pressure (100/58) and pulse (50 bpm). His temperature was 97.1. His companion stated he had never had a seizure before when asked. I gave him some water and sat with him until EMS arrived. He remained seated the entire time and said he felt week. A few minutes after EMS arrived, the patient left via stretcher by ambulance, but remained conscience.
40 2021-06-07 panic attack Vision loss, hearing loss, muscle control loss and fell over. Thought I was dying. Feel better now a... Read more
Vision loss, hearing loss, muscle control loss and fell over. Thought I was dying. Feel better now after breathing and trying to call myself down as it panicked me. Cuts and scrapes on hand and knee and elbow from falling. Scary as luckily I made it home driving ok.
40 2021-06-10 insomnia Insomnia; Cough; his body start jerking; This is a spontaneous report received from a contactable co... Read more
Insomnia; Cough; his body start jerking; This is a spontaneous report received from a contactable consumer. A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, on 03May2021 (at the age of 40 years) and second dose of BNT162B2 on 26May2021, as a single dose for COVID-19 immunization. The patient medical history included Ventricular tachycardia and concomitant medications included Amiodarone used for Ventricular tachycardia on an unknown date. Reporter stated that he took the highest dose in that medicine, yes the highest, I do not know what the highest is that he is taking I know it is the highest since they said they cannot give him anything now". Reporter stated, "My son might be having a reaction to the Pfizer vaccine and he has a test in the morning, but he already been into the emergency room and all these and I need to ask or talk to somebody that can medically give me some advice before his test specifically we do not know he can actually have this test now. Reporter added, "Now do you need to know his side effects that he is having from the vaccine that came from the vaccine. Okay the side effects he is having started right after his first vaccine on 03May2021 he started getting the sleep apnea well not sleep apnea sorry about that he started getting insomnia and he cannot sleep and he ended up getting a cough so when he went back to his second vaccine his insomnia started getting worse, he is like he cannot sleep at all and when he does fall asleep its only for 2 hours and he gets so tried, his body start jerking and makes him wake up. Report-er stated, "They are worsening". The patient underwent laboratory test and procedures which included chest X-ray, Nuclear test on Friday and have not got results for that test. Outcome of events was reported as unknown. Reporter seriousness for Insomnia, Cough, his body start jerking was unspecified.
40 2021-06-15 loss of personal independence in daily activities, anxiety, fear 2 days post vaccination onset of acute arthritic symptoms symmetrically along body beginning in the ... Read more
2 days post vaccination onset of acute arthritic symptoms symmetrically along body beginning in the hips, and escalating to back, neck, shoulders, wrists, hands, and knees, in that order. Right side is now becoming more severe for pain and stiffness, but still roughly symmetrical. Symptoms are more severe upon waking and some mobility is restored by regular movement within an hour, but it is becoming harder and more painful each day. Was taking ex str. Tylenol at 500mg 8 x3 times a day for pain management, have since switched to aspirin 500mg 4-5 x2 times per day but that too is becoming less effective. Severe mobility impact, cannot get groceries, walk dog, open bags, jars, cans, and am starting to develop anxiety around the worsening symptoms. No health coverage. No primary care physician. Sporadicly I have days that the symptoms are almost completely non-existent, but these ?relief days? are never consecutive and the next day will always have the symptoms worsen again. I have always generally been in pretty good health, and I?ve never taken anything regularly, but this has me terrified.
40 2021-06-20 feeling abnormal Following the vaccination on 2/23/21, Pt had fever, chills, fatigue the first two days. On the third... Read more
Following the vaccination on 2/23/21, Pt had fever, chills, fatigue the first two days. On the third and fourth days, he added diarrhea and headache to those symptoms. He felt awful over the weekend and spoke to his doctor on Monday, 3/1. The doctor began him on steroids and ivermectin. Over the next 24 hours his breathing began to worsen. He entered the hospital on Tuesday, 3/2, for supplemental oxygen. Things continued to get worse. He was intubated and put on a ventilator on 3/6/21 and ultimately spent 13 days in a coma. He was extubated on 3/19/21 but then had seizures on 3/20/21 and had to be reintubated to secure his airway. Pt was taken back off the ventilator on 3/24/21. He suffered vocal cord paralysis and ultimately wound up with both a PEG tube and tracheotomy. He was discharged from the hospital after 43 days and then spent 10 days in an inpatient rehab center. He continues to deal with vocal cord issues, tracheal stenosis, nerve damage in his neck and shoulder, muscle atrophy, and damaged lungs.
40 2021-06-21 impaired work ability A day later general flu like symptoms had to take a day off from work and then the following day my ... Read more
A day later general flu like symptoms had to take a day off from work and then the following day my symptoms decreased but i still felt tired and headaches.
40 2021-06-22 sleep disorder Chest pain that was much more severe when sitting or sleeping. Sleep was disrupted nightly and I was... Read more
Chest pain that was much more severe when sitting or sleeping. Sleep was disrupted nightly and I was not able to sleep on my left side. The chest pain lasted about 6 weeks and occurred most severely 3-4 times per day. I visited my PCP and he said that he heard a loud murmur or wooshing sound. He checked for a fib but heart ECG was normal. We scheduled an echo but the echo was not performed until 2 months post onset of the symptoms. Symptoms seem to point to subacute pericarditis. Increase of Petechiae on the torso. One spontaneously bled. Seems to be fading after three months.
40 2021-06-24 confusional state Chest pains, left rib area won't stop hurting, a few days after shot felt like my abs were having a ... Read more
Chest pains, left rib area won't stop hurting, a few days after shot felt like my abs were having a charley horse. Back pain, nausea dizziness and confusion on a daily basis. Doctors have no idea what's wrong with me suggesting upset stomach, ulcer, heartburn, spinal issues., anxiety, depression. They are just guessing.
40 2021-06-24 disorientation 6/25/2021 Patient was observed post Covid-19 immunization for 15 minutes . During the observation... Read more
6/25/2021 Patient was observed post Covid-19 immunization for 15 minutes . During the observation period, he experienced an adverse reaction with the following symptoms: loss of consciousness. Assessment : Time of assessment 0831am. Pallor, Clammy and disoriented. Actions taken: Vitals sign taken EMS called at 0831. VAERS form obtained and completed by RN. Hand off to EMS upon arrival at 856am. Patient refuses EMS transport. Water given 0835- BP- 67/44, P- 39, O2- 100 %, recheck- at 0839- BP- 105/66 , 0915- bp 012/82, P- 44, O2- 100% Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. EMS accessed patient, patient refuses transport. Wife with patient. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 6/25/2021 8:27 AM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8736 NDC: 59267-1000-2
40 2021-06-24 feeling abnormal, thinking abnormal Extremely High Fever, Chills, Urination burning, Nausea, Headache, Sore Throat, Extreme Fatigue, Men... Read more
Extremely High Fever, Chills, Urination burning, Nausea, Headache, Sore Throat, Extreme Fatigue, Mental fog and unusual thoughts.
40 2021-06-27 feeling abnormal Heart Palpitations, heart stopping, chest pain, chest irriation, heavy breathing
40 2021-06-29 feeling abnormal I got the vaccine shot on a Thursday, and woke up the next Friday morning feeling strong tingles on ... Read more
I got the vaccine shot on a Thursday, and woke up the next Friday morning feeling strong tingles on my face, weird sensations, & some swelling of lymph nodes had started. i thought i might be having a minor reaction, or it felt like i might. Saturday morning i woke up w' some bumps & inflammation w' a painful red sore on my nose bridge next to my right eye. i almost went to urgent care Saturday night but talked myself out of it, then Sunday woke up & had more inflammation & swelling, tenderness, & pain & discomfort. i went to my doctor on Monday as it felt intolerable & was getting worse, i told him about getting the vaccine, reporting it felt like my immune system was confused or something, he said there were some vaccine reactions, that it was possible for it to affect people differently, that it was rare, that he didn't know, but he said it looked like shingles was attacking me & referred me to the Eye Institute to see Dr, who tested me even as my eye was swelling shut. There was a danger it could get in the eye. Prescribed Acyclovir antiviral. My condition kept worsening but i kept taking the antivirals & eventually responded well to them. It hurt everywhere, & the pain was indescribable, at almost every level. It was excruciating. i was fighting off the attack by the 3rd week & could open my eye, but was still in a lot of pain, had to rest almost all the time, could barely eat & speak for weeks, or go outside in the sun for more than a couple minutes, because of the brightness etc. & was overall incapacitated for about 5 weeks. It was completely disabling. The doctors were very impressed w' how intense the condition was, & showed me to all the students at the Eye Institute. They were pleased w' how well i have been healing up. My immune system feels strong too. It was just brutal but i am recovering now, thankfully. i still feel prolonged effects though, w' even some pain at times during the day, or if i am active then i feel like i have to rest. i am just really thankful it doesn't hurt like that now. There is probably gonna be some permanent scarring because of the damage to my face from the nervous system inflammation, as my face is heavily scarred now because of the attack, i could maybeget plastic surgery for the scarring on the right side of my face.
40 2021-06-30 anxiety, impaired work ability Pt became severely sick with flu-like symptoms and could not work on April 20-22. He worked on Apri... Read more
Pt became severely sick with flu-like symptoms and could not work on April 20-22. He worked on April 23. He told people he was sick again on April 24. He was very anxious and committed suicide some time between April 27-28.
40 2021-06-30 depression Severe, acute depression that started a few days after the first dose and then mostly resolved befor... Read more
Severe, acute depression that started a few days after the first dose and then mostly resolved before the second dose. After the second dose, severe, acute depression occurred again, even more intense than that occurring after the first dose. This was the worst I've ever felt in my life mentally. No treatment. Resolved on its own after two to three weeks.
40 2021-07-01 insomnia insomnia started getting worse; he gets so tried; his body start 'jerking'; feels like he is suffoca... Read more
insomnia started getting worse; he gets so tried; his body start 'jerking'; feels like he is suffocating; it's like somebody is choking him/choking sensation/feels like somebody has his thumb in the middle of his adam's apple and his throat; light headed; This is a spontaneous report from a contactable consumer (patient's mother). A 40-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 26May2021 as the 2ND dose, single for COVID-19 immunization. Medical history included ongoing ventricular tachycardia. Concomitant medication included amiodarone (manufacturer unknown) taken for ventricular tachycardia, start and stop date were not reported, taking the highest dose (as reported). The patient previously received the first dose of bnt162b2 (lot number and expiry date unknown) on 03May2021 for COVID-19 immunization and right after the patient experienced insomnia and cough. When the patient went back to his second vaccine, his insomnia started getting worse. He can't sleep at all and when he does fall asleep it is only for 2 hours and he gets so tired, his body starts 'jerking' and it makes him wake up. Since the second vaccine, the patient said it's like somebody is choking him, he said it feels like he is suffocating and he said it feels like somebody has his thumb in the middle of his adam's apple and his throat and so they send him to the emergency room and they told him to go home and just take sleeping pills. However the reporter stated that the patient can't take the sleeping pills because of his ventricular tachycardia and the medicine that he is on. They were getting the patient setup for his test the following morning from the day of the report and when he woke the morning of the day of the report he experienced the choking sensation and all that kind of stuff but he is light headed and they don't know if he should be taken to that test the following morning but yes the test is really important because of his heart and they don't know if he can take the medication that they are going to give a 'nuclear' medication with having all these side effects like these if it is from the Pfizer vaccine so that was why the patient's mother was reaching out for somebody with medical knowledge about the vaccine and the side effects and if someone could tell them if the patient could continue with his test. They wanted to know how long the side effects will last and if the side effects need treatment. The patient had a lab test (unspecified) and a chest x-ray both on unspecified dates but they did not have the results at the time of the report. The outcome of the events was unknown. Information on lot number/batch number was requested.
40 2021-07-08 insomnia, feeling abnormal Increased yawn reflex to find air.; Chills immediately after/ cold body; Sweaty hands; Tight throat ... Read more
Increased yawn reflex to find air.; Chills immediately after/ cold body; Sweaty hands; Tight throat muscles; Sore upper left arm; Weird feeling in the body; Very slight difficulty breathing; Very slight difficulty articulating some words; Nausea; Difficulty sleeping; Loss of appetite; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EK8727) via an unspecified route of administration in the left arm on 24Mar2021 at 16:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient had known allergies to penicillin and amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN) 20mg once a day for unknown indication and from an unknown date. On 24Mar2021 at 16:45, the patient experienced increased yawn reflex to find air, chills immediately after / cold body, sweaty hands, fatigue, tight throat muscles, sore upper left arm, weird feeling in the body, very slight difficulty breathing (but SPO2 ok at 98%), very slight difficulty articulating some words, nausea, difficulty sleeping and loss of appetite. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab tests which included oxygen saturation test on an unknown date and the result was SPO2 at 98%. The clinical outcome of events increased yawn reflex to find air, chills immediately after / cold body, sweaty hands, fatigue, tight throat muscles, sore upper left arm, weird feeling in the body, very slight difficulty breathing, very slight difficulty articulating some words, nausea, difficulty sleeping and loss of appetite was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
40 2021-07-11 disturbance in attention Tinnitus - ringing in the ears. I was working from home that week while my family was out of town a... Read more
Tinnitus - ringing in the ears. I was working from home that week while my family was out of town and noticed the intensity of ringing ramp up over the course of the week. I received my shot on Monday afternoon and by the following Sunday morning, the intensity was so great that it was difficult to concentrate/comprehend what was said during a church service. I saw my ENT doctor the following week and got a hearing test, which picked up some slight hearing loss. Since then, intensity has fluctuated day to day and in different environments. The left ear is worse than the right ear. At the time of this report, I've experienced several days of consecutive ringing that has been about the most intense that I've experienced. I've been told there is no effective treatment for the condition, but I've utilized lipo-flavonoid with mixed results. Ringing seems to be less intense after nights where I've slept well, but that is increasingly challenging.
40 2021-07-11 loss of personal independence in daily activities, impaired work ability Following my second Pfizer dose on on 4/2/21 I began having a strong burning pain in my right forear... Read more
Following my second Pfizer dose on on 4/2/21 I began having a strong burning pain in my right forearm and wrist area. I perceived this initially to be carpal tunnel and it started on 4/5/21. I self treated with ibuprofen for a few days with no improvement, then saw my PCP on 4/9. My PCP thought this to be tenosynivitis, and prescribed Methylprednislone. The steroid treatment helped for the first few days but then the pain quickly spread to my right leg in the thigh area. Same type of pain, burning and intense. I was able to walk, but with a slight limp. I saw my PCP again on 4/15 to discuss the new symptoms. He began researching possible conditions and also ordered some blood tests for common auto-immune diseases (Uric Acid, C-Reactive Protein, CMP, ANA). Everything returned normal except for C-Reactive (value- 50+). To be sure it wasn?t a case of septic arthritis, I was placed on an antibiotic on 4/17 (Keflex) for 7 days. The Keflex did not help and actually gave me a slight fever (100.1) and I missed work on 4/19,20,21. I started to improve on 4/16 but the symptoms were still present. As a followup, my PCP ordered a more comprehensive blood panel to be reviewed at my next appointment on 4/30. The following blood tests were ordered: TSH 3rd Gen Blood, CBC, CMP (BAMP, TP ALB TBIL,ALK, AST, ALT), and LIPID Panel. On PCP appointment on 4/30, my symptoms continued to present in legs and right arm. All values from blood tests were normal. He ordered a lower back xray, which was scheduled for 5/11. At this point, my PCP referred me to a rheumetologist as he had exhausted his options. Unfortunately, the earliest rheumatology available was 5/18. On 5/18 appointment with rheumatology resulted in more tests: Parvovirus B19, Rheumatoid Factor, Serum Protein Electrophoresis, Urine PRotein/Creatinine Ratio, Immunoglobulin Assay-Blood, Immunofixation Procedure Blood, ASO- Blood, CPK Blood, Cyclic Citrullinated Peptide Antb, Hep B Surface AG, Hep C AB- Blood, Microalbumin urine random. All tests read as negative or normal except ASO. Rheumetologist referred me to Infectious Disease for further testing on 5/26, which resulted in the following blood tests: Ehrlichia Chaffeensis AB IGG, DNASE B Antibody, HLA Typing A B C Single - Blood, Legionnella -Blood, Prostate Specific Antigen, Unrinanalysis with Microscopic, Chlamydia and GC RNA AMP, Upper respiratory throat culture. He also ordered an ECG, a chest XRAY (PA and Lateral), CT scan of the pelvis. On 6/4 at a followup appointment, he ordered Crypto AG and C-Reactive Protein. At this point, CRP value was 180.74. I worked my last day of work on 5/14 as the pain became too intense to manage. As the week progressed, I slowly lost my ability to walk and care for myself. I could walk only 10-15 feet at a time, and doing so would cause a severe flare-up of pain in my legs. I was mostly bedridden for 2 weeks starting on 5/20 and was only getting up very minimally. I needed a wheelchair for transport to my appointments on 5/25, 5/26, 6/2, 6/3. By 6/4, I was barely able to walk to that appointment, but the office is very small so I was able to make a short distance. My rheumetologist, having reviewed all my normal test results ordered an EMG on my legs and right arm and also an MRI on my lumbar and cervical. EMG conducted on 6/24 and revealed some nerve damage and signs of neuropathy in my legs; and also carpal tunnel in the right wrist. MRI Lumbar (6/25) revealed some common lower back issues, but nothing affecting the nerves that may be the cause of my symptoms. MRI Cervical (7/12) completed but yet to be analyzed. As of today, July 12, I?m feeling much improved over how I felt in early June. I can walk a short distance of ? mile without needing a break. I have lost muscle tone and need to work on getting my strength back. My right arm has minimal pain but will flareup with heavy computer usage. However, for the past 2 weeks, my left arm (which has been symptom free since April) now has a similar burning pain that starts at the funnybone of the elbow and runs up to my wrist. The pain comes and goes but is sometimes very intense and can be debilitating. It is hard for me to open some doors with this hand or even hold a heavy cup of water. As a previously healthy person, and having done exhaustive testing, myself and my PCP believe I had a rare and negative reaction to the vaccine.
40 2021-07-15 hallucination, loss of personal independence in daily activities, disorientation, anxiety Patient came into pharmacy on 7/ 14/21 and described the following: Severe body pain in areas where ... Read more
Patient came into pharmacy on 7/ 14/21 and described the following: Severe body pain in areas where he has "recent" injuries (vasectomy, back issues). No control over bowel movements. Disoriented/ motor skills severely lacking; couldn't walk down steps or down the hallway. had to call for help to family to do normal tasks. mild hallucinations. mental anguish; things were true in his head but not true in reality; mental dysphoria. Thinking this was the end; was able to recognize it but also very concerning. 3:30 am saturday this started; not all gone yet (7/14). Tension headaches (not prior). Extremely cold, clammy, sweaty; had to change clothes based on the amount of sweat. Not drug user, not alcohol, active military, not 48 hrs prior till recent. no pre workout. no medications. ibuprofen later saturday morning. First vaccine he just had local pain at shot site, some pain to the older issue sites and tiredness but nothing more than 24 hours. No mental illness dx at this time; possible ptsd but never diagnosed, not something he suffers from on a daily basis.
40 2021-07-16 amnesia, hallucination I was hospitalized on 6/2/2021 due to viral Meningoencephalitis. Althought this was 6 weeks after 2... Read more
I was hospitalized on 6/2/2021 due to viral Meningoencephalitis. Althought this was 6 weeks after 2nd shot, was told I should still report it since it was caused by a virus that the hospital was unable to determine after negative tests for other viruses. Had high fever, which led to loss of consciousness and possible seizure. Experienced hallucinations and loss of self-awareness (forgot who I was). Taken to hospital, entered into ICU for 5 days. Spinal tap revealed viral infection. Throat culture revealed strep throat. Given antibiotics and IV fluids for several days. Restored self-awareness and fever disappeared after a few days. Intense headaches persisted for days. Was discharged from hospital on June 7, 2021 after 7 days. Experienced possible repeat seizure 5 days later in public, loss of sensation in legs, slurred speech. Was re-administered into different hospital on June 13, 2021. Spent ~5 days in that hospital, received EEG which showed brain damage on right temporal lobe. Received another spinal tap which showed infection was improving. Discharged on June 16, 2021.
40 2021-07-17 insomnia He experienced some leg shaking; Can not sleep; His legs started shaking and Friday it got worse; he... Read more
He experienced some leg shaking; Can not sleep; His legs started shaking and Friday it got worse; he went from 180 to, when he was at the doctor, they said 175; Nausea; After getting both doses he experienced Chills; Vomiting; Arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number, NDC number, Expiry Date of Pfizer Covid-19 Vaccine: Unknown), via an unspecified route of administration on 15Jun2021 at 10:00 AM (vaccinated at the age of 40 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing diabetes and reported as patient has had since he was 22 he thinks. He went with his ex-wife on vacation and came back, so probably 22, Caller clarifies that he thinks he is a type 1 diabetic but he is not sure, he takes insulin. Ongoing smoker and reported as I smoke and occasionally drink on the weekend maybe but nothing crazy. He has been smoking since he was 17 he guesses. Ketoacidosis and reported as caller adds that he did have ketoacidosis last year and they did do everything, CAT scans and all the blood work and everything. This was this past year. Caller does not know additional information but states it was prior to receiving the vaccine. The patient doctor a year ago gave some heart medication because patient had high blood pressure. The time before he saw him, he said it was too low and stop taking it. Family medical history reported as nobody has diabetes in his family, and he is the first. His dad had cancer and passed away when he was 58. Concomitant medications included insulin human injection, isophane (NOVOLIN N) and insulin human (NOVOLIN R) both were taken since he was 23 years for diabetes from an unspecified start date and ongoing. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: unknown) on 25May2021 for Covid-19 immunization and he got sick, it made him throw up, experienced chills. The first dose appointment was at 9:30 am. The patient states he got the second shot last Wednesday. Then, he went to work on Thursday. Friday on 18Jun2021, his legs started shaking and Friday it got worse. Saturday it got worse. Sunday, they felt a little better. Monday, or actually yesterday, he went to the doctor and the doctor said he has to go see a neurologist because the doctor kept him there for 3 hours looking at his legs and feeling them. They were moving out of control. Caller added as, considering his job, he walks 20-30,000 steps a day and he has never had trouble with his legs but he was diabetic. Caller adds that right now he kind of walks, like his girlfriend and son explained it, like a gimp and when he walks his legs pop. The patient cannot sleep. He slept maybe 6 or 7 hours since last Friday 18Jun2021. On an unspecified date the patient went from 180 to, when he was at the doctor, they said 175. Caller confirms this was new since receiving the vaccine. He has been 180 my whole life. He has not been able to work in a couple of day because he cannot walk. He guesses the weight loss is because of the vaccines. But, he is diabetic too, and was in pretty good health before this. Caller adds he has to pay for doctor appointments, his doctor kept him there for close to 4 hours and he looked at his legs for 45 minutes. He did not understand what was going on, and he sees him all the time for his diabetes. The doctor said that he has to see a neurologist, but none of these symptoms happened in his life until he got the shot. The patient arm of course was a little sore like when you get a shot and it hurts. Caller went to work and was fine, went to work the next day and was fine. This past Friday, his legs started shaking and he does not know. He could not sleep, they would not stop moving. He can control them if he uses muscle and really tries to control them. caller adds this is not going on still, he just thinks the pharmacist who gave the shot gave it rough. Also, his job is to walk a lot and lift stuff so that could be contributing to that part. Legs shaking, The patient spoke as per attached document in terms of nausea and vomiting. Treatment; cannot not sleep: caller adds he has a pool and when he goes swimming it feels better. If he walks around too much, how can he explain it, it gest worse but he can control it. If he flexes his muscles he can stop it, like flexing his legs that is how he stops it. If he does not, they just shake. He cannot not sleep because they shake so much they wake him up. The patient was diabetic and uses insulin and the same medication he has taken for years. The patient has been fine. His doctor a year ago gave him some heart medication because he had high blood pressure. The time before he saw him he said it was too low and stop taking it. The patient walks a lot and exercises or swims and uses insulins. One was long and one was short acting. Investigations were none, the patient saw a doctor yesterday who was trying to get him into a neurologist. He thinks it has to do with his nerves. He is trying everything he can. Adverse events do not require a visit to emergency room, but the doctor said if he cannot get him in to a neurologist in the next day or two, that he wants him to go to the emergency room. Needs visit to physician office. The patient doctor did not know what to do and just referred him to a neurologist. Caller just wanted to report this because none of these symptoms occurred until the second shot, or, well, it was the first shot that made him throw up and the other things with the second shot. his doctor did not know what to do and just referred him to a neurologist. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines was none. Adverse events following prior vaccinations was none, he has not had a vaccine since he was a kid or teenager he guesses. The patient underwent lab tests and procedures which included weight loss: went from 180 to 175 lbs on an unknown date and reported as He went from 180 pounds to 175 pounds. Outcome of the event cannot sleep and his legs started shaking and Friday it got worse were not resolved and event arm was a little sore was resolved on an unspecified date, and remaining events were unknown. Information about lot/batch number has been requested.
40 2021-07-19 insomnia, disorientation Blood pressure went up to 160; My heart rate went up to 130/Rapid heart rate; disorienting; unable t... Read more
Blood pressure went up to 160; My heart rate went up to 130/Rapid heart rate; disorienting; unable to eat; post-nasal drip 'dripping' into my lungs; Occasional shortness of breath; Dizzy; Unable to eat and actually zero desire to eat; Sweating/ sleep sweat; sleeping off and on; Was just physically ill/ malaise; Chills; Fever; Extremely tired/ general fatigue; I throw up the water I have been drinking all day; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 13Apr2021 at 08:00 (at the age of 40-years-old) as single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). The patient stated that it was just a standard rescue inhaler 100 mcg. The patient was vaccinated on 13Apr2021 at 08:00 and within 5 minutes his blood pressure went up to 160 and heart rate went up to 130, so they called paramedics over, who were already on site and did pulse check and blood pressure check until they knew what heart rate, blood pressure and oxygenated blood was. They did not allow him to leave for an hour because it was so highly elevated, he felt so dizzy and very disorienting. His friend dropped him home because he could not drive, there was no way he could drive. After an hour the blood pressure got back down to 140 and heart rate was still about 120, it was lower, so he went home and immediately lay down and rest the entire day. He was just physically ill and experienced chills, fever, sleep sweat, extremely tired, strangely no arm soreness at all. He got every other possible side effect and that lasted until 01:30 in the morning, after he throw up, he was finally able to get some sleep. He took rest the entire day, sleeping off and on, unable to eat and actually zero desire to eat, rapid heart rate, sweating, and occasional shortness of breath. He used the rescue inhaler as treatment, that was probably because he laid on his back for so long and also probably just post-nasal drip into lungs. At 01:30 in the morning, he throw up the water he had drank all day and felt a bit better. It was probably because he did not eat all day. He slept until noon and didn't went to work because he felt malaise, general fatigue, his arm didn't hurt. He didn't feel great on the day of reporting, but it was not like the previous day. He had to go to the emergency room, as his mom kept pushing him to go and he was like not going. He had not eaten anything on the day of reporting, so he was looking for something to (incomplete sentence). The patient took 1 gm of Tylenol (over the course of maybe 14 hours) on 13Apr2021 and was advised not to take Advil for whatever reason. The patient underwent blood volume the previous month which was normal and no STDs. He was negative for COVID. That's why he felt okay with vaccine and then before that he did a PCR test which was also negative. The patient have been in 11 countries in the previous year and might have undergone 20 PCR test. He was kind of scared taking the second shot. The outcome of all the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-07-21 confusional state Heart Rate for no reason would jump up to 180-200 beats per minute, confusion, high blood pressure. ... Read more
Heart Rate for no reason would jump up to 180-200 beats per minute, confusion, high blood pressure. Called 911 because I thought I was having a heart attack. I did not go to the hospital during that event. I told them I had a cup of coffee with breakfast and that I had my vaccine two days prior and they said it was probably from that. I had 20 other events the following months sometimes at night, same symptoms. The worst was on 6/13/21 I was helping my friend move and my heart rate jumped up and blood pressure went up as well. I called my wife to pick me up and I could not communicate my location, I was standing under a street sign in a neighborhood I am familiar with. I though I was going to lose consciousness. I called 911 and decided to go to the hospital and see what was happening to me. I have had several EKG and came back clean. The doctor said for some reason I am having episodes of SVT and that I need to wear a holter monitor to figure out what is happening to me. After that day I removed any and all alcohol and caffeine from my diet. Beers on the weekend and I would have one to two cups of coffee a day from our coffee machine at home. 6 weeks later the monitor has been approved and I am wearing it now. I set up a doctor because I did not one and had an EKG and explained my sysptoms and he said he has seen this happen to a lot of men specifically and it usually takes several months and it "should" go away. I meet with a Cardiologist on July 29th. Since removing alcohol and caffeine the episodes decreased and went away within a week and I have not had any episodes for the past 4 weeks.
40 2021-07-21 disorientation, hallucination Hallucinated after 1st shot then blacked out. Lost control of bladder functions. Disoriented and una... Read more
Hallucinated after 1st shot then blacked out. Lost control of bladder functions. Disoriented and unable to speak or hear for several minutes. Transported to emergency room. Still have hearing issues and headache a week later.
40 2021-07-21 insomnia, thinking abnormal Have songs playing in my head; Unwanted thoughts; Sleeplessness; Swollen glands; This is a spontaneo... Read more
Have songs playing in my head; Unwanted thoughts; Sleeplessness; Swollen glands; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 31Mar2021 at 22:30 (at the age of 40-year-old ) as a single dose for COVID-19 immunisation. Medical history included epilepsy. Concomitant medication included lamotrigine (LAMICTAL) taken from an unknown date for an unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 10Mar2021 at 23:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 22:45, the patient experienced sleeplessness, unwanted thoughts, swollen glands and had songs playing in his head (thinking abnormal). The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event sleeplessness, unwanted thoughts, swollen glands and thinking abnormal were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
41 2021-01-10 depression Patient received first vaccine 12/29/2020. While in waiting period post-vaccination, he developed ti... Read more
Patient received first vaccine 12/29/2020. While in waiting period post-vaccination, he developed tinnitus and was hot, flushed, and diaphoretic. He felt very cold and "wobbly" after other symptoms subsided. He had sharp pains in the joints on the side of injection which continued through 1/1/21 later that day. He was tired and had a minor headache 12/29/2020-12/31/2020. Patient had a bout of severe depression and "not caring about anything" beginning 12/29/2020 and lasting about 16 hours. He has no history of depression. He awoke 1/1/2021 and the depression was gone. Patient states all these symptoms disappeared when his arm pain resolved. He developed a "strained" throat on 1/1/2021 which is the only symptom that has continued to the day of this report.
41 2021-01-10 feeling abnormal 1. Lethargy 2. Intense Migraine 3. Joint pain 4. Foggy Brain 5. Heavy Chest 6. Chills
41 2021-01-11 feeling abnormal Lethargic not hungry Headache Weak Cloudy head
41 2021-01-12 confusional state High Fever 101.6 F, lethargy, Confusion, Muscle/Joint aches and pains, headache, Tiredness, Chills a... Read more
High Fever 101.6 F, lethargy, Confusion, Muscle/Joint aches and pains, headache, Tiredness, Chills all started about 17 hours after the shot(vaccine) Fever finally broke after taking 1000mg Tylenol. About 40 hours after the vaccine I felt normal again with just a mild aches and pains in joints.
41 2021-01-12 insomnia, impaired work ability Nose is stuffy; Shortness of breath; Felt not really ok; itchy; Muscle soreness, like arms would fal... Read more
Nose is stuffy; Shortness of breath; Felt not really ok; itchy; Muscle soreness, like arms would fall off; Couldn't sleep; joint pain; had to miss work; fever reaching 104 degrees; chills; muscle ache; headache; tiredness; weakness; This is a spontaneous report from a contactable consumer (patient). This 41-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via an unspecified route of administration on at arm left 05Jan2021 at single dose (lot number: EK9231) for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient previously received flu vaccine and felt a little tired and sore with Flu vaccine. The patient got his first dose and then worked all day on 05Jan2021. Around 18:00-19:00 on 05Jan2021, he had fever, chills, muscle aches, headaches, joint pain, tiredness, and weakness. Fever was up to 104. The patient was referring to the Pfizer COVID-19 Vaccine first felt short of breath on 05Jan2021. He was wearing a mask and felt like he couldn't breathe. He did not feel really ok on 05Jan2021 like with a flu shot. He was working and felt a little itchy. He came home around 18:00-19:00 and had chills, headache, muscle soreness like arms would fall off. He couldn't sleep. He had fever and chills through the night. He had fever up to 104 on 05Jan2021 and had to miss work. The patient stated his nose was stuffy on an unspecified date. No additional vaccines administered on same date of pfizer suspect. No prior vaccinations within 4 weeks. Outcome of all events was unknown.
41 2021-01-12 nightmare, hallucination Sweating, Chills, Extreme Body Aches, Wheezing(never in life before), Dryness of Mouth, 99.8 Fever b... Read more
Sweating, Chills, Extreme Body Aches, Wheezing(never in life before), Dryness of Mouth, 99.8 Fever but fealth much worse, Heart burn, felt like my inside of body was swelled up, slight Gas, Hallusinations, Nightmare, Extreme Back pain not able to stay still, but I had slight back pain before this was 1000 times worse. I thought its coming to an end. This is exactly what happened to me when I had peak of COVID except the wheezing, I though I had COVID all over again. I took Vitamin C, Vitamin D, Zinx, Tums, Ibuprofen and fell asleep around 2 AM. I woke up at 7 AM in a pool of sweat had to remove the blankets to washer. I had no fever and nothing else it seemed like a switch is turned off and everything went away. Injection site was hurting allot during this time, but when I woke up nothing even injection site was not hurting either. It was a horrible night but seemed that nothing happened in AM.
41 2021-01-13 feeling abnormal 99 degrees; felt really bad/feels like a 3 or 4 out of 10; muscle aches and pains; tired and fatigue... Read more
99 degrees; felt really bad/feels like a 3 or 4 out of 10; muscle aches and pains; tired and fatigue; felt like he was going to throw up; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: PFI302), via an unspecified route of administration in left arm on 05Jan2021 11:00 at single dose for ''front line worker''. Medical history included Crohn's disease from 2012. Concomitant medications included adalimumab (HUMIRA, injection, Lot: R22-03-A-01, Expiry: Feb2021) from Feb2019 and ongoing at 40 ml twice monthly for Crohn's disease (When providing weight he adds that he has had some weight gain due to medication side effects with Humira), ibuprofen (He took Ibuprofen on Tuesday night and 1 last night. He has not taken any today). Caller received the Pfizer covid-19 vaccine two days ago (05Jan2021). He has mild side effects to report. He is a Clinic Social Worker. Following the vaccine he experienced muscle aches and pains on 05Jan2021. He was tired and fatigued on 05Jan2021. His temperature was 97.5 yesterday (06Jan2021). It now 99 degrees (07Jan2021). His temperature went up 1.5 degrees. He felt like he was going to throw up in Jan2021. He received the vaccine at 11:00 am. At 05Jan2021 4:00 pm he felt really bad. He feels like a 3 or 4 out of 10. He is scheduled to get his second dose on 26Jan2021. The outcome of the events muscle aches and pains and tired and fatigue was recovering. The outcome of other events was unknown.
41 2021-01-15 impaired work ability The day after had myalgias and fatigue and arm pain. But on 1/10/21 began developing mild 2/10 head... Read more
The day after had myalgias and fatigue and arm pain. But on 1/10/21 began developing mild 2/10 headaches. On 1/11/21 the headache worsened to 4/10 and was associated with myalgias and neck stiffness. After a jog, I was in the shower and noticed a rash all over my body that had been pruritic. I went to the ER that night where I tested negative for flu A/B and also tested negative for covid (Antigen then PCR). Got a CMP, CBC, and coags to rule out ITP. everything was normal. The symptoms were so bad I stayed home from work on 1/12/21. Over the next few days the rash improved and the headache slowly went away
41 2021-01-19 insomnia Chills, stiff joints, insomnia, excessive sweating while sleeping, pain to injection site
41 2021-01-20 insomnia After 1st Pfizer shot I experienced the worst headache of my life 4-6 hours after the shot with loca... Read more
After 1st Pfizer shot I experienced the worst headache of my life 4-6 hours after the shot with localized pulsation in my right temporal region prior to the headache. The headache persisted through the night and I could not sleep and did not decrease with over the counter medication, my pain was rated 9/10 to 10/10 in the same area the pulsation happened. This headache continued for 4-6 hours at a severe level than for another 6-8 hours at a moderate to severe level. I ended up checking in at the Emergency department that I worked at after my shift and got labs and CT scan, this was after my symptoms resolved. I thought that I might have had a head bleed and wish I would have gotten my CT earlier when experiencing the symptoms. I was not provided a vaccine disclosure sheet or any information on what to do if experience severe symptoms or what symptoms to expect. I am upset that I was not provided guidance about what to expect and how to manage post vaccine symptoms, I would have gone into ED sooner with this information and feel I may have missed possible diagnosis due to lack of disclosure and guidance.
41 2021-01-25 impaired work ability About 4 hours after receiving the vaccine, began with headache and nausea/upset stomach. Symptoms pr... Read more
About 4 hours after receiving the vaccine, began with headache and nausea/upset stomach. Symptoms progressively worsened to create low grade temperature body / joint achiness. Notable extreme fatigue. Prevented from going to work.
41 2021-01-26 loss of personal independence in daily activities Feeling weak; Muscle pain; Chills; Not been able to work for last 3-4 days; Please specify other loc... Read more
Feeling weak; Muscle pain; Chills; Not been able to work for last 3-4 days; Please specify other location: Right shoulder; Shortness of breath; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231, Expiry Date: 30Apr2021) via an unspecified route of administration in right shoulder on 30Dec2020 20:30 at single dose for COVID-19 immunisation. The medical history was not reported. There were no concomitant medications. The patient previously took influenza vaccine on 2020 for immunization 2-3 months before this BNT162B2 vaccine, previously took flu shot in the past for immunization and got sick from it. That was about 3 years ago (2018). The patient went and got the Pfizer BioNTech about 2 weeks ago. Wants to know if side effects can start then after the vaccine. He has had chills, muscle pain, shortness of breath, and dizziness. Got this at hospital and has not been able to go to work on Jan2021 that last 3-4 days due to feeling weak. Received the vaccine on 30Dec2020 and the dizziness and shortness of breath kind of started days after that on Dec2020. The chills started a couple of days ago, about 3 days ago (Jan2021) and has been off and on. The muscle pains started today (13Jan2021). Just got a text message about getting the second dose next Wednesday. He did not get any other vaccines that day or 4 weeks prior. He got the shot to protect himself from the virus, but feels like he has the virus or something. The events did not require a visit to emergency room, but may go to be seen tomorrow. Events outcome of chills, muscle pain, shortness of breath, dizziness, and not been able to go to work that last 3-4 days due to feeling weak was not recovered.
41 2021-02-07 restlessness Roughly 12 hours after receiving the second dose of the vaccination, I began to be restless, especia... Read more
Roughly 12 hours after receiving the second dose of the vaccination, I began to be restless, especially when trying to sleep. I noticed that my resting heart rate was way above normal (normal = 76-80 bpm). My heart rate after about 10pm rose to about 115-120 bpm and stayed at that level for about 12 hours.
41 2021-02-09 impaired work ability low grade fever, chills, muscle aches in shoulders/neck, headache, light headed. Symptoms started b... Read more
low grade fever, chills, muscle aches in shoulders/neck, headache, light headed. Symptoms started becoming persistent during commute to work beginning at approximately 0630. Symptoms were significant enough to hinder productive work by 1100, went home early. Napped from 1200-1500. Symptoms subsided by 1800.
41 2021-02-10 sleep disorder, feeling abnormal Within our injection shot sore. No other adverse effects until 5:00 a.m. Woke up because body was ve... Read more
Within our injection shot sore. No other adverse effects until 5:00 a.m. Woke up because body was very hot similar to being in a sauna. Removing for changing the blanket to a thinner one resulted in extreme chills within one minute. Covering with blanket resulted in extreme hot within 10 minutes. Repeated this cycle for several hours until fall asleep. High discomfort throughout body. Woke up at 10:00 a.m. with mild grade fever of 99.5° (average resting temperature is 96.5). Felt extreme cold and chills shivering body aches headache until 6:00 p.m. felt hungry and okay enough to eat. Main concern is the extreme hot to extreme cold cycle in early morning. It felt as though the body was not in sync. During fever throughout day/afternoon body's reaction was normal - fever meant chills and shivering, putting on a blanket meant comfortable warmth (after long periods of time). But in early morning no no fever yet body burning hot almost suffocating sauna heat insider body, and removing the blanket a immediate and severe chills with uncontrollable shaking, instead of relief from heat... Concerned if vaccine affects body's heart regulation system (hypothalamus, thyroid, etc). General malaise during this period is an understatement... It was not a single spot or feeling pain it was the whole body wanting to twist itself and feeling 'deprssed' and very 'ill' all over all at once.
41 2021-02-14 feeling abnormal, insomnia Chills; Body aches; Barely able to move his arm; He feels horrible/not feeling well; He can't sleep;... Read more
Chills; Body aches; Barely able to move his arm; He feels horrible/not feeling well; He can't sleep; Ringing in the ears; Nausea; Flu like symptoms; Bad sore arm; Muscle aches; Joint pain; This is a spontaneous report from a contactable consumer (mother of the patient). The same consumer reported information for 3 patients. This is the first of 3 reports. A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 at single dose for COVID-19 immunisation at the age of 41-year-old. Medical history and concomitant medications were unknown. On 25Jan2021, the patient experienced Flu like symptoms, He had a bad sore arm, barely able to move his arm, Nausea, Muscle ache, Joint pain; no fever. On unknown date, the patient experienced not feeling well/ feels horrible, chills, body ache. Patient stayed home from work one day. On 27Jan2021, the patient felt a little better, but he still would have the symptoms. On 28Jan2021, the patient had ringing in the ears, he has muscle aches, he could not sleep. Patient reportedly as very well young man and he has no medical problems. The patient was recovering from the events. Information about lot/batch number has been requested.
41 2021-02-21 confusional state, feeling abnormal Patients spouse reports he started to feel "funny" 5 mins post vaccination administration. Patients ... Read more
Patients spouse reports he started to feel "funny" 5 mins post vaccination administration. Patients spouse called for assist when he he became unconscious at 7:25pm. He was found unconscious and failed to respond to a sternal rub. EMS called. Initial assessment: HR-weak pulse-not palpable, agonal, shallow breathing, and unresponsive. VS- BP 160/100 HR- 100 Wife used smelling salt to arouse the patient. He was confused after regaining consciousness. 7:37pm- EMS arrived and assumed care, transferring patient to a higher level of care.
41 2021-02-23 insomnia, feeling abnormal, sleep disorder Dose 2 of Covid vaccine given 2/18/2021, on 2/19/2021 felt bad, stayed in bed all day and that eveni... Read more
Dose 2 of Covid vaccine given 2/18/2021, on 2/19/2021 felt bad, stayed in bed all day and that evening had a sharp pain in chest. chest pain continued intermittent next day and then 2/22/2021 0200 it was a sharp crudhing pain that radiate down his L arm, same arm had the vaccine in, awoke him from sleep
41 2021-02-24 irritability, confusional state 95.4 body temp, grogginess, confusion, fatigue, headaches, confusion, irritation, lack of appetite, ... Read more
95.4 body temp, grogginess, confusion, fatigue, headaches, confusion, irritation, lack of appetite, lethargic
41 2021-03-03 feeling abnormal, insomnia cough; runny nose; fuzzy headed/scatter brained; not sleeping good; This is a spontaneous report fro... Read more
cough; runny nose; fuzzy headed/scatter brained; not sleeping good; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: WEN5318), via an unspecified route of administration on left arm on 28Jan2021 (at the age of 41years) at single dose for covid-19 immunization. Medical history included scratchy throat the day before the vaccine (27Jan2021). The patient had no concomitant medications and no investigation assessment. The patient got first dose of vaccine 28Jan2021 and was debating whether to get Covid test because of symptoms. The patient had a cough and runny nose on 29Jan2021 and fuzzy headed, scatter brained and not sleeping good in 2021. The patient considered the events as non-serious. Asked if these symptoms were from the vaccine and if getting the vaccine cause a false positive on the Covid test. Stated Friday had cough and runny nose. He stated that it felt like he had a pretty bad head cold and would not think about getting tested but since Covid was around. Wanted to know if these were common side effects of the vaccine or if he needed to get tested. The patient just moved houses and it was a stressful process. Sometimes when one gets stressed that one gets sick and may have contributed to his condition. Later clarified that this was for the Pfizer Covid 19 vaccine. The patient stated that the cough and runny nose worsened over the weekend and was a little better now and took alpha lipoic acid;minerals nos;quercetrin;vitamins nos (EMERGEN-C). The outcome of the events cough and rhinorrhea was recovering while unknown for the remaining events.
41 2021-03-15 confusional state Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: LEFT ARM TREMERS-Mil... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: LEFT ARM TREMERS-Mild, Systemic: Nausea-Mild
41 2021-03-17 confusional state Second Pfizer COVID vaccine given 2/12/2021. Developed symptoms one day after 2nd Pfizer vaccination... Read more
Second Pfizer COVID vaccine given 2/12/2021. Developed symptoms one day after 2nd Pfizer vaccination with headache, body aches, chills, followed by abdominal pain, vomiting and diarrhea over the next 3 days, then became confused per wife so he came to ED for evaluation on 3/16/2021 and evaluated by me. Also had black stools and vomiting blood. Diagnoses: Septic shock, Gastrointestinal Bleeding with severe blood loss, Hepatitis with Hepatic Encephalopathy, Liver cirrhosis. Admitted to hospital 2/16/2021-discharged 2/21/2021. Since symptoms developed day after vaccination, I am compelled to report.
41 2021-03-19 sleep disorder Muscle stiffness in Right arm (opposite of injection arm), neck stiffness (can not look up), could n... Read more
Muscle stiffness in Right arm (opposite of injection arm), neck stiffness (can not look up), could not sleep. This has been happening and slowly getting worse over the past 18 hours.
41 2021-03-22 insomnia Headache, nausea, fever, chills, soreness in right arm, and insomnia. No treatment provided. Symptom... Read more
Headache, nausea, fever, chills, soreness in right arm, and insomnia. No treatment provided. Symptoms ongoing as of 9:45am 03/23/2021
41 2021-03-23 insomnia woke up warm/sweaty; mild general body aches/stiffness; Mild arm soreness; trouble sleeping; This is... Read more
woke up warm/sweaty; mild general body aches/stiffness; Mild arm soreness; trouble sleeping; This is a spontaneous report from a contactable healthcare professional (patient). This 41-year-old male patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route on 18Feb2021 at 09:15 (at the age of 41-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included psoriasis for which he received guselkumab (TREMFYA) injections every 2 months. The patient had not received any other vaccines within 4 weeks prior to the vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccine. The patient did not receive any concomitant medications. The patient did not have any allergies to medications, food, or other products. The patient previously received dose 1 of BNT162B2 on 27Jan2021 at 01:30 as a single dose in the right arm for COVID-19. On 19Feb2021 at 00:00 after dose 2 of BNT162B2 the patient experienced mild arm soreness, woke up warm/sweaty, had trouble sleeping, and mild general body aches/stiffness. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of mid arm soreness, woke up warm/sweaty, had trouble sleeping, and mild general body aches/stiffness were recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
41 2021-03-24 anxiety felt heart was racing, comes and goes. clammy hands, anxious. HR 92 BP 136/82
41 2021-03-24 suicidal thoughts, depression suicidal thoughts; Site pain; chills; body aches; tinnitus; depression; This is a spontaneous report... Read more
suicidal thoughts; Site pain; chills; body aches; tinnitus; depression; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old (reported as 42-years-old) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the right arm, on 05Mar2021 at 12:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included pericarditis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included emtricitabine, tenofovir disoproxil fumarate (TRUVADA), omeprazole (PRILOSEC), cetirizine hydrochloride (ZYRTEC), and fluticasone propionate (FLONASE). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced suicidal thoughts, site pain, chills, body aches, tinnitus, and depression on 06Mar2021 at 04:00. The patient underwent lab tests and procedures which included nasal swab: negative on 01Jul2020. The clinical outcome of suicidal thoughts, site pain, chills, body aches, tinnitus, and depression was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
41 2021-03-29 feeling abnormal I felt fine at first for the 15 minutes they held me for observation. But as I walked out to my car ... Read more
I felt fine at first for the 15 minutes they held me for observation. But as I walked out to my car I quickly got heavy and tired and started to ache and have a headache. I had to rest in my car for a while before driving home. Once home I crashed immediately for around 4 hours in the middle of the day which is not like me. I had an important dinner meeting i had to attend for my livelihood. I thought I was feeling better but half way through Dinner I started feeling bad again. Got to the point that I stopped eating and excused myself to get home and rest. Symptoms progressed rapidly. Unfortunately I was pulled over for a minor traffic stop and tried to explain that I was having a bad reaction to the vaccine and needed to get home. They wouldn?t believe me and torturously treated me like an OVI. I?m hoping that I can get some kind of documentation and or assistance. I have court on the 1st and it will be devastating if I am convicted. I was not intoxicated and was not warned about the dangers of driving after the vaccine. Please call me. I need help
41 2021-04-01 impaired work ability 3/30-Adverse events experienced and are they still occurring now: Caller c/o fatigue & generalized ... Read more
3/30-Adverse events experienced and are they still occurring now: Caller c/o fatigue & generalized "feeling sick" since receiving 2nd vaccine on 3/25/2021. C/o shortness of breath beginning on Sunday 3/28/2021, called out of work yesterday and today, stayed in bed both days due to "feeling exhausted", no distress while on phone. Reports taking tylenol/ibuprofen as needed as well as using rescue inhaler for asthma as needed. Advised to follow up with PCP or Urgent Care due to SOB and asthma history. 4/1-Follow up call by Patient feeling better than yesterday, no longer feeling shortness of breath. Recommended to follow up with physician if symptoms worsen.
41 2021-04-01 sleep disorder Within 5 mins of the shot, I got dizzy but I sat down and that feeling went over. After dinner the s... Read more
Within 5 mins of the shot, I got dizzy but I sat down and that feeling went over. After dinner the same day, I had vertigo and had to vomit. Since then there has been nausea and headache, and I have trouble sleeping in. I feel some more discomfort after eating food. I have intermittent fever also. It has been about 10 days today since I got my COVID Pfizer shot and I still don't feel physically well. I just wanted to report this, as the impression from documentation I read is that symptoms should go away in 3-4 days.
41 2021-04-07 feeling abnormal started to sweat and felt "not right" post injection a few minutes, states has happened several time... Read more
started to sweat and felt "not right" post injection a few minutes, states has happened several times in past when getting injections. staff assisted to floor and states did lose consciousness for a moment. felt better once in obs, 1517 bp 119/68 hr 83 rr 20 sats 98% on ra. 1530 bp 138/72 hr 67 rr 17 sats 98% on ra. states s/s resolved, stood up with no issues, escorted to personal vehicle with no issues.
41 2021-04-07 irritability, disturbance in attention Starting 12 hours after dose: Rotating between fever and chills Fever of 103+ Numbness / loss of fee... Read more
Starting 12 hours after dose: Rotating between fever and chills Fever of 103+ Numbness / loss of feeling in tips of fingers / thumb Tinnitus Lower back pain Lack of focus / irritable Overall random shots of pain through body Diarrhea legs and feet turned purple Constant frontal headache Lack of appetite/ nausea Some foods taste metallic
41 2021-04-09 anxiety Patient reported feeling clammy, lightheaded, short of breath, anxious, and nauseated after vaccinat... Read more
Patient reported feeling clammy, lightheaded, short of breath, anxious, and nauseated after vaccination Patient seen by medical team and vitals improved after patient drank Gatorade Patient reported not having anything to eat in the morning Patient has history of anxiety Patient refused medical transport and signed medical form, patient stated symptoms improved Patient will have a family member pick him and his daughter up to drive home
41 2021-04-15 panic attack Panic attack, resolved with time.
41 2021-04-16 anxiety 4/17/2021 Patient was observed post Covid-19 immunization for 15 minutes . During the observation... Read more
4/17/2021 Patient was observed post Covid-19 immunization for 15 minutes . During the observation period, he experienced an adverse reaction with the following symptoms: dizziness. Assessment : Time of assessment 0903am. Alert and oriented, Anxious and dizziness. Actions taken: Vitals sign taken VAERS form obtained and completed by juice and water given. by RN 0903am- BP_ 140/87, P- 78, O2- 98%, 0910 , - BP- 143/94, P- 78, O2- 99% Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/17/2021 8:36 AM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8730
41 2021-04-17 feeling drunk, feeling abnormal Sleep for a few minutes, I didn't pass out but it was similar; Was pulled over "for minor traffic v... Read more
Sleep for a few minutes, I didn't pass out but it was similar; Was pulled over "for minor traffic violation." He was told "to get out of the car and had a field sobriety test, and I looked intoxicated."; Felt heavy and tired/Run down; Had a headache; Upset stomach; sleep for a few minutes, I didn't pass out but it was similar/crashed for 4-5 hours in the middle of the day which I never do; aching; Over all weakness; Started feeling sick again at dinner; Woke up feeling really bad; Bad diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Allergic to sulfa, PCN and amoxicillin. The patients concomitant medications were not reported. On an unspecified date the patient experienced sleep for a few minutes, I didnt pass out but it was similar, was pulled over for minor traffic violation. He was told to get out of the car and had a field sobriety test, and I looked intoxicated, felt heavy and tired/run down, had a headache, bad diarrhea, upset stomach, sleep for a few minutes, I didnt pass out but it was similar, crashed for 4 to 5 hours in the middle of the day which I never do, aching, overall weakness, started feeling sick again at dinner, he went to the bathroom a few times, woke up feeling really bad. The patient was worried because everything was coming to a head right now. The caller got the first shot, he waited for 15 minutes and felt fine. As the caller walked to his car he began feeling heavy, had severe diarrhea, headache, aching, it was almost like he passed out, it felt like he went to sleep. The patient got home and crashed 4 to 5 hours in the middle of the day and woke up feeling really bad. The patient went to a very important dinner meeting that night. While the patient was at the meeting he went to the bathroom a few times and then excused himself because he felt so bad. The patient did not even finish one cocktail with dinner. The caller got pulled over for a minor traffic stop, cutting the corner and crossing the line or something small. The officers believed the caller was driving under the influence and started making him do a sobriety test with 40 degree wind gusts, the patient was miserable. The caller told the officers that he needed to seek medical attention but they ignored him. The officers forced the caller to do the urine test. It has been 5 days since his vaccination and he is just now feeling better. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.
41 2021-04-18 anxiety Metal taste in mouth within 30 minutes of injection., similar to injection 1. I otherwise felt fin... Read more
Metal taste in mouth within 30 minutes of injection., similar to injection 1. I otherwise felt fine and had a normal day of moderate physical activity. I awoke in the middle of the night with chills and body aches and a strong feeling of anxiety. I was able to fall back asleep and woke up as normal a few hours later. I had a very strong head ache centered behind my sinuses, body aches in my pelvis and legs, and hot flashes mixed with chills. Aches were manageable with Tylenol. As the day progressed those continued and I was very fatigued. I went to bed earlier than normal and after a full night's sleep symptoms subsided.
41 2021-04-18 sleep disorder Ankle pain started and got continually worse throughout the day Friday with no acute injury. Could n... Read more
Ankle pain started and got continually worse throughout the day Friday with no acute injury. Could not sleep due to intensity of pain and went to Urgent Care Saturday morning. Prescribed diclofenac potassium and told to go to orthopedic doctor in 3-4 weeks if not improved. X-rays taken and negative for bone breaks. Constant and severe pain has continued.
41 2021-04-20 feeling abnormal lost hearing in right ear; everything sounds muffled; constant buzzing; felt foggy, like brain fog; ... Read more
lost hearing in right ear; everything sounds muffled; constant buzzing; felt foggy, like brain fog; tired, really tired; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 41-years, at single dose in left upper arm on 16Mar2021 at 12:00 (Lot Number: EP6955) for covid-19 immunisation. The patient medical history was none. Weight was 99.79 kg and Height was 191 cm. There were no concomitant medications. The patient previously received tetanus vaccine for immunisation when he was a kid. The patient reported that he had his first shot and was scheduled to take second shot today (on 06Apr2021). He stated that two days after the first shot, on 18Mar2021, he didn't have any arm pain, nausea, vomiting, or headaches. He lost hearing out of right ear. He already went to the physician about it. He was scheduled to go to Ear Nose and Throat doctor on 12Apr2021. He stated they checked his ear and everything. The hearing loss was not related to any kind of ear wax or anything. He went to urgent care, so they were limited to what they can do, and he was referred out to Ear Nose and Throat. He said everything sounded muffled and liked a constant buzzing in that ear. He had never had this problem. That doctor was going to check his ears and would do a hearing test on 12Apr2021. He confirmed that the hearing loss started on 18Mar2021. He also confirmed that the hearing loss was still ongoing and it was about the same, or persisting. The patient also reported that after the first one he didn't have the side effects that they claim to have. He hadn't died from it. He was just tired really tired, two to three hours after the shot, he got the shot at 12 noon, so about 2 to 3 o'clock. He laid down to rest and went to sleep. He woke up the next morning, went to work and was fine. He stated that other than that no headache, no arm pain, no diarrhea, no vomiting. He just felt foggy like brain fog the following morning after the vaccine till about mid-day and it went away. It only lasted four or five hours. He confirmed that was on 17Mar2021, as well as, that he had recovered completely. The patient received treatment and included that prescription medication for ear: Ofloxacin 0.3%. Instill five drops in the right ear two times a day for seven days. There was no additional vaccine administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Event outcome for Hearing loss, Muffled hearing in both ears and Ear buzzing was not recovered, while for Tiredness and Foggy feeling in head was recovered on 17Mar2021.
41 2021-04-22 feeling abnormal Day 1 after vaccination: Fever, chills, aches, headache, nausea; all day Day 2 after vaccination: No... Read more
Day 1 after vaccination: Fever, chills, aches, headache, nausea; all day Day 2 after vaccination: None Day 3 after vaccination: Woke up in the middle of the night with dizziness, or head "swimming" sensation, and body aches. Managed to get back to sleep after about an hour, but woke up at normal time still feeling a "swimming" sensation in the head where it's not dizzy, but similar, and still minor body aches. Submitting this report while I'm still in Day 3
41 2021-04-24 confusional state collapsed; weak/weakness; muscle pain; Confusion; Fatigue; Shortness of breath; This is a spontaneou... Read more
collapsed; weak/weakness; muscle pain; Confusion; Fatigue; Shortness of breath; This is a spontaneous report from a contactable physician. A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) via an unspecified route of administration on 04Apr2021 at a single dose for covid-19 immunization. Medical history included G72.3 periodic paralysis. Concomitant medication included diclofenamide (KEVEYIS) taken for an unspecified indication, start and stop date were not reported. It was unknown if the patient received other vaccines within four weeks. It was unknown if the patient had covid prior vaccination. The physician stated that the patient received the Pfizer vaccine on Sunday 04Apr2021. The patient collapsed about an hour and half later and, has felt very weak and was experiencing muscle pain since then - all experienced on 04Apr2021. The patient has also been experiencing weakness, confusion, fatigue, and shortness of breath all since Sunday 04Apr2021. The physician reported that there were two different kinds of potassium in the vaccine which he felt was contributing to this. It was informed that the patient has been currently resting and will follow-up if his symptoms don't improve. The outcome of the adverse events was unknown. It was unknown if treatment was received for the adverse events. It was unknown if the patient was tested for covid post-vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information and temporal relationship, a possible contributory role between BNT162B2 vaccine and the reported events can not be excluded. Case will be re-assessed upon the additional information provided. 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.
41 2021-04-24 feeling abnormal Ive been diagnosed with ADEM by findings from a MRI inflammation of cervical spine and brain , symp... Read more
Ive been diagnosed with ADEM by findings from a MRI inflammation of cervical spine and brain , symptoms began around a week after 2nd shot and got worse for about a month , pain in neck ,tingling though body , headaches, sunburn feeling in torso , fatigue , bilateral numbness in hands, loss of bladder pressure, erectile dysfunction
41 2021-04-26 feeling abnormal Shortness of breath, chest pain that feels like a heart attack, rapid heart rate, headache, muscle f... Read more
Shortness of breath, chest pain that feels like a heart attack, rapid heart rate, headache, muscle fatigue and extreme tiredness
41 2021-04-27 sleep disorder, euphoric mood, panic attack, feeling abnormal, impaired work ability 3/26 @ 3:15pm ? Got the first dose of Pfizer COVID-19 vaccine for the 1:10pm appointment. However ac... Read more
3/26 @ 3:15pm ? Got the first dose of Pfizer COVID-19 vaccine for the 1:10pm appointment. However actual time received was around 3:15pm. No vaccine reaction was observed and drove back home. However did not eat or drink much from morning till 4:30pm due to the long line at the vaccination center 4/4 @ 9:00pm ? Experienced first sign of near-syncope at the dinner table upon picking up a glass of milk 4/6 @ 8:45am ? Experienced brain fog, to be exact head felt like it was filled with cotton candy, at the back and top of the head. Felt this way the entire day. Went to work as usual. Logged out at around 5:30pm 4/7 @ 9:00am ? dizziness started getting worse. Started feeling imbalance and started losing depth perception which climbing down staircase 4/8 @ 10:00am ? started to get easily startled by any unexpected trigger. Whole body would ?twitch? or ?startle? upon slightest unexpected event. For e.g., sound, touch, taste (hot/cold) 4/10 @ 12:00pm ? Went to ER. ER ordered series of book tests, EKG, chest x-ray. Everything came out normal. ER doctor said to wait it out and after a week symptom may go away. ER doctor felt body?s immune response was over-working due to the vaccine immune response and possibly pollen allergy I may have experienced right after getting the vaccine. No prescription meds give. Advised to take Meclizine 25mg and Zyrtec. Below are the symptoms experienced on 4/10: ? Lightheadedness/Sudden Jerking body movements when triggered/passing out momentarily for a second when taking strain/not in my elements ? Feeling extremely fatigued. Did not sleep well at night on 4/8 and 4/9 ? Head feels Intoxicated, foggy, lightheaded, as if stuffed with cotton candy. Startled when unexpected things happen like a sudden jerking movement along with momentary passing out while anything unexpected happens. E.g., when I am pushing myself on the sofa to re-position, I feel my whole body is turning off for a second. Simply does not feel normal ? Rubbery legs ? Worsens after shower. I feel like I need to lay down as the foggy feeling worsens after shower ? Lightheadedness. Losing control sometimes. ? I am easily startled when climbing down the stairs - no Depth perception. ? Don?t have the strength to blow nose or cough. Feels like momentary fainting when doing these activities ? Dis-equilibrium. Whole body is twitching when something unexpected happens to my senses. ? Unable to control while laughing feels like momentary faint. I have felt like this when I was down with a fever. Tickled easily ? Difficulty pulling myself out of bed. Felt like muscle was giving away ? Tingling feeling in the right abdomen area ? Difficulty staying alert or focused and random rather unpleasant thoughts constantly coming to mind. Felt a bit of panic attack. 4/11 ? Went to PCP. Body weakness and fatigue got worse. PCP did blood sugar test and flushed out the left ear. Ordered Brain MRI to see if structurally anything was wrong. Brain MRI came out OK as well however noticed minor sinusitis. Prescribed Amoxicillin antibiotics and nasal spray. Referred me to Neurologist and Head and Neck Specialist. 4/11 ? 4/15 - Above symptoms progressively got worse. Especially weakness in the arms and shoulders. Arms quivered every time trying to stand up and felt like fainting. Hand-eye coordination progressively got worse. For e.g., could not pick up water bottle, hands were quivering badly 4/15 ? Neurologist conducted certain diagnostic tests and concluded that there are no neurological issues. Said with rest and plenty of fluids it should get better. Spinal tap was not recommended and said if symptoms got worse a spinal tap can be done during the next visit. Follow up visit with neurologist scheduled on 4/27 4/15 ? 4/27 ? Weakness in arms got better. Arm strength and coordination has improved however it?s still not back to normal. Brain fog and dizziness still persists with no improvement. Left limb and arms are stronger than the left. Difficulty climbing up and down stairs. Dizziness worsens after shower. Not feeling myself. In addition, not able to multitask - getting startled and need to be deliberate about having to do everyday chores need to just focus on one task 100% completely and if something else comes up then my body just goes into a momentary shock. Mostly I can feel my head feeling heavy and my eyelids shutting down when something shocking happens ? a feeling like body is ?turning off?, almost a fainting or passing out feeling. Sometimes when I turn to one side and sleep, I can feel a flickering sensation in the ear. Still always feeling woozy and as if there is something in my head ? a medicated or intoxicated feeling in the head 4/27 ? Neurologist said she sees a lot of improvement and reiterated again that I don?t have any neurological issues. She said I can go back to work starting 5/1. She said I may have Conversion Disorder / Disequilibrium. It?s hard for me to fathom why she would diagnose me with Conversion Disorder when so many people are reporting very similar symptoms that I am facing on the below forum: https://www.drugdiscoverytrends.com/dizziness-among-common-covid-19-vaccine-side-effects/ 4/30 ? Next appointment with Head and Neck / Audiology
41 2021-04-29 excessive sleepiness, feeling abnormal Felt extremely tired around 7:30pm. Went to bed. Woke up at 6:00am to get kids ready for school, fel... Read more
Felt extremely tired around 7:30pm. Went to bed. Woke up at 6:00am to get kids ready for school, felt intense headache joint pain, and intense cold feeling to the point of shaking. Went to bed again around 7:45 am. Slept most of the day with headache getting worse. Next day symptoms lessened slightly still bad headache and brain fog which I still have as of today but getting better.
41 2021-05-02 impaired work ability, irritability, confusional state fatigue, loss of appetite starting around 12:30 PM 5/2 napped from 2:00PM until 3:30 PM, no more fat... Read more
fatigue, loss of appetite starting around 12:30 PM 5/2 napped from 2:00PM until 3:30 PM, no more fatigue fatigue, irritability, confusion, body aches set in around 6:00 PM around 8:00 PM started alternating between feeling hot and chills, and presumabliy a fever (did not take temperature) went to sleep for the night around 1:30 AM on 5/3. Sometime between then and 7:00 AM woke up in a sweat, so fever presumably broke awoke for the day around 8:20 AM but was still too fatiuged to go to work as of now still feel some fatigue and headache
41 2021-05-02 loss of personal independence in daily activities Joint pains in knees elbows and shoulders for about 4 weeks pain in the left knee to the point where... Read more
Joint pains in knees elbows and shoulders for about 4 weeks pain in the left knee to the point where I could barely walk. Started taking glucosamine and chondroitin and MSM. One day after taking vitamins. started feeling much better all symptoms cleared up one to two weeks after second shot of covid-19 Pfizer. Feeling good now able to go to the gym and start working out again.
41 2021-05-04 excessive sleepiness Woke up at 0700 drenched in sweat with chills. Slight fever of 99.7F . Started my work day from home... Read more
Woke up at 0700 drenched in sweat with chills. Slight fever of 99.7F . Started my work day from home with a meeting at 0900 and knew by 0920 that I had to take the day off. Spent the entire rest of the day and night in bed. Fever peaked at 101.1F , nausea, constant headache, shaking chills and then sweats, extreme fatigue and full body severe muscle soreness. Light headed and very weak. I slept all day until almost 1500. When I woke up my fever was gone. I'm left tonight feeling hungry again along with some residual sore muscles and aches. The fever responded well to Ibuprofen. I hydrated with water and Gatorade. It pretty much felt like influenza for just under 48 hours. I feel like I'm past the worst of it now, but I'm not fully recovered.
41 2021-05-04 insomnia Severe pain in neck and bilateral arms radiating all the way down to hands. Pins and needles feelin... Read more
Severe pain in neck and bilateral arms radiating all the way down to hands. Pins and needles feeling in bilateral arms with numbness and tingling. Feels like Nerve pain unbeliever by Tylenol and motion. Unable to sleep in either sidelying position since numbess, tingling and pain develops in corresponding arms and then quickly moves to hands. Unable to make a fist with right hand where vaccine was administered. Fine motor and gross motor strength decrease.
41 2021-05-09 impaired work ability On April 18 and 19, following my 2nd injection, I had very bad chills and could not get warm. I was ... Read more
On April 18 and 19, following my 2nd injection, I had very bad chills and could not get warm. I was nauseous although I did not vomit. On April 22, I began having severe sharp stabbing pains just to the right of my belly button. It felt like I was being stabbed with a very hot knife, and after about 15-90 seconds, it would go away. Anytime I reached for something, bent over, twisted, turned or tried to hug someone, I would get this same pain and it would double me over in pain. On Monday April 26 at 7pm, I finally checked into the Emergency Room at the direction of my Primary Doctor. They did a bunch of blood work on me and sent me for a CT Scan of my abdomen. All of the blood work came back in normal ranges, and the CT Scan showed my appendix was "borderline" according to the surgeon. They consulted with Dr and decided to admit me for a surgical consult and further examination. They gave me fluids and morphine through an IV for the first 24 - 36 hrs, and then switched to Norco by mouth. I continued having pain throughout my stay. On Thursday, April 29, they took me to surgery for "exploratory surgery" with the intention of removing my appendix and looking around to see if anything else stood out to them that would cause me this pain. They stated my appendix had scar tissue on it and they removed it, but said they did not know if this would stop the pain I was having. On Friday April 30, I was released from the hospital at approximately 6pm. By 9pm on Friday, I began having those same sharp, stabbing, burning pains in my abdomen again, now to the right of my belly button again and further towards my right side. I also had sharp burning pain in the inside of my upper right arm, between my bicep and tricep muscles. This pain continued on through the weekend occurring more frequently and more severe. On Monday morning at about 1:30am, I woke up with severe abdominal pains all over and went into the bathroom. I had diarrhea and nausea and felt like I was going to vomit. Between 1:30am and 7:30am, I went to the bathroom 6 times. I went to work on Monday and continued having abdominal pains and diarrhea all day and night. On Tuesday, I went to the bathroom a total of 17 times. On Wednesday, I saw my primary Dr., who examined my abdomen and pains. He suggested I take immodium for the diarrhea and a supplement for muscle pain, as he felt this was the cause of my pain. On Wednesday, I went to the bathroom 21 times and was very nauseaus. I started the Imodium and it had no effect on me whatsoever. On Thursday, I had to call off work because I couldn't stop using the bathroom. By 4pm, I had been to the bathroom 18 times. I returned to the ER. They took a stool sample and did an ultrasound in the ER. They decided to admit me again for surgical consult and pain management. On Friday, Dr ordered another ultrasound of my abdomen, specifically my gallbladder, kidney, and liver. He also sent me for a CT Scan with contrast. They completed a total lab workup of my blood. All of these results came back normal, and nothing on the images showed anything wrong with my organs. On Saturday May 8, Dr came to the hospital to examine me. He stated everything related to my GI was fine. He asked if I have back pain, which I told him I do. At this time, I was in extreme pain and I couldn't even touch my skin. Dr attempted to examine my abdomen, and just by placing his hand on my stomach, I screamed in pain. He then put his hand behind my back and pushed a little, and it cause extreme pain in my abdomen. At this time, Dr suggested that maybe the pain is caused by something going on in my back. Maybe a pinched nerve or something. He ordered an X-ray of my upper and lower spine. Later that day, the results of the X-ray came back and showed there was nothing wrong with my spine. With these results, Dr then ordered an MRI of my lumbar and thoracic spine. On Sunday May 9 at 1030am, I was taken to radiology for an MRI. The initial report shows that I do not have any pinched nerves and nothing notable that would cause this type of pain in my body. As of now, no diagnosis or explanation for the pain I am experiencing. The pain is gradually getting worse and at times I am unable to move at all without extreme severe pain in my body. At times, my right groin hurts and I am unable to stand on my feet, as it feels as if I have pulled a groin muscle. The pain in my abdomen takes my breath away and feels like I am being set on fire in that area of my body. The pain no longer goes away and is constant, but moves throughout my right side from my groin to my shoulder only. I am not able to put my right arm behind my back because I get this pain in the back of my shoulder area. This pain is only on my right side at this time. So far, there is no explanation for this pain. I never had anything like this until I got the vaccine.
41 2021-05-10 poor quality sleep Ache and today he was feeling "more achy"; Burning sensation, discomfort, and aching in his arm "rig... Read more
Ache and today he was feeling "more achy"; Burning sensation, discomfort, and aching in his arm "right where he got the shot"; Burning sensation, discomfort, and aching in his arm "right where he got the shot"; Did not sleep well/ did not sleep good; This is a spontaneous report from a contactable consumer (patient himself) via a medical information team. A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in arm on 14Apr2021 (at the age of 41-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. He reports that on Monday 19Apr2021 he experienced a burning sensation, discomfort, and aching in his arm "right where he got the shot" and reports that it feels like he just received the vaccine. He tells me that right after he got the vaccine he worked out and that night (Wednesday night on 14Apr2021) he did not sleep well. He states on Thursday night he slept okay, Friday and Saturday night did not sleep good, Sunday "so so", and then states yesterday (22Apr2021) he started to ache and today he was feeling "more achy." Caller would like to know if it was normal to have a reaction this late to the vaccine. He was concerned about whether he should take the second dose of the vaccine because of this, and states his next dose was due 5May2021. Response: Spoke from the prescribing information PFIZER-BIONTECH COVID-19 VACCINE to let caller know that side effects were reported over a 7-day period following each dose of the vaccine and also let caller know that "the mean duration of pain at the injection site after dose 2 was 2.5 days (range 1 to 36 days)." Spoke from the attached documents regarding contraindications to receiving a dose of the vaccine and what signs of a severe allergic reaction could include. Referred caller to healthcare professional (HCP) for further guidance. Caller would like to know if it was okay to take a medication such as Advil to treat his symptoms that he was experiencing after receiving the Pfizer BioNTech COVID-19 vaccine. Response: Spoke from the attached document regarding the use of medications such as Tylenol and Ibuprofen after vaccination to treat symptoms. Referred caller to HCP for any further guidance on medication recommendations. The outcome of the events was unknown. No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
41 2021-05-10 restlessness, insomnia Nausea: 1hr Palpitations: 24hr Restlessness: 8hr Insomnia: 8hr Fatigue: 36hr Pain at injection site:... Read more
Nausea: 1hr Palpitations: 24hr Restlessness: 8hr Insomnia: 8hr Fatigue: 36hr Pain at injection site: 5hr Headache: 12hr
41 2021-05-11 anxiety Tinnitus with onset the next day after first injection. Hissing sound in both ears. Has lasted 5 1... Read more
Tinnitus with onset the next day after first injection. Hissing sound in both ears. Has lasted 5 1/2 weeks so far. Some days it is barely noticeable and other days it is very distracting and causes anxiety.
41 2021-05-15 agitation, anxiety, restlessness, insomnia Late night insomnia, agitation, restlessness, anxiety (awake between 3-6AM with racing thoughts); Ab... Read more
Late night insomnia, agitation, restlessness, anxiety (awake between 3-6AM with racing thoughts); Able to fall asleep at normal bedtime; THC, CBD, melatonin 6mg ineffective; Benadryl partially effective.
41 2021-05-19 anxiety Patient was given vaccine and while waiting the 15 minute monitoring period he fainted. He was respo... Read more
Patient was given vaccine and while waiting the 15 minute monitoring period he fainted. He was responsive right away and needed to throw up. We attended to him and called EMS. He said he had anxiety from the seeing the needle and is probably why he fainted.
41 2021-05-19 sleep disorder Arm soreness started on May 18 @ 3:30pm. Went to sleep with same arm soreness at 11pm. Woke up at ... Read more
Arm soreness started on May 18 @ 3:30pm. Went to sleep with same arm soreness at 11pm. Woke up at 1:15am on May 19, walked approximately 12 feet started experiencing cold chills. At 1:20am, while standing and holding cellphone in right hand, started experience of convulsive seizure to the point of cellphone health stats saying i walked 103 steps while standing still convulsing. After calming down enough to sit, i sat on couch to sleep. Heart rate was still registering in 200 bpms for next couple hours. May 20, 2021 started experiencing sore throat at 5:30am. As day progresses am experiencing flu type symptoms.
41 2021-05-21 confusional state Shortness of breath weakness tired chills achey heart palpitations headache dizzy confused lasted 2 ... Read more
Shortness of breath weakness tired chills achey heart palpitations headache dizzy confused lasted 2 weeks
41 2021-05-23 depression, irritability Recurrent tinnitus, ringing in the ears, which worsened about 2-3 days after second shot and made me... Read more
Recurrent tinnitus, ringing in the ears, which worsened about 2-3 days after second shot and made me question whether to get the second dose; Severe headache 30 hours after first dose, then sporadically especially if fatigued, need to rule out whether they are migraines which I have never been diagnosed with before, continued and worsened after second dose. Malaise; Night sweat about 36 hours after first dose; Chills all night one night after the second dose. Soreness at injection site for first 30 hours after first dose, not as much after second dose. Fatigue, depression and irritability in the weeks after the first dose. After the second dose it is too soon to tell.
41 2021-05-27 anxiety He got his first dose of Pfizer. I believe he was suffering from anxiety attack. He told me that is ... Read more
He got his first dose of Pfizer. I believe he was suffering from anxiety attack. He told me that is how he often feels seeing needles. His blood pressure and heart rate were all normal. EMS services were called and the patient was checked out and ok.
41 2021-05-27 impaired work ability, feeling abnormal Short-term (24-36 hours after both shots): Extreme fatigue, muscle pain/soreness, headache, fever, n... Read more
Short-term (24-36 hours after both shots): Extreme fatigue, muscle pain/soreness, headache, fever, nausea. Worst I've ever felt in my adult life, like my whole body was rebelling against me. Long-term (for roughly 10 days after both shots): Serious shortness of breath, irregular and very high heartbeat, extreme fatigue. Couldn't do any physical activity without immediately becoming out of breath (normally very healthy and active). Heart would race unpredictably, reaching 120 bpm (normal resting for me is 60-70). General malaise. Felt more like 80 years old than 40. Was unable to do normal physical activity and work for weeks. Feeling better overall, but still sometimes feel like I get tired unusually easily and heart behaves strangely now and then.
41 2021-05-28 excessive sleepiness had diarrhea; a fever of 103*F; He was shivering due to lack of energy; He was shivering due to lack... Read more
had diarrhea; a fever of 103*F; He was shivering due to lack of energy; He was shivering due to lack of energy; lost his voice; threw up; sleeping for 48 hours; terrible pain in his stomach which made him scream to the point where he lost his voice; metallic taste in the mouth; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 23Apr2021 14:15 (Batch/Lot Number: EW0171, not sure if the 0 is a O or a 0) as single dose at the age of 41-year-old for covid-19 immunisation, administered not at a military facility. Medical history included ongoing Hashimoto's disease diagnosed about 10 years ago, ongoing vitamin D deficiency diagnosed about 8 years ago, ongoing vitamin b12 deficiency diagnosed about 8 years ago, lung neoplasm malignant. Family history included: dad had lung cancer, mother had thyroid issues and Alzheimer's. The patient's concomitant medications were not reported. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks). No adverse events following prior vaccinations. The patient experienced terrible pain in his stomach which made him scream to the point where he lost his voice on 24Apr2021 with outcome of recovered on 27Apr2021, metallic taste in the mouth on 23Apr2021 with outcome of recovered on 24Apr2021, had diarrhea on 24Apr2021 with outcome of recovered on 26Apr2021, a fever of 103°F on 24Apr2021 with outcome of recovered on 26Apr2021, he was shivering due to lack of energy on 24Apr2021 with outcome of recovered on 27Apr2021, lost his voice on 24Apr2021 with outcome of recovered on 27Apr2021, threw up on 24Apr2021 with outcome of recovered on 27Apr2021, sleeping for 48 hours on 24Apr2021 with outcome of recovered on 27Apr2021. The patient underwent lab tests and procedures which included body mass index: 37 on an unknown date, body temperature: 103 Fahrenheit on 24Apr2021. Therapeutic measures were taken as a result of terrible pain in his stomach which made him scream to the point where he lost his voice, had diarrhea, threw up. The course of events was as follows: Within the 1st 24 hours, he mentioned that he was fine and easy but had a metallic taste in the mouth for 24 hours. He mentioned that the next 72 hours were really bad for him. On 24Apr2021, that night, he started to feel terrible pain in his stomach which made him scream to the point where he lost his voice. It was like knives cutting his stomach. He threw up everything he ate, had diarrhea for 2 days along with a fever of 103 degree F for 2 days. He would try to go to the bathroom and he was shivering due to lack of energy that he could not go to the bathroom. He slept for 48 hours after the 1st 24 hours after vaccination due to the side effects. By Monday afternoon, 26Apr2021, he noticed that his side effects were subsiding and by Tuesday, 27Apr2021, he was a different person and was like nothing happened, he was able to resume a normal life and go back to work. The events did not require a visit to Emergency Room or physician Office. He did not go he was taking orange juice and ibuprofen to treat himself. No relevant tests. He asked if this was contraindicated with him to get the 2nd dose. He has not spoken to his doctor yet. He queried if he should get the second dose or is it contraindicated. Patient mentioned he is very large at 6'6" and 320 lbs. He is wondering if he should have a different dose because he is so big. This report is not related to a study or program. Information on Lot/Batch number was available. No further information is expected.
41 2021-05-31 amnesia, thinking abnormal pt reported have amnesia and not clear thoughts 24 hours after receiving 2nd Pfizer dose
41 2021-06-01 feeling abnormal I felt completely fine for the first 5 minutes. I left the store. After 5 more minutes I started f... Read more
I felt completely fine for the first 5 minutes. I left the store. After 5 more minutes I started feeling bad (I was seated). My whole body was sweating and my vision was affected (everything was bright). I was able to return to the store but was close to passing out. I sat down for about 10-15 minutes while the symptoms persisted and I was not able to see well. After that time the sweating stopped and my sight was no longer affected. This was not anxiety and I have no history of fainting with shots. This was a reaction to the shot. After about an hour I felt fine except for muscle soreness at the injection sight. If the reaction was any worse I would have passed out or asked for help. I am hesitant to get a second dose out of concern that the reaction could be worse.
41 2021-06-02 loss of personal independence in daily activities Muscular pain in both upper arms well after initial vaccine reaction had subsided, normal movement o... Read more
Muscular pain in both upper arms well after initial vaccine reaction had subsided, normal movement of arm up and/or back and rapid movements in other axes cause intense muscle pain followed by severe minutes of pain fading to dull ache. The pain issue has only worsened since it's onset. The pain in each arm is proportionate to the initial vaccine reaction, meaning the arm that got the second dose experiences more sever pain than the one that got the first. The pain in both is preventing normal activities and affecting quality of life.
41 2021-06-07 sleep disorder Pfizer-BioNTech COVID-19 Vaccine EUA: Myocarditis, STEMI Patient received Pfizer COVID vaccines on 4... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Myocarditis, STEMI Patient received Pfizer COVID vaccines on 4/15/21 and 5/6/21. Patient presented to ED on 5/9/21 with complaints of acute onset substernal chest pain that woke him from sleep. Patient also endorses left arm pain, diaphoresis and nausea. No significant past medical history or family history of heart disease. ECG demonstrated inferior ST elevations. Patient was taken to cath lab and found to have no angiographic evidence of CAD. Patient discharged on aspirin 81 mg QD, Clopidogrel 75 mg QD, Metoprolol 12.5 mg BID, Rosuvastatin 5 mg QD.
41 2021-06-08 feeling abnormal He has had a lot of symptoms since second COVID-19 vaccine 5 weeks ago-Pfizer vaccine. Notes tinglin... Read more
He has had a lot of symptoms since second COVID-19 vaccine 5 weeks ago-Pfizer vaccine. Notes tingling and numbness in his left arm, dizzy, nausea, "brain fog" and "loosing motor skills". Headaches are tapering off. He is on Amantadine from Neurology. His symptoms came on immediately after the 2nd shot. Severe symptoms- headache , brain fog. Had been in ED- had CT head. Saw neurology and then sent to Headache clinic. He has several people he knows with similar symptoms and had gone thru long term
41 2021-06-14 anxiety 3 hours after vaccine, he experienced acute symptoms - dizziness, lightheadedness (described as room... Read more
3 hours after vaccine, he experienced acute symptoms - dizziness, lightheadedness (described as room spinning around), anxiety (not problematic before), profuse sweating, feeling of doom, nausea/wretching, pronounced shaking. called 911, taken by ambulance to ER, prior symptoms continued in varying intensity for the next 3 - 4 hours. He was given IV fluids, antibiotics, then admitted to the hospital. He had loss of balance, continued lightheadedness, loss of appetite. Hospitalized for 3 days. Went home with a walker (not used before). He gradually improved over a two week period.
41 2021-06-21 insomnia headache, itchy/burning eyes, muscle aches, bone pain, cold chills/hot flashes, insomnia, diarrhea, ... Read more
headache, itchy/burning eyes, muscle aches, bone pain, cold chills/hot flashes, insomnia, diarrhea, pain in testicals, and nausea
41 2021-06-23 feeling abnormal I have had NONSTOP ringing in my left ear since April 19th. I have sporadically experienced ringing ... Read more
I have had NONSTOP ringing in my left ear since April 19th. I have sporadically experienced ringing in my Right ear as well but not nearly to the extent I have in my left ear. I also experienced frequent, daily headaches for about the first month or so after the shot. I also experienced neck/right shoulder stiffness for about 3 weeks following the shot. I continue to wake up on a daily basis with a feeling in my head and ears like I've been listening to loud music or been in a loud sporting event for several hours (on top of the still nonstop/constant ringing in my left ear that will not go away). I have also experienced swelling in my feet and ankles anytime i'm active for an extended period of time
41 2021-06-23 nervousness, anxiety within 1 hour of taking the dose, I started feeling tingling on my face. I also got nervous and anxi... Read more
within 1 hour of taking the dose, I started feeling tingling on my face. I also got nervous and anxious. Tingling stayed for a couple of hours.also there was some pain in the right arm but at night...there was a lof of pain. I took Tylenol for pain. Next day pain disappeared. Although it was still sore.
41 2021-06-26 incoherent vaccine was administered and patient lost consciousness. he began to turn red and did not breathe fo... Read more
vaccine was administered and patient lost consciousness. he began to turn red and did not breathe for several seconds at which we were about to administer an EpiPen. He then took a breath and started to convulse. he regained consciousness and was not coherent at first. He was sweaty and pale. Pt became alert and oriented and stayed in the room while we waited for the emt to arrive. He declined to be taken to the hospital. He moved to the waiting room and was monitored for 30 minutes before leaving
41 2021-06-28 feeling abnormal Pt reports lymph node swelling to left side of neck began 5 days after initial dose of Pfizer vaccin... Read more
Pt reports lymph node swelling to left side of neck began 5 days after initial dose of Pfizer vaccine (3/25/2021); reports node was firm and "Pistachio size, swelling to a Pecan size." Pt reports muscle pain, and bilateral lower extremities "extremely hot and sweaty." "extreme fatigue and weakness." Pt was seen by his primary provider at local HCF and was prescribed "2 rounds of antibiotics, Zithromycin and steroid." Dr. also had an ultrasound at another HCF which he reports showed lymph note "reactive and inflamed." Pt continued to follow up with medical provider and waited 3 months to received Pfizer booster vaccine (6/23/2021), which he did receive and subsequently reports reaction is "worse." He reports left side of neck lymph node swelled to "Pecan size" and this time left under arm lymph node palpable "pea size" and he became "loopy;" "not fully present" described it as driving as in a fog "dissociated." Extreme fatigue and weakness continue. Pt reports he then again saw his primary medical provider and was prescribed more antibiotics (Rocefin I.M.) and steroids. He is being referred to an ENT MD and infectious disease MD for follow up. Pt reports he tested multiple times in the past for COVID-19 via rapid testing (No PCR confirmatory test done), he reports he never tested positive for COVID-19 but reports he had all the symptoms including loss of taste and smell back in July 2020.
41 2021-06-30 insomnia, anxiety RAPID HEART RATE - MULTIPLE VISITS TO ER WITH EKG AND BLOOD TESTS -RESULTS NEGETIVE LIGHT-HEADINESS ... Read more
RAPID HEART RATE - MULTIPLE VISITS TO ER WITH EKG AND BLOOD TESTS -RESULTS NEGETIVE LIGHT-HEADINESS SEVER HEADACHE'S TROUBLE SLEEPING ANXIETY
41 2021-07-12 sleep disorder Acute onset neck pain while sleeping began on date reported. Remained severe for ~5 days. Since th... Read more
Acute onset neck pain while sleeping began on date reported. Remained severe for ~5 days. Since then, waxing and waning pain. Significant improvement by June 2021 but not resolution.
41 2021-07-14 impaired work ability About two weeks after second dose. I started having pain in one leg, after a few days it was both le... Read more
About two weeks after second dose. I started having pain in one leg, after a few days it was both legs, then the numbness from waist down, tingling and burning sensation on both feet. Muscle spasms, nerve pain. Since then its been really hard to do my job. I completely stop working on May 18. Doctors orders. I been going to physical therapy, but not helping, My doctor recommended me to report , because, of all the testing and Xrays have got, nothing comes up. He referred me to see a Neurologist and Allergist to further make exams, to make sure its not Guillen Barre Symdrome. I have been in medication for pain , disinflamatory medication, but until now everything is the same.
41 2021-07-15 feeling abnormal Day 1-2 post injection: Severe body aches (whole body - hurt to even try to pick up cell phone), vi... Read more
Day 1-2 post injection: Severe body aches (whole body - hurt to even try to pick up cell phone), visibly swollen left armpit painful to touch and with arm movement, severe rigors, fever ~101, rapid temperature changes (burning up to freezing), sweating, headache, nauseousness, dizziness, exhaustion/low energy, no appetite, brain fog Day 3: above started to slowly subside Majority of symptoms have gone away. Still get nauseous and dizzy at some point every day. Low energy, lethargic still, no real appetite, still have brain fog.
41 2021-07-20 anxiety, restlessness Restlessness, anxiety, tinnitus, vertigo. Prior to the second dose of the vaccine I wasn't under a ... Read more
Restlessness, anxiety, tinnitus, vertigo. Prior to the second dose of the vaccine I wasn't under a doctor's care for any of those issues. One or more of the above issues have impacted me daily since 3/30. I visited the emergency room on 4/2 because my anxiety was so bad it felt like I was having a heart issue.
41 2021-07-23 sleep disorder, insomnia Started with shoulder and armpit aches (~15 hours after receiving the shot). Progressed into strong... Read more
Started with shoulder and armpit aches (~15 hours after receiving the shot). Progressed into strong pain in the shoulder and armpit. These symptoms kept me up all night. Then progressed into large golf-ball-size swelling in the left armpit which lasted several days. I took ibuprofen for the swelling, but didn't seem to do much. After a few days, the swelling started to reduce.
41 2021-07-26 anxiety Loss of equilibrium, aching muscles, soreness, shaking, symptoms of vertigo, anxiety, weakness, loss... Read more
Loss of equilibrium, aching muscles, soreness, shaking, symptoms of vertigo, anxiety, weakness, loss of balance, loss of dexterity, loss of muscle memory,
41 2021-07-28 feeling abnormal Chest pain; Headache; muscle fatigue; joint pain; muscle pain; muscle cramps; arm soreness; dizzines... Read more
Chest pain; Headache; muscle fatigue; joint pain; muscle pain; muscle cramps; arm soreness; dizziness; vertigo; blurry vision; tingly sensation in arm and leg; sharp toe pain; out of body experience; brain fog; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 02May2021 at 14:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and acid reflux. The patient did not take any concomitant medications. The past drug history was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 18:45, the patient experienced chest pain, headache, muscle fatigue, joint pain, muscle pain and cramps, arm soreness, dizziness, vertigo, blurry vision, tingly sensation in arm and leg, sharp toe pain, out of body experience and brain fog. The clinical outcome of the events chest pain, headache, muscle fatigue, joint pain, muscle pain, muscle cramps, pain in arm, dizziness, vertigo, blurry vision, tingling sensation, pain in toe, out of body experience and foggy feeling in head were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
42 2021-01-08 sleep disorder Fever, uncontrolled rigors, extreme/uncomfortable aching of the feet and hands that awoke from sleep
42 2021-01-09 anxiety Dizziness, Diarrhea, HYPERtension & Tachycardia Narrative: Mild dizziness 5 minutes after vaccinatio... Read more
Dizziness, Diarrhea, HYPERtension & Tachycardia Narrative: Mild dizziness 5 minutes after vaccination. 167/110, heart rate 77 at 1408. 144/01, heart rate 68 at 1417. Reported mild anxiety. Observed 30 minutes. No e/o allergic reaction and anxiety resolved.
42 2021-01-09 disorientation Headache fatigue, disorientation, loss of interest Narrative:
42 2021-01-10 feeling abnormal Immediate weird taste in his mouth ("like licking a kitty litter box and made his snickers taste gro... Read more
Immediate weird taste in his mouth ("like licking a kitty litter box and made his snickers taste gross"), dizziness, and nausea after getting the vaccine. Brain fog, dizziness, and nausea continued for the rest of the shift. 5 hours after the vaccine (10pm) he was very fatigued. When he woke up the next morning his arm felt like it "was in a vice" and he is still hazy.
42 2021-01-12 nightmare, impaired work ability DEVELOPED DIZZINESS, EXTREME FATIGUE, CHILLS, WEAKNESS, NIGHTMARES AND ELEVATED BLOOD PRESSURES SINC... Read more
DEVELOPED DIZZINESS, EXTREME FATIGUE, CHILLS, WEAKNESS, NIGHTMARES AND ELEVATED BLOOD PRESSURES SINCE 1/12/2021 AT NIGHT. UNABLE TO GO TO WORK.
42 2021-01-13 impaired work ability In the afternoon - pain in right shoulder; within a couple of days: lost of taste, fever, chills, sh... Read more
In the afternoon - pain in right shoulder; within a couple of days: lost of taste, fever, chills, shortness of breath, diarrhea . Tested for Covid 27th of December and was positive. Was on steroids and antibiotics and vitamins; and still on steriods and breathing treatments and still haven't gone back to work.
42 2021-01-14 confusional state, loss of personal independence in daily activities, impaired work ability, feeling abnormal I was vaccinated on 1/2/2021 and developed oral parasthesias the day of the vaccination. On day 3 af... Read more
I was vaccinated on 1/2/2021 and developed oral parasthesias the day of the vaccination. On day 3 after the vaccine, I developed a severe headache with ?brain fog,? confusion, and hyperacusis. The headache has now persisted for 10 days and was severe enough that I missed several days of work this week as I was unable to carry out my clinical duties. I was seen in ED this past weekend and ultimately followed up with neurology after the headache had persisted for 7+ days. The working theory is that I may have developed aseptic meningitis as a side effect of the vaccine and I am currently on a steroid taper which has resulting in partial but significant improvement in my symptoms. I am back at work but still experiencing a mild headache and facial parasthesias. I did request a Covid test in ED 1 on 1/10/21 and tested negative.
42 2021-01-14 impaired work ability fever, headache, nausea. called in sick to work.
42 2021-01-19 euphoric mood Severe dizziness/ light headed "euphoric" feeling
42 2021-01-21 impaired work ability, confusional state, memory impairment About 3 minutes after receiving the shot, I became dizzy. After 15 minutes, I was still dizzy. I h... Read more
About 3 minutes after receiving the shot, I became dizzy. After 15 minutes, I was still dizzy. I had a little shortness of breath and it felt like my heart was beating faster but this only lasted a few minutes. They had me wait an additional 10 minutes and the dizziness was better but not gone completely. I drove myself home and tried to work from home but was feeling confused. I took the rest of the day off. The next day (yesterday) I woke up exhausted. I took a sick day and slept until noon, which was about 14 hours in total. When I woke up, I felt okay but had no appetite and did not get out of bed for 5 hours. When I finally got up, I still felt dizzy. I ate dinner, watched some TV and went to bed. I woke up this morning without the fatigue but started to feel dizzy in the shower to the point where I almost lost by balance twice. I'm trying to work from home today but feel very dizzy and confused. I couldn't remember my office's phone number. I'm sweating but my temperature is 97.5.
42 2021-01-24 sleep disorder About 72 hours after receiving the vaccination i was shivering uncontrollably on and off, breaking o... Read more
About 72 hours after receiving the vaccination i was shivering uncontrollably on and off, breaking out in sweats on and off. Once i would start to feel better after sleeping 4-6 hours. I get out of bed thinking I was better, then another hour or so later the symptoms were back, so I would go back to bed shivering uncontrollably off and on again, sweating and uncomfortable until falling back to sleep.. This lasted for about 48 hours, which started 72 after receiving my vaccination. No adverse symptoms the first 2 days following the vaccination. I got vaccinated on Tuesday, 1/19/21 - symptoms started Friday, 1/22/21 - Saturday, 1/23/21. Sunday, 1/24/21 I finally felt normal again.
42 2021-01-28 anxiety Tingling hands, Feeling weak and tired Patient alert and oriented noted with tingling sensation in b... Read more
Tingling hands, Feeling weak and tired Patient alert and oriented noted with tingling sensation in both hands at around 5:35 pm, 6 minutes after being vaccinated for 1st dose of PFizer CoviD 19 vaccine. Vitals signs taken BP 156/96, HR 115, RR 20, T 98, O2 sat 98% RA. Patient offered beverage and tolerated well. Patient was monitored, Vitals re checked as Follows: BP 129/80, HR 105, RR 18, O2 sat 99% RA. At around 6:05 PM Patient verbalized that tingling was gone, monitoring continues, pt. noted anxious at all times. Patient states that he is taking Citalopram 30 mg For 2 years. Vitals rechecked at 7 PM BP 148/88, P 134, RR 20 MD evaluated pt with recommendation to send pt to ER For Further (monitor) evaluation. EMS arrived at 7:22 pm and take over the pt. Patient left Ambulating with Wife and EMS.
42 2021-02-05 impaired work ability On January 18, two days after getting the first dose of the vaccine I woke up with a sense of fullne... Read more
On January 18, two days after getting the first dose of the vaccine I woke up with a sense of fullness or pressure in my left ear, mild sinus congestion, and chills. The congestion and chills ended after one day, but the feeling of fullness in the ear has persisted to this day. Then, on January 29, I had a bout of positional vertigo and vomiting that lasted two to three hours. I also experienced ringing or roaring in my left ear. Ever since, I have a bout of vertigo approximately every 24 hours, and the ringing and sense of fullness in the ear ebb and flow on 24 hours cycles as well. This experience has been debilitating and affected my ability to work. My doctor has diagnosed Meniere's disease and says he has been seeing similar symptoms apparently linked to the COVID vaccines. I started taking prednisone on doctor's orders yesterday (February 5), which has stopped the vertigo. Ringing and occasional fullness in the ears persist.
42 2021-02-09 impaired work ability fever. called in sick to work.
42 2021-02-09 thinking abnormal Pt sitting up in chair became pale, pasty, diaphoretic, states he isn't thinkin straight. Pt laid in... Read more
Pt sitting up in chair became pale, pasty, diaphoretic, states he isn't thinkin straight. Pt laid in floor, legs elevated. EMS activated, evaluated by paramedics, orthostatics negative, patient allowed to rest for until 1635. Patient color returned, states he felt better, ambulated out of clinic independently. Wife at side.
42 2021-02-17 feeling abnormal Day of the shot (in the afternoon) I felt began feeling ?off?. Day after the shot I had pretty se... Read more
Day of the shot (in the afternoon) I felt began feeling ?off?. Day after the shot I had pretty severe body aches and exhaustion that lasted for two full days and lingered for a third day although not as severe. It?s now a week since the last vaccination shot and I went for my first run since the vaccination. I regularly run about 5 miles 3x a week in the mornings. On this run,; which was at about 75% of my normal pace, my lungs felt very heavy with very labored breathing, having to stop and catch my breath periodically. I eventually had to stop at mile 3.
42 2021-02-18 sleep disorder 1. That night I had an elevated blood pressure (around 140/100) but it did return to normal levels (... Read more
1. That night I had an elevated blood pressure (around 140/100) but it did return to normal levels (typically 125/80) the next day. 2. Also that night, I had significant body aches (joints and muscle) that was strong enough to effect my sleep. 3. I developed a sore throat 3 days post vaccine that persisted approximately 2-3 days.
42 2021-02-21 insomnia Sleeplessness. Unable to stay asleep for more than 2 hours at a time since receiving first dose of t... Read more
Sleeplessness. Unable to stay asleep for more than 2 hours at a time since receiving first dose of the pfizer covid vaccine.
42 2021-03-03 feeling abnormal, depression, anxiety, panic attack On Monday I had the COVID vaccination. I noticed no side effects on Tuesday other than tenderness at... Read more
On Monday I had the COVID vaccination. I noticed no side effects on Tuesday other than tenderness at the injection site. On Wednesday, I noticed light bruising up and down my arms. Thursday morning around 10 AM, I started to have side effect - some so severe they must be documented. At 10 AM, I felt lightheaded and had brain fog. By noon my head was pounding with a headache followed by an upset stomach. At 2 PM things started getting bad and continued to worse. It was not the headache or stomach that need to be noted but a sudden and severe onset of depression and anxiety. - Depression like I have not felt in years when I was at my worst. Throughout the day the depression worsened and by 7 PM, I was unable to stop crying and was overwhelmed with anxiety and PTSD panic attacks. While I have the training to understand this is temporary, - I am very worried about what I?m feeling , because there was no warning or mention of this side effect. I have the resources needed for this but people that are more fragile need to prepare for the sudden o set of critical/ debilitating depression.
42 2021-03-03 thinking abnormal soreness at the point of administration of his left arm; Muscle soreness/muscle soreness at the poin... Read more
soreness at the point of administration of his left arm; Muscle soreness/muscle soreness at the point of injection spread to his whole body; it was like aches all over his body; Fatigue; Frequent urination; Cognitive fuzziness; This is a spontaneous report from a contactable consumer (patient) reported that a 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date 31May2021), intramuscular on the left arm on 28Jan2021 16:15 at a single dose for Covid-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), mentioned he was a patient facing drug addiction counselor in training, smoke cigarettes but he has cut down to a half a pack a day, at most. The patient previously received flu vaccine on an unspecified date for flu vaccination and experienced soreness at the point of administration of his left arm. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken from an unspecified date for ADHD. The patient received his first COVID-19 vaccine this past Thursday, 28Jan2021. The next morning (29Jan2021), he woke up with real soreness at the point of administration of his left arm, well beyond what he remembered for a flu vaccine. The second night (30Jan2021), the soreness progressed. It was hard to sleep on his left arm. It was like he had been punched. He had to sleep on his right side versus his left side. On 29Jan2021, the muscle soreness at the point of injection spread to his whole body, it was like aches all over his body. The soreness has gotten a little bit better day by day. He confirmed he got a rapid nasal molecular COVID swab test because he was just covering his bases and he tested negative for COVID-19 on 02Feb2021. He also experienced fatigue. The fatigue really started to set in on Friday evening (29Jan2021), it was like he got hit by a truck. He was typically a high energy person and its very out of the ordinary for him to feel this way. He normally has class on Saturday from 9-noon but he had to cancel going with the amount of fatigue he was experiencing. He also had some cognitive fuzziness on Jan2021. His fatigue was still there, but it has gotten a little better. He was normally very high energy, but he missed two classes and skipped his internship today. He doesn't feel like himself. He also has had frequent urination which he noticed probably Friday night (29Jan2021), all the way up until now. However, he has been drinking a lot of water. The patient received a test/report showing he has no chromosomal issues and no likelihood of issues on an unspecified date. The outcome of soreness at the point of administration of his left arm and Frequent urination was not recovered; Muscle soreness/muscle soreness at the point of injection spread to his whole body and fatigue was recovering; it was like aches all over his body and cognitive fuzziness was unknown.
42 2021-03-10 anxiety Pt, Very anxious, dizziness,chest tightness. Vital signs taken 150/90 p80 r 16 145/100 80 r 16 160/1... Read more
Pt, Very anxious, dizziness,chest tightness. Vital signs taken 150/90 p80 r 16 145/100 80 r 16 160/100 p 81 r16 157/90 p 78 r16
42 2021-03-10 anxiety 42 yo male without h/o reaction to prior vaccinations or medical problems here for first covid vacci... Read more
42 yo male without h/o reaction to prior vaccinations or medical problems here for first covid vaccination. approx 9 min after vaccination with dizziness but no headache, no syncope np altered mental status no shortness of breath no wheezing no palpitation no chest pain no stridor no dysphonia no globus no rash no flushing no hives no angioedema. sx resolved with hydration. pt admitted to poor intake and anxiety.. pt discharged home alert and oriented.
42 2021-03-11 excessive sleepiness, sleep disorder After about 12 hours, I was woken up from sleeping with extreme body aches/headache and starting get... Read more
After about 12 hours, I was woken up from sleeping with extreme body aches/headache and starting getting the chills and shaking. I lost all energy and struggled to get out of bed and walk. Laid in bed all day, took Tylenol, slept off and on. Didn't subside until 6:00pm the next evening when I broke out in a sweat and got some energy back.
42 2021-03-14 anxiety Received 1st dose at mass clinic. After a few minutes while sitting in observation area, pat observe... Read more
Received 1st dose at mass clinic. After a few minutes while sitting in observation area, pat observed by Dr and med student to be very pale, dyspneic, lightheaded and complaining of nausea. BP 148/94 O2 applied at 1.5 LPN N/C. Pt able to sit in chair without problems, remained responsive. States he was fine until he saw others getting their vaccine and that made him anxious. Observed for 30 minutes, pulse ox 95%. Oxygen removed and pt was able to walk out without difficulty and go home after condition much improved. Local EMS on site with pulse and O2.
42 2021-03-15 impaired work ability Severe joint pain in left shoulder with burning/ electrical pain radiating down tricep to my elbow. ... Read more
Severe joint pain in left shoulder with burning/ electrical pain radiating down tricep to my elbow. I?ve used ibuprofen, heat, ice, rest and it still hurts a week later. I?ve missed three days of work now.
42 2021-03-24 feeling abnormal, mental impairment Complained of feeling weird/ tingly. No sense of pain to pinch. Dulled responses. Acting without ... Read more
Complained of feeling weird/ tingly. No sense of pain to pinch. Dulled responses. Acting without inhibition- wanted to pour water all over self, sleep face down in the grass, fly a plane. Acting inebriated or drugged.
42 2021-03-26 sleep disorder Started was a very cramped stomach and then the rest followed. Whole body turned red including eyes.... Read more
Started was a very cramped stomach and then the rest followed. Whole body turned red including eyes. Upset stomach with vomiting and diarrhea. Body was shaking and didn?t have a fever. Skin felt like it was burning whole body felt swollen. Started around 2:30am with the cramping. It woke me up. Once I got up everything came so fast. Was rushed to hospital where I was admitted very quickly. I was blacking out on the drive there and blacked out while in their care. This was from one dose of Pfizer vaccine for Covid. I was put on a GI, Allergy, and steroid medications. I was hooked up to an IV and 3 drugs were injected. I passed out numerous times but was discharged at 5am.
42 2021-03-29 anxiety, feeling abnormal Very anxious before vaccine; BP at home 154/90. Felt like "punched in face"/foggy; lightheaded. BP ... Read more
Very anxious before vaccine; BP at home 154/90. Felt like "punched in face"/foggy; lightheaded. BP 148/98; pulse 88; p ox 98%; gave water. Continued monitoring; after about 30 minutes, then noted chest "heaviness"; "sore throat"--no tightness, no vision changes. Rapid response evaluated; Patient refused ED; continued monitoring for 10-15. VSS; chest heaviness resolved. Accompanied to hospital entrance; had ride home.
42 2021-03-30 abnormal behaviour, confusional state, disorientation Equatable to the description of Alzheimer's or dementia patients; disorientation; confusion; Knowing... Read more
Equatable to the description of Alzheimer's or dementia patients; disorientation; confusion; Knowing your doing something wrong and unable to correct it; Motor skills slowed; Fuzzy tongue; generally out of sorts feeling; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) at the age of 42-years, via an unspecified route of administration in left arm at 12:15 AM on 16Mar2021 at single dose for COVID-19 immunisation, in Public Health Clinic. Medical history was reported as none. No other vaccine in four weeks. No COVID-19 prior vaccination. No known allergies. Concomitant medications were not reported. At 08:30 AM on 17Feb2021, the patient had periods of disorientation, confusion. Equatable to the description of Alzheimer's or dementia patients. Knowing you doing something wrong and unable to correct it. Motor skills slowed. Fuzzy tongue, and generally out of sorts feeling. Punctuated by periods of lucidity. No treatment received. Outcome of the events was recovering. No Covid-19 tested post vaccination.
42 2021-03-30 disorientation, feeling abnormal Felt a large amount of sensation in my injection arm 1-2 minutes after shot. Started to feel faint a... Read more
Felt a large amount of sensation in my injection arm 1-2 minutes after shot. Started to feel faint and light-headed 3-4 minutes after shot. Passed out about 5 minutes after shot. Felt sweaty, disoriented, spacey, and nauseated shortly after coming back to consciousness. Went to hospital in an ambulance and released a couple hours later.
42 2021-03-30 disturbance in attention Loss of hearing to last less than 5 min. followed by ringing ears through the following day. Uncon... Read more
Loss of hearing to last less than 5 min. followed by ringing ears through the following day. Uncontrolled palsy for head and neck intermittently through the injection day. I lost my voice and had spasms in my larynx. For several hours I had a hard time choosing my words and speaking which was the scariest. I could not focus enough to even wash my hands on injection day and had to be driven home from work. I got dehydrated because water tasted horrible. The next morning I am better on all fronts except the ringing in my ears wont stop
42 2021-03-30 sensation of foreign body 30-35 minutes after injection, while I was driving home, I felt some minor difficulty swallowing., b... Read more
30-35 minutes after injection, while I was driving home, I felt some minor difficulty swallowing., but no impediment to breathing or speaking. I rerouted to a plaza with a grocery store and urgent care clinic, and bought some Benadryl and took it at about 2:55PM. I waited 20 minutes in the parking lot before deciding I was safe to drive home. When I read about the possibility of a biphasic reaction, where my throat could close up again later, I went to a Clinic (5:40PM walk-in appointment with NP), and they could not treat me, and advised me to go to the Emergency Room. I initially decided to just go home, but went to the Emergency Room out of an abundance of caution at around 7PM. Dr. gave me a prescription for an epi pen and prednisone, just in case symptoms worsened. They did not, and I did not use either drug. The throat swelling started around 2:45PM and worsened for about half an hour. It remained steady (no airway constriction, no difficulty taking pills or drinking water) without getting worse, and started to subside around 5PM. By the time I woke up this morning (3/31), I don't think there is any lingering swelling. I can feel a very slight lump in my throat, but I can't tell if that is a very small amount of residual swelling or just hyper-vigilance based on yesterday's experience. Note: This swelling feeling is identical to my memory of what I felt when I was diagnosed as allergic to penicillin in 2000 or 2001. Back then, the only "treatment" was to immediately stop taking penicillin (and to never take it again), based on a phone call with my doctor's office. I did have a strong immune response after that (102° fever, chills, fatigue, muscle pain), but I don't consider that an adverse reaction. This report is focused on what appeared to be a mild anaphylactic reaction.
42 2021-03-30 sleep disorder Flu like symptoms next day. Vomiting and diarrhea. Body aches. Hot and cold sweats and chills. N... Read more
Flu like symptoms next day. Vomiting and diarrhea. Body aches. Hot and cold sweats and chills. Night cold sweats during brief sleeping periods. Third day was the same. Loss of appetite and dehydrated. Severe itching on my back. Today is the fourth day and I broke out with a rash on my back. Cortisone has relieved it thus far. My appetite is back. I did not vomit but still experiencing diarrhea.
42 2021-04-06 anxiety Paramedic called to observation for 42 YO male with dizziness, lightheaded, and anxiety. Upon arriv... Read more
Paramedic called to observation for 42 YO male with dizziness, lightheaded, and anxiety. Upon arrival PT found sitting in chair A&OX4, skins: pink/warm/dry, pupils: Equal and reactive. Pt speaks very little English and PT's wife translated for him. PT states that he started feeling symptoms 10 minutes after receiving his Pfizer vaccine. Upon assessment PT states he has 10/10 chest pain non radiating/dull in nature with increased pain on inspiration. Pt states that this has happed before a few months ago and was diagnosed with HTN but was not prescribed any medication by his primary care physician. PT does not take any medications and has no allergies. Pt status did not improve or decrease while in the care of the paramedic. Pt vitals then assessed and were as follows: 0943: BP 172/118, HR 71, RR 24, SPO2 99% RA, Lungs clear/equal bilaterally. 1002: BP 180/131, HR 80, RR22, SPO2 98% RA, Lungs clear/equal bilaterally. The paramedic made the decision to activate the EMS 911 system. Upon EMS arrival report given to responding paramedics and PT care transferred. EMS Paramedics began to treat patient for Chest Pain Protocol, and transported PT to Local ER.
42 2021-04-06 confusional state After Vaccine Administration pt pulled to observation lot to wait 15 minutes for observation of adv... Read more
After Vaccine Administration pt pulled to observation lot to wait 15 minutes for observation of adverse reaction. He lost consciousness after becoming confused for 1 minute. He was assessed by a guardsman and EMS staff regaining conciseness within a few minutes
42 2021-04-06 sensation of foreign body 1 minute after vaccine injection I experienced a tightening of my throat. It was very uncomfortable... Read more
1 minute after vaccine injection I experienced a tightening of my throat. It was very uncomfortable and made it difficult to swallow and felt like a "lump in my throat". I asked an onsite nurse if this was a common reaction, and she offered medical attention. I denied it because it was not getting worse. She gave me a bottle of water and it seemed to help it a bit while drinking. But, quickly returned after water was swallowed. I was monitored for 30 minutes as recommended. The tightness remained for 1 hour post vaccine injection and disappeared as quickly as it started. I fear the second dose may be worse.
42 2021-04-08 feeling abnormal I had a strange feeling in the left side of my face that I wasn't sure if it was a reaction or not. ... Read more
I had a strange feeling in the left side of my face that I wasn't sure if it was a reaction or not. It happened within the first 15 minutes but did not last more than 30 minutes. I did not experience anything else until the first evening when my arm was very sore. The next day my arm was more sore and I had a mild circular red mark around the injection site and the arm was much harder on that side. I also felt a little in my back and neck. By the second day in the evening the only thing I felt was pain in the arm which eventually traveled into my armpit by day 3. It wasn't until day 5 that all the pain was completely gone. I may have experienced fatigue the first two days also.
42 2021-04-10 feeling abnormal, restlessness, sleep disorder On 3/31/21 pt reports feeling "achy, like a wet blanket", headache, Restless and up every hour of th... Read more
On 3/31/21 pt reports feeling "achy, like a wet blanket", headache, Restless and up every hour of the night. "I felt like a freight train ran over me. " Treated for a sinus infection with Z-Pak. Notified he was covid (+) on 4/2/21. Fever, chills, dyspnea.
42 2021-04-14 sleep disorder Starting the night of the injection, my left arm gets numb from my elbow to my fingertips. Only my r... Read more
Starting the night of the injection, my left arm gets numb from my elbow to my fingertips. Only my ring and pinky finger are affected. The color and temp of the fingers are normal, but it feels like the circulation is cut off. If I get up and work it for about a half-hour it is completely normal (and stays so throughout the day). This wakes me up 3-4 times a night and continues to this day >3 weeks later. I started Zeposia medication a few days before this shot. I didn't have this effect with my 2nd shot in my other arm. I did use an ax to chop wood for 4 hours 2 days before the shot, and my arm was sore from that before the injection. It's possible this is unrelated to the shot altogether, and I did something to trigger some sort of carpal tunnel with the ax. I plan on discussing with my Dr at some point.
42 2021-04-15 sleep disorder Extreme soreness and discomfort at base of skull, sinus cavity?s below eyes felt inflamed and dried,... Read more
Extreme soreness and discomfort at base of skull, sinus cavity?s below eyes felt inflamed and dried, unable to sleep or get comfortable, alternated between feeling chills and feeling overheated, vomiting
42 2021-04-18 emotional distress Pt was found in severe distress in the bathroom by his wife. He couldn't walk or stand, complained ... Read more
Pt was found in severe distress in the bathroom by his wife. He couldn't walk or stand, complained of being dizzy with slurred speech and was throwing up a lot. 911 was immediately called. The EMTs during their assessment said his BP was normal but when he was asked his name, he started saying the alphabet"ABC... XYZ". He was transported by ambulance to ER. Cat scan showed he had a bleed on the brain. The doctors told us it was because he had very high blood pressure, however where the bleed was, they said he wouldn't need surgery and that the body would reabsorb it over time. He was admitted to the ICU and has been there ever since. Several days later, he started having difficulty breathing and they discovered several blood clots in his right leg that had broken off into his heart and lungs. He had emergency surgery to remove the clots in his heart (approximately 10) and was given heparin in small doses over an 8 hour period so that it wouldn't cause the bleed in his brain to increase. The doctor should fill in the rest.
42 2021-04-18 feeling abnormal Patient started 2 days after vaccine with shortness of breath and fever/chills. He says he was unabl... Read more
Patient started 2 days after vaccine with shortness of breath and fever/chills. He says he was unable to get out of bed for 24 hours. He said the rest of the week he didn't feel quite right. A week after the vaccine he started with red capillary veins popping up all over his legs. By Saturday his legs were purple and swollen. He has multiple tests run at the hospital. They doctor believes it is vasculitis that has resulted from patient getting the covid vaccine.
42 2021-04-18 feeling abnormal 3.5 hours after the vaccine shot my body shot full of adrenaline and my heart raced up to 150 beats ... Read more
3.5 hours after the vaccine shot my body shot full of adrenaline and my heart raced up to 150 beats per minute. I ended up checking myself into the emergency room 5 hours after the vaccine shot because my heart rate wouldn't slow down and my blood pressure increased. They found out my heart had gone into atrial fibrillation. I have had no known history of atrial fibrillation in the past and prior EKG's at physicals have been normal. I am an otherwise healthy individual.The doctor conducted an emergency Cardioversion to return the heart rhythm to normal.
42 2021-04-21 confusional state Flu-like symptoms. Weakness of muscles, soreness, tired. Missed work. Mental confusion. Sore left ar... Read more
Flu-like symptoms. Weakness of muscles, soreness, tired. Missed work. Mental confusion. Sore left arm where shot was received.
42 2021-04-22 feeling abnormal, insomnia Terrible loud ringing in ears and buzzing in head, hearing loss (high frequency ), fatigue, insomni... Read more
Terrible loud ringing in ears and buzzing in head, hearing loss (high frequency ), fatigue, insomnia, fever, chills, brain fog
42 2021-04-22 impaired work ability Bright, starry vision; could not use computer
42 2021-04-22 nervousness 42 y/o male, past medical history of Anxiety, who presents with possible seizure post vaccination. P... Read more
42 y/o male, past medical history of Anxiety, who presents with possible seizure post vaccination. Patient notified one of the observation nurses that he was not feeling well. The NP was assisting another patient but saw that the patient with his head back and pale. As soon as the NP was at the patient side, it was noted that the patient?s eyes were rolling back, his face was pale, and his lips were blue. The NP attempted a sternal rub with no response from patient. NP instructed police to please call Fire Rescue to transport patient to the ER. Patients left upper extremity was flexed at the elbow and stiff. At that time the patient was placed on the floor by several nurses and the paramedic and patient legs were elevated. Within 10-15 mins patient immediately sat up but was instructed to lay down. Patient was placed on 3L of O2 by nasal cannula and vitals were taken. Patient initial vitals 166/94 L Arm, 98% 3L O2, 84 Pulse and EKG was NSR. Patient no longer with pallor and lips were pink. Patient states that he isn?t feeling well and feels a nervousness throughout his body. Patient placed on stretcher in Trendelenburg. Vitals retaken, 137/97 BP, 98% 3L O2, 80 P. Patient pulses were thready and patient became diaphoretic. Fire Rescue arrive to site and transported patient to the ER. CNO and PM present during event and aware that patient transported to the ER for further evaluation
42 2021-04-23 feeling abnormal About six hours after receiving my shot, my arm became extremely sore, as to be expected. Circa 9pm... Read more
About six hours after receiving my shot, my arm became extremely sore, as to be expected. Circa 9pm I began to have significant trouble breathing, experienced acute pain in my abdomen, and began to hear ringing in my ears combined with feeling like I was going to pass out. I didn?t feel dizzy, rather I started getting tunnel vision that blocked out more of my field of view as the ringing increased. Circa 11pm, I lost consciousness while trying to move and collapsed on the floor. My wife called 911 while I was unresponsive, and I regained consciousness while being attended to by EMTs who checked my vitals. Around 12am I didn?t feel like I was going to lose consciousness again, and the EMTs recommended I be taken to the hospital. Since I was feeling better I politely declined. Today I am still feeling foggy and have joint pain (in addition to some bruising from falling after losing consciousness , but I no longer have the acute abdominal pain.
42 2021-04-28 feeling abnormal, insomnia Severe insomnia, severe brain fog, sinus pain, sore throat, shortness of breath, body aches and ting... Read more
Severe insomnia, severe brain fog, sinus pain, sore throat, shortness of breath, body aches and tingling, eye irritation, blurred vision, headaches, stomach discomfort.
42 2021-04-28 insomnia, sleep disorder initially began as what felt like jolts to my chest area from inside my chest over five days beginni... Read more
initially began as what felt like jolts to my chest area from inside my chest over five days beginning on March 31, 21 @ 1:20am; next on April 01, 2021 @ 12:02am; then April 02, 2021 @1:02am; then April 03, 2021 @ 1:36am; and on April 04, 2021 @ 2:46am. I ended up in the emergency room the afternoon of Sunday March 04, 2021 with severe chest, abdominal, and intestinal pain. I followed up with doctors on April 05, 2021; April 09, 2021; and April 28, 2021 with continued painful symptoms described below. All they has done so far is 1) took a chest X-ray, 2) taken blood, and 3) referred me to a sleep laboratory. The X-ray and blood work came back negative per ER. Symptoms: 1. Inability to sleep. most nights feels as if I just drank five cups of coffee before bed. When I am able to fall asleep, pain and/or jolts coming from inside my trunk/core area wake me up within about an hour. 2. Constant pain coming from my chest, abdomen, and intestines. Intestinal and abdominal pain (gut wrenching, pain/burning sensation, cramps). At times feels like radiation or waves/currents are passing through my intestines/trunk. I wake up with intestines feeling sore. I also have discomfort when I eat or drink something the following morning. Also, my trunk/core area feels tight all day and night. I constantly feel a burning sensation in my chest and gut areas. The discomfort in my chest area (tightness, burning sensation) with occasional burst of pain the size of a nickel that comes from the left side of my chest and underneath my rib cage. 3. Limbs twitch/jerk on their own (both hands, both feet, neck, both shoulders, both legs, fingers) during the day and during the night. tingling sensations in legs. 4. ringing in the ears with headaches. 5. Woke up from sleep due to both nostrils getting clogged while I slept; woke up gasping for air. 6. Penis no longer has the same sensation and difficulty with erection.
42 2021-04-28 thinking abnormal, feeling abnormal, disturbance in attention, confusional state 3 hours after injection, felt like hands, arms, and legs were swelling (but they weren't), and had a... Read more
3 hours after injection, felt like hands, arms, and legs were swelling (but they weren't), and had a total brain fog, felt like I was either on drugs or had alzheimers. Paced around my house and backyard in a fog, confused, not clear of thought. Had a hard time spelling words in emails. Symptoms went away within 45-60 minutes and did not return. Since that time felt a little tired but nothing serious. Today I feel completely normal.
42 2021-04-30 memory impairment, insomnia Personality changes; headaches; extreme fatigue; Also, I was unaware on conversations that I had.; I... Read more
Personality changes; headaches; extreme fatigue; Also, I was unaware on conversations that I had.; I had high blood pressure and insomnia.; I had high blood pressure and insomnia.; It would seem that I had cerebritis from the shot; This is a spontaneous report from a contactable physician (patient). A 42-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL1284, expiry date not reported), via an unspecified route of administration, administered in right arm (at the age of 42 years old) on 08Jan2021 14:30 as a single dose for covid-19 immunisation. There were no medical history (reported as none) and no concomitant medications. The patient had no known allergies. The patient had no covid prior vaccination. The patient received the first dose of bnt162b2 (brand as Pfizer) for Covid-19 immunisation on 18Dec2020 (at the age of 42 years old) at 03:30 PM administered on the right arm. The vaccine was administered on a hospital. The patient had no other vaccine in four weeks and no other medications in two weeks. On 08Jan2021 11:00 PM, the patient experienced personality changes, headaches, and extreme fatigue, and also was unaware on conversations that he had. The symptoms lasted about 24 hours acutely, but for the 3 weeks afterwards, patient had high blood pressure and insomnia (2021). It would seem that patient had cerebritis from the shot since an unspecified date in 2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit. There were no treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The outcome of the events was recovered with lasting effects.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available clinical data, the event encephalitis most likely represented an intercurrent medical condition not related to vaccination with BNT162B2. This case will be re-assessed when relevant follow-up information is received. 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.
42 2021-05-05 impaired work ability Developed severe ongoing pain in left shoulder and arm which has persisted to current date. I had mi... Read more
Developed severe ongoing pain in left shoulder and arm which has persisted to current date. I had minor pain prior to second vaccination but beginning in the hours immediately following the second dose it became much worse. It migrates throughout the arm and shoulder throughout the day. I am taking prescription pain medication and muscle relaxers for the first time in my life. I could not go to work for 5 days, I now can make it through the day with heavy medication. I have also been prescribed physical therapy for 7 more weeks.
42 2021-05-05 sleep disorder, impaired work ability I had minor pain in left shoulder prior to the second injection. In the hours following the second i... Read more
I had minor pain in left shoulder prior to the second injection. In the hours following the second injection, the pain became severe and ultimately debilitating. I missed several days of work and was prescribed muscle relaxers and Norco, I have never taken this type of medication in my life. I cannot sleep more than 4-5 hours total per night due to pain. I have also been prescribed 7 weeks of physical therapy which provides relief at the moment but does not last.
42 2021-05-06 loss of personal independence in daily activities, poor quality sleep, impaired work ability, feeling abnormal Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and f... Read more
Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and fatigue. About 1 1/2 weeks after the dose, he started to get significant fatigue. He started to sleep poorly. He developed arthralgias described as bilateral, distal joints (hip down, wrists mainly). He developed tingling sensations in his arms and legs. He has had mental fog. He had some HA and eye pain. His PCP sent him to the ED for evaluation. He was evaluated by neuro consult on 4/4, had an LP. THe LP only showed some elevated protein (somewhat traumatic tap based on 10 RBC in tube 4). MRI brain, cervical/thoracic spine was unremarkable. He was dx w/ possible post-infectious polyneurophathy, and suggested f/u w/ neuro clinic for further eval. Pt reports his paresthesias lasted 2 days and has since resolved. He has not been seen by outpatient neuro clinic yet. He did have a post LP HA which he returned to the ED for. He reports that the HA has resolved. In the past 2-3 days he has had felt less fatigue. He still has arthralgias, continuous. They do not seem to be worse in AM or PM. He can do most activities and just tired working out this week. Activity does not seem to make it better or worse. The joints are not red or swollen but feel "tight". He has not noticed any fevers but gets occasional nightsweats or sometimes feels flush and measures only a low grade temp that does not last (<100F). He has had slight decrease in wt but no change in appetite. No n/v/d. NO cough, sob, CT/CP, wheezes. No rash. He does have some sinus sx's which he thinks could be c/w seasonal allergies. Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and fatigue. About 1 1/2 weeks after the dose, he started to get significant fatigue. He started to sleep poorly. He developed arthralgias described as bilateral, distal joints (hip down, wrists mainly). He developed tingling sensations in his arms and legs. He has had mental fog. He had some HA and eye pain. His PCP sent him to the ED for evaluation. He was evaluated by neuro consult on 4/4, had an LP. THe LP only showed some elevated protein (somewhat traumatic tap based on 10 RBC in tube 4). MRI brain, cervical/thoracic spine was unremarkable. He was dx w/ possible post-infectious polyneurophathy, and suggested f/u w/ neuro clinic for further eval. Pt reports his paresthesias lasted 2 days and has since resolved. He has not been seen by outpatient neuro clinic yet. He did have a post LP HA which he returned to the ED for. He reports that the HA has resolved. In the past 2-3 days he has had felt less fatigue. He still has arthralgias, continuous. They do not seem to be worse in AM or PM. He can do most activities and just tired working out this week. Activity does not seem to make it better or worse. The joints are not red or swollen but feel "tight". He has not noticed any fevers but gets occasional nightsweats or sometimes feels flush and measures only a low grade temp that does not last (<100F). He has had slight decrease in wt but no change in appetite. No n/v/d. NO cough, sob, CT/CP, wheezes. No rash. He does have some sinus sx's which he thinks could be c/w seasonal allergies. Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and fatigue. About 1 1/2 weeks after the dose, he started to get significant fatigue. He started to sleep poorly. He developed arthralgias described as bilateral, distal joints (hip down, wrists mainly). He developed tingling sensations in his arms and legs. He has had mental fog. He had some HA and eye pain. He was dx w/ possible post-infectious polyneurophathy, and suggested f/u w/ neuro clinic for further eval. Pt reports his paresthesias lasted 2 days and has since resolved. He has not been seen by outpatient neuro clinic yet. He did have a post LP HA which he returned to the ED for. He reports that the HA has resolved. In the past 2-3 days he has had felt less fatigue. He still has arthralgias, continuous. They do not seem to be worse in AM or PM. He can do most activities and just tired working out this week. Activity does not seem to make it better or worse. The joints are not red or swollen but feel "tight". He has not noticed any fevers but gets occasional nightsweats or sometimes feels flush and measures only a low grade temp that does not last (<100F). He has had slight decrease in wt but no change in appetite. No n/v/d. NO cough, sob, CT/CP, wheezes. No rash. He does have some sinus sx's which he thinks could be c/w seasonal allergies. Now experiencing substantial disruption of the ability to conduct normal life functions, including the ability to work.
42 2021-05-09 anxiety Patient fainted after vaccine but was assisted to the floor. States that he has anxiety. Patient car... Read more
Patient fainted after vaccine but was assisted to the floor. States that he has anxiety. Patient carefully watched in observation and did deep breathing exercises. He stated he felt better and vitals were within normal limits
42 2021-05-10 insomnia Ringing and buzzing in ears and head; insomnia; high blood pressure; This is a spontaneous report fr... Read more
Ringing and buzzing in ears and head; insomnia; high blood pressure; This is a spontaneous report from a contactable consumer reporting for himself. A 42-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 04Apr2021 12:00 (Batch/Lot number was not reported) as 2nd dose single for covid-19 immunisation (Age at vaccination 42 years) . The patient medical history was not reported. The patient received the first dose of BNT162B2 vaccine on 14Mar2021. The patient's concomitant medications were not reported. The patient experienced ringing and buzzing in ears and head on 06Apr2021 08:00 with outcome of not recovered , insomnia on 06Apr2021 08:00 with outcome of not recovered , high blood pressure on 06Apr2021 08:00 with outcome of not recovered. All the reported events were considered Important Medical Events. The patient underwent lab tests and procedures which included polymerase chain reaction: negative on 22Apr2021 Nasal Swab. The patient received prednison and zolpidem (AMBIEN) as a results of the event. Information on Lot/Batch number was available. Additional information has been requested.
42 2021-05-16 feeling abnormal, sleep disorder, memory impairment At first it was a lot of joint and muscle pain all over, and then I got shingles by the weekend. I t... Read more
At first it was a lot of joint and muscle pain all over, and then I got shingles by the weekend. I thought they were bug bites and I wasn't sure where all the pain was coming from and I ended up in the emergency room where I was diagnosed with shingles. After my second shot I started getting shingles by laterally on my right side, but I was already on medication so it didn't get that bad. I also have a lot of joint pain and burning pain in my hands and wrists that shoot up my arms and haven't stopped since the symptoms started. It's much worse at night and keeps me up from sleeping. I have also have been very forgetful and my mind is always cloudy.
42 2021-05-17 impaired work ability Pt first began to notice left leg "stiffness" after receiving his first COVID vaccine (Phizer) sever... Read more
Pt first began to notice left leg "stiffness" after receiving his first COVID vaccine (Phizer) several weeks ago. Pt states that after receiving his 2nd dose on 05/06, he noticed his leg stiffness got significantly worse. He tells me that he tried to "push through the pain" and mow his lawn but had to stop d/t severe cramping of the LLE and pelvis. He states he rested his leg and went to bed, and when he woke up he noticed that his left leg was severely swollen. Pt decided to take 3 days off work to continue to rest the leg, but ultimately came in for evaluation at the suggestion of his coworkers. Pt denies fever, chills, chest pain, or SOB. He denies history of smoking, prior clotting, long car travel, air travel, leg injury, or recent surgery. On exam, the left lower extremity is significantly swollen, erythematous, and hot to the touch. Physical exam otherwise unremarkable. Will admit to the hospitalist service for further medical management. ED Course: Hypertensive with BP 170/93. Initial workup significant for WBC 13, K 3.3, glucose 159. CT chest/a/p with findings suggestive of multiple PE's of the left and right lower lobes as well as extensive LLE DVT extending slightly into the IVC. Trop <0.03. BNP 66. ECG shows sinus tachycardia.
42 2021-05-18 sensation of foreign body Sore shoulder for a week after the shot. Also had a lump in my throat for about 2 weeks after. Felt ... Read more
Sore shoulder for a week after the shot. Also had a lump in my throat for about 2 weeks after. Felt like a sick lymph node, but no adverse affect to me, I didn?t feel sick at all after the shot.
42 2021-05-20 loss of personal independence in daily activities Within 3-5 minutes developed dizziness, tingling in feet and hands, elevated blood pressure, mild na... Read more
Within 3-5 minutes developed dizziness, tingling in feet and hands, elevated blood pressure, mild nausea. Within an hour started having trouble with focusing his vision. Was given IV fluids at hospital in ER 5 hours after the injection, while leaving the hospital developed a slight limp on right leg Felt feverish when he got home, took Tylenol when he got home. Noted extreme fatigue. The next morning was lethargic, dizzy and right side of face felt heavy, around 11 am. Called for a telemedicine visit around 12:30p. Became weak and unable to use right side of body, upper and lower extremities and right side of face was drooping, visible to wife. Wife had support of right side of body to move around. Went to urgent care around 2p. During urgent care evaluation, his vision became more impaired and speech became unclear, had to really focus to speak. Transferred to ER. Lost ability to write name, couldn't respond when asked for SSN. Admitted as a "stroke 4". Had CT scan, CT angiogram, MRI, blood labs, cognitive tests, neurologic tests. Neurology consult. Had lost sensation to heat and pressure. All imaging and labs were normal. After MRI, had convulsions. Wasn't dx'd as a seizure. Neck felt tight afterwards. Admitted to hospital x 1 week. Had a burning, red, rash on hands, feet. No bumps, hives, but just a "splotchy" red discoloration on surface of skin that would burn and itch, often flaring at night. Rx'd ativan. Checked for autoimmune disease, Bell's palsy, followed by neurologists, repeat MRI normal. Started to improve, discharged after one week with no clear diagnosis. Discharged to rehab facility. Patient preferred to transfer care to outpatient rehab service closer to home with more social support. Repeat hospitalized 3 weeks later, less extreme, went back to ER, stroke eval neg. Developed more aphasia. Called back to ER for further evaluation of C-spine due to mild abnormality on first scan. On further evaluation not thought to be connected to symptoms. EEG report pending. +Right hemiplegia, aphasia persists. +Rash, itching, burning persist.
42 2021-05-22 impaired work ability Stayed home from work the Monday I got the shot as well as the following Tuesday. Woke up Wednesday ... Read more
Stayed home from work the Monday I got the shot as well as the following Tuesday. Woke up Wednesday with my By Sunday the 16th I began having pressure and some irritation. Went to urgent care Monday the 17th. They said I had pink eye. I immediately began using the prescribed eye drops. It's important to mention no one in my family has or had pink eye nor have I knowingly come in contact with it. By Friday the 21st there was no improvement from the medication and I began t developed severe light sensitivity and blurry vision. I went back to urgent Care 5/22. They prescribed a different medication for pink eye and referred me to an eye specialist.
42 2021-05-22 insomnia - Uncomfortable feeling in chest around 8pm on 4/24, tried to sleep it off - Couldn't sleep very wel... Read more
- Uncomfortable feeling in chest around 8pm on 4/24, tried to sleep it off - Couldn't sleep very well, and woke up with a tightness of chest and unable to draw a full breath - Went to county ER and was advised I was suffering a heart attack (non stemi) (troponin levels were over 7,000) - transferred to hospital for further diagnosis and treatment - Had a echocardiogram, cardiac catheridisation and MRI, which found that I had inflammation of my heart muscles - treated symptoms with medication and was discharged after an overnight stay
42 2021-05-22 sleep disorder I woke up from sleeping with one big cough. I felt chest pressure and some pain, trouble breathing, ... Read more
I woke up from sleeping with one big cough. I felt chest pressure and some pain, trouble breathing, nausea but did not vomit. My wife called 911 and I was admitted to the hospital.
42 2021-05-26 disturbance in attention, restlessness pain at injection site 24 hours later; Fever; chills/shakes; joint pain; muscle pain; fatique; restl... Read more
pain at injection site 24 hours later; Fever; chills/shakes; joint pain; muscle pain; fatique; restlessness; difficulty concentrating; gas; extreme thirst; headache; shakes; This is a spontaneous report from a non-contactable other hcp (health care professional). A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262) via intramuscular route of administration, administered in left arm on 02Feb2021 at 09:00 (at the age of 42-year-old), at a single dose for covid-19 immunization in doctor's office/urgent care. The patient had no allergies and medical history. Concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3246) via intramuscular route of administration, administered in left arm on 11Jan2021 at 11:45, at a single dose for covid-19 immunization and received Influenza vaccine (within 4 weeks of vaccine) on an unknown date for immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 at 19:00, after receiving the second dose of vaccine the patient experienced fever, chills, joint pain, muscle pain, fatigue, restlessness, difficulty concentrating, gas, extreme thirst, headache, shakes and on 03Feb2021 (24 hours later), the patient experienced pain at injection site. The patient did not receive any treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
42 2021-05-26 feeling abnormal Weakness began after first dose and was accompanied by malaise. Second dose intensified symptoms an... Read more
Weakness began after first dose and was accompanied by malaise. Second dose intensified symptoms and progressed to body aches, loss of taste and smell, episodes of sweating, shivering and brain fog.
42 2021-05-27 insomnia I almost immediately started getting soar in my arm. After a few hours my arm down to my elbow was ... Read more
I almost immediately started getting soar in my arm. After a few hours my arm down to my elbow was VERY soar, my back around my shoulder blade became soar, and over my shoulder up to my neck into the left side of my head was very soar and achy. Headaches were present most of the first day. That night, around supper time I felt nauseous and then had some severe stomach cramps. I didn?t sleep well and woke up with the same bad pain from my elbow to my shoulder and also my shoulder blade to my neck and head. Most of the symptoms were gone after 48 hrs.
42 2021-06-02 sleep disorder Skin began to ache and became sensitive about 11 hours after vaccine was received. Began having chi... Read more
Skin began to ache and became sensitive about 11 hours after vaccine was received. Began having chills, lethargy, body aches (it felt like both inside of body and outside of skin), nausea, and high fever. Took Tylenol and Advil to attempt to alleviate symptoms. Could not get to sleep until about 12:30 a.m. and woke up at 2:30 a.m. with headache, extreme chilling, and intense body aches. I didn't know if I could walk. I put a sweatshirt and a coat on, and my teeth were chattering uncontrollably. I can't remember the last time that I was that sick. I contemplated going to the ER but didn't think I could drive. The entire day was a headache, nausea and lethargy. When at the clinic, I stated that I had heard that there could be some minor side effects with the 2nd shot and was told, "Nah, people make things up." I'm so glad that I'm vaccinated, but people need to be forewarned of those kinds of side effects. They have to be aware because that was dangerously sick and was totally unprepared to combat it. 103+ degree fever and this kinds of symptoms aren't things that a person should have to try to make it through alone.
42 2021-06-07 nervousness decline in muscle function; sick; aches and pains all over his body; did not feel well; muscle mass;... Read more
decline in muscle function; sick; aches and pains all over his body; did not feel well; muscle mass; scared; he really thinks the biologics in the Humira he takes and the biologics in the vaccine are counter acting each other and putting him into a major flare; he really thinks the biologics in the Humira he takes and the biologics in the vaccine are counter acting each other and putting him into a major flare; generalized aches and pains; This is a spontaneous report from a contactable other HCP (patient's mother). This other HCP reported for patient (reporter's son). A 42-year-old male received (age at vaccination: 42 year) first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0169 and expiry date was reported), via an unspecified route of administration, in Arm Right, on 22Apr2021, as a single dose for COVID-19 immunization. The patient's medical history included spinal muscular atrophy, osteoporosis, and ankylosing spondylitis. Concomitant medications included adalimumab (HUMIRA) which was started about a year and a half ago for ankylosing spondylitis, denosumab (PROLIA) which started about a year ago for osteoporotic bones and Evrysdi: (Start: Dec 2020 Stop: Ongoing). This female consumer reported her son/patient received his first injection of the Pfizer covid-19 vaccine on 22Apr2021. The patient has been taking Evrysdi over the past year and experienced some gains in muscle function. After receiving the Pfizer covid-19 vaccine, the patient began experiencing a decline in muscle function described further as losing all the muscle function he had gained while taking Evrysdi. The reporter/mother said her son has been sick ever since receiving the Pfizer covid-19 vaccine and was experiencing flare-up and been prescribed prednisone as treatment. The reporter stated that since their son got the vaccine, he had gone downhill and clarified he had generalized aches and pains all over his body since the vaccine, mostly in the spinal and sacral area, but they were also in his arms, elbows, everything ached, he really did not feel well and could not do anything he used to do after the vaccine. He was starting to gain muscle mass and everything and since the vaccine all that was gone. The reporter stated they took him to both doctors, and they have been zooming with him and want him to get the second dose. He really thinks the biologics in the Humira he took and the biologics in the vaccine were counter acting each other and putting him into a major flare. The patient was treating symptoms with a dose pack of prednisone, getting a little better but did not have strength back at all. The reporter also stated that prior to this vaccine, the doctors were saying was an anomaly, the newer medication he was on was supposed to stop the progression of muscular dystrophy and he was doing so well on the medication until he got the vaccine. The patient was scared he was going to get worse; they were looking for information about getting the second dose, stated their doctors did not have a lot of information. The reporter asked could the Pfizer COVID-19 vaccine reverse the progress our son made in his muscles while taking Evrysdi for spinal muscular atrophy and should her son get the second dose after what has happened after the first dose of the Pfizer covid-19 vaccine. Also asked how long you could wait to get the second dose of the Pfizer covid-19 vaccine and was there an interaction with Humira. The reporter got response that spoke per FAQ and referred to HCP. Outcome of the event generalized aches and pains was not recovered and for all other events, it was unknown. Additional information has been requested and will be provided as it becomes available.
42 2021-06-09 feeling abnormal 3/21/21 - SVT event with easy exercise (2 weeks afer first vaccine) 3/23/21 - worst SVT event of lif... Read more
3/21/21 - SVT event with easy exercise (2 weeks afer first vaccine) 3/23/21 - worst SVT event of life with intense exercise. stopped exercising 4/12/21 - PVC 4 a minute never had them before. irregular rythm. feeling heart irritation (2 weeks after second dose) 4/25/21 - continues heart inflamation issues pvc's, rythm issues, chest tighteness, complete uncomfortableness 5/14/21 - after 3 weeks of absolute hell worst feeling of my life with my heart inflamation/irritation. test not showing anything I started 600mg of Ibuprofen 3 times a day. 5/18/21 - Cardiac MRI but most irritation was going away after ibuprophen 5/25/21 - EP study and SVT ablation. most issue had subsided before the proceedure from ibuprophen 6/5/21 - inflamation symptoms returned. possible due to proceedure 6/9/21 - 600mb ibuprohen 3x a day started again. conidtion starting to improve again I was running 40 miles a week for over 4 years with no issues. This all blew up shortly after starting vaccination and has been the most horrible experience of my life by far!
42 2021-06-09 impaired work ability, motion sickness Motion sickness without motion and vertigo lasting from June 1st through June 10th. Affects abilit... Read more
Motion sickness without motion and vertigo lasting from June 1st through June 10th. Affects ability to function properly at work.
42 2021-06-22 impaired work ability I was giving my second dose of the Pfizer at the drug store, the shot was administered and a little ... Read more
I was giving my second dose of the Pfizer at the drug store, the shot was administered and a little dribbled out so the pharmacist gave me a double dose. I don't believe this was necessary and could have been avoided if the pharmacist would have followed better protocol administering the due to the poor quality of the administration of the shot I missed three days of work. My arm was unusable for 3 days.. I had some mucus buildup in my lungs.. but luckily after 5 days of good rest I'm okay.
42 2021-06-22 impaired work ability The pharmacist carelessly gave me the second shot of my Pfizer.Some dribbled out of the arm.. withou... Read more
The pharmacist carelessly gave me the second shot of my Pfizer.Some dribbled out of the arm.. without asking my permission he gave me a second dose Basically overdosing me. My tongue felt strange my lips sweated. The injection site hurt for 7 days and is still uncomfortable. My lungs have been extra congested with mucus. I missed 3 days of work due to the inability to use my left arm (sore) and general fatigue. Experienced strange twitching of the left arm muscle at injection site on the third day.
42 2021-06-23 feeling abnormal Heart rate speed up to over 180 beats a minute. Fatigue. Out of breath. Felt horrible for two d... Read more
Heart rate speed up to over 180 beats a minute. Fatigue. Out of breath. Felt horrible for two days prior to ending up in hospital for heart.
42 2021-06-24 loss of personal independence in daily activities, anxiety For 1st vaccine- I experienced first vaccine- one week later I got sick for 15 days, symptoms like I... Read more
For 1st vaccine- I experienced first vaccine- one week later I got sick for 15 days, symptoms like I had Covid, body aches, chills. For 2nd vaccine- after one week I experienced had excruciating headaches and shakiness that do not go away. I take Tylenol for pain and as a result have upset stomach. I went to see my PCP who performed exams, lab work, x-rays, CT scan of the head, CT scan of the abdomen and my doctor does not find anything wrong for me. To this day I continue wit the headaches that do not go away. I do not feel well to do my daily living activities and I get anxiety. I feel very tense and frustrated due to my symptoms. I do not have the lot # for my vaccines to provide.
42 2021-07-01 feeling abnormal Arm really sore; Felt like he had a cold and felt like he was coming down with the flu; Felt like he... Read more
Arm really sore; Felt like he had a cold and felt like he was coming down with the flu; Felt like he had a cold and felt like he was coming down with the flu; Tired; Got pretty sick after the second vaccine; He just felt blah; This is a spontaneous report from a contactable consumer (patient wife). A 42-year-old male patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date, at the age of 42-year-old, (Lot number and expiration date was not reported) as dose 2, single for COVID-19 immunization. The vaccine was administered at airforce base. The patient medical history and concomitant medications were none. No other additional vaccines administered on same date of the suspect. No other vaccine was administered within 4 weeks. Historical vaccine included first dose of BNT162B2 (as reported), via an unspecified route of administration on an unspecified date, at single dose for COVID-19 Immunization and the patient had no reaction. The reporter mentioned that her husband got pretty sick after the second vaccine. The patient was still able to work but his arm was really sore, felt like he had a cold and felt like he was coming down with the flu, and he was tired but not throwing up or anything. He just felt blah. This only lasted 24 hours and then he was fine. The patient did not take any treatment and did not had emergency room/physician office visit and it was gone the next day (as reported). The patient did not have any relevant tests performed. The reporter stated that she guessed it is normal for the second one (second dose of vaccine). The outcome of the events was recovered. Information on the lot/ batch number has been requested.
42 2021-07-02 disorientation, loss of personal independence in daily activities Received first dose of Pfizer on 6/4. Four days later (6/8) I developed debilitating dizziness and ... Read more
Received first dose of Pfizer on 6/4. Four days later (6/8) I developed debilitating dizziness and accompanying nausea. After 24 hours of vomiting I visited the emergency room (6/10) and received IV fluids. Head CT scan, ECG, blood, and urine all tested negative. Nausea subsided but dizziness continued. Consulted ENT on 6/15 and was diagnosed with vestibular neuritis. Confirmed with ENG/VNG testing on 6/25. As of 7/3 I am still experiencing disorientation when moving head. Activities like driving and grocery shopping are difficult. Next step will be vestibular rehabilitation therapy. Not sure if this will be a permanent condition.
42 2021-07-08 anxiety Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chest Tightnes... Read more
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: patient describes shakiness, anxiety, swelling under and around arm, and pain. Reports taking 600 mg ibuprofen on tues and wed (600 mg po bid on Tues and Wed) "went away a bit and came back a little bit"
42 2021-07-09 disturbance in attention Rather intense headache and fatigue night of vaccination, but that was expected. Since then (from d... Read more
Rather intense headache and fatigue night of vaccination, but that was expected. Since then (from day 2 up till now), persistent headache (dull at the back of the head), neck and shoulder ache. Very annoying and makes it difficult to think and/or concentrate. Also having strange inflammation (both in the head and cardiac) and erratic heartbeat, likely contributing to increased blood pressure.
42 2021-07-20 anxiety, sleep disorder Had typical sore arm 1-2 days after. Then went away. Started noticing my arm was sore again April 9-... Read more
Had typical sore arm 1-2 days after. Then went away. Started noticing my arm was sore again April 9-10th. However, woke up on April 11th with a high pitched changing ringing in my right ear. Over the course of about 3-4 weeks ringing became louder and more intense. Culminating to such a loud ringing in my ear April 29-May 5 or so. Was so loud I could not get normal sleep for almost a month. Went to see my primary doctor who didn't seem worried about it. Was told it was anxiety. Went to see an Audiologist to have my hearing checked. Hearing was fine. Went to see an ENT and confirmed hearing was fine and no infection. Was told the Tinnitus would go away or not go away. No likely cause. Over the last 3 months since the loud ringing the sound has abated ever so slightly week by week. I can tolerate quieter environments ever so slightly. I hear multiple tones. At first it was a loud screeching modem type sound. Then that went away/got quieter. Was replaced with a loud EEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEE. That got quieter as well then was replaced with a high pitched hissssssssssssssssssssssssssssssssssss, which has changed/got quieter but is still around. There is a third sound that sounds like grinding metal ever so slight. I noticed as the sounds dissipated I could pick up sounds that were not audible. I first remember hearing the fridge running, then hearing crickets, to my PC fan etc. As the ringing got quieter I could pick up minute sounds again in my right ear. Still the ringing is there.
42 2021-07-21 depression Have not yet sought out medical attention, joint pain, fatigue (had these issues, but they were exac... Read more
Have not yet sought out medical attention, joint pain, fatigue (had these issues, but they were exacerbated). Pain in knees, back, and hands (marked increase in pain). Depression has been getting much worse, have sought therapy (father died recently, so can't point to vaccine specifically, may be a coincidence).
42 2021-07-21 impaired work ability Severe headache, had to take off work 2 days
42 2021-07-21 loss of personal independence in daily activities I started with left sided chest pain, which was worse when I was laying down or taking deep breaths.... Read more
I started with left sided chest pain, which was worse when I was laying down or taking deep breaths. I was out of the county when I experience it. We came home early. Motrin helped a little. I keep getting worse I went to my doctor, and they did an x-ray and EKG which both came back normal. Those were done on May 20th. By the 23rd I couldn't walk with chest pain. The cardiologist did a scan of my heart, and they found a small left sided pleural effusion. They still do not know why I have that pleural effusion. They check my labs which I had a small elevated inflammatory lab. Over the next few days after that it went way, and I was able to go back to my normal activities. I have not had problems since.
42 2021-07-27 feeling abnormal All issues are still present to this day: Fatigue, lethargic, Brain fog, mild Vertigo, hands and le... Read more
All issues are still present to this day: Fatigue, lethargic, Brain fog, mild Vertigo, hands and leg numbness (feels like they are asleep), out of breath, can't think of simple words or statements, forgetting what I am doing in the middle of a process (simple stuff), heart arrhythmia.
43 2021-01-04 anxiety Client started c/o headache, tightness in chest, and was anxious. He was helped out of his truck and... Read more
Client started c/o headache, tightness in chest, and was anxious. He was helped out of his truck and taken to triage where they administer o2 4Liters via nasal cannula. He self administered his albuterol inhaler. He admits to having anxiety issues. He was monitored for 20 mins and no other problems arose and he felt better after that. He has had no other problems related to the vaccine since that occasion. He did not contact his doctor.
43 2021-01-04 anxiety Anaphylaxis Narrative: Pt reported trouble swallowing around 20 minutes into the observation period ... Read more
Anaphylaxis Narrative: Pt reported trouble swallowing around 20 minutes into the observation period and was transferred to the treatment area in the vaccine clinic. Vital signs were assessed by a Registered Nurse and a Physician. Oxygen saturation was noted to be 88% on 2 liters of O2 by nasal cannula. Verbal order received at 10:03am from Physician and EpiPen administered to right thigh with improvement of symptoms. She was transferred to the Emergency Department (ED) via stretcher. In the ED, she was re-dosed with an EpiPen secondary to her airway type symptoms. She was reevaluated after 15 minutes and received Solu-Medrol, Pepcid, Benadryl IV, as well as IV fluids. She also received Ativan for her generalized jitteriness and anxiety. She improved and felt significantly better at approximately 11:43am. She was monitored for 3 hours in the ED and was discharged home at 3:34pm in good clinical condition and advised to continue to take Benadryl as needed. She carries and EpiPen on her person and was advised to return immediately if symptoms return.
43 2021-01-06 anxiety SWEATING ANXIETY, HEADACHE, NAUSEA, SWEATING AT APPROXIMATELY 1410. HR 100-105. OBSERVED 5 MINUTES. ... Read more
SWEATING ANXIETY, HEADACHE, NAUSEA, SWEATING AT APPROXIMATELY 1410. HR 100-105. OBSERVED 5 MINUTES. DENIED SOB. NO TACHYPNEA, RASH OR ORAL SWELLING. NO AUDIBLE WHEEZING OR STRIDOR. SENT TO ER AT 2:19 FOR OBSERVATION. OBSERVED 1 HOUR.
43 2021-01-07 feeling abnormal 100.6 Fever, body aches, mental fogginess
43 2021-01-07 feeling abnormal 100.6 Fever, body aches and mental fogginess
43 2021-01-07 feeling abnormal Fever, body aches, Mental fogginess
43 2021-01-07 impaired work ability fever, muscle aches, joint pain staying home
43 2021-01-10 confusional state Confusion, Dizziness, 11:33 Tingling in forehead BP 137/87 HR 91 O2 98% 11:48 138/84 HR 79 O2 100%.... Read more
Confusion, Dizziness, 11:33 Tingling in forehead BP 137/87 HR 91 O2 98% 11:48 138/84 HR 79 O2 100%. Felt better Narrative:
43 2021-01-11 anxiety myositis; This is a spontaneous report from a contactable physician. A 43-year-old male patient re... Read more
myositis; This is a spontaneous report from a contactable physician. A 43-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date in Dec2020 reported as around the end of December, at single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On an unspecified date after he received the vaccine he had right arm pain and swelling (states it was in his bicep brachial radialis in the muscle) which is the opposite arm of the injection site. He had an MRI done on an unknown date that showed myositis. He thinks could be due to the vaccine since it started two days after he received the vaccine. His pain peaked at about a week and a half and now the pain was improving and the swelling was down. He still had function in the right arm but when he strained it would hurt. His concern was that the reaction may be an autoimmune reaction and the first response was muted. He was worried the second dose may elicit a larger response. At the time of the reporting the patient was recovering from the events. Information on Lot/Batch number has been requested.; Sender's Comments: Based on the available information, the company considers that a causal relationship between the myositis and vaccination with BNT162B2 cannot be excluded. Additional information regarding onset latency, relevant medical history, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. 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.
43 2021-01-13 feeling abnormal Sore throat, chills, headache, body aches, cough, sneezing, runny nose, fatigue, mental fogginess, a... Read more
Sore throat, chills, headache, body aches, cough, sneezing, runny nose, fatigue, mental fogginess, and soreness at the injection site.
43 2021-01-17 sleep disorder The day after receiving the second vaccination, I began to have mild intermittent abdominal pain2-3/... Read more
The day after receiving the second vaccination, I began to have mild intermittent abdominal pain2-3/10. The pain gradually increased, became more intense, and more constant. Mild fever and chills started happening, and I took Ibuprofen. By about 4 days after the vaccine, the abdominal pain was severe enough that I had some difficulty walking and I couldn?t sleep at night. Pain was 6-8/10. I went to the ER, and CT scan with IV contrast showed 18 mm appendicitis. I underwent laparoscopic surgery and it was found to be perforated. It was removed. I am currently recovering in the hospital. I received the vaccine as a health care provider at my hospital, specifically I am a practicing pediatrician physician for over 10 years.
43 2021-01-19 impaired work ability A few hours after the shot my hands and feet where tingling and felt clammy/ swollen. After work i ... Read more
A few hours after the shot my hands and feet where tingling and felt clammy/ swollen. After work i noticed that my heart rate would increase when walking around and that the heart beat felt heavy. If i was lying down the heart rate would be slightly elevated compared to normal resting heart rate. The heart rate beat felt heavy. I went to bed early and slept through the night. I woke up the next morning and felt fatigued, dizzy, slight body ache and nauseated. no fever, no headache. i tried to take a shower but symptoms got worse. i was unable to go to work that day. I took a few naps during the day and by late afternoon most symptoms where going away. the last symptom was the issue with the hands and feet. Heart rate returned to normal. The next day i was able to return to work.
43 2021-01-20 nightmare, sleep disorder I had a very bad dream over night. It was a nightmare. I woke up and went back to sleep 3 times and ... Read more
I had a very bad dream over night. It was a nightmare. I woke up and went back to sleep 3 times and the night continued each time until about 4am. Then I couldn't sleep again.
43 2021-01-20 sensation of foreign body After the required wait period of 15 minutes I started to drive back home which is 77 miles from the... Read more
After the required wait period of 15 minutes I started to drive back home which is 77 miles from the hospital that administered the vaccination. Around 15 minutes down the road I started feeling like something was caught in my throat and was coughing a little. At that time I decided to turn around and go back to the hospital. I took an oral Benadryl 25mg and decided to wait in my car and see if it was something else. After 30-45 minutes I took a drink of water and realized I was having trouble swallowing. I then preceded into the ER and was admitted immediately. In the ER, they started an IV, administered Benadryl, methylprednisolone and a bag of saline. The physician discussed with me and we agreed to hold the Epinephrine to see how I reacted to the previous medications. I was then monitored for a couple hours then released with a prescription of Prednisone 60mg for 5 days and an EpiPen. One day out, no new symptoms besides injection site pain.
43 2021-01-21 feeling abnormal Body aches, tired, hard time catching my breath, mind foggy
43 2021-01-26 disorientation, feeling abnormal numbness in right side of face and right arm; hard time swallowing; felt foggy; dizzy; disoriented; ... Read more
numbness in right side of face and right arm; hard time swallowing; felt foggy; dizzy; disoriented; This is a spontaneous report from a contactable consumer. A 43-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on arm left from 11Jan2021 to 11Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included was reported as none. There were no concomitant medications. The patient states about 24 hours later he felt foggy, disoriented, and dizzy (all three occurred on 12Jan2021), states he then woke up at 3 am this morning and had a lot of numbness on right side of face and arm and had a hard time swallowing (both occurred on 13Jan2021), states a couple hours later he went to hospital, went to ER and had to do an MRI, states the MRI of brain and neck came back clear and checked out, states doctors concluded it was an adverse reaction to vaccination. Outcome of the events was recovered on 13Jan2021. Information on the batch/lot number has been requested.
43 2021-02-02 feeling abnormal I had some sort of reaction. I was glad to get the shot and was not nervous about getting the shot.... Read more
I had some sort of reaction. I was glad to get the shot and was not nervous about getting the shot. 5 minutes after the shot I felt something cold go down my left arm from my shoulder to my hand. A minute or two after that both my hands went numb, then both my arms went numb. I asked others around me if anyone felt anything and everyone else was fine. A minute or two after that both my legs went numb. I started to black out but made it to a chair before this happened, I drank some cold water and felt awake about 5 minutes later. 30 minutes after that i felt comfortable enough to walk. For the rest of the day i felt like i was legally drunk and felt lots of pins and needles on the back of my hands and feet. I did not feel dizzy or nauseous at that time. i also felt a lot of pressure on the inside of my skin all over my body. I've never felt anything like that and it was a bit uncomfortable. The next day i was too dizzy to walk without becoming very nauseous. I still had pins and needles on my feet. i had chills as well which i guess is a good sign. my appetite was fine. i felt clear-headed as well. Two days after the shot i felt slightly dizzy and by the third day i felt fine except for minor muscle cramps all over my body. For the three days after the shot i also had some pretty strong forearm and calf muscle cramps and my arms (biceps and triceps) felt pumped up like i just had a great arm workout, but they weren't swollen at all.
43 2021-02-04 confusional state Patient had vasovagal syncopal event. This event was not a vaccine side effect but a vasovagal respo... Read more
Patient had vasovagal syncopal event. This event was not a vaccine side effect but a vasovagal response (previous history of syncope with vaccinations/procedures). Patient received 1st dose of Pfizer vaccine around 11am today. Within 2 minutes of receiving the vaccine, he started to feel dizzy and passed out for around 45 secs. He had cold extremities, looked pale and was sweating. He was immediately transferred from chair to floor and his legs were raised. Cold towel was placed on his head. He regained consciousness but was confused for less than a 1min. Vitals were checked and his BP was 95/50's and HR was around 56. Pulse O2 was 99% during entire event. He was able to converse well after that and was oriented. He informed having anxiety/panic attacks, had taken his medication that morning. He reported similar syncopal episodes in the past. He was monitored in same posture. He was gently hydrated orally with water and soda. He was given sublingual zofran due to nausea and retching. He did not vomit. We continued to monitor his BP on regular intervals. He had slow improvement in BP and after 2 hrs while sitting his BP was 104/65, pulse 56/min (reports being an athlete and previous records show baseline bradycardia). He denied any symptoms and was awake, alert, oriented. As he was not accompanied by anyone, his wife was contacted who came to clinic in 10mins and helped to drive him home. He was transported by wheelchair till entrance of clinic. He reported feeling better and thanked for helping. He does not have any contraindications to receive 2nd dose of vaccine.
43 2021-02-04 impaired work ability Left arm at injection site felt cold after five minutes after injection. Lasted a minute. Dizziness... Read more
Left arm at injection site felt cold after five minutes after injection. Lasted a minute. Dizziness. Has lasted so far four hours Jaw bones hurt Running temperature. Started three hours after injection. Current temp is 100.2. taken orally at 4:15pm PST I called in sick for work, stating it's vaccine related for my shift on 2/5/2021. My shift would have started at 11:00pm.
43 2021-02-05 disorientation Patient felt warm, off balance, disoriented, and was sweating profusely after his vaccination. This ... Read more
Patient felt warm, off balance, disoriented, and was sweating profusely after his vaccination. This reaction started less than 5 minutes after administration of the Pfizer vaccine. EMS took the patient's blood pressure. The first reading was 80/50 mmHg and the second reading was 104/66 mmHg. After having water and sitting for 30 minutes the patient felt fine.
43 2021-02-06 impaired work ability 11/17/20 J&J Ad26.CoV2.S vaccination. The next morning patient began mild achiness & fatigue that ... Read more
11/17/20 J&J Ad26.CoV2.S vaccination. The next morning patient began mild achiness & fatigue that lasted 48 hours and mild arm pain that lasted 72 hours. severity: Gr 1 1/5/21 Pfizer #1. Sudden onset at 10 hours of shaking chills, temperature 103+, severe myalgias and malaise. Severe for 36 hours. 80% better at 48 hrs; at baseline by 72 hours. 1/26/21 Pfizer #2. 10 hours later again noted shaking chills, temperature >103, severe myalgias and malaise. 1/27 could not work. Worked 1/29 & 1/29 at half capability. 1/30 & 1/31 felt worse with temperature >103 both days. 2/1 had to leave work early; noted multiple aphthous ulcers on palate and tongue. Continued to have myalgias and temperature 102-3 through 2/3; tempera
43 2021-02-08 excessive sleepiness Approx 10-15 minutes after the shot client started c/o severe nausea and did vomit. He was sweating,... Read more
Approx 10-15 minutes after the shot client started c/o severe nausea and did vomit. He was sweating, and c/o throat tightening, was pale and still nauseated. Benadryl 50 mg Im given. His brother in law was called to drive him home. After he was stable, and no longer c/o any symptoms he was release to his brother-in=law. He says he went home and slept 3 hours and then slept til noon the next day which is not normal for him.
43 2021-02-11 sleep disorder, impaired work ability Headache (severe), muscle aches (mild), chills (mild), and fatigue (mild). Symptoms lasted approxima... Read more
Headache (severe), muscle aches (mild), chills (mild), and fatigue (mild). Symptoms lasted approximately 48 hours after onset. Could not work/bedridden for approximately 36 hours. Tylenol did nothing to help, ibuprofen effective to lessen the headache so I could sleep.
43 2021-02-16 abnormal dreams, insomnia, hallucination hallucinations; drowsiness; Insomnia; extremely vivid and realistic dreams; metallic taste in mouth;... Read more
hallucinations; drowsiness; Insomnia; extremely vivid and realistic dreams; metallic taste in mouth; muscle soreness; joint pain; headache; nausea; This is a spontaneous report from a contactable consumer reporting for self. A 43-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration on 01Feb2021 08:15 at single dose for covid-19 immunisation. Medical history included allergies to azithromycin, erythromycin, amoxicillin, penicillin. Concomitant medication included influenza vaccine inact split 4v (FLUZONE), diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL), hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ). The patient experienced Insomnia, extremely vivid and realistic dreams, hallucinations 16-20 hours after injection (that night), metallic taste in mouth, muscle soreness, joint pain, headache, nausea, drowsiness for approximately 36 hours on 01Feb2021 11:00. Outcome of events was recovering.
43 2021-02-17 anxiety Vomiting. He anxiety with symptom vomiting. Heart rate decreased as relax sat in lobby away from pe... Read more
Vomiting. He anxiety with symptom vomiting. Heart rate decreased as relax sat in lobby away from people and felt better went home
43 2021-02-19 impaired work ability Entire body rash for 7 days, started at my neck and then to involve my entire body. Fever 101.8-102... Read more
Entire body rash for 7 days, started at my neck and then to involve my entire body. Fever 101.8-102.9 for 3 days with 1 gram Tylenol and Benadryl. Weakness for a week, unable to work.
43 2021-02-25 anxiety Pt reported increased HR, anxiety, and sweaty.
43 2021-03-02 feeling abnormal After about 10 minutes I started feeling weird. I became light headed. Then I felt a burning sensati... Read more
After about 10 minutes I started feeling weird. I became light headed. Then I felt a burning sensation done both arms and my tounge. My heart was beating fast and I was struggling to get my breathing under control. My throat also got tight or warm and that feeling seem to go down through my chest. The monitor told me to take off my mask and gave me water. Shortly after I started to gag and almost vomited. The monitor checked my blood pressure and it was 180 over 120. I was admitted to the ER. I stayed there for about an 90 minutes as was released as the symptoms seemed to leave. While driving home many of the symptoms resurfaced. When I returned home I took a zyrtec and an anxiety medication. A day after I am light headed and a little nautilus but otherwise ok.
43 2021-03-02 feeling abnormal Day after second vaccine dose, patient began having extreme fatigue, overall body chills on/off thro... Read more
Day after second vaccine dose, patient began having extreme fatigue, overall body chills on/off throughout every day, joint aches in fingers and ankles, bilateral calf pain, wheezing, heart burn, brain fog, cold feeling in feet. These occur throughout every day, on and off. We are now at week 5.
43 2021-03-04 nervousness Per patient, left site feeling fine, after being monitored for 15 minutes per protocol. Claims he fe... Read more
Per patient, left site feeling fine, after being monitored for 15 minutes per protocol. Claims he felt light headed, nervous, and blacked out and hit a car in front of him. Per client, he was taken to the hospital and all tests came back clear. He later walked to another mini pod and reported the incident to them.
43 2021-03-08 excessive sleepiness Bloody diarrhea. Blood dripping from anus. Fever. Lethargic. Sleeping constantly. Body aches all ... Read more
Bloody diarrhea. Blood dripping from anus. Fever. Lethargic. Sleeping constantly. Body aches all over. Extreme abdominal pain.
43 2021-03-10 impaired work ability Narrative: As written per ED notes dated 3/9/2021: This 42-year-old female is here for evaluation ... Read more
Narrative: As written per ED notes dated 3/9/2021: This 42-year-old female is here for evaluation of increasing nausea and vomiting. The patient has gotten worse the past 24 hours. She got her second COVID-19 shot yesterday here at the VA Medical Center. She is complaining of consistent nausea and vomiting and can't keep any fluids down. She is here for evaluation of possible dehydration and weakness. The patient feels markedly improved after oral Zofran. I counseled her at length about this is a possible intolerance to the second Covid 19 immunization. She will be discharged home with Zofran 4 mg tablets 3 times a day as needed for nausea #20, increase fluids and rest, no work until Thursday, March 11, 2021. First covid19 vaccine: 2/15/2021, no adverse events Second covid19 vaccine 3/18/2021: presented to ED
43 2021-03-11 impaired work ability significant persistent nausea unrelieved by zofran. no vomiting. same reaction with vaccine on 2/7 b... Read more
significant persistent nausea unrelieved by zofran. no vomiting. same reaction with vaccine on 2/7 but reaction is more severe this time causing work loss
43 2021-03-18 impaired work ability Severe spinning, nausea, vomiting, occurred at 2:15 a.m. while on duty, was transported to ER and di... Read more
Severe spinning, nausea, vomiting, occurred at 2:15 a.m. while on duty, was transported to ER and diagnosed with Peripheral Vertigo. Follow ups with ENT, Neuro and PCP have continued with Vestibular Rehabilitation. While in ER, the MRI, MRA, CT, CT with Contrast was done, showed no signs of anything that could have caused this. Ironically tracking back, I received my 2nd Dose of the Pfyzer Vaccine on January 6, 2021 at 8:45 a.m. and this occurred on February 13th at 2:15 a.m. I have not had any other issues before this nor any signs of damage to the nerve or ear that regularly affects Vertigo Patients per my Neuro and ENT. The incident took place 4 weeks and 2 days after the 2nd vaccine. 2 days after the 2nd dose, I experienced Low grade fever, chills, and body aches that lasted only 12 hours, but nothing with the 1st vaccine nor anything after the 2nd dose issue until the Vertigo. I am unable to drive, conduct my job, which requires me to go to emergency calls and carry a Taser (CEW). I have been off work since this occurred and still not eligible to go back to work.
43 2021-03-22 insomnia Day 1 none 3/21/21 at approx 8pm Dizziness Nausea Joint pain Light fever Dehydrated Insomnia 3/22... Read more
Day 1 none 3/21/21 at approx 8pm Dizziness Nausea Joint pain Light fever Dehydrated Insomnia 3/22/21 all day Joint pain Dizziness Nausea Vertigo Foot pain Insomnia
43 2021-03-23 sensation of foreign body Dry mouth, "feels like a knot in my throat" ED Note: 43 y.o. male with a history of hypertension and... Read more
Dry mouth, "feels like a knot in my throat" ED Note: 43 y.o. male with a history of hypertension and eosinophilic esophagitis presenting s/p allergic reaction. Patient received his first dose of the Pfizer COVID vaccine around 17:30 today and states that he developed hives down his left arm and was having difficulty swallowing. He does have a known egg allergy and states that he has had prior anaphylaxis reactions to the flu vaccine. Patient was given PO Benadryl with complete relief of his symptoms. He has no complaints at this time and states that he feels "perfectly fine". At bedside for initial evaluation. Discussed plan for continued Benadryl throughout tomorrow and follow-up with his PCP. Patient is agreeable. Plan for discharge. The patient is comfortable with further observation of his symptoms at home. I discussed our workup, answered all questions and made sure there were no other concerns. I provided counseling about standard home and self-care measures and advised on standard return precautions including new, persistent, or worsening / concerning symptoms.
43 2021-03-24 confusional state, incoherent Rapid onset of blurred vision and partial blindness, confusion, inability to form complete or cohere... Read more
Rapid onset of blurred vision and partial blindness, confusion, inability to form complete or coherent thoughts or sentences. Started with blurred vision around 5:45pm. I immediately sat down on the couch, and tried to explain to my wife what was going on. However, I was unable to complete the thoughts I was trying to form. Eventually I began confusing words (such as saying "king" when I wanted to say "kind" or "kite") and was unable to produce more than one word every 1-2 seconds with great difficulty. Then a headache came that was both extremely painful and somehow "painless," as if I was observing myself having the pain as a bystander. All of this happened within one minute of onset. I laid down and after about 10 minutes from onset the difficulty speaking subsided and I could make complete sentences, although with some difficulty. After around 20 minutes from onset my vision had fully returned. I called 911 out of concern for stroke-like symptoms. The dispatcher sent an ambulance, and I was taken to the Hospital Emergency Department for treatment. Around three hours after the onset of the incident I was diagnosed with a complex migraine and discharged.
43 2021-03-27 excessive sleepiness, mental impairment Extreme fatigue starting day following the vaccination. Slept for three days nearly continuously. L... Read more
Extreme fatigue starting day following the vaccination. Slept for three days nearly continuously. Loss of appetite. Did not eat for three days. Decreased cognitive functions. Sweats and chills (sometimes simultaneously)
43 2021-03-29 confusional state Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Syncope-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Bradycardia
43 2021-03-30 impaired work ability Patient reports he has noticed over the past week increased shortness of breath on exertion--at base... Read more
Patient reports he has noticed over the past week increased shortness of breath on exertion--at baseline able to exercise with walking 45-60 minutes without dyspnea, however noticed over the last week getting some shortness of breath even walking to the garage. No chest pain, no fevers, chills, cough. He saw his PCP for these symptoms who ordered EKG and CXR 1 day PTA which per patient were normal--plan was for referral to cardiologist. However on the morning on presentation around 6:45 AM after taking an elevator for work he began feeling lightheaded and lost consciousness, awakening on the floor. He went home as he was not feeling well however proceeded to have another 2-3 episodes of loss of consciousness at home witnessed by his girlfriend--the later 2 occurred while lying down and were not clearly associated with any presyncopal symptoms.
43 2021-03-31 poor quality sleep hot and cold, restless sleep the night of vaccination. Next day felt fatigue, sick
43 2021-04-05 sensation of foreign body, feeling abnormal On March 24 I got the first dose of the Pfizer COVID-19 vaccine and I experienced side effects almos... Read more
On March 24 I got the first dose of the Pfizer COVID-19 vaccine and I experienced side effects almost immediately. By the time I got to the resting/observation area I felt that the site of the injection got really warm and I became dizzy/lightheaded and started to feel heavy on the chest and little problem in swallowing and breathing. I was taken to the paramedics on site, they checked my blood pressure (which a little high 150/90), oxygenation, pulse, and EKG (which were normal). It did not became too bad after and was allowed to come back home. However, the heavy chest and swallowing problem lasted for three days. The heaviness in the chested turned into a sensation of feeling like my trachea or the anything under the sternum area was behind strangled. Although I felt like this my breathing and swallowing was almost normal. Every now and then when I swallowed I felt some pain but I could withstand it.
43 2021-04-06 feeling abnormal Next day fatigue, and brain fog. Within 24 hours noticed swollen lymph node in left armpit and tend... Read more
Next day fatigue, and brain fog. Within 24 hours noticed swollen lymph node in left armpit and tenderness (same side as shot). Swelling about the the size of a fist. 7 days later swelling remains, but reduced by 1/2 the size. Within 48 hours notices pain and swelling lymph node under right collar bone and tenderness (opposite side of shot). Swelling is minimal, but collar bone discomfort. 6 days later since onset and collar bone discomfort remains.
43 2021-04-09 insomnia Below and above normal temperature, headache, lower back ache, general body ache, nausea, insomnia.
43 2021-04-10 anxiety Patient received vaccine at 1144a, left site, started feeling palpitation and drove back to site. M... Read more
Patient received vaccine at 1144a, left site, started feeling palpitation and drove back to site. MD assessed, O2 at 93%, O2 4L initiated by onsite Paramedics. Pt vomited and stated he feels dizzy and has SOB. Ambulance called, vitals taken: BP 159/96, HR 88, 98% 4L NC. Last taken BP was 133/66, patient stated he was feeling anxious, recommended to go to the hospital for further assessment. Patient was driven by his wife.
43 2021-04-10 sleep disorder Severe muscle spasms from muscle scarring from an accident 20 years ago. See earlier accident histo... Read more
Severe muscle spasms from muscle scarring from an accident 20 years ago. See earlier accident history for more details.
43 2021-04-12 impaired work ability At around 10 pm on the day of vaccination, I started to develop a sore throat, runny nose and minor ... Read more
At around 10 pm on the day of vaccination, I started to develop a sore throat, runny nose and minor headaches. The following day, April 8, I had more severe symptoms. I had a pounding headache, body aches, chills, fatigue, low grade fever, sore throat, and a runny nose. I spent the day in bed and could not go to work. Towards the end of the day, my low grade fever had subsided, and my sore throat as well. Now I had a slight cough but still had minor chills, fatigue, headache, and body aches. I was able to sleep mostly, and by the following morning, April 9, I was only suffering from body aches, a cough, and a runny nose. I was able to attend work remotely but found my desire to engage in almost any activity very minimal. By that night, most evertything was returning to normal, though a runny nose was still present.
43 2021-04-13 abnormal dreams Vivid Dreams Body felt like I was hit by a truck. Had trouble getting around. Pain and stiffness thr... Read more
Vivid Dreams Body felt like I was hit by a truck. Had trouble getting around. Pain and stiffness throughout body. This was at 3am At 6am when I woke up, I felt like there was a band around my right calf, and there was shooting pains through my left foot / ankle The second night, I woke up at 3am in a night sweat and feverish. Headache and vivid dreams.
43 2021-04-16 feeling abnormal Headache, fever, painful joints, painful teeth, sore dry throat, brain fog, fatigue
43 2021-04-16 loss of personal independence in daily activities, sleep disorder The night after I received my first dose, my tinnitus has gotten very loud, to the point where I fin... Read more
The night after I received my first dose, my tinnitus has gotten very loud, to the point where I find it hard to sleep or function. That started on 04/09/2021 and still just as loud on 04/17/2021
43 2021-04-17 feeling abnormal Fever of 103.5 Fatigue Headache Dehydration Diarrhea Foggy brain Itchiness
43 2021-04-19 insomnia Within a few hours my left should joint started to hurt. Within 8 hours I was in extreme pain and ... Read more
Within a few hours my left should joint started to hurt. Within 8 hours I was in extreme pain and could not move my left arm. Any movement of my left arm resulted in strong stabbing pain in my shoulder. After three days it improved and after one week it was completely gone. The AE reminded me of calcific tendonitis flare up which I have in both shoulders. I went to urgent care as I could not sleep due to pain and they told me to wait a few days and take OTC pain meds.
43 2021-04-20 anxiety Patient while sitting in the post-vaccination area for 15 minutes, started experiencing lightheaded ... Read more
Patient while sitting in the post-vaccination area for 15 minutes, started experiencing lightheaded and faint when he got up. I instructed the patient to sit back down and he complied. I went to grab the patient water and calm him because he seemed a little anxious and then he started shaking, so we immediately called 911. I tapped him to see if he was okay, and he said yes was okay but really faint and the patient was sweating. I asked if he was having trouble breathing, but he denied. He drank the water and had chocolate and I kept conversing with him to assess for any physical/mental status changes, and during the conversation the patient said he usually feels faint and anxious when he gets blood drawn but did not mention it during the screening because he never has when receiving vaccinations. The patient was appearing to improve, less anxiousness, less sweating, and getting more color back to his face. When the EMS arrived within 5-10 mins, they assessed his vitals which were all normal and the patient requested not to be taken to the hospital. The EMT personnel felt the patient was doing okay and left. I had the patient stay for another 30 minutes to make sure he was remaining okay before he left.
43 2021-04-22 disturbance in attention Fever 101-103.4 / fever chills every day for 6 days. Neck pain with swollen neck lymph nodes x 9 da... Read more
Fever 101-103.4 / fever chills every day for 6 days. Neck pain with swollen neck lymph nodes x 9 days, Ringing in ears interrupted sleep for 1 month, had decreased some although continues to this day. Malays for 2 weeks. Vomiting for the first 4 days.
43 2021-04-23 loss of personal independence in daily activities At first, my nose hairs were itchy, then I got runny nose. I sprayed Flonase, which didn't seem to h... Read more
At first, my nose hairs were itchy, then I got runny nose. I sprayed Flonase, which didn't seem to help that much except to dry out my nasal passage. Then, I started feeling lightheaded in the same evening and somewhat disconnected from my body. Then, the next morning, and all day, I've been clumsy and uncoordinated.
43 2021-04-24 confusional state Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient was coherent after shot sat down passed out. Hit head trauma scrape on head and knees and called ems showed up 5 minutes took pt walking away.
43 2021-04-25 feeling abnormal Had minimum side effects during my first shot on 2/9/21 (lot # EL-9261). About 3 hours after my sec... Read more
Had minimum side effects during my first shot on 2/9/21 (lot # EL-9261). About 3 hours after my second shot on 3/2/21, the room was spinning wildly to the point I could not look at the ceiling, I may have started to have "brain fog" that night as well. 3/3/21 I had chills, no fever. 3/4/21 while talking to a coworker I experienced a "neurological event", I felt like I received a flash software upgrade to my brain, and things "paused" for a short amount of time. Later on 3/4/21 brain fog was significantly impacting me and it was hard to complete sentences and communicate effectively. From 3/2/21 to 3/ 3/7/21 I experienced brain fog, fatigue, dizziness, and chills (no fever). I was fine on 3/8/21. All 4 side effects came back on 3/24/21. I was having chills, no fever, early in the day then led a meeting in the early afternoon and could barely finish my briefing. I was having issues with fatigue, some dizziness, and brain fog. From 3/24/21 to 4/19/21 the side effects that mainly bothered me was dizziness/vertigo and some brain fog. Majority of time throughout this period the side effects were sporadic. I was able to function at 100% then wham, I was out of commission for 2-3 hours, then back to normal again for a multi-hour window. Hydrochlorothiazide worked well. I also took Meclizine with limited impacts. Also took a prednisone pack that took the edge off.
43 2021-04-25 nervousness Pt. had a Syncopal episode post 10 from vaccination. Was lowered to floor without injury .Did not re... Read more
Pt. had a Syncopal episode post 10 from vaccination. Was lowered to floor without injury .Did not recover immediately . Became nauseous and shaky then began vomitting. Pt remained lightheaded and near syncopal whenever brought to a sitting position or standing position. Pt. refused Benadryl . Pt. admitted having nausea and diarrhea for past 1-2 days intractable vomitting 5 yrs ago Agreed to EMS transport to ED
43 2021-04-27 sleep disorder Pt received Pfizer COVID vaccine on 3/26 at facility. Pt presented to the ED on 3/30 for evaluation ... Read more
Pt received Pfizer COVID vaccine on 3/26 at facility. Pt presented to the ED on 3/30 for evaluation of chest pain at around 0722 on 3/30. Per ED provider note, "This patient is a 43 y.o. male who presents to the ED for evaluation of chest pain. The patient drove here two days ago and was feeling well when he went to sleep. He was awoken from sleep early yesterday morning with "intense" left sided chest pain with radiation and tingling sensation down his left arm. The patient says that his pain has since been fairly constant, waxing and waning in intensity. He says that his chest pain is still currently present, mostly localized in his left shoulder, but improved when compared to the pain that woke him up again this morning around 03:00. No reported vomiting, abdominal pain, fevers, chills, cough, or shortness of breath. Patient notes that he received the second dose of the COVID-19 vaccine 4 days ago. Patient reports family history of cardiac disease in his father. He denies any personal history of cardiac disease, and says that his last cardiac work up was a couple years ago for PVCs. The patient is not a smoker and denies any history of diabetes, hypertension, or high cholesterol. There are no other complaints. There are no other exacerbating or alleviating factors. There are no other reported associated signs or symptoms" Pt was given nitroglycerin ointment and aspirin chewable 324mg in the ED. " In addition, "This is a 43-year-old male presenting to the emergency department with just over 24 hours of left-sided chest pain with radiation into the left shoulder and down the left arm. Symptoms were more severe prior to the patient's arrival to the hospital. He was given nitroglycerin and aspirin upon arrival here. EKG shows subtle ST abnormality in the inferior lateral leads. Troponin is elevated at 11. Differential includes non ST-elevation myocardial infarction, myopericarditis. Patient will be admitted to telemetry. He will undergo a cardiac catheterization today." Pt was admitted, and per hospitalist note on 4/1, "Patient presented hospital with chest pain and EKG changes-there was initial concern for NSTEMI. Had cardiac catheterization with clean coronaries. Then thought to have pericarditis. Patient had trivial pericardial effusion on echocardiogram. Had MRI that demonstrated myocarditis as well. Patient improved on colchicine and NSAID therapy. Discussion had with cardiology will continue this and to be tapered in the office setting. Will continue NSAIDs for approximately 2 weeks then begin tapering. Will likely need colchicine for approximately 3 months. Patient was placed on beta-blocker to help with symptomatic treatment and help alleviate plain. Patient was started on metoprolol, was cautioned side-effects of hypotension, bradycardia, exercise intolerance .Patient should monitor heart rate and blood pressure daily. Hold if heart rate <50 or blood pressure less than 100 systolic and notify provider. Patient was advised he may follow-up with Dr. Caution GI upset, nausea vomiting diarrhea. If diarrhea with colchicine would recommend back down to daily from b.i.d. treatment. Patient was ambulatory and functional without significant symptoms, vital signs within tolerable limits, and agreeable to discharge plan.. Patient ultimately discharged in stable condition. All questions answered to apparent satisfaction. Patient cautioned side effects of medications. Patient was instructed if reoccurrence or any concerning symptoms to contact provider or present to nearest emergency department based on acuity. Patient and family voiced understanding of recommendations and in agreement with discharge plan."
43 2021-04-29 panic attack Left shot clinic after 15 min with no adverse effects. Driving home mouth and tongue went completel... Read more
Left shot clinic after 15 min with no adverse effects. Driving home mouth and tongue went completely dry instantly and could not swallow. This was 28 min after initial shot (2nd dose). Concerned that airway would be restricted. In a panic went to ER at different hospital that I was near. No signs of anaphylaxis. Waited in hospital for ~3 hours. Symptoms did not get worse and could breath through nose. Decided no steroid shot (did not want to negate covid shot). Went home without additional treatment. Mouth was dry for 1 additional day, but not as extreme as initial dryness.
43 2021-04-30 panic attack, anxiety Systemic: Pt had a panic attack and felt weak, laid on floor to avoid fainting-Mild, Additional Deta... Read more
Systemic: Pt had a panic attack and felt weak, laid on floor to avoid fainting-Mild, Additional Details: PT has severe vaccine anxiety. Pt always passes out after vaccination from the anxiety and adrenaline. Pt took a valium at some point prior to receiving vaccination at home.
43 2021-05-01 sleep disorder Patient developed acute psychosis w/ transient changes in cognition, sleep, mood, and psychomotor ac... Read more
Patient developed acute psychosis w/ transient changes in cognition, sleep, mood, and psychomotor activity.
43 2021-05-03 feeling abnormal Right after receiving the vaccination began to develop very high resting heart rate(150bpm), along w... Read more
Right after receiving the vaccination began to develop very high resting heart rate(150bpm), along with dizziness and some mild shortness of breath, along with an out of body feeling. Some muscle tightness in neck. Took one benadryl after 15min, began feel better after 1hr. Then had more common reactions later that evening. Regular bpm is 55-60.
43 2021-05-05 loss of personal independence in daily activities Severe neurological and cognitive decline. Patient is currently unable to walk unassisted and is be... Read more
Severe neurological and cognitive decline. Patient is currently unable to walk unassisted and is between a walker and a wheelchair. His cognitive function has also been affected to the point that some days he is unable to process how to even feed himself.
43 2021-05-06 anxiety, feeling abnormal, panic attack during the following 3 weeks, I'd experienced weird things like anxiety( excessive worries about any... Read more
during the following 3 weeks, I'd experienced weird things like anxiety( excessive worries about anything, feeling of my heart beating fast, sometimes feeling my breathing is very fast, chest tightness or heaviness, and feeling that I'm losing control for few seconds, feeling cold that I put on the heavy jacket that I never used except in cold winter! feelings of boneaches especially in my fingers joints, some days I'd nausea and feeling that my stomach torture me! All the previous symptoms were on and off many times per day, I was using Tylenol and Ibuprofin almost every day. lately, I'd 4 days of continuous symptoms, that I feel like panic and cold with all the above symptoms.(from 29th April to May 3rd).
43 2021-05-07 crying, depressed mood, suicidal thoughts he started having thoughts of killing himself for no reason that it would be very nice for him to go... Read more
he started having thoughts of killing himself for no reason that it would be very nice for him to go and shoot himself; what a nice day for killing himself, he was self-thinking that all day; He got really sad and he had cry; He started crying; He got really sad and he had cry; He started crying; This is a spontaneous report from a contactable reporter. A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 on 23Apr2021 (Lot Number: ER8735) and dose 1 on 30Mar2021 10:00 (Lot number was not reported) as both via an unspecified route of administration, administered in Deltoid Left SINGLE DOSE for covid-19 immunisation (Age at vaccination: 43 years). The patient's medical history and concomitant medications were not reported. The patient stated that he started having thoughts of killing himself for no reason that it would be very nice for him to go and shoot himself. He also think that what a nice day for killing himself, he was self-thinking that all day, he got really sad and he had cry; He started crying on an unspecified date. Outcome of the events was unknown. Information on the lot/batch number has been requested.
43 2021-05-07 sleep disorder, excessive sleepiness The night after getting the vaccination I had extreme pain in the joints and muscles as well as head... Read more
The night after getting the vaccination I had extreme pain in the joints and muscles as well as headache and fatigue. The pain kept me from sleeping, and woke me up at night for several nights in a row. The joint pain didn?t completely subside for over two weeks. I was also very fatigued, sleeping 10 to 12 hours a night for two weeks. I normally sleep 7 to 8 hours a night. My muscles also felt weak and sore for over a week. Shot one messed me up bad. The first night I also had clammy feeling skin and a slight feverish feeling, although I didn?t take my temperature.
43 2021-05-16 disorientation 18 hours after receiving the vaccine, passed out while walking in my house. No signs of dizziness or... Read more
18 hours after receiving the vaccine, passed out while walking in my house. No signs of dizziness or nausea preceded the episode. Lost consciousness for about 10 seconds, then was disoriented for about 2 minutes before being able to get up with assistance and move to my bed.
43 2021-05-17 sleep disorder In between my first and second shots I started having pain in my right side back and right side fron... Read more
In between my first and second shots I started having pain in my right side back and right side front. Dull kinda pain, soreness...not super sharp or anything. It was severe enough that I couldn't sleep at night. I still kept my second vaccine appointment which was in a couple days and booked an appt. with my doctor. It was about a week until I could get in to the office. In that time I got a small herpetic rash about the size of two fifty cent pieces on my right side. I went to the office and the doctor identified it as Shingles...which is not something I've had before. He put me on an oral steroid for 6 days, anti-viral medicine(Valacyclovir), and something for nerve pain (Gabapentin). All of which helped and I appear to have recovered so far.
43 2021-05-19 feeling abnormal Migraines 5 days after 1st dose Head Pressure Tinnitus Headaches Brain Fog Eye Floaters
43 2021-05-19 sleep disorder arm where injection occurred has had pain since injection. Can be enough to wake him from sleep. ... Read more
arm where injection occurred has had pain since injection. Can be enough to wake him from sleep. Better if avoids using arm, worse if exercises or uses arm in other ways. Also tingling from upper arm to fingers, off/on with no clear pattern
43 2021-05-23 feeling abnormal Increased heart rate a couple of minutes after the shot. Unusual sensation. Had to lower my mask fo... Read more
Increased heart rate a couple of minutes after the shot. Unusual sensation. Had to lower my mask for additional air. Symptoms subsided completely after about 5 minutes following the shot. Remained in the lobby area for a few minutes past my required 15 minutes. After leaving I felt fine. No symptoms hours later or to this point, 5/24/2021 other than pain at the injection site for 2-3 days.
43 2021-05-25 incoherent Pt. Had glucose level drops. Down into 60's with no previous issue with hypoglycemia, pale skin in f... Read more
Pt. Had glucose level drops. Down into 60's with no previous issue with hypoglycemia, pale skin in face. Severe fatigue, low blood pressure readings of 112/60 and 110/90. Hot flashes and nausea. Non-coherent with glassy eyes with no awareness. Fluctuations in symptoms and slept for Three days in and out. Pt. Took approx. Three days to feel back to himself.
43 2021-05-30 loss of personal independence in daily activities Upper arm pain and decreased range of motion remaining at 5 weeks post shot. Unable to do typical a... Read more
Upper arm pain and decreased range of motion remaining at 5 weeks post shot. Unable to do typical activities of daily living as pain is restrictive and severe.
43 2021-05-31 disorientation Patient was administered shot by RN and he immediately stiffened up and eyes became distant and twit... Read more
Patient was administered shot by RN and he immediately stiffened up and eyes became distant and twitched. He was like this for 10 sec and was disoriented when he became aware of surroundings. EMS was contacted. They assessed him and took him to the hospital
43 2021-06-01 sleep disorder chest pain made him go to the emergency room because it was too much, it was multiple throughout the... Read more
chest pain made him go to the emergency room because it was too much, it was multiple throughout the day not just one time; his penis sensations are a lot different; has had a bad headache where it feels like he has vibrating inside of his head, in his chest and in his abdomen; when he falls asleep he wakes up in an hour; getting shocked in the middle of the night when he is sleeping- in his chest and intestines; getting shocked in the middle of the night when he is sleeping- in his chest and intestines; limbs twitch; This is a spontaneous report from a contactable consumer. A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: ER8732; Expiration Date: 31Jul2021), 1ST DOSE SINGLE via an unspecified route of administration, administered in Arm Left on 27Mar2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced chest pain made him go to the emergency room because it was too much, it was multiple throughout the day not just one time, has had a bad headache where it feels like he has vibrating inside of his head, in his chest and on 31Mar2021, when he falls asleep he wakes up in an hour 31Mar2021, getting shocked in the middle of the night when he is sleeping- in his chest and intestines on 31Mar2021, getting shocked in the middle of the night when he is sleeping- in his chest and intestines on 31Mar2021, limbs twitch on 31Mar2021, his penis sensations are a lot different. It was reported that 5 days after he got the first dose of the COVID vaccine he started getting pains and the major thing is at night. If he falls asleep, he wakes up in an hour and that has been every night for a month and a half. That is the main thing that is pissing him off. He confirms that he is having issues with his chest and his intestines like he mentioned previously and he has started keeping track and has kept a journal of the pains. This stuff is new. He has never experienced this before and it has been happening every day starting 5 days after when he got the COVID vaccine. He had the COVID vaccine on 27Mar2021 and on 31Mar2021 he got the first shock in his chest at 0120 in the morning when he was sleeping. Then that went on for a week, he had it on 31Mar2021, 01Apr2021, 02Apr2021, 03Apr2021 and 04Apr2021 where he was getting shocked in the middle of the night when he is sleeping. On 04Apr2021 he had to go to the emergency room and have them look at him. But since 31Mar2021 he has been getting up every hour after he falls asleep. This was all worse when it first started because he has never experienced anything like this. The first shock he had was a hard feeling in his chest and then he couldn't go back to sleep. It is so bad. After he went to the emergency room, that is when it started being not as much of a shock pain that woke him up but he was still waking up every hour. The pains are in his upper chest and in his intestines. Also his limbs twitch and he has had a bad headache where it feels like he has vibrating inside of his head, in his chest and in his abdomen. He confirmed that these also began on 31Mar2021 and have been happening whenever they want and he has never experienced all of that before. Never. Everything has all stayed the same. The sad part is that he just thinks that he is getting used to this "new normal" because he is now going on the second month of this and his body is adapting but this is not normal. Also, he guesses that he shouldn't be shy now but the last thing is that his penis sensations are a lot different and he didn't notice until the first time that he was having relations with his wife after the COVID vaccine and it is all different. He noticed and she did too as far as whenever they were trying to have relations. It has been more than once, it has been every time they have tried afterwards. He says his doctor is going to send him to a sleep lab but he wasn't expecting that. He thought that maybe he would need to go somewhere else. But there he will go to sleep and be hooked up and they will read his whole body and tell the reason why he is waking up every hour. The outcome of the event headache, sleep disorder, chest discomfort, muscle twitching was not recovered and penis order, headache was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
43 2021-06-07 disorientation I woke up disoriented; I had severe double vision; loss of balance; severe nausea; diagnosed a 4th n... Read more
I woke up disoriented; I had severe double vision; loss of balance; severe nausea; diagnosed a 4th nerve palsy of my left eye; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0176), via an unspecified route of administration at the age of 43-year-old administered in arm left on 18May2021 10:30 AM at single dose for covid-19 immunisation. Medical history was reported as none. Prior to vaccination, the patient wasn't diagnosed with COVID-19. The patient's concomitant medications included ibuprofen received within 2 weeks of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0176), at the age of 43-year-old at the arm left on 27Apr2021 01:30 PM for COVID-19 immunisation. The patient had his second dose of the Pfizer COVID vaccine at 10:30am on 18May2021. By 2:30am on 19May2021, he woke up disoriented and realized that he had severe double vision resulting in loss of balance and severe nausea. A 19May2021 visit with his primary care doctor diagnosed a 4th nerve palsy of my left eye. This was confirmed by a 19May2021 visit to an ophthalmologist. It is now 21May2021 and nothing has improved and an MRI (Magnetic resonance imaging) was pending. The adverse events result in Doctor or other healthcare professional office/clinic visit. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was not recovered.
43 2021-06-07 feeling abnormal Dryness in his throat/ extremely, extremely sore and dry throat; Headaches; Feeling terrible; Fever;... Read more
Dryness in his throat/ extremely, extremely sore and dry throat; Headaches; Feeling terrible; Fever; Chills; Chest pain; Oppression in his chest that does not allow him to breathe normally/ pressure in his chest not letting him breathe normally; Sore throat/ extremely, extremely sore and dry throat; Chest pain is like a pressure; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information Team. A 43-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 27May2021 09:00 as 2nd dose, single dose (at the age of 43-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization. Patient mentions that yesterday (27May2021) he got the second dose of the Pfizer covid vaccine at 9 am and since then he had fever, chills, sore throat, chest pain like a pressure in his chest, oppression in his chest that does not allow him to breathe normally. On 28Feb2021, experienced dryness in his throat (extremely sore and dry throat), headache, feeling terrible. He wants to report the situation. Patient what should he do, does he need to go to a hospital. Communication included Advising patient to seek medical attention or the care of a doctor. The outcome of the events was unknown. No further information is provided or obtained. Information on lot/Batch number has been requested.
43 2021-06-13 feeling abnormal Vertigo, dizziness, on-a-boat feeling, headache, sinus pressure, brain fog, elevated blood pressure,... Read more
Vertigo, dizziness, on-a-boat feeling, headache, sinus pressure, brain fog, elevated blood pressure, elevated pulse. Most symptoms lasted for 6-9 weeks. Dizziness, on-a-boat feeling, occasional headaches continue still (3 month after)
43 2021-06-19 sleep disorder 1) Event: Unilateral Tinnitus (right ear) on 5/16/21 9PM turned into Bilateral Tinnitus on 5/17/21 7... Read more
1) Event: Unilateral Tinnitus (right ear) on 5/16/21 9PM turned into Bilateral Tinnitus on 5/17/21 7AM (~12kHz tone and slight ~4kHz tone both in both ears). Sleep is interrupted Treatment: None Outcome: Saw primary care (5/25/21), had an audiogram and tympanometry (5/27/21) showing normal hearing, and saw ENT (6/10/21). Bilateral Tinnitus and resulting interruped sleep persists. 2) Slight dizziness accompanied the Unilateral Tinnitus only (5/16/21 9PM)
43 2021-06-20 feeling abnormal With my 1st vaccine I just had soreness around the injection site. After the 2nd vaccine I woke up a... Read more
With my 1st vaccine I just had soreness around the injection site. After the 2nd vaccine I woke up at 4am on 1/31/2021 with muffled hearing in my left ear and mild numbness in the entire left side of my body from top of my head to bottom of my feet. I experienced vomiting and diarrhea also. I had blood pressure of 150 /105 and pulse rate of 100. My doctor was afraid I had a stroke, so I went to the ER and had a CT scan in brain. I tried to go to work the next day but my head was foggy so I had to leave work. I had a test for carotid arteries and heart test that came back fine. I was sent to a neurologist. He suspected I had possible swelling in the spinal cord, but since I was feeling a little better he thought it was ok to wait to have a spinal tap. He described that the symptoms were MS dialed symptoms but did not feel I had MS. I've gotten better but continue to have a neuropathy pain in my left foot, left hand, and left side of my face. It tends to get worse at night but in the morning it is ok. It continues through the day. None of these symptoms were there before the vaccine.
43 2021-06-21 feeling abnormal, confusional state At 1258. Patient started feeling itch, slightly lightheaded when sitting up, "weird tingle" in throa... Read more
At 1258. Patient started feeling itch, slightly lightheaded when sitting up, "weird tingle" in throat, dizziness, slight confusion. Vital sings 140-78/HR76 /R16, 93@ O2Sat. Skin warm and dry. Forehead is slightly flushed and war, Cap refill good, breath sounds clean bilaterally. Had patent lay down for vital signs, sat up and given water. Patient became dizzy upon sitting, returned to supine position. 1313 vital signs 122/80/HR76/R20. Skin warm and dry, good cap refill, breath sound clear bilaterally. 1328 had patient sit up, no initial dizziness orthostatic vital signs: Supine 118/80/HR80/R20. Sitting 140/100.. Patient discharged in stable condition in the company of his wife. Pt is alert and oriented times 3. Skin pink, warm and dry. Agrees to follow up with PCP or EMS if any signed of diff breathing, throat tightness were to occur on his arrival home.
43 2021-06-21 loss of personal independence in daily activities, impaired work ability After 2nd dose following events occur deteriorating overall health. I don't have any preexisting hea... Read more
After 2nd dose following events occur deteriorating overall health. I don't have any preexisting health conditions. 1. On May 24th at around 12.15 am, I started experiencing 100 degree fever followed by chills. The blood pressure shot up to 165-95 and heart rate was around 140. Was feeling breathless and sweaty and was being rushed to ER . 2. On 30th May again experienced BP at 165-90 and pulse was at 150 and rushed to ER 3.Again on May 31st, BP shoot up to 170-90 and pulse 145 and ER visit. 4. Consulted cardiologist and on Metoprolol medicine 5. Always feeling dizzy and lightheaded with unprovoked rise in BP and pulse. 6.Unable to resume regular day to day activities including office work. 7. Daily fluctuation in BP and pulse observed till now since 2nd dose of vaccine.
43 2021-06-23 anxiety PATIENT COMPLAINED OF FEELING ANXIOUS. WANTED TO LAY DOWN. LAYED DOWN ON COT AND WAS OBSERVED.
43 2021-06-28 anxiety tired / fatigue; headache; soreness; chest had a weird feeling like pressure, along with some stingi... Read more
tired / fatigue; headache; soreness; chest had a weird feeling like pressure, along with some stinging sensations localized; chest had a weird feeling like pressure, along with some stinging sensations localized; passed out while he was sitting and hit his head that left a bloody scrape; felt dizzy, hot, clammy; felt dizzy, hot, clammy; felt dizzy, hot, clammy; heart rate increased; felt anxious; passed out while he was sitting and hit his head that left a bloody scrape; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old male patient received BNT162B2 (Lot Number: EW0178), dose 1 via an unspecified route of administration, administered in arm right on 11Jun2021 15:00 (at the age of 43-year-old) as single dose for covid-19 immunisation. Medical history included slight heart myopia, high tryglicerides that medicine was keeping at normal levels. No past drug history. Concomitant medication included atorvastatin and fenofibrate. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Within 5 minutes of the injection (11Jun2021 15:05), the patient felt dizzy, hot, clammy, his heart rate increased and felt anxious, then he passed out while he was sitting and hit his head that left a bloody scrape. Then it took about 45 minutes to feel a little better. Then 24 hours later (12Jun2021) the patient really was tired, headache, fatigue, soreness, and his chest had a weird feeling like pressure, along with some stinging sensations localized. The outcome of events felt dizzy, hot, clammy, heart rate increased, felt anxious, passed out while he was sitting and hit his head that left a bloody scrape were recovering, the rest of events were unknown. No follow-up attempts are possible. No further information is expected.
43 2021-06-29 disorientation First four days normal symptoms. Patient started having tremors and shakes. Patient felt somethin in... Read more
First four days normal symptoms. Patient started having tremors and shakes. Patient felt somethin in his lung almost like he had Pneumonia. Patient stated that he would go to sleep and wake up disorientated. patient is experiencing neck stiffness and tightness in his right arm.
43 2021-06-30 feeling abnormal Almost about 1 week after getting second shot of covid-19 vaccine I started feeling weird on right s... Read more
Almost about 1 week after getting second shot of covid-19 vaccine I started feeling weird on right side of my body. Swollen right side of my body specially facial area, which got worse over the period of time. Now main symptoms i am having are tender facial muscles , hoarseness, loss of voice and blurry vision on right side. Symptoms got worse last week.
43 2021-07-03 insomnia Insomnia, chills, body aches, headache (next day, following sleepless night)
43 2021-07-06 impaired work ability I got Bell's Palsy. Over 5 weeks later and still no improvements. Also have severe vertigo from t... Read more
I got Bell's Palsy. Over 5 weeks later and still no improvements. Also have severe vertigo from the Bell's Palsy and cannot work.
43 2021-07-08 sleep disorder About 6 hours after the first dose, I started experiencing ringing in my ears. Mainly I thought it w... Read more
About 6 hours after the first dose, I started experiencing ringing in my ears. Mainly I thought it was the left ear but the fact is both are ringing and the left side is worse. I was panicking and I didn't know what was going on. I went to urgent care three days later and they found nothing that was causing the ringing. They urgent care doctor made a phone call a specialist and she stated that the ringing in the ears is a rare side effect of the COVID vaccine and it should go away. I then went to my primary care doctor and she thought she saw some redness in my left ear and thus prescribed me methylPREDNISolone and an ear drop with the name Ofloxacin. They both did not work. She then prescribed me Azithromycin which also did not work. Since I was not responding to medication, I was diagnosed with tennitus by my primary care doctor. About a week later after the vaccine, I was been experiencing popping in my left ear as well as the noise. But on the right ear, there is only noise. Prior to vaccination, I never had any issue with my ears before. The tennitus is debilitating and life altering in so many ways. I'm still not getting more than four hours of sleep even with melatonin and I'm someone that has never used melatonin or had sleeping issues prior to vaccination.
43 2021-07-26 confusional state Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Med... Read more
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: Patient received vaccine and 10 minutes later, he fainted. We sat with patient until emergency services arrived. Patient reporst history of fainting for the past 10 years and takes no medication. Patient was breathing normally and regained consciousness fully AxO x3 after recovering from fainting. Patient drank water. After emergency services arrived, patient began vomiting under their care. Patient ended up leaving with the emergency crew.
43 2021-07-26 feeling abnormal Dizzy, rapid heart beat, nausea, ended of having a ?zombie like episode? according to my 10 year old... Read more
Dizzy, rapid heart beat, nausea, ended of having a ?zombie like episode? according to my 10 year old daughter who was with me. Apparently I fainted but she described me as twitching and having my hands up and my head to the side with my eyes closed. I can remember a repetitive loop that I was experiencing. It was an image that was distorted and I could not control it and I could not get out of it I could hear my daughter but not control my actions. After I came to a few moments later my legs felt tingly and tired and were shaking like they had the chills. Was advised to go to hospital by EMS Still having very achy joints all over my body. Diarrhea, sweats/chills
44 2021-01-05 disorientation nausea, fatigue, disorientation
44 2021-01-11 agitation extremely bad dry mouth; lips were going numb; facial numbness; rash from his neck to his nipple lin... Read more
extremely bad dry mouth; lips were going numb; facial numbness; rash from his neck to his nipple line; BP was 180/110 / BP stayed around 160/100; felt an "amped" feeling; felt flush; uncomfortable; This is a spontaneous report from a contactable healthcare professional. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), dose number 1, intramuscularly on 21Dec2020 14:00 at a single dose on the right arm for COVID-19 immunization. Medical history included gluten allergy with causes dermatitis herpetiformis, osteoporosis, and fibromyalgia. The patient previously took Benadryl and experienced allergies. Concomitant medications were not reported. The patient reported that immediately after receiving vaccine on 21Dec2020, he felt an "amped" feeling and felt flush. It was uncomfortable but not alarming at first. About ten minutes after shot, he started to have extremely bad dry mouth. He went back to work, but he went back downstairs after feeling like he was getting seriously ill and his lips were going numb. His BP was 180/110. The facial numbness went away but his BP stayed around 160/100. He was asked to go to ER, but he refused because he would have to pay for it and he was feeling better. He also noticed after going back upstairs that he had a rash from his neck to his nipple line. The doctor asked for Benadryl, but he was not given due to possible Benadryl allergy. He went home and his BP returned to normal 2 hours later. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested for COVID-19 since the vaccination. The outcome of the events was recovered in 21Dec2020 for blood pressure increased and facial numbness, and recovered on an unspecified date for the other events. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the BP increased and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. 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.
44 2021-01-12 loss of personal independence in daily activities Fluid collection and discomfort of left axilla, no erythema, hematoma starting approximately 1.5 d... Read more
Fluid collection and discomfort of left axilla, no erythema, hematoma starting approximately 1.5 days after injection and ongoing. Also had low grade temp and dizziness that was self-limiting.
44 2021-01-12 sleep disorder Arm soreness 1st day, 3pm next day body aches, weakness and fatigue, heavy head, fever 102. Next da... Read more
Arm soreness 1st day, 3pm next day body aches, weakness and fatigue, heavy head, fever 102. Next day, still experiencing fatigue and body aches but not as much. 1/12/21 feeling flu type symptoms again body aches, muscle, nausea, chills, severe sweating during night sleeping awoke several times . 1/13/2021 feeling flushed and sweating again while working, stomach cramps, nausea and then vomited x1. Tiredness and extreme fatigue, almost hard to walk, heavy head, chills, fever 100. Has taken Tylenol some relief
44 2021-01-14 impaired work ability vomiting, diarrhea, cramps. called in sick to work.
44 2021-01-23 feeling abnormal On same day of the first Pfizer COVID-19 vaccine, patient developed left facial numbness, left arm a... Read more
On same day of the first Pfizer COVID-19 vaccine, patient developed left facial numbness, left arm and left leg weakness with difficulty negotiating stairs, and left arm > left leg involuntary muscle "spasms." Symptoms have improved, but not totally gone away. Patient also complained of severe "brain fog," and severe left arm tenderness after Pfizer vaccine.
44 2021-01-28 feeling abnormal Fever/a temp of 101; feels something is different; intermittent minimal pain especially when he wake... Read more
Fever/a temp of 101; feels something is different; intermittent minimal pain especially when he wakes up; Tachycardia; His CRP was up a little at 1.1; Nausea; Shortness of breath; Fatigue; Pain at injection site left shoulder; This is a spontaneous report from a contactable physician reporting for himself. A 44-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 28Dec2020, at a single dose on the left shoulder (arm left) for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 28Dec2020. Since receiving the vaccine, he has experienced multiple side effects at varying time points: pain at injection site left shoulder (experienced pain first day of receiving vaccine on 28Dec2020 and couple of days after fever (unspecified date) resolved (on an unspecified date); he was currently experiencing intermittent minimal pain especially when he wakes up; feels something is different; fever (experienced 08Jan2021); fatigue (developed 07Jan2021). He went to the ER on 08Jan2021 when he developed fever, nausea and shortness of breath which also resolved that day. When he went to ER, his CRP was up a little at 1.1. His PCR and antigen test was negative at that time (08Jan2021); a retest of PCR done 5 days after sxs started (unclear of time window) was negative. He was concerned that he had the fever many days after the vaccine. HCP was asking if any cases of fever and fatigue reported after 7 days (around the 10 day mark) of receiving the first dose. He stated that he is planning on taking the second dose. The patient is a physician calling about the Pfizer covid vaccine. He received his first dose on 28Dec2020. He had a little bit of pain in his left arm on same day, but it went away. About 10 days later, 07Jan2021, he had fever and fatigue. On 08Jan2021, he went to the ER with a temp of 101. He had tachycardia, nausea and shortness of breath. He was not admitted, stated his fever was controlled and his breathing was better. His oxygen was 100% and everything was ok and he was sent home. In the ER he had xrays and labs and everything was ok, except his CRP was a bit up. In the ER he had an antigen and pcr covid test (08Jan2021) and they both came back negative. About 4 or 5 days after the symptoms started, he had an outpatient repeat pcr test and nucleic acid rapid test (unspecified dates) and they both came back negative. He is on his way to get his second dose and he is asking if the symptoms could be side effects from the vaccine. Outcome the event fever was recovered on an unspecified date. Outcome of nausea and shortness of breath was recovered on 08Jan2021, while outcome of pain at injection site left shoulder was recovered on 28Dec2020. Outcome of the remaining events was unknown. Information about lot/batch number has been requested.
44 2021-02-28 anxiety Nausea Dizziness / lightheaded Weakness Anxiety
44 2021-03-07 confusional state Arm and hand twitchy, extreme fatigue, double vision, mental confusion
44 2021-03-09 restlessness sore arm; restlessness; Body aches; chills; fatigue; Swollen lymph node under left clavicle; This is... Read more
sore arm; restlessness; Body aches; chills; fatigue; Swollen lymph node under left clavicle; This is a spontaneous report from a contactable consumer (reported for himself). A 44-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: 9262), on Left Arm via an unspecified route of administration on 26Jan2021 13:30 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of PFIZER-BIONTECH COVID-19 VACCINE (Lot no: 3248) on left arm on 07Jan2021 12:00 PM for Covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 10:00 PM No symptoms besides a sore arm and restlessness for first 12 hours. Body aches, chills, fatigue for following 24 hours. Fatigue for an additional 24 hours. Swollen lymph node under left clavicle starting at 36 hours and still present. Outcome of the events was not recovered.
44 2021-03-18 panic attack pt got vaccine and was sitting for observation. Pt thought he was having a panic attack so he put h... Read more
pt got vaccine and was sitting for observation. Pt thought he was having a panic attack so he put his head between his knees, he fainted, hit is head on the floor, and a witness said he was shaking on the floor. The patient came to quickly and said he passed out due to stomach cramps . EMS was on site and did an evaluation. Pt was given ice for his head and had vitals checked and and EKG done. EMS recommended hospital transport but patient refused.
44 2021-03-20 insomnia I have had off and on chills; sometimes fever; body aches; fatigue; tiredness; can't sleep at night;... Read more
I have had off and on chills; sometimes fever; body aches; fatigue; tiredness; can't sleep at night; This is a spontaneous report from a contactable Other HCP. A 44-years-old male patient received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL3302; dose number=2) via an intramuscular on 01Feb2021 at 14:00 at single dose for Covid-19 immunization. Medical history included colitis ulcerative and gastrooesophageal reflux disease (GERD) from an unknown date and unknown if ongoing. Also, the patient had covid-19 prior to vaccination. The patient had allergy to erythromycin. The patient received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EN9581; dose number=1) via an intramuscular on 11Jan2021 at 14:00 at single dose for Covid-19 immunization. Concomitant medications included famotidine, finasteride and omeprazole. As per the adverse event description, on 02Feb2021 01:00 AM, the patient had off and on chills, sometimes fever, body aches, fatigue, tiredness since the second dose. He can't sleep at night, because each night around 2am, he woke up with severe chills. He probably have a fever, but don't tested himself. He took 800mg of Ibuprofen and within an hour to his chills break. That usually lasts till midafternoon. Then he get the chills again, take more ibuprofen and wait for bed. He usually an active person, but have been unable to work out since the shot. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
44 2021-03-27 feeling abnormal Tiredness, body aches, discomfort in lungs, brain fog (15 days, acetaminophen)
44 2021-03-31 feeling abnormal I had shingles. Starting next date I had a poking feeling in my forehead, and head heck for couple d... Read more
I had shingles. Starting next date I had a poking feeling in my forehead, and head heck for couple days guess 3rd day started seeing pimples in forehead and it started developing on my left forehead and until my left eye.
44 2021-03-31 nervousness Unsteady feeling in my head and body, like a shaky feeling and headaches. Been experiencing this for... Read more
Unsteady feeling in my head and body, like a shaky feeling and headaches. Been experiencing this for almost 3 weeks now.
44 2021-04-05 feeling abnormal Tinnitus. Fuzzy, ringing in ears. Tinny hearing. Inner ear inflammation.
44 2021-04-05 feeling abnormal Loss of appetite, malaise, nausea, falls, mental fog, death.
44 2021-04-06 amnesia seizure; I fell of my hight; headache; total amnesia; my waking is wobbly and not steady; This is a ... Read more
seizure; I fell of my hight; headache; total amnesia; my waking is wobbly and not steady; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8727) via an unspecified route of administration, administered in Arm Left on 22Mar2021 12:30, at the age of 44-year-old, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); colecalciferol (VITAMIN D [COLECALCIFEROL]); fish oil (OMEGA 3 [FISH OIL]). On 23Mar2021, at 03:00 AM, the patient fell off his height and had a seizure. This was his first seizure in his life. The patient was rushed to the ED where a CT of the head and neck was done in Mar2021. The CT did not show any bleeding or fracture. The Neurologist dismissed the patient home and had the patient go back and see him in 2 days. The patient has been complaining of headache and taking Tylenol PRN for it. His walking was wobbly and not steady. The patient had a total amnesia of the accident. The patient did not receive treatment for seizure, fall, total amnesia and walking was wobbly and not steady. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID since the vaccination. Outcome the events was not recovered.
44 2021-04-06 sleep disorder With in a few hours of the shot I had pain up and down my right arm, up and down my right side and i... Read more
With in a few hours of the shot I had pain up and down my right arm, up and down my right side and into my shoulder/ neck. I went to home and had a slight fever with chills and could not sleep that night. I called off from work and stayed home. Over the weekend the pain in my neck. shoulder and arm continued. I went to a chiropractor treatment that Tuesday 3/2/21. He made some adjustments and the shoulder / upper arm still did not feel better. My right arm became more numb and weak on Thursday 3/4/2021 . My wife was sitting next me on our couch when I suddenly had a spasm in the upper arm. The next morning I waking and had even more trouble lifting the arm or moving it. I attempted to suffer through it thinking it would get better. Over that weekend conditions with the arm became even worse and was unable to lift it. I returned to chiropractor. He evaluated me and i described what had happened after the second covid shot. He recommend an MRI and I attempted to contact my PCP. With no answer from the PCP i went to the ED who said My PCP would need to order a MRI. I was then sent to physical therapy and Orthopedics. They ordered an X ray and MRI. Both showed nothing. Still seeing physical therapy with some improvement and movement. Have a EMG scheduled for April 22,2021
44 2021-04-07 anxiety Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Sys... Read more
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: ANXIETY-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient drank water as we talked to him. He started to look and feel better after a few minutes. He was able to hold a steady conversation throughout event. Within 5 minutes of being notified of event, patient was scrolling through his phone with no difficulty. We made patient wait for 20 additional minutes while monitoring him and patient stated \"I feel back to normal\" before leaving.
44 2021-04-09 disturbance in attention Fever from 2pm until about 2am. Next day felt OK. Day after that was fatigued with slowed brain func... Read more
Fever from 2pm until about 2am. Next day felt OK. Day after that was fatigued with slowed brain function and mild headache. This lasted about 5 more days.
44 2021-04-09 feeling abnormal Patient received their vaccine at 5:12pm and at 5:15pm felt light headed, sweaty, and spaced out. He... Read more
Patient received their vaccine at 5:12pm and at 5:15pm felt light headed, sweaty, and spaced out. He did not faint, he did get back to baseline after drinking a bottle of water, and resting .
44 2021-04-09 insomnia couldn't sleep one night; have had a tightening in the chest; This is a spontaneous report received ... Read more
couldn't sleep one night; have had a tightening in the chest; This is a spontaneous report received from contactable consumer (patient). This 44-year-old-male patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EN6206) via an unspecified route of administration on 04Mar2021 at 13:30 (at the age of 44-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure and COVID-19 diagnosis on an unspecified date prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included lisinopril and hydrochlorothiazide from unknown dates for unknown indications. On 07Mar2021 at 23:00, the patient could not sleep one night and since had a tightening in the chest. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of couldn't sleep one night and tightening in the chest were not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
44 2021-04-11 feeling abnormal, disturbance in attention Temporary, minor brain fog for a few hours, approximately 18 hours after injection. Noticed when wor... Read more
Temporary, minor brain fog for a few hours, approximately 18 hours after injection. Noticed when working on a simple excel spreadsheet and had trouble concentrating. I was able to complete the task in about 5 minutes with focus. I was back to normal a couple hours later. Would have not realized the brain fog had it not been for the spreadsheet project.
44 2021-04-11 feeling abnormal Following injection, patient reported arm and hand numbness and feeling "dizzy" and stated they "Fel... Read more
Following injection, patient reported arm and hand numbness and feeling "dizzy" and stated they "Felt weird in my head." Patient was given water and noted that they had not eaten anything this morning. Vital signs at 11:30am - Blood pressure :140/80, Heart rate: 80, temperature 99.1, O2 sat: 98% on Room air. EMS was called. Assessed by EMS, vital signs reassessed by RN at 11:43, standing blood pressure: 150/100, heart rate:82, O2 sat: 98%. Patient released by EMS to home with partner driving car. Patient stated "I will be okay"
44 2021-04-11 insomnia I got the Phizer 2nd shot this past Wednesday. 24 hrs later I had the normal symptoms, headaches, fa... Read more
I got the Phizer 2nd shot this past Wednesday. 24 hrs later I had the normal symptoms, headaches, fatigue. Through the weekend things were fairly normal till Sunday night. I had a hard time sleeping and a low grade temperature 99.4. Over night I hoped it would get better but in the morning it got a little worse 100.0. Didn't sleep till 2am. A little bit ago I took my temp again and it's 100.2. I don't have flu type symptoms, just tired and fever. I've been taking Tylenol every 8 hrs or so. Drinking water and resting.
44 2021-04-13 sleep disorder Bad Migraine with sensory issues - sensitivity to sounds, Trouble sleeping, Acidity, Sweating
44 2021-04-19 loss of personal independence in daily activities I have fever, throats scratch, cough, breath with dificulties, body pain, back pain, very very tire,... Read more
I have fever, throats scratch, cough, breath with dificulties, body pain, back pain, very very tire, thirsty, Head pain, congestion, dificulties to function
44 2021-04-20 feeling abnormal Woke up with extreme severe migraine dizziness, vertigo nausea and loud tinnitus! Scalp and face ti... Read more
Woke up with extreme severe migraine dizziness, vertigo nausea and loud tinnitus! Scalp and face tingling. Ear fullness, head pressure, sinus pressure, visual haze, brain fog. Never experienced this in my life! Persisting for weeks and weeks and continues. Still ongoing. Please help!
44 2021-04-21 feeling abnormal Pt became diaphoretic and light-headed 5 minutes after vaccine was administered. He requested water... Read more
Pt became diaphoretic and light-headed 5 minutes after vaccine was administered. He requested water and as I was giving it to him he started to pass out. He was conscious but slightly convulsing. He appeared to have a minor seizure for approximately 5-10 seconds. He was transferred to a wheelchair and sent into our recovery room. As we were transporting him, he had two episodes of vomiting and continued to feel diaphoretic and weak. He rested laying down but was not feeling better. He could not tolerate any water or juice.
44 2021-04-24 disorientation Extreme fatigue; Light dizziness; disorientation; Sore/stiff muscles, particularly lower extremities... Read more
Extreme fatigue; Light dizziness; disorientation; Sore/stiff muscles, particularly lower extremities; Sore/stiff muscles, particularly lower extremities; This is a spontaneous report from a contactable consumer (Patient). A 44-year-old male patient received first dose of BNT162B2 (Pfizer COVID Vaccine, solution for injection, Lot# EN6202), via an unspecified route of administration, administered in left arm on 23Feb2021 at 05:00 AM (at the age of 44-years) as single dose for COVID-19 immunisation. Medical history included sleep apnea, headache and CALM supplement. The patient had no known allergies. Concomitant medication(s) included naproxen sodium for headache. On 23Feb2021 at 06:15 (1-hour and 15-minutes after vaccination), patient experienced extreme fatigue, light dizziness, disorientation, sore/stiff muscles, particularly lower extremities. The patient had not taken any other vaccine four weeks prior vaccination. The patient not had COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.
44 2021-04-26 anxiety 44 year old male, while in post-vacc recovery area, c/o diaphoresis, feeling anxious, wiping sweat ... Read more
44 year old male, while in post-vacc recovery area, c/o diaphoresis, feeling anxious, wiping sweat from brow and forehead. Initial vitals: 144/80, 60, 20. Encouraged to do breathing exercises to assist with relaxation. Remained seated, upright. Second set of vitals at 0850: 11/60, 60. Reassessment of client- clam, no s/s of distress. Final set of vitals at 0905: 110/78, 60. Discharged from clinic at 0906, unassisted.
44 2021-04-26 sleep disorder, disturbance in attention nausea, headache, fatigue on 4/19/21. He begin having difficulty concentrating today, 4/20/21 and ad... Read more
nausea, headache, fatigue on 4/19/21. He begin having difficulty concentrating today, 4/20/21 and admits to sleeping poorly last night. He has not taken anything for his symptoms. It was advised for him to obtain quality restful sleep tonight, take multivitamin with D and C, APAP/NSAID for pain/fever, drink plenty of fluids. 4/21-Woke up this morning feeling better after a restful nights sleep. He did not take anything for his symptoms and his symptoms resolved completely.
44 2021-04-28 restlessness, delirium Delirium; Severe fever 102+; Aches; chills; Restlessness; Headache; Weakness; This is a spontaneous ... Read more
Delirium; Severe fever 102+; Aches; chills; Restlessness; Headache; Weakness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration administered in arm right on 14Apr2021 09:30 AM (Lot Number: EW0158) at vaccination age of 44 years old as single dose for covid-19 immunisation. Medical history included hypertension, high cholesterol, Cephalosporin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications within 2 weeks of vaccination included atorvastatin calcium (LIPITOR) taken for blood cholesterol increased; tadalafil (CIALIS). The patient previously took 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EN6206) via an unspecified route of administration administrated in Left arm on 24Mar2021 at time of 09:45 AM at vaccination age of 44 years old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe fever, 102+, aches, chills, delirium, restlessness, headache, weakness on 14Apr2021 at time of 11:00 PM. No treatment received for the adverse event. The patient underwent lab tests and procedures which included body temperature: greater than 102 fahrenheit on 14Apr2021. The outcome of events was recovering. Since the vaccination, the patient had not been tested for COVID-19.
44 2021-05-01 anxiety Anxiety attacks began after taking the vaccine. Never had anxiety before getting the vaccine.
44 2021-05-03 feeling abnormal, mental impairment, emotional distress Adverse event occurred Friday February 5th around 1430hours, I began to feel "not right" Having bee... Read more
Adverse event occurred Friday February 5th around 1430hours, I began to feel "not right" Having been in mental health services and care for a number of years, I naturally am and have developed great self-awareness of my condition. I began to feel a developing despair and decline to overall mental function. As if a switch had been turned in my brain, and it became more difficult to focus. Myself and others close to me started to notice that I would space out and kind of shut down at random moments without regard to what was currently going on around me. I must note that I did not have anxiety related to receiving the vaccine, even after becoming ill after the first dose. I cannot get back to my baseline level of functioning (mentally), and I struggle every single day (some worse than others) to focus, be productive, stay connected to those around me, and sometimes just stay on track getting through the day. I understand "battle-fatigue" and this long, on-going pandemic and it's toll of myself and others around me. I am an infection preventionist, during the pandemic, in an acute care hospital, being only in my role for a year when it all hit. Absolutely something occurred after receiving the vaccine. I have waited this long to help rule-out other potential causes, and to see if things would get better. I feel broken, though things are not getting worse, I cannot get back to where I was.
44 2021-05-05 feeling abnormal May 1 18:15 dose 2 of vaccine received. No immediate adverse effects. Shot hurt less than first one.... Read more
May 1 18:15 dose 2 of vaccine received. No immediate adverse effects. Shot hurt less than first one. May 2 09:00 woke up with severe muscle soreness, joint pain, mental fog, extreme fatigue and a slight temp. Took Advil and went back to sleep. Didn't get out of bed majority of the day due to continued fatigue and muscle soreness and joint pain. May 3 went to work with continued mental fog, extreme fatigue, muscle soreness (still everywhere), and joint pain. Continued taking Advil to keep working. Condition did not get better at all throughout this day. May 4 woke up with mental fog lifted, fatigue gone, however; the muscle soreness and joint pain continued... but ONLY from my lower back all the way down both legs. I have never felt anything quite like this before. Continued to take Advil to deal with the pain May 5 aching and pain still present in lower back and both legs May 6 aching and pain still present and annoying in lower back and both legs and is not getting better. At this point I'm concerned as I was completely healthy before receiving the second dose of the vaccine with ZERO health problems and ZERO pain. Please tell me what is going on and if this will pass with time. I was healthy before and want to be healthy again. I'm dealing with the pain and will not miss work if I can help it. My wife is a pharmacist and insisted I get the vaccine.
44 2021-05-10 impaired work ability Vision and gait disturbances began 4/9/21, progressively worsened and he began nausea/vomiting 4/11/... Read more
Vision and gait disturbances began 4/9/21, progressively worsened and he began nausea/vomiting 4/11/21, requiring ER visit on 4/12/21 then hospitalization for 5 days. Comprehensive labs done. Follow-up advised with Dr. (has not occurred). Per Dr. (Neurology), do not get second dose of Covid-19 vaccine as there is a chance the vaccine contributed to development of these symptoms. Doctor said it could possibly be Guillain-Barre Syndrome. As of 5/11/21, significant vision impairment still exists and patient is unable to work. Patient is uninsured.
44 2021-05-13 mental status changes Patient is a 44 y/o gentleman with acute renal failure, elevated BNP and LE edema. Pulmonary consult... Read more
Patient is a 44 y/o gentleman with acute renal failure, elevated BNP and LE edema. Pulmonary consulted for medical management. Thrombocytopenia: - plt count stable today, Hgb stable - hematology consulted, appreciate recs: plan to send for serum antibodies to test for drug induced thrombocytopenia for carbamazepine and valproic acid - will hold protonix as possible offender - peripheral smear (Mercy OKC, 5/8/21): macrocytic red blood cells, moderate thrombocytopenia, rare focal platelet clumping present - less likely vaccine induced TCP---usually this is seen with the AstraZenca and Johnson and Johnson vaccine, not in Pfizer vaccine - if plt remains stable, may d/c home with plan for f/u with Dr outpt COVID-19: - case discussed with Health Department, COVID test for variant testing sent 5/6 - for now, will cont care in isolation - patient with positive COVID-19 test - positve COVID-19 test in January 2021, negative COVID-19 screen in April 2021 - pt with no active respiratory sx AMS: unchanged - waxing and waning mental status - improved AMS with improved renal fxn Acute renal failure: improving - Cr: 1.64, cont PO intake LE edema: - unchanged, low albumin levels, need to increase protein intake Chronic systolic heart failure: stable - cont to hold diuresis Disposition: - cont care in COVID unit, Pulmonary to follow Estimated length of stay is 5 day(s).
44 2021-05-14 feeling abnormal I had a 102.5 degree fever off and on for two days; severe body aches; chills; headaches; injection ... Read more
I had a 102.5 degree fever off and on for two days; severe body aches; chills; headaches; injection site soreness; redness; skin sensitivity; brain fog; hot flashes; fatigue; swollen lymph nodes (left armpit); This is a spontaneous report from a contactable other hcp. A 44-year-old male patient reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9268), via an unspecified route of administration, administered in Arm Left on 12Feb2021 14:00 (at the age of 44-year-old) as 2nd dose, single for COVID-19 immunization. Medical history included migraines. Patient had no known allergies. Patient had not covid prior and post vaccination. Concomitant medication(s) included ibuprofen (ADVIL LIQUI GELS); acetaminophen (ACETAMINOPHEN). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 26Jan2021 02:45 (at the age of 44-year-old) as 1st dose, single for COVID-19 immunization. The patient stated that on 13Feb2021 02:00, he had a 102.5 degree fever off and on for two days, severe body aches, chills, headaches, injection site soreness, redness, skin sensitivity, brain fog, hot flashes, fatigue, and swollen lymph nodes (left armpit). Patient did not received any treatment for the events. The outcome of the events was reported as recovering. Follow-up attempts have been completed and no further information is expected.
44 2021-05-16 impaired work ability, excessive sleepiness Severe body ache, chills, sweating, nausea, and vomiting. Vomited 9 times in a row and spent the ent... Read more
Severe body ache, chills, sweating, nausea, and vomiting. Vomited 9 times in a row and spent the entire night with a bucket. For the next week every morning, diarrhea and unsettled stomach, lack of energy, excessive sleep, no ability to exercise without severe fatigue or a return of digestive problems. This lasted a week. Sexual activity also impossible, erection quality greatly reduced. Many of these symptoms got better but have now returned with my second dose. Second dose has given me significant fatigue, digestive problems again, diarrhea, and reduced erection quality once more. I hope these problems resolve themselves. The vaccine has made going to work very difficult and I will seriously reconsider taking any vaccine in the future.
44 2021-05-18 hallucination possible hallucinations; severe chills; severe back spasm; nausea; dizziness; the lymph node under m... Read more
possible hallucinations; severe chills; severe back spasm; nausea; dizziness; the lymph node under my right arm (the arm that was injected) was swollen to the size of a softball.; This is a spontaneous report from contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EP7533) via an unspecified route of administration, administered on the right arm on 30Apr2021 09:15 (Batch/Lot Number: EP7533) as unknown, single for COVID-19 immunization. The patient had no medical history. Concomitant medication included ascorbic acid, betacarotene, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine, tin, tocopheryl acetate, vanadium, vitamin k nos, zinc (CENTRUM MEN). The patient had severe chills, severe back spasm, nausea, dizziness, possible hallucinations, and the lymph node under my right arm (the arm that was injected) was swollen to the size of a softball on 30Apr2021 07:00 PM. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Outcome of the events was recovering.
44 2021-05-20 feeling abnormal Fatigue, back pain, joint pain, lack of mental acuity
44 2021-05-20 sleep disorder This is a 44 M with NIDDM, HTN, HLD, Schizophrenia here with c/o fever and generalized body aches fo... Read more
This is a 44 M with NIDDM, HTN, HLD, Schizophrenia here with c/o fever and generalized body aches for about 7-8 days. Says was having body aches for about 8 days, had COVID 19 vaccine first dose on 5/14/21. Since then, had worsening body aches and also started having fever(not sure how much). Urine color changed to brown in the past week. No change in appetite or nausea or vomiting prior to admit as per him. No new medications and does not consume recreational drugs. Not an alcoholic, no recent trauma, does not work out and was not exposed to extreme heat or cold recently. In ER, patient was found to having AKI, shock liver, CK level which is too high to be calculated, had 1 episode of high-grade fever. He was therefore started on IV fluids and admitted for further management of rhabdomyolysis. Overnight had no urine output and having poor urine output since this a.m.. Had 1 episode of nausea and vomiting this morning. No more fever since on the floor. Complaining of epigastric pain that woke him up from sleep this afternoon.
44 2021-05-25 anxiety the first 36 hours was normal pain with flu type symptoms, now there's vision changes and I had to g... Read more
the first 36 hours was normal pain with flu type symptoms, now there's vision changes and I had to go to the ER because it was really bothering me. They only helped with the anxiety and did an eye exam. It seemed to have gone away some but now it's coming back and it's like having dirty contacts in and having hypersensitivity to light and dark textures.
44 2021-05-27 anxiety Patient experienced apprehension, flushing and numbness and tingling. Patient verbalized "Throat ti... Read more
Patient experienced apprehension, flushing and numbness and tingling. Patient verbalized "Throat tightness" and elevated BP even though pt reports being on BP medications. O2 sat and pulse remained normal. Lungs CTA. Patient has a history of reactions to bee stings. Pt was given 50mg Diphenhydramine observed by staff and released
44 2021-06-01 restlessness, insomnia rash on arms; little restless; noticed how sore his arm was/pain in his arm; trouble sleeping/proble... Read more
rash on arms; little restless; noticed how sore his arm was/pain in his arm; trouble sleeping/problems with sleep; felt movements in his chest at times; felt like he had COVID all over again/ if he possibly has COVID-19 again; soreness; heart rate accelerated; some swollen in lymph nodes; This is a spontaneous report from a contactable pharmacist (patient) via a Pfizer sponsored program. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 at around 13:00 or 13:30 (at the age of 44 years old) (Lot Number: EP7534, unknown expiration) as 1st dose, single for COVID-19 immunisation. Medical history included COVID-19 in Nov2020; sneezing and runny nose both on 21Mar2021. The patient's concomitant medications were not reported. The patient reported that he received his first dose of Pfizer COVID vaccine on 22Mar2021. He felt fine after receiving the vaccine, but there was little bit rash on arms just afterwards and felt maybe a little restless but felt fine and went for a walk on 22Mar2021. As the night went on, he really noticed how sore his arm was/pain in his arm and when he was sleeping, he had trouble sleeping/problems with sleep (Mar2021) and felt movements in his chest at times (Mar2021). It felt like he had COVID all over again and had chills, soreness, and his smell was kind of gone in Mar2021. He was previously feeling pretty good. He had COVID-19 in Nov2020, and his symptoms feel very similar including loss of sense of smell but no coughing. He had a fever but that has gone away in Mar2021 and he did not take aspirin or anything for it. He also had fatigue, some swollen in lymph nodes, and his heart rate accelerated in Mar2021. He had sneezing and runny nose the day prior to receiving the vaccine. The patient would like to know if his symptoms are related to the vaccine or if he possibly has COVID-19 again. His symptoms are the same as COVID as far as what he can see, and his symptoms are really high. He would like to know if he can still receive the second dose of the vaccine if he has a positive COVID test after the first dose of the vaccine. The patient mentioned that there was very pretty high percentage of people having the symptoms after having the vaccine, kind of virus "causing". The patient asked if he needs to be tested to see if he had the virus before he was vaccinated and to know if these are one of the side effects or one of the symptoms of the virus, and to make sure that these are not actually corona virus. The patient recovered from fever in Mar2021, while unknown outcome for the remaining events. No follow-up attempts are possible. No further information is expected.
44 2021-06-02 abnormal behaviour About a week and half to two weeks after getting the shot, I had a short (3-4 days) but severe spike... Read more
About a week and half to two weeks after getting the shot, I had a short (3-4 days) but severe spike in the symptoms of my ongoing mental health issues. Symptoms of the spike included wild mood swings, VERY strong emotional reactions to otherwise manageable situations, and very erratic, even reckless, behavior. I can't remember ever having symptoms this severe before. No other source for the symptoms could be identified.
44 2021-06-17 anxiety Throat/tongue and neck area swelling for about an hour. Anxiety and some dizziness. Problem began a... Read more
Throat/tongue and neck area swelling for about an hour. Anxiety and some dizziness. Problem began about half hour after injection then went away after an hour or so after it began - but my doctor recommended that I do not to get second shot because of this reaction.
44 2021-06-18 feeling abnormal Since the day after my first injection (4/3) I have had a constant headache. Every single day since ... Read more
Since the day after my first injection (4/3) I have had a constant headache. Every single day since that headache has not left. It varies in intensity, it is generally the worst in the morning and evening or at least I block it out enough to do my job. Pain is in the back of my head/upper neck, in front of my ears on the sides of my head, sometimes I also get it on the crown of my head. I have also been nauseous pretty much every day since then. I have vomited once. Nausea is worst in the mornings. Occasionally I feel like I have a concussion, hard to describe that feeling.
44 2021-06-22 sleep disorder Altered sense of taste and smell. Things tasted different. I had a very dry mouth as well. I also sm... Read more
Altered sense of taste and smell. Things tasted different. I had a very dry mouth as well. I also smelled things that were not there. I lost my sense of smell 10 years ago due to sinusitis. I experienced lethargy about 5 days after the shot up to 4 weeks after. I had some tightness in my chest, my albuterol inhaler helped with that. The tingling in my hand and feet happened on a few occasions. I had numbness that lasted about an hour. I had frequent night sweats that woke me. I had muscle tightness in my leg and abdomen. I also had soreness in my arm, which made it hard to grasp a pen. I did test my reflexes which were normal.
44 2021-06-29 fear Approximately one month after my second shot, beginning around 5/20, I began to lose the sense of ta... Read more
Approximately one month after my second shot, beginning around 5/20, I began to lose the sense of taste on the right side of my tongue. I thought it would go away but by 5/23 I had partial paralysis on the right side of my face. Fearing a stroke I went to the ER and after a full battery of tests I was diagnosed with Bell's Palsy. The symptoms worsened for a few days and I was unable to close my right eye, had difficulty breathing out of my right nostril and both eating and drinking were difficult because my lips would not close fully. The symptoms stabilized and then finally began to improve after steroid and antiviral treatment for a week, then on to regular aspirin.
44 2021-06-30 sleep disorder Interrupted his sleep; Stuff in his throat/weird stuff on his throat; Cough; weird stuff on his thro... Read more
Interrupted his sleep; Stuff in his throat/weird stuff on his throat; Cough; weird stuff on his throat; Rapid heart rate; really bad chest pains; vomit; nausea; gasping for air; Neck spasms; Blood pressure, clarified as low blood pressure; It was like he was catching pneumonia but then his nose was running,; severe congestion, like bad stuff in his chest and lungs; severe allergies; tired; he got really sick; It was like he was catching pneumonia but then his nose was running,; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team and from a Pfizer sponsored program. A 44-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0167, Expiry date: UNKNOWN, NDC number: Unknown), via an unspecified route of administration at the right arm on 29May2021 11:15 as a SINGLE DOSE for covid-19 immunization. Medical history included myocardial infarction from an unknown date and unknown if ongoing, illness from Feb2020 to an unknown date, whole family was sick in February, palpitations from an unknown date and unknown if ongoing. History and investigation included "he said he had nothing to add during that time. But about a year ago he had gone to the emergency room for a heart attack scare. he thought, because this was when COVID first started happening, his whole family was sick in February and they would not test them at that time because they had not been to China and they never found out if they had it but he ended up getting tested for COVID when he was sick like 6 months later and then that went away and he started having heart palpitations and then after that he thought he would get a COVID antibody test and that came back negative, they told him by the time he got the antibody test, they told him he could have had it but it is not showing up on their antibody rapid test thing. He confirms this all occurred last year in 2020, he thinks it was almost a year ago. He would be sitting on the couch and his heart started racing like crazy. He did not know what that was all about". He said he had no discomfort at all. Concomitant medications were not reported. On an unspecified date in 2021 patient experienced it was like he was catching pneumonia but then his nose was running, neck spasms, blood pressure, clarified as low blood pressure, tired, he got really sick, severe congestion, like bad stuff in his chest and lungs, it was like he was catching pneumonia but then his nose was running, on an unspecified date in 2021 severe allergies, on 29May2021 rapid heart rate, really bad chest pains, stuff in his throat/weird stuff on his throat , cough, on an unspecified date in May2021 vomit, nausea, on an unspecified date in May2021, gasping for air, on an unspecified date interrupted his sleep. Caller received his first dose and was experiencing symptoms such as rapid heart rate and neck spasms and blood pressure. He was too tired to go to the emergency room. He had the weird cough and also stated he had weird stuff on his throat and severe allergies. Regarding his second dose, he wanted to receive but he wanted to know if he could receive a half dose. He also had really bad chest pains and he was going to go to the emergency room but he was too tired to even go. The other reason for calling, he was trying to find out because he was afraid to take the second dose, he wanted to know if he could take a half dose or something, he was trying to find out what he should do. Severe allergies, caller clarified it was like severe allergies or like hay fever kind of, but it was different. Rapid heart rate: He said this began happening the same day as the dose was given, 29May2021, 4 hours after he got the shot. It was not ongoing, it lasted about a day. The rapid heart rate went away the next morning, it stopped doing the crazy things it was doing the next morning, 30May2021. He confirmed that has recovered completely. The chest pain coincided with the rapid heart rate. It went way the same time as the rapid heart rate. It seemed like they both would come and go until the next morning, He confirmed that had recovered completely. He said then the low blood pressure was going on too. It was like it interrupted his sleep, he did not know how to explain it, like he had low blood pressure or like his heart would stop beating and he would wake up gasping for air. It was kind of like a nauseous feeling, he wanted to vomit. It happened with the low blood pressure and was mostly when he was sleeping and a little through the day, the nausea he means, it lasted about a day and a half. The nausea went away on the 30May or the 31May he cannot remember for sure. The cough and stuff in his throat began at the same time the heartbeat stuff started and the cough went away after 2 days. He felt pretty good for about 3 days and then he got really sick, with severe congestion, like bad stuff in his chest and lungs. It was like he was catching pneumonia but then his nose was running, it felt weird like a sickly poison kind of feeling like after he got the shot, he could not tell but it seemed like severe allergies or like hay fever kind of but it was different, it was a weird feeling. He had taken a bunch of herbal remedies Benadryl took herbal allergy stuff and it worked really fast and after like 3 days it was gone. He does not know what that was but it was pretty intense. No further information provided. It was reported that, caller got his first dose of the Pfizer Covid-19 vaccine on 29MAY2021 and had side effects. He wanted to know if he could get only a half dose of the COVID-19 vaccine. He also wanted to know if there was any correlation to having COVID-19 and having more of a reaction. Caller wanted to know if there was a correlation between having COVID-19 and having more side effects to the vaccine. He stated that his Pharmacist said there might be a correlation to people having COVID before getting the vaccine and having more problematic side effects from the first vaccine instead of the second. Response was given as "he should not get the Pfizer-BioNTech COVID-19 Vaccine if he had a severe allergic reaction after a previous dose of the vaccine or if he had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. He was referred to speak to healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Healthcare provider would have known the health situation and could access to information that better help inform the decision. From the CONS document on efficacy. Two shots were generally needed to provide the best protection against COVID-19 and the shots were given several weeks apart. The first shot primes the immune system, helping it recognize the virus, and the second shot strengthens the immune response. Side effects after the second shot might be more intense than the ones experienced after the first shot. The side effects are normal signs that body is building protection and should go away within a few days". The patient underwent lab tests and procedures which included sars-cov-2 antibody tested negative. Therapeutic measures were taken as a result of severe allergies (drug hypersensitivity). He visited emergency room due to the event chest pain. On an unspecified date in 2021 the outcome of the events it was like he was catching pneumonia but then his nose was running, neck spasms, blood pressure, clarified as low blood pressure, tired, he got really sick, severe congestion, like bad stuff in his chest and lungs, it was like he was catching pneumonia but then his nose was running was unknown, on an unspecified date in 2021, severe allergies was recovered, rapid heart rate, really bad chest pains, cough was recovered on 30May2021, on an unspecified date in May2021 vomit, nausea was recovered, gasping for air, interrupted his sleep and stuff in his throat/weird stuff on his throat was unknown. Information on the lot/batch was available, Additional information has been requested.
44 2021-07-01 anger Pt stated that in addition to the expected side effects of the vaccine, he experienced extreme anger... Read more
Pt stated that in addition to the expected side effects of the vaccine, he experienced extreme anger and rage for about3 days after the vaccine. The anger resolved after that period and the proximity of the anger to the vaccine made him feel the two were related.
44 2021-07-01 disturbance in attention Headache, congestion, aches and pains, joints, loss of energy, Concentration, loss of testosterone, ... Read more
Headache, congestion, aches and pains, joints, loss of energy, Concentration, loss of testosterone, chest pain, heart
44 2021-07-02 agitation Throbbing in my head as if to start a headache, shortness of breath, pressure in the chest, dizzines... Read more
Throbbing in my head as if to start a headache, shortness of breath, pressure in the chest, dizziness, fluttering of the heart, feeling agitated.
44 2021-07-15 irritability Hard lump in left arm near injection site. Swollen lymph node. Slight fever. Irritability. Tiredness
44 2021-07-23 feeling abnormal, sleep disorder Beginning the second day following vaccination to current day, I have the following symptoms: a st... Read more
Beginning the second day following vaccination to current day, I have the following symptoms: a stiff neck, severe headache, brain fog, and highly disturbed sleep.,
44 2021-07-27 nervousness, insomnia Hypertension; Tiredness; Weakness; losing some muscles; He is also experiencing muscle deterioration... Read more
Hypertension; Tiredness; Weakness; losing some muscles; He is also experiencing muscle deterioration (no muscle pain); he's been feeling a light body (not hard to move); elevated liver enzymes; he told him he doesn't get enough sleep; nervous; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration on 22Apr2021 (at the age of 44-year-old) as dose 2, single for covid-19 immunisation. Medical history included, hypertension from 29Apr2021 to an unknown date, glucose tolerance impaired from 2010 to an unknown date Verbatim: Prediabetes, haemorrhoids from 09Mar2021 to an unknown date Verbatim: Hemorrhoids, hypovitaminosis from an unknown date and unknown if ongoing, asthenia from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (TYLENOL) taken for haemorrhoids, pain, start and stop date were not reported; ascorbic acid, biotin, folic acid, iron, nicotinic acid, pantothenic acid, pyridoxine, riboflavin, vitamin b1 nos, vitamin b12 nos, vitamin e nos (CENTRUM ADULT B+ IRON) taken for hypovitaminosis from an unspecified start date and ongoing; ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]) taken for covid-19 immunisation from an unspecified start date and ongoing; vitamin b complex (VITAMIN B) taken for asthenia from an unspecified start date and ongoing. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration on 01Apr2021 (at the age of 44-year-old) as dose 1, single for covid-19 immunisation. On 25Apr2021, patient experienced losing some muscles, 0n 26Apr2021, patient experienced weakness, on 27Apr2021, patient experienced tiredness, on 29Apr2021, patient experienced hypertension. on an unspecified date in 2021, patient experienced muscle deterioration, he's been feeling a light body, elevated liver enzymes, he told him he doesn't get enough sleep, nervous. The patient underwent lab tests and procedures which included aspartate aminotransferase: 28 on 22Sep2020 Normal, aspartate aminotransferase: 46 on 30Apr2021 slightly elevated, blood test: elevated liver enzymes on 30Apr2021. Therapeutic measures were taken as a result of hypertension included losartan 25mg. The outcome of the events losing some muscles, tiredness, weakness were not recovered and the outcome of the remaining events were unknown.
45 2020-12-31 feeling abnormal LEFT HAND NUMBNESS, FEELS DIFFERENT. 97.8, 118/77, 80
45 2021-01-06 feeling abnormal I am an anesthesiologist reporting my own event: injection received 0900. At 1400 I began low grade... Read more
I am an anesthesiologist reporting my own event: injection received 0900. At 1400 I began low grade fever and not feeling well. By 1600 I had extreme fatigue and severe mental fogginess. This fogginess lasted approximately 24 hours. Other reactions included chills, fever, myalgia, arthralgia, headache as expected. I feel the mental effects could put patients in danger if healthcare practitioners are not aware of the possibility of this and receive the vaccine while on duty. I did not experience this with the first dose.
45 2021-01-06 nervousness Patient received vaccination approximately at 10:45 am, he had told immunizer he had felt nervous ... Read more
Patient received vaccination approximately at 10:45 am, he had told immunizer he had felt nervous and had fainted previously with other vaccinations. Patient was monitored after vaccination patient said he felt dizzy, approximately 11:15 am he feel forward from chair and was attended to by staff. EMTs were called and patient was taken to hospital for observation. After vaccination pt had blood pressure readings of 130/80 5 min after 150/80 15 minutes after his blood sugar readings reported by family member on scene were 325 the previous evening and 255 the morning before he came in. EMTs took a blood sugar reading 365 upon their arrival.
45 2021-01-08 feeling abnormal Mild Fuzzy head, light headed Narrative: occurred for only that night after the vaccine
45 2021-01-09 feeling abnormal Increased bp, diaphoretic, skin turned red, pins and needle sensation, increased heart rate , swoll... Read more
Increased bp, diaphoretic, skin turned red, pins and needle sensation, increased heart rate , swollen lower lip, nauseated, weird sensation of not feeling right almost like out of body
45 2021-01-10 feeling abnormal He developed episodes of vertigo like dizziness, allong with feeling like he was going to pass out,... Read more
He developed episodes of vertigo like dizziness, allong with feeling like he was going to pass out, feeling unsteady, sweaty, nauseated. They would last for about less than a minute, but he had several episodes. He had pulsatile tinnitus. He also had an elevated LFT.
45 2021-01-13 feeling abnormal Pfizer-BioNTech COVID-19 Vaccine EUA - I woke up in the middle of the night sweating, and felt tired... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA - I woke up in the middle of the night sweating, and felt tired the next morning with slight brain fog. Otherwise, I felt fine.
45 2021-01-17 sleep disorder, insomnia Starting from the first night after the vaccination and each and every night after that to date of t... Read more
Starting from the first night after the vaccination and each and every night after that to date of this form completion, I have had extremely interrupted sleep. I have woken up several times in the middle of the night (i.e., 2 am, 4 am, etc..). Each time I have woken up and felt wide awake and difficulty going back to sleep. As a consequence each of the following days after this poor sleep I have been in extreme fatigue and not able to function properly. I do not have any other notable side effects. No fever or major headaches. This disturbed sleep which coincidentally started right after the vaccination is highly concerning for me, especially since it has happened on 4 consecutive nights. This has not happened to me before. In the past even if I woke up in the middle of the night, I would fall back asleep relatively quickly. Furthermore, it has not been the case of this type of lack of sleep for this many consecutive nights. Another observation is that my feeling of hunger seems to have increased for some reason. Even in the middle of the night when I wake up I have felt great hunger and then starting in the morning that hunger continues. This is more hunger than normal for me. My diet and eating patterns have not changed compared to what it was before getting the first dose of the vaccination. Given that today is Martin Luther King Day and a Holiday my PCP is closed, so could not make an appointment or report this to her. I will call my PCP again tomorrow, 01/19/21. If this disturbed sleep continues, then I am sure how I can properly function during a normal work day on the job. Given all the above I am also concerned about the second dose of the vaccination and what side effects that may result in.
45 2021-01-18 feeling abnormal feeling bad; 100 degree fever; chills; body aches; headache; This is a spontaneous report from a con... Read more
feeling bad; 100 degree fever; chills; body aches; headache; This is a spontaneous report from a contactable nurse. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number CH9899), via an unspecified route of administration from 11Jan2021 08:30 to 11Jan2021 08:30 at a single dose for covid-19 immunization. The patient's medical history was not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) On 21Dec2020 at first dose. Concomitant medication included melatonin. It was reported that the patient feeling bad after injection, got 100 degree fever, chills, body aches and headache; all on 11Jan2021 16:00. Took aspirin to reduce side effects but headache remains. The outcome of the event headache was not recovered while recovering for the other events.
45 2021-01-24 motion sickness Motion sickness, and fatigue started about 11am; Motion sickness, and fatigue started about 11am / s... Read more
Motion sickness, and fatigue started about 11am; Motion sickness, and fatigue started about 11am / slept for 3 hours woke to just severe fatigue; Headache started about 6 hours after, progressively worsening about 12hrs; This is a spontaneous report from a contactable consumer (patient). This 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EH9899), via an unspecified route of administration at single dose in the left arm on 11Jan2021 14:00 to for Covid-19 immunisation. Medical history included was none. Concomitant medication included fluticasone propionate and multi vitamin. The patient experienced headache started about 6 hours after, progressively worsening about 12hrs on 11Jan2021 20:00, motion sickness, and fatigue started about 11am on 12Jan2021. Completely wiped out by noon and had to lay down could not work slept for 3 hours woke to just severe fatigue, slight headache no nausea. Therapeutic measures were taken as a result of headache included Advil but no help. No treatment received for the other events. The vaccine was administered at Workplace clinic. 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 had not been tested for COVID-19 since the vaccination.
45 2021-01-25 feeling abnormal brain is still in a fog; received the first dose of the Pfizer COVID Vaccine and then 2 weeks later ... Read more
brain is still in a fog; received the first dose of the Pfizer COVID Vaccine and then 2 weeks later got COVID again; received the first dose of the Pfizer COVID Vaccine and then 2 weeks later got COVID again; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140 and expiry date: Mar2021), via an unspecified route of administration on 19Dec2020 at single dose for Covid-19 immunization and tetanus vaccine (manufacturer unknown) via an unspecified route of administration on unspecified date at single dose for immunization. Medical history included COVID diagnosed in Mar2020. Concomitant medication was not reported. The patient received the first dose of the Pfizer COVID Vaccine and then 2 weeks later on 05Jan2021 got COVID again. He wanted guidance as to when he can get the second dose of the vaccine. His vaccination provider refused his second dose and the 21-day interval has passed. He was tested for COVID on 05Jan2021 and was positive. The patient said that his brain is still in a fog on unspecified date. He is normally not this cloudy. It was also reported that around the same time he got a Tetanus shot, and he can not remember which one was given in which side. The outcome of the events was unknown.
45 2021-01-27 sleep disorder Days after receiving first shot, would wake up within 2 hours of falling asleep with a sharp headach... Read more
Days after receiving first shot, would wake up within 2 hours of falling asleep with a sharp headache on left side of head. Would sit up and move around and headache would dissipate with 30 minutes. Am not able to lay on back or on side. Received booster on 1/26/2021 and have had same events. OTC pain killers are not working. Once I initially wake up I move to recliner and fall asleep. We have a sleep number bed and have not had this issue in the past, although don't know if it is the vaccine or a unknown subtle change in day to day activities.
45 2021-01-30 confusional state approximately 30 minutes after injection of shot, felt dizzy, confusion, face and throat swelling, ... Read more
approximately 30 minutes after injection of shot, felt dizzy, confusion, face and throat swelling, rapid heart rate, feeling on the verge of passing out. Was driving home at the time and pulled over to call 911. 3 to 4 minutes of very intense reactions, had initial difficulty calling 911 and driving off the road to pull over. Paramedics arrived 10 minutes after the initial call to 911, symptoms had improved greatly after 3 to 4 minutes and after 10 was starting to feel back to normal.
45 2021-02-04 feeling abnormal Patient finished observation period and went to his car 50 minutes post vaccine where he then starte... Read more
Patient finished observation period and went to his car 50 minutes post vaccine where he then started feeling tingling to tongue and fat and fuzzy feeling. Returned to site - received Benadryl IM with good resolve. DC'd home to care of friend for further observation.
45 2021-02-06 impaired work ability Symptoms began 12 hrs after injection and lasted for 24 hrs from onset of symptoms. Sore deltoid/ine... Read more
Symptoms began 12 hrs after injection and lasted for 24 hrs from onset of symptoms. Sore deltoid/inection site, chills, body aches, fatigue, mild headache, max recorded oral temp = 99.6 degrees (personal norm 96-97 degrees oral). Out of work x1 day due to COVID-19 screening/symptom algorithm.
45 2021-02-07 impaired work ability, loss of personal independence in daily activities Local nerve injury/significant numbness and weakness in his upper extremities specifically in his le... Read more
Local nerve injury/significant numbness and weakness in his upper extremities specifically in his left deltoid muscle, affects his ability to perform usual work; At the time of vaccination he experienced discomfort in left deltoid which was the injection site; Cannot lift his arm greater than 45 degrees; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle; Developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle; This is a spontaneous report from a contactable pharmacist. A 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular n deltoid left on 09Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. At the time of vaccination he experienced discomfort in left deltoid which was the injection site, cannot lift his arm greater than 45 degrees, local nerve injury, systemic fatigue ,myalgia and other arthralgia for 24-36 hours, developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle, affects his ability to perform usual work or task, all in Jan2021 with outcome of unknown. He called the employee health on 17Jan2021 and 19Jan2021 he saw a neurosurgeon. The neurosurgeon didn't think it was a cervical spine injury rather a local nerve injury related to the injection itself and he was prescribed a steroids taper, unclear whether if it was a temporary or permanent issue. Because this was like 10 days after the vaccine and he didn't really describe how much this issue affected his ability to perform usual work or task but he was a surgeon. The outcome of the events were unknown.; Sender's Comments: Based on the compatible time association, the peripheral nerve injury is possibly related to the injection technique, not vaccine BNT162B2. 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.
45 2021-02-18 anxiety PATIENT STATES IS HAVING DIFFICULTY SWALLOWING ON HIS OWN . PATIENT APPEARS IN NO APPARENT DISTRES... Read more
PATIENT STATES IS HAVING DIFFICULTY SWALLOWING ON HIS OWN . PATIENT APPEARS IN NO APPARENT DISTRESS BUT SEEMS ANXIOUS. PATIENT GIVEN WATER AND DRANK WATER WITH NO DIFFICULTY. HEART RATE 80 AND REGULAR. PATIENT MONITORED ADDITIONAL 15 MINS AND STATES STILL HAS SYMPTOMS BUT ARE LESS INTENSE . PATIENT APPEARS TO HAVE NO APPARENT DISTRESS AND DOES NOT APPEAR AS ANXIOUS. PATIENT REFUSES ANYMORE MONITORING AND LEFT. PATIENT WAS INSTRUCTED THAT IF SYMPTOMS PERSISTED OR GOT WORSE TO FOLLOW-UP WITH EMERGENCY DEPARTMENT.
45 2021-02-18 feeling abnormal, feeling drunk 2 days after 2nd dose of vaccine, there were vision changes (blurred vision), pressure in head, and ... Read more
2 days after 2nd dose of vaccine, there were vision changes (blurred vision), pressure in head, and palpitations. Vision (only have one eye) has been hazy when looking at computer. This is still on going. Work up done by optometrist at this point eye checks ok but problem persist. Referral to ophthalmologist is place. Feeling of fogginess in head - "drunk like feeling" persisted for several weeks. This still seems to be on going. Palpitations and some check pain. - This was never a finding prior to 2nd dose of vaccine. This has resolved.
45 2021-02-23 disturbance in attention moderate fatigue/tiredness; some difficulty concentrating; This is a spontaneous report from a conta... Read more
moderate fatigue/tiredness; some difficulty concentrating; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL 3247, expiry date unknown) in the workplace clinic, via an unspecified route of administration on 26Jan2021 at 13:45 at a single dose on the left arm for COVID-19 immunization. The patient had no medical history and no known allergies. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. It was reported that on 27Jan2021 at 06:45, the morning after the patient was vaccinated, he had moderate fatigue/tiredness with some difficulty concentrating. The patient stated that it felt similar to getting 2-3 hour sleep, but he had no issue sleeping last night. The patient did not receive treatment for the event. The patient was recovering from the events. The events were reported as non-serious.
45 2021-03-02 feeling abnormal Mental fogginess, to the point a coworker had to drive him home. In the evening became achy all over... Read more
Mental fogginess, to the point a coworker had to drive him home. In the evening became achy all over severe arm pain at injection site, and temperature. Phoned PCP who told to go to the ER and he did not. went to PCP office 2/1/21.
45 2021-03-04 anxiety Complaint of "tingling" and "feeling" of edema in lips. Patient subsequently went to the bathroom t... Read more
Complaint of "tingling" and "feeling" of edema in lips. Patient subsequently went to the bathroom to see if his lips were swollen and they were not. Paramedic reported that the patient expressed anxiety about injections/needles and this may have contributed to perceived adverse effects. Patient asked for Benadryl and was given 25 mg po x 1.
45 2021-03-10 feeling abnormal Recipient reports feeling bad all over started immediately, shaking but waited in his car in the par... Read more
Recipient reports feeling bad all over started immediately, shaking but waited in his car in the parking lot after the 15 minute waiting period. Reported back into the vaccination site approx 45 minutes after his injection. Elevated BP 150/105, few minutes later was 170/110 hr 125 rr 20 skin clammy at intervals. Glucose 148 per his report from his insulin pump. No hypertension history or meds per his report.
45 2021-03-14 nervousness, feeling abnormal FEELING FUNNY, QUEEZY AND NERVES
45 2021-03-23 anxiety A few days after receiving the vaccine my blood pressure became elevated to 190. If I calmed down it... Read more
A few days after receiving the vaccine my blood pressure became elevated to 190. If I calmed down it got better. I felt like my heart rate raised a couple of times a day. The spikes in my blood pressure and heart rate lasted about four days. It felt a little like an anxiety attack. I was prescribed a Diuretic which I took for a week. When you got the second dose I did not have any of the same symptoms.
45 2021-03-24 feeling abnormal Burning Skin (face, feet) alternating with deep chills (but no fever); Extreme fatigue; Brain fog f... Read more
Burning Skin (face, feet) alternating with deep chills (but no fever); Extreme fatigue; Brain fog fatigue and brain fog still persistent 6 days after symptom onset (13 days post-vaccination). Burning skin significantly lessened after 5 days (still happens occasionally)
45 2021-03-25 feeling abnormal The patient reported vision changes and not feeling normal. Patient returned to baseline after 15 m... Read more
The patient reported vision changes and not feeling normal. Patient returned to baseline after 15 minutes.
45 2021-03-30 feeling abnormal Within the first few day - typical AEs (low grade fever, sore arm, fatigue). However, the atypical ... Read more
Within the first few day - typical AEs (low grade fever, sore arm, fatigue). However, the atypical AEs included daily and persistent dizziness, "brain fog", fatigue, difficulty going up the stairs without getting winded (difficulty with physical exertion). These symptoms are still present on March 31st (11 days post injection). GI / diarrhea symptoms are also present. Of note, I did have COVID in the past (January 2021) - and had similar symptoms that had resolved at the time of the vaccine. These symptoms are severe enough that it may prevent the second shot (due to concerns of worsening AEs or prolonged events). Of note, the fatigue was worse with the actual disease vs. the vaccine.
45 2021-03-31 confusional state All started the morning of the day after the vaccine shot and got progressively got worse the entir... Read more
All started the morning of the day after the vaccine shot and got progressively got worse the entire day. They were all gone by the next day. Fatigue Nausea Muscle Aches Confusion/dizziness
45 2021-03-31 impaired work ability There were chills (like I was having a fever) at mid-night of the shot (shot was given in the mornin... Read more
There were chills (like I was having a fever) at mid-night of the shot (shot was given in the morning), to the extent that I was shivering. I had a low grade fever for most of the day. I measured it once and it came to 99F. I felt like I had a bad cold or mild flu. Symptoms prompted me to take the day easy (took off work and stayed in bed). Symptoms completely resolved by the next morning. I did not take any medication. I had no reaction to the first shot at all (besides a sore arm which was common for both shots)
45 2021-04-01 feeling abnormal sore arm, brain fog, headache, swollen lymph nodes, pain in brain stem, sore neck, lethargy, diarrhe... Read more
sore arm, brain fog, headache, swollen lymph nodes, pain in brain stem, sore neck, lethargy, diarrhea, bowel discomfort, arthritis flare-up
45 2021-04-05 anxiety Within 60 seconds of receiving the injection, I experienced moderate breathing difficulty. After 1... Read more
Within 60 seconds of receiving the injection, I experienced moderate breathing difficulty. After 10-20 minutes, I noticed that my throat felt slightly swollen (slight difficulty swallowing). Due to a hyperallergic event that occurred about 12 years ago, I occasionally run into something that triggers the respiratory effect - although usually the reaction is milder than that caused by the vaccine. However, the throat swelling is new. I took a single puff of an Albuterol inhaler around 5 minutes after the injection, but it had no effect (usually the case for me when the cause is allergic in nature). About 37 minutes after the injection, medical staff advised me to take an antihistamine. I took approximately 6 mg of doxylamine succinate (orally). However, by this point, the breathing had already started to ease slightly. Approximately 30 minutes later, my breathing was back to normal and the throat inflamation was gone. It's uncertain how much of that would have occurred through time alone and how much of it was the antihistamine starting to take effect. My BP was very high when measured during treatment. Partially explained by the albuterol inhaler combined with pseudoephedrine taken earlier in the day, along with anxiety and exertion from the event itself.
45 2021-04-05 insomnia Persistent mild fever (99.5+) Ache (bone-ache, almost like arthritis) Fatigue Sleep trouble
45 2021-04-08 sleep disorder Dull pain at the injection site; second shot seemed fairly high on my shoulder/ pain at injection si... Read more
Dull pain at the injection site; second shot seemed fairly high on my shoulder/ pain at injection site and general shoulder area was severe; I could'nt move my arm at all due to pain; barely sleep due to shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EL9266, Expiration Date: Not provided) via unspecified route on 16Feb2021 at 09:45 AM in the left arm as single dose for covid-19 immunisation. Patient's medical history included shoulder injury due to fall (5 years ago). Concomitant medications were none.The patient previously took Ibuprofen and Amoxicillin and experienced allergies, also historical vaccine includes on 26Jan2021 at 10:00 AM, the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EN5318, Expiration Date: Not provided) via unspecified route in the left arm as single dose for covid-19 immunisation. The patient did not receive any other vaccines in four weeks. On 16Feb2021 at 15:00, the patient experienced pain at the injection site, "barely sleep due to shoulder pain", shoulder injury. Clinical course of the event as follows: On 16Feb2021, about 5 hours after the shot in the left arm, patient started feeling the typical dull pain at the injection site, about at 11pm (13 hours after injection) the pain at injection site and general shoulder area was severe. About 9 out of 10 he could barely sleep due to shoulder pain. Patient couldn't move his arm at all due to pain. The pain began receding about 24-36 hours later till 8 days after injection, he still had shoulder pain when he moves arm a certain way. It was reported that it felt like a shoulder injury for him. It was further stated that, the same shoulder was injured mildly about 5 years ago due to a fall but made a full recovery a couple months later. The patient informed that pain after first shot was only mild dull pain at injection site. Also, of note is that the injection site for second shot seemed high on shoulder as opposed to the side of the deltoid for the first shot. Events were not treated. Outcome of events was resolving.
45 2021-04-09 confusional state Patient had generalized weakness, dizziness, fatigue, confusion, blurry vision, lethargy, neck pain ... Read more
Patient had generalized weakness, dizziness, fatigue, confusion, blurry vision, lethargy, neck pain 5 minutes after the first dose of Pfizer coronavirus disease vaccine. MRI C spine negative for COVID related transverse myelitis. CT head negative. His glucose was also low that was treated. He felt better the next day and was discharged.
45 2021-04-13 nervousness Patient had gotten COVID-19 vaccine (Pfizer) and he had finished his 15 minutes waiting time. We was... Read more
Patient had gotten COVID-19 vaccine (Pfizer) and he had finished his 15 minutes waiting time. We was leaving when his wife and his mother mentioned he had swollen eyes. Pt said he was feeling well and that his eyes were fine. However, family member insisted he had an allergic reaction to the vaccine and he mentioned he started to feel lightheaded and nervous afterwards. His BP was 107/81 mmHg and pulse 100 bpm and he mentioned he wanted to take something for allergies, so patient was given 50 mg Benadryl after confirming his weight (80 kg). After 15 minutes waiting, patient mentioned he was feeling fine, and he wanted to leave. BP was taken again and it was 125/76 mmHg and pulse was 89 bpm. Pt refused calling 911 because he was feeling ok and he did not feel his eyes swollen.
45 2021-04-15 confusional state, excessive sleepiness 2 hours after 2nd shot I became tired and slept for 24 hours. Had mild fever and itching skin. heada... Read more
2 hours after 2nd shot I became tired and slept for 24 hours. Had mild fever and itching skin. headache. confusion. 48 hours after 2nd shot random blurred vision and Hives all over but more on the arm I received the shot. Random cough followed by extreme heartburn with a lot of saliva being produced and nasua.
45 2021-04-15 restlessness - In the early morning of 4/14/21 Pt called Kaiser help line complaining of cold hands/ feet, restle... Read more
- In the early morning of 4/14/21 Pt called Kaiser help line complaining of cold hands/ feet, restlessness, pallor, R arm pain. - Telephone visit 4/14/21 complained of chills, nausea, vomiting, abdominal cramping, diarrhea. Fluids and rest recommended. - 4/15/21 presented to Kaiser with chest pain, shortness of breath, abdominal pain. Diagnosed with late presentation of acute coronary syndrome / anterior ST elevation MI. Echo with low EF < 25%, LV apical thrombus - 4/16/21 heart catheterization showed 100% occlusion of LAD treated with PCI / DES x 2, IABP. Endotracheal intubation for respiratory failure.
45 2021-04-19 feeling drunk, feeling abnormal I suffer from Meniere's disease and have had 2 episodes over the past 6 months. Since the vaccine I... Read more
I suffer from Meniere's disease and have had 2 episodes over the past 6 months. Since the vaccine I've had several small episodes and two big episodes in the span of 2 weeks and ongoing. A big episode will knock me out for hours even up to a day. See symptoms below. Small episodes: Dizziness-feel tipsy Nausea Headaches Vomiting Big episodes: (includes small) Full vertigo, feels like I'm drunk and have trouble walking. Feels like room is spinning Migraines Pressure in my head makes me feel like a bobble head and wobbly This has affected my work. My doctor told me to report this to you. I got the 1st vaccine shot on 04/05/21. I suffer from Meniere's disease and have had 2 episodes over the past 6 months. Since the vaccine I've had several small episodes and two big episodes n the span of 2 weeks and ongoing. . A big episode will knock me out for hours even up to a day. See symptoms below. Small episodes: Dizziness Nausea Headaches Vomiting Big episodes: (includes small) Full vertigo, feels like I'm drunk and have trouble walking. Feels like room is spinning Migraines Pressure in my head makes me feel like a bobble head and wobbly My second does is scheduled for 04/26/21, should I take it?
45 2021-04-19 insomnia SWOLLEN MOUTH, EVERY 4-6 HOUR LEFT SIDE LUNG DISCOMFORT BELOW THE RIB BUT ABOVE THE STOMACH. ULCER ... Read more
SWOLLEN MOUTH, EVERY 4-6 HOUR LEFT SIDE LUNG DISCOMFORT BELOW THE RIB BUT ABOVE THE STOMACH. ULCER LIKE PAIN AND DISCOMFORT EVERY 4-6 HOURS, LESS SLEEP LIKE 5 HOURS DAILY.
45 2021-04-20 anxiety ~2230 chest tightness/pain (unlike asthma) that radiated to neck and left arm with left arm numbness... Read more
~2230 chest tightness/pain (unlike asthma) that radiated to neck and left arm with left arm numbness, anxiety He had taken 325mg of ASA 4x that day d/t right shoulder pain from previous injury
45 2021-04-20 feeling abnormal Day after shot, progressively felt sicker and more sore throught the day. Had a slight fever at 4 pm... Read more
Day after shot, progressively felt sicker and more sore throught the day. Had a slight fever at 4 pm. By 630 pm at a 102 fever. Very high blood sugars that I couldn't manage for the day. Night sweats and fever over night but fever broke by morning. Felt off on the third day. On the fourth day woke up with a locked neck which never happens and felt ill, tired, sore, had a cough and mild vertigo for next 4-5 days.
45 2021-04-21 feeling abnormal Patient experienced a headache within 4 hours of vaccination. Took recommended dose of Tylenol. 4 h... Read more
Patient experienced a headache within 4 hours of vaccination. Took recommended dose of Tylenol. 4 hours after that (8 hours after vaccination) he was still experiencing extreme headache and also vomiting and took another dose of Tylenol. Was still feeling poor at 1am but coherent and talking, not thinking that it was serious enough to warrant going to hospital, as he believed it was just a bad headache and the vomiting was from the headache. At 6am, he was found blue/dead in his bed.
45 2021-04-22 depressed mood Patient reports that 3-4 days after 2nd dose of Pfizer COVID vaccine, he developed auditory and visu... Read more
Patient reports that 3-4 days after 2nd dose of Pfizer COVID vaccine, he developed auditory and visual hallucinations, paranoia, depressed mood. Symptoms lasted about 1 wk and then improved.
45 2021-04-22 euphoric mood, feeling abnormal After first dose, Subject was on the way to observation area when staff were summoned to an adverse ... Read more
After first dose, Subject was on the way to observation area when staff were summoned to an adverse event. Responding staff observed Subject had vomited on himself in the car. Subject reports he felt very euphoric, leaned his head back and was floating. Thinks he may have passed out (does not know how long) and woke up with vomit all over him. Thinks he may have had a seizure as his neck was stiff and had bite marks on his tongue. As of 4/23/2021 Subject reports full recovery. Has passed out before after having blood drawn x 2 in the past, but not shots.
45 2021-04-22 sensation of foreign body Patient notes knot in throat and feeling like her throat is being coated. Given Benadryl and monitor... Read more
Patient notes knot in throat and feeling like her throat is being coated. Given Benadryl and monitored for 45 minutes. She felt better and left in stable conditions.
45 2021-04-23 insomnia Headache. Body aches. Hot/cold/freezing. Boiling eyeballs. Not able to sleep. Perfuse sweating. Dizz... Read more
Headache. Body aches. Hot/cold/freezing. Boiling eyeballs. Not able to sleep. Perfuse sweating. Dizzy. Nausea. Like bad flu symptoms, like the worst flu I have ever felt.
45 2021-04-25 sleep disorder Starting around 9am Tuesday 4/6/21 I began getting chills and my entire body hurt. By 12 noon I had... Read more
Starting around 9am Tuesday 4/6/21 I began getting chills and my entire body hurt. By 12 noon I had a splitting headache. I left work and went home to sleep. I was unable to sleep due to the headache. I took my temperature with a digital thermometer around 4PM. I was running a 102 fever. I took three 200 mg Advil around 6pm. My headache got better over the next hour. My fever broke around 9pm that night. I soaked through a shirt. That afternoon and evening I experience joint pain. It felt like needles being jabbed into my joints. Or like lightening strikes in my joints. I got a full nights sleep and the next day I felt 95% better. This was my second shot. I got it at the pharmacy.
45 2021-04-26 amnesia, feeling abnormal He received the show on 4/23. That night he thought he was a little more achy. The next morning he w... Read more
He received the show on 4/23. That night he thought he was a little more achy. The next morning he was driving his family to a track meet around 9:30. He and his wife were having a conversation. According to his wife, he seemed to become dazed. Their conversation just stopped. The car started to veer off the road and they were onto the rumble strips. He wasn't making a correction, so his wife had to tell him to drive back into their lane, but he overcorrected and ended up into the lane of oncoming traffic. He was able to correct that and pull the car off of the road. He and his wife switched so that she was driving. He seemed to have a glazed look on his face, but he didn't have any difficulty walking or getting in/out of the vehicle. He does not remember the incident of the car veering and overcorrecting. When they got to the track meet he felt tired and just laid down for 10-15 minutes. Afterwards, he felt like he was fine. They entire incident lasted about 30 minutes. He has been fine since.
45 2021-04-26 disturbance in attention Tinnitus. The ringing in my ears has become so bad that I can?t hear and I can?t concentrate. I do... Read more
Tinnitus. The ringing in my ears has become so bad that I can?t hear and I can?t concentrate. I don?t want to live any longer like this.
45 2021-04-27 insomnia Dull pain in injection shoulder two weeks after injection. Major discomfort. Unable to sleep comfort... Read more
Dull pain in injection shoulder two weeks after injection. Major discomfort. Unable to sleep comfortably. Advil doesn?t help. Ice has helped some.
45 2021-04-27 loss of personal independence in daily activities, disturbance in attention, feeling abnormal 12 hours after vaccination developed debilitating inability to think clearly, brain fog, shortness o... Read more
12 hours after vaccination developed debilitating inability to think clearly, brain fog, shortness of breath, activity intolerance, heat intolerance , headaches, fatigue that have not subsided since.
45 2021-04-28 feeling abnormal, confusional state When I woke up the day after (Day #2) being given the vaccine I was extremely tired exhausted, I had... Read more
When I woke up the day after (Day #2) being given the vaccine I was extremely tired exhausted, I had intense chills and hot flashes. Never a fever. I felt nauseated. Completely lethargic. Muscle aches all over my body, was hard to move. I couldn't stay awake. My eyes hurt. I had intense migraines. And no appetite. My right arm hurt, but not as bad as many others' reported. I took ibuprofen to help, it didn't. I drank lots of water and gatorade zero for the electrolytes. It didn't help either. On day #3, this was when it got scary. The previous symptoms carried over, minus the nausea and I was able to be mobile (less lethargic). But something new started to happen. I took my dog out for a short walk, a slow pace, I am very athletic, and I had shortness of breath. I was winded from just walking slowly. Then the brain fog started to set in. This I hated the most. I wasn't able to comprehend things. I tried to assemble an item I bought from Amazon and it was extremely hard to follow simple instructions. I wasn't able to see clearly for some reason. And even comprehending emails that I was receiving was troublesome. I kept drinking water, and was able to eat a little. Had two more bottles of Gatorade Zero. On day 3, most of all the symptoms subsided except that I still got winded from movement. On day 4, I was fine.
45 2021-04-30 abnormal behaviour, feeling abnormal stroke/mini stroke; he couldn't move/loss of motor function/movements were off; Loss of motor functi... Read more
stroke/mini stroke; he couldn't move/loss of motor function/movements were off; Loss of motor function including movement and speech/couldn't speak; head was very tingly; speech was not slurred but more like there was an impediment; he couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to; Caller states he thought he was going to die, his body was shutting down; behavior change; his legs are shaky; eyes feel a little dry; thumbs weren't working right; rule out MS or Parkinson's; rule out MS or Parkinson's; I have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head; he was a little dry thought he may be dehydrated; very tired; pounding headache in the back of his head constantly; he was twitching; really off-feeling; digestive issues/digestive problems; eyes were real mucusy/First week mucous in my eyes/could be allergy; eyes were real mucusy/First week mucous in my eyes/could be allergy; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 25Mar2021 as single dose for COVID-19 immunization on an unspecified facility. There were no medical history. No known allergy. The patient had no health issues with any severity, he is pretty athletic, pretty healthy. The patient's concomitant medications were not reported. No COVID-19 prior to vaccination. On 26Mar2021, the patient had digestive issues/digestive problems, eyes were real mucus, first week mucous in my eyes which could be allergy which resolved on 01Apr2021. On 06Apr2021 08:00 the patient reported that he couldn't move/loss of motor function and movements were off but his cognitive functions were fine, loss of motor function including movement and speech/couldn't speak, had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head, suffered a stroke or mini stroke and was sent to the emergency room. On 06Apr2021 at unspecified time the patent couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to, head was very tingly, speech was not slurred but more like there was an impediment, very tired, pounding headache in the back of his head constantly, he was a little dry thought he may be dehydrated, he was twitching, really off-feeling, and states he thought he was going to die, his body was shutting down. On an unspecified date, the patient had eyes feel a little dry, thumbs weren't working right, his legs are shaky, and noticed behavior change. The patient was hospitalized for 3 days from 06Apr2021 to 09Apr2021 due to thought he was going to die, his body was shutting down, stroke/mini stroke, couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to, couldn't move/loss of motor function/movements were off, head was very tingly, speech was not slurred but more like there was an impediment, loss of motor function including movement and speech/couldn't speak. The patient underwent lab tests and procedures which included IGG antibody test: positive and IGM antibody test: negative both on 19Apr2021, computerised tomogram: showed nothing on 06Apr2021, echocardiogram: unknown result on unspecified date, magnetic resonance imaging brain: showed nothing both on an unspecified date in Apr2021 (not sure if 15Apr2021 or 16Apr2021) and on 07Apr2021, COVID-19 test: negative on 06Apr2021, repeat COVID-19 test: negative on 07Apr2021. Therapeutic measures were taken as a result of stroke/mini stroke, loss of motor function including movement and speech/couldn't speak have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head which includes TPA and digestive issues/digestive problems were treated with high fiber diet. The outcome of the event he was going to die, his body was shutting down, stroke/mini stroke, he couldn't move/loss of motor function/movements were off, head was very tingly, speech was not slurred but more like there was an impediment, loss of motor function including movement and speech/couldn't speak, have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head, very tired, pounding headache in the back of his head constantly was not recovered, for the events digestive issues/digestive problems, eyes were real mucusy/first week mucous in my eyes/could be allergy was recovered on 01Apr2021, while for the rest of the events was unknown. Caller states he has an appointment with a neurologist and he's trying to get it moved up. Caller states his doctor wants to do a lumbar puncture to rule out MS or Parkinson's that sort of thing. Caller states but at this point they are trying to rule things out. Caller states he doesn't have a family history of really either them. Caller states there was no diagnosis. Caller states the doctor said he was pretty sure its a stroke, mini stroke, but his general practitioner doesn't think its a mini stroke. Caller states the effects are so long going and they will improve and fall back and then the doctor also said at the fact that has been cognitively aware the whole time, so there's been no official diagnosis yet.
45 2021-04-30 feeling abnormal It's difficult to pinpoint the exact time the symptoms started, but they were definitely present by ... Read more
It's difficult to pinpoint the exact time the symptoms started, but they were definitely present by the time I awoke the following morning. No arm pain -- but nine days of brain pain, waking up feeling like my head was split, at least five days of altered vision, and most disturbed were my breathing and my heart. I felt for many days like I had a Brillo Pad in my lungs and heart, as well as lots of pressure in the chest and shortness of breath/labored breathing. Two days ago I thought I might be having a heart attack. The symptoms lightened yesterday morning (day nine) though I still have strange sensations in the head and taking a full, deep breath is not totally easy yet. .
45 2021-05-04 disorientation, feeling abnormal cold sweat; headache; cramping/spasm; bumps on the side of neck; body aches; Bumps on his head that ... Read more
cold sweat; headache; cramping/spasm; bumps on the side of neck; body aches; Bumps on his head that were also painful; stomach cramps; diarrhea; he threw up several times; nauseous; disorientated; just not feeling good at all; tired; neck pain; felt weird; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; /Lot Number: ER2613), via an unspecified route of administration, administered in right arm on 04Apr2021 (at the age of 45-years-old) at 14:00 as single dose for covid-19 immunisation. Medical history included COVID: he had gotten diagnosed with COVID back in December or January and twice tested positive for covid and his body had fought it off (as reported). Medical history included also back pain Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken to sleep, start and stop date were not reported. The patient reported that around the night of vaccination he experienced cold sweat, headache, and cramping for several hours then subside and come back later. Patient had some bumps appear on the side of his neck. He stated that he could not say that's from the shot, something may have bit him. The patient did bump his head a chandelier and went to the ER. He received Ibuprofen for the symptoms. Patient stated that the reported events occurred the same day as his COVID Vaccine and began a couple of hours later and wakes up every night in a cold sweat; stated he was in and out of the emergency room in about an hour and they gave him Ibuprofen 400mg and a of nights had to take two Ibuprofen because his head and body was hurting so bad and he had to take some kind of relief and he does not like taking stuff like that and pain pills make his stomach hurt. Patient stated he did a whole Ibuprofen and did not feel good after that and can't take the Ibuprofen anymore and then took 1-2 Aleve after that and does not like taking pain medication. He stated he was healing with the bumps but had this every day since the Pfizer Vaccine and he was starting to heal but the bumps were still there on the side of his neck and were improving and healing and he had the bumps on his head that were also painful; states the bumps occurred the same day as his Pfizer COVID Vaccine; states he was up in his attic and could have gotten into a spider nest and might have poison in him from the spiders and then went to the hospital emergency room with these issues. States he told the emergency room about the bites and bumps and that he had the Pfizer COVID Vaccine and they gave him the Ibuprofen and sent him home. The patient stated that this was a real concern for him due to the blood clots stuff coming out about how people have different reactions after a vaccine. States he felt like the hospital did not even do anything; he could have hit his head a couple of times on a chandelier; states the emergency took an image of his head and they did not address the bumps or anything else and said his head was not bleeding and gave him Ibuprofen and he did not think you should take Ibuprofen like when you have COVID and they sent him home and nothing was done. Caller states he does not know but when he received the Pfizer COVID vaccine he noticed a patch of bumps in his neck, and his neck got really tight and his neck still hurts on the left side; states he could have gotten bitten by something. The patient reported that after he had the Pfizer COVID vaccine, he was waking up every night with cold sweats, and recently last night had extreme cramps in his stomach area like was crawling around the floor getting away from the pain and is still having abdominal cramps. He ate a burger and had extreme cramps and diarrhea for days and this was after his Pfizer COVID vaccine and he is doing this again with stomach cramps and diarrhea; he can't distinguish what the cramps and diarrhea were from and maybe he ate something bad and is confused about his body; states the cramps are way worse and the diarrhea began after the burger. States the diarrhea is a lot and this time is less diarrhea but more abdominal cramps and he threw up several times last night and did not throw up a lot but was so nauseous and threw up twice a little bit. Patient stated that the reported events were just like when he had covid and after waking up at 12:00 he had body pains and was not able to go back to sleep until 4:00; states he had pretty bad headaches which are ongoing and had had headaches ever since he was diagnosed with COVID, stated it is the same thing also as when he had covid; states with covid he got sick and was up from 12:00 4:00 and had fatigue, had body pain, had headaches and nausea and then it got better and he started sleeping through the night. States the Pfizer COVID shot and it was like the same all over again where he was up from 12:00 4:00, had pain and was disorientated, just not feeling good at all which has gone on since the shot; states there were two nights where he slept through the night and was up in a cold sweat which wakes him up and drenches him head to toe and he has to get out of bed to change clothes and sit there til he is tired again and sometimes goes to sleep in the chair and then sleeps ok. Patient stated he took Benadryl just to sleep through the night and did not and got up once and then went back to sleep. He stated on the left side where the headaches were and he had neck pain and it was kind of the left side and felt weird. The patient stated also that in the emergency room he was given Valium in his arm and also has a knot on the back of his neck and tried to address it with the emergency room and they said it was a spasm and did not seem concerned and it felt hard and not a bump under his skin in his neck and it just felt like maybe a pea sized hard knot and noticed this after his Pfizer COVID Vaccine. Caller stated he actually felt pretty good and was sleeping through the night after he had COVID and felt back to normal and then after his Pfizer COVID vaccine everything went downhill. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.
45 2021-05-04 sleep disorder Tinnitus got worse. I had very low level tinnitus before. The second night after the vaccine the tin... Read more
Tinnitus got worse. I had very low level tinnitus before. The second night after the vaccine the tinnitus was quite bad, then the next day it settled down to be two or three times as noticeable as my baseline tinnitus was prior to the vaccine, at least. At this point, normally don't hear it, but when I'm going to sleep it's very noticeable. Ten weeks later, it's steady and hasn't gotten worse or better since it steadied out on the third day.
45 2021-05-20 disorientation Shortly after receiving the vaccine the patient fainted and bumped his head from the fall. He was ve... Read more
Shortly after receiving the vaccine the patient fainted and bumped his head from the fall. He was very pale, clammy, hot and somewhat disoriented from the reaction. After some water, food, and sitting patient recovered almost fully. He does report having similar reactions to other vaccines/blood draws. He was checked on by phone that same night and about 36 hours later and overall was doing ok.
45 2021-05-22 sleep disorder Chills, fever of 101 degrees, body aches, headache, unable to sleep. 18 hours.
45 2021-05-24 insomnia Upon injection, felt immediate soreness at injection site (left arm, near shoulder). Had also felt s... Read more
Upon injection, felt immediate soreness at injection site (left arm, near shoulder). Had also felt soreness after first shot in series, which went away. Ten weeks after the second shot, I still feel considerable soreness at the injection site, which sometimes increases from general soreness to mild pain. A specific example is a general difficulty sleeping on my left side, which will wake me with pain and often cause mild pain for the remainder of the day.
45 2021-05-25 feeling abnormal, excessive sleepiness A little more than 5 minutes after receiving shot had a seizure. Told me his wife he didn't feel rig... Read more
A little more than 5 minutes after receiving shot had a seizure. Told me his wife he didn't feel right and hands were very sweaty cold his eyes rolled back in head. Lost his color loss control of bodily functions( urine). Throwing up hard. EMT were called vitals were alright. Once we were home vomiting subsided and he slept hard.
45 2021-05-25 sleep disorder From hospital discharge summary: "45 y.o. right-hand-dominant male who presents with few hours of i... Read more
From hospital discharge summary: "45 y.o. right-hand-dominant male who presents with few hours of improving left arm heaviness/left hand cramping in the setting of getting his second Pfizer COVID-19 vaccination in his right arm 3 days ago and 3 weeks of mildly increased exercise/intermittent fasting. The patient reports getting his first Pfizer COVID-19 vaccination on April 7, 2021. Reports some mild symptoms afterwards. Around that same time, the patient reports having a checkup with his primary care doctor that was notable for a cholesterol elevation to 200. This prompted him to try and lose weight including intermittent fasting and increase in exercise, especially for exercises and cardio. The patient reports approximately 20 pound weight loss over the past 3 weeks. 3 days ago, the patient reports getting his second Pfizer COVID-19 vaccination in his right arm. Reports fever (maximum 103 Fahrenheit) and mild headache the subsequent 2 days after the vaccine. Last night, the patient went to sleep on his left side at around 8 PM. He woke up at 4 AM with significant left arm heaviness and left hand cramping. He tried to massage his hand with some slight improvement of the symptoms but otherwise the symptoms persisted. Hence, this morning, he called his PCP, who told him to come into the ER for further evaluation. Here, the patient reports improving left arm heaviness/left hand cramping. He also does report family history of heart attack and an uncle at a similar age and massive heart attack of his grandfather in their 60s. He denies fever, anorexia, unexpected weight change, headache, blurry vision, sinus pressure, cough, hemoptysis, orthopnea, PND, SOB, DOE, chest pain, pleurisy, changes in taste/smell, N/V/D, abdominal pain, flank pain, urinary sxs, genital sxs, black stools, incontinence, absence of flatus, calf pain, leg swelling, numbness/tingling, streaking redness/rash/skin changes, easy bruising. Also, deny history of HTN, DM, smoking, prior MI, prior PCI, prior CABG, prior TIA/CVA, or history of PAD. Further, denies recent trauma/fall, history of cancer, blood thinner use, recent drug use, recent travel, sick contacts, family history of connective tissue disease/congenital aortic anomaly, or family history of similar sxs. --- Hospital Course by Problem # Troponinemia (Likely myopericarditis) The patient has a family history notable for MI and CABG in relatives aged 50-70 on his mother's side. The patient notes that most of these family members were heavy smokers and drinkers, which he is not (never-smoker, rare EtOH, never illicit drugs). His symptoms are notable for L arm heaviness/cramping that began around 8pm on 4/30/21 at 9/10 severity and subsequently was 3-4/10 severity on presentation to ED and is 0-1/10 severity at time of admission to the floor; he has no associated numbness, weakness, coolness, or pallor. His symptoms are non-exertional. He denies CP, SOB, lightheadedness, nausea, jaw pain, abdominal pain, fatigue. He noes that he recently got the second COVID shot in the R arm, and had a post-vaccine course notable for Tmax 103 ~3d ago and 101 as recently as yesterday. His EKG was notable for ST-elevation in II/III/aVF and his troponins were elevated 305 -- > 298 -- > 328. Of note, his CRP was elevated at 69. The patients symptoms and findings could certainly be compatible with atypical ACS and, given the low risk of bleeding associated with heparin, he was treated conservatively upon admission with heparin infusion, metoprolol tartrate 6.25mg q6h, atorvastatin 80mg (he received ASA 325mg in the ED). However, given his recent covid vaccination and elevated CRP and reported fevers, this could also be compatible with myocarditis or other inflammatory etiology. TTE on 5/3 demonstrated preserved EF 55% with no WMA. Given reassuring TTE, a cMRI was ordered to assess for myocarditis vs scar tissue from recent ischemic event. Cardiac MRI on 5/5 was notable for finding consistent with myopericarditis (see below). Aspirin and atorvastatin was stopped on discharge. Patient was discharged with metoprolol 25 mg daily."
45 2021-05-26 loss of personal independence in daily activities cannot talk properly; his body and mind are responding slow; It affected him and he didn't know a ca... Read more
cannot talk properly; his body and mind are responding slow; It affected him and he didn't know a car was coming and didn't even see them; Not able to make good decision/made the wrong decision; weak when he walks and knees are bending; left side very slow and weak, unable to use left side; weak; could not stand up or be on his feet/ left side weak an unable to stand or walk; cannot type on the keyboard; fell on the floor; numbness on his left hand/numbness and tingling in hand; tingling in hand/numbness and tingling in hand; This is a spontaneous report from a contactable consumer (Patient, self-reported) via medical information team. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER729; Expiration Date: 31Jul2021), dose 2 via an unspecified route of administration, administered in Hand Left (shoulder) on 10Apr2021 12:00, as 2ND DOSE, 0.3 ML SINGLE; for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes dose 1 (Batch/Lot Number: EP75334, Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Hand Left (shoulder) on 20Mar2021 02:30PM, as 1ST DOSE, SINGLE. It was reported that patient received the second dose of the Pfizer Covid-19 vaccine on 10Apr2021 and he started experiencing numbness on his left hand and next morning he could no feel anything on the left side of his body, it was so weak that he could no lift his hand, walk on stand on his feet. He went to the ER, they made some tests, but primary care doctor did not provide a diagnosis. He started feeling better but today he could not stand up or be on his feet, he cannot talk properly, cannot type on a keyboard and the left side of his body is very slow and weak. Reportedly, the primary care provider was not able to provide him with any diagnosis. He was feeling better, but today, he noticed that he was not able to stand up on his feet again. He cannot talk properly due to weakness. He cannot type on the keyboard. The left side is very slow and very weak. It has been several weeks and he is not feeling better. Stated that he is 46 and was 46 when he experienced these events. Last week, patient went to the neurologist and no one had helped him. The only thing was about the side effects and were not telling him how that can be fixed. Numbness in hand has been more than 2 weeks. He doesn't feel numbness now but is very weak. The left side of his body has less strength. The numbness was minutes after the shot and the tingling was immediately after. The numbness and tingling lasted 30 to 40 minutes after the shot. The emergency doctor gave him some medicine but he does not remember what medicine. They also gave him fluids and then he got some strength. Woke up the next day and was unable to stand. He tried to go to the restroom and was so weak, he fell on the floor. They did all the tests and could not find anything. He is still not feeling normal. His right hand is fine. The left side, where they did the shot had less strength. He can't even move his finger properly and can't type on the keyboard, from the left hand side. if there are any cases like this and how that person got better and what was the root cause. So many weeks, this has been affecting his day to day life. He can not work. He is a software programmer. He needs to use his hands. He can't use his hands. Is feeling like his body and mind are responding slow. When he drives, he is not able to make good decisions. One time he really made the wrong decision. It affected him and he didn't know a car was coming and didn't even see them. States that he spoke to medical information, they could not provide any medical advice. Everyone is making this hard. They could not find another person with similar symptoms. Patient did not receive other vaccine in four weeks of vaccination. On an unspecified date, the patient experienced cannot talk properly, on 10Apr2021 12:05, numbness on his left hand/numbness and tingling in hand, 12:01 tingling in hand/numbness and tingling in hand, on 11Apr2021 weak, could not stand up or be on his feet/ left side weak an unable to stand or walk (was reported as worsened), fell on the floor, cannot type on the keyboard, weak when he walks and knees are bending, left side very slow and weak, unable to use left side, on an unspecified date his body and mind are responding slow, it affected him and he didn't know a car was coming and didn't even see them, not able to make good decision/made the wrong decision. Patient went emergency room on 11Apr2021 they made some tests, but primary care doctor did not provide a diagnosis. Patient was sent home to recover at home. wife was with him and brought him home. They gave him medicines and fluids. He was able to walk and stand up and somehow was recovering well. The patient underwent lab tests and procedures which included blood test: didn't find anything, nothing significant, electrocardiogram: didn't find anything, nothing significant, laboratory test: didn't find anything, nothing significant on an unspecified date. Therapeutic measures were taken as a result of left side very slow and weak, unable to use left side (asthenia). Outcome of the events numbness on his left hand/numbness and tingling in hand and tingling in hand/numbness and tingling in hand was recovered on 10Apr2021 12:45; left side very slow and weak, unable to use left side was not recovered and other events outcome was unknown. Follow-up attempts are needed. Further information is expected.
45 2021-05-28 anxiety PT was feeling anxious after shot. Stated last time BP was high.
45 2021-06-06 confusional state Fever, headache, confusion, encephalopathy, hospitalized 5/28/21-6/1/21.
45 2021-06-07 feeling abnormal 1 day after receiving vaccine I experienced "brain fog". Approximately 10 days afterwards (around 2... Read more
1 day after receiving vaccine I experienced "brain fog". Approximately 10 days afterwards (around 2/25), I experienced symptoms of a minor stroke - I experienced lack of coordination in typing and later that evening experienced difficulty with speaking and comprehension, but only for a few minutes. A few days later, that weekend, I had some issues playing songs on the piano I had played before, making a lot of mistakes. About another 2 weeks afterwards, on 3/9/2021, I experienced more symptoms of stroke. For most of the day I had issues with typing, and later that evening I had some coordination issues with closing a soda bottle. On the morning of 3/10/2021, I continued to experience issues with typing and also had difficulty speaking and understanding my wife. At this point I went to the emergency room and was found/diagnosed to have experienced multiple TIA strokes.
45 2021-06-10 anxiety 15 - 20 min post vaccine, patient complained of bilateral hand/feet tingling/numbness. Vague heavine... Read more
15 - 20 min post vaccine, patient complained of bilateral hand/feet tingling/numbness. Vague heaviness across chest and throat. Feels warm and anxious. Treated with diphenhydramine 25 mg po x 1, diphenhydramine 25 mg IV x 1, Diphenhydramine 50 mg IV x 1 (had developed angioedema/throat swelling). Admitted to hospital and then transferred to another facility.
45 2021-06-15 impaired work ability, emotional distress, feeling abnormal, loss of personal independence in daily activities Severe migraine severe dizziness vertigo brain fog it?s relentless nonstop 24 seven from the time I ... Read more
Severe migraine severe dizziness vertigo brain fog it?s relentless nonstop 24 seven from the time I wake up until the time I go to sleep severe pain in every single droid back arms legs feet it doesn?t matter I literally can?t function thank you I really appreciate the vaccine and went along way to help give me Covid symptoms is what I did I?m beyond frustrated every single day I can?t go to work I can?t do anything I can?t live I can?t function I?m in chronic pain. Let?s not forget the increased heart rate where I feel like I?m going to die Please get this poison out of me help me The pain is relentless in all my joints I can?t function why did I take this my push something. Everywhere I?ve ever had a problem from concussion two herniated disc it seems like the pain is exacerbated in all these areas even my notes wrist arms. I was perfectly fine until I got the shot. Oh I also can?t look at a cell phone I can?t look at screens that makes the migraines worse. 2 months of daily suffering thanks
45 2021-06-17 sleep disorder - Chest pain after 1.5 months from the second shot - Left arm numbness - Shortness of breadth - Har... Read more
- Chest pain after 1.5 months from the second shot - Left arm numbness - Shortness of breadth - Hard to stay asleep - Lack of energy
45 2021-06-23 feeling abnormal, loss of personal independence in daily activities After the 1st dose (3/29/2021), neck inflammation started on the right-side of the neck. The neck in... Read more
After the 1st dose (3/29/2021), neck inflammation started on the right-side of the neck. The neck inflammation got worse after the 2nd dose (4/19/2021). The neck inflammation is still present. Starting 5/11/2021: Intense adrenaline surges started happening every night between 3 am-7 am. My heart feels like it is beating extremely hard. I have checked my pulse and it is normal during the events (ranges from 65-90 bpm). I have checked blood pressure and it is usually in the 120/80 range (normal for me). However, there have been occasions where blood pressure drops to 100/70. These adrenaline surges and hard heart beats tend to get better if I stand up and move around. It will get worse again if I lay down. I have these on occasion during the day, but I am usually able to calm myself down. I have had scenarios where I feel fine during the day, but will lay down. The hard heart beats start almost immediately. I'm also exercise intolerant now. If I do anything more than a brisk walk, I feel very terrible and faint with a hard heart beat. One interesting data point, my father has the same symptoms and his started about the same general timeframe after his second dose of the Pfizer vaccine.
45 2021-07-05 feeling abnormal patient came in for his second dose of the Pfizer covid vaccine, patient stated on their intake form... Read more
patient came in for his second dose of the Pfizer covid vaccine, patient stated on their intake form that the TDAP vaccine had caused him to faint in the past. after discussion with the patient, he stated that the first dose of the Pfizer vaccine did make him dizzy for a few minutes after the vaccine, but he did not faint following the first dose. After the first dose, because of his history with TDAP, patient was asked to stay for 30 minutes on site, after 30 minutes not further side effects other than the temporary dizziness. After that discussion it was decided to administer the second dose. Immediately after the dose, patient appeared to suffer from syncope, immediately becoming dazed and his eyes closing, within 1 to 2 minutes he became alert, aware of name and dob, etc. Patient's pulse and vitals were WNL. Offer was made to call ambulance for further evaluation, but patient declined. The pharmacist, remained with patient for 30 minutes to monitor, he continued to be fine.
45 2021-07-09 restlessness Sense of restlessness requiring exercise to relieve it. Akathisia? Intermittent started approx 3 mo... Read more
Sense of restlessness requiring exercise to relieve it. Akathisia? Intermittent started approx 3 months after 2nd dose and increased over the next two months. Now much improved. Note: I have low suspicion that this is related to vaccination, given the time course. However, the folks at V-Safe asked me to report in VAERS.
45 2021-07-12 fear Numbness in left arm from elbow to 4th and 5th digits. The numbness largely went away but persists ... Read more
Numbness in left arm from elbow to 4th and 5th digits. The numbness largely went away but persists to this day with the sides of the ring finger and pinky finger remaining numb. I fear at this point is is permanently damaged nerves
45 2021-07-15 sleep disorder Experienced twitching in right ear in or around ear drum at night after my second dose in the aftern... Read more
Experienced twitching in right ear in or around ear drum at night after my second dose in the afternoon. The twitching produced a sensation of throbbing sound and was very frequent and constant, occurring almost every other second. The next day was even worse with constant twitching throbbing sensation and I my sleep was hugely affected. I would stay up and walk at night. Got an appointment on May 11 with my Dr. who said basically I have ringing ears, Tinnitus, which might be due to hearing loss from childhood etc. He checked hearing which was still fine. I did mention it all started happening right after 2nd dose of COVID vaccine but he didn't think there was any connection with that. He did say he will keep this in mind and see if any link between vaccine and Tinnitus is found as cases are reported. He said there is not much that can be done for Tinnitus other than reducing noise levels.
45 2021-07-20 anxiety Client reported anxiety and nausea about one minute after receiving the COVID vaccination Pfizer. Cl... Read more
Client reported anxiety and nausea about one minute after receiving the COVID vaccination Pfizer. Client moved from a regular chair into the in anti-gravity chair. The client reported feeling anxiety and nausea. The client denied any other s/s of anaphylaxis. The client reports a history of anxiety with is controlled with an oral medication he takes daily for "stress". The client was unsure of the name of the medication name. Vitals obtained at 7:04PM were as follows: automatic BP 135/96, HR 88, O2 99%. The client stated he was "feeling better." The client denied any history of anxiety with injections. The client his current status was a new feeling for him. The client began drinking a juice. Repeat vitals obtained at 7:10PM were as follows: automatic BP 129/88, HR 96, O2 98%. The client denied any persistent nausea at 7:13PM. The client reported "numbness" around the vaccination site. No redness was observed around the vaccination site. Palpated around the vaccination site and client reported in tact sensation to physical touch. Repeat vitals obtained at 7:10 PM were as follows: Client ambulated to EMT observation area unassisted with a steady gait. At 7:23 PM asked the client if he was feeling okay, and the client replied "yes." At 7:36PM the client stated that he "still feels good." Repeat vitals obtained at 7:36PM were as follows: automatic BP 132/86, HR 88, O2 98%. The client left the vaccination site at 7:36PM. The client ambulated unassisted with a steady gait.
45 2021-07-20 feeling abnormal, disturbance in attention Foggy headedness; difficulty concentrating; This is a spontaneous report from a contactable consumer... Read more
Foggy headedness; difficulty concentrating; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot Number: ER8732) via an unspecified route of administration in the left arm on 01Apr2021 at 08:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient was reported as none. The patient was allergic to fruits and nuts. Concomitant medications included ibuprofen (ADVIL) taken for an unknown indication from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 02Apr2021, at 09:30, the patient experienced foggy headedness and difficulty concentrating. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events foggy headedness and difficulty concentrating was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
45 2021-07-21 feeling abnormal Terrible pain in left arm; Sore throat; Runny nose; Grogginess; Lethargy; Fogginess; Wobbliness; Mil... Read more
Terrible pain in left arm; Sore throat; Runny nose; Grogginess; Lethargy; Fogginess; Wobbliness; Mild general achiness; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 17:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as no chronic health conditions. The patient did not have any known allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 01Apr2021, the patient experienced terrible pain in left arm, sore throat, runny nose, grogginess, lethargy, fogginess, wobbliness and mild general achiness. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events terrible pain in left arm, sore throat, runny nose, grogginess, lethargy, fogginess, wobbliness and mild general achiness was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
45 2021-07-27 disturbance in attention slight achiness to upper back; slight inability to focus on complex tasks; Reduced sense of taste; T... Read more
slight achiness to upper back; slight inability to focus on complex tasks; Reduced sense of taste; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 31Mar2021 at 14:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included hemochromatosis. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN) and fexofenadine hydrochloride (ALLEGRA), both from unknown dates for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration on 10Mar2021 at 11:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 12:00, the patient experienced slight achiness to upper back, then slight inability to focus on complex tasks, then reduced sense of taste. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events slight achiness to upper back, slight inability to focus on complex tasks and reduced sense of taste was recovered with lasting effects. No follow-up attempts are needed. No further information is expected.
45 2021-07-27 insomnia Partial clot; has been experiencing pain and aching in his leg; didn't sleep at all that night; hear... Read more
Partial clot; has been experiencing pain and aching in his leg; didn't sleep at all that night; heart was feeling weird; having pain in the vein; Venous insufficiency; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date : unknown), dose 2 via an unspecified route of administration, administered in arm right on 27Apr2021 11:15 as dose 2, single for covid-19 immunisation. Medical history included peripheral venous disease from 2019 and ongoing. The patient's concomitant medications was not reported. Historical vaccine of BNT162B2 for COVID-19 immunization on Mar2021 at the age of 45-year-old as per first dose. Prior Vaccination (within 4 weeks prior): None. He has no family medical history, just his personal medical history. He already had venous insufficiency to some degree present but the COVID vaccine made it worse. He was diagnosed in 2019. Caller says that he got the Pfizer COVID vaccine and he is having some little adverse events. He has called a couple doctors today for an appointment to go in and be seen and they all suggested for him to call Pfizer as well. He clarifies that his adverse event is that he has a little bit of venous insufficiency already but it was relatively okay but with both doses of the COVID vaccines, immediately it was like a a switch. As soon as he got the COVID vaccines the situation got much worse for him. He had pain in his leg that felt like a clot for the first week and a half to two weeks after his first dose. Then he got a little bit better, even though he had almost went to the emergency room but he got better after a couple weeks. After his second COVID vaccine, starting that same night, last Tuesday, to now he has been experiencing pain and aching in his leg and he feels like his venous insufficiency went from a 5 to a 10 and it doesn't seem to be getting better so he is going to go see a doctor but they suggested for him to let Pfizer know about this. It was reported that first dose, his pain began the day after he had his COVID vaccine. His second dose was on 27Apr2021 and his 1st dose was 4 weeks before that, so his first dose was either on 30Mar2021 or 31Mar2021. His clarifies that his pain actually began the second day after his first dose. Second dose, the same day of his COVID vaccine, 27Apr2021, he felt pain in his legs and his whole body was flushed and he felt hot. He also didn't sleep at all that night and his heart was feeling weird. He had read that the racing feeling is part of the initial reaction so he had let it go. Then the next couple of days he had felt better and then he started having this feeling of stinging, burning pains in his leg where he knows that vein is, it's his superficial great saphenous vein. He has been having pain in the vein and it has been stinging, burning and aching and he can't sit for more than 20 minutes. He has been exercising every day, drinking water, elevating his leg on the wall to drain it but as soon as he sits again it starts hurting. He feels like it could be a partial blockage but he doesn't really know. He doesn't know if it is actually a partial clot or if it is just his venous insufficiency to such a degree that the fluid pressure inside is making it hurt. It has been this way everyday even though he has been exercising. Honestly, before the COVID vaccine he could exercise and his circulation would be fine that night and for about the next 3 days with no problems but since the COVID vaccine he has been exercising everyday and it doesn't seem to make a difference. He already had a situation but then the vaccine was like a switch and instantly made it worse both times. Probed for 2nd dose outcome and he says that when he is moving around, exercise is the only thing that provides relief, but after that he typically would of been okay for the next few days, but when he gets home from the gym tonight he knows his legs are going to start hurting as soon as he sits down. Even though he sits on his bed and elevates his legs on the wall he knows that as soon as he stands up his legs will start hurting. That's what has happened every day since last Tuesday. Therapy start date populated as Mar2021 since caller is unsure of the exact date of his first COVID vaccine and the therapy stop date populated as the date for his second COVID vaccine. History/ Investigations showed probed for test results, medical conditions or concomitant products and caller says no, there has been nothing out of the ordinary. Anatomical Location of Administration of Pfizer vaccine considered as suspect: right arm for both. No, but he is waiting for the doctor's office to call back him back to schedule for testing. He spoke with them and they said that if it gets worse or continues like it is for another day then he needs to go to the emergency room. The outcome of event pain and aching in his leg was recovered. The outcome of remaining events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
45 2021-07-27 insomnia Severe muscle spasms in the bicep of arm he got the vaccine/now it is (muscle spasms) spread to othe... Read more
Severe muscle spasms in the bicep of arm he got the vaccine/now it is (muscle spasms) spread to other muscle groups; He could not sleep; This is a spontaneous report from a contactable physician (patient's wife). A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported) via an unspecified route of administration, administered in Arm Left on 03May2021 at 11:00 (at an age of 45-year-old) as dose 1, single dose for COVID-19 immunization. The patient medical history was not reported and had no problems with vaccines in past. Concomitant medications were not reported. The patient had no other vaccines given the same day or 4 weeks prior. On 03May2021, approximately 3-4 hours after the injection (dose 1), he developed a severe muscle spasm in the bicep of the same arm of the injection. Physician saw the contraction of the head of the bicep muscle. The first night was very frequent, overnight, and he could not sleep. He had not had that before the vaccine and did not do any exercises that could have caused it. After 5-6 days, it had improved but now spasms had spread in other muscle groups (at the time of report), like the quadriceps and on the back, but less severe compared to the arm. Spasms have continued, although improved and it was mainly at night now (at the time of report). The reporter was concerned if this could happen to anywhere in the body. Wonders if this could happen to any other part of body for the rest of his life. The reporter asked if patient should get his second dose if he has developed severe muscle spasms after the first dose. Physician did not feel that it was medically significant. On 03May2021, patient recovered from event could not sleep, the patient had not yet recovered from severe muscle spasm. Information on lot/batch number has been requested.
45 2021-07-27 insomnia Temperature 100.4; Muscle aches; Insomnia; Chills; Headache; Inflammation/feeling of significant ful... Read more
Temperature 100.4; Muscle aches; Insomnia; Chills; Headache; Inflammation/feeling of significant fullness; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO171), via an unspecified route of administration in the arm left on 28Apr2021 at 14:30 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history was not provided. The patient previously took bupropion for hives. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate 60 mg QD (ADDERALL) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 for COVID-19 immunisation (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150), via an unspecified route of administration in the arm left on 07Apr2021 at 11:30 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Apr2021 at 20:30 (after 6 hours of vaccination), the patient experienced inflammation/ feeling of significant fullness at site. On 29Apr2021 at 01:30 (after 11 hours of vaccination), the patient experienced insomnia, chills, headache and muscle aches. On 29Apr2021 at 08:30 (after 18 hours of vaccination), the patient experienced high temperature. On 29Apr2021 at 08:30, the patient underwent body temperature and the result was 100.4. The clinical outcome of the events headache and muscle aches was recovering; while the clinical outcome of the events inflammation at site, insomnia, chills and high temperature was not recovered. No follow-up attempts are needed. No further information is expected.
46 2021-01-04 poor quality sleep, abnormal dreams, restlessness, feeling abnormal No immediate reaction within 15 minutes of injection. Increasing injection site pain throughout the ... Read more
No immediate reaction within 15 minutes of injection. Increasing injection site pain throughout the day with mild chills and nausea starting around 7:00 pm (Approx 11 hrs after injection). Chills steadily intensified, with fever beginning, became severe over the next 2-3 hours, and persisted throughout the night. Along with the fever/chills & nausea, there was also moderate muscle/joint pain (mainly neck and back), moderate to severe fatigue and weakness, weird freaky dreams, restlessness, and moderate headache. Symptoms started to relent around 6:00 am the morning after injection, however fatigue/weakness, nausea, and mild fever/chills have persisted throughout the day with minimal improvement.
46 2021-01-07 disturbance in attention Pfizer-BioNTech COVID-19 Vaccine Approx 8 hours after receiving the vaccine, I suddenly became slig... Read more
Pfizer-BioNTech COVID-19 Vaccine Approx 8 hours after receiving the vaccine, I suddenly became slightly dizzy and moderately nauseous. I also became very tired even though I was well rested. The nausea and dizziness lasted approx 2-3 hours. At that time I developed moderate injection site pain. I was very fatigued for the remainder of the night and through the next day (6 Jan). I was no longer fatigued as of 7 Jan but starting that morning I had a very difficult time focusing mentally. That condition lasted until late on the evening of 7 Jan. As of 8 Jan, all symptoms have resolved and I feel fine.
46 2021-01-07 disturbance in attention Approx 8 hours after injection I suddenly became slightly dizzy and had moderate nausea. I also bec... Read more
Approx 8 hours after injection I suddenly became slightly dizzy and had moderate nausea. I also became very tired and fell asleep for about 1.5 hrs even though I was well rested. For the remainder of the night of 5 Jan and all day on 6 Jan I was fatigued and had moderate injection site pain. On 7 Jan, I felt much better (no fatigue or injection site pain) but had a very hard time mentally focusing. All symptoms resolved by the night of 7 Jan and as of 8 Jan feel normal.
46 2021-01-12 impaired work ability About an hour after taking vaccine I begin to get a headache. I went to get breakfast & coffee think... Read more
About an hour after taking vaccine I begin to get a headache. I went to get breakfast & coffee thinking that would help but it didn't. While eating I become nauseous. I stopped eating but still vomited (only once). At this time I started having shoulder pains and headache was worsting so I left work. About 2/3 hours after taking vaccine my entire upper body(shoulders up) was stiff! I took muscle relaxers and rested remainder of day. About 10/12 hrs after vaccine my headache was gone but still had moderate muscle pains. Upon waking up up my body aches were only moderate so I went to work. 26 hrs after vaccine, I'm still having mild/moderate body aches.
46 2021-01-12 insomnia EH9899 - Lot number wasn't indicated as different on the second dose. Few hives returned - had taken... Read more
EH9899 - Lot number wasn't indicated as different on the second dose. Few hives returned - had taken Benadryl 50mg - prophylactically . Subsided. Next evening (7th) - Hives returned and I took Zyrtec - 10 mg and they went away. (24 hours also - on the 7th) Did feel feverish, chills and achy after 24 hours after and I took an ibuprofen for that. Bumpy night; fitful sleeping but when I woke I was symptom free. Feverish went away sometime in the night and hives by the morning.
46 2021-01-14 feeling abnormal feeling "not quite right"; nausea; headache; arm was sore/ it felt like someone shot him in the arm;... Read more
feeling "not quite right"; nausea; headache; arm was sore/ it felt like someone shot him in the arm; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0140), via an unspecified route of administration on 24Dec2020 10:00 at SINGLE DOSE at left arm for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 31Dec2020, the patient experienced headache, "lungs felt uber clean and clear," and nausea. The patient stated about a week afterward he started feeling "not quite right" He stated his arm was sore for about 12 hours after the shot, but this has resolved. He has already seen his PCP, lungs are clear, and Covid test was negative. He said that a week ago, he started to feel not quite right. He said that his lungs felt uber clean, but stated that he had a headache and nausea every now and then. He was wondering if it is related to the vaccination. He said that he went to the doctor and his O2 sat was 99% and she did not even think he needed a Covid test, but the rapid test was Covid negative. He stated that on the website that it says that up to 7 days after vaccination 77% of people reported fever, chills, headache and other symptoms. He said that he did not know that you could experience side effects a week after getting a vaccine. He said that his eases his mind a little bit. He wanted to know if it could be because of the vaccine? He stated that sometimes he feels fine and other times he feels strange. He stated that sometime he just feels different. He said that he received the vaccine on 24Dec2020. Caller said that sometimes he is perfectly fine and then he will get the headache or nausea for a few moments and then it would go away. Caller said that at the doctor's office his blood pressure was 118/78 and his O2 sat was 99% He stated that he does work around Covid patients and takes all precautions when he is around them. He said that exactly 12 hours later after receiving the vaccine at 2200 24Dec2020, he said that it felt like someone shot him in the arm. 2-3 hours after he got up on 25Dec2020 it was gone. Caller said that he rarely gets sick and has not had the flu vaccine. The outcome of the events nausea, and headache was not recovered, and arm was sore was recovered on 25Dec2020, while unknown for the event feeling abnormal.
46 2021-01-25 impaired work ability That evening extreme funny feeling in left arm. Next day chills. After slight pain above chest and b... Read more
That evening extreme funny feeling in left arm. Next day chills. After slight pain above chest and below neck. Lathirgec and joints creeking. These feelings off and on even to today. Unable to go to work and stayed in bed with very little movement for over 12 hours. Able to function once I got up.
46 2021-01-28 anxiety, panic reaction 30 minutes after injection started feeling extreme anxiety, panic, and feelings of doom. Fast heart... Read more
30 minutes after injection started feeling extreme anxiety, panic, and feelings of doom. Fast heart rate, headache, and fatuige.
46 2021-02-02 feeling abnormal headaches for 20+ days, fatigue; brain fog and vertigo that still continue 38 days now.
46 2021-02-07 loss of personal independence in daily activities, mental impairment, impaired work ability, insomnia AFTER INJECTION GOT FEVER, NORMAL, NEXT DAY I STARTED TO GET RINGING IN MY EARS, SAW PRIMARY PHISIIS... Read more
AFTER INJECTION GOT FEVER, NORMAL, NEXT DAY I STARTED TO GET RINGING IN MY EARS, SAW PRIMARY PHISIISON AND HE SAID IT WAS FROM THE VACCINE, RINGING IN EARS FOR 11 DAYS NOW, CAN'T SLEEP, THINK, WORK, SCHOOL, ALL EFFECTED.
46 2021-02-11 feeling abnormal 12/15 vaccination 1/1 4:30 started having tingling and numbness in face, L side. Felt 'off'. My le... Read more
12/15 vaccination 1/1 4:30 started having tingling and numbness in face, L side. Felt 'off'. My left arm started to tingle and numb. Didn't last very long. Would come and go. Laid down. Ate some dinner; queasy. 1/2 Still felt 'off' 1/3 Symptoms occurred again with the numbness; face down to arm. HR was high for resting; 130's. BP 200/100. ED - CTA head/neck EKG, blood panel Symptoms resolved in ED; vitals normal 1/7 Neurology. Normal exam. MRI of brain; normal. Referral to cardiologist. Echocardiogram; normal Heart Monitor - waiting on results COVID - negative *DR/MGR of vaccine clinic
46 2021-02-15 sleep disorder Got First Pfizer Covid vaccine on 06JAN2021. About 4 days after that I started noticing allergy symp... Read more
Got First Pfizer Covid vaccine on 06JAN2021. About 4 days after that I started noticing allergy symptoms and mild intermittent wheezing. Then on about the 5th day after, my lower back pain increased, causing significant sciatic pain worse than ever before. On 22JAN21 I ended up going to urgent care for increased breathing problems, and also had to have pain management appointment within days as sciatic pain was debilitating and also significantly interfered with my sleep. After steroid injection (In spine)on FEB 3rd for sciatica/back pain, and steroids/inhaler treatment for the breathing stuff, I would say I was pretty good to go . I didn't think too much of these unusual events for me both in timing and severity. On 12FEB2021, I got my second pfizer covid dose. I 14FEB I started noticing allergy symptoms again, and slight shortness of breath, used inhaler I had from before to help as breathing in seemed to not give me full breaths. Then, on 15FEB2021, in the evening out of nowhere while walking, my lower back/sciatica pain came back in full force, as if my leg were a lighting rod like before. So it almost seems as if the covid vaccine triggered an inflammatory reaction in my body. I am not certain, but because the series of events seem the same and in timing after my first covid vaccine, I figured I would at least report it.
46 2021-02-17 impaired work ability, loss of personal independence in daily activities, excessive sleepiness 1/10/2021-Approximatley 34 hours after vaccination developed left facial numbness followed by severe... Read more
1/10/2021-Approximatley 34 hours after vaccination developed left facial numbness followed by severe dysequilibrium 5 hours later. 1/11/2021-left facial numbness and dysequilbrium significantly worse along with severe rotary nystagmus in the left eye. Had appointment with primary care and then ENT , who started me on prednisone 30 mg and antivert. ENT refered me to Neurology. Neurology ordered MRI/MRA that night and increased my prednisone to 60mg/day for 5 days followed by a taper over next five days. Currently, Symptoms of dysequilibrium and numbness have not subsided, on a second course of prednisone 60 mg/day for 3 days followed by taper. MD , Neurologist, provided Diagnosis of vaccine induced polyneuropathy affecting cranial nerves 5 and 8. Since the onset on January 10, Cannot work(physician/anesthesiologist) , drive, or perform minor tasks due to the severity of the symptoms. Symptoms during 1/10/21-1/17-21, bed-ridden, slept 18-20 hours/day, could not walk without assistance-would fall to the left, could not read, nystagmus of left eye, had to keep eyes closed due to severe vertigo/dysequilibrium, nausea. 1/18/21-1/24/21 slight improvement in disequilibrium/able to walk, no change in facial numbness severity , started on 100 mg gabapentin at night, and low dose valium 1.25 mg to 2.5 mg to help with dysequilibrium 1/25/21-1/29/21 50% improvement in facial numbness, began vestibular PT, slow improvement in dysequilibrium and ability to walk and read 1/30/21 Symptoms worsened again, facial numbness returned, dysequilibrium returned to its original severity, difficulty reading/focusing 2/1/21 Followed up with Dr, started another prednisone 60mg/day for 3 days, followed by taper over the next 5 days 2/4/21 Left Facial numbness not improved, dysequilibrium still severe, having difficulty focusing and reading
46 2021-02-23 nightmare "I had an uncomfortable night and bad dreams, left arm soreness more painful than flu soreness. 1/4... Read more
"I had an uncomfortable night and bad dreams, left arm soreness more painful than flu soreness. 1/4/21 5am fever 100.5, and took Tylenol at 5am." Reported feeling better now at 10:30 am
46 2021-02-26 confusional state Shortly after the vaccine confusion and hard time focusing along with fatigue, muscle aches, chills,... Read more
Shortly after the vaccine confusion and hard time focusing along with fatigue, muscle aches, chills, and swollen glands around his neck,
46 2021-02-27 feeling drunk Pale, SOB, cold/chills, nausea, emesis, feels like I am drunk the patient stated. EMS evaluated. Ref... Read more
Pale, SOB, cold/chills, nausea, emesis, feels like I am drunk the patient stated. EMS evaluated. Refused transport.
46 2021-03-04 feeling abnormal Patient received his Pfizer vaccine at 08:10 and at 08:25 he started feeling light headed and nausea... Read more
Patient received his Pfizer vaccine at 08:10 and at 08:25 he started feeling light headed and nauseated and had a vagal response. Episode lasted about 40 seconds but he did not become cyanotic or stop breathing. Pt denies any chest pain but was diaphoretic after episode. Called EMS for transport to CPH. Pt had syncopal episode with persistent Bradycardia. Current VS are P=40 R=22 BP 101/63 Pt A&O x4 with no focal neural deficits. Pulse ox is 100% on RA and pt states still feels a little "foggy". No rash or evidence of an allergic reaction.
46 2021-03-12 excessive sleepiness Starting about 5-6 hours after the shot I developed severe bloating, cramping and gassy-ness, litera... Read more
Starting about 5-6 hours after the shot I developed severe bloating, cramping and gassy-ness, literally constant burping. My stomach has been in constant pain. I?ve also had a slight fever and a very sore arm. Tylenol and rest has worked for the fever and arm, and I've had some addition body aches. Not sure how much is due to being in bed for an extended period. Also on Friday (about 24 hrs after getting the shot I was pretty fatigued. I just woke up from 13 hours of sleeping. But the stomach cramps/pains was severe and prompted me to try to find a way to report it, especially since it doesn't seem to be too common. It's been really bad.
46 2021-03-18 anxiety Progress Notes (Nurse Practitioner) Family Medicine Cosigned by: MD at 3/18/2021 2:57 PM Expand All... Read more
Progress Notes (Nurse Practitioner) Family Medicine Cosigned by: MD at 3/18/2021 2:57 PM Expand AllCollapse All Subjective male who was seen at Clinic today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the left deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience lightheadedness. He denied rash, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, itching, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, collapse, hypotension and rapid progression of symptoms. Pmh: htn, hld and sleep apnea. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches (negative for headaches) Denies vision changes.: +lightheaded, lips tingling: Previous Reactions: none Objective Vitals Vitals: 03/16/21 1429 03/16/21 1432 BP: (!) 182/96 (!) 173/105 Pulse: 86 SpO2: 99% Physical Exam Vitals reviewed. Constitutional: General: He is not in acute distress. Appearance: He is obese. He is not ill-appearing. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds and air entry. Skin: General: Skin is warm. Coloration: Skin is not pale. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Thought Content: Thought content normal. Judgment: Judgment normal. Tingling resolved. Still feeling lightheaded. Pt rested and had snacks and water. Slowly lightheadedness was reducing in severity. After 15 minutes of observation, he was able to stand w/o increased lightheadedness. He ambulates the bay w/o difficulty. Assessment/Plan Treatment included: water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Lightheadedness/elevated bp. Anxiety as well. Review of his prior bp numbers in epic records show fluctuation of his bp ranging from 180's to 140's. Recommended that he monitor bp at home. He doesn't have red flag symptoms related to elevated bp. He's to follow up with pcp accordingly. Electronically Signed 3/16/2021 2:29 PM
46 2021-03-18 insomnia Woke up next morning at 7am with itching hands, slight swelling in lips and ears, nausea and diarrhe... Read more
Woke up next morning at 7am with itching hands, slight swelling in lips and ears, nausea and diarrhea. Itching and swelling subsided with a dose of Loratadine. Nausea worsened that night and vomiting ensued with diarrhea worsening. At bedtime, itching returned, sleeplessness, vomiting and sweating profusely from the scalp and face, slight difficulty filling lungs with air. Another dose of Loratadine calmed symptoms. Wednesday (10th) through the next Thursday (18th ), nausea persisted, but eased with Benadryl and Emerton. Diarrhea persisted through Monday (15th). No fever, no soreness, no headache.
46 2021-03-23 anxiety, panic reaction facial paralysis; dizziness; weakness; palpitations; tingling; extremities numbness; panic; anxiety;... Read more
facial paralysis; dizziness; weakness; palpitations; tingling; extremities numbness; panic; anxiety; chills; This is a spontaneous report from a contactable consumer(patient) reported for himself. A 46-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 06Mar2021 12:00 at single dose for covid-19 immunisation. Medical history included left kidney missing. Patient had allergies to Ambroxol, levofloxacino, cefalosporina, hidrocortizona. The patient's concomitant medications were not reported. First symptom took place 5 minutes after receiving the vaccine, it started with a severe dizziness followed by body weakness, quite accelerated and uncontrolled palpitations, tingling and extremities numbness, mild right-sided facial paralysis, panic feeling and anxiety. Finally, severe chills. Full recovery after 40 minutes with a mild lightheadedness for a few hours. Vital signs kept stable at all times according to paramedics' diagnosis. Patient received treatment for these events. Outcome of events was recovered. Information on the lot/batch number has been requested.
46 2021-03-23 feeling abnormal Weird sensation on jaw area BP 130/88
46 2021-03-25 agitation Patient describes fatigue starting 1 hour after receiving vaccination. Patient now calls COVID19 hot... Read more
Patient describes fatigue starting 1 hour after receiving vaccination. Patient now calls COVID19 hotline 3 days after initial symptoms and states fatigue is more moderate. Patient experiencing loose stool. Patient has hx of IBS however symptoms are worse than baseline. Patient describes mild headache and increase in agitation/moodiness. Hx of bipolar disorder.
46 2021-03-25 insomnia, impaired work ability I had trouble sleeping and became very emotional. This may be unrelated to the vaccine but I thought... Read more
I had trouble sleeping and became very emotional. This may be unrelated to the vaccine but I thought it best to report because I had an unusual night. I called off from work today because I couldn't sleep.
46 2021-03-26 nervousness Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: Patient's wife communicated ... Read more
Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: Patient's wife communicated that patient was nervous before getting his shot. Shortly after getting shot, he vomited.
46 2021-03-30 fear Patient felt faint and feared passing out. Staff help patient to prone position and elevated feet. B... Read more
Patient felt faint and feared passing out. Staff help patient to prone position and elevated feet. BP monitored and after ten minutes, patient returned to seat, waited another thirty minutes and left under own accord.
46 2021-04-02 feeling abnormal Same day experienced heart racing and palpitations on a regular basis, usually every 40 min.- 1 hr. ... Read more
Same day experienced heart racing and palpitations on a regular basis, usually every 40 min.- 1 hr. Since that first day, heart has felt enlarged.
46 2021-04-02 impaired work ability Body has been weak and shaky since I got the vaccine. I have had 2 episodes where I am short of brea... Read more
Body has been weak and shaky since I got the vaccine. I have had 2 episodes where I am short of breath and my blood pressure has gone up. The doctor has put me on anxiety medication but I still feel no difference. I have not been able to work for the past 3 weeks.
46 2021-04-04 sleep disorder, thinking abnormal Headache, nausea, cloudy thinking, overall body aches, swelling in neck and under arm pit-breast are... Read more
Headache, nausea, cloudy thinking, overall body aches, swelling in neck and under arm pit-breast area on arm where shot was given, fatigue not able to sleep, day 5 and symptoms have continued and are getting worse.
46 2021-04-06 anxiety, panic attack patients appointment is the same day as Covid vaccine, 28Feb2021; States he was told by the physicia... Read more
patients appointment is the same day as Covid vaccine, 28Feb2021; States he was told by the physician that it is possible the Covid vaccine is note safe; them on Saturday and his kinase was 1015; he wasn't feeling well; nausea; unable to articulate how he feels due to depressed ability to speak; panic; anxiety; This is a spontaneous report from a contactable pharmacist. A 46-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 04Feb2021 15:45 as single dose for COVID-19 immunization. Medical history included learning disability (found out last March he has a genetic disability, MECP2, which is a gene that carries Rhett's, autism, and Asperger's), rectal hemorrhage, fecaloma. The patient previously took Lipitor and experienced blood creatine phosphokinase increased, Aricept (2 doses, 1 in am and 1 in pm) and experienced gait inability and rhabdomyolysis, simvastatin (20mg for years and that was discontinued back in Jan or Feb of 2020), atorvastatin and experienced rhabdomyolysis and coumadin and experienced atrial fibrillation. Concomitant medications was not reported. Around Apr or Mar of 2020, the patient was hospitalized, and his creatinine kinase level was about 6000 and got better and was diagnosed with rhabdomyolysis. The creatinine kinase level on 16Jun2020 was 131 and on 17Dec2020 his creatinine kinase total level was 56 and that the range is 44-196. After receiving the first dose of vaccine, the patient wasn't feeling well, he reportedly has at baseline of being unable to articulate how he feels due to depressed ability to speak, but "he began talking to himself, had nausea and wasn't feeling well". So they took him to the doctor and had labs drawn on 12Feb2021 which showed elevated creatinine kinase levels measuring 1,019. They were instructed to speak to a rheumatologist and got another level on 22Feb which came back as 66. The pharmacist reported that back in Dec2020, the patient's kinase level was 55. Kinase was 1015 (blood creatine phosphokinase increased) on 12Feb2021, feeling unwell, nausea, unable to articulate how he feels due to depressed ability to speak, panic, anxiety in 2021. The pharmacist reported that he was told by the physician that it is possible the COVID vaccine is not safe. They were instructed to speak to a Rheumatologist and got another level on 22Feb which came back as 66. The patient's appointment is the same day as COVID vaccine, 28Feb2021. The patient is scheduled to receive his second dose of the vaccine this Thursday and he asked if it is safe to receive the second dose of the vaccine after reacting to the first. The patient underwent lab tests and procedures which included blood creatine phosphokinase: 6000 on 2020, 131 on 16Jun2020, 55 on Dec2020, 56 on 17Dec2020, 1015 on 12Feb2021, 1019 on 13Feb2021, 66 on 22Feb2021, magnetic resonance imaging: diagnosed with MECP2 on 12Feb2021, weight: 180-190 lbs, weight: 141-142 lbs, weight: 140.2 or 140.8 lbs on 12Feb2021. The reporter assessed the events to be non-serious. The outcome of the events was unknown. Information about lot/Batch requested.
46 2021-04-06 hallucination Hallucinations lasting approximately 1.5 hours
46 2021-04-08 confusional state Site: Pain at Injection Site-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: ... Read more
Site: Pain at Injection Site-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Tachycardia-Medium, Additional Details: PT HAD FLUSHING AT 9 PM HEADACHE AND PASSED OUT FRACTURING HIS MANDIBLE IN PROCESS. PT HAD ATRIAL FIBRILLATION PT IS IN STABLE CONDITION ON DILTIAZEM HAD NO HX OF HEART DISORDERS PRIOR TO VACCINE
46 2021-04-10 feeling abnormal After sitting in waiting room at 10:00, at 10:03 a.m. began to feel strange with a sort of coldness ... Read more
After sitting in waiting room at 10:00, at 10:03 a.m. began to feel strange with a sort of coldness and dizziness. Woke up on the floor with nurses around. Was told by nurses, I was convulsing and was placed on the floor by nurse. After several minutes paramedics arrived and checked all vitals and blood pressure.
46 2021-04-10 insomnia Tinnitus. Continuous ringing in ears that will not go away. I was perfectly healthy before the sh... Read more
Tinnitus. Continuous ringing in ears that will not go away. I was perfectly healthy before the shot.. then several days after developed an ache in my right abdomen, fatigue and constant ringing in ears that will not go away. I'm also having a very hard time sleeping.. sometimes only being able to get 2 or 3 hours a night regardless of how tired I am. I'm very disappointed and not sure if I should get the second shot or not given how I'm feeling now. Before the shot I was perfectly healthy. I eat well, exercise and have never in my life experienced tinnitus or any type of hearing problem. This shot was the ONLY thing that could have caused this. I'm not sure what to do next or if I should get the second shot which could make it worse. I'm very worried because the ringing and aches have been constant for 10 days.. some days worse than others.
46 2021-04-12 anxiety Patient began experiencing feeling hot and flushed approximately 10 minutes after injection. He fel... Read more
Patient began experiencing feeling hot and flushed approximately 10 minutes after injection. He felt it was similar to his anxiety attacks he had in past. He had multiple "waves" where he said he would feel anxious, his heart rate would increase. His vital signs remained stable. At 09:26 am, he had a tightness in chest and states he normally gets that with his anxiety. Site captain consulted and continued to monitor patient and vitals. At )9; 33 a.m. he had chest pressure, and tightness. Described the pressure was 'different' than his usual. EMS was called and recommended follow up at hospital since his father died of heart attack at age 38, and he has had no follow up with heart since he was in high school. Patient refused EMS transport but his wife said she would drive him to be evaluated. EMS loaded patient into private vehicle.
46 2021-04-13 impaired work ability Symptoms: lethargic, exhausted, tired, sleepy, low energy, short of breath while talking, short of b... Read more
Symptoms: lethargic, exhausted, tired, sleepy, low energy, short of breath while talking, short of breath even with minimal physical activity , it's been 7 days since vaccine, unable to finish 8 hr shift at work
46 2021-04-16 disturbance in attention, memory impairment, confusional state A 46 y.o. male who presents today with numbness in both legs, difficulty concentrating and forgetful... Read more
A 46 y.o. male who presents today with numbness in both legs, difficulty concentrating and forgetfulness, and cough with chest tightness. Covid symptomatic in November. Received Covid Pfizer vaccine on 4.13.21 at 1pm. Felt fine headed into the vaccine. He completed the observation period and felt chest tightness after about 5 minutes similar to Covid in November. He felt slightly better and went to work. At work his cough and chest tightness worsened. Very tired, unable to eat with no appetite. Extreme fatigue Wednesday sleeping most of the day. Cough and chest tightness and feeling he cannot catch breath like being submerged in a pool. On 4.15.21 his feet became numb and tingling bilaterally. He felt more confusion, forgetting what he was doing, left frozen food in the sink and unable to recall why. He is also having headache posteriorly 7-8/10 which began on 4.14.21. He reports headache is not common, now 3-4/10 and feels very similar to Covid in November. Does have some mild neck stiffness associated. Chest tightness almost identical to Covid in November. Reports numbness and tingling in the feet has been ascending in nature. He felt unsteady on his feet yesterday morning. He is having tingling and cramping in the bilateral calf muscles today. His cough continues with no phlegm. Comes in coughing spells with chest tightness. He also noted cough is worse with exertion. Fever 99.8 yesterday. No diarrhea. No loss of smell or taste. In ED noted to have right LE weakness. Wife reports that he seemed unsteady while walking Kept for observation. difficulty concentrating - back to baseline 4/17/21 at 3:26 pm assessment SOB: CTA thorax 4/16/21 unremarkable CT angiogram thorax Symptoms began approximately 5 minutes after his Pfizer. Reports that his cough and shortness of breath now seems to be improving. Continues to have some mild chest tightness, intermittent cough. Robitussin significantly helped. Extensive workup including CT angiogram of the thorax reveals no evidence for pulmonary embolism or infiltrate. COVID-19 PCR testing is negative x2, severe respiratory isolation has been discontinued. Patient has a negative D-dimer, LDH, ferritin, CRP. Cardiac troponin has been negative x2. Patient does have some wheeze, after cough, suggesting some bronchospasm. Will trial albuterol inhaler q.i.d.. Patient does report a history of what sounds like an environmental triggers asthma like event in the past, though reports that he has undergone evaluation for asthma and was told that he does not carry a diagnosis of asthma. Patient is currently on room air. I have reviewed the reported adverse reactions from the Pfizer vaccine and coughing shortness of breath are not listed. Continue supportive care, with Tessalon and Robitussin, IS
46 2021-04-18 insomnia Following the first shot I have developed what appears to be tennis elbow in my left arm. Not sure ... Read more
Following the first shot I have developed what appears to be tennis elbow in my left arm. Not sure if it is related or not. Symptoms did not begin until after I received the shot. Also, I have not been sleeping as well. I have never had a sleeping issue but now find myself waking up around 4-5AM whereas this never occurred before. These are not terrible side effects but just wanted to report them to see if anyone else is experiencing anything similar.
46 2021-04-18 sleep disorder On March 25, 8 days after the vaccine shot in my left arm, I began experiencing intense pain on the ... Read more
On March 25, 8 days after the vaccine shot in my left arm, I began experiencing intense pain on the left side of my neck and head. By March 28 the pain had become so excruciating I went to an Urgent Care facility and they sent me to the Emergency Room. While in the ER I had blood tests and a CT scan which all came back negative. I was given Oxycodone-Acetaminophen for the pain and prescribed Cephalexin in case there was some type of infection. They also ruled out Shingles. I continued to have pain and contacted my Primary Care Physicians Office and spoke with one of the Physician Assistants two times the next week. She prescribed Baclofen 10 mg and took me off the Cephalexin and put me on Amoxycillin because we thought the problem might have been an ear infection. The next week I spoke with my Primary Care Physician, and he believed I was suffering from Trigeminal Neuralgia, so he put me on Carbamazepine 200 mg twice a day. That same week, on April 9, I was finally able to meet with the Physician Assistant at the Neurologists office and she also believed I was suffering from Trigeminal Neuralgia. I continued to take the Carbamazepine daily and the Baclofen and Oxycodone-Acetaminophen as needed. On Monday April 12 I informed the nurses at the Neurologist office that I was experiencing several symptoms/side effects that included dizziness, weakness, difficulty swallowing and a pounding heartbeat. The nurses talked with the PA and the PA took me off the Carbamazepine and put me on Oxcarbazepine 150 mg twice a day and she prescribed Methylprednisolone 4 mg. On Thursday April 15 I began to have intense prolonged pain behind my left ear down to the neck and in the Trigeminal nerves in the forehead and top of the head on the left side. I was in so much pain I slept for less than 2 hours. The next morning, I vomited and went to the Emergency Room again. At the ER they treated my pain with a headache IV cocktail that included Ibuprofen, Benadryl, an anti-nausea medication, Fentanyl, and a steroid. Within an hour my pain level dropped from a 9 to a 3 and I was released. The ER prescribed Gabapentin 300 mg (3 times a day) which I started the evening of April 16. I have had less constant pain since leaving the ER and starting the Gabapentin, but I continue to have pain in the Trigeminal nerve areas and neck with some flare ups that reach a 7 out of 10 in pain. I am scheduled for an MRI on April 23 and a visit with the Neurologist on May 10.
46 2021-04-20 confusional state Pt recieved 2nd dose of pfizer vaccine on 4/14. on 4/15 pt had fever up to 103. Pt has had ongoing ... Read more
Pt recieved 2nd dose of pfizer vaccine on 4/14. on 4/15 pt had fever up to 103. Pt has had ongoing fevers since. On 4/20 pt became confused and displayed s/s of stroke. Brought to hospital by EMS and evaluated for stroke like sx. Pt was treated for stroke- given TPA and placed in ICU. CT showed show evolving subacute infarct. Pt has word difficulty, confusion, diaphoresis. Currently still in ICU.
46 2021-04-21 nervousness Pt was nervous before getting shot. After receiving shot he was in a monitor area. He raised hand ... Read more
Pt was nervous before getting shot. After receiving shot he was in a monitor area. He raised hand and stated he felt weak. He was pale and diaphoretic. Helped him to ground and allowed to rest. Felt better. Pt evaluated by paramedics. VS @ 1107 HR 68, OxSat 99%, BP 96/47. @1115 Sit in chair. BP 104/56, HR 70, OxSat 100%. @ 11:45 Pt ambulated w/o difficulty. Taking bus home. Told to call nurse when he arrives home.
46 2021-04-27 confusional state Within 15-minutes of vaccination, the patient reported dizziness, but they did not syncopize. EMS ev... Read more
Within 15-minutes of vaccination, the patient reported dizziness, but they did not syncopize. EMS evaluated the patient on-site. The patient was slightly hypertensive (147/92). EMS transported the patient to Emergency Department. In the ED, the patient presented with dizziness and confusion. Physician administered 1L normal saline bolus. Labs and imaging were unremarkable. Physician spoke with patient's mother who stated that the patient is at baseline given significant psychiatric history. Patient was discharged with a diagnosis of dizziness.
46 2021-04-27 nervousness After both shots. About 1-2 minutes after I started feeling nauseous, shaky, dizzy and then my heart... Read more
After both shots. About 1-2 minutes after I started feeling nauseous, shaky, dizzy and then my heart pounding out of my check for 30-40 seconds. My heart settled down and I was shaky and jittery the rest of the day.
46 2021-04-28 anxiety 46 year old male with history of depression, polio, HTN/HLD, chronic lung disease 2/2 remote PNA, a... Read more
46 year old male with history of depression, polio, HTN/HLD, chronic lung disease 2/2 remote PNA, and cirrhosis suspected 2/2 schistosomiasis, who presents with 1wk of dyspnea, w/ waxing waning subjective fevers. Per ED Note: Endorses chronic fatigue until 4/16 when he received first dose of Covid vaccine (Pfizer). Since then, pt reports persistent dyspnea, worsening fatigue. Reports 2 days of left-sided chest pain w/ periumbilical abd pain and enlarging abdomen. Pt believes these are 2/2 covid vaccination. Chest pain is described as constant generalized discomfort under left breast that worsens with pressure. Also worse with deep inspiration. No radiation or migration since onset. Pt describes abdominal pain as periumbilical tightness, "pain". Describes subjective, unmeasured fevers that "come and go" over last week. When asked to repeat the story of what happened on arrival to the unit, wife speaks for the patient since he is slightly dyspnic. States this morning, went to small clinic, husband had a headache and slight fever. Clinic said to come in to the big hospital. Fever and pain in legs and head, started a few days after he got the covid vaccine. The fever came and went. Didn't measure the fever. Also has some problems with Abdominal pain - doesn't know how to describe it. Feels like stomach ache. Stomach pain is getting better. Has since gone away since arriving to the hospital. He denies any cough, denies chills, denies nausea or vomiting. States he took some medications at home for constipation because he felt like he couldn't go. From the conversation it appears he does not take lactulose for HE, more for constipation. ED workup included an Xray, CT C/A/P with multifocal lung lesions suspicious for multifocal pneumonia. Lactate of 16. Na of 124. Noted to be anemic and thrombocytopenic. UA cloudy, pyuric, w/protien >100. Chest and abdominal pain resolved by the time pt was examined on the floor. Still tachypnic and tachycardic. Stated most bothersome was feeling anxious. Has anxiety at a baseline. Not complaining of any pain at the moment. Cannot describe chest pain in more detail, put his hand over the right side of his chest and presses on it but does not say if it hurt more when he would press on it, does not say it was reproducible. Not painful when he touches or presses on it now. Per chart, patient recently re-established care after long-time from follow up during pandemic. At visits last month c/o gingival bleeding, fatiguem & found to have Hgb drop from 13 in 2018-> 9.7 on 3/2/21. Referred for EGD but cancelled due to anxiety. I am the Infectious Diseases attending asked to see him for septic shock. He developed septic shock and respiratory failure requiring mechanical ventilation and 3 vasopressors. He has evidence of DAH, DIC, acute renal failure, progressive liver failure and he has Klebsiella pneumoniae bacteremia.
46 2021-04-30 confusional state Numbness and Paresthesia bilateral feet and shins; Numbness and Paresthesia bilateral feet and shins... Read more
Numbness and Paresthesia bilateral feet and shins; Numbness and Paresthesia bilateral feet and shins; right lower extremity weakness; cough; shortness of breath; chest tightness; confusion; This is a spontaneous report from a contactable physician reporting for a patient. A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 13Apr2021 13:00 (Batch/Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation at 46 years old. Medical history included DJD cervical spine and Raynaud's Phenomenon from an unknown date. Concomitant medications included amlodipine taken for an unspecified indication, start and stop date were not reported. The patient experienced numbness and paresthesia bilateral feet and shins; right lower extremity weakness, cough, shortness of breath, chest tightness, confusion on 13Apr2021 13:15. Treatment included albuterol. The patient was hospitalized for the events on an unspecified date for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (Nasal Swab): negative on 16Apr2021 and 17Apr2021, and blood test (SARS-CoV-2 antibody test) negative on 16Apr2021.Outcome of the events was recovered with sequelae (Recovered with lasting effects) on an unspecified date in 2021.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available information and the temporal association of BNT162B2 administration to the events, a possible contribution of the drug to the 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
46 2021-05-03 feeling abnormal, anxiety Initially developed fatigue, myalgias, and headache after vaccine administration. On 5.3.2021 devel... Read more
Initially developed fatigue, myalgias, and headache after vaccine administration. On 5.3.2021 developed "brain fog" where patient had difficulty focusing, completing tasks, and subsequently developed anxiety symptoms.
46 2021-05-03 loss of personal independence in daily activities I had a Stroke; Blood clot travelled to my brain; effected left side of my body; ability to speak; T... Read more
I had a Stroke; Blood clot travelled to my brain; effected left side of my body; ability to speak; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: ER 8729), via an unspecified route of administration in left arm on 10Apr2021 (at the age of 46-years-old) as single dose for covid-19 immunisation. The vaccination facility type was a pharmacy/drug store. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not have covid prior vaccination. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had a stroke. Blood clot travelled to his brain and effected left side of his body and ability to speak on 15Apr2021 at 17:30. The events resulted to emergency room/department or urgent care, hospitalization for 3 days, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received unspecified treatments for the event. Covid test post vaccination on 15Apr2021 with result of negative. The outcome of the events was recovering.
46 2021-05-04 feeling abnormal This is a spontaneous report from a contactable consumer (patient's fiance). A 46-year-old male pati... Read more
This is a spontaneous report from a contactable consumer (patient's fiance). A 46-year-old male patient received the first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 18Apr2021 11:20 (Lot Number: EW0162) (received at the age of 46-years-old) as SINGLE DOSE for COVID-19 immunisation. Medical history included right knee pain. Concomitant medications were not reported. The patient received the Pfizer 1st shot 18Apr2021 11:20 am. On 19Apr2021, at midnight, he had low grade fever then swelling right leg. On the day of the report, 20Apr2021, he had swelling to both legs. The patient had taken ibuprofen as treatment beside propping legs up. The reporter wanted more information on the swelling and if it's related to taking ibuprofen. It was further reported that the patient experienced severe swelling from the knees down to the calves on both legs on 19Apr2021. He also experienced night sweats, fever, lightheadedness and dizziness on 19Apr2021. They want to know if there are any reports regarding the swelling side effects and if it is from the vaccine. The first dose of the vaccine was given 2 days ago (18Apr2021) and the second dose is due on 09May2021. The patient got his first shot on 18Apr2021 about 11:20am. After about 15 hours he developed swelling in one leg, she later clarified this to be his right leg, and now reports that both of his legs are swollen at the time of report (20Apr2021). She noted that patient told her his legs are not painful. She doesn't know if it's a blood clot or if they needed to go to the hospital. She also wanted to know if there is information about this as a side effects or if other people are having this too. She then reported that the patient started experiencing a fever, profuse sweating, and was spacey about 12 hours after the vaccine, a little after midnight 19Apr2021. She doesn't know if the dehydration made it worse. His fever was low-grade 99.8 degrees and lasted 4 and a half to 5 hours and has now resolved. When asked if patient received any treatment for fever, caller said it was so recent, and that was listed as a common side effect that goes away. Reported the patient drank fluids and she kept an eye on him. Leg swelling was about 15 hours after the vaccine, early morning 19Apr2021. She noted that the swelling in the right leg got bigger and didn't go down, but the left leg did. But today the left was more swollen and more prominent today. She further clarified that the patient takes ibuprofen for pre-existing right knee pain. Caller also reported that the patient propped his legs to alleviate the swelling, it has improved some but the swelling did not go away. The adverse events did not require a visit to the physician office or emergency room. Outcome of the event fever was resolved on 19Apr2021 (lasted 4 and a half to 5 hours); outcome of the event "severe swelling from the knees down to the calves on both legs" was not resolved; outcome of the remaining events was unknown.
46 2021-05-04 feeling abnormal full body aches; headache/headachy; fogginess/cloudiness; This is a spontaneous report from a contac... Read more
full body aches; headache/headachy; fogginess/cloudiness; This is a spontaneous report from a contactable consumer reported for himself that a 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm on 02Apr2021 (Lot Number: EP7533; Expiration Date: 30Jul2021) as SINGLE DOSE for covid-19 immunisation. Patient took the first dose of vaccine on 12MAR2021 (Lot number: EN6208, Expiry date: 30Jun2021), also at age of 46 years old for covid-19 immunization. He didn't have any kind of soreness after the first COVID vaccine. He had no tenderness, no side effects, nothing. For the first time it was about 13:30 in the afternoon and then the second time was he wanted to say about 10:00 am. He had both dose in his shoulders, one was in the left and one was in the right. Vaccine Administered at Military Facility was No. Vaccination Facility was Hospital. Prior vaccination (within 4 weeks prior) was none. The patient medical history and concomitant medications were not reported. Patient had the headaches and also had bad fogginess about 6 hours after the COVID vaccine was administered and the full body aches kicked in the next morning which was about 20 hours after the COVID vaccine was administered and then like he said the body aches went away and the only thing that has really lingered from time to time was the headaches. The body aches started on 03Apr2021 and were over by the following Monday, so 05Apr2021. The cloudiness and the headaches began on 02Apr2021 but he did not have the cloudiness anymore. He got headachy very easily now and he has never experienced that before. He got headaches really easy, they were lingering, but they were not migraines it was just an achy head in the background, in the distance, and he can tell it was something different. The outcome of event headache was not recovered, the outcome of event full body ache was recovered on 05Apr2021,the other event was unknown. No follow-up attempts are needed. No further information is expected.
46 2021-05-05 panic attack Pt. self identified panic attack post second pfizer vaccine. PT declined RN interventions, self mana... Read more
Pt. self identified panic attack post second pfizer vaccine. PT declined RN interventions, self managed symptoms. Pt. ambulated from clinic after describing improved symptoms
46 2021-05-06 amnesia, mental impairment, feeling abnormal Within seconds of my first vaccine I had a massive headache. 20 mins later I had brain fog. An hour ... Read more
Within seconds of my first vaccine I had a massive headache. 20 mins later I had brain fog. An hour later I had exhaustion and then injection site arm began hurting. This lasted for 48 hours and then I was fine. It came on fast and stayed. I had difficult time thinking or retaining a memory. Second shot had no instant reaction, injection site just slowly began hurting. An hour later, and very suddenly, brain fog hit me and i lost all short term memory, mid sentence. Similar to what I would consider a form of Alzheimer?s. At the same time I developed a headache, not as severe as the first shot, but I was more exhausted than the first shot. Forming sentences, being able to think was very difficult for 72 hours. I was exhausted, arm hurt. After the 72 hours, I lost my sense to smell. I am in my 96 hour since my second injection and still have no sense of smell. I can taste. Never had a fever but for both shots it felt like it was absorbed by my muscles and was then converted to something else which was then released back into my system. It was like I had sore muscles it was like my muscles became the poison. This effect was grossly more profound after the second vaccine. The ability to think was the scariest side effect.
46 2021-05-07 insomnia On 4/14, had a series of rashes on left side of face - eye lid, eye brow, forehead and well into the... Read more
On 4/14, had a series of rashes on left side of face - eye lid, eye brow, forehead and well into the scalp. Following a visit to Dr, He confirmed this to be Shingles and referred me to the Ophthalmologist as the Shingles had affected eye surroundings. I have been prescribed and taking Valacyclovir, Gabapentin, and Prednisolone eye drops to treat the Shingles. Into week 3, Shingles rashes have all healed, blisters have all crusted out and cleared, however nerve pain continues in the head and around the eyes. The ophthalmologist suspects this to be post-Shingles effect, i.e., Postherpetic Neuralgia. My current condition results in Insomnia during various nights, and itchiness/tingling sensations, for which I have to apply cold/wet compress and Calamine Lotion to provide temporary relief. As a result of above following the 1st COVID vaccine, I have postponed my 2nd COVID-19 (Pfizer) vaccine to 5/22. However, my confidence level to proceed and get this 2nd vaccine on 5/22 is low at this time, until CDC is able to let me know whether there is a link between the COVID-19 vaccine and this causing Shingles in rare cases, to help me avoid a repeat of the stressful experience after the 1st COVID-19 shot. I would greatly appreciate a callback or an email.
46 2021-05-12 feeling abnormal NORMAL COMMON SYMPTOMS FIRST THREE DAYS, EVERY 4 OR 5 DAYS FLU LIKE SYMPTOMS NO FEVER. WEEK THREE HI... Read more
NORMAL COMMON SYMPTOMS FIRST THREE DAYS, EVERY 4 OR 5 DAYS FLU LIKE SYMPTOMS NO FEVER. WEEK THREE HIVE LIKE BUMPS ON BOTH ARMS SMALL BUMPS ON FOREHEAD, LOSS OF APPETITE, KIDNEY, LIVER PAIN, BACK ACNE. COGNITIVE CLARITY LOSS.
46 2021-05-14 feeling abnormal brain fog; itching; hives; Rash; This is a spontaneous report from a contactable consumer (the patie... Read more
brain fog; itching; hives; Rash; This is a spontaneous report from a contactable consumer (the patient, reported for self) A 46-year-old male patient received first dose of PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration, administered in arm left on 03Mar2021 10:15 (At 46-year-old) as single dose, for COVID-19 immunization. The patient medical history included ongoing anxiety, blood cholesterol, cardiac disorder from an unknown date. Patient reported that he was diagnosed with anxiety like 8 years ago. Patient reported that he started to have issues with his cholesterol maybe 5 or 10 years ago. Patient reported that his cholesterol had been going up and down. Patient reported that couldn't keep it down so he started taking medication, Atorvastatin. Patient reported that he has heart problems, with his bicuspid aortic valve. Patient reported that the problems with his heart valve were diagnosed when he was 14 years old. Additional Administered Vaccines were None. No Family Medical History Relevant to adverse event. Concomitant medications included sertraline hydrochloride (ZOLOFT) 100 mg, by mouth, once daily taken for Anxiety, atorvastatin 20 mg, by mouth, once daily taken for blood cholesterol for all start and stop date were not reported. Additional Information for Concomitant Products Zoloft included: Patient reported that he took the after market off brand of Zoloft. No further details provided regarding this statement. Patient stated that he began taking Zoloft like 8 years ago. Patient reported that he began taking Atorvastatin about a year ago, maybe in 2019 or 2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, patient reported that he doesn't normally take the flu shot and hasn't had a vaccine in 10 or 15 years. Patient reported that on 04Mar2021 he had the first shot of the Pfizer vaccine for Covid-19, a week and a half into it, he developed a rash all over his body. Patient stated that the rash came up at night and was gone the next morning. Patient reported that 2 days later, the rash came up again and went away and then came up again, the rash is currently present, that he has a little bit all over in certain spots. Patient reported that he is due for the second dose of the Covid-19 vaccine on Wednesday, 24Mar2021. Patient stated that the report said if you develop a rash all over your body it is listed as a serious side effect. Patient reported that he didn't have any issues other than the rash/itching and that he is looking for some advice as to whether he is at risk and if he should take the second dose of the Covid-19 vaccine or not. Patient reported that he went to see his physician regarding the rash that developed after the first dose of the Covid-19 vaccine. Patient reported that his physician stated that it was a side effect and didn't really say much as to whether he should worry or not. Patient reported that he went to see his physician the following day after the rash disappeared, patient showed his physician pictures of the rash as he didn't have the rash at the time. Patient was unable to provide NDC number, lot number, or expiration date of the Pfizer Covid-19 vaccine as he does not have his vaccine card with him and was in his car and that he would be able to provide that information at a later date if he was contacted by Pfizer for a follow-up. Patient reported that he didn't want to end up in the ICU or anything like that and that he wants to be protected. Patient reported that he was looking at the Covid-19 vaccine fact sheet from Pfizer provided to him by CVS. Patient stated that it says there's risks and they're all listed- listed under signs of severe allergic reactions is a bad rash all over your body. Patient reported that he doesn't know if his rash would be considered severe, it was just itchy and a little scary, but he felt fine besides that. That is why he is seeking guidance on what to do for the second dose. Rash: Patient reported that in the beginning when the rash first developed it was itchy, now he doesn't feel the rash and there is very little of the rash now. Patient doesn't know if the rash is getting better but it seems like it has improved. Therapeutic measures were taken as a result of the adverse event, Treatment: Patient reported that he just took allergy medicine to treat the rash, he tried Benadryl at first and then Claritin. Patient reported that the Claritin seemed to work a little better. Patient reported that Benadryl didn't really do anything for the rash. Lot: 1800414; Expiration date: Aug2022; NDC: 50580-228-24; Strength: 25 mg; Package size: 24 capsules. Relevant tests: Patient reported that his physician looked at pictures of rash and looked at information about the Pfizer Covid-19 vaccine. No Emergency Room visit, but patient had visited the Physician Office. Outcome of the event rash was reported as recovering, outcome of other events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
46 2021-05-14 mental impairment mental dullness; Severe fatigue; muscle aches; body heaviness; This is a spontaneous report received... Read more
mental dullness; Severe fatigue; muscle aches; body heaviness; This is a spontaneous report received from a contactable consumer reported for himself and a other healthcare professional. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EW0170) at left arm on 26Apr2021 13:00 at single dose for COVID-19 immunization in Hospital. Medical history and Concomitant medications were none. No Known Allergies. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. the patient did not receive within 2 weeks of vaccination. It was reported nothing that made him feel in danger. Severe fatigue, mental dullness, body heaviness, muscle aches, all on 27Apr2021, 06:00 AM. Received shot at 1pm. Bicycle ride that late afternoon. No side effects until next morning. Major effects lasted until about 2pm the next day. All was back to normal the following morning after a normal night's sleep. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has note been tested for COVID-19. No treatment received for the events. Outcome of the events was recovered on 28Apr2021. Batch/Lot number has been obtained. further information has been requested.
46 2021-05-21 feeling abnormal Almost fainting 3 minutes/Almost fainted/Really close to blacking out; Almost passed out; Nauseated/... Read more
Almost fainting 3 minutes/Almost fainted/Really close to blacking out; Almost passed out; Nauseated/Swirling strong nausea through the body up to the chest; Rapid heart rate; Hyperventilation; Labored breathing; 5-10 minutes before able to uncramp his hands; Waves of the feelings came throughout the day; This is spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: ER8733), via an unspecified route of administration, administered in Arm Left on 15Apr2021 11:00 as single dose for covid-19 immunization. Medical history included sensitivities to ephedrine from an unknown date and unknown if ongoing. The patient had no concomitant medications. The patient experienced almost fainting 3 minutes/almost fainted/really close to blacking out, nauseated/swirling strong nausea through the body up to the chest, rapid heart rate, hyperventilation, labored breathing, 5-10 minutes before able to uncramp his hands, waves of the feelings came throughout the day, almost passed out/ really close to blacking out; all on 15Apr2021. The events were not required a visit to emergency room, nor physician office. Caller is a 47 years old patient who received the 1st dose of the Pfizer Covid vaccine on 15Apr2021. He complained of feeling nauseated, and rapid heart rate, with hyperventilation, and almost fainting 3 minutes after the 1st dose of the Pfizer Covid vaccine. This lasted approximately 15 minutes. 3 minutes after receiving a vaccine. He started to complaint about feeling nauseated. He started rapid heart rate which caused him to have hyperventilation and almost fainted. The episode last for 15 minutes and he just want to go and report it. Consumer confirmed it was the Pfizer Covid19 vaccine. The consumer wasn't still experiencing the side effects. They lasted to 5pm. I got my shot at 11am. The event was no longer persisting but he was wanting to understand the effect of the second shot, the consumer wasn't took any treatment for adverse event. Caller states that he is calling about the Covid Vaccine. Says with the first round of the vaccine he had an adverse event. He is looking to Pfizer and his doctor for some feedback to understand whether or not he should get the second dose. Says that about three minutes after the vaccine he felt a swirling, strong nausea throughout his body up to his chest. He had labored breathing and a really fast uncontrolled heart rate for about 5 minutes. States he was hyperventilating and almost passed out. He had to sit on the ground of the parking garage where he had gotten his vaccine. About 5-10 minutes later he was finally able to uncramp his hands. States that before the vaccine he was calm and not at all in an elevated state. States he is wondering about the second dose being stronger. He almost blacked out after the first dose. States it was close to the limit of what he could tolerate. States he needs further details. He was reading about clinical trials and some doctors. States that he did not have all the symptoms of anaphylaxis that they described. Says his symptoms lasted about 5 minutes or so. About 10-15 minutes later he was recovered. Says waves of these feelings came over him throughout the day. Says they decreased each time and ended that evening around 1700. Caller says he did not go to the Emergency Room when it happened. The nurses at the vaccination site attended him. At the end of the call the caller mentions that he has a sensitivities to ephedrine. States he does not take any Sudafed or Dayquil or anything like that. States he didn't know if that was relevant to mention or if anything like that is in the vaccine to make him have the response that he did. History of all previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No prior Vaccinations (within 4 weeks). No family medical history relevant to events. No Relevant Tests. The outcome of events was resolved on 15Apr2021.
46 2021-05-23 feeling abnormal A week after second shot: Intermittent 2 degree fever, lower back pain, tiredness, headache, weaknes... Read more
A week after second shot: Intermittent 2 degree fever, lower back pain, tiredness, headache, weakness, brain fog.
46 2021-05-28 confusional state Headache, Malaise, Confusion, Blurred Vision, Nausea, Joint Pain, Dizziness, and TMJ flare ups. All ... Read more
Headache, Malaise, Confusion, Blurred Vision, Nausea, Joint Pain, Dizziness, and TMJ flare ups. All symptoms have not subsided since the day after the 2nd vaccination shot. It has been 10-days.
46 2021-05-28 sleep disorder, thinking abnormal I only slept 1 hour; My arm, head and back hurt.; My arm, head and back hurt.; My arm, head and back... Read more
I only slept 1 hour; My arm, head and back hurt.; My arm, head and back hurt.; My arm, head and back hurt.; Dry mouth; coughing; random thoughts; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 15May2021 12:00 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 15May2021 12:15, the patient only slept 1 hour, his arm, head and back hurt. Dry mouth, coughing, random thoughts. He felt like he was dying over here. Events were considered serious, disability. No treatment was received for the events. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
46 2021-06-01 insomnia Spasms in hands and feet/spasms in his feet was a weird sensation like little explosions going off, ... Read more
Spasms in hands and feet/spasms in his feet was a weird sensation like little explosions going off, like a nerve issue, around feet, toes, and ankles; Both hands went numb; Both hands went numb and were tingling quite a bit and the next day when he woke up it was worse; He is having the tremors around ankles and feet; It is very uncomfortable and has not been able to sleep well because of it.; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0183), via intramuscular route administered in left arm (left shoulder as reported) on 17May2021 (age 46-year-old at time of vaccination) (in noon as reported) as single dose for preventative/COVID-19 immunisation. Medical history included had an allergy to penicillin and that was when he was a child, he thinks he had a rash. He does not know if he was still allergic. Prior Vaccinations (within 4 weeks) were none. Concomitant medications were none. It was reported that the evening after getting the first shot on 17May2021, both hands went numb and were tingling quite a bit and the next day when he woke up it was worse. On the third day after getting the shot he started getting and was still have spasms in hands and feet on 20May2021. The spasms in feet was a weird sensation like little explosions going off, like a nerve issue, around feet, toes, and ankles, stated it was also in his hands but not quite as much in hands. He still has numbness and tingling in hands and fingers. It was worrisome since he was an artist and paints. It is hard to paint with numbness and tingling. The numbness and tingling has stayed the same but there are periods of it getting intense from time to time, it has not subsided. He was hoping it would only last 2 or 3 days. As he was talking, he was having the tremors around ankles and feet in 2021. It was very uncomfortable and had not been able to sleep well because of it in 2021. The spasms are still the same, if anything they have worsened. No treatment received for events. The outcome of events tremor and insomnia was unknown and for remaining events was not recovered. Follow up needed, further information has been requested.
46 2021-06-03 loss of personal independence in daily activities had to go to sleep; Could not function correctly; They had headache; body aches; chills; He felt rea... Read more
had to go to sleep; Could not function correctly; They had headache; body aches; chills; He felt really exhausted and drained.; Pfizer Covid Vaccine first dose Date: 19 Apr 2021/Pfizer Covid Vaccine second dose Date: 03 May 2021; Pfizer Covid Vaccine first dose Date: 19 Apr 2021/Pfizer Covid Vaccine second dose Date: 03 May 2021; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable 46-year-old male patient reported that who received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, (Lot Number and expiry date unknown) via an unspecified route of administration at left arm as a single dose for COVID-19 Immunisation. Past drugs included Lisinopril taken for quite some time, 3 or 4 years, Nifidipine for blood pressure. Historical vaccine BNT162B2 via an unspecified route of administration (Lot Number / Expiry Date was not reported) on 19-APR-2021 as a single dose at left arm for COVID-19 immunisation. On an unknown date patient could not function correctly the day after both shots. They had to go to sleep. He said that the headache, body aches and chills started the same day as the shot after both shots. He felt exhausted and drained. Patient did not visit physician office or emergency room visit due to the event. Outcome of the events were recovered on an unknown date. Information on the lot/batch number has been requested.
46 2021-06-07 loss of personal independence in daily activities treatment received for the adverse event?: Yes: Advil; Started to feel fatigue; fatigue/fatigue inte... Read more
treatment received for the adverse event?: Yes: Advil; Started to feel fatigue; fatigue/fatigue intense that prevent me to do habitual physical activity; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: Unknown), via an unspecified route of administration, administered in left arm on 09Mar2021 at 09:30 (age at the time of vaccination: 46-year-old) as unknown, single dose for covid-19 immunization. The patient also received ibuprofen (ADVIL [IBUPROFEN]), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included hypertension and allergy with shellfish. Patient not administered other vaccine in four weeks. Patient not had Covid prior vaccination; Patient was tested Covid post vaccination. Concomitant medications included losartan potassium (COZAAR), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), vitamin d (VITAMIN D [VITAMIN D NOS]). On 14Mar2021 at 13:00 after vaccination, the patient experienced fatigue and received Advil for the treatment of adverse event. It was reported that the patient started to feel fatigue on 14Mar2021 (D5) but on Mar162021 (D7) fatigue intense that prevent him to do habitual physical activity. (Patient was an athlete preparing for a triathlon but 16Mar2021 and he was not able to finish a 4mile run, which was very simple to his fitness level. The outcome of the events was resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
46 2021-06-08 feeling abnormal, anxiety, depression Depression and anxiety/gotten worse; Depression and anxiety/gotten worse; Brain fog/gotten worse; Br... Read more
Depression and anxiety/gotten worse; Depression and anxiety/gotten worse; Brain fog/gotten worse; Brain fog/gotten worse; Fatigue /gotten worse; This is a spontaneous report from a contactable other health professional (registered nurse reporting for her son).A 46-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on on 16Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization.On an unspecified date, A week or two later after first dose he started getting a lot of fatigue and brain fog and became depressed and anxious over the last few months. The patient had second dose 09Mar2021. States it has just gotten worse. Caller wants to know if this has been reported or if this could be related to the vaccine. The outcome of the events was not recovered. Information about batch/lot number has been requested.; Sender's Comments: Based on the plausible temporal relation, the association between the events of anxiety aggravated, depression worsened, brain fog, brain fog condition worsened and fatigue aggravated with the suspect product of BNT 162B2 cannot be completely ruled out. 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.
46 2021-06-08 loss of personal independence in daily activities Could not function correctly; Headache; Body aches; Chills; They had to go to sleep; He felt really ... Read more
Could not function correctly; Headache; Body aches; Chills; They had to go to sleep; He felt really exhausted and drained.; This is a spontaneous report from a contactable consumer or other non-Healthcare professional. A 46-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 19Apr2021 at 11:30 am (age at vaccination was 46 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure. The patient did not have any family medical history relevant to adverse events. Concomitant medications included lisinopril (40 mg, taking for quite some time, 3 or 4 years) taken for blood pressure and nifedipine (30 mg, taking for same amount of time as Lisinopril) taken for blood pressure. The facility where the most recent COVID-19 vaccine was administered was other. The vaccine was not administered at Military Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other additional vaccines were administered on same date of the Pfizer Suspect. On an unknown date, the patient could not function correctly and experienced headache, body aches and chills. The caller and his wife had both doses of the Pfizer vaccine. After the first dose, both could not function correctly. The caller explained that both he and his wife could not function correctly the day after both shots. They had to go to sleep. He said that the headache, body aches and chills started the same day as the shot after both shots. The caller reported that he took Advil and he was sleeping. The patient did not have physician office or emergency room visit due to the events. No relevant tests were done. The outcome of the events could not function correctly, headache, body aches and chills was resolved on an unknown date in 2021. The outcome of the events they had to go to sleep and he felt really exhausted and drained was unknown.
46 2021-06-09 anxiety, agitation feel minor aching; I felt faint/ inconsistent dizziness spells; It could of been anxiety; feeling of... Read more
feel minor aching; I felt faint/ inconsistent dizziness spells; It could of been anxiety; feeling of adrenaline rush; my vision was slightly askew as though I could not focus on objects.; my vision was slightly askew as though I could not focus on objects.; This is a spontaneous report from a contactable consumer, the patient. This 46-year-old male patient reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8735) via unspecified route on 21Apr2021 at 10:00 (at the age of 46-years-old) in the left arm as a single dose for COVID-19 immunization. Medical history included migraines. Patient had allergies to sulfa. Patient did not have COVID-19 prior to vaccination. There were no other vaccines received within four weeks of vaccination. Concomitant medications taken within two weeks included collagen, multivitamin and THC-free cannabidiol (CBD). On 21Apr2021 at 10:00, after a few seconds of being injected, patient felt faint. It could have been anxiety but then minutes later he had these inconsistent dizziness spells and a feeling of adrenaline rush. He felt many times like he could faint. It subsided after a few hours. Also his vision was slightly askew as though he could not focus on objects. On 22Apr2021, the next morning, he just felt minor aching. There was no treatment received for the events. The clinical outcome of the events felt faint/dizziness spells, anxiety, feeling of adrenaline rush, vision was slightly askew, could not focus on objects, and minor aching was recovering. Patient was not COVID tested post vaccination.
46 2021-06-10 fear This is a spontaneous report from a contactable consumer (father) or other non health care professio... Read more
This is a spontaneous report from a contactable consumer (father) or other non health care professional. A 46-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration administered in arm left on 24Mar2021 as 1st dose, single dose for COVID-19 immunization. Medical history included Parkinsons diagnosed 12 years ago and dystonia diagnosed 8 years ago from an unknown date and unknown if ongoing states the patient has had four deep brain stimulations and was in neurological care and takes a lot of medications. The patient's concomitant medications were not reported. Patient did not receive any vaccination 4 weeks prior to receiving Covid 19 vaccine. On 24Mar2021, the patient had the Pfizer Vaccine and a day and a half later could not feel his legs and has not been able to walk since; states the vaccine was the only different thing he had and everything else was routine and going on for years and his dystonia did not just jump and he can't say the reason this happened but it should be looked at. He can't say the Pfizer Vaccine was the reason for the reported events and he can't say it isn't the reason. On 26Mar2021, the caller stated that in the morning but could have been the night before as the patient was in bed and said he could not feel his legs and couldn't walk; states he could not stand up to this day on an unknown date and was in a wheelchair and everything was done in a wheelchair. Caller stated the patient had nothing new and no kinds of other medication or vaccines done other than what was prescribed by his doctor. Stated he was healthy other than what the disease has done to him. Stated for treatment everything was exactly the way it has always been and they adjust his deep brain stimulations once in a while and basically try to help out the dystonia and the Parkinsons seems to be taken care of but the dystonia was really the culprit. Stated that the patient had the Pfizer Vaccine and a day and a half later could not feel his legs and had not been able to walk since, the patient went to the health care professional and was going back again next week and the health care professional tried to adjust the batteries and increased his medication to see if that would help and the increased medication did nothing and nothing changed. The medication that did nothing was Carvidopa or Levodopa or whatever it was called and he went from taking 2 pills twice per day to taking three pills twice per day after the incident with the Pfizer Vaccine trying to help out and nothing changed. Caller states for some reason the Pfizer Vaccine just went in and did something to some part of his brain and must have gone after the weakest point and he was only guessing this as no doctor has answers and they don't know. The patient had been Carvidopa Levodopa for 12 years. Patient was afraid to take 2nd dose which was scheduled on 14Apr2021, and the patient did not take that. The event he could not stand up to this day and was in a wheelchair and everything was done in a wheelchair was assessed as serious (disability).The adverse events resulted in physician office visit. The vaccination facility type was reported as hospital. The outcome of the events was reported as unknown.
46 2021-06-10 mental impairment, confusional state, memory impairment Bad headache on Left side of head where ear is toward the back. Confusion, Dizziness, , Light headed... Read more
Bad headache on Left side of head where ear is toward the back. Confusion, Dizziness, , Light headed, Tingling and numbness from left eye to jaw. Drooping of left eye and lips. Memory and processing information issues. One month later still some head pain off and on and numbness around left eye. Still have memory and processing issues. I've never had any other prior issues with the head or face. No falls or activities such as boxing
46 2021-06-13 anxiety Patient was waiting in our observation area when he began to experience dizziness, cold sweats and t... Read more
Patient was waiting in our observation area when he began to experience dizziness, cold sweats and tunnel vision. He lay down on the floor, and our technician asked him if he was OK. I immediately went out to him, and he told me he was already feeling better. I had him put his feet up on the chair, and he told me that he thought this reaction was due to anxiety. He was talking and breathing normally. I offered to check his blood pressure and get him some water, but he declined. He rested on the floor for approximately 5 minutes and then said he was feeling well enough to go.
46 2021-06-24 feeling abnormal her husband said he got itchy immediately after receiving his first COVID-19 Vaccine; She clarified ... Read more
her husband said he got itchy immediately after receiving his first COVID-19 Vaccine; She clarified her husband's rash is on both sides of his left and right upper abdomen, between his ribs and hips, and on both his left and right shins; a week after her husband received his first COVID-19 Vaccine dose, he said he felt so bad; her husband said he felt run down a week after he received his first COVID-19 Vaccine dose; Injection site pain; This is a spontaneous report from a contactable consumer (patient's wife). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302, Expiration date: Not reported) via an intramuscular route of administration, administered in Arm Left on 12Jan2021 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included ongoing psoriasis, Allergic to penicillin. The patient's concomitant medications were not reported. It was reported that her husband had the same experience after he received his first COVID-19 Vaccine dose on 12Jan2021, clarifying her husband said he got itchy immediately after receiving the COVID-19 Vaccine. She said her husband has had psoriasis for a long time. She said her husband has had psoriasis outbreaks before, but not in that area of his body. She said her husband usually has a psoriasis outbreak at his waist where his belt buckle is located, as well as, his elbows, and knees. She said her husband doesn't have any allergies, except for Penicillin. She said her husband didn't think anything of his itchiness and rash after he received his first dose of the COVID-19 Vaccine because he has a history of psoriasis. She said the rash he developed after his first COVID-19 Vaccine dose went away. She clarified her husband's rash is on both sides of his left and right upper abdomen, between his ribs and hips, and on both his left and right shins. She said a week after her husband received his first COVID-19 Vaccine dose, he said he felt so bad, and felt run down. She said he was told at that time what to expect after receiving the COVID-19 Vaccine, and after a couple days he was OK. She said her husband said his left arm was so painful with the first COVID-19 Vaccine dose, that he said couldn't put on his shirt. The outcome of the events was recovered on Jan2021. Follow-up attempts are completed. No further information is expected.
46 2021-06-26 confusional state Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient reported extreme dizziness and light headedness; found on floor in waiting error. Remained conscious the entire time. Improved with water and cold compress. Called 911 but by the end of conversation patient was up and moving, no need for them to respond.
46 2021-06-28 hallucination I am unable to locate my vaccine card for that information but the adverse event started about a wee... Read more
I am unable to locate my vaccine card for that information but the adverse event started about a week after my vaccine. So after I had the second dose, my blood platelet count dropped dramatically, also my ammonia levels were elevated. Normal ammonia levels are 11-32 MM/L and my ammonia levels spiked up to the 70s on 4/29/2021. My vaccination was received on the 19th of April I think, I am not positive. So my levels spiked and I became hallucinogenic. It was quite an event, I had three police officers in my house. So we have had problems controlling my ammonia levels since then. My iron levels are also elevated and my platelet count is way way down as well. The vaccine may have triggered some sort of autoimmune response is kind of what my DRs are thinking right now. Once we get more information on that then we will be able to see why my body reacted the way it did. I went to the ER on 4/29/2021 and they did tests and then they sent me home. I have follow up appointments with DRs.
46 2021-06-29 anxiety Diaphoresis; Dizzy/lightheaded; Increased anxiety; Chills; This is spontaneous report from non-conta... Read more
Diaphoresis; Dizzy/lightheaded; Increased anxiety; Chills; This is spontaneous report from non-contactable other healthcare professional. A 46-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration, on 18Mar2021, (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 18Mar2021, during 15-minute waiting period after the vaccination, the patient experienced diaphoresis, dizzy/lightheaded and increased anxiety. The patient also complained of chills and dizziness. The patient denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light headedness, dizziness, facial swelling, lip swelling and tongue swelling. The patient received treatment as a result of adverse events experienced which included water, snacks and laying down. The patient had excellent response to treatment. The patient was stable to go home and was asked to follow up with primary care physician (PCP). The clinical outcome of diaphoresis, dizzy/lightheaded, increased anxiety and chills were recovered on 18Mar2021. No follow-up attempts are possible. No further information is expected.
46 2021-07-01 loss of personal independence in daily activities Approximately 1-2 days after my second dosage i developed progessivly severe pain in what i can best... Read more
Approximately 1-2 days after my second dosage i developed progessivly severe pain in what i can best describe as my rotator cuff. Over a couple days I then developed severe pain in both rotator cuffs, both knees throughout my back and in both thumbs at the bases between my thumb and wrists. This pain has persisted in all areas to this day and continues at varying levels and has at times severely affects my mobility/activity. I wore at times two or alternated knee braces and took lots of advil, ice, heat and self therapy with a vibrating muscle massager. I honestly feel that although the vaccine may not have caused all these issues it somehow attacked or targeted previous injuries or weak points in my body. I have had injuries or pain in these areas before but most not for 5-15 years and they all became almost unbearable within days for no reason. The severe lower groin pain that I felt very shortly after the first dosage had lessened substantially over the month. After the second shot it abruptly came back and has not left. It changes in severity but is now continually present and i will be seeking medical attention for it.
46 2021-07-09 disturbance in attention Rash eczema/psoriasis behind left knee and by right knee. Knee pain including significant swelling b... Read more
Rash eczema/psoriasis behind left knee and by right knee. Knee pain including significant swelling behind left knee which has resolved. Rash behind left knee resolved but right knee rash (burning/itching) has persisted but improved and using topical steroid. Severe diffuse headache, difficulty concentrating, slow performance, tachycardia to 120's mainly and some shortness of breath and left sided chest pressure for 48 hours along with fatigue. June 01, had tinnitus for a day. June 07, general intense feeling of not feeling well and headache. June 15, developed severe left leg pain and malaise. June 23, 8-9/10 pain behind left thigh and difficulty walking. Later developed exacerbation of prior mild right knee pain of recent onset to point could not walk.
46 2021-07-14 confusional state Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Additional Details: After giving the vaccine to the patient he fainted and fell off the chair hitting his head on the floor. This was a few minutes after the vaccine was administered. After fainting the pt was a little out of it and was bleeding on his nose/forehead. I gave him a water and ice pack for his head. I had him stay sitting on the floor and after 20 mins we decided to the ambulance because his family was not coming. He was checked out and decided not to go to the hospital.
46 2021-07-17 fear Next day left arm soreness lasted 2 days. Also 2nd day started feeling tired, exhausted for 1 week a... Read more
Next day left arm soreness lasted 2 days. Also 2nd day started feeling tired, exhausted for 1 week and nauseous for about 4-5 days. I fely hung over, achey, had slight fever and chills for 5 days. I am feeling 95% better now going on 9 days. I'm scared 2nd shot will be worse?
46 2021-07-17 feeling abnormal Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both ye... Read more
Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; This is a spontaneous report received from a contactable consumer (patient himself). A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: Ew0164) via an unspecified route of administration in left arm on 05May2021 10:00 for COVID-19 immunization. Patient medical history included High blood pressure and acid reflux. Concomitant medications included amlodipine besilate, benazepril hydrochloride (LOTREL) and esomeprazole magnesium (NEXIUM) 40mg. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE and lot number: Ew0164) administered in left arm on 01May2021 10:00 for COVID-19 immunization. On 29May2021 06:00 patient was experienced with Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting. Patient was went to physician office/clinic visit, Emergency room/department or urgent care. Patient was treated with Steroid shot and prednisone 50mg from urgent care. Outcome of events was not recovered.
46 2021-07-19 feeling abnormal Dose 1: 4/10/21, Dose 2: 5/3/21 hx obtained 6/24/21: per wife: was out of town, came home 6/13. 6/1... Read more
Dose 1: 4/10/21, Dose 2: 5/3/21 hx obtained 6/24/21: per wife: was out of town, came home 6/13. 6/17 went to casino, came back 6/18. ate a bag of sausage. dog bite that Friday. stomach felt weird. 3 days of HA, stomach ache, vomiting started Monday, went to urgent care the 21st - noticed some nystagmus, given tdap, given meclizine. was told if still not better, to ER. ER yesterday - was told dehydration, got IV fluids, got zofran IV, no imaging, had bloodwork and urine (WBC normal, h/h normal, abn neutrophils/lymphocytes. normal CMP), per wife was told blood in urine. since yesterday, continued HA, nausea, vomited in ER x 1. after zofran no vomiting today was ok, was getting out of car, felt like tripped, then almost fainted. no head trauma, no LOC. heaving. no chest pain, no shortness of breath, has not eaten today. Did take Tylenol today. 325 mg x 1. and ibuprofen 200 mg x 1. 730 am. since out of town, has been drinking couple drinks per day. marijuana gummies. marijuana from dispensary. no other drugs, no cigarettes. no hx of HA or lightheadedness sometimes when flying gets sinus HA on landing. no fever did have 99F when sleeping/hot, normal since then no blood in stools. primary sx is HA - constant throbbing 10/10 (currently 6/10) b/l frontal HA, nonradiating, better with lying down. +light sensitivity. no sound sensitivity. +nausea, +vomiting, several times per day. 2 episodes in 24 hours. no abdominal pain. has had lower back pain. tolerating PO. has had zofran and Tylenol. 2 days ago also had meclizine x 1. per pt always had low HR. no other changes to diet/medications. no facial droop, no one-sided weakness no speaking nonsense. several weeks ago "my heart felt like constant adrenaline" thought was stress - felt like something scared you adrenaline, lasted several days, coming on for several minutes at a time. last dose tadalafil was 1 week ago Pt sent to ER after this visit, but was then discharged home. pt presented to urgent care couple days later and was transferred to hospital after findings below
46 2021-07-28 emotional distress PATIENT CALLED PHARMACY TO REPORT FACIAL SWELLING. WAS ADVISED TO TAKE A COUPLE BENADRYL AND GO TO T... Read more
PATIENT CALLED PHARMACY TO REPORT FACIAL SWELLING. WAS ADVISED TO TAKE A COUPLE BENADRYL AND GO TO THE EMERGENCY ROOM. HE WAS UPSET AND ACCUSED US OF MAKING HIM TAKE THE VACCINE AND CLAIMED THAT WE SHOULD BE ABLE TO FIX HIS ADVERSE REACTION WITHOUT HIM HAVING TO VISIT THE ER OR COME BACK TO THE PHARMACY. HE CLAIMED THAT HE TOOK 3 BENADRYL AND THAT HE WILL WAIT TO SEE HOW HE FEELS.
47 2021-01-12 impaired work ability Myalgia Malaise missed one day of work following second dose due to symptoms
47 2021-01-13 sleep disorder patient was up all night after vaccine with high fever and chills, went to ER due to symptoms and wa... Read more
patient was up all night after vaccine with high fever and chills, went to ER due to symptoms and was admitted to hospital overnight for observation. He said his temperature hit 107. Was released from hospital and resting . Was COVID + previously where he had to be hospitalized .
47 2021-01-14 abnormal dreams 1/13/21 0740 Received second dose of COVID-19 vaccine, which was scheduled for that morning. Did not... Read more
1/13/21 0740 Received second dose of COVID-19 vaccine, which was scheduled for that morning. Did not experience anaphylaxis or other symptoms of vaccine injury. I took 1gram of Tylenol PO when I got back to my motel by 0830. By 0924 I noted that my left deltoid (injection site) and arm were very sore/achy. I fell asleep until 1740. I noted that I was experiencing more body aches at this time (joint and muscle, especially in my bilateral shoulders, lower back, knees and pelvis). Calf muscles were quite sore. I made pasta with red sauce and made a pot of blueberry tea, ate and went back to bed. 2327 I woke again with weird fever dreams and my right bicep was intermittently twitching. I think I was starting to run a low grade fever at this time (my ears felt hot, and my stomach was queasy but was not nauseous), no diaphoresis, shortness of breath or airway constriction. I remained awake until 0200, 1/14/21. By 0400 I was experiencing mild chills, face was flushed, headache on the right, with pressure behind my right eye, parietal and occipital areas of my skull. The pain extended into the right muscles of my neck (trapezius, levator scapulae and sternocleidomastoid muscles). Bilateral upper arm muscles and joints were 5:10 pain. I was also experiencing mild photophobia, but not migraine related, and a mild non-productive cough and pressure behind my facial and ethmoid sinuses with scant viscous secretions at the back of my throat. 0433 I forced myself to get out of bed and head to the bathroom. My temp was 101. I took a very hot shower and am back in bed. Experiencing a lot of malaise and lethargy. 1/15/21 0830 temp is currently 99.1, headache is present, 3:10. Joint aches have mostly subsided. Injection site is warm and tender, but no erythema is present.
47 2021-01-14 feeling abnormal Pulse dropped to 30. Low pressure too. Brachycardia. Lost consciousness. Did not seem to be Vasovag... Read more
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