Pfizer

Psychological symptom reports

Female, 60 - 75 years

Age Reported Symptoms Notes
60 2021-01-04 abnormal behaviour Employee received the vaccine around 1130. She was monitored for a least 30 minutes due to her hist... Read more
Employee received the vaccine around 1130. She was monitored for a least 30 minutes due to her history of CA and Immunosupressed state. She went back to her office post monitoring. Around 1535, one of her employees called reporting that she didn't look good and was acting weird - pale; stumbling; slurred speech. The coworker brought employee to the immunization clinic in private vehicle. Dr. along with the CNE and another RN went to the vehicle to asses. It was noted that employee did have slurred/slow speech; droopiness to face. She reported that she started to not feel well while in her office. V/S: B/P 141/102; pulse 108; O2 sat 96% on RA; skin pale. She stated that she felt "loopy". Employees husband was called and her co-worker was instructed to take the employee to the ER where her husband would meet them. At 1540, employee was taken to ER for evaluation.
60 2021-01-05 feeling abnormal Rec'd Covid vaccine after 15 min obs stated she felt "swooney, dizzy, like" BP 168/86 HR 68 states s... Read more
Rec'd Covid vaccine after 15 min obs stated she felt "swooney, dizzy, like" BP 168/86 HR 68 states she has a hx of HTN she usually runs 120's/70's Monitored for another 25 min BP ranging 157/87 - 173/86, prior to leaving states she was not feeling dizzy anymore BP 164/88 HR 69, and wanted to go back to work. Could not find anyone to take care of her patients and was concerned. Coworker states they would monitor her.
60 2021-01-05 feeling abnormal Dizzy right after vaccine, foggy increased through evening, tired in the evening of injection, muscl... Read more
Dizzy right after vaccine, foggy increased through evening, tired in the evening of injection, muscle aches, headache, and nausea about 2am, fever 99.8 at 1pm on 1/6/21. All these symptoms still persist now 5:40pm 1/6/20
60 2021-01-05 feeling abnormal 19th received Covid Vaccine at noon 21st negative Covid surveillance test completed due to ED Clust... Read more
19th received Covid Vaccine at noon 21st negative Covid surveillance test completed due to ED Cluster 22nd Bedtime approx. 2100 A very strange feeling of overwhelming fatigue "spacey feeling"" 23rd nausea dizzy general malaise 24th nausea dizzy general malaise 25th nausea dizzy general malaise Contacted Health Service 26th still nauseous dizzy general malaise and then chills Health Service Ordered Covid Test 26th negative Covid. 26th video appointment with PCP states no need for labs feels it's Vaccine related 27th minimal nausea no chills episodes of feeling ?spacey? and tired 28th Minimal nausea 29th Morning nausea and fatigue 30th Morning nausea and fatigue 31st increased nausea and fatigue all day easing as day progresses "spacey" with fatigue
60 2021-01-05 impaired work ability Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in b... Read more
Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in bed. Woke up in middle of night with body aches , chills and headache. By 10 am felt increase in flu like symptoms, mild nausea, swollen glands, mouth cold sore and red hot face. Temp was 101.2. All joints hurt, general malaise.
60 2021-01-06 feeling abnormal 12 hours post injection 7:30p, low grade fever 99F, queasy, brain fog and exhaustion. Fever went awa... Read more
12 hours post injection 7:30p, low grade fever 99F, queasy, brain fog and exhaustion. Fever went away over night, the rest of the symptoms stayed through the day.
60 2021-01-07 mental impairment, anxiety Facial flushing, different sensation to head and ears, anxiety, unable to think. Pt. evaluated by MD... Read more
Facial flushing, different sensation to head and ears, anxiety, unable to think. Pt. evaluated by MD, Benadryl 50mg IM administered with 1 hour in clinic observation. Pt. with improved breathing and relaxation, vitals stable.
60 2021-01-08 impaired work ability Headache very fatigue, soreness at injection site Narrative: stayed home from work
60 2021-01-10 feeling abnormal Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache... Read more
Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache/ So much pain in my head; Couldn't talk; Complete brain fog; nausea; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (Patient) reported that received bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included Atrial fibrillation, Chronic Lyme, Lupus and Autoimmune. Concomitant medications included Metoprolol at 12.5 mg for Atrial fibrillation and acetylsalicylic acid (BABY ASPIRIN). No diabetes, no hypertension. None of the usual common diseases. Registered Nurse stated, "I received vaccine this past Wednesday. I was just talking to a couple of my colleagues and honestly I received the vac. at work. I did not really read through the paperwork and was 'weird' sharing reactions to the vaccine which for me was pretty bad reaction and thought like I need to go through your paperwork and report it. So I thought I should call and just give some information. The usual fatigue which I go to after being normal, my arm was not sore. However, as the week progressed into Friday I had a constant headache but it was manageable and then by Friday night my glands swelled, my nerves behind my ears, my neck and I was extremely fatigued, bad headache and went to bed and I had not gone out and finally I got out today I spoke with my Physician yesterday. What happened it looked like an encephalopathy but my head swelled, my face was all swollen, complete brain fog, fatigue and I couldn't talk. I was in so much pain in my head resulting in (incomplete sentence)." Lab work included the only thing is the PCR swabbing. No blood test. Registered Nurse further stated, "I don't know if that is important. But I will tell you and if it is you can send me the questions. I do have a history of Autoimmune. So my Physician thought that this was just like an enhancement of like my bodies reaction I have Chronic Lyme and I have lupus like my ANA has always been stressful. But we think that it is a family thing. No treatment for the Lyme. I did a lot of antibiotic and a lot of naturopathic stuff but that is in the past. But anyhow for anything else what I did was when I got the injection they said try and just take Tylenol not Ibuprofen but there was no way I was going to make it through with just that . So I took Ibuprofen. I called my Physician yesterday morning because I was not sure about what was is happening and I thought it might be secondary sinus infection or something else going on and it reassured me that it is definitely due to the vaccine. He said it is just your body's reaction, take the Ibuprofen, hydrate. Had me take what I had in my house Tigan for nausea. So I was extremely nauseous from the severity of the headache." Registered Nurse stated, "I just wanted to let you know what happened and the intensity of what it was because normally I would expect a headache. But this was a 'go dated'. Registered Nurse stated, "I guess the only question that I have is so do my work has this question and I was going to call my doctor tomorrow may be might know it better. I know that I have to take the second dose. But I understand the second round can be worse than the first. Is there anything that they are recommending that I can do may be prior to ease the reaction?" The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The reported clinical manifestations including swelling face and head swelled, which was suspected as encephalopathy by the reporting nurse, was probably related to the bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), due to temporal relationship. The subject's underlying Chronic Lyme, Lupus and Autoimmune were likely the risk factors to the onset of the events. 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.
60 2021-01-10 impaired work ability Muscle and joint weakness with chest muscle pain x 5 days hurts all over and worse when gets up and ... Read more
Muscle and joint weakness with chest muscle pain x 5 days hurts all over and worse when gets up and moves. Diarrhea started 1-5-2021. No fever 97.7. Off work for 4 days. Using heating pad and inhalers. Has appointment with provider 1-5-2021 and 1-7-2021. Test for COVID on 1-7-2021 and negative Symptoms resolved 1-9-2021 and returned to work on 1-11-2021
60 2021-01-10 sleep disorder four hours after receiving vaccine, I experienced diarrhea, then fever. Weakness, fatigue and incre... Read more
four hours after receiving vaccine, I experienced diarrhea, then fever. Weakness, fatigue and increased fever continued thru the night and not able to sleep, very restless. The next morning after I had more weakness and major flair up with my MS, where I fell several times and was not able to get myself off the floor. Each time I fell it too approximately 20 minutes for me to get either in bed or a chair. Still had fever of a 100-101 through out the day, took ibuprofen to help, which it did for a short time but then fever was back. About 7pm I took some Benadryl and was finally able to fall asleep. The next morning, no fever but very weak. Went to health club to help with my legs. This day was ok, weak but improved. No falls
60 2021-01-11 anxiety Dizzy and very anxious
60 2021-01-11 feeling abnormal, disturbance in attention Headache, NauseaVomiting, severe migraine, arm pain-sore for 2 weeks, red streak up the shoulder a... Read more
Headache, NauseaVomiting, severe migraine, arm pain-sore for 2 weeks, red streak up the shoulder and neck Narrative: Experienced a red streak that went up the shoulder and neck from the injection site. Also felt very foggy, difficulty focusing.
60 2021-01-11 feeling abnormal Pain at injection site; Tiredness; Headache; Chills; Joint pain; Fever; Felt paralyzed at one point;... Read more
Pain at injection site; Tiredness; Headache; Chills; Joint pain; Fever; Felt paralyzed at one point; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: K5730, via an unspecified route of administration from 29Dec2020 16:15 at a SINGLE DOSE for covid-19 immunization. Medical history included migraine with aura. Concomitant medication included gabapentin, pravastatin, estradiol, diphenhydramine hydrochloride (ALLERGY), and ascorbic acid, calcium pantothenate, colecalciferol, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol (VITAM). The patient previously took amoxicillin and had allergies. On 30Dec2020 15:00, the patient experienced pain at injection site, tiredness, chills, joint pain, fever and felt paralyzed at one point. The outcome of events was recovering. No follow-up attempts possible. No further information expected.
60 2021-01-11 impaired work ability developed nausea and light headedness approximately 6 hours post vaccine. patient unable to report ... Read more
developed nausea and light headedness approximately 6 hours post vaccine. patient unable to report to work the following day, symptoms then resolved.
60 2021-01-14 anxiety Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus,... Read more
Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus, and pressure on her upper back. She reported feeling anxious when she laid down. She went to see her doctor last week and was treated with benadryl.
60 2021-01-14 feeling abnormal reported "weird" sensation in her body and "like a pulsing in my chest". 1337 - Patient reports wea... Read more
reported "weird" sensation in her body and "like a pulsing in my chest". 1337 - Patient reports weakness,
60 2021-01-15 excessive sleepiness, sleep disorder, insomnia Received shot at 10:53pm; I did take all of my medications and supplements listed except for the Thy... Read more
Received shot at 10:53pm; I did take all of my medications and supplements listed except for the Thyroid medicine before going to before at midnight; very restless night of sleep. The pain in my arm woke me up. I never felt like I fell asleep. I woke up at 530am and took my Thyroid medicine and went back to bed until 6:30am. Felt fine until about 830am. I noticed I was starting to feel lightheaded and had this pressure on my head. I went back to bed and tried to fall asleep but really never did. I noticed that I would lose track of my train of thought often. Got up at 11am and took a shower and still just didn't feel like I had any motivation to do anything, so rested again. I then noticed my face, ear lopes and cheeks felt a little numb. I would pinch them and I noticed they were numb. Also, there was still pressure on the back of my head and on the bridge of my nose. Still light headed. I layed in bed until about 3pm when I did notice the numbness going away and the pressure on the back of my head and on the bridge of my nose getting a little better. Also, no appetite.
60 2021-01-17 restlessness itching all over, restlessness, patient allergic to benadryl.
60 2021-01-18 feeling abnormal, disturbance in attention Approximately 20 minute after vaccine administration, returned to unit and became lightheaded and fo... Read more
Approximately 20 minute after vaccine administration, returned to unit and became lightheaded and foggy. Unable to fully concentrate on tasks. Flushed in face and unsteady lasting approximately 1 hour. Developed headache lasting remainder of shift. Developed body aches/chills in evening
60 2021-01-18 feeling abnormal Within approximately 2 hours of receiving vaccine, patient experienced slurred speech, dilated pupil... Read more
Within approximately 2 hours of receiving vaccine, patient experienced slurred speech, dilated pupils, and was slow to respond to questions. Patient felt "foggy," similar to waking up from anesthesia.
60 2021-01-18 excessive sleepiness Feeling sick/Not feeling well; Exhaustion; Dizziness; Shakiness; Sore throat; Sleeping nonstop; Head... Read more
Feeling sick/Not feeling well; Exhaustion; Dizziness; Shakiness; Sore throat; Sleeping nonstop; Headache; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (batch/lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient worked at a hospital doctor's office. On 22Dec2020, the next day of vaccination, patient immediately for two days had "immense" (not clarified) headache and then had two days of vomiting and diarrhea. And she had been sick "ever felt" (not clarified) on an unspecified date. She had extreme exhaustion. She had been tested for everything from "manual" to mild "disease" (not clarified). She had extreme exhaustion, dizziness, shakiness, sore throat and Monday would be three weeks that she had been feeling like this. She had never been sick like that she felt like this way. She was supposed to get the second vaccine the day after the time of the report yeah so any way. They wouldn't give her because she was not feeling well but she wished just going to hold off and might be try it all over again in couple of weeks when she felt better but she really felt not well since had gotten this vaccine. She had never felt like this before in her life had ever felt this way all ever. She had taken an over the counter medication cold and flu medication (further clarified CareOne (batch/lot number: OCE2948, expiry date: Nov2021)), and ibuprofen (ADVIL, batch/lot number: R85569, expiry date: Mar2023) and she had been doing lot of sleeping. She had been sleeping nonstop. The patient underwent lab tests and procedures which included EKG and all kind of blood work with unknown results. Outcome of the events was unknown. Causality was reported as yes by the consumer.
60 2021-01-18 nervousness WHEN I GOT TO WORK I DIDN'T FEEL AT MYSELF. I WAS DIZZY AND VERY SHAKEY AND DIDN'T FEEL RIGHT THE M... Read more
WHEN I GOT TO WORK I DIDN'T FEEL AT MYSELF. I WAS DIZZY AND VERY SHAKEY AND DIDN'T FEEL RIGHT THE MAIN PROBLEM IS IF I CLOSE MY EYES AND GET REALLY DIZZY AND GET SICK AT MY STOMACH
60 2021-01-19 nervousness Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing . Treated at WS ... Read more
Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing . Treated at WS GSH ED Was given Benadryl, Prednisone and Pepcid orally Was discharged after 4 hours
60 2021-01-20 feeling abnormal, memory impairment Within an hour of the vaccine face was hot and muscle in face were painful in the jaws, sinuses up i... Read more
Within an hour of the vaccine face was hot and muscle in face were painful in the jaws, sinuses up in nose felt weird and dry like menthol. Put ice on face. Took Tramadol. Having fatigue. Next day felt better, then started having brain fog difficulty remembering, vision is blurry, no energy and feel exhausted.
60 2021-01-21 feeling abnormal, memory impairment Extreme fatigue day of and following week of vaccine. On 1/20/21 had episode of brain fog or complet... Read more
Extreme fatigue day of and following week of vaccine. On 1/20/21 had episode of brain fog or complete lapse in memory of event I talked to a person just the day before. (Never happened before) Today, 1/22/21 I was sitting at my desk talking to another person and fainted for no reason. (Never happened before). I came to and after short while felt better.. Left work to rest at home. Have not seen a doctor yet but worried about 2nd vaccine dose. The syncope episode concerns me.
60 2021-01-24 feeling abnormal, impaired work ability Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate... Read more
Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
60 2021-01-25 confusional state, memory impairment, disturbance in attention Fever 100.7; dizziness; fatigue; labile hypertension; confusion; forgetfulness; difficulty concentra... Read more
Fever 100.7; dizziness; fatigue; labile hypertension; confusion; forgetfulness; difficulty concentrating; nausea; severe headaches; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ElL0142), via an unspecified route of administration in left deltoid on 03Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included wheat allergy, celiac disease, and hypotension from an unknown date and unknown if ongoing. Concomitant medication included buspirone, cefixime (FLEXERIL), paracetamol (TYLENOL) and esomeprazole. On 05Jan2021 09:00 PM, the patient experienced fever 100.7, dizziness, fatigue, labile hypertension, confusion/forgetfulness, difficulty concentrating, nausea and severe headaches. No treatment was given to the patient for the events. The outcome of the events was not recovered. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. 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 has been tested for COVID-19, PCR and Nasal swab both negative on 06Jan2021.
60 2021-01-25 feeling abnormal Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizz... Read more
Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizziness, and horrible fatigue. Feeling out of it.
60 2021-01-26 insomnia allergy like symptoms/allergy; nose running; congested and blockage in her nose; shortness of breath... Read more
allergy like symptoms/allergy; nose running; congested and blockage in her nose; shortness of breath; couldn't sleep during the night; burning sensation in her chest; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on the upper left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization. Medical history was not reported. There were no concomitant medications. The patient reported that she took it yesterday and an hour into it she started having a burning sensation in her chest. What happen next, around 8pm, she started having allergy like symptoms that lasted throughout the night. She was experiencing nose running, congested and blockage in her nose, and shortness of breath. She couldn't sleep during the night until this morning. She had to breathe through her mouth because she couldn't' breathe through her mouth. For treatment, she took Mucinex tablets for allergy. She couldn't sleep during the night until this morning. She had to breathe through her mouth because she couldn't' breathe through her mouth. This was the first dose, her second dose is due on 02Feb2020 and she wants to know if she can skip it. Before she got it she contacted her primary care due to having allergies before the vaccine and asked if she should take; she was told to hold on but then she went ahead and took it. Within the first 30 minutes she was ok but in an hour is when she had the burning sensation in her chest. The burning sensation lasted about an hour. The dose was administered around 4pm on 12Jan2021.The caller reports that the Mucinex and she has breathing treatment, nebulizer treatments for her lungs, that she did and these things helped. Early this morning she felt she can now close her mouth and breathe normally. It was administered in the upper left arm. She did not require a visit to the doctor or ER. The patient has had no reactions to vaccines in the past nor were any administered on the day of or within the prior 4 weeks. Therapeutic measures were taken as a result of allergy like symptoms, congested and blockage in her nose and shortness of breath which included Mucinex. The patient recovered from burning sensation in her chest on 12Jan2021, from allergy like symptoms/allergy and shortness of breath on 13Jan2021 while the outcome of the other events was unknown. Information on the lot/batch number has been requested.
60 2021-01-26 sleep disorder First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and ... Read more
First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and missed work. Second vaccine she has 4 bruises and clots on her inner leg from ankle to thigh. So painful she can't sleep and she is having a hard time walking. Her left shoulder is limited due to extreme pain. She sought care from her physician and he is sending her for scans that the facility is requiring a deposit.
60 2021-01-27 sleep disorder Severe Left Leg, Hip and Lower left leg pain (Sciatic Nerve) it appears the vaccine may have irritat... Read more
Severe Left Leg, Hip and Lower left leg pain (Sciatic Nerve) it appears the vaccine may have irritated sciatic nerve pain. Left left leg numbness. Decreased mobility, difficulty sitting, walking, and even lying in bed. Started very quickly without andy known injury. Pain continued to worsen. Pain even worse after second injection. Now two weeks after second shot, the pain is going away. It is like the nerve irritation is subsiding. The way the irritation is subsiding makes it seem that the vaccination may have caused irritation to the nerve. After receiving 1st and continuing through the second vaccine, started having severe sciatica pain going down left hip and leg. Left leg pain and numbness. Thought I had done something to damage the nerve. Hurt to sit, hurt to stand and even hurt when in bed. The pain was so severe it caused issues with any mobility. Took Advil, Aspiring, Tylenol and nothing helped. Received second vaccine 1/12/2021 the pain continued and even got worse. It was to the point I couldn't even walk. I couldn't figure out how I had damaged the nerve. I am now thinking it was from the vaccine. I believe the vaccine irritated the nerve. The nerve pain is starting to go away. Normally if you have a sciatic nerve issue, it just doesn't go away on its own. I know there have been reports of severe back and neck pain. I believe it can irritate the nerves which cause severe pain. I wanted this reported in cases others complain of similar issues. The good thing it is improving.
60 2021-02-01 anxiety pt stated about 2 hours after receiving her covid vax that her heart was racing, beating harder than... Read more
pt stated about 2 hours after receiving her covid vax that her heart was racing, beating harder than normal but subsided after about 2 hours. She was about to go to the ER but waited a little longer since she thought she was just having anxiety issues and did not have to go. She will contact her PCP today to let them know and discuss getting the second dose.
60 2021-02-01 feeling abnormal Received Phizer vaccine dose #2 Tuesday 1/26/21 at 0915. Feverish and tired at 6pm(8hrs 45 min lat... Read more
Received Phizer vaccine dose #2 Tuesday 1/26/21 at 0915. Feverish and tired at 6pm(8hrs 45 min later) Wed 1/27/21 5am fever, aches, chills, foggy, slight headache, exhausted. Wed 1/27/21 7pm exhausted, foggy Thurs 1/28/21 5am exhausted, foggy, no reserve Fri 1/29/21 5am tired, foggy Sat 1/30/21 Much better.
60 2021-02-01 feeling abnormal Received vaccine #1 Phizer on Jan 5th 2pm. Started to feel tired by 7pm. 5am woke up achey with gene... Read more
Received vaccine #1 Phizer on Jan 5th 2pm. Started to feel tired by 7pm. 5am woke up achey with general malaise. Took Tylenol 500mg and came to work. I started the attestation form and called employee health to let them know about my aches. They recommended me getting tested for Covid 19 in which I did before I left at 8:30am. My health continued to decline as I became ferverish, with a headache, nauseas, foggy, and exhausted. When I got home, I couldn't get off the couch. I felt horrible for 36hrs. My headache lasted for 5 days. Covid 19 test and flu test negative.
60 2021-02-02 anxiety, feeling abnormal Pt reports feeling "out of body", lightheaded, impending doom, nauseated and diaphoretic.
60 2021-02-02 mental impairment, confusional state Was okay Friday morning then stomach started getting upset Friday night and I tried to eat food to c... Read more
Was okay Friday morning then stomach started getting upset Friday night and I tried to eat food to calm down. A slight headache was starting. The next morning I had a massive headache all day Saturday, by 8 PM it was a full-fledged nauseating migraine. The severe migraine lasted from 8 PM the previous night to 10 PM on Sunday night. By Monday I was doing better but a bit confused and having difficulty thinking. Now it is Wednesday and I am a bit exhausted and still having trouble thinking but doing so so much better! I am so happy to be feeling better!
60 2021-02-03 feeling abnormal slurred speech/ responded slowly to questions within 2 hours of receiving the vaccine; dilated pupil... Read more
slurred speech/ responded slowly to questions within 2 hours of receiving the vaccine; dilated pupils; "foggy."; This is a spontaneous report from a contactable other hcp. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248), intramuscular on 19Jan2021 09:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and oedema. Concomitant medication included phentermine hydrochloride (ADIPEX-P), olmesartan medoxomil (BENICAR), furosemide (LASIX), amlodipine besilate (NORVASC), doxycycline (VIBRAMYCIN). The patient previously took Ciprofloxacin, Clopidogrel, Meperidine, Flagyl, Macrobid, Penbutolol and experienced drug hypersensitivity. The patient had the first dose of vaccine on 20Dec2020 (Lot number=EK5730). The patient exhibited slurred speech, dilated pupils and responded slowly to questions within 2 hours of receiving the vaccine. The patient felt like she just woke up from anesthesia and was "foggy" and 19Jan2021. The outcome of the events was unknown.
60 2021-02-03 impaired work ability I had covid Sept 26th 2020.The day after the second shot I had covid symptoms. Seven days later I st... Read more
I had covid Sept 26th 2020.The day after the second shot I had covid symptoms. Seven days later I still have chills,fever,muscle aches and fatigue. I am going for a covid test today.I have missed days of work due to this vaccine.
60 2021-02-03 impaired work ability I got up and had a really bad headache and fatigue. I did not go to work due to the headache. I to... Read more
I got up and had a really bad headache and fatigue. I did not go to work due to the headache. I took a Tramadol, got an ice pack, placed it on my head and put some lavender on my pillow, called into work and went back to bed. I still have the headache and fatigue, but I am able to work so far.
60 2021-02-04 anxiety At 2:30 pm after being in observation for 30 minutes, patient became concerned about a rash to her l... Read more
At 2:30 pm after being in observation for 30 minutes, patient became concerned about a rash to her left arm. There was a small area that had a lace modeling appearance. Patient denied any pain or itchiness to this area and there were no hives. Patient very anxious and concerned and asked if she could take her own liquid Benadryl which she had on hand. She was offered Benadryl from the clinic but refused and really wanted to take her own. Approval from supervisor obtained and Benadryl was verified. VS BP 110/60, HR 76 and pulse ox 98% at 2:35 pm. Patient denied any other signs and symptoms of allergic reaction except anxiety. VS repeated at 2:55pm and were; BP 110/60, HR 68, Pulse ox 100%. No change in condition and patient felt good enough to leave. Patients sister accompanied her to the clinic today and will stay with her tonight.
60 2021-02-04 feeling abnormal 12 hours after shot, all over body aches, sore arm and shoulder, fever. Shortly after, a headache o... Read more
12 hours after shot, all over body aches, sore arm and shoulder, fever. Shortly after, a headache occurred. The symptoms lasted all day and were mostly gone except for a small headache and fuzzy brain after 30 hours. All clear after about 36 hours.
60 2021-02-04 sleep disorder, disorientation 1/12 vaccine 1/13 woke up at 5-6am, shaking, chills, fever, dizziness and vertigo. ER later that da... Read more
1/12 vaccine 1/13 woke up at 5-6am, shaking, chills, fever, dizziness and vertigo. ER later that day; blood work. Declined IV fluid. Monitored vitals. Body aches continued that weekend, went back to work the 14-15th but 'pushed it' to go back. 1/17 ER - blood panel; negative. Admitted to Inpatient to monitor heart and MRI of brain. still experiencing dizziness, 'disorientated'
60 2021-02-06 feeling abnormal, impaired work ability High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking ... Read more
High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking on the outside. Headache & extreme stomach pain. Which all of this has made it to where I'm unable to work.
60 2021-02-07 sleep disorder Had trigger finger in right hand lasting 3 days -resolved. Began experiencing tingling and electrica... Read more
Had trigger finger in right hand lasting 3 days -resolved. Began experiencing tingling and electrical impulses down both legs (no pain). This becomes worse with walking. Comes and goes throughout the entire day and wakes me up at night at intervals. Began 4 days after vaccine and has continued since.
60 2021-02-08 sensation of foreign body, anxiety The symptoms began 10 minutes after administration of the vaccine. The symptoms were: anxiety and g... Read more
The symptoms began 10 minutes after administration of the vaccine. The symptoms were: anxiety and globus sensation pale and tremulous. Nurse noted that she had a 4mm hive above her lip. The treatment of the reaction was: o Epinephrine: x1 Transferred to ED
60 2021-02-09 anxiety Pt reported tachycardia post receiving vaccination. Pt reported PMHX of anxiety. Symptoms response... Read more
Pt reported tachycardia post receiving vaccination. Pt reported PMHX of anxiety. Symptoms response within 5 minutes. No Treatment or Transport.
60 2021-02-14 feeling abnormal, confusional state 2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYE... Read more
2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYELIDS, 1 HR LATER STILL VERY CONFUSED IN A FOG. VERY CONGESTED , SNEEZING, ITCHY EYES, STUFFY EARS, VERY CONFUSED. STRANGE FEELING INSIDE MY BODY - TINGLING . FEELING OUT OF BODY .... NOT MY SELF ...ITCHING. VERY CONFUESED AND VERY DIZZY FOR ABOUT 4 HR... SEVERED HEADACHES. NAUSAUES. 6 HRS LATER SWOLLEN FACE RIGFHT SIDE.
60 2021-02-14 loss of personal independence in daily activities About 12:30 AM on 2/14/21, I woke with extreme chills, muscle weakness, possible fever and sweats, j... Read more
About 12:30 AM on 2/14/21, I woke with extreme chills, muscle weakness, possible fever and sweats, joint pains. About 2:30 AM, I took two 325 MG aspirin. About 9:30 AM, I woke again with the same extreme symptoms listed above. I took an additional two 325 MG aspirin. About 4 PM, my symptoms were not as severe, but I was still unable to engage in daily activities, and I took an additional two 325 MG aspirin. Symptoms continued, but lessened, and about 9 PM, I told an additional two 325 MG aspirin and a zolpedim CR to help me sleep throughout the night. I woke about 6:45 AM on 2/15/21, with mild muscle weakness, joint pain, and feeling slow and tired. As of this report at 11:15 AM on 2/15/21, I am functioning at about 80% capacity, some chills and muscle/joint pain.
60 2021-02-14 loss of personal independence in daily activities shortness of breath, heart rate high, dizziness, low blood pressure, dry mouth, feeling faint, weakn... Read more
shortness of breath, heart rate high, dizziness, low blood pressure, dry mouth, feeling faint, weakness, fatigue all over, numbness in feet and hands, two -three weeks of morning anxiety, difficult to operate a car, two tp three weeks stiffness in joints, and headache.
60 2021-02-15 feeling abnormal Right after the vaccine I felt a little funny. Within 10 minutes of receiving the vaccine I started ... Read more
Right after the vaccine I felt a little funny. Within 10 minutes of receiving the vaccine I started coughing, lost my voice, Itchy eyelids, my chest was pounding, and overall just did not feel right. EMS Took my blood pressure and it was 255, then they waited a smidge and decided to give me an injection of Benadryl, within 10 minutes of the Benadryl my blood pressure went down to 225, and I overall felt a little bit better. My eyelids were still swollen and itchy and I didn?t have a voice, they took my blood pressure again and it went down to 218. They stayed with me. I was starting to feel a little bit better. My blood pressure went down to 180 and there?s no wheezing in my chest. They let me leave shortly after that. I still do not have a voice. My eyelids are still swollen slightly and very itchy and my lips tingle.
60 2021-02-15 feeling abnormal Day 4 sudden feeling unwell, out of it, severe burning pain throughout whole body, joint pain , head... Read more
Day 4 sudden feeling unwell, out of it, severe burning pain throughout whole body, joint pain , headache, cough, fatigue, upset stomach, diarrhea. Subsided in about 36 hours.
60 2021-02-15 insomnia, anxiety 1/6 1:30 vaccination Later that evening, I had extreme HA. I had 2-3 aura migraines, a day or 2 late... Read more
1/6 1:30 vaccination Later that evening, I had extreme HA. I had 2-3 aura migraines, a day or 2 later. Insomnia. *still experiencing insomnia and anxiety
60 2021-02-15 insomnia 12/19/2020 130 vaccination. When got up to leave, near syncope episode. Monitored for 15+ more minu... Read more
12/19/2020 130 vaccination. When got up to leave, near syncope episode. Monitored for 15+ more minutes. Left after. Later that evening, I felt like I was on 'speed'. Chills, HA, couldn't sleep. HR was increased. I wasn't able to eat; no appetite. Symptoms lasted for several days. Don't think I ran a fever. I was very dizzy, double vision, extreme fatigue. Did what i could with work online. *HX of aura migraines and happened during this episode. Within that week, saw NP.
60 2021-02-16 confusional state Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for... Read more
Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for about 10-12 hours, then lessening to feeling tired, bouts of vertigo and occasional headache. Five days later on 1/25 I experienced blurry vision, nausea, confusion, dizziness, and impaired speech (to a co-worker). This lasted about an hour.
60 2021-02-16 impaired work ability, sleep disorder Pfizer-BioNTech COVID-19 Vaccine EUA At 2:30 am woke up with nausea and stomach ache. Continued thr... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA At 2:30 am woke up with nausea and stomach ache. Continued through the night. I could not sleep. In the morning (9:00) I tried to sleep but had very bad chills for over an hour. Went down to couch and covered up with many blankets. Chills continued for 4-5 hours. Also experienced tiredness, and general 'feeling unwell' throughout the day, as well as extreme heartburn. I stayed home from work and sat on the couch all day, feeling unwell. By about 8pm all of the symptoms disappeared.
60 2021-02-17 feeling abnormal This is a spontaneous report from a contactable nurse. A 60-year-old female patient received the sec... Read more
This is a spontaneous report from a contactable nurse. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), other route on the right arm at the age of 60 years, on 02Feb2021 12:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included depression Depression, Hypothyroidism, High Cholesterol, Osteopenia, Occasional vertigo. Concomitant medication included simvastatin (SIMVASTATIN), duloxetine (DULOXETINE), raloxifene (RALOXIFENE), chlorthalidone (CHLORTHALIDONE), levothyroxine (LEVOTHYROXINE) , calcium (CALCIUM), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), folic acid (FOLIC ACID), fish oil (FISH OIL), vitamin b12 nos (VITAMIN B12 NOS) , calcium carbonate, colecalciferol (VITAMIN D 2000) and Tumeric. The patient had the first dose of vaccine on 12Jan2021. After the 2nd shot, the patient's arm didn't get heavy, just felt a weakness going from shoulders down to hands on Feb2021. She couldn't move or feel them for 15 min. Slowly she could move her fingers then hands then lift arms. The next day her brain felt kind of fuzzy and still a little "off kilter" on 2nd day (Feb2021). She did not have any anxiety about either shot, even with what happened with the first one. The outcome of the events was recovering.
60 2021-02-20 sleep disorder Left shoulder has periodic pain and stinging as if someone with a heavy hand is giving me an injecti... Read more
Left shoulder has periodic pain and stinging as if someone with a heavy hand is giving me an injection now. The pain wakes me up at night. Sometimes in the day I feel the pain level at about a 6.
60 2021-02-24 anxiety Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details:... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient explained she was very anxious, light headed, flustered, headache - more than 15 mins after the dose. She waited the 15 mins and when heading home, felt sick and returned to the pharmacy where the staff sat with her for an additional 30 mins
60 2021-02-27 impaired work ability slight fever for 2 days, then flu-like symptoms (body aches, fever, chills, lack of appetite, loss o... Read more
slight fever for 2 days, then flu-like symptoms (body aches, fever, chills, lack of appetite, loss of taste and smell, fatigue) since Wednesday 2/24/21. Missed work due to symptoms on Thursday 2/25/21. Returned to work amidst continuing flu-like symptoms on Friday 2/26/21. As of Sunday, 2/28/21, symptoms continue; maybe slightly diminished.
60 2021-03-01 disturbance in attention At first I didn't feel anything or any different. I started to get a weird sensation behind my eyes ... Read more
At first I didn't feel anything or any different. I started to get a weird sensation behind my eyes like before with the first vaccine. The muscles of my eyes and eye lids feel weak and difficult to focus. I started having extreme nausea and could not go to work. No appetite either. I now have Oscillopsia and feel sick.
60 2021-03-04 confusional state Pt was observed to drop her phone on the floor. When it was picked up & RN attempted to hand it to ... Read more
Pt was observed to drop her phone on the floor. When it was picked up & RN attempted to hand it to her, she appeared to be sleeping. She did wake after physical stimulus but was lethargic, confused & stated she "felt dizzy"
60 2021-03-04 nervousness COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient dev... Read more
COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient developed evidence of Immediate (within 4 hours of dose) adverse reaction starting 3/5/2021 2:02 PM. Signs/Symptoms: Dry Mouth, Flushing, Lightheadedness, Nausea/Vomiting and Other (see comments) Reaction Comments: Skin blotchiness, dizziness, shaky, responsive but limp Treatment Administered: Cold Compress and Sips of Water Treatment Comments: Crackers, put in supine position Disposition: Home Disposition Comments: Next vaccine should be supine when receiving it. Additional Documentation: Pt became faint immediately after vaccine, warm, shaky and went limp I her chair but was responsive. BP: (!) 150/94 Pulse: 75 Supervising Provider Notified of Reaction: MD
60 2021-03-06 sleep disorder Starting about one hour after the injection, my left shoulder began to hurt a little bit. As the d... Read more
Starting about one hour after the injection, my left shoulder began to hurt a little bit. As the day progressed the pain increased substantially into my shoulder. It then started to hurt on the left side of my neck. I took Tylenol before bed, 500 mg is all I can take. This pain kept me awake all night and this morning I am not able to lift my arm up or down or sideways without pain, quite a bit of pain. Today is Sunday and I do not plan to seek medical care unless it continues to worsen. I will probably talk with my medical provider tomorrow if this continues.
60 2021-03-07 feeling abnormal I received the shot at 4:30 pm. About an hour after receiving the shot, I felt a little dizzy, and ... Read more
I received the shot at 4:30 pm. About an hour after receiving the shot, I felt a little dizzy, and my heart started beating faster. My body felt weird. I had a small headache and was very tired and laid down. I fell asleep pretty quickly. I woke up around 2:30 am the following morning, with a greater headache. I took tylenol for the headache. I took another dose of tylenol 4 hours later. I had loose stools, fatigue and my lungs felt heavy (cough) for approx 12 hours. Most symptoms resolved by the following day. A little fatigue and heaviness remains.
60 2021-03-07 sleep disorder, mental impairment Beginning 20 hours after vaccine, became extremely chilled and fatigued followed quickly by pain in ... Read more
Beginning 20 hours after vaccine, became extremely chilled and fatigued followed quickly by pain in all bones of body - face bones, leg and arm bones, ribs, etc. Thinking became foggy - everything became difficult to do. I went to bed at 7:30 pm on 2/25/2021 - slept fitfully until 6:30 am on 2/26/2021. All symptoms had lessened by 30%-50% during the day on 2/26/2021. By 2/27/2021, I felt pretty much like me again.
60 2021-03-08 disturbance in attention Syncope, difficulty focusing- Evaluated by EMS-Transported to Emergency room/department or urgent ca... Read more
Syncope, difficulty focusing- Evaluated by EMS-Transported to Emergency room/department or urgent care.
60 2021-03-08 feeling abnormal fever, chills, back pain, fatigue, loss of appetite, foggy
60 2021-03-08 feeling abnormal Low-grade fever, chills, body weakness, aches, brain fog, fatigue
60 2021-03-09 impaired work ability Saturday, March 6 felt fine all day with normal activity. Woke up at 7:05 am Sunday, March 7 with d... Read more
Saturday, March 6 felt fine all day with normal activity. Woke up at 7:05 am Sunday, March 7 with dizziness, nausea and sweats that would last about a minute. Remained sitting still with my eyes closed about 3 hours and then eyes could be open but could not move without the dizziness and subsequent nausea. I did not vomit. My temperature was-low in the morning but climbed just to 99.3 Sunday. By Sunday afternoon, I no longer had the short sweats but remained dizzy and nauseous mostly upon any movement. I went to sleep at 11:00 pm Sunday night with the slight 99 fever. Woke Monday , March 8 much improved from the dizziness and temperature 98.6., but felt extreme tiredness. I did not go tot work Tuesday and rested on the couch most of the day-temperature 98.6.
60 2021-03-09 insomnia On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3... Read more
On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3, chills, body aches and weakness On day 4 after second dose had severe back pain, painful to walk, despite taking Motrin. Went to doctor and had MRI done. Then by early February started having insomnia, hard time falling asleep and staying asleep . I feel the second dose of vaccine might have caused my immune system to become over active. The back is now ok after rest and physical therapy but the insomnia still persist.
60 2021-03-10 anxiety, sleep disorder 1/11 vaccination 1/12 I just had body aches, chills. 2:13 PM i was on my couch, I could hear myself ... Read more
1/11 vaccination 1/12 I just had body aches, chills. 2:13 PM i was on my couch, I could hear myself having trouble breathing while dreaming. I sat up, elevated, and went back to sleep. SOB that afternoon. I slept and woke up the next day and felt fine, went to work. 1/14 I worked all day. 3:10 I couldn't breath. Was with my neurologist. Pulsox was 79. I went to the ER. Hooked me up to IV, chest xray. Dr. said anxiety was up. After 4.5 hours I was able to go home. symptoms subsided.
60 2021-03-10 anxiety heart racing, anxious. Evaluated by EMS-Cleared
60 2021-03-11 disorientation Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started aro... Read more
Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started around 1 pm March 8 and subsided by 8 am March 9
60 2021-03-13 sleep disorder 2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:... Read more
2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:50 am woke to hot sweating and cold lightheaded and dizzy, nauseous and dry heaves. Rash on shot spot and surrounding area. Skin peeling at bandage area. 11:00 am shot area sore. Bandage area still a rash and slight peeling of skin.Dizziness is gone and nausea is gone. No headache
60 2021-03-15 anxiety After receiving her vaccine, client stated she felt lightheaded and anxious. Vital signs obtained b... Read more
After receiving her vaccine, client stated she felt lightheaded and anxious. Vital signs obtained by EMS BP 177/106, HR 83, O2 sat 99%. Client stated she feels better. Client discharged home.
60 2021-03-15 feeling abnormal Within the first 30 min of receiving first COVID vaccine pt report feeling dizzy and nauseated. Pt t... Read more
Within the first 30 min of receiving first COVID vaccine pt report feeling dizzy and nauseated. Pt taken to vaccine clinic observation area to be closely monitored. Pt placed on gurney and given water to drink. VS stable. Pt report headache 5/10, feeling sensitive to light, and nauseated. While in observation area pt reports feeling what she describes as "feeling weird wavey sensation over entire body, warm head, and cool body." Pt offered but declined to go to ED. explained risks and benefits to pt. Pt states that she drove herself to vaccine clinic. Pt advised that it it would be unsafe to drive herself home and advised to to contact husband for ride home. Pt called her husband to pick her up. After several min pt states stated that she was "feeling a little better" and "headache was also a little better" 3/5 on pain scale but still feeling dizzy and chest feeling a little tight. " Pt states having a history of Asthma. Pt again offered to be treated in ED and accepted. Pt transported to ED by gurney accompanied by three RN's.
60 2021-03-15 impaired work ability experienced chills and body pain on the 3rd day after receiving the 2nd dose vaccine . chills and bo... Read more
experienced chills and body pain on the 3rd day after receiving the 2nd dose vaccine . chills and body pain lasted for 2 days . on the fifth day felt like black curtain in front of my eyes and felt dizzy. checked my blood pressure was 170/90. Blood pressure went up to 200/100 . went to the hospital emergency and was admitted for observation overnight. CT, MRI , blood work done. BP controlled with medication Nefidefine 60mg. discharge home next day. was still having very light headedness and BP will shoot up to 190/90. physician had to change the medications couple of time. felt very exhausted . could not go to work almost 3 weeks because of the symptoms like lightheadedness. lasted at least 4 weeks to get back to work normal. never experienced this before. I was taking Olmasartan 5mg for blood pressure and my Bp always stated 130/80s
60 2021-03-16 anxiety Felt anxious, with chills/tingling in feet. BPs 174/77 (pulse 71), O2 sat 98%. Final BP 134/75.
60 2021-03-16 anxiety Pt in COVID-19 Observation Area complained of weakness to body. Per pt felt dizzy and anxiety earli... Read more
Pt in COVID-19 Observation Area complained of weakness to body. Per pt felt dizzy and anxiety earlier but better now. . B/P @ 141/92 02 Sat. @ 96-99%. Doctor evaluated pt rechecked B/P @ 100/50 02 @ 96-99%. After evaluation pt states less wekness to body. Pt keep in Obsrvation area.Pt felt better and wants to go home Doctor notifed. Instructions given to pt to go to Urgent care or E.R. @ Medical Center if sympyoms worsen and return tomorrow if s/s continue. Can be discharged. Pt accompanied to vehicle to daughter. Instruction given to daughter verbalized all discussed.
60 2021-03-16 feeling abnormal, loss of personal independence in daily activities Just a few hours after receiving my first Vaccine, I started running a fever of 99.9, Got real sick ... Read more
Just a few hours after receiving my first Vaccine, I started running a fever of 99.9, Got real sick at my stomach, started have Diarrhea, Severe Headache, My arm hurt really bad could not use it for a Day and 1/2. Just felt like I had been run over by a Bulldozer.
60 2021-03-18 anxiety Heart palpitations, anxiety,(felt this prior to today). 126/84, 87, 6, 99%, BGL 176
60 2021-03-18 feeling abnormal Dizzy; Nausea; Vomit; Pain on all body; Frequent fall; Severe fatigue; Strange feeling; Abdominal pa... Read more
Dizzy; Nausea; Vomit; Pain on all body; Frequent fall; Severe fatigue; Strange feeling; Abdominal pain on and off; Arrhythmia; This is a spontaneous report from a contactable physician. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in left arm on 11Feb2021 09:00 (batch/lot number was not reported) as single dose for COVID-19 immunisation. Medical history included (G60.9) PN - Peripheral neuropathy (SCT42658009), (M79.2) A Neuralgia (SCT16269008), (R55) Syncope (SCT271594007), (I10) HTN - Hypertension (SCT38341003), (R00.0) Tachycardia (SCT3424008), (E16.2) Hypoglycemia (SCT302866003), (R55) Vasovagal symptom (SCT248229009), (M25.50) Joint pain (SCT57676002), (F41.9) Anxiety (SCT48694002), (K21.9) Acid reflux (SCT235595009), and (M06.4) Polyarthritis (SCT416956002); all were current or ongoing. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 12Jan2021 for COVID-19 immunization (product: COVID 19, brand: Pfizer, administration time: 09:00 AM, route: intramuscular, vaccine location: left arm). On 11Feb2021 11:00, the patient experienced dizzy, nausea, vomit, pain on all body, frequent fall, severe fatigue, strange feeling, abdominal pain on and off, and arrhythmia. The AEs resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. There were no treatments given for the events. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID post vaccination. The patient has no known allergies. No other vaccines received within four weeks prior to COVID vaccine. The events were reported as serious and disabling. The patient has not recovered from all the events. Information on the lot/batch number has been requested.; Sender's Comments: Drug causality for suspect drug in the onset of the reported events cannot be excluded assuming a plausible temporal association and considering the known safety profile of the product. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
60 2021-03-18 loss of personal independence in daily activities Had vaccine on Tuesday, 3/9 and on Thrusday night and Friday evening , my right elbow area was very ... Read more
Had vaccine on Tuesday, 3/9 and on Thrusday night and Friday evening , my right elbow area was very sore. The pain is very localized and responded to a couple of days of ibuprophen. Started again this week and the arm is swollen/inflammed. Uncomfortable for daily activities like typing or eating. Does respond to ibuprophen. Trying to rest it and have it in sling to rest it.
60 2021-03-19 feeling abnormal, confusional state Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, ... Read more
Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, violent headache, chills fevers ,dry heaves, red and hot arm developed after couple days lasted about six days spread to 4x6 inches got itchy then sore to touch. Became vague and almost disoriented, had to sleep due to overwhelming fatigue w vile headache
60 2021-03-19 impaired work ability Severe debilitating fatigue that began the day after the vaccine (as expected), but has persisted; f... Read more
Severe debilitating fatigue that began the day after the vaccine (as expected), but has persisted; fatigue is so severe that I have had to stop working. I am a physician doing telemedicine
60 2021-03-19 sleep disorder Pfizer-BioNTech COVID-19 Vaccine EUA Date of Tuesday, Mar 16, 2021. Intense neuropathy pain in both... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Date of Tuesday, Mar 16, 2021. Intense neuropathy pain in both feet and both lower legs mainly at night. Difficulty sleeping. This continued each night but during day of Friday, Mar 19, 2021 the neuropathy continued and the numbness and tingling migrated up into my legs and into my arms and hands but not as intense as in my feet and lower legs Tingling, shakiness felt in muscles is continuous now, not just at night. I was scheduled to have 2nd dose today but decided not to go through with getting it. Consulted with my APRN on phone and they advised to get 2nd dose and we would follow up if needed on neuropathy. I decided I did not want the 2nd dose.
60 2021-03-21 impaired work ability 03/19/2021 - 4 PM I STARTED TO NOT FEEL WELL. LEFT WORK - WENT HOME , STARTED TO SHAKE REALLY HARD... Read more
03/19/2021 - 4 PM I STARTED TO NOT FEEL WELL. LEFT WORK - WENT HOME , STARTED TO SHAKE REALLY HARD WITH COLD CHILLS. LAID DOWN WITH TWO BLANKETS AND WAITED FOR THE SHAKING TO STOP...THEN FELL ASLEEP. I AM GUESSING SHAKING WENT ON FOR A GOOD 1/2 HR TO HOUR. i WAS VERY WEAK TO GET UP TO GO THE BATHROOM. MY HUSBAND HELPED ME.
60 2021-03-21 nervousness, feeling abnormal 8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscl... Read more
8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscle soreness. Initially I noticed my knees hurting with radiating pain up into my thighs. My head hurt, particularly at the back of my skull, near my neck. My neck muscles were sore, as were BOTH shoulders - my right shoulder (injection site) was only slightly sorer than my left shoulder. I called a 24/7 nurse associated with insurance company to ask if ibuprofen or tylenol were acceptable treatments for my symptoms. She told me I could take either and alternate if I felt I needed to maximize relief. I noticed the joins in my toes and fingers were hurting. It was frightening to experience tightness in my chest and back muscles. I never felt like my lungs were compromised, there was just a heaviness as the muscles seemed constricted. I felt a slight rise in my heart rate and experienced a few palpitations mostly because I kept pondering how much worse my symptoms could get. I was a little cold, so I decided to go to bed after drinking extra water (also a suggestion from the nurse). I slept for a few hours 10:00 PM - 4:00 AM then got up and called an advise nurse to report that my joint and muscle pain were not subsiding. She encouraged water and more painkiller. As the day wore on, I felt less achy and more shaky/jittery. My thinking was somewhat unclear - I felt a little dizzy, out of balance, off-kilter and brain "foggy." As I write this 36 hours after my injection, my symptoms are subsiding. Where I felt a little chilled during our cool and rainy afternoon, I now feel a wave of heat sort of traveling through my body. It isn't a fever - just an odd sensation that something is still going on.
60 2021-03-22 anxiety Patient was walking to the bathroom when she became dizzy. Patient provided with chair on her walk t... Read more
Patient was walking to the bathroom when she became dizzy. Patient provided with chair on her walk to the bathroom and made aware that we needed her to be stable before getting up again. Patient took a 5 minute rest and felt better. Patient guided to the bathroom but once she came out of the bathroom she became dizzy again. Patient was provided with a chair again but started to become frantic so we provided her with a cot and laid her down but patient started to become very short of breathe. Medics called and provided with hand off.
60 2021-03-22 anxiety woke up with severe vertigo. Then had an anxiety attack.
60 2021-03-22 loss of personal independence in daily activities March 21 I had fever 101 , fatigue, nausea, body aches, headache that kept me from my daily function... Read more
March 21 I had fever 101 , fatigue, nausea, body aches, headache that kept me from my daily functions. Reporting app did not ask about that date and I want to report that was a bad day. I did not seek medical treatment. Treated with ibuprofen and rest
60 2021-03-22 loss of personal independence in daily activities Within 1 hour after receiving vaccine, approx 45 min., Both ears suddenly felt as if I was on a pla... Read more
Within 1 hour after receiving vaccine, approx 45 min., Both ears suddenly felt as if I was on a plane and was blocked as you would feel by altitude change. I kept trying unblock by swallowing etc. That last 15ish minutes followed by a constant sound in both ears as if someone was rubbing sand paper back and forth in front of each year. That lasted 40-50 minutes. Approximately 32 hours after feel like I have to keep swallowing to unblock my ears. That altitude flucuation again feeling but not as bad as the first encounter. This was related to the vaccine. No doubt in my mine. Never had anything like this before unless on an airplane. Sand paper sound, never. I let my physician know tonight via email. In addition I felt dizzy within 5 minutes of receiving the injection. Subsided within 15 -20 minutes. Felt aloof the remainder of the day. Also arm hurt so bad the next day I had to cancel golf. Low grade fever plus headache
60 2021-03-22 sleep disorder I could actually feel the vaccine entering my blood stream above and below injection area. I had sh... Read more
I could actually feel the vaccine entering my blood stream above and below injection area. I had sharp pain on right upper side of my chest that came and went for several hours along with dizziness. Arm hurt so bad later that night from my elbow to my neck it woke me up and I took aspirin until pain died down some.
60 2021-03-23 feeling abnormal Felt abnormal and went to bed. Woke up at 9:35am with 101.7 temperature and called into work to advi... Read more
Felt abnormal and went to bed. Woke up at 9:35am with 101.7 temperature and called into work to advise I will not be coming in. I went back to bed no food no medicine, Most information I read and was aware is that it would be better with sleep. Only to wake up at 8:30pm with a 102.7 had 500 mg acetaminophen went back to bed. Woke up Thursday morning at 9:45am fever free. Friday afternoon I noticed swelling on my left neck area. Just inside my left clavicle. I made a Dr appointment for Monday and Dr. found several Lymph nodes swollen as well as under my left arm pit area. Due to some chest pain she sent me for a chest x-ray.
60 2021-03-23 feeling abnormal Began to feel bad one week after receiving injection and made appt with provider, xray showed infi... Read more
Began to feel bad one week after receiving injection and made appt with provider, xray showed infiltrate, pnuemonia, in right lower lobe, antibiotics prescribed and taken increased shortness of breath at time of visit.
60 2021-03-23 feeling abnormal Extreme exhaustion, chills, muscle aches, brain fogginess, headache - all the symptoms I experienced... Read more
Extreme exhaustion, chills, muscle aches, brain fogginess, headache - all the symptoms I experienced when I had COVID-19 in early November 2020. All symptoms improved within 18 hours except headache, which lasted for 36 hours. Headache was also a lingering effect after all other COVID-19 symptoms subsided when I had the virus, as well.
60 2021-03-23 sleep disorder, loss of personal independence in daily activities The injection was in the shoulder. Pain began less than one day later. I waited for the pain to re... Read more
The injection was in the shoulder. Pain began less than one day later. I waited for the pain to resolve. It has not. My shoulder is still sore. The pain is getting progressively worse and it now hurts to comb my hair, it hurts to raise my arm to put dishes in the cabinet, and it is hard to carry lift and carry objects of 8 ounces more. This pain also make it difficult to sleep through the night.
60 2021-03-24 thinking abnormal Mania and hyperactivity and fragmented thinking. Pressured speech
60 2021-03-25 hallucination Hallucinations Possibly fever, fatigue & dehydration 1-2 days ago Mild headache
60 2021-03-25 impaired work ability Initially, mild nausea, immediately (with 15 minutes of administration) . Resolved promptly within 3... Read more
Initially, mild nausea, immediately (with 15 minutes of administration) . Resolved promptly within 30 minutes of injection. Then, three hours after administration (at approx. 12.30 p.m.), the following symptoms in order of severity: 1. Severe tiredness/fatigue. Lasted 4 hours. Resolved when I took a half hour nap. 2. Sore throat. Still present at 10.30 pm. 3. Swollen lymph nodes (lymphadenopathy). Significant improvement after 4 hours from onset (3 hours after administration). However, still present at 10.30 p.m. 4. Feeling unwell/malaise. Resolved after I took a nap. 5. Dry eyes. I had to remove my contact lenses and put on eyeglasses when I got home at approx. 2pm. 6. Dry mouth. Unresolved, even with drinking a lot of water and tea. Symptoms were fairly severe. I had to leave work and go home to rest. I was unable to drive myself home.
60 2021-03-26 sleep disorder Day 1..... couldn't sleep that night Day 2.....fever, chills, bad headache, fell asleep at 4pm and s... Read more
Day 1..... couldn't sleep that night Day 2.....fever, chills, bad headache, fell asleep at 4pm and slept all night with 800 mg Tylenol. Day 3.....fever, Chills, bad headache, cough, diarreha Day 4..... headache, cough diarreha
60 2021-03-27 confusional state Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness... Read more
Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: vomiting-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
60 2021-03-28 anxiety BP 153/89, HR 84,O2 100%, 12 lead normal. Anxiety, weakness, palpitations. Exit time 11:22 am.
60 2021-03-30 anxiety pt. reported hx of anxiety and forgot to take medication. BP 152/84. HR-WNL. pt. now wants her BP ... Read more
pt. reported hx of anxiety and forgot to take medication. BP 152/84. HR-WNL. pt. now wants her BP checked. No interventions other than reassurance. pt. verbalized understanding to call 911 for any assistance after leaving clinic.
60 2021-03-31 anxiety Feels dizzy but thinks it may be anxiety. No other signs or symptoms. Informed to seek medical adv... Read more
Feels dizzy but thinks it may be anxiety. No other signs or symptoms. Informed to seek medical advice if any further problems.
60 2021-04-02 anxiety After 30 minutes , Pt C/O throat dryness, cough, SOB nausea and anxiety
60 2021-04-02 feeling abnormal I'm fairly certain that the vaccine caused a severe fibromyalgia flare-up, about 3 days after gettin... Read more
I'm fairly certain that the vaccine caused a severe fibromyalgia flare-up, about 3 days after getting the vaccine. This flare-up has been much more severe than the ones I usually get. The pain, fatigue, and brain fog has been extreme. No fever or flu-like symptoms.
60 2021-04-03 feeling abnormal, irritability my body is killing me; body pains; fever/Had a 101 fever at night; experienced ulcer on the side of ... Read more
my body is killing me; body pains; fever/Had a 101 fever at night; experienced ulcer on the side of her tongue; eye stye/I started with some kind of infection like stye something; felt terrible/ I am just feeling bad/Started freaking out; Swollen eyes/more puffy; irritable; stressed/Shot stressed my body; headache; Drug sensitivity/Reaction to medicine; I didn't have a taste; my 'eye' also started getting kind of sore; And then 3 days later, it started with an ulcer in eye; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Formulation: Solution for injection, Lot number: EN6204; Expiration Date: 30Jun2021), via an unspecified route of administration, in the left arm on 12Mar2021 around 1:15- 01:20 PM (at the age of 60-years-old) as 0.3 mL, single for covid-19 immunisation. Medical history included arthritis, anxiety and I had the virus in November. Concomitant medications included meloxicam (MOBIC) taken for arthritis as needed; alprazolam (XANAX) at 1 mg daily for anxiety. On an unspecified date in Mar2021, the patient had body pains, had a 101 fever at night, headache, ulcer on tongue, swollen eyes, stye in eye, felt terrible/started freaking out, irritable, drug sensitivity/reaction to medicine, shot stressed my body. Consumer stated, I had gotten the vaccine the other day, Friday. You don't know me but if you know me, I am going to have the side effects and it's going to happen, and it happened. From the next day my body is killing me. I had a 101 fever at night, felt terrible. Anyway, the next day, I felt better, whatever. And then yesterday, I felt pretty good except I started with all of a sudden, I got ulcer on my tongue. Now, I have got like, I don't know a stye happening on my eye and I know, it's all due to that vaccine because I have reactions to the medicines. I got to watch what I do. And I was scared to get this thing anyway, I already didn't want to get the shot and I did it. But anyway, right now, I am just feeling bad because of my tongue and I kind of looked up that and it did say that it can be caused from like a drug sensitivity. I do know it's all because of that." Consumer further stated, "Like 3 days later, I started with some kind of infection like stye something on my eye. Yesterday it started, and also, I have an ulcer on my tongue now. But I guess what I am afraid of, in less than 3 weeks, I have got to take this vaccine again. The patient had the virus in November, and I did test positive at some point for the antibodies and when I looked up something, as I was running a high fever. I started looking up stuff and it said if you already have a pre-existing immunity which I did due to the antibodies. I believe it's still there because it has been 4 months, but you might get. It says you will get side effects worse; you will get side effects. People that have never got exposed and have antibodies, don't get the side effects but I got them. So, I guess what I am afraid of because now I am like, I know it's a reaction to the medicine. And now I got ulcers on my tongue. And my eye, yesterday it started with the stye thing, and I never get them, it was swollen. I know this was a reaction from that vaccine, I know it was. I don't have fever and none of that no more, the body aches have left me. It was pretty bad, but it left me. But I am scared to get that next vaccine. Consumer stated, my 'eye' also started getting kind of sore and now it's swollen and I know this was a reaction to that because my body did not like that's all I can tell you. I am afraid if I get the next vaccine which was on 02Apr2021 (later confirmed), am I going to get, I am scared that something worse is going to happen to me. Because everybody knows if you had the vaccine, any of them, nobody and they say with the first vaccine usually you don't get anything, it's the second one. Well, I know, it was going to happen to me, and it did happen to me. So, I am scared what's going to happen with the second one. If my body still has antibodies from the virus, it did say or I read, maybe it's not true but what I read, it said 89 or 87% people that have already been having pre-existing immunity which would be me because I had the antibodies, you won't get the side effects more than people that never had the antibodies or had the virus. I didn't have a taste because I was having a high fever initially when I had the virus. It was weird. I cannot explain the feeling. I was laying down that night, that Saturday night, I thought let me check my temperature and it was like 99.5 and then maybe an hour later 100 and at 1:30 in the morning, it was 101 and then a couple of hours later, I checked it and it was like down to 100.5. I was calling a Pharmacist when I started freaking out on that. And they said no, nothing was going to happen. On Sunday morning, it was 99.5 and then when I checked it yesterday, I had nothing, no more fever. But then I started with ulcer and I looked it online and it said that it could be due to the stress and I was very stressed out because of getting a shot. I didn't want to do it and I did it but one of the things, it said a sensitivity to foods and drugs can cause ulcers in the mouth and I know it was that and then my eye, I don't know about the eye, it's swollen underneath. I know this was a reaction, I know it was. Eye was a little worse. I guarantee you, it's due to the shot. Shot stressed my body. That was just my reaction to that shot because it started all the side effects. And then 3 days later, it started with an ulcer in eye. And I guess that it's just too coincidental. It just stressed my body bottom line. The eye was a little bit worse today. The ulcer was going to go away, but it is at its peak right now. I am worried about the eye. It started sore yesterday and then today it is more puffy and I kind of put my contact lenses on it. It's not in the eye. It's on the tissue of bottom lid near the edge of the eye. The patient underwent lab tests and procedures which included blood test which showed okay, everything was okay. Therapeutic measures were taken as a result of ulcer on the tongue included had a mouth wash that she used and had done great to my teeth. The ulcers are going to go away, but the eye was. I am just kind of watching it if it gets like whatever tomorrow. I might go to emergency room. It's not in the eye. It's in the lower lid. It's very tender and close to eye." Consumer further stated, "I want to know an answer. This is really important to me because this time, I have to take a nerve because as soon as they put the needle in me, my nerves, I just had a panic attack. I was scared. I need to know do I need to afraid to get next vaccine because I won't do it if I knew something worse going to happen, I won't do it. I already have the reaction, but I don't want to risk our lives again. I got the side effects. Consumer stated, I'm a little sensitive to the medicines. I keep a check on what do I take. The outcome of the events body pains and fever recovered on Mar2021, ulcer on the side of her tongue, felt terrible/ I am just feeling bad/started freaking out was recovering, swollen eyes/more puffy; eye stye/I started with some kind of infection like stye something; my 'eye' also started getting kind of sore; And then 3 days later, it started with an ulcer in eye was not recovered and other events was unknown. Causality assessment for events had a 101 fever at night, ulcer on tongue, swollen eyes with BNT162B2 was related per reporter.
60 2021-04-04 impaired work ability She got the vaccine, only had the real sore arm. She went to bed and trying to get ready to go to w... Read more
She got the vaccine, only had the real sore arm. She went to bed and trying to get ready to go to work, had a slight fever, headache, chills, aches, stomach didn't feel right. Felt like she had the virus again. She was in bed all day on Friday, and then that night she still had chills and 101.1 fever. Did not feel well on Saturday and was out of work for 2 days. She is feeling better, tired. The arm is still sore to touch, but not as bad. She just felt sick, and is feeling better today. Her stomach is still not right, but overall feeling better. She did take Tylenol which helped and a couple of other times for the symptoms.
60 2021-04-04 restlessness Massive headache at front of head, dizziness, ringing in ear, nausea, restless, diarrhea, stomachach... Read more
Massive headache at front of head, dizziness, ringing in ear, nausea, restless, diarrhea, stomachache, shallow breathing, hearing sensitivity, exhaustion, sleep sweat, lack of appetite.
60 2021-04-05 feeling abnormal TINGLING IN THE CHEST ABOUT 1/2 HOUR AFTER SHOT, FEELING OF SWOLLEN LIPS STARTING ABOUT 2HRS AFTER S... Read more
TINGLING IN THE CHEST ABOUT 1/2 HOUR AFTER SHOT, FEELING OF SWOLLEN LIPS STARTING ABOUT 2HRS AFTER SHOT LASTING ABOUT 4 HOURS..THEN TONGUE AND FACE FELT TINGLING ..TONGUE FELT SWOLLEN METAL TASTE IN MOUTH AND A VERY FUZZY FEELING FOR THE DAY OF AND DAY AFTER SHOT WENT TO WALK IN CLINIC AT 620 PM ON 4/3. RECOMMENDED BENEDRYL RATHER THAN STEROID METAL TASTE AND FEELING OF SWOLLEN TONGUE SUBSIDING....FACE TINGLE REMAINS ON 4/6/21
60 2021-04-06 insomnia rapid heartbeat; she has been having insomnia ever since she went to the hospital; This is a spontan... Read more
rapid heartbeat; she has been having insomnia ever since she went to the hospital; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration administered in the right arm in a hospital facility on 10Mar2021 at 12:30 PM (at the age of 60-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks and had no additional vaccination administered on same date of the Pfizer suspect. The patient had no medical history (including any illness at time of vaccination. The patient had no family history. Ongoing concomitant medications included amlodipine besylate from 2019, vitamin D3 taken for general health, calcium taken for bone density, and fish oil taken for heart health. On 12Mar2021, the patient experienced rapid heartbeat. The patient continues to have rapid heartbeat "on and off." The patient asked if it was considered a severe allergic reaction. The patient added that she went to the ER and was admitted to the hospital on 12Mar2021 and discharged on 14Mar2021 due to rapid heartbeat. While hospitalized they did an electrocardiogram (EKG); and Echocardiogram and a computerized tomogram (CT) of the heart and chest and all showed no heart disease and no pulmonary embolism. Adds whenever she gets up and does some slight activity, her heart goes for about 30 seconds. Sometimes it goes from 70 to 115 and then goes back. also added that she was going to see her primary care doctor on 29Mar2021 about it. She was scheduled to get the next dose but she was asking if she should get the next dose. She also added that she has been having insomnia on 12Mar2021 ever since she went to the hospital and it was still happening because she was so anxious about this. The events did require emergency room visit but did not required physician office visit. Therapeutic measures were taken as a result of rapid heartbeat which includes amlodipine and metoprolol. The patient had not yet recovered from rapid heartbeat and insomnia.
60 2021-04-07 mental impairment March 28: Bright red cheeks, extreme thirst, cold sores, severly chapped lips, clammy sweat (contin... Read more
March 28: Bright red cheeks, extreme thirst, cold sores, severly chapped lips, clammy sweat (continued through entire series of symptoms) March 31 - April 2: Fever, Chills, Excrutiating muscle and joint pain, nausea, severe headache. Unable to function, think clearly, or eat/drink. No vomiting April 2 - April 5: Severe upper stomach pain and burning/soreness under right side rib cage. Uncontrollable watery diahhrea. Unable to eat the first two days of this. Able to drink some. April 5 to current: Still fighting the diahhrea but pain stopped. Have been on the BRAT diet since April 4th. Began taking a prescription from doctor to help with diahhrea on April 8. Still experiencing dizzyness, lack of clarity.
60 2021-04-07 mental status changes, hallucination shortness of breath, chest pain, altered mental status, weakness, hallucinations, admit to hospital ... Read more
shortness of breath, chest pain, altered mental status, weakness, hallucinations, admit to hospital and discharged on 4/2
60 2021-04-08 nervousness, anxiety Numbness and tingling of tongue and lips. Patient reports she felt and still feels nervous and anxi... Read more
Numbness and tingling of tongue and lips. Patient reports she felt and still feels nervous and anxious about COVID vaccine. Vitals when arrived at meds observation at 11:09 am, HR96, resp 18, BP 183/89, 98% SaO2. BY 11:11 resolving numbness and tingling of mouth. Vitals at 11:12am, HR 95, Resp 18, BP 171/85, 98% SaO2. At 11:20 am, patient reports only slight numbness and tingling in tongue, lips resolved. Vitals at 11:20, HR 94, Resp 18, BP 165/80, SaO2 98%. Patient came back from bathroom( assisted to & from bathroom by med obs RN), vitkas when back at 11:33 Hr81, resp 18, BP 194/82, SaO2 100%. Rechecked vitals 11:39, Hr 88, Resp 18, BP 180/80, SaO2 97%. Vitals at 11:56 am, patient reports most of tongue tingling is gone, Vitas at 11:56, HR84, Resp 18, BP 174/87 , SaO2 98%. Vitals at 11:49, HR 93, Resp 18, BP 164/83, SaO2 97%. Patient anxious and wants to leave. Vitals at 12:05, HR 86, resp 16, BP 184/84, SaO2 97%. Spoke with provider about patient's situation. Okay for patient to leave since being worked up by PCP for HTN. Patient instructed to check BP once she got home (has been monitoring BPS at home due to HTN) and notify PCP about BPs while here. Patient's vitals at time of leaving via own personal vehicle, HR 90, Resp 16, BP 183/83, SaO2 98%. Patient reported only a little tingling in tongue when she left.
60 2021-04-08 nervousness Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Sys... Read more
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
60 2021-04-09 feeling abnormal around 1106am patient complained of "harsh" throat and "just not feeling right" EMS on scene perform... Read more
around 1106am patient complained of "harsh" throat and "just not feeling right" EMS on scene performed EKG 11:10am patient had emesis, 118/72, HR-76, 98% on room air, PA evaluated pt on site and ordered Hydroxyzine 25mg po x1. pt took this and has no complaints.
60 2021-04-10 agitation Almost immediately felt flushy and a bit hyper and then started to develop numbness (not pins and n... Read more
Almost immediately felt flushy and a bit hyper and then started to develop numbness (not pins and needles) of the front of my face. Somewhat milder than for the first dose, both of my upper arms started to feel discomfort within a few minutes. The numbness dissipated within an hour and a half, by which time I started to feel achy and have some of the common side effects. Next day was very achy and did not have much stamina. Was feeling much better in the morning of 04/11/2021. In the evening of 04/11/2021 started to feel some numbness in my nose again.
60 2021-04-10 restlessness, hallucination, insomnia Mild to moderate hallucinations for about 10 hours, starting about 6 hours after vaccine. insomnia ... Read more
Mild to moderate hallucinations for about 10 hours, starting about 6 hours after vaccine. insomnia & restlessness - at its worst during first 24 hours, then tapering off in severity but continuing for 48 hours. Both were tolerable but uncomfortable. These were very unusual symptoms that were not listed as expected symptoms so I thought they should be reported.
60 2021-04-11 anxiety 9 minutes after vaccination patient developed chest discomfort with burning sensation and anxiety. B... Read more
9 minutes after vaccination patient developed chest discomfort with burning sensation and anxiety. BP 151/86 HR 75 RR14 Sat 98% 0.9 % NSS to keep vein open Benadryl 50 mg IV one dose stat
60 2021-04-11 sleep disorder, impaired work ability, loss of personal independence in daily activities, feeling abnormal My arm was sore immediately. As the hours progressed after the shot, my left upper arm became very ... Read more
My arm was sore immediately. As the hours progressed after the shot, my left upper arm became very swollen, hard, and painful enough to wake me in the middle of the night. The hard lump was as big & wide as my right hand and began 2 inches above my elbow up to the place of injection. When my morning alarm went off, I was very fuzzy and extremely weak. I was unable to go to work or remember a lock combination I use every day. My energy began to return the next day enough to work a half day but returned to bed for the afternoon. The tiredness was all but gone by 8:30 pm. Reaction began Sunday morning and was gone by Tuesday night.
60 2021-04-11 sleep disorder Extreme pain from top of left shoulder to the elbow. Unable to stretch, scratch my neck, wash my ba... Read more
Extreme pain from top of left shoulder to the elbow. Unable to stretch, scratch my neck, wash my back or put on my seatbelt. The are aches so much that I can not sleep at night. I am unable to lay on my left arm. I have a large hard lump on my left arm at the injection site. Weakness in left hand. Unable to raise my arm to remove my shirt. The pain seems to be getting worse. Left inner leg bruises and pain.
60 2021-04-12 anxiety Dizziness, diaphoretic Felt like throat was tight Chest clear, airway clear and was very anxious Ben... Read more
Dizziness, diaphoretic Felt like throat was tight Chest clear, airway clear and was very anxious Benadryl 25mg given by mouth
60 2021-04-12 anxiety pt states after receiving vaccine about one minute after pt states she felt arm tingling and pins an... Read more
pt states after receiving vaccine about one minute after pt states she felt arm tingling and pins and needles feeling in left arm and metallic taste in mouth, and very anxious pt shaking and was unable to sit still in stretcher, refused wheelchair to observation area and ambulated self without difficutly. pt also very guarded and did not want to talk about health history or meds upon assessment. pt state feeling hot and cold chills as well. pt anxious about previous anaphylaxis had in past with darvocet. denies feeling symtpoms of anaphylaxis, site of injection healthy no observed hives or redness in area. vs as noted, pt feeling better and wanting to be sent home pt ambulated to exit with husband at 1438 vs: 1410 bp123/81 hr 84 rr 18 o2 97 1415 bp 140/96 rr 18 hr 78 o2 98 1420 bp 137/80 hr 80 rr 18 o298 1425 131/89 hr 80 rr 18 o2 99
60 2021-04-12 feeling abnormal, loss of personal independence in daily activities very bad migraine, nausea, chills, overall very sick feeling, could not get out of bed Took migraine... Read more
very bad migraine, nausea, chills, overall very sick feeling, could not get out of bed Took migraine meds & some Tylenol, did not help to counter symptoms and migraine The entire day, starting at 4am, I was unable to get out of bed For the past 1 1/2 weeks I feel very run down and my brain is foggy Will not take a booster vaccine ever! These entire after effects are not worth the taking the vaccine.
60 2021-04-12 feeling abnormal, memory impairment, amnesia Brain fog and memory loss, since vaccine 1st dose, 04/07/2021 On 04/08/2021 I woke up to find my lef... Read more
Brain fog and memory loss, since vaccine 1st dose, 04/07/2021 On 04/08/2021 I woke up to find my left eye with filled with blood over most of the sclera. Severe joint pain. Muscle pain, and lethargy. Extremely forgetful with new onset 04/07/2021. Eye pain left eye. L eye hemorrhage is not resolved yet.
60 2021-04-12 feeling abnormal I have suffered from tinnitus for a very long time but about a week after receiving the vaccine I wo... Read more
I have suffered from tinnitus for a very long time but about a week after receiving the vaccine I woke up to a ramped up ringing in my ears that has not subsided. The noise level increased at minimum 50% and it causes brain fogginess I have not previously experienced.
60 2021-04-13 feeling abnormal 04/07/21 at 1205 Pt. sitting in Vaccination monitoring area post first dose Pfizer vaccine (lot ER87... Read more
04/07/21 at 1205 Pt. sitting in Vaccination monitoring area post first dose Pfizer vaccine (lot ER8733); noted to be tearful with hand over chest. Voiced "feels like heat is beating fast all of a sudden". 1207 Pt. moved to monitoring cot into semi - reclined position. 1208 BP 140/82, HR 103, O2 sat 99%, R 20. Skin slightly clammy with no skin redness / rash or throat / tongue edema. 1208 EMS called to site. Pt denies medical hx or any allergies. 1213 Pt. voiced "HR starting to feel better, only notes some lightheadedness / spacey feeling; P 91 / Sat 98%. 1215 BP 132/78, P 65, R 18, Sat 98% - Voiced "thinks everything is okay now; notes only dull ache at right arm injection site. Pt. also called husband to site at time. 1217 EMS arrives and pt. assessed. 1226 EMS provided pt. education on self monitoring & hospital f/u. Pt. declines transport to hospital; will monitor self at home with assist of husband: sitting on side of cot. 1228 EMS departed scene and pt. husband now present; P - 61 and O2 98%. 1229 Pt. and husband voiced readiness to leave. Educated to let pt. PCP know about events post vaccination. Pt. voiced understanding and will just monitor self at home. Both ambulated to from site together
60 2021-04-14 excessive sleepiness Slight headache, fever (100.4), reduced appetite. It felt like a mild case of the flu. I was allow... Read more
Slight headache, fever (100.4), reduced appetite. It felt like a mild case of the flu. I was allowed to leave work and go home. I slept for a few hours, ate a little bit and went to bed very early (8:45pm). By the next morning, the fever broke and I was fine.
60 2021-04-15 sleep disorder, feeling abnormal Felt fine until 11 hours after 2nd shot, then felt like I was hit by a truck so went to bed. Could n... Read more
Felt fine until 11 hours after 2nd shot, then felt like I was hit by a truck so went to bed. Could not sleep all night because bones started to ache terribly...felt like my bones were going to explode, which seemed like a very unusual reaction. Halfway through the night, got nauseous. Later in the night got stuffed nose and headache. Woke with headache, body aches, fuzzy head and had fever up to 101.5 all day. Took a Tylenol in the morning and drank a cup of coffee and lots of water which made headache disappear. Finally took a Motrin at 6pm and started feeling much better by 9pm. Slept well. By 7am next morning, was 100% fine albeit tired.
60 2021-04-16 anxiety Nausea vomiting throughout the day and continuous the next night, sense on impending doom
60 2021-04-16 anxiety Pt c/o anxious and claustrophobic, & nausea. "I just want to get out of here, I want to go outside."
60 2021-04-16 insomnia experienced extreme pain on my inner thigh on my left leg; It was hot to the touch, very red and swo... Read more
experienced extreme pain on my inner thigh on my left leg; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; difficulties to sleep and walk; difficulties to sleep and walk; Superficial Thrombophlebitis; This is a spontaneous report from a contactable consumer (patient). A 61 year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL9263, expiry date not reported), at the age of 60 years old, via an unspecified route of administration, administered in left arm on 02Feb2021 09:00 at a single dose for covid-19 immunisation. The patient then received the second dose of covid-19 immunisation on 23Feb2021 08:00 AM (lot EN6200), via an unspecified route of administration, administered in the left arm. Medical history included rheumatoid arthritis and multiple sclerosis, both from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination and the events. The patient no covid prior to vaccination. The patient's concomitant medications were not reported. The patient was not tested for covid post vaccination. Soon after COVID-19 vaccination, on 21Feb2021, patient experienced extreme pain on inner thigh on left leg. It was hot to the touch, very red and swollen causing difficulties to sleep and walk. Patient then saw a vascular doctor for the pain on 16Mar2021 and was advised that patient have superficial thrombophlebitis (since 21Feb2021) and was prescribed to take Xarelto 15 mg for two weeks. Therapeutic measures were taken as a result of the events reported which included Xarelto 15 mg and had a venous ultrasound of area on an unknown date (unknown results). The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events reported was recovering.
60 2021-04-17 impaired work ability Patient received Pfizer for her first dose on 3/17/21 and a moderna for her second dose on 4/8/21. S... Read more
Patient received Pfizer for her first dose on 3/17/21 and a moderna for her second dose on 4/8/21. She states at the 24 hour mark of receiving the moderna she experienced extreme joint pain and swelling. She states she has not been able to work when I called to check on her on 4/13/21.
60 2021-04-18 feeling abnormal Abdominal cramp/diarrhea on day of injection and 2 days later 4/17/21, 4/18/21, 4/19/21 Headache and... Read more
Abdominal cramp/diarrhea on day of injection and 2 days later 4/17/21, 4/18/21, 4/19/21 Headache and feeling of weakness and foggy head day after injection 41/18/21 subsided by third morning 4/19/21.
60 2021-04-18 impaired work ability Pain in left shoulder/ arm started approximately two hours after vaccine. Pain Consistently getti... Read more
Pain in left shoulder/ arm started approximately two hours after vaccine. Pain Consistently getting worse into Wednesday evening to where I was having trouble moving my arm up down behind me a crossed my midsection and out away from my side, pain getting worse intoThursday morning. Called off work Thursday/Friday. Other symptoms subsided after 48 hrs but not the pain in Site area and shoulder. Saturday not improving went to clinic in afternoon.
60 2021-04-18 sleep disorder Shingles-left shoulder blade and left breast (vaccine in left arm); began two days after vaccine wit... Read more
Shingles-left shoulder blade and left breast (vaccine in left arm); began two days after vaccine with tingling on shoulder blade, then red rash, then painful blisters; stinging/stabbing pain; inability to sleep due to discomfort Lymphadenopathy-swelling in my left breast and chest; much discomfort
60 2021-04-19 feeling abnormal Received the shot about 1:30. Everything was fine. By evening, the arm was sore and left armpit hu... Read more
Received the shot about 1:30. Everything was fine. By evening, the arm was sore and left armpit hurt. Went to bed about 10. Woke up about 1:30/2:00 with left arm hurt a lot. Took Advil and went back to bed. Woke up at 4 am to get ready for work and felt awful. Noticed was out of breath on short horizontal walk from bedroom to bathroom, chest tight, acting like an asthma attack. Took a puff of albuterol inhaler and went back to sleep. Got up just before 7, still sore to breath. Grabbed oximeter (being asthmatic, I have one) and noticed )s level down to 94/95 when normally it reads 98/99 on this one. Called allergist to cancel allergy shot scheduled for that morning. Took another puff of albuterol. (Waiting to see if need nebulizer.) Breathing becoming easier and reading now about 97/98 with pulse lower, more normal. Lungs a bit touchy this time of year anyway. And I have had allergic reactions in the past take place as an asthma attack. (For instance, if I eat a small quantity of something with yellow dye 5 in it, I will notice that my breathing is more difficult.)
60 2021-04-19 feeling abnormal Sat (4/17): severe chills for two hours starting at 11:55 pm Sun (4/18): woke and could not walk acr... Read more
Sat (4/17): severe chills for two hours starting at 11:55 pm Sun (4/18): woke and could not walk across the room without falling down due to dizziness, was nauseated, strong headache, fever of 102 all day, bedridden Mon (4/19): Fever was reduced but nausea, headache still persisted all day, continued chills. Right middle finger began to swell and turn purple Tues (4/20): Lost feeling/sensation in right middle finger, head feels off, nausea still persists, stomach pains. Called doctor and had televisit with nurse practitioner
60 2021-04-19 sleep disorder Tinnitus in both ears, noted the morning after second dose and fairly constant since then (4 days). ... Read more
Tinnitus in both ears, noted the morning after second dose and fairly constant since then (4 days). Loud enough to interfere with sleep at night. I hope it goes away!
60 2021-04-20 delirium DIZZINESS, ATAXIA, WEAKNESS FOR 1 WEEK, THEN DEVELOPED HYPERGLYCEMIA AND DEHYDRATION AND ACUTE DELIR... Read more
DIZZINESS, ATAXIA, WEAKNESS FOR 1 WEEK, THEN DEVELOPED HYPERGLYCEMIA AND DEHYDRATION AND ACUTE DELIRIUM AND HYPERTENSIVE EMERGENCY REQUIRING ICU HOSPITALIZATION
60 2021-04-20 feeling abnormal her MS started to flare; I have a lot of numbness and tingling in my left side; it's still a little ... Read more
her MS started to flare; I have a lot of numbness and tingling in my left side; it's still a little tingling; I have a lot of numbness and tingling in my left side; it's still a little tingling; I had 3 days of sheer misery I couldn't use my left side as I am left handed; it made it kind of difficult; I couldn't hold anything in it, if I wanted to put my hand back; I could not even grab my head up to put it off; I have been not feeling that good; shot I went to home I had gastro intestinal problems; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in arm left (reported as "Left shoulder") on 31Mar2021, at the age of 60-year-old (Batch/Lot number was not reported, it was reported that "it says Pfizer and then 8733") as single dose for covid-19 immunisation. Medical history included multiple sclerosis (MS) and she had the GA (gallbladder atony) thing it was awful she mean anything she ate or drank, right to the toilet. Concomitant medications included ibuprofen (ADVIL) taken for an unspecified indication, start and stop date were not reported and Vitamins. Consumer stated, she had the COVID-19 shot last Wednesday 31Mar2021 and she have MS so what it happens was she have got the shot she went to home she had gastro intestinal problems she had she could not get off the toilet for a while and then her MS started to flare, So she have a lot of numbness and tingling in her left side and it's still a little tingling but she had 3 days of sheer misery. She couldn't use her left side as she was left handed so it made it kind of difficult and she live alone. The reporter wanted to know that it was as potential side effects, she was just glad they didn't go full blown affect because they are miserable. When paraphrased the above concern, Consumer stated, No she was starting to get a lot better because she would be really going to say it if it didn't come, because she was not going to stand it but 3 days she couldn't use it at all, she mean she couldn't hold anything in it, if she wanted to put her hand back and probably feel she could not because she was not she could not hold anything she could not even grab her head up to put it off, as she said she had the GA thing it was awful she mean anything she ate or drank, right to the toilet. Consumer stated, No she haven't talked to anybody like any she have been not feeling that good, the first thing she had blown up in because when she had MS it starts to flare she don't she actually want to do is laid down and sleep. For treatment, consumer stated, no treatment, she stayed home, she just rested that's it, it's like her left side is affected her left leg was affected and her arm is affected all the left side is numb and tingly, so she don't like to do anything she don't like to walk anywhere, it's not good. Consumer stated, she just wanted to let us know in case anyone called us with and MS. Date for second shot of COVID-19 Vaccine is "21Apr2021." The outcome of the event "tingling" was recovering; of the other events was unknown. Information about lot/batch number has been requested.
60 2021-04-20 sleep disorder The following morning,, back pain/sciatica began after waking. As the day went on, it got worse. N... Read more
The following morning,, back pain/sciatica began after waking. As the day went on, it got worse. Night-time ... difficult to sleep. Next morning (today) very painful ... difficult to stand (at times) and sit. All similar to my back condition in December that I thought was under control. Taking over the counter medications haven't helped yet. Alternating heat / ice / bacx-brace.
60 2021-04-21 insomnia Tiredness, insomnia, achy, headache; aspirin and rest
60 2021-04-21 loss of personal independence in daily activities On 4/10/21 I had fever and severe chills. On 4/11/21 the fever broke. I was fine but weak. On the ni... Read more
On 4/10/21 I had fever and severe chills. On 4/11/21 the fever broke. I was fine but weak. On the night of 4/11/21 (9:00pm) fever returned. I took advil and went to sleep. On 4/12/21 I woke up with my arm very swollen and it was hot to touch. By the afternoon I was worse and the area was turning red so I went to the Urgent care and diagnosed with Cellulitis (which I have never had and didn't understand at first what this was about). I was treated and returned to my regular Doctor for follow up. I still have this thing and although it's better it's not gone as of this report and it is causing me distress in typing, cleaning and so on.
60 2021-04-21 nervousness 15 minutes after vaccine, I felt a sudden burning, warm feeling spread through my arms and head. I c... Read more
15 minutes after vaccine, I felt a sudden burning, warm feeling spread through my arms and head. I checked my Watch and heart rate was 127. I had a similar reaction with the first shot on 3/24/21 and was told by staff that it was probably due to hyperventilation and panic after they took my vitals. I did not seek medical attention the second time as the burning sensation disappeared quickly and I was able to lower my heart rate through breathing exercises. I left the medical location about 15-20 minutes after the episode and drove home without incident. I had moderate arm pain and fatigue the rest of the day. On the morning of 4/22/2021, I woke up feeling well except arm pain. At around 7:45 that morning, I had a sudden shaky episode where my watch registered heartrates from 105 up through 153. My hands tingled and they developed a significant tremor. These symptoms are typical for me during a panic attack. I took 1/2 of a Clonazepam and did some breathing exercise and was able to get my heart rate back to normal (in the 70s) within 10 or 15 minutes.
60 2021-04-22 sleep disorder Have had rapid heartbeat, little shortness of breath, blood pressure has been elevated. More severe ... Read more
Have had rapid heartbeat, little shortness of breath, blood pressure has been elevated. More severe than normal heartburn, little burning in chest and gallbladder pain. not sleeping well because of it
60 2021-04-23 confusional state Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Additi... Read more
Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Additional Details: patient said a few days after 1st vaccine she had flu like symptoms: fatigue,brain fog,headache and has not gotten better,also depression,loss of interest in doing things
60 2021-04-24 feeling abnormal, nervousness, sensation of foreign body Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc... Read more
Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) lump in my throat; turned red on my face and neck and chest and arms; when I get nervous; between my eyes on my forehead felt like a round circle (no bump) (past the bridge above eyebrows). It didn't hurt, but I felt something; felt odd; felt like my eyes were moving back and forth; very very cold; hands were ice cold; This is a spontaneous report received a contactable consumer, the patient. A 60-year-old adult female received the first dose BNT162b2 (solution for injection; batch/lot and expiry information not reported) as a single dose via unspecified route on 14Mar2021 (at 60-years-old), for COVID-19 immunisation. Relevant medical history included high blood pressure, and diabetes. There were no concomitant medications or past drug history reported. The patient reported that she had a couple of reactions the first day, so she was afraid to take the second one. The patient stated that within eight minutes she had a lump in her throat, which she gets when she is nervous and was unsure if from shot or nervousness. The patient reported that then she turned red on her face, neck, chest, and arms. The patient reported that the redness lasted about six or seven hours and did not bother her at all. The patient explained that then between her eyes on her forehead felt like a round circle (no bump) past the bridge above eyebrows. The patient stated that it did not hurt but felt like something. The patient also stated that she felt like she was going to get headache, though did not. The patient reported that it just felt odd. The patient also stated that she felt like her eyes were moving back and forth. Though when she looked in the mirror, they were fine. The patient stated that the eyes happened three times but by the time she looked in the mirror they looked fine. The patient added that she never felt sick or anything though about six or eight hours later she got very very cold which only lasted about a minute. The patient stated that her hands were ice cold and then it all went back to normal. The outcome of the events turned red on my face and neck and chest and arms was recovered on an unspecified date in Mar2021 after 6-7 hours. The outcome of the event she got very very cold was recovered on an unspecified date in Mar2021 after one minute. The outcome of the events hands were ice cold, and felt like my eyes were moving back and forth was recovered on an unspecified date in Mar2021. The outcome of the events, lump in my throat, get nervous, between my eyes on my forehead felt like a round circle (no bump), felt something, and felt odd, was unknown. Information on lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
60 2021-04-25 feeling abnormal Sore arm High fever 103 Foggy brain Fatigue Aches
60 2021-04-25 sleep disorder Exactly ONE WEEK after I had the 2nd dose of Pfizer, both my arms began to tingle and hurt by 2 pm o... Read more
Exactly ONE WEEK after I had the 2nd dose of Pfizer, both my arms began to tingle and hurt by 2 pm on a Monday. Within a few hours, this spread to my entire body; every joint and muscle was in severe pain and discomfort. I went to bed around 5 pm and had the chills, but no fever. I continued with this pain for Monday night and could barely sleep. It continued but not as severe on Tuesday and Wednesday. By Thursday, I forced myself to take a shower. By Thursday, the pain in the upper body was gone, but I still had severe pain in both lower legs from the knees down. It was unbearable if I stood for more than 20 seconds, however, if I lifted each leg and then alternated legs, the pain would go away. This felt like enormous pressure in my legs and at one point, I thought maybe I had blood clots, but my legs were not red or swollen. The lower leg pressure finally went away on its own by Sunday, April 25th, 2021. At no point did I have a fever and I could get some relief by taking Ibuprofen, but not a lot of relief.
60 2021-04-26 disturbance in attention, disorientation her whole left side, including the left side of her face went numb; lost focus; throw up; Emotional ... Read more
her whole left side, including the left side of her face went numb; lost focus; throw up; Emotional instability; head hurts; nauseous; Disorientated; Dizzy; Slurred speech; Balance impaired; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in left arm on 30Mar2021 17:30 (Lot Number: EW0150; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. Medical history included depression from 2005 to an unknown date, blood pressure high in 2020 and unknown if ongoing, and high cholesterol in 2020 and unknown if ongoing; stated she was diagnosed with high blood pressure and high cholesterol about a year ago and was on low doses of blood pressure medication and cholesterol medication. There were no concomitant medications. The patient has no prior vaccinations (within 4 weeks). The patient experienced her whole left side, including the left side of her face went numb on 31Mar2021 with outcome of recovering, lost focus on 11Apr2021 with outcome of not recovered, head hurts on 31Mar2021 with outcome of not recovered, nauseous on 31Mar2021 with outcome of not recovered, disorientated on 31Mar2021 with outcome of unknown, dizzy on 31Mar2021 with outcome of not recovered, slurred speech on 31Mar2021 with outcome of recovered in Apr2021, balance impaired on 31Mar2021 with outcome of not recovered, throw up on 10Apr2021 with outcome of recovered on 10Apr2021, emotional instability on 31Mar2021 with outcome of not recovered. The patient received her 1st dose of the Pfizer COVID19 Vaccine on 30Mar2021 and experienced a bucket load of side effects listed with the vaccine. She mentioned that she has lost focus, her head hurts, and so nauseous. She mentioned that half of her face is numb and that she was hospitalized for 24 hours because the doctors thought she had a stroke. She mentioned she has never had a reaction to anything and the doctors told her that this was related to the vaccine. She is asking how long does this side effect last, if the 2nd dose would have more severe side effects than the first, and could she receive her 2nd dose scheduled this Saturday after experiencing this side effects. She mentioned that her doctors recommended that she get vaccinated. She is in distress as she mentioned that this side effects have affected her life and her job. Further clarified, on 31Mar2021 she was disoriented, dizzy, nauseous, and had a massive headache. She said her symptoms were all on the list of possible COVID-19 Vaccine side effects. She said then her (whole) left side, including the left side of her face went numb. She said she called the nurse on the help line, and the nurse told her to call #. She said she didn't call # because she thought it wasn't necessary. She said she went to urgent care. She clarified at the urgent care they flipped out and wheeled her into a back room and hooked her up to a heart monitor, and brain monitor. She said that was around 5:00PM-6:00PM on 31Mar2021. She said she was taken by ambulance from the urgent care to the hospital emergency room. She said she stayed in the hospital overnight. She said she also had slurred speech, couldn't balance, and couldn't track (clarified as focus). She said it was awful. She said they thought she had a stroke because the left side of her face, and her whole left side were numb. She said if she tried to smile, one side of her face didn't work like other side of her face. She said when she was at the hospital, the hospital did all kinds of tests on her. She said she was told she didn't have a stroke, and her symptoms had to be a side effect of the COVID-19 Vaccine shot. She said the doctors at the hospital told her to "tough it out", and wait until her symptoms were done. She said the numbness was gradually going away on the left side of her body. She said the left side of her face was partially numb, and she had parts of left arm that were still numb. She said Thursday, 08Apr2021, was the first day she felt good. She said she was able to focus, and work. She said she felt she had a steady focus, and was not losing her mind. Friday morning (09Apr2021) was "iffy", but she felt she had improved some during the day. She said by Friday night (09Apr2021), she was dizzy, had a headache, was nauseous, and her balance was off. She said on Saturday morning (10Apr2021), she was nauseous, and started throwing up. She said she continued to throw up until Saturday night (10Apr2021). She said she was still nauseous on Saturday night, but was able to have soda crackers. She said she felt like she was standing at a cliff, because she was still nauseous, but not throwing up. She said Sunday morning (11Apr2021) she was not great. She clarified she was still nauseous, had a headache, was constantly dizzy, and lightheaded. She said she didn't throw up, but her focus kept coming and going. She said she felt worse as Sunday night (11Apr2021) came on. She said today (12Apr2021), she was so nauseous, her head hurts, she was dizzy, and couldn't track (focus) well. She clarified she never had a fever with her other symptoms. Caller asked what the hell was going on, and why was it still happening, and how long were her symptoms going to last. She said she was scheduled to get her second COVID-19 Vaccine shot on Saturday (17Apr2021). Caller asked should she get the second COVID-19 Vaccine shot. Reported also had emotional instability from day one (31Mar2021) of her symptoms. Reported she had been resting for a half hour at a time. She said she would feel better for a period of time after resting, so the resting helped. She said she also took Ibuprofen and Tylenol (clarified as generic (place name withheld) Acetaminophen 500mg). She said the Ibuprofen and Acetaminophen helped to keep her headache in the background. Hospital Treatment: She said while she was at the hospital, she was given Aspirin and Tylenol because of her headache. She said the doctors at the hospital didn't change her home medications. The patient underwent lab tests and procedures which included blood test: normal on 01Apr2021, head CT (computerised tomogram): normal on 31Mar2021, echocardiogram: normal on 01Apr2021, tests: unknown results on an unspecified date (the hospital did all kinds of tests on her), MRI brain (magnetic resonance imaging): normal on 31Mar2021, carotid artery ultrasound: normal on 01Apr2021. Therapeutic measures were taken as a result of head hurts (headache). Reporter seriousness for her whole left side, including the left side of her face went numb: hospitalization from 31Mar2021 to 01Apr2021, required a visit to Emergency Room and Physician Office/Urgent Care.
60 2021-04-26 feeling abnormal This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old fem... Read more
This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0158), via an unspecified route of administration, administered in right arm on 08Apr2021 at 16:00 (at the age of 60 years old) at a single dose for COVID-19 immunization. Medical history included overactive immune system, valley fever, Lyme disease, and known allergies to penicillin and morphine. The patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. Concomitant medications included supplements. Patient had no other vaccines in four weeks. On 09Apr2021, patient experienced very sore arm and vertigo. Then 24 hours later, on 10Apr2021, a feeling of dizziness/severe dizziness and nausea that comes and goes - which has been going on for days. It felt like patient was about to pass out. The patient was not able to stand, she can't stand up. Her body suddenly got hot then followed by feeling chills, but no fever. She was feeling so odd and severe brain fog. The patient was feeling so ill. She tried to call Pfizer because she wanted to know how long this will be going on. She didn't know whether to take the second dose. She felt so sick she couldn't drive or work. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified treatment was received for the events vertigo, dizziness, nausea, "Not able to stand/can't stand up" and "feeling so ill/feel so sick". The outcome of the events was not recovered.
60 2021-04-27 agitation, confusional state Extremely confused and agitated. Vision was reduced significantly. Not able to understand or compr... Read more
Extremely confused and agitated. Vision was reduced significantly. Not able to understand or comprehend simple tasks. This went on for 3 days.
60 2021-04-27 delirium delirium; chills; fever; headache; body aches; This is a spontaneous report from a non-contactable c... Read more
delirium; chills; fever; headache; body aches; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 13Apr2021 10:00 (at the age of 60-years-old) as single dose for COVID-19 immunisation. The patient took the first dose on 23Mar2021 at 10:00. The patient's medical history and concomitant medications were not reported. On 13Apr2021 at 22:00, about 12 hours after receiving the 2nd dose, the patient experienced chills, fever, delirium, headache, and body aches. By 35 hours after the dose, symptoms were mostly past. The patient did not have COVID prior vaccination and patient was not tested post vaccination. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
60 2021-04-27 insomnia Muscle aches, fever, sleeplessness, fatigue
60 2021-04-29 anxiety Cardiac Arrest at 1:30 pm on 4/30/2021. . Arrest was witnessed by family and Emergency Medical Pe... Read more
Cardiac Arrest at 1:30 pm on 4/30/2021. . Arrest was witnessed by family and Emergency Medical Personnel. Cardiopulmonary Resuscitation was initiated. Pt was very anxious when EMS arrived.
60 2021-04-30 feeling abnormal Back disorder; lower back issues; Feeling abnormal; felt fuzzy; Vaccination site pain; sore arm; Diz... Read more
Back disorder; lower back issues; Feeling abnormal; felt fuzzy; Vaccination site pain; sore arm; Dizzy; Fatigue; Energy decreased; not feeling as much energy as before; Pain upon movement; walk about a block but then starts to hurt; This is a solicited report from a contactable consumer (patient) via a non-Pfizer sponsored program, based on the information received by Pfizer (Manufacturer Control No: 21K-163-3774842-00). Solicited report from a consumer of a 60 year old female with events of heart/atrial flutter, atrial fibrillation, eye surgery and arm surgery and non-serious weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt with humira 40mg/0.4ml (adalimumab). The patient had a relevant medical history of tobacco use/four cigarette sticks per day, seropositive high titer rheumatoid arthritis, fingers swelling, joint pain, joint swelling and lost of blood flow in hands and legs. On unknown dates, the patient experienced eye surgery, arm surgery, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt. In 2020, the patient experienced heart/atrial flutter and atrial fibrillation. In Sep2020, the patient experienced weight gain due to attempting to stop smoking. On 24Feb2021, the heart/atrial flutter and atrial fibrillation resolved. Covid-19 vaccine was also considered suspect. The patient had eye and arm surgery in the past. On 24Feb2021, she underwent pulmonary vein cryoballoon ablation surgery for the atrial fibrillation and atrial flutter. She had a procedure done and went into her heart and froze the nerve endings that were causing the atrial fibrillation, and also fixed the flutter in her heart. The causality as per reporter for this procedure was reported as no reasonable possibility. She still recovering. She discontinued the Humira two weeks before the surgery and took her last injection on 10Feb2021 and was paused it for four weeks, but she started back it on 10Mar2021. She follows up with her surgeon at the end of the month and she hopes this helps got her off of the blood thinners and other medicines, she been on for this. She stated that this was not related Humira. She was advised by her physician to increase the exercise to lose some weight. With her lower back issues, she was hoping that when she got off of the blood thinners, she could do pain shots again and start exercise. She could walk about a block but then she started to hurt. She had been careful with her diet also, cut out the salt also. This had nothing to do with Humira and she did not want to be contacted about this again for this also. She felt fuzzy, it took her most of the morning to get woken up. Her Doctor thinks once she would off of the blood thinners she would be back to normal. Other than that she feels fine. She does not wanted to be contacted about this. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received first dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown. She agreed to have physician contacted. Blood thinner was also considered as co-suspect. Other medical history included abstains from alcohol, contrast dyes allergy manifested by scratch throat, allergy manifested by bowel movements (oral medications for rheumatoid arthritis; up to eight times a day and slept 15 hours per), prevent esophagus damage, heart, low thyroid, and attention-deficit/hyperactivity disorder. The patient's concomitant medications included pantoprazole to prevent esophagus damage, metoprolol for heart, levothyroxine for low thyroid, vortioxetine hydrobromide (TRINTELLIX) for depression, and dexamfetamine sulfate (DEXTROAMPHETAMINE) for attention-deficit/hyperactivity disorder. The patient underwent laboratory tests and procedures which included blood work: everything was fine in Jan2021; chemical stress test and treadmill stress test: confirmed atrial fibrillation and atrial flutter in Sep2020; body weight: gain in Sep2020; and X-ray: confirmed atrial fibrillation in Sep2020. The action taken in response to the events for adalimumab and apixaban was unknown. The patient recovered from atrial flutter and atrial fibrillation on 24Feb2021. Outcome of Feeling abnormal and Pain upon movement was unknown. The patient had not recovered from the remaining events. Change History: On 05Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, suspect drug information, concomitant drug information, past drug information, laboratory/diagnostic procedures and narrative description. The events of "atrial flutter", "atrial fibrillation" and "weight gain due to attempting to stop smoking" were added. On 11Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, laboratory/diagnostic procedures and narrative description. The events of "LOWER BACK ISSUES" and "WALK ABOUT A BLOCK BUT THEN STARTS TO HURT" were added. the event of "atrial flutter" was amended to "heart/atrial flutter". On 08Apr2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "felt fuzzy", "got first dosage of covid-19 vaccine and experienced sore arm", "fatigue and dizzy from the blood thinners after surgery" and "still not feeling as much energy as before" were added. Causality for humira 40mg/0.4ml(adalimumab): The reporter's causality for the event(s) of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood THINNERS after surgery unknown onset and fatigue and dizzy from the blood thinners after surgery unknown onset with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of felt fuzzy, still not feeling as much energy as before and walk about a block but then starts to hurt was not provided. Manufacturer opinion is that there is no reasonable possibility that the events of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery unknown onset, fatigue and dizzy from the blood thinners after surgery unknown onset, still not feeling as much energy as before and walk about a block but then starts to hurt are related to humira 40mg/0.4ml(adalimumab). The reporter's assessment of the causal relationship of the events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information , the events of sore arm, fatigue and dizzy could be related to the suspected drug of BNT162B2. The other events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. 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.
60 2021-04-30 excessive sleepiness I have been extremely and unusually fatigued since the 2nd vaccine. I was walking approx 10 -12 mil... Read more
I have been extremely and unusually fatigued since the 2nd vaccine. I was walking approx 10 -12 miles a week and now am lucky if I walk 4. I need to rest/nap constantly and have a constant headache. I have never had headaches like this prior to 2nd vaccine.
60 2021-04-30 excessive sleepiness Since my first vaccine shot on March 3, 2021 I have required a tremendous amount of sleep, and tired... Read more
Since my first vaccine shot on March 3, 2021 I have required a tremendous amount of sleep, and tired all the time. In addition, I have had headaches twice for 5 days in a row. The fatigue that necessitates sleeping for 12 hours a night is ongoing. Ironically, an approximately 54 year old friend received the Moderna vaccine and is experiencing the same persistent fatigue and headaches. She's in very good health except for a Shingles episode 4 and a half years ago.
60 2021-04-30 sleep disorder anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both,... Read more
anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both, had severe pain/her right knee joint is in severe pain; she could barely walk and she couldn't bend at all; really weak; had leg aches; she couldn't stay awake/she couldn't sleep again; diarrhea; severe pain at the back of her neck with a headache; severe pain at the back of her neck with a headache; had extreme fatigue; lightheadedness; upper back pain; bloody nose; she couldn't see out of her left eye for about 2 hours; she couldn't breathe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:41 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 60 years). Medical history included ongoing chronic obstructive pulmonary disease, ongoing chronic kidney disease and Positive ANA. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) on 18Mar2021 for covid-19 immunisation and experienced First dose: a little bit of soreness and swelling all on the site. The patient stated that during her second dose last Thursday on 08Apr2021, she had an anaphylactic reaction and she couldn't breathe and long story short she had to go to the emergency room and she was given all kinds of epi shots and treatment and stuff and eventually she had to be kept in the ICU unit. She is not sure why she had such a severe reaction. She wanted to report that since then she has kept track every day on how she has been and she actually thought yesterday was the first day that she had felt better. She had extreme fatigue, lightheadedness, upper back pain and even a bloody nose on 10Apr2021 and also she couldn't see out of her left eye for about 2 hours. Then on 11Apr2021, she had severe pain at the back of her neck with a headache that lasted about 20 minutes and she couldn't move her neck. She had diarrhea and the only temperature she had was on 12Apr2021, it was only 99.5 degrees Fahrenheit, which isn't bad, but she had really bad diarrhea on 12Apr2021 and she took Imodium. She had a headache and slight breathing difficulties and things like that. On 13Apr2021 she had a headache, was really weak, had leg aches, fatigue that was really bad and she couldn't stay awake and her temperature that day was 98.7 degrees Fahrenheit which is normal. Then yesterday, 15Apr2021, she thought she was over all the things and that she was feeling better from the fatigue, nausea (occurred on an unspecified date), lightheadedness but she couldn't sleep again. She didn't sleep since Wednesday morning until last night finally and she only slept for an hour since Wednesday morning. She woke up on 15Apr2021 and had no symptoms except her left and her right hips, both, had severe pain and she could barely walk and she couldn't bend at all. All she could do it take Tylenol and she used a heating pad and the pain was excruciating. She went to bed last night and she did sleep for maybe a total of 2 hours and when she woke up this morning her left hip seemed to be a little better but her right hip is still in severe pain and now her right knee joint is in severe pain too. Other than that, she has no other symptoms just the joint pain. She didn't know it would go on for this long, it has been over a week now and she just wanted to let us know about this. The patient was hospitalized for the event anaphylactic reaction from 08Apr2021 to 08Apr2021. The patient underwent lab tests and procedures which included Blood typing: anti kell antibodies (doctor randomly decided to do a blood typing and they found anti kell antibodies in her blood) on an unspecified date, temperature: 99.5 degrees fahrenheit on 12Apr2021, temperature: 98.7 degrees fahrenheit on 13Apr2021. Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, diarrhea and arthralgia. Outcome of the event anaphylactic reaction was recovered with sequelae on 09Apr2021 while outcome of the events nausea, dyspnea, arthralgia, sleep disorder and movement disorder was unknown. Outcome of the event vision impairment was recovered on 10Apr2021 while outcome of the event neck pain was recovered on 11Apr2021. Outcome of the remaining events was recovered on 15Apr2021.
60 2021-05-01 impaired work ability My right eye twitched continually for two weeks after the second injection. Although it was not pai... Read more
My right eye twitched continually for two weeks after the second injection. Although it was not painful or itchy, the twitch was disruptive to me at work and during various other activities requiring sight.
60 2021-05-02 sleep disorder Intense increase in volume of ringing in my ears sometime around my second dose. I have had mild ti... Read more
Intense increase in volume of ringing in my ears sometime around my second dose. I have had mild tinnitis for >5 years, but sudden increase in volume (and absolute volume) of ringing was noticeable. Whereas previously I had to concentrate or focus to hear it, it is now loud and intrusive-- much harder to ignore, much more disruptive to sleep, thought, etc.
60 2021-05-06 feeling abnormal A few seconds after the injection my eyes started burning. This lasted for a few minutes, then clea... Read more
A few seconds after the injection my eyes started burning. This lasted for a few minutes, then cleared up and hasn't returned as of today. Then a few hours after the injection, the inside of my body had an electric / itchy / shaking feeling which lasted for approx. 2 days -- it cleared up and hasn't returned as of today.
60 2021-05-07 feeling abnormal I started feeling worst anymore and woke up and my arm was sore; little sore onthe injection site; I... Read more
I started feeling worst anymore and woke up and my arm was sore; little sore onthe injection site; I started feeling worst anymore and woke up and my arm was sore; Rigorous, just shaking uncontrollably; Fever; profuse sweating; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 60-years-old female (non pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: en6201), dose 1 via an unspecified route of administration on 20Feb2021 13:30 (at the age of 60-years-old) as SINGLE DOSE for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 to vaccination. Medical history included drug hypersensitivity, seasonal allergy, blood pressure increased, vascular device user from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had the Covid vaccine on Saturday afternoon and didn't feel anything. She was really impress the way it went. Sunday, on an unspecified date, she started feeling worst anymore and woke up and her arm was sore. It was not that big deal. Then by Sunday night on 21Feb2021 , she started to have a severe not chills but rigorous she meant just rigorous, just shaking uncontrollably and then her fever went up. This was same thing Monday and sweat so bad so profusely (on 21Feb2021). But it was such a violent reaction, she was wondering was that normal. She was enquiring that she should get second dose or what. She meant it was, she better today. She felt like she had been drunk to (statement incomplete). She had not none of today but that was terrible. She asked was that normal. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received treatment for the adverse event rigorous, just shaking uncontrollably, fever and profuse sweating. The outcome of event i started feeling worst anymore and woke up and my arm was sore, little sore on the injection site was unknown. The outcome of rest event was not recovered. No follow-up attempts are needed. No further information is expected
60 2021-05-09 insomnia Adverse Event - Shoulder Pain since date of the vaccination, hurts all of the time, shoulder so sore... Read more
Adverse Event - Shoulder Pain since date of the vaccination, hurts all of the time, shoulder so sore, can't sleep on right side. No treatment - Taking Advil for pain (doesn't really help). Will talk with MD at next MD appt. June 1, 2021 Outcome - Right shoulder pain continues
60 2021-05-11 insomnia March 31, 2021 - second injection was given left arm top and slightly right-not centered in the delt... Read more
March 31, 2021 - second injection was given left arm top and slightly right-not centered in the deltoid muscle. I yelled, "Ouch," when given the injection because it was very painful.. Since then, my left shoulder has been swollen and painful. The pain keeps me up at night so I am not getting the needed sleep. I sometimes wake up in excruciating pain from sleeping on my left arm, which although I try not to, it's my normal sleeping position. I feel pain throughout the day and my arm range is limited. May 12, 2021 - treatment is ice 5-minutes a day; aspercreme with lidocaine, arm movement exercise and Alleve.
60 2021-05-11 sleep disorder Right arm did not hurt immediately after shot. By 12:30 am arm hurt extensively and I started with c... Read more
Right arm did not hurt immediately after shot. By 12:30 am arm hurt extensively and I started with chills that were so bad my teeth were chattering. By approx 2am I had a fever of 103.2 and every single part of my body felt like I had been beaten with a baseball bat. I hurt so badly that I was unable to sleep at all that night. I took two 500mg Tylenol at approx 2:15 am but it was vomited right back up. Nausea continued through the night. Started vomiting every time I had to get up for something. Was not able to take my morning meds or more tylenol until approx 11:00am. even with tylenol, fever hovered between 101.6 - 102.5. Unable to do anything all day. Now, at 5:54pm on day 2 I still hurt all over, though not as badly. My fever is 100.9.
60 2021-05-18 mental status changes Patient tested positive for COVID on April 12th after having received both COVID-19 vaccines - pfize... Read more
Patient tested positive for COVID on April 12th after having received both COVID-19 vaccines - pfizer. Patient has known COVID19 exposure from her son and was COVID19 positive in April. The patient had a positive asymptomatic COVID-19 test. Patient was tested prior to planned colonoscopy. The patient completed 10 days of quarantine until April 22. Patient presented to hospital (sister hospital) on May 2nd after 1 week of fevers and productive cough. At MSQ patient received cefepime/vancomycin/doxycycline for CAP. She initially improved, but on 5/5 she had recurrent fever with rapid decline, her respiratory status requiring 2L of NC to HFNC to NRB. CXR with B/L opacifications. CTA chest was negative for PE, but patient with diffuse groundglass and consolidative opacities. Also had TTE that showed LVEF 71% and grade 1 diastolic dysfunction. She was evaluated by MSQ Infectious Diseases physician and was started on bactrim for PCP prophylaxis and resumed on broad spectrum antibiotics. She was also evaluated by rheum in sitting of her SLE and patient was started on prednisone 40 mg q8h methylprednisolone for potential SLE flare. Continued on cefepime and vancomycin. Patient was transferred to Hospital due to worsening respiratory status and tested positive for COVID-19 at MSH on 5/9. Admitted to the MICU, patient received a loading dose and one 100 mg dose of remdesivir - stopped due to elevated liver enzymes. On 5/16 extensive new ischemic/hemorrhagic strokes throughout intracranial vascular distribution, DIC d/t COVID vs AF and intubated for mental status changes. Patient's clinical picture worsening - requiring pressors. Chest x-ray with diffuse ground glass opacities, ARDs and pulmonary edema. Patient remains in critical condition in MICU as of 5/19.
60 2021-05-20 disturbance in attention, sleep disorder Felt pinpoint pressure 1 minute after receiving the vaccine in the middle of the back of her head. R... Read more
Felt pinpoint pressure 1 minute after receiving the vaccine in the middle of the back of her head. Resolved within 24 hours. Felt pressure building up that she thought was a headache developing although she does not really get headaches. Does not take any medications regularly. While driving home, she began to feel very woozy and developed vertigo. 10 minutes after getting home developed pressure in head that was very intense between ears - ears were popping like she was on a plane. Lasted on and off for over a week. Pressure has diminished a lot but still present - about 25% of what it initially was. She realized that she could not focus when she sat down at the computer soon after that. Any time she looked at her devices could not focus and device would blur out. When she tried to focus her eyes would get woozy and pressure in head would get more intense. Currently can only spend about 1/2 the amount of time she normally can at her computer. Reports that I appear blurry to her on video visit. When she went to lay down that day had tingling and numbness of R side of face. Could not go to sleep because there was a sensation change. Did not improve with position change. Still present about 80%. No facial droop.
60 2021-05-20 sleep disorder First vaccine on April 5th, 24 hours later I had painful blisters in my chest Second vaccine on Apr... Read more
First vaccine on April 5th, 24 hours later I had painful blisters in my chest Second vaccine on April 26. Had no immediate symptoms but on May 13 I started having pain in my gums, then severe canker sores all over my mouth. Could not eat, sleep or talk. I thought it was mouth infections and went to see my dentist but I was told they were canker sores. He thought it was unusual to have that many especially when I had not diet change, eat home cooked meals, with normal stress level. He asked about the vaccine. Later I googled on the internet and found out other Pfizer patients had same reaction.
60 2021-05-23 insomnia Severe Puritic Body Rash that started as Pustules and progress to full blown Cellulite to Boils. Ra... Read more
Severe Puritic Body Rash that started as Pustules and progress to full blown Cellulite to Boils. Rash over upper 1/3 of body and arms as well as buttock lesions and Left foot. No Sleep from 5-6-2021 to today 5-24-2021. Atarax and Steroids and Antibiotics have not helped.
60 2021-05-25 disturbance in attention, anxiety incredible chest pressure; shortness of breath; anxiety; chest started hurting; pain across her brea... Read more
incredible chest pressure; shortness of breath; anxiety; chest started hurting; pain across her breasts; concentration levels are off; but being that sick makes her so weary.; She goes to the bathroom 12 times a night to urinate; body aches; feet hurt/top of her feet hurt really super bad/legs hurt; pressing under her arm and she had pain really bad there; pain went around her back /whole back started hurting; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration administered in right arm on 27Apr2021 (Batch/Lot Number: ER8731) as single dose for COVID-19 immunisation. Medical history included ongoing congestive heart failure, diabetes, high cholesterol and high blood pressure. Concomitant medication(s) included aripiprazole (ABILIFY) taken for an unspecified indication, start and stop date were not reported; atorvastatin calcium (ATORVASTATIN CALCIUM) taken for an unspecified indication, start and stop date were not reported, noted as on of the 2 new heart medication; and another unspecified heart medication. No other vaccine within 4 weeks. The patient received the first dose of the COVID-19 vaccine on 27Apr2021, then 2 days later on 29Apr2021 she developed side effects of body aches and couldn't get comfortable sitting, laying down, or standing, and her feet hurt, the top of her feet hurt really super bad and her legs hurt. She stated she was feeling "fair to partly cloudy" and "this is just beyond anything". She stated she literally didn't want to exist anymore the pain was that horrible, that when she was experiencing adverse effects she couldn't get comfortable in any way, nowhere to go, nothing to do, no warm bath, no hot warm or cool compresses, it was just her whole body. She said there was nothing that would help and she just didn't know if she could do that again. She only had relief through paracetamol (TYLENOL) and she took so much that she felt her liver was in jeopardy. She stated it was a really bad experience. The patient was also having incredible chest pressure and shortness of breath, onset date unspecified. She had a diagnosis of heart failure/a history of congestive heart failure, with the body aches she was having, she thought she was going into heart failure. She did call an ambulance twice (maybe 29Apr2021 then 01May2021; she didn't remember exactly which days) and the emergency medical technicians (EMT) took an EKG each time. The first time she called the ambulance the EMT's offered to take her to the hospital. Her EKG did look abnormal but it could have been attributed to her history of heart related issues or anxiety. The second time her chest started hurting it was hard to distinguish between pain and pressure. There was definitely pressure. There was also pain across her breasts (onset date unspecified) and underneath her arm (on 29Apr2021; initially she was pressing under her arm and she had pain really bad there), she was questioning her lymph nodes. Then the pain went around her back and then her whole back started hurting and her whole body was hurting, onset date 29Apr2021. She had never experienced anything like this before, as stated. She also reported that her concentration levels were off (onset date unspecified). She couldn't listen to music or do anything like that. She spoke with her doctor but being that sick made her so weary (onset date unspecified). The patient reported she didn't know if her symptoms were because of the COVID-19 vaccine or because of her new heart medication, but she said it's stupid to think her symptoms could be caused from her new pills. Her doctor wanted blood work on 27Apr2021 primarily because of all the medical diseases she had. She's guessing maybe blood work would give her an indication of why the vaccine made her feel the way it did. She went on 05May2021 to get bloodwork. She went to the bathroom 12 times a night to urinate (onset date unspecified) and she asked her doctor to put her on Lasix so she could just get the urine out. The doctor told her that her heart and her lungs sound good. The patient asked if she should still get the second dose of the vaccine as she was worried that the symptoms could be worse after the second dose. She was supposed to return for her second COVID-19 vaccine on 14May2021, but she was not going (though she knew she needed to get the second dose), she did not want to get it. The events body aches, feet hurting/legs hurting, pain underneath her arm, back pain, were ongoing but lessened in severity. As of the time of reporting, she had started to feel better, these events (body aches, feet hurting/legs hurting, pain underneath her arm, back pain) were resolving. The outcome of the other events was unknown.
60 2021-05-25 feeling abnormal An hour after vaccination, it hurt around my heart and for 3 days there was pain in my collar bone o... Read more
An hour after vaccination, it hurt around my heart and for 3 days there was pain in my collar bone on the left side, a lot of heart burn or air bubbles in my chest also, and now I'm scared to get the 2nd dose and I've not felt right since.
60 2021-05-27 loss of personal independence in daily activities At 6:00 a.m. on May 23, 2022, the 9th day after my 2nd dose of the Pfizer COVID-19 vaccine I stood ... Read more
At 6:00 a.m. on May 23, 2022, the 9th day after my 2nd dose of the Pfizer COVID-19 vaccine I stood up and became so dizzy I feel head-first into a chair next to the place I was standing. Since that time I have experienced extreme vertigo (for the first time in my entire life I have never been dizzy in my life, at all). I can?t lay on my left side because I can?t turn my head to the left. I can?t drive because I can?t turn my head to the left. When I do, my head becomes swimmingly dizzy. It is an extreme dizziness. Not just lightheaded. Also I cannot lean my head backward to look up because I experience the same thing. I have joined a website for COVID-19 Vertigo side effects in order to get information or ideas as to what I can do and when I can hope for relief.
60 2021-05-28 confusional state Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tig... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild
60 2021-05-28 impaired work ability Vaccine given in the afternoon of 1/16, a Saturday. By Sunday am on the 17th, the hearing was gone ... Read more
Vaccine given in the afternoon of 1/16, a Saturday. By Sunday am on the 17th, the hearing was gone in my right ear. Got into the ENT doctor on Monday the 18th. Had an exam and hearing test. Started high dose of steroids on 1/19. Had to be out of work for 1 month. About 80% ish of the hearing returned in that ear. Had 1 steroid injection into ear drum of that ear. Throughout the month, had many ENT appointments and hearing tests. Hyperbaric chamber was recommended by the dr. But my insurance would not cover it.
60 2021-05-31 feeling abnormal feeling tired; mild heart increase; mild heart palpitations; chills; feeling bad; low-grade fever of... Read more
feeling tired; mild heart increase; mild heart palpitations; chills; feeling bad; low-grade fever of 100; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EL9264) via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:45 (at the age of 60-years-old) as single dose for covid-19 immunisation. The patient's medical history includes history of colon cancer, anaemia, hypertension and asthma and drug hypersensitivity. The patient previously known allergies includes: Sulfa, EES, Augmentin, oxycodone, vancomycin, duramorph. The patient's concomitant medications included budesonide, formoterol fumarate, glycopyrronium bromide (BREZTRI AEROSPHERE), hctz, meloxicam and zolpidem tartrate (AMBIEN). It was reported that on 02Feb2021, at 08: 45 AM initially within five minutes after the vaccine, the patient felt mild heart palpitations with mild heart increase. She monitored on her (company name) watch heart rate, ECG and oxygenation level. This resolved within 15 minutes. During the day following she started having chills just generalized feeling bad. Had a low-grade fever of 100 last evening. This morning feeling tired on 03Feb2021. The outcome of the events was recovering. Therapeutic measures were not taken by the patient for resolving of the events. Follow-up attempts are completed. No further information is expected.
60 2021-06-02 insomnia shot entry is the size of an apple; heart palpitations; diarrhea; blisters in her mouth on her cheek... Read more
shot entry is the size of an apple; heart palpitations; diarrhea; blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips; Because of the blisters she had a hard time breathing and couldn't can't eat; had a fever of 102°F; weak; tooth throbbing; body aches; food tasted like crap for anything that she could get into there; Because of the blisters she had a hard time breathing and couldn't can't eat; Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling; injection arm was "swollen so bad" from her neck to her fingertips; vomiting; lightheaded, dizziness; Migraine headache/migraine; her arms swollen down to her fingertips which she could not sleep on her left side; could not get out of bed; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 18May2021 (Batch/Lot Number: EWO182) as single dose for COVID-19 immunisation. Medical history included allergic reaction to back yard tree and had sniffles and watery eyes prior to shot. There were no concomitant medications. The patient received her first Pfizer Covid vaccine dose on 18May2021. That evening she began to experience side effects. Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling. She had Migraine headache and vomiting. At 5 AM the following day 19May2021, she was vomiting, had diarrhea, a migraine, and then developed blisters in her mouth. Because of the blisters she had a hard time breathing and couldn't can't eat, had a fever of 102 degree F, was feeling weak, had to crawl to bathroom. She reported that 24May2021, was the first day that she felt ok. It was reported that her arms swollen down to her fingertips which she could not sleep on her left side, blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips, stated that she could not go to her dentist appointment the following day because of blisters and her tooth was throbbing on 19May2021. Stated that she had migraine headaches with vomiting, diarrhea, heart palpitations, weak, 102 fever, food tasted like crap for anything that she could get into there. The patient is supposed to go on 08Jun2021 for her second shot and was told that the second is worst than the first. Stated that she refused second shot. Stated that she could not get out of bed. Stated that she has a 7 and 8 year old to take care of by herself. Stated that the shot entry is the size of an apple on 24May2021. Clarified that she had the shot in her left arm. Caller stated that she had the Covid shot 18May2021 and she still does feel well today. Clarified that the blisters all started at the same time. Stated that she has had no heart palpitations since 5am this morning (24May2021). Stated that her fever is 99.9 Caller keeps rambling on; unable to clarify details with each event. Stated that the migraine is now a headache. She wants to know what would happen if she doesn't get the second dose of the vaccine. The patient received no treatment. Outcome of the events could not sleep on her left side, could not get out of bed was unknown; peripheral swelling was recovered with sequelae on 23May2021, vomiting was recovered with sequelae on 24May2021; Heart palpitations was recovered on 24May2021; Fever, migraine, couldn't lift up her arm, hard time breathing was recovering; all other events was not recovered. Follow up attempts needed. Further information is expected
60 2021-06-02 panic reaction The caller's heart was really fast and heart pressure went up; has been experiencing runny nose, has... Read more
The caller's heart was really fast and heart pressure went up; has been experiencing runny nose, has the flu; has been experiencing runny nose, has the flu; Only pain on arm for two or three days; got a panic; got a panic; The caller's heart was really fast and heart pressure went up; This is a spontaneous report from a contactable consumer (Patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0182) via an unspecified route of administration in right arm on 10May2021 at 11:30 (age at vaccination 60-year-old) at single dose for covid-19 immunisation. Medical history included tachycardia from 12Apr2021 and ongoing, transient global amnesia from 25Mar2021 and ongoing, anxiety from 25Mar2021 to an unknown date, panic reaction from 25Mar2021 to an unknown date, amnesia from 25Mar2021 to an unknown date. Concomitant medication included cannabidiol (CANNABIDIOL) taken as needed for amnesia from 28Mar2021. The patient is not taking the CBD oil right now, only takes when needed. Has not taken in two weeks, was not she should take it. Suspended for four or five days before first dose. Really does not need it. No other vaccine in four weeks. On 26May2021, patient experienced runny nose, on 25May2021 patient experienced flu like symptoms, on 10May2021 patient got a panic after receiving the first dose Pfizer Covid Vaccine on, the caller got a panic and had to stay at the vaccine facility for half an hour. The patient's heart was fast and heart pressure went up. The patient stayed at the vaccine facility like thirty minutes after receiving the first dose Pfizer Covid Vaccine. The patient stated this went away. The patient knew every time she has anxiety her heart goes up, it is something that happens. The patient let the persons know at the vaccination facility it is not the Pfizer Covid Vaccine, because the patient has that problem right now. Patient's heart was fast and heart pressure went on, on 11May2021 patient experienced pain on arm for two or more days. Patient also experienced cardiac discomfort. The patient stated that the side effects were only pain on arm for two or three days and this began on 11May2021, the day after receiving the first dose Pfizer Covid Vaccine. The patient is experiencing a runny nose right now had the flu but doesn't have any high temperature. The patient states she does not speak English that well HCP: the caller does not wish to provide name, address, telephone number or email. The physician stated she doesn't have a primary care physician yet. The patient was experiencing a runny nose right now began on 26May2021 and is persisting. Had the flu but doesn't have any high temperature: The patient states this began on 25May2021 is ongoing and is improving a little bit. The patient states she is taking CBD oil because she had an issue back on 25Mar2021 of amnesia. The patient has tachycardia and has issues with anxiety and panic. The patient stated after receiving the first dose Pfizer Covid Vaccine on 10May2021, the caller got a panic and had to stay that the vaccine facility for half an hour. The caller's heart was really fast and heart pressure went up. The caller stayed at the vaccine facility like thirty minutes after receiving the first dose Pfizer Covid Vaccine. The caller states this went away. The caller knows every time she has anxiety her heart goes up, it is something that happens. The patient let the persons know at the vaccination facility it is not the Pfizer Covid Vaccine, because the caller has that problem right now. The caller states this went away in thirty minutes. Anxiety and panic not diagnosed, she can just feel it. This started after problem of amnesia the caller had on 25Mar2021. Transient Global Amnesia, had a problem of amnesia on 25Mar021. The patient is not taking the CBD oil right now, only takes when needed. Hasn't taken in two week, wasn't she should take it. Suspended for four or five days before first dose. Really doesn't need it. The patient received the first dose Pfizer Covid Vaccine on 10May2021 and is scheduled for the second dose on 31May2021. The patient has a runny nose right now and had the flu. The caller is asking if they should get a Covid test prior to receiving the second dose Pfizer Covid Vaccine. Only pain on arm for two or three days The patient states the side effects were only pain on arm for two or three days began on 11May2021, the day after receiving the first dose Pfizer Covid Vaccine. She has recovered from the arm and everything. The patient mentioned she was scheduled to receive the second dose Pfizer Covid Vaccine next Monday, 31May2021. Patient did not undergo lab tests and procedures. The outcome of event was recovered in 2021. Information on Lot/Batch number was available. Additional information has been requested.
60 2021-06-03 insomnia soreness on her arm/ sore arm; felt very cold; weird sensation which she can't fully explain. It was... Read more
soreness on her arm/ sore arm; felt very cold; weird sensation which she can't fully explain. It was like electrical impulses all over her body started appearing and like her blood is running inside all over her body; heart rate went a little fast, recorded at 110-112; could not sleep; This is a spontaneous report from a contactable Nurse. A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 01Mar2021 (Batch/Lot Number: EN6205; Expiration Date: Jun2021) as 1st dose, single dose for covid-19 immunisation. Medical history included covid-19 from 27Nov2020 to an unknown date and aggressive fever. The patient's concomitant medications were not reported. The patient previously took albuterol, tylenol and mucinex for covid-19. The patient reported that she was fine after 1st dose of the Pfizer vaccine but experienced some soreness on her arm and took tylenol. When she got home, she felt very cold but did not have a fever and had a normal temperature. As she was laying down, she felt a weird sensation which she can't fully explain. It was like electrical impulses all over her body started appearing and like her blood is running inside all over her body. Her heart rate went a little fast, recorded at 110-112 while her normal is 100-110. She could not sleep because of this. She woke up today and mentioned that her symptoms are lessening, not as intense as they were last night, and there is a little improvement. She took Tylenol for her symptoms and did not go to work. She received the vaccine amidst having a previous COVID Diagnosis last thanksgiving, 27Nov2020 and stated that she may still have antibodies from her infection and that the vaccine might be interacting with it. She knew that the Pfizer vaccine was not tested in people with previous COVID Diagnosis and just followed the CDC's recommendation to get vaccinated after 90 days after the infection and inquired for information, Pfizer may have on these topics and if she should receive the 2nd dose on 22Mar2021. She had covid around thanksgiving being about 3 months ago, so she waited the 90 days to get the vaccine. She reported that since she was a covid patient, she was thinking is it because she had antibodies. She was checked 2 weeks in Feb2021 and she was positive for antibodies and wanted to know the relationship between antibodies and the vaccine. Therapeutic measures were taken as a result of soreness on her arm/ sore arm. The patient underwent lab tests and procedures which included heart rate: 110-112, heart rate went a little fast, recorded at 110-112 while her normal is 100-110, sars-cov-2 antibody test: positive on Feb2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
60 2021-06-03 loss of personal independence in daily activities, nightmare needle was put in and burned like hell and her head kind of exploded; arm was throbbing; pain rotate... Read more
needle was put in and burned like hell and her head kind of exploded; arm was throbbing; pain rotated out everywhere after 30 minutes; burn a little regarding; incapacitated; injection site swelled and turned red; injection site swelled and turned red; non-anaphylactic reaction; nightmare; Bruise; This is a spontaneous report from a contactable consumer (patient). A 60-year-old (age at vaccination) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 22Feb2021 (lot number: EN6198; expiration date: 30Jun2021) as 1st dose, single, dose 2 via an unspecified route of administration on 15Mar2021 (lot number: EN6204; expiration date: 30Jun2021) as 2nd dose, single for COVID-19 immunisation and varicella zoster vaccine rge (cho) (SHINGRIX), via an unspecified route of administration, administered in left deltoid on 01May2021 (lot number was 9NH54 and expiration date was 14Oct2022), at an unknown, single dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient family history included shingles (caller mother had shingles). On an unspecified date, the patient experienced needle was put in and burned like hell and her head kind of exploded, arm was throbbing, pain rotated out everywhere after 30 minutes, burn a little regarding, incapacitated, injection site swelled and turned red and non-anaphylactic reaction. The clinical course of the event was reported as: caller stated that her pharmacist told her to report because she had Shingrix vaccine injection on 01May2021 and had a non-anaphylactic reaction but her reaction was epic and her pharmacist said that the company would want to know this information for the numbers related to the product. It was reported that her weight was when she was fully dressed. The caller stated for Shingrix vaccine, the needle was put in and burned like hell and her head kind of exploded and that was epic. The nurse said it did burn a little regarding the patient stating Shingrix vaccine burned upon administration; stated the nurse let her go but she wanted to stay in the store for a few minutes and it felt really awkward; her head settled down and her arm was throbbing and started screaming; stated the pain began in her lower back and her arm, head and right side of her hip and moved throughout her body and the pain rotated out everywhere after 30 minutes the pain settled down and she just had the pain in her arm. She stated the area where Shingrix was injected was almost like a baseball sized circle and was read and she had to drive to care for her parents and that made this a nightmare. She removed the band aid from the injection site because the band aid caused a bruise and the injection site swelled and she remembers taking the band aid off and not being able to put ice on it and could not bear the pain. She could not put ice or clothes on top of the injection site and could not take it. She reported her head was just killing her and it was ridiculous to had to use that arm and to lift it like a disabled arm, she would say she was incapacitated and only if forced could she do something under those conditions. She stated the injection site swelled and turned red and just continued to swell, turn red and was burning and hurting and did not go farther and was the size of a baseball. She reported that the other symptom was she had her head back down and no pain in her back anymore, no pain in her chest anymore, and no pain in her legs anymore. She stated the pain after Shingrix vaccine was localized but gave her a headache; states using that arm was insane and if she was not forced to use the arm she could not use it effectively and this was not an anaphylactic reaction and the reaction was not moving anywhere else; stated the area of the injection site is now black all around it like the nurse gave a bad vaccine but she did not do a bad job; stated she could see the dot where the Shingrix vaccine went in. Stated the indication for which she had Shingrix vaccine was that her mother had shown up with shingles and they took her to the emergency room on Sunday (as reported) with a rash that began to bubble so the caller called for her mother; stated her mother was transported to the hospital and the caller had been wearing gloves and thought it was contagious and it was shingles; states the six doctors for her mother in the ER pressed the caller to get Shingrix vaccine. Caller stated the reported reaction for Shingrix vaccine lasted 11 days and sort of calmed down and all she could see now was the red dot where the vaccine was administered; stated she was sure she would have to do Shingrix again due to her reaction and did not have an anaphylactic reaction but wanted to report this as she was told. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
60 2021-06-05 anxiety, nervousness 60-year-old Female was found by EMT sitting upright and complaining of being lightheaded. Client was... Read more
60-year-old Female was found by EMT sitting upright and complaining of being lightheaded. Client was alert and tracking with her eyes while nervous. Client had a chief complaint of anxiety post vaccination. Client stated she began to feel anxious shortly after her vaccination and requested to lie down for the duration of her observation. Client has a history of anxiety for which she is taking CBD oil. Client also has a history of new onset tachycardia and periodic irregular heart rate for which she sees a cardiologist. Client was recently diagnosed with transient amnesia. She denies any allergies. Assessment revealed no swelling, hives, discoloration, shortness of breath or other signs of anaphylaxis. Airway, breathing, and circulation were intact. Client denied any pain throughout her body. Client's initial vitals were a heart rate of 76 and irregular, blood pressure 160/98, respirations 20 and regular, alert and oriented to person, place, date and event, eyes equal and reactive to light, lung sounds clear bilaterally and SPO2 100% on room air. Client was shaking while anxious but consolable. Client consented to an additional 30-minute observation after her first set of vitals. She was provided water during her observation. Her remaining vitals at 1152 - 158/98, pulse 86, O2 99% respirations 16. After approximately 5 minutes, client reported that she felt much "better" and remained calm for the rest of her observation. Client's vitals improved at the completion of her observation with a heart rate of 80 and regular, respirations 16, blood pressure 140/88 and O2 98%.. Client departed vaccination site after 30mins of observation feeling "better".
60 2021-06-06 suicidal thoughts Hospital Principal Problem (Discharge Diagnoses): Suicidal ideation All Hospital Problems (Other D... Read more
Hospital Principal Problem (Discharge Diagnoses): Suicidal ideation All Hospital Problems (Other Diagnoses): Active Hospital Problems Diagnosis ? Principal Problem: Suicidal ideation ? COVID-19 Assessment & Plan Note: Post Pfizer vaccination for COVID 3/12 and 4/2 Test positive by PCR 6/4 This likely reflects either an asymptomatic infection or at worst a mild one She is currently asymptomatic and does not fit criteria for COVID therapy Would maintain isolation for now ×10 days out of caution Your supportive care No further ID recommendations, please contact if clinical situation warrants ? Electrolyte imbalance ? Alcohol withdrawal syndrome with perceptual disturbance ? Bipolar 1 disorder Overview Note: This patient with a history of bipolar illness and alcohol abuse presents in a manic state. She appears to be still intoxicated and has very poor judgment as she is trying to leave. ? Hypertension ? Chronic back pain Resolved Hospital Problems No resolved problems to display. Consultants: Provider HCP From To MD Consulting Physician Psychiatry 06/05/21 1156 ? DO Consulting Physician Infectious Disease 06/05/21 0227 06/05/21 1352 DO Consulting Physician Family Medicine 06/05/21 0138 ? Procedures Performed: none Pending Tests at Discharge Order Current Status Drugs of Abuse with Confirmation, Urine Preliminary result Evaluation on Day of Discharge: Yes. Hospital Course: 60 yrs old female admitted with suicidal ideation and positive covid test, she has stable respiratory status, cleared by psych service to be dc home Pt informed to quarantined for total of 10 days
60 2021-06-07 anxiety, depression Anxiety Depression
60 2021-06-07 poor quality sleep She could not sleep the whole night; Right hand is swollen; She has a sprained wrist; Her hand, that... Read more
She could not sleep the whole night; Right hand is swollen; She has a sprained wrist; Her hand, that is somewhat in pain from the sprain, and is most of the time fine, was in; Her left knee was hurting her a lot worse; Sore arm; First dose: sore arm; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6206) via an unspecified route of administration (age at vaccination 60-year) in Left Arm on 09Mar2021 as single dose for COVID-19 immunization. Medical history included accident (The accident was 25 years ago, and they told her that she had shrunk an inch from the accident. It is hard for her to say) and cardiac disorder (Her dad has heart disease) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 09Mar2021 the patient experienced sore arm after receiving first dose; On 30Mar2021 her hand, that is somewhat in pain from the sprain, and is most of the time fine, was in; her left knee was hurting her a lot worse; sore arm; her right hand is swollen and she has a sprained wrist. On 30Mar2021 09:30 she reported she could not sleep the whole night. The seriousness of all the event was reported as non-serious. Her left knee was hurting her a lot worse was recovering. The clinical outcome for all other events was unknown. No follow-up attempts are needed. No further information is expected.
60 2021-06-08 feeling abnormal Right away the vaccine made my arm tingle and it was painful. I woke up that morning and I had chill... Read more
Right away the vaccine made my arm tingle and it was painful. I woke up that morning and I had chills and I felt very nausea. I had body aches and I was breaking out into sweats. I took some Tylenol , I had a headache. The nausea was very horrible, and I didn't have much dizziness. The brain fog is the worst thing that I have experienced. I have severe brain fog . I have no appetite and certain smells will bother me and make me more nausea. When I am sitting still , I feel a dizziness where I feel like I am seeing stars. After the vaccine I wasn't able to keep up anything not even ginger ale or water.
60 2021-06-08 feeling abnormal vomiting; fever; chills; diarrhea; dizzy and shaky; dizzy and shaky; she "felt [her] gut and pieces ... Read more
vomiting; fever; chills; diarrhea; dizzy and shaky; dizzy and shaky; she "felt [her] gut and pieces of tissues from [her] gut were coming out; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 01Jun2021 (at the age of 60-year-old) as single dose for COVID-19 immunization. Patient medical history included COVID-19 in Nov2020 and long haulers before getting the vaccine. Concomitant medications were not reported. On an unspecified date in Jun2021, after receiving first dose of vaccine, patient experienced violent vomiting, fever at 101.9F, chills, diarrhea, felt dizzy and shaky. Patient explained she was sitting on the bowl, had diarrhea, and had her "head in a bucket" but the force at which she was vomiting was unbelievable. Patient described she felt [her] gut and pieces of tissues from [her] gut were coming out; and the content sprayed on her walls, even 6 feet away reaching the shower. Patient specified she didn't vomit when she was infected with COVID-19. Patient explained that she feels better this morning but would like to know if she was contagious. Patient asked if she should quarantine for 14 days after experiencing side effects from the Pfizer-BIoNTech COVID-19 vaccine. Outcome of the events was unknown. Information about lot/batch no has been requested.
60 2021-06-08 memory impairment Forgetting where I parked car; not getting everything I went to the store for. Burning food on stove... Read more
Forgetting where I parked car; not getting everything I went to the store for. Burning food on stove.; patient took 1st and 2nd dose both on 02Apr2021; This is a spontaneous report received from a contactable consumer or other non hcp (patient). A 60-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0150, expiration date not reported), via an unspecified route of administration in left arm on 02Apr2021 10:30 (age at vaccination 60years old) as 1st dose, single dose for covid-19 immunisation. Reportedly, same day patient was administered second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0167, expiration date not reported) via an unspecified route of administration in right arm on 02Apr2021 as 2nd dose, single dose for covid-19 immunisation. The most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Medical history included fibromyalgia, allergies to tannins from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. On 27May2021 11:30 the patient experienced forgetting where he parked car, not getting everything he went to the store for and burning food on stove. The patient did not receive any treatment for the adverse events. The case was assessed as non-serious as per the reporter. The clinical outcome of the event was unknown. No follow up attempts are possible. No further information is expected.
60 2021-06-10 feeling abnormal really bad flare up of rheumatoid arthritis; she had a fever of 101.5 degrees Fahrenheit; she had ch... Read more
really bad flare up of rheumatoid arthritis; she had a fever of 101.5 degrees Fahrenheit; she had chills; After her second COVID-19 Vaccine, she had a headache; After her second COVID-19 Vaccine, she was tired; her hands and feet got real swollen; She said she hadn't felt right; hadn't felt right; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 60-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0162) via an unspecified route of administration in left arm on 23Mar2021 between 17:20-17:30 as 1st dose, single dose for COVID-19 immunization. Medical history included ongoing rheumatoid arthritis (from 2003), she has had rheumatoid arthritis for almost 20 years. Concomitant medication included Xeljanz XR 11mg. On 24Mar2021, patient had fever of 101.5 degrees Fahrenheit, chills, headache, she was tired. On an unspecified date in Mar2021, her hands and feet got real swollen, she had not felt right since she had COVID-19 Vaccine. It was reported that patient received her second shot of Pfizer (COVID-19) Vaccine on 13Apr2021 and experienced really bad flare up of rheumatoid arthritis in Apr2021. The patient stated she got both doses of the Pfizer (COVID-19) Vaccine, and after her second (COVID-19) Vaccine, she had a really bad flare up of rheumatoid arthritis. The patient stated her doctor put her on Prednisone for 2 weeks. Reported she had received her second COVID-19 Vaccine dose right before her 61st birthday. She said she went to her rheumatologist, and her rheumatologist told her she should report her side effects to Pfizer. She said she already reported her COVID-19 Vaccine side effects on V-Safe. Patient took 1 Tylenol (8HR Arthritis Pain Extended Release 650mg, Lot Number: LPA095, Expiration Date: Aug2020) for a fever of 101.5 degrees Fahrenheit. She said the Tylenol helped her fever, providing. Reported the Tylenol 8HR Arthritis Pain Extended Release 650mg was expired, but the product still worked. Patient stated for Rheumatoid Arthritis Flare Up, her rheumatologist prescribed 1 Prednisone 5mg tablet, once a day, for 2 weeks. She said she saw her rheumatologist on 17May2021. She said she completed her Prednisone 5mg prescription, and the Prednisone 5mg tablets were dispensed in a pharmacy bottle, and she didn't have the Prednisone 5mg NDC, Lot, and Expiration Date. Reported she was feeling better now, but wanted to report her Pfizer BioNTech COVID-19 Vaccine side effects to Pfizer, so she could help other people with rheumatoid arthritis. Reported she continued to take her Xeljanz XR 11mg while she took the Prednisone 5mg tablets, providing the Xeljanz XR 11mg (NDC Number: 0069-0501-30, LOT Number: DJ2906, Expiration Date: 31May2022). Reported she was feeling better now, but she was not 100%. She said she could actually walk now. She said she still had swelling in her hands and feet. She said the swelling had improved in her hands, saying she could make a fist now, but she couldn't wear her wedding ring. She her sandals still felt tight on her feet. Reported she was very reluctant to get a COVID-19 Vaccine booster shot in 12 months with her auto immune disease. She said she was not going to get the COVID-19 Vaccine booster, if she was going to have the same reaction she had after her second COVID-19 Vaccine dose. Patient asked if Pfizer had done any studies with people who had rheumatoid arthritis and the COVID-19 Vaccine. The outcome of the event fever, chills, headache was recovered on 25Mar2021 and outcome of the other events was recovering. Follow up attempts are needed. Further information has been requested.
60 2021-06-12 disturbance in attention, memory impairment, loss of personal independence in daily activities May 1, 2021 ? Received 1st Covid19 shot around 3:00PM at a Pharmacy. No concerning reaction. May 2,... Read more
May 1, 2021 ? Received 1st Covid19 shot around 3:00PM at a Pharmacy. No concerning reaction. May 2, 2021 ? Arm a little sore at site of shot. Not a problem. Later afternoon some posterior leg muscle pain. Not severe. May 3, 2021 ? Bowels are hardened and a little difficult to push out. In the afternoon definite pain in various places in the large posterior muscles of both legs. In the evening abdominal cramping. A little tired feeling. May 4, 2021 ? Bowels hardened. Abdominal cramping. Deep specific areas of pain in both my posterior leg muscles including: calves, hamstrings, gluteals ? felt like someone sucker punched me up and down the backs of my legs. Right thigh is going numb while I work. Forearms and hands are going much more numb. Extreme fatigue by afternoon, to the point I had to sleep for a while. Diarrhea by early evening. May 5, 2021 ? Hardened bowels. Pain in legs is less severe but still there plus pains in inner thigh. Slight headache (I very rarely get headaches), extreme fatigue by afternoon, Debilitating, I had to take a nap. Thigh continues to go numb off and on while I work. My forearms and hands are tingling and going numb at times. May 6, 2021 ? I am noticing mild headache comes and goes, am experiencing ringing in head like I had with past concussion. Extreme fatigue by afternoon and have to lie down. My bowels are less hardened but still not regular. Still have deep pains in legs muscles but not as severe. Joints are achy: wrists, elbows, hips, knees. May 7, 2021 ? Same as day before. Also realize my blood pressure is running high. May 8, 2021 ? One Week Since Shot. Have noticed I am not able to focus in on specific things as well as normal. The fatigue is debilitating at times. It is affecting my daily chores. I have definitely gained weight, joints continue to be achy and stiff. Less headaches and leg pains are much less. No more abdominal cramping. Bowels are still a little hard. May 8, 9, 10, 11, 12 ? Still more tired than usual but not as debilitating. Bowels are better. My joints and muscles are still sore but not as bad. I am noticing swelling in my arms and legs and face ? feels like I am retaining fluid. I have occasional periods where I am not mentally focused/ forgetting things/ not as observant. Ringing in head happens from time to time. Blood pressure is higher than normal. May 13, 14, 15, 16, 17, 18 ? No more leg muscle pains but continue to have fluid retention. My joints are more sore than normal. Thigh and forearms are no longer going numb. Still more tired than normal but no longer need naps. Mental clarity is better but still feel ?off.? May 19, 20, 21 ? Exhausted. Completely exhausted. Legs and arms and face swollen. Bowels are hardened again. I feel like I have regressed. No deep muscle pain. Joints are stiff again. Mentally out of it. Not able to intently focus. Blood Pressure is up again. May 22, 23, 24 ? Body edema continues. On Sunday the 23rd my face literally swelled up! I took a benedryl and did lymph drainage massage on myself. It eventually went down after several hours. Never experienced difficulty breathing, my parotid glands did not seem to be swollen. May 25 to June 13 - Some days I feel okay, other days I am having swelling in legs, arms / seems like I am still retaining fluid, still more tired than I was before the Covid shot/ still have times a don't focus in as well as normal / joints are stiff at times from swelling and right thigh goes numb off and on when standing.
60 2021-06-13 sleep disorder The jab was administered directly into my joint approximately 1 inch from the top of my left shoulde... Read more
The jab was administered directly into my joint approximately 1 inch from the top of my left shoulder which, at the time, I did not realize was the wrong place. That evening I was up all night in a great deal of pain from my shoulder and directly across my should blades. It has now been 2.5 months and I still have limited movement in my left arm and still experience a sharp pain when I move my arm in certain directions. Hoping this will eventually go away. I did not have any trouble with the 2nd jab which I had administered into my right arm and in the correct place approx 3 inches below the top of my shoulder.
60 2021-06-14 insomnia Insomnia only on the night of vaccination happened with the first shoot also. Have absolutely no his... Read more
Insomnia only on the night of vaccination happened with the first shoot also. Have absolutely no history of any hearing issue, but woke up 6/11/21 with this strange noise in my left ear. Whenever I spoke or someone else spoke there would be this strange noise. By Sunday if got worse whereby there?s would be this continuous strange noise in my ear, and it was getting more difficult hearing what people were saying. Saw doctor yesterday 6/14/21 who spent less than 5 minutes with me took out some wax, but never asked me any questions about anything, By late evening I realized that I Have lost hearing in my left ear
60 2021-06-15 altered state of consciousness Migraine, Seizure, Grand Mal, could not move out of bed, low awareness for 2 weeks. Took 3 months to... Read more
Migraine, Seizure, Grand Mal, could not move out of bed, low awareness for 2 weeks. Took 3 months to get to walk. Dizzy and off-balance, nausea
60 2021-06-16 nervousness 61 y/o with past medical history of Diabetes who presents with shortness of breath, nervousness and ... Read more
61 y/o with past medical history of Diabetes who presents with shortness of breath, nervousness and possibly elevated glucose. Patient states that she did not take any of her prescribed medications this am or check her glucose. Patient states that she had Cuban coffee, café con leche and pastelitos (Cuban pastries) prior to arrival. Patient states that this is the first dose in the two-dose series (Pfizer). Patient states that she received the vaccination to the left arm. Patient denies previous reaction to vaccinations in the past. Patient denies sore throat, difficulty swallowing, chest pain or rash. NP and Paramedics at patient side. Patient vitals within normal limits (156/81, 127/85, 132/79, 146/82, 133/85 BP, O2 Sats 96-99% RA, 86-98 HR). Patient glucose markedly elevated (202). Patient placed on 2 L O2 by nasal cannula. Within 5 mins of observation patient states that she is feeling better. Patient states that prescribed medication is on her person. NP instructed patient to take prescribed Metformin. Patient states was nervous to get the vaccination and didn?t want to take medications. Patient states also didn?t want to check sugar in case it was high. Glucose rechecked 25 mins post medication administration. Patient glucose decreased to 194. Advise patient needs to seek further medical evaluation/Fire Rescue. Patient denies need for transport and states that she wants to go home. Patient signed Against Medical Advice form. Patient walked off site with husband at side.
60 2021-06-20 feeling abnormal After the vaccine I started feeling dizzy , and I was extremely tired the next day. I woke up probab... Read more
After the vaccine I started feeling dizzy , and I was extremely tired the next day. I woke up probably about 4 in the morning and I woke up very nausea, had diarrhea, and stomach cramping. I had body aches all over my body, I felt horrible, I also had a massive headache. It felt like I had the flu but it was painful. Following the vaccine I also had to get my left thyroid removed on May 25,2021.
60 2021-06-23 anxiety about 15 min. after injection pt. began feeling anxious, tearful, difficulty swallowing, pt. able to... Read more
about 15 min. after injection pt. began feeling anxious, tearful, difficulty swallowing, pt. able to drink water, speaking in full sent., no rash, no hives, no itching, voice normal, no audible wheezes noted. Team alert called and pt. taken to ED for evaluation
60 2021-06-24 fear About a week later from both shots I experienced extreme dizziness that lasted 5 seconds A total o... Read more
About a week later from both shots I experienced extreme dizziness that lasted 5 seconds A total of 4 dizzy spells that totally frightened me. I went to the ER had MRI and multiple tests done for stroke, heart attack mass. All perfect! Thank God It?s been 5 weeks after second shot and at times I still feel at times unsteady and fearful it will happen again. I am a very healthy person exercise not overweight and eat healthy.
60 2021-06-24 feeling abnormal A vibrating, pulsing sensation off and on near her lower trunk; This is a spontaneous report from a ... Read more
A vibrating, pulsing sensation off and on near her lower trunk; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the right arm on 04Mar2021 at 18:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. 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 was not having any allergies to medications, food, or other products. Concomitant medication was not reported. On 05Mar2021 at 04:30, the day after shot, and every day since, she had a vibrating, pulsing sensation off and on near her lower trunk. It doesnt hurt, but was concerned as she never had it before. She cannot control it whatsoever. At first, she thought she was feeling a small earthquake, then thought that might be her phone in purse was vibrating, but it was her. She was very scared to take second shot. The clinical outcome of vibrating, pulsing sensation off and on near her lower trunk was not recovered. No follow-up attempts are needed. No further information is expected.
60 2021-06-27 loss of personal independence in daily activities I walk daily in hills around my neighbor with my dog. I noticed it being more taxing to walk uphill... Read more
I walk daily in hills around my neighbor with my dog. I noticed it being more taxing to walk uphill after having the vaccination. Also I do daily dance exercise classes for an hour. I could do it fully no issues but after vaccination I have a harder time completing the class with 100% participation all the way to the end. I noticed my feet feeling numbness in toes after lots of walking as well. Never had this happen before though I walk daily and occasionally all day at the local adjustment park.
60 2021-06-29 motion sickness 4 Days after 2nd injection I woke up having pulsing in my ears, I was very lightheaded and nauseous ... Read more
4 Days after 2nd injection I woke up having pulsing in my ears, I was very lightheaded and nauseous as if I was having motion sickness at 11 a.m. I checked my blood pressure and it was extremely high, Over the course of 15 minutes, I got a pain in my shoulders, and could barely walk. I check my blood pressure again it was 180/120. My stomach was upset and I had to crawl to the bathroom, too dizzy to walk. I checked my blood pressure again and it was 178/130. My head was pounding and I was losing my ability to walk. I was taken to the Emergency Room, I wasn't sure if this was a stroke or Heart attack, or neuro problem. I was admitted for two nights and released on January 19, 2021. I still had extremely high blood pressure and motion sickness. The hospital did several tests and ruled out a heart attack and stroke. As of today, I am still undergoing treatment for high blood pressure. I had no issue with this before the vacine
60 2021-07-01 confusional state I am so confused; There is a sore there where I got it; I got a burning sensation in my whole body, ... Read more
I am so confused; There is a sore there where I got it; I got a burning sensation in my whole body, like a hot flash almost.; I got a burning sensation in my whole body, like a hot flash almost.; I am not taking the second shot; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, in Left Arm on 28May2021 (at the age of 60-years-old), as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history included Fibromyalgia syndrome; Diabetes; Conversion disorder; Arthritis; and consumer stated, "I have a Pacemaker. The patient's concomitant medications included insulin aspart (NOVOLOG) taken for diabetes mellitus; gabapentin (GABAPENTIN) taken for neuropathy peripheral; tizanidine (TIZANIDINE) taken for muscle relaxant therapy; meloxicam (MELOXICAM) taken for inflammation; and Klonopin. Consumer stated, no prior vaccinations within 4 weeks of prior vaccination. On an unspecified date, the patient reported that she was so confused, there is a sore there where she got it, she got a burning sensation in her whole body, like a hot flash almost, and she supposed to get the second shot on 07June2021but she was not taking it. She further stated that she had a bad reaction to the Pfizer shot. They had to put her in a nursing home. On an unspecified date, the patient underwent lab tests and procedures which included blood test: unknown, and sars-cov-2 test: unknown. The outcome for all the events was unknown. Information about batch/Lot number has been requested.
60 2021-07-01 feeling abnormal, thinking abnormal, anxiety Sick with had fever; flu-like symptoms; She felt like she was having neuro symptoms in her head, lik... Read more
Sick with had fever; flu-like symptoms; She felt like she was having neuro symptoms in her head, like she was having a stroke; Palpitations; Blood pressure high; Tingling in her feet, fingers, face, arms, legs, and head; She reports having extreme anxiety; D-dimer is still high; She says her feet have gone numb; Waking up in the morning feeling like the petal was to the metal, feeling everything is revved up. She couldn't control that; Abdominal pain; Fogginess in the head; fever; Shaking; Chills; This is a spontaneous report from a contactable consumer or other non health care professional. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EM9809, Expiration date: Unknown), dose 2 via an unspecified route of administration, in Left Arm on 20Feb2021 (at the age of 60 years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included high blood pressure Diagnosed 20 something maybe 30 years ago, underactive thyroid Diagnosed 20 something maybe 30 years ago, autoimmune thyroid disorder. Patient previously received first dose of bnt162b2 (Solution for injection, Lot number EL3248, Expiration date: Unknown) via an unspecified route of administration, in Left Arm on 30Jan2021 (at the age of 60 years-old) as 1 ST DOSE, SINGLE for Covid-19 immunisation. The patient concomitant medications included Atenolol years ago, she doesn't know taken for hypertension, Levothyroxine taken 20 years ago, a long time ago for thyroid disorder. The patient experienced abdominal pain on 01Mar2021. Patient had, palpitations, blood pressure high , tingling in her feet, fingers, face, arms, legs, and head, she reports having extreme anxiety, d-dimer is still high, she says her feet have gone numb, waking up in the morning feeling like the petal was to the metal, feeling everything is revved up. she couldn't control that, She flu-like symptoms, she felt like she was having neuro symptoms in her head, like she was having a stroke in Apr2021. she was sick with had fever on an unspecified date. she had fever, shaking, chills, had fogginess in the head in 2021. She stated she was at the emergency room 3 times since receiving the vaccine. The reason she went to the emergency room was she felt like her blood pressure was very high, and it was extremely high, they had to bring it down with a beta blocker. She was on blood pressure medication prior to this but her blood pressure was under control, it then became un-controlled. She had to start seeing a Cardiologist. she has become an extremely anxious person. She states that due to SOB and pulse ox and all, he did CAT scan to determine if she had pulmonary embolism. She did not. She states her D-dimer is still high so he changed blood pressure meds, increasing and manipulating them. Now she feels her blood pressure is under control. The cardiologist has manipulated her medications, increased them, and that has brought her blood pressure under control. She is seeing a neurologist. She states she was perfectly fine until she took the vaccine. She hopes that will show some things on the status of her nerves. She does not know where all of this came from as she was perfectly fine before the vaccine. Waking up in the morning feeling like the petal was to the metal, feeling everything is revved up. She couldn't control that; that went on for awhile. She tried different antidepressants which didn't work. She tried 2 antidepressants and that didn't help, it made it worse. Since she has gotten off these she feels a little bit better now. she was calling were for the cardiology, neurology, and anxiety issues. still has to work and her feet and legs are not the best. She reported that going to the ER on 17Apr2021, and she also thinks she went on the 25th and 29th. She reports they put her on gabapentin, a nerve drug and it is helping her nerve problem. states she does not have results of the tests other than she does not have a blood clot in her lung. After the first dose she had total and complete brain fog for an entire day, also she had a sore arm. Patient was working with the elderly in nursing home type of environment. The patient underwent lab tests and procedures which included computerised tomogram results unknown, fibrin d dimer was high, magnetic resonance imaging showed mri of brain it was ok. She has a nerve conduction test on 12Jul2021. The Outcome of event abdominal pain was recovered on an unspecified date in 2021. Outcome for the events palpitations, blood pressure high, She reports having extreme anxiety, Waking up in the morning feeling like the petal was to the metal, feeling everything is revved up. She couldn't control that, fever, Shaking, Chills, flu-like symptoms, She felt like she was having neuro symptoms in her head, like she was having a stroke was recovering. Outcome for the other events tingling in her feet, fingers, face, arms, legs, and head, She says her feet have gone numb, fogginess in the head was not recovered. The outcome of D-dimer is still high, Sick with had fever was unknown. Information on Lot/Batch number was available. Additional information has been requested. No Follow-up attempts completed. No further information is expected.
60 2021-07-01 feeling abnormal sore arm; headache; Fatigue; feeling drugged; This is a spontaneous report from a contactable consum... Read more
sore arm; headache; Fatigue; feeling drugged; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER2613) via unspecified route of administration in the left arm on 22Mar2021 at 14:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included mild osteoporosis and herpes. Concomitant medication included vitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. It was unknown if the patient had allergies to medications, food, or other products. Prior to vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient experienced fatigue and feeling drugged on 22Mar2021 at 19:00. The patient experienced sore arm and headache on 23Mar2021. No therapeutic measures were taken for the reported events. The clinical outcome of the events fatigue, feeling drugged, sore arm and headache was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected
60 2021-07-01 feeling abnormal Complete brain fog for an entire day; Sore arm; This is a spontaneous report from a contactable cons... Read more
Complete brain fog for an entire day; Sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL3248, Expiration Date- 30Jan2021) via an unspecified route of administration in left arm on 30Jan2021 as dose 1, single (at the age of 60-years-old) and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EM9809) via an unspecified route of administration in left arm on 20Feb2021 as dose 2, single for COVID-19 immunization. Patient medical history included high blood pressure, diagnosed 20 something maybe 30 years ago, underactive thyroid, diagnosed 20 something maybe 30 years ago. The concomitant medications included atenolol at a dose of 25 mg and 75 mg taken for high blood pressure, patient started taking it years ago, levothyroxine at a dose of 0.075 taken for underactive thyroid, taking since 20 years ago, fish oil. Vaccination facility type was reported as hospital. Vaccine was not administered at Military Facility. Patient stated that she received the vaccine on 01Feb2021 and 20Feb2021. She was having abdominal pain and she did not know if that was related. She was also having very high blood pressure and palpitations. She felt like she was having neuro symptoms in her head, like she was having a stroke. The reason she went to the emergency room was she felt like her blood pressure was very high, and it was extremely high, they had to bring it down with a beta blocker. She reports that after, she was unable to get her blood pressure under control. She was on blood pressure medication prior to this but her blood pressure was under control, it then became uncontrolled. She had to start seeing a Cardiologist. She reported having extreme anxiety, since all of this happened, she had become an extremely anxious person. She reported her D-dimer was high. She stated that due to SOB and pulse ox and all, he did CAT scan to determine if she had pulmonary embolism, she did not. She stated her D-dimer was still high so he changed blood pressure medicines, increasing and manipulating them. Now she felt her blood pressure was under control. She was perfectly fine until she took the vaccine. The real issue was neuro symptoms. Her feet had gone numb, she has tingling in her feet, fingers, face, arms, legs, and head. She has a nerve conduction test on 12Jul2021 (as reported). She hoped that will show some things on the status of her nerves. She did not know where all of this came from as she was perfectly fine before the vaccine. She went through a bout of extreme anxiety, which she was a little better from now. Waking up in the morning felt like the petal was to the metal, felt everything is revved up. She could not control that, that went on for awhile. She tried different antidepressants which did not work. Since she has gotten off these she feels a little bit better now. The main reasons she was calling were for the cardiology, neurology, and anxiety issues. These are the adverse reactions she has had since the vaccine. She mentioned she still had to work and her feet and legs were not the best. She reported they put her on gabapentin, a nerve drug and it was helping her nerve problem. It was explained, regarding her blood pressure, the beta blockers worked to bring her blood pressure down. The cardiologist had manipulated her medications, increased them, and that had brought her blood pressure under control. She tried 2 antidepressants for extreme anxiety and that did not help, it made it worse. Since she got off of them she had improved. She still had it but it is not as bad as it was. She was on blood pressure medication and also on thyroid medication. Patient did not have a blood clot in her lung. She reported that after receiving the second dose she was sick with had fever, shaking, chills and flu-like symptoms and fogginess in the head. On an unspecified date in 2021, after the first dose she had total and complete brain fog for an entire day, also she had a sore arm. She stated for the neuro symptoms she woke up, put her feet over the side of the bed and could not feel her heels. Description of complaint included she was on blood pressure medication prior to this but her blood pressure was under control, it then became uncontrolled after the vaccine. She stated she was taking atenolol. She tried 2 antidepressants and that did not help, it made it worse. Since she got off of them she had improved. She still had anxiety but it was not as bad as it was. No additional information was provided regarding this statement. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
60 2021-07-01 sleep disorder Itching on the arm (started within the first hour) and sore and my arm felt heavy (injection site a... Read more
Itching on the arm (started within the first hour) and sore and my arm felt heavy (injection site arm). Hard to lift my arm. I noticed my fingers were swelled up. The itching never has gone away. I still get it. The swollen fingers took about two weeks to go away. I hadn't been able to take my wedding rings off. Heaviness didn't go away. When I got the second shot that got worse (heaviness). March 28 was date of second Pfizer vaccine - LOT# ER8730. The itching felt more prominent and I couldn't scratch by that time so I would try to rub it lightly to calm it. I would put warm compresses on my arm jus to fall asleep. I went to the doctor - I had to see a resident doctor in the office - that might have been 6/2/2021. He prescribed me to take two Aleve's morning and night. And he prescribed a muscle relaxant and Naproxen but none of that worked. I can't extend my arm unless I use my other arm to do it. It wakes me up at night. They also prescribed physical therapist and I had my second Physical therapy appt yesterday but it just hurts - they have scheduled me for12 sessions. I had realized there was a lump on the arm on the first week of May. Now the lump is bigger and you can feel hardness inside. Doctor could see it. The lump is a little lower to the right of the injection site. If I put my three middle fingers together it kind of covers the size - so it's the width of three finger. And that hurts - it wakes me up at night even if I'm not sleeping on it. I'm usually pretty tolerant of pain and I don't usually have time to go to the doctor but this is how bad it hurts - I had to go to the doctor. My physical therapist says they have had patients come in with those same symptoms after their vaccines. I also get lightning bolt pain on the left side of top of my hand - on my left hand. It feels like a neurological issue.
60 2021-07-02 anxiety Left-arm shot area very sore first 24 hours. Slight headache. Left work nauseous feeling day after... Read more
Left-arm shot area very sore first 24 hours. Slight headache. Left work nauseous feeling day after. Slept very heavily 2nd night 2nd day woke up with hives on my left arm as the day progressed had a rash on my chest, stomach, back, and arms causing my anxiety to spike. Went to urgent care. Informed that I have hives,/rash, anxiety and that it had been day 2 of vaccine from pharmacy on Thursday
60 2021-07-06 sleep disorder Worst part so far is inability to sleep, feels like heart racing since at least 07/06/2021 around n... Read more
Worst part so far is inability to sleep, feels like heart racing since at least 07/06/2021 around noon or 1:00; many many feelings like heart flip flops during same period - these things are continuing. injection site still hot, red and swollen and painful. Had fever 100.4 to 101.6 for twelve hours, head and body aches, joint pain - the fever and aches and pain started subsiding today. - the fever, aches and pains I understand are fairly common. Really had not expected the feeling that my heart is racing and flip flopping or the inability to sleep - may have got two hours last night - so that is why I am reporting. Not planning to seek medical care unless it continues another night or two.
60 2021-07-07 insomnia I got my first dose of the vaccine on the advice of my Rheumatologist. I have not been able to see h... Read more
I got my first dose of the vaccine on the advice of my Rheumatologist. I have not been able to see him yet. Two days after the first dose my left arm was really bothering me. My arm was red below the injection site and it was hot, raised up and painful. I couldn?t sleep on that side. I was very tired that week. I used antibiotic ointment and alcohol pads with a cold washcloth. I went back to the pharmacy. It looks better now after eight days. It is a little splotchy now, but the pain has gone down. I have also had more joint pain since I got the vaccine but that may be because I have not had any Embrel for two weeks. It feels like my Rheumatoid Arthritis is flared up.
60 2021-07-08 feeling abnormal I couldn't work, I could not function; I am sick, I feel horrible if it is I don't get another one; ... Read more
I couldn't work, I could not function; I am sick, I feel horrible if it is I don't get another one; it cause permanent damage; I couldn't work, I could not function; I am sick, I feel horrible if it is I don't get another one; it cause permanent damage; Inflammation in neck and inside ears; Inside of head feels really heavy; massive dizziness; headaches; vestibular system all messed up; I feel like I have an ear infection; I thought it was vertigo; have been miserable for 3 months; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8737, Expiration date: 31Jul2021), via an unspecified route of administration, administered in left arm on 31Mar2021 as dose 1, single for covid-19 immunisation. Medical history included ongoing high cholesterol (a couple of years ago), ongoing arthritis of neck (5-7 years ago), covid-19 from 25Jan2021 to an unknown date. Family history included diabetes (her sister has diabetes, patient reported that she thought that her sister got gestational diabetes and within a couple of years after that, ended up with diabetes). Concomitant medication included atorvastatin taken for cholesterol at 40 mg daily, start and stop date were not reported. No prior vaccinations were given within 4 weeks. On an unspecified date, she couldn't work, she could not function; she was sick, she felt horrible if it was, she does not get another one; it causes permanent damage. On an unspecified date of Apr2021, the patient experienced massive dizziness, headaches, vestibular system all messed up, felt like she has an ear infection; she thought it was vertigo, have been miserable for 3 months, inflammation in neck and inside ears and inside of head feels really heavy. The event Massive dizziness resulted in emergency room and physician office. Patient stated, she got her first shot on 31Mar2021 and within 4 days, she has experienced massive dizziness, headaches, vestibular system all messed up. She felt like she has an ear infection, she has been to all her doctors the ear, nose, and throat, then they send her the ER. She had CT scans of her head, she had X-rays on her lungs everything, they ruled everything out and the only thing we got left is that she is having a bad reaction to the vaccine. First, she thought it was vertigo, she tried the exercises, and they said no that's not vertigo that's some different that's why they send her to the hospital and what she wants to know she keep asking what she do if it was the vaccine (Unspecified Vaccine). Does it wear off, how she fixes this, can she flush this out of my system she does not know what to do but she has been miserable for 3 months and it doesn't seem like its ending. She had to retire from the post office she works there, and she was planning on retiring next year but she couldn't work she could not function. When paraphrased the above concern, Patient stated, What she asking you was when she went, she only had one shot she refused to get the next one because she told the doctor she was sick, she felt horrible if it is she don't get another one until she felt better, so we were trying to little down what it was but she told the lady when she got the vaccine that literally 60 days ago, she actually had COVID and she said it was ok for her to get the shot and that's what she need to know how does this stuff that Pfizer (hence checked the Pfizer tab) shoot in me does it wear off or has it cause permanent damage. Patient reported that she had Covid-19 in late Jan2021, 25Jan2021. Patient reported that she informed the vaccination facility staff member that she just had Covid-19 2 months ago and inquired if it was ok to get the Covid-19 vaccine. Patient reported that the staff member asked if the caller had gotten plasma and something else. Patient reported that she had not gotten plasma or anything else. Patient reported that she really wasn't very sick, she was sneezing a lot and ended up with a sinus and ear infection from the drainage. Patient reported that the staff member gave her the Covid-19 shot and within 3-4 days, everything went to hell and she's been suffering since. Patient reported that she went to the doctor. She was not dizzy when she turns her head. Patient reported that she feels like she's walking on a rocking boat. Patient reported that when she's walking, she looks fine, but her head feels like it's going side to side. Patient reported that she was sent to the emergency room from the doctor's office. Patient reported that she had a CT scan of her head and neck to make sure there were no blockages. Patient reported that she also had blood work drawn, and everything came back fine. Patient reported that she asked her physicians why she was so dizzy and miserable and if it could be from getting the Covid-19 vaccine so close to having Covid. Patient reported that her physicians said they didn't know. Patient reported that she has been through 5 doctors and her last appointment was with a physical therapist to help with the dizziness. Patient reported that the physical therapist informed her that her dizziness could possibly be from the Covid-19 vaccine. Patient reported that her physical therapist stated that he has seen a lot of people with what happened to the caller come in after the got the Covid-19 vaccine. Patient reported that no one knows what to do. Patient inquired if there was a way to flush the vaccine out. Patient inquired if the side effects will wear off or will she have it the rest of her life. Weight: Patient reported that she is a little overweight right now. Massive dizziness: Patient reported that when it first started, she got into the doctor. Patient reported that the doctor said it was vertigo and that there was a lot of wax in the patient's ear. Patient reported that the physician put oil in her ears, said to leave it for 4 days, then come back to the nurse's station to get them flushed out. Patient reported that after they flushed out her ears, the dizziness got way worse. Patient reported that the physicians thought that she may have had some dis embarkment syndrome as she had taken a trip to (withheld) and had taken an airplane and went on a boat ride. Patient reported that she did not think it was dis embarkment syndrome, as she had been back for over a week and it usually sets in when you get off the plane or a couple of hours later, but it had been a couple of days since she got back. Patient reported that she has been out on sick leave since 13Jun2021 because her head was splitting, and she was spinning. Patient reported that she experiences the dizziness only when she walks or moves. Patient reported that she can turn her head and look up and down, it's only when she walks forward that she feels unbalanced. Patient reported that she knows there were some temporary side effects from the Covid-19 vaccine, such as inflammation and dizziness. Massive dizziness: Caller reported that the dizziness began on Sunday 04Apr2021 or Monday 05Apr2021, following the Covid-19 vaccine. Patient reported that she didn't get any indications of dizziness immediately after the Covid-19 vaccine on 31Mar2021. Patient reported that the dizziness has gotten way worse from when it started, but now it has stayed worse. Headache: Patient reported that she thinks the headache is evolving from her moving and trying to compensate for the rocking boat motion in her head. Patient reported that when she's walking the inside of her head is going side to side, and she thinks if she does too much of that, she ends up with a headache whether she was taking Advil or not. Patient reported that the headache has gotten worse since it first started. Patient reported that for maybe a month or, so the headache was not that bad, it was just in the last month and a half to 2 months that the headache got worse, and it stayed there. Inflammation in neck and inside ears: Patient reported that she has arthritis in her neck from 30 years of carrying mail and her neck's not in great shape. Caller reported that she thinks because of the inflammation and postal work, it caused the inflammation in her neck to get way worse. Patient reported the inflammation started a few weeks after receiving the Covid-19 vaccine. Patient reported that she has put in for her retirement. Patient reported that she thinks the inflammation just slowly seeped in. Patient reported that she's had arthritis in her neck for a very long time, but she doesn't even take anything for it. Patient reported that she was told that she had arthritis in her neck and her neck was curved the wrong way, and that maybe way later on she'd have to deal with it. Inside of head feels really heavy: Patient reported that her side effects started with vertigo, not crazy, but that got worse. Patient reported that when the vertigo got worse, that's when she noticed the inflammation or the heaviness in her ears. Patient reported that they say it's her vestibular system that's out of whack and causing the dizziness. Patient reported that was why she went to physical therapy; it's actually called vestibular physical therapy. Patient reported that she is doing exercises every day, and she looked up the exercises online, but it doesn't do anything. Atorvastatin: Patient reported that she was going to get off the Atorvastatin, but her doctor inquired why. Patient reported that her doctor informed her that it will protect her from heart attack and stroke, and she should just keep taking it. Investigations: Patient reported that everything was normal with her blood work and CT scan. Caller reported that the next step was neurology, but neurology refused to take her because they said that the dizziness was related to the (address) trip, but she had been back for a week. Patient reported that she got back from (address) on 28Mar2021 and 3 days after she got back, 31Mar2021, she did get the Covid-19 vaccine. Patient reported that before getting the Covid-19 vaccine, she wasn't having any dizziness or anything. Patient reported that she was working, and everything was fine. Patient reported that she went to urgent care twice. Patient reported that the second urgent care trip is when the sent her to the emergency room at (address). Patient reported that's when they did the CT scan, chest X-ray, and all the blood work. Patient reported that she thinks it was the last week of May2021 that she was sent to the emergency room from urgent care. Patient reported that the first time she went to urgent care, she had her ears done. Patient reported that she went back because the dizziness got worse, not better. Patient reported that she was working and trying to deal with the rocking boat feeling and dizziness. 3-4 days after vaccination, she had massive dizziness, headache, inflammation in the neck and ears and they were very heavy. The dizziness has worsened, and it has stayed in that worsened state. Patient wanted to know how long it would last and would it be permanent She said that she was amazed that Pfizer has no information about dizziness after getting the Pfizer COVID-19 vaccine. She has information about various people having dizziness after getting the vaccine. The patient underwent lab tests and procedures which included blood test: normal on unspecified date of May2021, chest x-ray: normal on unspecified date of May2021, computerised tomogram: normal on unspecified date of May2021, sars-cov-2 test: positive on 25Jan2021, x-ray: unknown results on unspecified date of May2021, blood test; everything came back fine on an unspecified date. The outcome of she couldn't work, she could not function; she was sick, she felt horrible if it was, she does not get another one; it causes permanent damage was unknown and not recovered for other events. Information about the lot/batch number has been requested.
60 2021-07-08 sleep disorder Patient reported several itchy wheals/hives that started on the writs of the arm the vaccination was... Read more
Patient reported several itchy wheals/hives that started on the writs of the arm the vaccination was given in, and some on the opposite arm. They were limited, not widespread. These began the day following vaccination. Roughly 12 hours post-vaccination she stated she had a severe headache that woke her up. This headache continued 7 days, peaking on day 3. She almost went in for treatment, but did not end up doing so. She also reported swollen, tender lymph nodes in axilla on side of vaccination, as well as a blood nose.
60 2021-07-11 amnesia No treatment was sought, I immediately had elevated heart rate at rest and upon exertion for the fol... Read more
No treatment was sought, I immediately had elevated heart rate at rest and upon exertion for the following 2 1/2 weeks. The most troublesome adverse event was the extreme short-term memory loss. It is beginning to rectify itself now hopefully.
60 2021-07-11 anxiety Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient recovered pretty quickly. Orig... Read more
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient recovered pretty quickly. Original BP 159/90 HR 71 and 2nd reading 160/89 HR 65. Patient was also anxious will recheck once she gets homoe.
60 2021-07-11 excessive sleepiness, disorientation, thinking abnormal, memory impairment Face bright red & swollen, red rash all over my body, headache, dizziness within the first few hours... Read more
Face bright red & swollen, red rash all over my body, headache, dizziness within the first few hours of vaccination. The first evening my headache got significantly worse. I was extremely thirsty, very tired, nauseous, vomiting, diarrhea, muscle pain, chills, fever, my left arm was very sore & swollen @ the injection site. I slept for longer periods of time than normal, very disoriented & not clear on my thoughts & memory for days after.
60 2021-07-11 impaired work ability Hi I got my second Covid shot on Saturday July 10. Shot was in the left arm. Severe headache withi... Read more
Hi I got my second Covid shot on Saturday July 10. Shot was in the left arm. Severe headache within five minutes like last time. Felt like a migraine. After an hour the worse pain was in my left breast & armpit. My left armpit was swollen significantly & my breast felt like I was punched or stabbed. I couldn?t lift my left arm. I applied heat & ice alternately & took Tylenol. Then whole body ached like the flu. No worries there, it?s the swollen left armpit & pain in breast that is bad. Yesterday it got worse. I continued with heat, ice & Tylenol. I took today off because the pain is severe & I can only lift my arm half way up. The severe pain feels like how you feel after a surgery when pain meds start to wear off. Do you know how long this will last?? Thanks & have a great day.
60 2021-07-12 disturbance in attention, feeling abnormal hives on my knees; light sensitivity; concentration difficult throughout experience; felt very dizzy... Read more
hives on my knees; light sensitivity; concentration difficult throughout experience; felt very dizzy; Knees swollen; neck discomfort; headache; area swollen from nose to chin; sore injection site,; fatigue; foggy during day; felt my heart beating hard within 5 minutes of vaccine; my lips were numb; I felt a little trouble swallowing.; Had chills; had swelling around lips/mouth; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no : ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 11:300 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. The patient had no Medical history. Concomitant medications included with supplements. The patient previously received Sulpha Drugs on an unknown date for unspecified indication and experienced a sulfonamide allergy. 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 24Mar2021 at 11:00, the experienced heart beating hard within 5 minutes of vaccine and her lips were numb and she felt a little trouble swallowing, and had chills, and had swelling around lips/mouth. On 25Mar2021, the Patient experienced area swollen from nose to chin and Had headache, sore injection site, fatigue, foggy during day. On 26Mar2021, the patient experienced Fatigue and neck discomfort. On 27Mar2021, the patient experienced very dizzy, Knees swollen and Could not sleep on injection site. On 28Mar2021, the experienced hives on her knees, Light sensitivity and concentration difficult throughout experience. The patient underwent lab tests and procedures, which included Blood pressure on unknown date and resulted normal. The patient called clinic for instructions and receive Benadryl for lips numbness, heart beating hard, trouble swallowing and chills. Patient had called doctor and awaited to call back. The clinical outcome of felt heart beating hard, numb lips, trouble swallowing, chills, area swollen from nose to chin, headache, fatigue, foggy during day, neck discomfort, dizzy, swollen knees, hives on knees, light sensitivity and concentration difficult was not recovered and of the vaccination site pain was recovered on 26mar2021. No follow-up attempts are possible. No further information is expected.
60 2021-07-13 feeling abnormal I began having a high heart rate and I felt my heart beating out of my chest. Heart rate was up to 1... Read more
I began having a high heart rate and I felt my heart beating out of my chest. Heart rate was up to 115. I felt pretty weird. I went to cardiologist and had all the cardiac tests done: wore a heart monitor for 48 hours, echocardiogram, several EKG's, and a stress test. All the tests came back normal. But I still didn't feel good. Cardiologist put me on Bystolic and it helps.
60 2021-07-15 disorientation, memory impairment passing out 3 days after vax, missing days, 2 days in hospital, passed out in car wreck, disorientat... Read more
passing out 3 days after vax, missing days, 2 days in hospital, passed out in car wreck, disorientated, fell down stairs, passed out eating, passed out in bathtub face first, nearly drown.
60 2021-07-17 feeling abnormal Dizzy; wretched; blood pressure was got high; fast heart rate beating; I was very sick; This is a sp... Read more
Dizzy; wretched; blood pressure was got high; fast heart rate beating; I was very sick; This is a spontaneous report from a contactable consumer (patient herself). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration, administered in Arm Left on 14Mar2021 as single dose for COVID-19 immunization. Medical history included blood cholesterol abnormal and blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medication included potassium (POTASSIUM) taken for an unspecified indication. It was reported that, she got one Pfizer shot and she was due for the next one in the morning at 11:25. The first shot that had gotten, she went to the emergency room; on 23Mar2021 she was wind up, dizzy, wretched and blood pressure was got high. It was one she thought like 184 over like a 160 or 170 and she had fast heart rate beating and it. She was in the emergency room with elevated blood pressure; she had fast heartbeat and pressure was very high. She was very sick and was afraid to take that second shot of vaccine. Therapeutic measures were taken as a result of blood pressure was got high as she was taking Metoprolol tartrate pills for it. The patient underwent lab tests and procedures which included blood pressure measurement which was elevated and heart rate which was fast on an unspecified date. The outcome of all events was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
60 2021-07-17 nervousness Client reported nausea, tingling in her left hand, and slight dizziness at 6:45ish. Vitals obtained ... Read more
Client reported nausea, tingling in her left hand, and slight dizziness at 6:45ish. Vitals obtained at 6:53PM PM were as follows: BP 120/78, HR 71, O2 96%. The client reported a history of nausea when she is nervous. Client was provided an emesis bag. Vitals obtained at 6:58PM were as follows: BP 120/68, HR 65, and O2 98%. The client reported a history of hypotension. The client stated she has to be sure to stay adequately hydrated or she notices a decrease in her blood pressure. Current medications include Avapena. The client denied any s/s of anaphylaxis. At 6:55PM the client reported a headache. The client did eat today. At 7:02PM RN provided the client a cotton ball with peppermint oil on it to smell.. The client stated her headache was very light at 7:05PM. The client left at 07:10PM.
60 2021-07-17 sleep disorder Hands and feet were burning, very painful and felt locked up. By the end of the day the extreme pain... Read more
Hands and feet were burning, very painful and felt locked up. By the end of the day the extreme pain had subsided but now, hands, feet, ankles, back and arms hurt. So much so it?s keeping me up at night. Prior to the shot I did have hand pain due to RA. But not like this. Shooting pains start from wrists and go down into palms. Those come and go. Mornings are terrible. The pain is getting worse. Taking over the counter pain pills reduces the pain a little bit.
60 2021-07-19 loss of personal independence in daily activities The morning following vaccination, the patient reported pain and heaviness in middle portion of her ... Read more
The morning following vaccination, the patient reported pain and heaviness in middle portion of her left arm (the arm that received the vaccine). The patient stated that the pain was fairly localized around the elbow area, with the area of the pain starting about six inches below the elbow and stopping about six inches above the elbow. The pain made normal activities uncomfortable and became more intense as the day progressed. The patient also reported noticing occasional shooting pains originating at her shoulder and traveling down her left arm. She did not mention any systemic signs or symptoms nor did she report any areas of redness or swelling. After about a week of the elbow-area pain, the patient sought care at an urgent care provider who ordered x-rays of her arm, which did not show any detectible damage. After that visit, the patient saw her primary care doctor for the arm pain as well as for routine care. The patient noted that the provider suggested possible nerve involvement due to the vaccine and/or its administration and mentioned to the patient that the arm pain should improve over the next few months. The patient regularly sees her primary care doctor and a cardiology due to poorly controlled hypertension.
60 2021-07-21 confusional state, agitation, excessive sleepiness pain/heaviness in left arm; pain/heaviness in left ram; pain/heaviness in left arm; sweats; chills; ... Read more
pain/heaviness in left arm; pain/heaviness in left ram; pain/heaviness in left arm; sweats; chills; diahrea; Weakness; nausea; fatigue; low tolerance to sound and light; low tolerance to sound and light; vertigo; feeling cold; headaches; muscle/joint pain in all extremities; muscle/joint pain in all extremities; diminished sense of taste; blurred vision; confusion; mood changes; increased sleep; physical agitation; difficulty breathing; Aggravation/exacerbation of underlying neurological/ pulmonary conditions; Pain in injection arm persists; This is a spontaneous report from a contactable consumer or other healthcare professional (patient). A 60-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL9261) via an unspecified route of administration in Arm Left on 29Jan2021 07:00 (age at vaccination 60 years old, Pregnant at Time of Vaccination No) as single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing, vertigo from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing None in past 5-6 years, arthritis from an unknown date and unknown if ongoing, affective disorder from an unknown date and unknown if ongoing, nervous system disorder from an unknown date and unknown if ongoing. The patient had unknown allergies Darvon. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included umeclidinium bromide, vilanterol trifenatate (ANORO); levothyroxine sodium (UNITHROID); valproate semisodium (DEPAKOTE); paliperidone (PALIPERIDONE). All taken for an unspecified indication, start and stop date were not reported. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EK9231) via an unspecified route of administration in Arm Left on 07Jan2021 17:00 (age at vaccination 60years old, Pregnant at Time of Vaccination No) as single dose for covid-19 immunisation. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced after second dose pain/heaviness in left ram, sweats, chills, diahrea, nausea 3 days. Weakness and fatigue for 3 weeks, low tolerance to sound and light, vertigo, feeling cold, headaches, muscle/joint pain in all extremities, diminished sense of taste, blurred vision, confusion, mood changes, increased sleep, physical agitation, difficulty breathing. These lasted 5 weeks. Mood changes, breathing difficulties, vertigo, muscle and joint pain persist. Aggravation/exacerbation of underlying neurological/ pulmonary conditions. Pain in injection arm persists on unspecified date. Therapeutic measures were taken as a result events which included injection of a medication with high NSAID levels. AE resulted in Doctor or other healthcare professional office/clinic visit. The clinical outcome of the events was recovered with sequelae in 2021. No follow-up attempts are possible. No further information is expected.
60 2021-07-21 insomnia Similar to allergic/immunity response; Intense and long term hives; rash; itching; burning on neck, ... Read more
Similar to allergic/immunity response; Intense and long term hives; rash; itching; burning on neck, back of neck (top of back), chest, arms, legs; Unable to sleep; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: 8727) via an unspecified route of administration on 29Mar2021 (at the age of 60 years old) as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Known allergies was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced similar to allergic/immunity response, intense and long term hives, rash, itching, burning on neck, back of neck (top of back), chest, arms, legs, unable to sleep on 08Apr2021. Event reported as intense and long term hives, rash, itching, burning on neck, back of neck (top of back), chest, arms, legs. Similar to allergic/immunity response. Nothing at injection site or on torso or face. Unable to sleep, work, leave house. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse event included prednisone, antihistamines, steroid oil, EpiCeram. Since the vaccination, the patient has not tested for COVID-19. Outcome of the events were not recovered. Follow-up attempts are completed. No further information was expected.
60 2021-07-22 feeling abnormal I started feeling bad about mid May, May 15 2021. I was feeling very out of sorts. I had started cou... Read more
I started feeling bad about mid May, May 15 2021. I was feeling very out of sorts. I had started coughing, some of the coughing was to the point where I could not breath. I went to the DR and they put me on antibiotics. May 18th 2021, that was when I went to the DR. Then on June 1st 2021 I went to the DR as well and I think that is when they put me on Z-Pack. I continued to cough and get very exhausted regardless of the medication. Then July comes along - through the rest of June I could not even walk without getting winded and panting for my own breath. So then on July 6th 2021 I just couldn't go anymore and decided to go to the ER, at the Hospital and I was admitted. They did tests and I was in the hospital until July 8th 2021. My heart is apparently not pumping as it is supposed to. I thought maybe I had bronchitis because of the coughing but apparently not. The DRs say I have Cardiomyopathy, never having heart problems before I was really taken aback by this news. I was sent home with a life vest for my heart now that is scary too. The DRs tell me I am not allowed to do much of anything, basically sit around. I see an electrophysiologist and I see a heart DR. I saw my PCD on the 19th of July 2021 as well. I will see the electrophysiologist on August 10th 2021 as well. Oh I was also put on four new medications: Entresto 2x daily, Carvedilol 2x daily, Atorvastatin 1x daily, Spironolactone 1x daily. I was also taken off of Vyvanse and now I just kind of play the waiting game.
60 2021-07-25 crying flu like symptoms Sunday morning, knees hurt - by Sunday afternoon every thing hurt so bad I was cry... Read more
flu like symptoms Sunday morning, knees hurt - by Sunday afternoon every thing hurt so bad I was crying and it was indescribable. Monday I was some better - not sure if would have been able to drive to work, Tuesday better - Wednesday all good.
60 2021-07-26 excessive sleepiness pressure in head , slight tingle in right hand and spine at 3 am , noticed veins on hands and legs a... Read more
pressure in head , slight tingle in right hand and spine at 3 am , noticed veins on hands and legs are all I can see , green in color , back to normal in the morning. tired and sleep for 4 days
60 2021-07-28 feeling abnormal Vertigo; Diarrhea; Brain fog; Muscle pain; Headache; Tiredness; This is a spontaneous report from a ... Read more
Vertigo; Diarrhea; Brain fog; Muscle pain; Headache; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0164) via an unspecified route of administration in the left arm on 22Apr2021 at 15:15 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included polycystic kidney disease, dry eye, iritis and uveitis. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) of dose 180 milligram (mg), irbesartan (MANUFACTURER UNKNOWN) of dose 75 mg and valaciclovir (MANUFACTURER UNKNOWN), all from unknown dates for unknown indications. The patient past drugs included paracetamol (TYLENOL), topiramate (TOPAMAX), penicillin (MANUFACTURER UNKNOWN), latex and cefalexin (KEFLEX). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955) via an unspecified route of administration in the left arm on 29Mar2021 at 16:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. 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 4 weeks prior to the COVID vaccine. On 23Apr2021, next day of vaccination, the patient experienced muscle pain and headache and on an unknown date in Apr2021, the patient experienced tiredness for three days then felt fine until brain fog started on 8th day after vaccination on 30Apr2021 at 12:00. On 02May2021, 10th day after vaccination, the patient experienced diarrhoea and on 03May2021, 11th day after vaccination, the patient experienced vertigo. The clinical outcome of the event tiredness was resolved on an unknown date in Apr2021 where as the outcomes of the events muscle pain, headache, brain fog, diarrhoea and vertigo were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
61 2021-01-03 disturbance in attention, thinking abnormal About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, ... Read more
About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, feeling that I would pass out, lightheafdedness, increased heart rate and blood pressure, mild difficulty with speech/thought/concentration, freezing hands, wabbly/shaky., chest tightness, very slight throat soft tissue sensation
61 2021-01-04 depressed mood Headache, fever, chills, cough, congestion, malaise, patient reports she has been "down" since Satur... Read more
Headache, fever, chills, cough, congestion, malaise, patient reports she has been "down" since Saturday and is still experiencing all of these symptoms overall. Patient has been taking TheraFlu
61 2021-01-04 feeling abnormal aches/pains/body aches and pains; hot flashes; a little fever/fever of a little over 100; she was fr... Read more
aches/pains/body aches and pains; hot flashes; a little fever/fever of a little over 100; she was freezing/chills; cold was worse; couldn't get comfortable; started feeling bad when she went to bed; This is a spontaneous report from a contactable consumer (patient's husband). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EH9899), via an unspecified route of administration on 27Dec2020 at 12:45 on Left Upper Arm at single dose for COVID-19 immunization in hospital. No additional vaccines administered on same date of bnt162b2. The patient medical history included she may be a little overweight, but she was not obese. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), levothyroxine sodium (SYNTHROID), lubiprostone (AMITIZA) for stomach. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the flu shot (influenza vaccine) in the past for immunization and got sick once afterward, she was not sure if it was food poisoning or the flu vaccine, she didn't get one this year. Patient's husband reported that patient got the vaccine yesterday (27Dec2020). She felt fine all day but started feeling bad when she went to bed on 27Dec2020. She was experiencing aches, pains hot flashes and a little fever a little over 100. She had a miserable night. She had body aches and pains, hot flashes and a little fever started around one in the morning of 28Dec2020. The fever was a little over one hundred. It looked like she what she got was normal side effects. The reporter didn't know how long approximately and how high her fever could get before he called the doctor. She had started to feel better on 28Dec2020. Then she was down again. She didn't feel great when she went to bed and then was up from 1AM to 2AM until now (28Dec2020). From 1AM or 2AM until 7AM or 8AM of 28Dec2020 it was the worse with bad aches and pains. She couldn't get comfortable. Alternating between fever and chills. Around 8AM to 9AM it started to get less and the aches started to get less. She didn't have a fever and he had checked 4 or 5 times. Around 2:00PM on 28Dec2020 she had the fever of a little over 100. The hot flashes were moderate to severe. The cold was worse and she was freezing in the middle of the night on 28Dec2020. He gave her heating pads and blankets and she was still freezing. Reporter thought the second shot would be worse with reactions. She was concerned about getting the second shot. No event required a visit to Emergency Room or Physician Office. No Investigation Assessment provided. The outcome of the events was unknown. This report was reported as non-serious.
61 2021-01-05 feeling abnormal I went to the emergency room which after the Pfizer injection I had numbness sensation to my face a... Read more
I went to the emergency room which after the Pfizer injection I had numbness sensation to my face and upper lips, nose and mouth. I feel a pulling sensation to her lips and nose. I have brain fog. I feel the injection affected a nerve in my face. She went to see her primary doctor put her on anti-histamine medication. She states she has no itching at the moment.
61 2021-01-06 disturbance in attention, anxiety, mental impairment Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside t... Read more
Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside the body; Lightheadedness; Blood pressure went up; Heart rate went up; Hands freezing; Mild difficulty with thought/speech/concentration; Mild difficulty with thought/speech/concentration; Weakness; Mildly shaky; Anxiety; Feeling that may pass out; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 61-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) via unspecified route on left arm single dose for COVID-19 immunization on 02Jan2021, 02:30 PM, at 61-year-old. Medical history: allergies to sulfa, paclitaxel (TAXOL); breast cancer in 2003 and 2007. Prior to vaccination, the patient did not be diagnosed with COVID-19. Concomitant medication in two weeks included: escitalopram oxalate (LEXAPRO, strength: 10m); omeprazole; multivitamin; ibuprofen. About 5 minutes after the vaccine (02Jan2021, 02:35 PM), the patient had a strong wave of burning sensation growing inside the body, lightheadedness, blood pressure went up, heart rate went up, hands freezing, mild difficulty with thought/speech/concentration, weakness, mildly shaky, anxiety, feeling that may pass out. Emergency room/department or urgent care visited. Treatment received for the adverse event included: heart rate H20 and BP monitor, water, observation. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Mental impairment cannot be totally excluded. The case will be reassessed if additional information becomes 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.
61 2021-01-06 fear, anxiety worry; frustration; regrets/wishing she would have never taken it; phlegm; can't talk; taking her vo... Read more
worry; frustration; regrets/wishing she would have never taken it; phlegm; can't talk; taking her voice, she felt like she was losing her voice; scary/"scaring" her; coughing/cough; difficult for her to catch her breath/lost her breath, couldn't catch her breath/couldn't breath; allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284, expiry date 30Apr2021) intramuscular on 29Dec2020 09:16 at 0.3 mL, single for Covid-19 immunization in a hospital. Medical history included diabetic, allergy reactions, blood pressure (abnormal), cholesterol (abnormal); all ongoing, and reaction to dust. Concomitant medications included ongoing amlodipine;hydrochlorothiazide;valsartan for blood pressure, ongoing potassium for unspecified indication, BP pills (unspecified) and has cholesterol medications. The patient informed that yesterday (29Dec2020), she got the COVID vaccine shot at work, received it at 9:16 am and was monitored for 30 minutes post administration. The patient went to work and was holding the babies. The patient worked in transport in the NICU at a hospital. Few hours after the injection, while working in the NICU, she experienced coughing to the point where it was difficult for her to catch her breath. The patient started coughing so bad, she had no control. She mentioned trying to drink water and continued coughing more. The patient lost her breath, couldn't catch her breath, she had to call for the charge nurse (manager), as she couldn't breath and they took her to the ER and consulted at the ER of her facility. The patient informed that she kept coughing and couldn't catch her breath. They made her drink water. The patient has allergies, so she always has an epi pen with her. The patient felt like she had an allergic reaction to the vaccine. The doctor there explained that her symptoms were not related the Covid-19 vaccine she received earlier. The patient specified that the last time she had a similar reaction was at work and was due to dust. The patient explained that she was perfectly fine before receiving the vaccine, laughing, and so what can her symptoms be related to, if it was not the vaccine. The patient was coughing all night, can't get rid of the cough. She has called her doctor. The nurse said just to watch herself for now. The patient informed that she was supposed to go back to work tomorrow and she was afraid to go around the babies. The patient informed that today (30Dec2020), she gargled apple cider vinegar and salt water, and phlegm came out. The patient continued saying that she has still been coughing, can't talk and that it was scary. The patient informed that she was taking her voice, she felt like she was losing her voice. It was "scaring" her. She was unsure if it was the Pfizer vaccine. The patient attempted to reach her HCP and that she cannot be seeing at her clinic due to her cough. The patient mentioned that she won't have access to a respiratory clinic until Tuesday. The patient expressed her concerned about returning to work with babies and asked if she should return to work tomorrow. The patient pursued verbalizing her worry and frustration. The patient asked if she can decide not to get the second dose. The patient voiced her regrets on receiving the first dose of the COVID-19 vaccine. She stated wishing she would have never taken it and that all who have an EpiPen should not receive it. The outcome of the event cough was not recovered, Dyspnoea, Allergy to vaccine, Productive cough, Speech disorder, Aphonia, Nervousness, Anxiety, Frustration tolerance, Depressed mood was unknown.
61 2021-01-06 feeling abnormal left fingers felt cold and numb slightly light headed Felt 'goofy' and headache still feeling the s... Read more
left fingers felt cold and numb slightly light headed Felt 'goofy' and headache still feeling the same today - did register for V-safe
61 2021-01-06 impaired work ability Headache, Myalgia, Arthralgia, Chills, Fatigue, Injection Site Pain Narrative: Adverse reaction last... Read more
Headache, Myalgia, Arthralgia, Chills, Fatigue, Injection Site Pain Narrative: Adverse reaction lasted 3 days, employee did not report to work on day 3 after vaccine.
61 2021-01-08 anxiety About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left d... Read more
About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left deltoid muscle felt completely numb; palms slightly flushed, felt as if heart rate slightly elevated, but not tachycardia. No rash, no hives, no difficulty breathing. Acute episode lasted about 20-30 minutes, then just felt a little off for 1.5 hours more, then back to normal. For next 34-48 hours-mild fatigue.
61 2021-01-08 impaired work ability Headache, Myalgia, Arthralgia & Fever Narrative: Missed work following vaccine administration sec... Read more
Headache, Myalgia, Arthralgia & Fever Narrative: Missed work following vaccine administration second dose due to headache, fever, myalgia, arthalgia.
61 2021-01-10 impaired work ability, irritability, euphoric mood, anxiety Euphoria began ~2hours after vaccine lasting ~2.5 hours. Unable to process information, irritabilit... Read more
Euphoria began ~2hours after vaccine lasting ~2.5 hours. Unable to process information, irritability, anxiousness, generalized not feeling well around 5pm day of; went to bed. Woke up at 10:30pm with headache, took Tylenol. Wednesday didn't feel well in general, left work at noon, went home to bed. Thursday felt better but not baseline self. Friday generalized not feeling well. Saturday went to ER due to feeling much worse generally, SOB. Tests Urine, blood. Everything within normal limits.
61 2021-01-10 impaired work ability Myalgia, Fever chills, fatigue Took a couple of days off from work, laid in bed x2 days and let it r... Read more
Myalgia, Fever chills, fatigue Took a couple of days off from work, laid in bed x2 days and let it run it course.
61 2021-01-11 confusional state After patient had received vaccine, a vaccinator was called by a member of the healthcare facility t... Read more
After patient had received vaccine, a vaccinator was called by a member of the healthcare facility to assess the patient. The patient was jittery and exhibited signs of confusion approximately 20 minutes (3PM) after her vaccination. The vaccinator asked if she was diabetic and the patient replied "yes" and takes metformin. Further questioning revealed that the patient had not eaten since 9AM - it was then around 3PM. The ambulance was called and the patient went to the hospital. Probe revealed that she had not taken her diabetic medication and that the patient had not eaten or drink. Patient was encouraged by vaccinator to eat on time and take her medicine as prescribed.
61 2021-01-11 feeling abnormal Red cheeks hot face dizzy shortly after. Had to pull over and needed my son to come get me. Two hour... Read more
Red cheeks hot face dizzy shortly after. Had to pull over and needed my son to come get me. Two hours later cheeks still red not as red. Am home. Don?t feel normal. Very dry mouth and throat.
61 2021-01-12 impaired work ability Headache, Myalgia & Fever Narrative: missed two days work following second dose of vaccine due to fl... Read more
Headache, Myalgia & Fever Narrative: missed two days work following second dose of vaccine due to flu like symptoms
61 2021-01-12 insomnia Pfizer-BioNTech COVID-19 Vaccine EUA Chills and low grade fever (highest it got was 99.7)- started a... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Chills and low grade fever (highest it got was 99.7)- started at 11:00 p.m. on 11/12/21. Not able to sleep in the night, headache started sometime in the night. Fever and chills were gone by morning. Headache resolved about 5:00 p.m. on 1/13/21.
61 2021-01-12 nervousness Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and mo... Read more
Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and moderate to severe abdominal cramping with moderate chills lasting 6 hours. Any fluids taken ran right through me. 4 lb weight loss and muscle cramping from dehydration. 12 hours after symptoms started I was able to take fluids and eat crackers. 24 hours after start felt shaky with mild abdominal soreness but improvement progressed and by 28 hours after start if symptoms felt normal other than I felt like I did 100 sit ups!
61 2021-01-13 depression, amnesia Short term memory loss, Severe fatigue, Chills, Mild HA, Depression - lasted 5 hours and was gone.
61 2021-01-14 impaired work ability Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at inje... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at injection site radiating up and down arm and up into neck ; Body aches especially lower back developed within 24 hours with a severe throbbing type headache and ringing in the ears. Elevation of temperature by 1-2 degrees normal for me runs 97 degrees F and was up to 99 degrees F. Headache intensified with movement(ex. .bending over ,etc) Treated arm soreness and lower back with heat compresses... elevated temp and headache with rest and a lot of water. It is now over 48 hours since vaccination and all symptoms are subsiding but still present with temperature normal for me and no arm soreness. Scheduled day off from work day after vaccination but also a second day due to the severe headache mostly.
61 2021-01-17 anxiety, insomnia, impaired work ability Patient seen on 1/8, 1/9 and 1/11 in ER at Hospital for Chest pain. Work up negative for acute coro... Read more
Patient seen on 1/8, 1/9 and 1/11 in ER at Hospital for Chest pain. Work up negative for acute coronary syndrome. This started hours after 2nd dose of COVID 19 vaccine. Pleuritic type pain. She was sent with aspirin and monitored. On her 3rd ER visit was given medication for anxiety and to aid in sleep (ativan). Symptoms continued and she was off work the week of 1/11 because of this. Seen in Clinic on 1/18 and symptoms had stopped on 1/17.
61 2021-01-17 feeling abnormal 2nd and 3rd branches of trigeminal nerve, bilateral, more left than right: odd feeling throughout mu... Read more
2nd and 3rd branches of trigeminal nerve, bilateral, more left than right: odd feeling throughout muscles, tongue felt thick, mild tongue coordination alteration. Left 2nd and 3rd branch trigeminal nerve mild numb sensation though unclear if I have mild paresis too. Mildly reduced tongue coordination continues.
61 2021-01-18 feeling abnormal Cough; Headache; Dizzy; Nauseous; Low grade fever; Little Noxious, whole body aches completely aches... Read more
Cough; Headache; Dizzy; Nauseous; Low grade fever; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231 and expiration date 30Apr2021), via an unspecified route of administration on 07Jan2021 second dose at single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included lisinopril for blood pressure. The patient stated that she took her second dose on 07Jan2021 afternoon and today 08Jan2021 the patient feel really cough "ing" (not clarified), light headache, dizzy. I am having fever "99.4" (not clarified). The patient asked are not they not safe to take Tylenol, is it okay to take Motrin or just have to be Tylenol (treatment)." It was clarified that patient experienced Dizziness, headache, fever, a low grade fever and little Nauseous. Just my whole body aches completely aches my whole body like I have the flu." The patient was treated with Tylenol for the events. The outcome of the events was unknown.
61 2021-01-18 excessive sleepiness Pfizer-biotech COVID-19 Vaccine EAU Expected extreme sleepiness, could only stay awake for 20 minute... Read more
Pfizer-biotech COVID-19 Vaccine EAU Expected extreme sleepiness, could only stay awake for 20 minutes at a time for next 24 hours. O2 saturation went down as low as 91 but mostly was at 93, heart rate 112 on Jan 13, along with a 100.1 oral temp. I did not Check on Jan 12. Morning of Jan 14: 99 oral temp and 95 O2 saturation. By evening temp and O2 were back to normal: 98° and 98%. Jan 17 I experienced some wheezing. I did have COVID with pneumonia Sept 2020.
61 2021-01-18 loss of personal independence in daily activities Doesn't feel like eating; Fever; Chills/ Chilled; Nausea; Severe Headache/Dull headache/Frontal head... Read more
Doesn't feel like eating; Fever; Chills/ Chilled; Nausea; Severe Headache/Dull headache/Frontal headache; Fatigue; Body aches; This is a spontaneous report from a contactable Nurse (patient). This 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1686), via intramuscular, on 06Jan2021 (at 14:30) at single dose at left deltoid for COVID-19 immunisation, administered at hospital. Age at vaccination is 61-year-old. Historical vaccine included Diphtheria and Tetanus vaccine (intramuscular, at single dose) on 15Dec2020 for immunization; and Shingles vaccine (intramuscular, at single dose) on 15Dec2020 for varicella immunization. Relevant medical history included usual tenderness. No relevant concomitant medications were provided. On 07Jan2021, she woke up at 2:00 in the morning, she had a high temperature, she was chilled, she had a severe headache, nausea, fatigue, and body aches. She got up and took ibuprofen (ADVIL). She was basically in bed, she had to cancel all her appointments in the morning, she just laid in bed and the following afternoon her fever broke at about 4:30 in the afternoon then she just had a low grade temperature and a dull headache, nausea through the next day, Friday the 08Jan2021. She still has a very dull headache and just not right, kind of like a flu bug. She had no fever; she had not had any fever after Friday afternoon or Saturday. Fever started at 2 in the morning 07Jan2021 and she experienced the chills until after fever broke. Fever went above 102 degrees. She still had a little of the nausea, she just didn't feel like eating. She still had the dull headache. The nausea and headache have improved when compared to how it was on the 07Jan2021. She was back to work now she just has a dull frontal headache. The reporting nurse assessed all the events, except of 'Doesn't feel like eating', serious for disability. She stated she may have had usual tenderness but nothing like this. The patient had recovered from the event fever on 08Jan2021 and from the event 'chills/chilled' on 07Jan2021; the patient was recovering from 'nausea' and 'severe Headache/Dull headache/Frontal headache', while the outcome of the remaining events was unknown.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events cannot be excluded due to temporal relationship. It is worth noting that patient had other vaccines not far ago, including Diphtheria and Tetanus vaccine and Shingles vaccine on 15Dec2020 for immunization. The case will be reassessed should additional information become 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.
61 2021-01-19 feeling abnormal, anxiety I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a wa... Read more
I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a warm sensation after the vaccine in my deltoid muscle then felt it go up both my ears, around my head. I then felt the same warm sensation in my abdomen, followed by buzzing of my entire body with light headedness. I could breath, I could talk, but I had an urgency for others around me to know that I wasn?t feeling well and something was not right. I asked my colleagues if someone could take me to the ER for monitoring. They immediately put me in a recliner and elevated my legs. This did not relieve my symptoms and asked to go to the ER. I got to the ER and laid on the stretcher with continued increased buzzing sensation especially in my finger tips and arms. My vital signs were 148/88 and HR 88 (elevated from my normal of 100-120/60-70, HR 60s). The buzzing turned into a sensation in my arms that rumbled erratically. I thought something bad was about to happen and that my blood cells would burst. Then I also felt icy cold in my arms and my gut. Next what happened were teeth chattering shivers. All these symptoms occurred in a matter of minutes. They started an IV, drew blood, gave me Benadryl and ran IV fluids. My vitals did not reflect what I felt inside, but as symptoms let up, my VS returned to normal. As quickly as the symptoms started, they eventually calmed down and I was able to leave the ER in 1.5 hours to go home. I was very scared. The ER doctor thought I had a hyperimmune response to the vaccine.
61 2021-01-19 feeling abnormal Joint pain (all joints felt like they were on fire - different than usual arthritis pain - could bar... Read more
Joint pain (all joints felt like they were on fire - different than usual arthritis pain - could barely walk or hold a cup of water due to pain), significant fatigue (barely able to get out of bed) recurrence, brain fog recurrence, headache , muscle pain, I felt almost like I did when I had COVID - starting to subside now 4 days after vaccination
61 2021-01-20 feeling abnormal felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fati... Read more
felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL0140 and Expiration Date: 31Mar2021), via an unspecified route of administration in the right deltoid on 27Dec2020 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included progesterone (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), testosterone (MANUFACTURER UNKNOWN); all taken for hormonal treatment from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: some extreme fatigue (non-serious) on 27Dec2020 with outcome of unknown, nausea (non-serious) on 31Dec2020 with outcome of unknown, dizziness/lightheaded (non-serious) on 31Dec2020 with outcome of unknown, vertigo (non-serious) on 31Dec2020 with outcome of unknown, felt very uncomfortable (non-serious) on an unspecified date with outcome of unknown, mental fogginess (non-serious) on an unspecified date with outcome of not recovered. The patient stated she wanted to report her experience with the first dose of the Pfizer Vaccine (COVID Vaccine), which was received on 27Dec2020. The patient stated she experienced some extreme fatigue starting that first day and then about four days later on 31Dec (not clarified), she experienced some nausea, some dizziness that advanced to vertigo and that occurred late at night; at the time she was getting ready for bed time around 22:00, but it just lasted for about one hour. The patient "went to bed just thinking about and staying in bed and then I felt very uncomfortable and I got up and then I went back to bed about at 01:30, that's how I just fell asleep." Then the next day, the patient was not feeling the vertigo, however, she was feeling lightheaded for about two days and then the fatigue continued to 08Jan (not clarified). Then starting on a Saturday, the patient "felt normal myself energetic and positive." The patient was still feeling mental fogginess, " I was getting here." The patient stated that dizziness and vertigo, or the mental fogginess were not listed on her list of possible side effects. The patient even asked her doctor what it would be, and the patient let her know that she received the vaccines. The events did not require any emergency room or physician office visits. The causality assessment from the reporting patient was reported as: "Yes, I believe it did."
61 2021-01-20 loss of personal independence in daily activities The first thing I had nausea and stomach pain (for 2 days) in the AM and then it went to achy, joint... Read more
The first thing I had nausea and stomach pain (for 2 days) in the AM and then it went to achy, joint hurting and headache. It was not like I could not work or anything, it was just there. On the 9th day I woke up with fever and chills and a super bad headache and I felt so bad I could not even go seek medical care, I finally went after 3 or 4 days feeling like that. At the walk in clinic they tested me for flu, covid and strep and on the rapid the result was negative but when done the PCR it came back positive (around 12/29/20). I did not have any respiratory issues on this one. I do remember having diarrhea.
61 2021-01-21 impaired work ability STarted having nausea around 10am on 1/21/21, then at noon started having chest pain and a migraine.... Read more
STarted having nausea around 10am on 1/21/21, then at noon started having chest pain and a migraine. Went home early from work. As of 1/22/21 0830, still has chest pain but not as intense and it radiates to left shoulder and towards back (advised employee to have this evaluated)
61 2021-01-21 nervousness, impaired work ability I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs fe... Read more
I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs feeling weak and wobbly. Could not perform my work duties. Progressed to Rigors. Lasted at least 3 hrs in it's severest form. Now, 24 hrs later I still have some hand tremors, and legs are weak. Shoulder, knees, hips achy. I'm very fatigued. Right arm soreness @ injection site. All events were reported. I was sent home from work, had to be driven home. I rested, slept and hydrated the remainder of the day. Did not go to work today.
61 2021-01-23 sleep disorder Severe base of neck and frontal head pain. Unable to sleep. Lasted x 2 days; 01-18 & 01-19-21.
61 2021-01-24 anxiety, disorientation Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfor... Read more
Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfort, disoriented, feeling a sense of impending doom.
61 2021-01-24 feeling abnormal Left fingers tingling 10 minutes post vaccine. Next day felt it spread to whole left side and left... Read more
Left fingers tingling 10 minutes post vaccine. Next day felt it spread to whole left side and left eye felt "weird." Took Advil, got better after no difference with Tylenol. Then stopped the Advil and symptoms persisted. Then had tingling of head and neck. Saw her physician and Carotid flow study was normal. Waiting for MRI approval. Has been working with the symptoms.
61 2021-01-26 feeling abnormal, insomnia Headache 1st day Day 2/3 severe body aches, muscle and joint pain, fatigue, brain fog, insomnia
61 2021-01-26 feeling abnormal After first dose I felt an overall odd feeling . no shortness of breath etc, just odd. I was ... Read more
After first dose I felt an overall odd feeling . no shortness of breath etc, just odd. I was thinking it may have been just some anxiety. I left the center after 15 minutes and came back to Pediatric office where I work. I did take a Zyrtec and felt completely better after approx. an hour. After the 2nd dose I did mention I had felt odd after 1st dose and decided to sit for 30 min. I felt about the same as I did after the 1st dose so I left. when I got to my car my face was flushed. I was not tachycardia just a very odd felling in my head and then my tongue did start to itch (or feel funny) . I took a Zyrtec and went home. I never had any swelling of lips or tongue, no trouble breathing. Pulse stayed constant around 80. This time the symptoms lasted approx. 4 hours. I I did continue to take Zyrtec for 3 days after injection.
61 2021-01-26 impaired work ability, insomnia Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, sl... Read more
Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, slight left arm ache, loss of appetite, insomnia, body/joint aches. I took a couple of Aleve tabs 24 hours after the vaccine and then switched to 500 mg Tylenol 30 hours after the vaccine, with no relief of symptoms from either meds. I've been sleeping (taking 2 hour naps) and called off of work (I work in home health). Today, 1.27.21 I feel better, still having 'hot flashes' and some chills (again, without fever). I feel tired, slept last night for 12 hours (no further insomnia). I am eating, but really have no appetite.
61 2021-01-26 loss of personal independence in daily activities, impaired work ability unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffnes... Read more
unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffness and pain; neck and leg muscle stiffness and pain; difficulty ambulating; neck and leg muscle stiffness and pain; fatigue; body aches; chills; sweats; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 18Dec2020 at single dose for COVID-19 immunization. No medical history. The patient's concomitant medications were not reported. Patient had been otherwise well prior to receiving the bnt162b2 on 18Dec2020. Within 72 hours, she experienced fatigue, body aches, chills and sweats since 21Dec2020, though she was able to work Xmas week. On 31Dec2020, she contacted her PCP to report neck and leg muscle stiffness and pain, difficulty ambulating, fatigue, chills and sweats. She had a negative COVID test on 02Jan2021 and essentially negative blood work, other than an ESR of 124 mm/hr and CRP of 4 mg/dl. I had a negative PET scan on 12Jan2021. Currently, she had pain/stiffness in her neck and legs, and progressive difficulty w/ ambulation (both of which are worst in the early hours of the AM), and difficulty with ADLs since 31Dec2020. She had been unable to work since 03Jan2021. Her physician had not indicated or endorsed any relationship between her symptoms and the vax. She forewent dose 2 out of an abundance of caution. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The events muscle stiffness , neck pain and gait disturbance appeared 13 days after administration of single dose BNT162B2. The Company considers that the events are less likely related to suspect BNT162B2 injection given the weak time association. The detailed clinical course and cause of the events would be helpful for further assessment. 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.
61 2021-01-27 anxiety Increased HR, Weakness, Throat Irritation, Diaphoresis. Patient was asked to sit in observation for... Read more
Increased HR, Weakness, Throat Irritation, Diaphoresis. Patient was asked to sit in observation for 30 min. Hx of allergies. Very anxious, anxiety causing increased HR and Sweating. throat itching/tightness. Legs elevated, 50 mg of Benadryl given.
61 2021-01-29 impaired work ability alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves ... Read more
alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves over the next week. Also fatique,, muscle and joint pain. for 6 days also had sever headace, numbness in face and lips, spasm of left eyebrow. Mised wek of work, ended up in Emergency room. Had negative covid test. sent home. Was fatiques and dizzy and brain fog for next three weeks. Took a month to feel rigtht.
61 2021-01-30 feeling abnormal, sleep disorder 12 hr after vaccine, sore arm, a little achy. 15 hrs after vaccine (11 pm) and through the night, fe... Read more
12 hr after vaccine, sore arm, a little achy. 15 hrs after vaccine (11 pm) and through the night, felt very cold and had difficulty getting warm, headache, all body achy, unable to get into any comfortable position and very limited sleep. By 24 hr after vaccine and continuing until 40 hr after, nausea most of day, severe muscle pains, headache, difficulty moving from pain and general weakness, head swimming sensation. felt like skin crawling sensation all over. By 48 hrs, much less headache and nausea, able to eat, still had skin crawling sensation and achy but able to walk around a bit, not able to go outside. By 58 hr after (at time of report), just weak all over feeling, head fuzzy but better. Treatment: ondansetron x 2 doses (at 24 hr and 20 hr), Nurtec x 2 doses at 15 hr and 20 hr), Acetaminophen 8 hr x 2 doses (at 36 hr and 48 hrs)
61 2021-01-31 insomnia, impaired work ability (This is a duplicate entry. I mistakenly entered that patient received the Moderna vaccine, but she ... Read more
(This is a duplicate entry. I mistakenly entered that patient received the Moderna vaccine, but she in fact received the Pfizer.) I got the 2nd dose of the Pfizer vaccine late last Wednesday afternoon (1/20). Before the 2nd dose, I premedicated (as instructed by my medical office) with Benadryl 50mg and Pepcid 20mg (for the histamine blocking effect) since I had terrible itching for about 36 hrs after the 1st dose; but the itching didn't begin-after the 1st dose-until about 8hrs after the shot & became intense 2 more hrs later. I had itching the night of the 2nd dose that kept me awake part of the night but was FAR less intense than after the 1st dose. I came to work Thurs not feeling ill--just cold and tired all day (I attributed to the cold weather and not sleeping well). Thurs about noon I began feeling ill--like I was coming down with the flu; I went home after my shift and found my temp to be 100.4. Shortly thereafter it was 100.9. I thought it would pass by morning so I just showered, drank fluids, took Tylenol and slept. By 0200ish Fri 1/22 I still had a fever of 100.9 (even with Tylenol on board), a bad headache, sinus congestion, and significant neck and back pain so I called out for work. I continued to treat the fever and by noon Fri the fever finally had resolved-along with the head, neck and back pain. I've been fine since.
61 2021-01-31 loss of personal independence in daily activities Severe sudden diarrhea, headache, weakness, taste of smoke with burning sensation. Today unable to... Read more
Severe sudden diarrhea, headache, weakness, taste of smoke with burning sensation. Today unable to do anything, very tired.
61 2021-02-04 thinking abnormal, nervousness, anxiety feeling tired but also edgy; edgy/ nervous; anxious; unable to focus; headaches; blood pressure was ... Read more
feeling tired but also edgy; edgy/ nervous; anxious; unable to focus; headaches; blood pressure was much higher than normal; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284) via an unspecified route of administration on the left arm on 11Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included hypothyroidism and back pain. Concomitant medication included levothyroxine sodium (SYNTHROID), ibuprofen and ergocalciferol (VIT D). The patient previously received 1st dose of BNT162B2 on 20Dec2020 for COVID-19 immunization (left arm, lot number: EH9899). After receiving second dose on 11Jan2021 the patient was feeling tired but also edgy, nervous, anxious, unable to focus, some headaches. Discovered 18Jan2021 that blood pressure was much higher than normal and associated with the way I was feeling. Had to go to primary care to have medication prescribed. The events resulted to a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. Patient was not pregnant. No known allergies. The facility where the vaccine was administered was in a workplace clinic. 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. Post vaccination, the patient has been tested for COVID-19 (Nasal swab), on 13Jan2021 and 16Jan2021 both test results were negative. Outcome of the events was not recovered.
61 2021-02-06 feeling abnormal I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty ba... Read more
I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty bad symptoms on first dose by all info i have found. The actual shot was given by another facility than listed previously. I recieved the first dose of Pfizer at Health Dept . No other location information was provided by them. When i got the shot, a blood vein and possibly a nerve was hit. The nurse did everything properly i think to correct and notify other RN. It caused immediate pain in left fingers and arm felt heavy. That continued for days, but not too bad and injection site itself really was not very sore. My concern was how sick I felt starting within 6 hours of the injection and how long it lasted. I had pretty much instant nausea- no vomiting- mild but persistant, severe fatigue and general overall uneasy/sick feeling. Joint pain started within the 6 hours, along with a few odd pains in neck and right abdomen. Was extremely chilled for hours, pretty bad tension /tight feeling headache, jittery feeling and foggy. I took a 500mg Tylenol about 8 hours after the shot, and it helped to relieve most symptoms to a degree that was nagging, but tolerable. I pretty much went through this for about the next 3 days and off/on to the 5th day
61 2021-02-07 nervousness facial flushing for 1 hour after shot. Redness on nose and cheeks for about an hour. No hives, no it... Read more
facial flushing for 1 hour after shot. Redness on nose and cheeks for about an hour. No hives, no itching. Didn't notice until I left the vaccine site and was on the way home in car because covered by mask. Note I am a very fair skin, freckled red haired woman. I was very, very nervous and had gotten myself to the point of tears. Perhaps the flushing was from that. Have had similar flushing when drinking red wine. Swelling in lymph node in supraclavicular area on same side as shot. Has happened with Flu shot once. Slight fever for a short period of time and fatigue. I continue to have slight shortness of breath from having covid on. 4/3/20. Nothing different.
61 2021-02-08 anxiety Rapid heart beat, high blood pressure, sinuses blocked, and anxiety.
61 2021-02-08 anxiety Patient described having a "mild reaction" to first dose Pfizer BioNTech vaccine, and pre-mediated w... Read more
Patient described having a "mild reaction" to first dose Pfizer BioNTech vaccine, and pre-mediated with 50 mg diphenhydramine as well as her morning cetirizine 10 mg before the second dose. Approximately 10 minutes s/p second dose the patient experienced dizziness, facial tingling, anxiety, hard and soft palate numbness, and flushing. She was helped to a stretcher and her BP was 204/94. The patient was taken to the ED for further monitoring. In the ED, she denied any throat swelling, tongue swelling, or difficulty breathing on arrival. She also denied any chest pain and palpitations. She received methylprednisolone 125 mg IV x 1 and a liter of normal saline, underwent observation, then discharged home uneventfully.
61 2021-02-09 disorientation, confusional state 30 minutes after injection: severe headache, general feeling of illness. Following day in the mornin... Read more
30 minutes after injection: severe headache, general feeling of illness. Following day in the morning, headache, left arm in extreme pain, facial numbness, disorientation, inability to talk, confusion, difficulty breathing
61 2021-02-09 feeling abnormal Headache; cramps; Woke up feeling terrible; Over all body ache; Like no energy; This is a spontaneou... Read more
Headache; cramps; Woke up feeling terrible; Over all body ache; Like no energy; This is a spontaneous report from contactable Pharmacist (patient). A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)Lot number EL1284, expiration date 30Apr2021, Intramuscular on 13Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient previously received first dose of BNT162B2 on unknown date. The patient received her second dose of the Pfizer vaccine a week ago on Wednesday, '2 days ago' (not clarified), so it's 9 days ago and she was wondering if she could still have, she felt fine for over a week and then yesterday (22Jan2021) she woke up feeling terrible, just over all body ache, 'cramps' (voice feeble not clarified further) like no energy and she was wondering that. She was getting a headache now from this conversation. She did take Acetaminophen yesterday and she was ready to take it now, that's a bad headache. The outcome of all events was unknown.
61 2021-02-11 feeling abnormal pt stated about 10 minutes after rcvg vax she started feeling funny, warm and her heart was racing. ... Read more
pt stated about 10 minutes after rcvg vax she started feeling funny, warm and her heart was racing. She was checked out by the attending nurse at the vaccine facility. Her pulse was 120 and BP was 189/89. Pt drank a bottle of water while her pulse came down. About 5 minutes later her heart was racing again and BP back up. She was monitored for additional 15 minutes. During this time she had another episode with the same symptoms so she was rushed to the ER. Her heart rate was 110 and blood pressure still 189/? She was monitored for about an hour and 20 minutes. Pt was released from ER about and 1 1/2 ago and has not had another episode so far. She was told to FU w/ PCP in 2-3 days.
61 2021-02-11 feeling abnormal AT 3:41PM PATIENT TONGUE FEELS "OFF", HAS HAD FEELING FOR 10 MINUTES BEFORE REPORTING. PATIENT REPOR... Read more
AT 3:41PM PATIENT TONGUE FEELS "OFF", HAS HAD FEELING FOR 10 MINUTES BEFORE REPORTING. PATIENT REPORTS FEELING SMALL AMOUNT OF DRAINAGE IN THROAT. ADMINISTERED 50MG OF DYPHENHYDRAMINE, IM, RO AT 3:43PM. PATIENT MONITERED VITALS EVERY 5 MINUTES. AFTER MEDICATION PATIENT REPORTS FEELING DIZZY AND "LOOPY" AT 5:17PM PATIENT COMPLAINS OF TONGUE SWELLING AND BLOOD PRESSURE ELEVATED. EMS CALLED, ARRIVED AT 5:34PM, PT TRANSPORTED TO NORTHSIDE HOSPITAL. FOLLOW UP CALL, NEXT DAY PATIENT STATES SHE WAS GIVEN STEROIDS IN THE ER AND PRESCRIBED AN EPI PEN FOR FUTURE USE.
61 2021-02-14 abnormal dreams, crying I am a teacher, so thankful to have received my vaccines. 40 years ago, as a young teacher I had a ... Read more
I am a teacher, so thankful to have received my vaccines. 40 years ago, as a young teacher I had a bad reaction to a flu shot and I have never had another one. I didn't think this vaccine would be similar. I am not someone who gets very sick often and I don't miss days of teaching for illness. Note that my first vaccine on 1/21 had no effects. I did not even get a sore arm. I even sort of bragged about it. The 2nd vaccine on 2/11 seemed fine until I woke up the following morning feeling like I had been hit by a truck. I yawned for 3 hours straight, but still made it to school and worked and taught 6 online classes. I took an ibuprofen that morning because I was feeling so odd. By 3:00 I was driving home (40 minute drive) and I cried uncontrollably the whole way home while my hands and feet were shaking. Not normal for me. When home I went almost immediately to bed. I had a slight temperature and was dizzy. I thought I had the chills but it didn't feel like any chills I have had before. Usually my teeth would chatter and I would feel hot and cold at the same time. The hottest temperature I had was 100.5. But by 9 I started shaking so profusely that I couldn't pick up the thermometer any more, I couldn't use my phone, or take a sip of water. I stumbled to the bathroom holding onto things all the way. My husband was not home, or I imagine he would have called 911 at that point. I kept shaking a lot through the night and kept praying that it wouldn't happen to my heart. I fell asleep eventually and dreamed of fish flopping inside me and my neighbors coming over to to see why the bed was knocking against the wall. Saturday morning I woke up and all the shaking had stopped, but I found I was too weak to get up much. Today is Monday and I mostly feel normal, except a little dizzy when I move and the top of my head is tender to the touch.
61 2021-02-14 feeling abnormal After patient received first dose of Covid vaccine patient experienced a reaction as described "feel... Read more
After patient received first dose of Covid vaccine patient experienced a reaction as described "feel fuzzy" and lack of self awareness five minutes after dose. That evening patient contacted her primary care provider and has not spoken until then. Patient still complains of not feeling herself and currently has not received her second dose and is worried of lack of self awareness.
61 2021-02-18 feeling abnormal Around 1 am on 1/29/2021, hot flashes, fever 99, & a little bit nauseas this lasted 48hrs. My legs f... Read more
Around 1 am on 1/29/2021, hot flashes, fever 99, & a little bit nauseas this lasted 48hrs. My legs felt weak & shaky legs and fuzzy head. I feel with no energy. This symptoms are still going on.
61 2021-02-18 feeling abnormal Around 2am on 1/8/2021 I woke up having chills, nauseas, fever, dizzy felt like I was going to faint... Read more
Around 2am on 1/8/2021 I woke up having chills, nauseas, fever, dizzy felt like I was going to faint, foggy head, very fatigue, shaky weak legs & body aches. The chills, body aches, fevers & dizziness were under 48hrs. The other symptoms lasted till 2 days before I got my second dose. Tight Chest going on but I think it might of been anxiety. Phone consult with doctor and prescribe some steroids.
61 2021-02-23 confusional state, amnesia I don't want to file two reports. I had an episode of feeling very dizzy and when I laid down for an... Read more
I don't want to file two reports. I had an episode of feeling very dizzy and when I laid down for an hour and I got up I couldn't remember names of anyone, went to hospital to rule out stroke. EEG and double echo both normal. MRA and MRI, no evidence of stroke, transient global amnesia, it took a couple hours for me to get back to normal. I also had a shingles outbreak 10 days post both vaccines.
61 2021-02-27 feeling abnormal Pain at the injection site was typical for vaccination and was essentially gone by the next day. Hea... Read more
Pain at the injection site was typical for vaccination and was essentially gone by the next day. Headache started within one hour after vaccination and was severe 4 hours after vaccination. Next day morning I woke up with all my face swollen, runny nose, headache, stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year and dizziness. Face edema and runny nose subsided 3 days after injection. Stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year persists 7 days after injection. Dizziness and foggy head became worth 7 days after injection.
61 2021-03-02 feeling abnormal, insomnia rash on neck; felt a little off, it could have been in her head or maybe was paranoid, but wasn't go... Read more
rash on neck; felt a little off, it could have been in her head or maybe was paranoid, but wasn't going to wait for the reaction to be full blown over her body and took one Hydroxyzine HCL; developed a bad rash, hives, all over her body; developed a bad rash, hives, all over her body; itching; a few bumps kept increasing up to 3 days later; her feet were incredibly hot over the next 3 days; arm soreness; She was unable to sleep from being so itchy; Allergic reaction; This is a spontaneous report from a contactable consumer herself. A 61-year-old female patient received bnt162b2 (, Solution for injection, Batch/lot no: EN5318), via an unspecified route of administration on 04Feb2021 15:00 in the left arm at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously did get a flu shot in Nov or Dec2020. The patient developed a bad rash, hives, all over her body and itching on 10Feb2021. She reports, her feet were incredibly hot over the next 3 days on 07Feb2021. What started off as a few bumps kept increasing up to 3 days later. She was unable to sleep from being so itchy. Her doctor said it was an allergic reaction and prescribed an antihistamine after which it left in Feb2021. She was due for the 2nd dose of the vaccine on 25Feb2021. The patient did not had any investigation assessment. The patient states that there was little information out there to compare the experience she had. Wanted to call to make Pfizer aware of that and maybe get some more information out there. Has printed out the fact sheet and assumes she should not get the second vaccine because of what happened the first time. Wants to clarify what happened and share with Pfizer this information since she can't find much information for people who have had a delayed reaction. Went to get the vaccine on 04Feb and doesn't consider herself an allergic type person. Has no allergy to foods, medicines, only gets poison ivy and bug bites like most people. By Monday, the 4th day (08Feb2021) after getting the vaccine, noticed a couple of bumps on the wrist and does not know where else and didn't think of it as anything else. Thought it was a bite or she touched a plant and then it went away. It was not much. In the evening of Tuesday she had a bad reaction and on the 10th (10Feb2021) she had rash, hives, and itching that just moved to different places over the body. Her feet were so hot on the 3rd day and had to plunged them into cold water and used Epsom salt off and on and it helped some. This happened only for 2 nights and the reason she didn't go to the doctor, it went away. Again, mentions the first night she had a couple bumps and didn't think much about it. The second night, it was all over her body, the rash, and she took Epsom baths that helped, but she didn't get much more than an hour of sleep. She tried to take pictures of her thighs and backside, but unable to take good pictures, not a selfie person. The next morning she had her husband take pictures in case it went away and she went to the doctor they would have pictures to show. Her husband thought it may be shingles. Called the doctor on Thursday and had pictures to show her since the rash went away. Again, mentions the reaction was so bad on Wednesday. The doctor didn't believe areas on pictures of her back were shingles since shingles does not come and go away like that and that she must have had an allergic reaction to something. Provider didn't believe it was from the vaccine. Was given a prescription for Hydroxyzine HCL 25mg and was informed if areas didn't improve or returned she may need to see an allergist or immunologist. After the appointment she didn't get much sleep and woke up at 4pm in the afternoon and felt a little off, it could have been in her head or maybe she was paranoid, but she wasn't going to wait for the reaction to be full blown over her body and took one Hydroxyzine HCL and went to bed at 7:30pm and didn't do anything since. Got up and the reaction/rash, hives, itching was all gone after taking only one. It's like an antihistamine or Zyrtec. No further details provided. Later mentions after getting the first vaccine on the 4th, the next day she had arm soreness up until that Monday when the rash started. No further details provided. Says as far as recommendations were concerned for the paper she printed, the fact sheet. It says pretty much listed, she shouldn't have the second dose if difficulty breathing, swelling in the face and throat. The only thing she had was the rash on the neck, not the face. Paperwork also lists heart beating fast, or severe allergic reaction. The patient had no emergency room visit. The patient visited the physician office. The outcome of the event hot feeling in feet was recovered on feb2021 and rest of the events was recovering.
61 2021-03-04 amnesia, confusional state Slurred Speech, fever, aches, feet and hand swelling, confusion, headache, memory loss - mostly reso... Read more
Slurred Speech, fever, aches, feet and hand swelling, confusion, headache, memory loss - mostly resolved some memory issues and headache still 2 days later
61 2021-03-04 feeling abnormal still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 wen... Read more
still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 went to get covid test but due to blood in my nose received antibody test which was neg; bad headache; winded; vomited; diaherra; coughing/cough; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; This is a spontaneous report from a contactable other hcp (patient). A 61-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiry date not reported), via an unspecified route of administration on the left arm on 20Jan2021 18:45 at single dose for COVID-19 immunization. Medical history included diabetes mellitus and high BP from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, losartan potassium and sodium fluoride (CREST CAVITY PROTECTION). The patient previously took septra and experienced allergies. The patient reported that on 21Jan2021, they woke up and brushed their teeth then at 6:40am blood with large clots gushed from their right (rt) nostril. The patient went to ER and stopped bleeding after 2 hrs. On 22Jan2021, the patient woke up with bad headache, winded, vomited, diaherra (as reported), coughing. On 23Jan2021, they went to get covid test but due to blood in their nose, they received antibody test which was negative. On 24Jan2021, the patient was still feeling bad with all the above symptoms. Then on 25Jan2021, they went to ENT doctor who cauterized their nose and stated that since antibody was negative to take the maderna vaccine since they have no antibody in their system, the Pfizer vaccine did not work. From 26Jan2021 to 13Feb2021, the patient felt same started feeling better 14Feb2021 but still have sore muscles in their shoulders and cough. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 23Jan2021. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of epistaxis and clot blood which include the doctor cauterized their nose. The patient recovered with sequel from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the epistaxis 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 CBC and coagulation 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.
61 2021-03-06 impaired work ability, disturbance in attention, confusional state On day 2, I developed confusion and could not focus making it impossible for me to complete my work ... Read more
On day 2, I developed confusion and could not focus making it impossible for me to complete my work at my job. The confusion made driving dangerous. By Friday, I went to my PCP and they noticed that my blood pressure was only 90/58 and they were concerned so she told me that she was calling my cardiologist who said to reduce the dose of my Diltiazem from 180 mg daily to 120 mg daily. She also said to take a few days off of taking the Diltiazem. I have also had a serious increase in Tachycardia. That evening I went to the ED because I was so weak and couldn't breath well. I am also retaining a lot of fluid. The lab work indicated an elevated Pro-B-Natriuretic Peptide level of 227. I am still not well and each doctor I have spoken to said they believe it is due to the vaccine. I do not know if I should take the second dose.
61 2021-03-06 loss of personal independence in daily activities With in an hr. my left thigh muscle hurt and my left knee was starting to stiffen up. In 2 hrs., var... Read more
With in an hr. my left thigh muscle hurt and my left knee was starting to stiffen up. In 2 hrs., varicose vein in left thigh was extremely throbbing, I could barely walk on stiff knee. I had a trouble night of pain on Sunday 2-28, Monday , I could barely walk on left leg & still had thigh pain, I almost fell down stairs 2x from leg buckling, I did fall down in the kitchen and the fam. room from knee buckling, not supporting my body. I used heat, ice, rest, ibupfen, advil, tynelol, ben-gay, icyhot, CBD cream. I used it all. Today is one week and the thigh pain is gone but knee is still stiff. It no longer buckles, but I still can not fully walk. I am using a cane. I have been working from home all week, but can not cook for myself. I have to sit in a chair in the shower. I did contact my Dr., who said keep doing everything I am doing, that as long as it getting better every day. I am afraid to take 2nd dose.
61 2021-03-10 anxiety Patient received first Pfizer COVID vaccine and in observation area started complaining of scratchy ... Read more
Patient received first Pfizer COVID vaccine and in observation area started complaining of scratchy throat. Exam was normal. Calm patient, clear lungs, strong pulse. No rash. Gave positive answers to all questions, such as do you itch 'a little,' do you have trouble breathing 'a little.' I suspect anxiety. Given Benadryl and continued monitoring. All symptoms resolved. Observed total of 45 minutes and discharged home. Ok for next vaccine.
61 2021-03-10 sleep disorder, hallucination, crying I had hallucinations. I thought it was vivid dreams but I could not wake myself. I even went to bath... Read more
I had hallucinations. I thought it was vivid dreams but I could not wake myself. I even went to bathroom three times during the night and could not stop them while getting up and walking to bathroom. I would sit up in bed and even get out of bed but they would not stop. I?ve never had this happen ever in my life. I was crying out and sweating. I have also had severe fatigue, even much more than what I experience with CFS.
61 2021-03-11 confusional state Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
61 2021-03-11 euphoric mood Pt. c/o "feeling high" like she had some drink. She felt light headed. Denies SOB denies chest pain... Read more
Pt. c/o "feeling high" like she had some drink. She felt light headed. Denies SOB denies chest pain. @ 1040 BP 160/100, HR 84, RR 18. @ 11:49 BP 160/82. @ 1050 BP 160/90, HR 80, RR 18, no dizziness, Ox.Sat 97%, 160/82. Stated she is fine and wants to go home.
61 2021-03-11 excessive sleepiness Monday 3/08/21 after work, I was very tired and achy. I went to bed and slept 10 hours. When I eat I... Read more
Monday 3/08/21 after work, I was very tired and achy. I went to bed and slept 10 hours. When I eat I had diarrhea. On Tuesday, no appetite. Ate very little - crackers, and some chicken noodle soup. I had headache and chills on Tuesday evening, Wednesday and Thursday. I didn't feel well at all. Lightheaded Thursday morning, another diarrhea after a small breakfast. Called my doctor, suggested a covid test. Had a rapid covid test. It was negative. Teleconference call with my doctor on Thursday at 3pm. Nose bleed Friday morning 11:00am.
61 2021-03-13 excessive sleepiness Everyday since vaccination fever of 99.5 (no higher ), chills, headache, extreme tiredness (sleeping... Read more
Everyday since vaccination fever of 99.5 (no higher ), chills, headache, extreme tiredness (sleeping 15-18 hours per day)
61 2021-03-14 sensation of foreign body, emotional distress Constriction of throat followed by heaviness in chest, followed by a headache. Had distress but was ... Read more
Constriction of throat followed by heaviness in chest, followed by a headache. Had distress but was afraid to say something. hands tingling fingers both hands. NOT hyperventilating. Oriented but sluggish to respond to questions. initially elevated bp then hypotensive. after leaving vaccine clinic throat felt like a golf ball and went to ER to seek treatment. DX- allergic reaction and given IV Benadryl, Pepcid and solumedrol.
61 2021-03-15 anxiety 3-10-21 7:15PM PT 'FEELING ANXIOUS, NUMB, DIZZY - IS DIETING AND IS TAKING ADIPEX. ONLY ATE TOAST TO... Read more
3-10-21 7:15PM PT 'FEELING ANXIOUS, NUMB, DIZZY - IS DIETING AND IS TAKING ADIPEX. ONLY ATE TOAST TODAY AND 2 BITES OF CANDIES'. GIVEN JUICE AND CRACKERS. 7:25PM 'FEELS BETTER'. AMBULATORY TO EXIT WITHOUT DISTRESS. 3-11-21 9:30AM PT STATES 'FEELS 100% BETTER NOW'.
61 2021-03-15 insomnia Bi-lateral breast pain. I have not had much breast pain with my fibrocystic disease as I have gotten... Read more
Bi-lateral breast pain. I have not had much breast pain with my fibrocystic disease as I have gotten older but for 6 weeks after the second dose it felt as bad as it ever has. It kept me up at night and I had to take OTC pain relievers.
61 2021-03-16 anxiety, feeling abnormal Within 10 min I started feeling dizzy, kind of loopy. I didn't think anything of it. I Waited 15 mi... Read more
Within 10 min I started feeling dizzy, kind of loopy. I didn't think anything of it. I Waited 15 min, got in my car, and felt the need to defecate. Went back in the store, completed, got in my car to drive home. Started to feel even dizzier but kept driving. Felt like maybe I was having a little bit of a strain swallowing but was breathing fine. I took 2 puffs of my Albuterol. Still felt unnatural and anxious. Got home and started to feel a little better within 15 minutes. The arm is sore, not too much of a bother, body aches. Chills for a few hours. Got up and went about my day. Tired and anxious.
61 2021-03-16 confusional state acute subdural hemorrhage (presented as word finding difficulty and confusion for 2 days per son who... Read more
acute subdural hemorrhage (presented as word finding difficulty and confusion for 2 days per son who convinced his mother to come in to ED)
61 2021-03-17 anxiety anxiety, numbness around mouth but resolved
61 2021-03-17 anxiety anxiety, lightheaded, flushes - resolved; VS 97%, HR 84
61 2021-03-17 insomnia Headache INSOMNIA, INJECTION SITE PAIN Narrative:
61 2021-03-18 feeling abnormal, loss of personal independence in daily activities I had significant chills (causing strong body shaking) starting 3 hours after the shot, followed by ... Read more
I had significant chills (causing strong body shaking) starting 3 hours after the shot, followed by 36 hours of intermittent fever combined with chills, fever was high but not measured. I was very weak and at times was unable to get out of bed or stand. I had significant joint and overall body pain, at times unable to stand up straight. As this subsided about 36 hours I remained quite weak. On the night of 16 March I was woken up at 1 am with a very severe headache. I took Tylenol and 5 hours later still had the headache - it subsided after about 8 hours. I additionally had stomach cramping but no vomiting or diarrhea, and had no bowel movements until the episode cleared up. During the 4 days that this occurred I tried to keep well hydrated but still had quite concentrated strong urine. I took Tylenol periodically throughout the 4 days, not starting until after the injection was administered. I still feel a little loss of balance/brain fog and have recurring headaches (not migranes).
61 2021-03-18 impaired work ability Hot flashes, Injection site pain, body aches Narrative: Patient received first dose on 2/24/21. Pat... Read more
Hot flashes, Injection site pain, body aches Narrative: Patient received first dose on 2/24/21. Patient reports experiencing headache (9/10 pain scale), nausea, hotflashes, injection site pain, and body aches approximately I hour after vaccine. Patient had to use " sick leave" for work.
61 2021-03-20 feeling abnormal Fever as high as 100.7, muscle aches, headache severe, fatigue moderate to severe, Three asthma att... Read more
Fever as high as 100.7, muscle aches, headache severe, fatigue moderate to severe, Three asthma attacks. One was severe taking 2 hours to resolve. Worse on 3/20 than today on 3/21. I?ve taken 2 Tylenol and used my rescue inhaler 4 times. The inhaler improves my breathing, but I don?t feel normal yet. Oxygen saturation between 93-96%. If still experiencing symptoms will call PCP and/or go to urgent care. If I?m still coughing I will have to reschedule a hematologist appointment.
61 2021-03-20 sleep disorder 1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, starte... Read more
1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, started to shiver, jaw rattling, immediately had hot tea and wrapped in blanket. 3. Nosebleed, very unusual for me, 7 am. 4. Nosebleed, severe tinnitus, nausea, had to get out of bed and get to restroom, immediate bowel movement, severe dizziness vertigo getting back to bed. Slight tinnitus day after while writing report. Still have low nausea. 5. Sore arm for 4-5 days.
61 2021-03-21 anxiety Patient DOB 5/16/1959 received 1st dose of Pfizer Lot # ER8730 and was waiting in the 15 minute obse... Read more
Patient DOB 5/16/1959 received 1st dose of Pfizer Lot # ER8730 and was waiting in the 15 minute observation section when she stated that she felt "swelling of her face and tingling of her lips." Blood pressure was 196/98, HR 85, O2 97%, Temp 98.1. Patient was alert and oriented x 4. Patient stated that she was very anxious today and has allergies to dairy and pollen. Patient confirmed that her husband was on the way to pick her up and drive her home. EMT administered 25 mg of Benadryl PO at 12:32 pm. Patient observed for an additional 50 minutes until her husband arrived to pick her up at 1:22 p.m. Patient stated that she was feeling better and was able to walk unassisted with her husband. informed patient to go to ER or call 911 if symptoms worsen.
61 2021-03-21 excessive sleepiness Sore arm at injection site with both shots. With the second shot only: Next day @ Approximately 7:00... Read more
Sore arm at injection site with both shots. With the second shot only: Next day @ Approximately 7:00 am started feeling dizzy. Approximately noon stated feeling chills and general body aches. 6:00 pm took ibuprofen and slept until 6:00 am next day . All symptoms then gone
61 2021-03-21 impaired work ability On 3/19/2021 around 4:00 I started with body aches, headache, fever, and chilling. I continued with... Read more
On 3/19/2021 around 4:00 I started with body aches, headache, fever, and chilling. I continued with that during the night and on 3/20/2021 I still had the body aches and felt weak. On 3/21/2021 I noticed that I had a rash developing in places. On 3/22/2021 I woke at 5:00 a.m. covered with a rash over my entire body that itched. I took Benadryl and that is when I went to the ER.
61 2021-03-22 feeling abnormal Immediately: headache, left eye pain, nausea, cold sensation and felt ?weird? but thought it was nor... Read more
Immediately: headache, left eye pain, nausea, cold sensation and felt ?weird? but thought it was normal and thought I might feel flying for a bit but that it would wear off so I did not report feeling anything at the clinic. I left the clinic and got in the car to drive home and felt a weird feeling in my throat reminiscent of my esophageal spasm and then it felt like someone had their hand on my throat squeezing my throat and felt like I needed to take deep breaths to expand my lungs. Within a minute or two at most, my lips, tip of my tongue, tip of my nose and face beside my lips and under my cheeks started to tingle and go numb. My insides felt swollen. I had a doctors appointment and went there after picking my son up at home. I reported my feeling to my doctor who prescribed a steroid for 3 days and told me to also take Benadryl or Claritin, which I did. However, today is day 4 after my vaccine and today is the first day my insides don?t hurt.
61 2021-03-22 impaired work ability Around 11, 11:30 the pain woke me up because it was so bad. It was hot and there was a big lump unde... Read more
Around 11, 11:30 the pain woke me up because it was so bad. It was hot and there was a big lump under my left arm pit (was very tender). I did not go to sleep like that. I did not have any symptoms by the time I went to bed. I also felt hot, and then cold, then hot, then cold, I would feel too hot and then too cold, freezing, I could not keep my temperature under control. I had to call in at work during the weekend I was feeling so bad. I had a lump under my armpit the size of a fist and I could not close my arm completely. It was huge and painful. I decided to go to a clinic over the weekend (unsure if Saturday or Sunday) to seek medical care and they ran some labs and a CBC to check for infection. All results came well no infection. They suggest to keep taking Tylenol. By Monday or Tuesday I started feeling well enough to return to work. The lump was still present and took about a week to go down. The injection site also was sore for a while, about a week also like the lump.
61 2021-03-23 insomnia I had swollen and very, very painful - the muscle on top of my shoulder (Trapezius) on the right sid... Read more
I had swollen and very, very painful - the muscle on top of my shoulder (Trapezius) on the right side and I took Advil late at night time because it was so painful I couldn't sleep. My arm was not sore but that muscle was. That seemed to calm it down (Advil). The next morning, I was very swollen under my right armpit - I figured it was my lymph node. It was uncomfortable and very noticeable - quite swollen for three days. It took about a week to go back to normal. I also had abnormal fatigue and that took longer to resolve - that took about two weeks to be resolved.
61 2021-03-24 disturbance in attention Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tigh... Read more
Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tightening of chest every so often; acid reflux; hot flashes; sweating; stomach aches; upper abdominal pain radiating to back; severe fatigue; Dizzy/dizziness; stomach feels odd; Headaches; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6198), via an unspecified route of administration, administered in upper left arm on 25Feb2021 9:00 (at the age of 61-year-old) as single dose for virus (COVID-19 immunisation). Medical history included chronic pain, pancreatitis, allergic to medications, old injury in her right arm, menopause and an ongoing mass in parotid lobe discovered in 2019 with CT scan. MRI performed in Mar2020 and CT scan in Oct2020. She stated that they are just watching it because it has not changed. Well defined borders are present, caller stated that doctor was unconcerned. Her mother had heart disease. Ongoing concomitant medications included ibuprofen for chronic pain and gabapentin from 2019 for chronic pain. The patient also took unspecified medication for pancreatitis. She has taken all kinds of stuff after pancreatitis but they do not work. The patient got deadly ill from the flu shot. Unsure of onset age, vaccine/brand name, or vaccination date. She stated that it was before 2003, possibly in the late 1990's or early 2000's. The patient had no history of all previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the Pfizer suspect. On unspecified date the patient experienced diabetes; on 25Feb2021, the patient experienced dizzy, stomach feels odd, hot flashes, severe fatigue, sweating, stomach aches, acid reflux, upper abdominal pain radiating to back; on 26Feb2021 she experienced tightening of chest every so often; and in Feb2021, she had headache. It was further reported as follows: The patient stated that she took the Pfizer shot, clarified that she received the Covid-19 vaccine, on 25Feb2021, not quite 2 weeks ago. She stated that she had a little bit of a reaction after receiving the vaccination while there, so they were monitoring her. She has been experiencing hot flashes, sweating, and stomach aches for 2 days. She cannot get rid of hot flashes and that she has not had a hot flash in 2 years. She states that she has been down for 2 days with fatigue, that it's really bad. She is inquiring if the side effects that she is experiencing are common side effects and if it is ok to get 2nd shot. Her second vaccine is scheduled for 17Mar2021. She stated that she wanted to take the time to make a report as she is allergic to medications. While inquiring about dates of vaccines and side effects, she stated that she was experiencing tightening of chest every so often. She stated that she only had a few days of stomach pain and she has not stopped eating. She is unable to concentrate (unspecified date) and she has been experiencing headaches, experiencing them twice in 2 weeks. She also reported that she has been having upper abdominal pain radiating to her back. This concerns her, every time she gets it, it scares her. She had pancreatitis when she was 36. It is a nightmare thought. Does this sound like maybe she is possibly starting Diabetes? She reported that this shot has triggered everything. She has an old injury in her right arm. Her arm is killing her, her hands are swelled up, she has acid reflux again, she felt terrible. She stated that the dizziness not as strong as it was at the beginning. The fatigue it comes and goes and that she has spurts where she is energetic. She stated that it's more on than off. She is no longer having stomach aches. She compared the pain to pains of constipation. She also stated that she was constipated after receiving the vaccine on unspecified date. She had nausea at the beginning. The tightening of chest happened off and on, the last day that she experienced tightening of chest was on Sunday. For acid reflux, she is taking Zegerid as treatment, 20mg 20 mg capsules by mouth once daily as needed. She started this on 02Mar2021. She experienced upper abdominal pain yesterday and some this morning, but it was mostly in her back this morning. Her Sweating is off and on. She experienced headache just a couple of times but that she has not had one in a while. She stated that they lasted only an hour or two, and that she does not usually get headaches. She suggested that these may be due to sinuses and weather change. She has been taking Ibuprofen twice a day as treatment. But she normally takes Ibuprofen for chronic pain. Supposed to be 3 times a day but she does not want to take that much. She stated that all of this could also be stress related and that this could also be menopause. The patient recovered from stomach aches on 02Mar2021. The outcome of the events dizzy, sweating, tightening of chest every so often, upper abdominal pain radiating to back, headache was recovering; the outcome of stomach feels odd, hot flashes, severe fatigue, acid reflux was not recovered. The outcome of the remaining events was unknown.
61 2021-03-24 loss of personal independence in daily activities, excessive sleepiness Directly after getting the shot I was sleeping harder than I ever have for about 14 days then on Mar... Read more
Directly after getting the shot I was sleeping harder than I ever have for about 14 days then on March 4 woke up after a very deep sleep tired the next day the same thing March 5 woke up extremely fatigued March 6 same thing woke up extremely fatigued and after going for a short bike ride started getting an intense headache, set up got very dizzy, then proceeded to throw up harder than I ever have and so debilitatingly that I had to call the paramedics and they took me to the emergency room. The ER doc at first said that this could not be an adverse effect 14 days later of the first Covid shot, but then he said he didn?t know, for the next nine days I did not leave my house I was so exhausted. I am an athlete and exercise every day have tons of energy all day long and have never felt this way before. I then met with my regular Doctor Who ordered tests of different varieties everything came back normal and to this day which is now March 25 I have extreme fatigue and I can barely work. Like I said above I am an athlete I run five days a week ride my bike two days a week and swim generally two or three days a week and work as a teacher and I can barely do any of that.
61 2021-03-24 loss of personal independence in daily activities On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 10... Read more
On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 102. On 3/22/21 and continue to have swelling in my left armpit (Lymph node area), spasms in my left shoulder blade and surrounding soft tissue adjacent to my left armpit and neck area. I have experienced soreness in that arm/shoulder but not at the injection site - overall bicep and clavicle area. I have been able to alleviate symptoms to a degree by taking a tylenol once or twice a day but the pain is limiting some of my daily activities to a degree.
61 2021-03-24 sensation of foreign body Within 15 minutes following her COVID vaccine with concerns for a lump in her throat. She states she... Read more
Within 15 minutes following her COVID vaccine with concerns for a lump in her throat. She states she is able to swallow without difficulty. She denies any shortness of breath, chest pain, nausea, rash, or any other symptoms. Benadryl 25 mg given. Continued to monitor and improved
61 2021-03-25 anxiety Patient expressed anxiety. Had same symptoms with flue vaccine in 10/2020. Left arm injection site... Read more
Patient expressed anxiety. Had same symptoms with flue vaccine in 10/2020. Left arm injection site no redness, warmth. Patient expressed both parents recently passed away and expressed increased anxiety. Pt walked to the car, steady and stable. Pt will take tylenol as prescribed, rest, and hydrate. Recommend pt to follow-up with PCP on Monday for anxiety and elevated BPs. Pt denied HTN. Vitals: At 13:25, 160/82. 1 minute after 99 At 13:45, 160/82, 98HR, 99% spo2.
61 2021-03-25 feeling abnormal Between 10 and 15 minutes after receiving the vaccine, I felt like someone had thumped me in the che... Read more
Between 10 and 15 minutes after receiving the vaccine, I felt like someone had thumped me in the chest over my left breast. I tried to breathe deeply, and I started to feel light headed. I didn't tell anyone, I was let go after 15 minutes. I sat in my car about 5 minutes and then decided I was worse. I was weak and shaky and light headed, my top lip was fuzzy feeling. I didn't feel like there was a blockage in my airway but I felt like I was having trouble getting my rib cage to expand so I could breathe. I went back in and was sat down, I was evaluated. Paramedics were called, by time they came I was lightheaded and I was foggy brained. I couldn't respond easily. My BP was 165/99 and my heart rate was 98. my O2 was fine but by that time I felt like I had to work hard to get a deep breath. I was feeling worse quickly. I was taken to the ER in a wheelchair. I was put in a bed and hooked me up to monitors. I was left alone for a while. When the dr came in he checked me out and listen to my lungs. I had a hard time getting my lungs to expand. Doctor ordered a blood sugar test and it was below 100. Chest x-ray, EKG and blood work. He told me later that everything was normal. I was there for 2 hours before I felt like I could go home. I didn't receive any medication. I was able to breathe easier by time I left the hospital. I was thinking more clearly as well. The next day I was still feeling shaky and weak. I went to my PCP on friday and I was feeling normal by then.
61 2021-03-26 feeling abnormal, nervousness Pfizer COVID-19 Vaccine EUA Patient presents 3/23/21 for medical monitoring of syncopal episode s/p... Read more
Pfizer COVID-19 Vaccine EUA Patient presents 3/23/21 for medical monitoring of syncopal episode s/p COVID - 19 vaccine # 2. Lowered to the floor by vaccine staff. Patient reports symptoms of weakness, other wise states she ""feels fine"". Two additional syncopal episodes witnessed by myself when patient attempts to change position. Past medical history is significant for mild persistent allergic asthma, pre-diabetes, OSA, obesity and BPPV. Patient reports history of same reaction s/p previous vaccine. At a approximately 0837 patient was noted to have a worsening rash present to her face. EpiPen administered via left lateral thigh at 0838. EMS called to transport patient the ED for further evaluation. Treatment administered: epipen (lot 0FM406, exp 02/22) left lateral thigh at 0838. Upon arrival to the ED, patient's temperature is 98.8° F, heart rate 92-103, respiratory rate 30, saturating 99% on room air with blood pressure 164/91. The patient's laboratory studies were largely unremarkable. While in the ED, the nurse was getting ready to get the patient up to the commode when the patient started to ""not feel right again."" She asked her to administer the medications for allergic reaction and reports wall the 2nd medication was being infused, she felt paralyzed and unable to talk, although she was able to hear everything and was aware, she was unable to move or speak for a short amount of time. CT head with completed at this time and showed no acute intracranial findings. Chest x-ray unremarkable. EKG showed normal sinus rhythm with sinus arrhythmia, heart rate 80 and prolonged QT at 470. The patient was administered Solu-Medrol 125 mg IV, Pepcid 20 mg IV, Benadryl 50 mg IV, normal saline 1 L IV. Pt was admitted to hospital for observation. The patient was seen on the unit laying in bed with her husband at the bedside. She reports that she is feeling slightly better and hungry and has never felt at paralyzed/unable to speak feeling before and is very nervous about this. She was wondering if she had a seizure, although she reports feeling aware the entire time and did not lose bowel or bladder function. We discussed that that is not typical for a seizure, but even if we did an EEG at this time, it would not be able to tell us what occurred in the past. We discussed continue the Benadryl, Pepcid, and IV steroids for today and likely decreasing them tomorrow. We discussed the workup of syncopal episodes as well. The patient and her husband were agreeable to this plan. Patient was discharged from the hospital on 03/24/2021 in a stable medical condition. Patient was instructed to follow-up with her PCP in 1 week.
61 2021-03-26 impaired work ability Pfizer-BioNTech COVID-19 Vaccine EUA The area received vaccination was sore, about two hours later b... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA The area received vaccination was sore, about two hours later became drowsy, had to leave work and go home, woke up around 5 p.m. body ached on left and right side, took Aleve for pain.. Overnight had chills, headache, next morning, took Aleve for pain. Whole body ached for about a week, headaches, lethargic, tiredness. About week and half later only ache in right arm, sore like I sprained it, still tender today.
61 2021-03-27 feeling abnormal Both arms feeling like on fire. Headache, body aches, stomach ache, throat feels tight
61 2021-03-27 hallucination total of 4 days tired/weak, and right arm sore (from thursday through sunday) early saturday morning... Read more
total of 4 days tired/weak, and right arm sore (from thursday through sunday) early saturday morning had 4 hours of hallucinations, nausea and extreme vomiting, dizzyness ,loss of appetite slept for 12 hours on saturday and sunday after the 4 hrs of events listed above. still weak after feeling better on sunday afternoon
61 2021-03-27 nervousness lightheaded, dizzy,feeling nervous 160/90,82, 16
61 2021-03-27 sleep disorder Speeding-like an extreme caffeine high. Couldn?t sleep for two nights. Blinding headache. Diarrhea. ... Read more
Speeding-like an extreme caffeine high. Couldn?t sleep for two nights. Blinding headache. Diarrhea. Chewed up inside of mouth until bleeding. On day three and symptoms slowly leaving. Now slight headache and extreme fatigue.
61 2021-03-29 disorientation, loss of personal independence in daily activities Within hours became disoriented, thirsty and achy. Next morning, arm was numb and fingers tingly, ... Read more
Within hours became disoriented, thirsty and achy. Next morning, arm was numb and fingers tingly, Achy, fever, nausea, headache, extreme thirst, disoriented. Extremely sore arm that I couldn't lift to my waistline without extreme pain.. Hard to dress/undress. Never felt so sick in my life!
61 2021-03-29 feeling abnormal Hit with heaviness limbs; whelps all over body arms legs stomach back groin; pain in joints; felt li... Read more
Hit with heaviness limbs; whelps all over body arms legs stomach back groin; pain in joints; felt like fire ants; chills; no energy; tightness in chest; This is a spontaneous report from a consumer reported for herself. An 61-year-old female non- pregnant is unknown female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198), via an unspecified route of administration on Left arm on 02Feb2021 17:45 at single dose for covid-19 immunisation. Medical history included COVID-19, Congested Heart disease, and Penicillin allergy. The patient's concomitant medications were not reported. The patient experienced Hit with heaviness limbs pain in joints whelps all over body arms legs stomach back groin felt like fire ants chills no energy tightness in chest on 22Feb2021. Received Inhalers for breathing and steroids. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events was "Recovering".
61 2021-03-29 insomnia, impaired work ability Following day: major headache; body ache; dizzy; coughing; short of breath; chills; nausea; extreme... Read more
Following day: major headache; body ache; dizzy; coughing; short of breath; chills; nausea; extreme tiredness (stayed home from work) 2nd day: big headache; very light headed; some coughing; short of breath; nausea (stayed home from work). Not restful sleep. 3rd day: pressure headache; very light headed (went to work). Very tired at night. Hard time sleeping. 4th day: light headed; pressure in head; short of breath when going for a walk; hard time sleeping. Since 4th day, haven't slept well; light headed; on-and-off headache; at work but moving slow. Feels like when I returned from being out with Covid + double pneumonia 6/30/2020-7/23/2020.
61 2021-03-30 agitation, feeling abnormal Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and ... Read more
Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.
61 2021-03-30 feeling abnormal Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appet... Read more
Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appetite; Nausea; Sore arm at injection site (minor); Swollen lymph gland under left arm; Dizzy; This is a spontaneous report received from a contactable nurse (reported for herself). A 61-year-old female patient received second dose of BNT162B2 (Comirnaty, Solution for injection and Lot number: EL3246), intramuscularly to left arm on 12Jan2021 10:00 at a single dose for COVID-19 Immunization. Patient medical history was reported as none. Patient concomitant medications included calcium, ergocalciferol (VITAMIN D), multivitamin and probiotic. The patient previously took BNT162B2 (Comirnaty, Lot number: EJ1685) vaccination, intramuscularly to left arm on 22Dec2020 for COVID-19 immunization. On 12Jan2021 22:00, 12 hours after the second dose of vaccination the patient experienced with fatigue, fever (101.6), chills, shakes, muscle pain, joint pain, headache, foggy head, loss of appetite, nausea, sore arm at injection site (minor), swollen lymph gland under left arm. patient was on bed and felt dizzy after fever broke for about 24 hours. Seriousness was reported as non-serious. Patient received on advil at night for treatment of events. The outcome of events was recovered on an unspecified date. No follow-up attempts are possible, No further information available
61 2021-03-31 feeling abnormal felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quen... Read more
felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quenching, it was kind of weird; body jerking; feeling weird/felt like she was not herself/ she felt her body was trying to fight off something; heaviness in her legs; felt pain in her face; flinching; This is a spontaneous report from a contactable consumer(patient). The 61-year-old female patient received first dose BNT162b2, via an unspecified route of administration on 04Mar2021 (Lot Number: EN6205) as single dose for CIVID-19 immunization. Medical history included blood pressure issues from 2010 and ongoing, ongoing sinus issues which was diagnosed in 1973 or 1974, hypoglycaemia, reaction to tetanus shot several years ago. The patient's concomitant medications were not reported. She received postnasal drip started on 02 Mar2021 or 03 Mar2021 before the vaccine. She got the first Covid shot on 04 Mar2021. She wait 30 minutes because had reaction to tetanus shot several years ago. She had flinching, jerking and feeling weird 10 minutes after vaccine on 04 Mar2021. She and husband in holding area waiting. One time jerk so bad felt that she felt she had to lay down. She felt like she was not herself like she was out of body like there and she was not (AS REPORTED). She had a weird feeling after vaccine, she felt her body was trying to fight off something, felt like little bit out of body feeling, felt like she was going to hit the floor on unknown date. She felt lightheadness on 04 Mar2021. They checked her pulse and there was nothing with her heart rate. She does not know if it was an anxiety attack or not. She was nervous about getting the vaccine because it was so new. She felt this way for four days. On the fourth day that she felt she was coming around and on the fifth she felt herself. She has other underlying health issues and does not want the virus. She had heaviness in her legs, felt a pain in her face both on 04 Mar2021. The doctor wanted to rule out if she was having a stroke. She went to the ER, the ER kicked her out and did not find them. Her BP was 130/60 on 09Mar2021. They did blood work and an EKG(Electrocardiogram). They ruled out stroke. The doctor stated that the allergies could have made her feel dizzy but did not know about the twitching and jerking. She has lightheadness and dizziness because of other health reasons like sinuses, blood pressure and low blood sugar which these were before the vaccine. She had the normal EKG on 09 Mar 2021. There was unknown treatment received for events. Outcome of heaviness in her legs was recovered on 06Mar2021, of felt pain in her face, feeling weird, Dizziness was recovered on 07Mar2021, flinching, jerking was recovered on 04Mar2021, of felt like I was going to hit the floor was unknown. Case was assessed as serious.
61 2021-03-31 mental status changes received second dose of vaccine on 3/30. On 3/31 presents via EMS due to altered mental status and v... Read more
received second dose of vaccine on 3/30. On 3/31 presents via EMS due to altered mental status and vomiting. EMS reports that she was found sitting in her van lethargic and actively vomiting. When EMS arrived they noticed that the patient had her fingers in her throat trying to induce vomiting. EMS reports EKG in sinus rhythm with HR 84, BP 178/106, and O2 sat 99% on RA. EMS did not notice focal weakness. Pt c/o HA and is noted on arrival to not be moving her LUE. I spoke with her daughter, who said she spoke to the pt on the phone at 10:45 am today and that she seemed normal at that time. She reports the pt does not have h/o cancer or heart disease and is unaware of any pt medication allergies. She reportedly received her COVID vaccine yesterday.
61 2021-04-01 feeling abnormal Dizziness, nausea, sleepiness, fog brain, temperature of 96-96,4 (taken with more than one thermomet... Read more
Dizziness, nausea, sleepiness, fog brain, temperature of 96-96,4 (taken with more than one thermometer), throbbing pain in left arm traveling to neck.
61 2021-04-02 loss of personal independence in daily activities, feeling abnormal Massive headache, so bad I could not get out of bed. Fever of 102 that was gone the next day. Sore, ... Read more
Massive headache, so bad I could not get out of bed. Fever of 102 that was gone the next day. Sore, tired, cranky. I still have a headache only I can function. It is a 4 today on a pain scale of 1 to 10. On April 1st it was so bad I could not get out of bed. I felt like my head was a giant toothache. I am not too sure about getting the second dose. I was truly frightened. I don't think I have ever felt that bad. Having kids was easier.
61 2021-04-03 insomnia Vaccination was at 1pm. At 2am I got a horrible headache- stabbing pains in the back upper right ?co... Read more
Vaccination was at 1pm. At 2am I got a horrible headache- stabbing pains in the back upper right ?corner? of my head. Couldn?t sleep. I would test the frequency every once and a while. I had 1-4 sharp pains every minute. I talked to my doctor at 2pm that day. She said I could take 800mg Ibuprofen/8 hrs. That worked. Had to do this for 2 days after my shot. I was very tired. I was fine after that.
61 2021-04-03 sleep disorder Dull ache in left side of chest near breastbone.Unable to sleep. Began 9:30pm. Emergency room visit ... Read more
Dull ache in left side of chest near breastbone.Unable to sleep. Began 9:30pm. Emergency room visit 2pm next day.
61 2021-04-03 thinking abnormal ears plugged and ringing; ears plugged and ringing; tongue sore; chills; muscle aches; weakness; joi... Read more
ears plugged and ringing; ears plugged and ringing; tongue sore; chills; muscle aches; weakness; joint stiffness; nausea; sharp pains in stomach and breasts; sharp pains in stomach and breasts; tightness in chest; fatigue; dizziness; impaired mental clarity; 102 fever/99 degree fever; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 15Mar2021 at 18:00 (06:00 PM) (Batch/Lot Number: EN6208) at the age of 61-years-old as single dose for COVID-19 immunization; administered to the patient in public health clinic/administration facility. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient's medical history included known allergies (unspecified). The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in the left arm on 22Feb2021 at 07:30 PM (lot number: EL9266) at the age of 61-years-old for COVID-19 immunization. The patient experienced 102 fever the night of 16Mar2021 (also reported as 16Mar2021 at 06:00 AM) with chills, muscle aches and weakness, joint stiffness, nausea, sharp pains in stomach and breasts, tightness in chest, fatigue, dizziness, and impaired mental clarity. On 17Mar2021, the patient experienced ears plugged and ringing, weakness, tongue sore, and impaired mental clarity. The patient had 99 degree fever during the nights of 17Mar2021 and 18Mar2021 thus far. The patient did not receive treatment for the events. The patient has not been tested for COVID post vaccination. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects).
61 2021-04-05 crying, depression, feeling abnormal 3 days later began to feel very depressed, emotionally volatile, crying a lot. It has continued wit... Read more
3 days later began to feel very depressed, emotionally volatile, crying a lot. It has continued with some better days and some awful days, I am now 7 days post vaccination and today was awful. I have not had any major physical reactions other than some fog and headache.
61 2021-04-05 disorientation, excessive sleepiness I was fine for 3 days after the shot. On the 4th day I was tired in the morning and had a headache. ... Read more
I was fine for 3 days after the shot. On the 4th day I was tired in the morning and had a headache. During the morning I started becoming disoriented and very tired. I was at work. I sat down and slept for 3 hours not hearing anyone. When I woke up my coworkers said I moved about 10 things around where they didn't belong. Like a cactus in the fridge along with a soap dispenser. I don't remember any of it. I felt better when I woke up. When I got home I slept for 11 hours. I was a little groggy the next day. I was fine 2 days later.
61 2021-04-05 feeling abnormal 5 MINUTES AFTER RECEIVING COVID VACCINE PATIENT REPORTED EXTREME DIZZINESS, AND A FEELING OF FULLNES... Read more
5 MINUTES AFTER RECEIVING COVID VACCINE PATIENT REPORTED EXTREME DIZZINESS, AND A FEELING OF FULLNESS IN HER LEGS. SHE LOOKED PALE AND HER SKIN WAS CLAMY. GAVE HER SOME WATER AND 1 GLUCOSE TABLET (4GRAM CARBOHYDRATE). TOOK HER BLOOD PRESSURE AS WAS LOW AT 76/51, RECHECK 86/62, RECHECK, 86/58. ATTEMPTED TO CALL 911 BUT PATIENT REFUSED AND WANTED HER DAUGHTER TO COME GET HER. AT 3:54 PM SHE REPORTED THAT THE DIZZINESS WAS GETTING BETTER AND BLOOD PRESSUER RECHECK WAS 98/68. AT 4:01 HER BLOOD PRESSURE WAS 117/71 HR 73 THEN EVENTUALLY CAME BACK UP TO 128/80 AT 4:08PM. PATIENT LEFT AT 4:17PM. WILL FOLLOW UP WITH A PHONE CALL TODAY.
61 2021-04-06 amnesia, abnormal behaviour Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs ac... Read more
Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; temp of 101.6; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Right on 01Mar2021 17:15 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included end stage renal disease (ESRD), high blood pressure and pulmonary hypertension; all from an unknown date and unknown if ongoing. The patient has no COVID prior vaccination and not tested to COVID post vaccination. There was no other vaccine in four weeks. Concomitant medications (reported as Other medications in two weeks) included clonidine (CLONIDINE), macitentan (OPSUMIT), minoxidil (MINOXIDIL), carvedilol (CARVEDILOL), and tadalafil (ADCIRCA); all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (lot number: unknown) first dose on 22Jan2021 at 02:45 PM right arm for covid-19 immunization. The patient also previously took Hydralazine and experienced allergies. It was reported that on 01Mar2021 08:00 PM the patient went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs., acting stiff and unusual behavior. The patient's daughter took the patient and had a temp of 101.6 was sent home Tuesday morning. The events resulted in: Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered with sequalae (reported as with lasting effects). No treatment was given for the events. Information on the lot/batch number has been requested.
61 2021-04-06 feeling abnormal Did fine day of shot but next morning woke up felt like I got hit by a Mack Truck my left arm that ... Read more
Did fine day of shot but next morning woke up felt like I got hit by a Mack Truck my left arm that I received shot swelled alot. I not experience that with previous flu shots or my pneumonia shot. I felt weird and sort of sick for 2 weeks.
61 2021-04-06 insomnia In order of occurrence: Chills Face and neck hot and itchy, red rash on face Back itchy, red rash ac... Read more
In order of occurrence: Chills Face and neck hot and itchy, red rash on face Back itchy, red rash across back Head itchy, can't tell if a rash Bad arm pain to touch, not usual shot arm pain, couldn't lay on left side to sleep Cold all night, used 2 blankets instead of usual 1; fitful sleep As of this writing: arm pain better but minor arm redness/swelling; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday. Feel cold.
61 2021-04-06 sleep disorder In order of occurrence: Chills Face and neck hot and itchy, red rash on face Back itchy, red rash ac... Read more
In order of occurrence: Chills Face and neck hot and itchy, red rash on face Back itchy, red rash across back Head itchy, can't tell if a rash Bad arm pain to touch, not usual shot arm pain, couldn't lay on left side to sleep Cold all night, used 2 blankets instead of usual 1; fitful sleep As if this writing: arm pain better but minor arm redness/swelling; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday
61 2021-04-06 sleep disorder Began with soreness at the injection site and tiredness about 16hours post injection. Then I had bod... Read more
Began with soreness at the injection site and tiredness about 16hours post injection. Then I had body aches headache and low grade fever (99-100 degrees), about 18 hours after the injection. I had a rough night waking intermittently but all symptoms were gone when I woke at 10:30 am on 4/7/2021.
61 2021-04-07 disorientation The first day she felt severe fatigue within hours. Went to bed and slept all day and all night. The... Read more
The first day she felt severe fatigue within hours. Went to bed and slept all day and all night. The next day woke up disoriented and weak. Called dr and dr recommended her call the ambulence. Went to ER and admitted to hospital. They said she had an infection and got on antibiotics. In the hospital 2-3 days and dismissed. Continue to have weakness and severe fatigue. Had 3 "MS hug"- muscles severely contract during this time- has to take muscle relaxer.
61 2021-04-07 feeling abnormal Arm soreness/pain impulses upon lifting of arm; pain about 10 minutes after injection; a fluttered f... Read more
Arm soreness/pain impulses upon lifting of arm; pain about 10 minutes after injection; a fluttered feeling as if a fast heart rate; Difficulty lifting arm; This is a spontaneous report from a contactable nurse. A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Jan2021 16:00 (Batch/Lot Number: EL9262) as SINGLE DOSE for COVID-19 immunisation. Medical history included diabetes, HTN (hypertension), Elevated Cholesterol, glaucoma, GERD (gastroesophageal reflux disease) and Known Allergies: black pepper. The patient's concomitant medications were not reported. The patient previously took Flexeril, codeine and fentanyl for all these drugs experienced drug hypersensitivity. Initially a fluttered feeling as if a fast heart rate, but 60 second counts revealed pulse regular and no more than 80. Arm soreness; pain about 10 minutes after injection. Continued despite use of Tylenol and heat packs. Difficulty lifting arm; pain impulses upon lifting of arm on 23Jan2021 16:00. The patient underwent lab tests and procedures which included heart rate was 80/min. The outcome of the events was unknown.
61 2021-04-07 sleep disorder In order of occurrence: Chills/Face and neck hot and itchy, red rash on face Back itchy, red rash ac... Read more
In order of occurrence: Chills/Face and neck hot and itchy, red rash on face Back itchy, red rash across back Head itchy, can't tell if a rash Bad arm pain to touch, not usual shot arm pain, couldn't lay on left side to sleep Cold all night, used 2 blankets instead of usual 1; fitful sleep As of this writing: arm pain better but minor arm redness/swelling; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday. Feel cold. Note that after my shot I was out until about 4:30 pm. While out, I noticed that my face and neck felt hot and my neck was getting itchy, but I did not check it. After returning home, the itchiness, chills. etc. slowly increased until at 6:30 pm I was very
61 2021-04-08 feeling abnormal Headache, chills, nausea, fever that went higher as day went on, went up to 101 with taking ibuprofe... Read more
Headache, chills, nausea, fever that went higher as day went on, went up to 101 with taking ibuprofen, severe fatigue, could not stay awake more than half hour, fuzzy headed feeling, constant ringing in the ears , day 4 of effects couldn't catch my breath when walking more than 10 feet. Day 6 still have ringing in ears, some fatigue, breathing better but not 100%.
61 2021-04-09 feeling abnormal feels a little dizzy; Noticed her voice is not quite right; feels kind of wierd; significant loss of... Read more
feels a little dizzy; Noticed her voice is not quite right; feels kind of wierd; significant loss of hearing in right ear; when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear; muscle pain in injection site the first night after her dose; Sore Arm Left; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose bnt162b2 (PFIZER COVID VACCINE), via an unspecified route of administration, administered in Arm Left on 20Mar2021 (Batch/Lot Number: ER2613) as single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient received first dose of PFIZER COVID VACCINE last Saturday 20Mar2021. On 26Mar2021 the patient reported muscle pain in injection site the first night after her dose but it only lasted one day. Today 26Mar2021 noticed significant loss of hearing in right ear and feels a little dizzy. Noticed her voice was not quite right. She stated she felt kind of weird. When she eats fruit, she notices blocked feeling in her ear. When she talked she noticed an echo in her ear. She stated she was typically healthy. had this been reported and wondering when it will go away. On 29Mar2021 she stated she called last Friday and reported it because she was so frightened that she had lost her hearing in her right ear. She stated that after one day, her hearing half recovered and after two days, her hearing completely recovered. The patient experienced hearing loss in right ear from 26Mar2021 and sore arm left from 20Mar2021. She stated that she was 61, almost 62 and was very healthy, no medications, not sick. She stated her last vaccine that she had was in childhood. She stated that she doesn't get the flu shot and doesn't get the flu, nothing really. She stated that she had this vaccine for other people, for their concern, she was not worried. She stated the first night, she felt muscle pain in her arm and then she forgot about the vaccine, until Friday. She stated she realized when she searched sudden loss of hearing. She stated that it was all gone. She stated she thought should she have the second one, She stated she thinks it was fine. Clarifies that the first morning she noticed it when she got up it was a little weird, She stated she couldn't hear something, so she started searching this and said she better check it out because it said she needed to get treated sooner. She stated she thought what should she do and was in a panic and that was how she went on the internet and make the link. She stated she wanted to let Pfizer know that everything was back to normal. The outcome of event 'significant loss of hearing in right ear' and 'when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear' was recovered on 28Mar2021, of event 'muscle pain in injection site the first night after her dose' and 'Sore Arm Left' and was recovered on 21Mar2021, of other events was recovered on an unspecified date.
61 2021-04-09 loss of personal independence in daily activities Approximately 12 hours after vaccines, chills, fatigue, nausea, weakness. These lasted 48 hours afte... Read more
Approximately 12 hours after vaccines, chills, fatigue, nausea, weakness. These lasted 48 hours after start of symptoms 2nd vaccine symptoms were worse then previous vaccine and include having diarrhea. Still have activity intolerance
61 2021-04-10 excessive sleepiness Threw up about an hour later 2pm. Threw up 2 more times in about a 3hr. total time frame. Achy and... Read more
Threw up about an hour later 2pm. Threw up 2 more times in about a 3hr. total time frame. Achy and sore went to bed and slept till 4:30am. Felt better but still achy with a headache. Sun. feeling better.
61 2021-04-11 feeling abnormal Approximately 10 min after receiving vaccine, patient obtained a headache proceeding with tingling i... Read more
Approximately 10 min after receiving vaccine, patient obtained a headache proceeding with tingling in both hands, difficulty swallowing, and feeling funny. She states as soon as she got it she developed an immediate headache, on her drive home she became lightheaded and had pins and needles sensation in her face and got a strange aura that lasted all her way home. She said for a while she felt like she couldn't swallow. She feels that she might have had a panic attack versus an adverse reaction to the vaccine and is declining any further evaluation.
61 2021-04-11 feeling abnormal Patient returns to Covid Clinic 3 hours after injection with her husband. CC: Feeling Funny, Weaknes... Read more
Patient returns to Covid Clinic 3 hours after injection with her husband. CC: Feeling Funny, Weakness, and Shuffling Gait. Denies Respiratory involvement. Vital Signs Stable No Rash observed. Patient reports s/s started while shopping at shopping center three hours after injection. Reports history of Anxiety and reports taking Xanax the night before the Covid Appointment.
61 2021-04-12 sleep disorder, anxiety Anxiety thanks to crowds and fleeting initial dis-organization at the vaccine facility. Sore arm t... Read more
Anxiety thanks to crowds and fleeting initial dis-organization at the vaccine facility. Sore arm the evening of the injection and the next day. Joint/muscle aches and pains nights the 10th and 11th that interrupted sleep; took acetaminophen. Aches during the day and tired the 11th, 12th and 13th (so far). Strange taste in mouth, upset stomach 12th and 13th (so far). Not looking forward to second dose though happy to have started process.
61 2021-04-13 disorientation, disturbance in attention I started symptoms late Sunday 4/11/2021, on Monday 4/12/2021 I became very lethargic, aches and p... Read more
I started symptoms late Sunday 4/11/2021, on Monday 4/12/2021 I became very lethargic, aches and pains, severe headache, all night has night sweats and chills., temperature reached 101.4 Tuesday 4/13/2021, felt disoriented, (this bothered me, I couldn?t even have a conversation with work or psychiatrist. I could think straight. Still headache, no fever. Very sleepy and achy.. started feeling better later in the evening. Wednesday, 4/14/2021. Hardly any side affects at all. Minor headache and sweats.
61 2021-04-13 sleep disorder Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills... Read more
Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills, nausea, could not sleep, Swelling, warmth, burning swellinge first dose size of 1/2 orange. No fever. Second not as severe as the first. Body aches, muscle pain, dizziness, chills, nausea, painful injection site not as much swelling,No fever. Blood Sugar spikes: 1/31/2021 280, 2/1/21 2112/27/21 319, 2/28/21 418. 9 days after second vaccine. Purple swelling of both feet. cellulitis rt foot pain worse in lt than rt .PCP to ER (soles, top lower legs black): susp tibial artery occlusion lt . Heparin. Farxiga, Ultram, baby aspirin, procardia, metformin.Possible Reynauds.Still pain discoloration and swelling.
61 2021-04-14 confusional state dizzy, weak, stomach pain, loose bowel movements, confusion, heart palpitations
61 2021-04-14 fear At approx. 9:22 AM on 4/2/21, I began having problems swallowing my saliva and felt my throat begin ... Read more
At approx. 9:22 AM on 4/2/21, I began having problems swallowing my saliva and felt my throat begin to close. I also began having problems breathing, began coughing and choking, chest pain, and dizziness. The nursing staff at Hospital immediately got a wheelchair and rushed me next door to the ER. The nurses had called ahead so that the ER doctors were ready to assist me. I was given Epinephrine, steroids, nubilizer treatments, Bendryl, IV fluids and oxygen. After some time I began feeling a little better but then the reaction restarted and treatments had to be re-administered several times. It was quite frightening. I also had a severe headache and tightness of the chest . The ER doctor believed that I should be admitted which was done on 4/2/21 and was kept thru 4/4/21.
61 2021-04-14 feeling abnormal, excessive sleepiness April 12th - 4:30 pm and on - I was very tired and groggy April 13th - 7:30 am until 10:00 pm - I ha... Read more
April 12th - 4:30 pm and on - I was very tired and groggy April 13th - 7:30 am until 10:00 pm - I had a headache, nausea, no appetite, chills, fever up to 101.6, constipated and overall felt crappy - slept most of the day. I took Tylenol as advised by the medical center to help reduce the fever and aid injection site tenderness. April 14th - 7:15 am - 11:00 pm - I had a headache (not as bad as previous day, nausea, no appetite, chills, fever up to 99.4, constipated and overall felt crappy - slept a bit less than previous day. Between 2:00 am and 6:00 am, I believe the fever broke - sweats were consistent. I took Tylenol as advised by the medical center to help reduce the fever and aid injection site tenderness. April 15th - 7-20 am - current - All above listed symptoms have gone away. I also had a bowel movement twice today. I feel a bit tired but almost back to normal.
61 2021-04-14 feeling abnormal Lightheadedness/dizziness the second day after receiving the shot (was fine the day after). Couldn'... Read more
Lightheadedness/dizziness the second day after receiving the shot (was fine the day after). Couldn't stand for more than a few minutes without support. The third day still a bit lightheaded/foggy, but much better than the day before.
61 2021-04-15 anxiety after receiving vaccine started to get anxious due to environmental factors was feeling faint and wa... Read more
after receiving vaccine started to get anxious due to environmental factors was feeling faint and wanted to lay down assisted to stretcher placed in trendelenburg snacks and water and juice provided bp elevated sat up bp cont to be elevated pt states having anxious thoughts about covid vaccine expressed to nurse bp elevated pt agrees to lay down and rest for a few minutes and close eyes deep breathing exercises enc to pt. per pt stress relieved after a few minutes and feeling better and requesting to leave, escorted to exit ambulated without difficutly, spouse awaiting in car and driving pt home. pt left at 1053 vs as noted VS 1015 bp 144/89 hr 72 rr 18 o2 95, 1020 bp 157/91 hr 80 rr 18 o2 98 1025 bp 177/107 hr 81 rr 18 o2 100 1035 bp 162/83, 1041 bp 137/87 1045 bp 155/84 1051 148/89
61 2021-04-15 anxiety 1 hour after shot numbness left side of face. 19 hours later extreme fatigue. 24 hours later dizzin... Read more
1 hour after shot numbness left side of face. 19 hours later extreme fatigue. 24 hours later dizziness. 11 days later extreme anxiety. 12 days later chills, body ache, fatigue, and anxiety. 13 days later severe ocular migraine.
61 2021-04-15 feeling abnormal Pt reports feeling fuzzy (mental clarity wise) and a buzzing feeling since receiving Pfizer COVID-1... Read more
Pt reports feeling fuzzy (mental clarity wise) and a buzzing feeling since receiving Pfizer COVID-19 vaccine #1. Pt reports after receiving Pfizer COVID-19 vaccine #2, buzzing has gotten slightly worse. Pt reports when she takes a deep breath it causes her breath to catch and for her to cough. Pt reports no SOB or difficulty breathing.
61 2021-04-15 sleep disorder left leg seriously cramped up around 11pm last night waking me out of sleep. continues to feel wor... Read more
left leg seriously cramped up around 11pm last night waking me out of sleep. continues to feel worse it is 9:50am . can barely move left leg
61 2021-04-16 impaired work ability Swollen portions of hands, portions of feet, knees. Inflamed, red, hot, itchy and very, very painful... Read more
Swollen portions of hands, portions of feet, knees. Inflamed, red, hot, itchy and very, very painful. The issues move from area to area and seem to inflame fatty areas most. I thought this would go away and didn't document with pictures, like I should have. I now have a couple of pictures and will continue to do so. I've tried hot baths, cold packs, hot packs, elevating the area and topical relievers. I couldn't feel the heat of the pain reliever on the affected area. This has been absolutely debilitating and I've had to miss some work because of it.
61 2021-04-17 euphoric mood, nervousness, feeling abnormal, nightmare My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super water... Read more
My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super watery bowel movement then went into clay like and drier consistency but still dark (I never had stool this dark).; I was dry/ I needed water; room seemed like it was so much further away, my stairs the spindles were larger in size, it was if I was high on something/feeling of peace, calm/high feeling; I was whistling in my breathing/ I had a loud whistle; feeling my eyes and hearing were sharp/ my eyes were changed eventually; had my eyes dilated; felt I like I was getting hemorrhoids/I woke up feeling like I had too much sugar; black stool; constipation; Chills; wanted to vomit; I got shaky; scares; There's a feeling of hardness in my lower abdomen and heart area (Belch); There's a feeling of hardness in my lower abdomen and heart area (Belch); reversed my beta blockers (it keeps it in the 50s) it went to 79; My energy was so much more.; The next day I gained 3.2 pounds then the next day lost 3 pounds; My injection site for the first 2 weeks,I had an itch/ extreme itch; injection site for the first 2 week/there's pain there on touch (no throbbing pain); My tooth broke; movement under my skin/shingles feeling; My skin is extremely dry; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. It was reported that the patient vision wasn't as good. She also had glasses to read (eyeglass wearer and ongoing) and behind her eyes they were dry one (left) mostly. Concomitant medications included unspecified beta blockers. On 11Mar2021, she got chills on the same day. Right as she got the shot, she wanted to vomit also and got shaky. On 12Mar2021, she woke up with whistling in her breathing for a few minutes then it was done. At the same moment, her eyes were changed eventually. She had mucus in my eyes as her vision wasn't as good and behind her eyes, they were dry one eye (left). So, watching TV wasn't as good and became bothersome. She later noticed, the black in here eye was taken up most of her eye (as if her eyes were dilated). Her eyes and hearing were sharp also now sharp as she was reading better (without my read glasses) and had to turn down the volume in her TV. She also felt like she was getting hemorrhoids for a few days but then it went away. She also had black stool, then constipation (harder stool) eventually went the day right after the shot (12Mar2021). Then around 5pm, she had feeling like she had too much sugar and was dry which she needed water. Once she sat down, her living room door seemed like it was so much further away, stairs the spindles were larger in size, it was if she was high on something. It was different nothing but this injection. She was also experiencing a feeling of peace and calm. As if nothing was wrong, no stress (stressing about something) she couldn't even think of- everything was gone, a calming effect. It was high feeling. The next day (13Mar2021), she had a super watery bowel movement then went into clay like and drier consistency but still dark (she never had stool this dark). In Mar2021, she also stated that there was a movement under her skin like a pre-herpes or a pre-shingles. She mentioned that she knew herpes and the movement under her skin was shingles feeling. Her skin was also extremely dry. On 17Mar2021 (a week after the injection), she woke up to my heart spasm. It was beating real fast (beating like right under her skin), no pain and heart attack but more than a heart flutter. She didn't know whether it was going to beat or stop. She also woke up with a loud whistle (louder than before) out of a dream. She stated that during the day she doesn't get the stressed, but in her dream, it was magnified and woke up in a violent vicious fury. She had 3 nights of this (uncalm coming into my dreams viciously, morbidly gross) started on 14Mar2021. The heart spasms come as a few seconds and goes away but that's happened twice which it scares her. She also stated that there was feeling of hardness in her lower abdomen and heart area (belch) in Mar2021. The injection almost reversed her beta blockers (which keep it in the 50s) it went to 79 (same as it was before she started taking beta blockers) but her blood pressure was normal 121/something (that was a good thing). She also mentioned that her energy was so much more while other people woke up early, cleaning up -would get sleepy and a little tired. But this (injection) gave her energy. Her injection site for the first 2 weeks also had an itch, that would come up (not constant) almost like a yeast infection which had an extreme itch. There's pain was there on touch (no throbbing pain) it took over a week before it was gone. She also mentioned that the chills were off and on for 4 days. The vaccine also did something to her weight as she was expecting to lose weight, but she didn't. One day, she gained 3.2 pounds then the next day lost 3 pounds. Her tooth also broke (but no pain in her tooth) even she had a sensation of her teeth being weak which she could feel it. Her tooth broke eating a tortilla chip and that's weird. She wanted to know if other people had called in with the symptoms that she had experienced. The patient recovered from breath sounds abnormal and constipation on 12Mar2021; cardiospasm, chills and vaccination site pain in Mar2021 while the remaining events were unknown. No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.
61 2021-04-17 feeling abnormal Fatigue 4/16/2021-4/18/2021 Pain on left side of neck and behind ear 4/17/2021, 8:00AM-2:00PM Fog-Br... Read more
Fatigue 4/16/2021-4/18/2021 Pain on left side of neck and behind ear 4/17/2021, 8:00AM-2:00PM Fog-Brain 4/17/2021, all day Low grade Fever 4/17/2021, 1:00pm-middle of the night when I woke up sweating, 99 degrees during the day time hours Took no fever reducing medications during this time.
61 2021-04-17 irritability This is a spontaneous report from received from contactable consumer. A 61-year-old female patient r... Read more
This is a spontaneous report from received from contactable consumer. A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7534), via an unspecified route of administration on 24Mar2021 via an unspecified route of administration in top of left arm as single dose for covid-19 immunization. Medical history included Salpingo-oophorectomy (resection to remove an ovary and fallopian tube) in Mar2016 and an operation in 2016 for diverticulitis. Concomitant medications were not reported. There were no allergies to medications, food, or other products. No known allergies. No, she says this is her first vaccine, she has never even had the flu vaccine. Caller clarifies she is talking about the Pfizer BioNTech vaccine. Later in the call clarified as the COVID-19 vaccination. She is calling to report that she contracted COVID. She says she is so discouraged, she did everything right and she ended up getting COVID, she was shot in the arm, her family forced her to get it, 7 days later she was sick, so sick Wednesday(31Mar2021)/Thursday(01Apr2021), positive on Saturday (03Apr2021). She says she is been googling this, it has only been only 6 months, less than 6 months in. On 30 Mar2021, patient had experienced ill, Sneezing, coughing, choking, coughing up phlegm, Fever, Chills and aches. Patient says she did not get her second shot, she is supposed to go for it on 14Apr2021 but she suspects she had to get tested before she gets the vaccine. She says she does not know what to do. She says she is isolating herself and has her own bathroom. She says her card has a patient number and an ISS number. She says she is got this vaccine for society to get this vaccine rolling so we can be whatever the word is, for social status, to be in the cool club. Patient says she had no tests since she does not have a primary. The adverse event was not resulted in emergency room. The patient was resolving from the event COVID. At the time of reporting the outcome of the events were unknown. Additional information has been requested.
61 2021-04-18 insomnia Started with slightly sore arm, and a headache, headache got worse, took advil, didn't sleep well, s... Read more
Started with slightly sore arm, and a headache, headache got worse, took advil, didn't sleep well, severe headache, muscle and joint pain, took more advil. Morning, felt like a flu, slight fever, body aches, joints, major pain trying to lift left (shot) arm. Not severe enough to seek medical attention.
61 2021-04-18 sleep disorder tinnitus - constant high pitched whistling sound in my ears, intensity varies, wakes me up at night
61 2021-04-19 anxiety Six days after my 2nd vaccine I had an anaphylaxis reaction. Out of the blue while I was driving my... Read more
Six days after my 2nd vaccine I had an anaphylaxis reaction. Out of the blue while I was driving my face started to burn like acid was rubbed on it. It got really hot and turned very bright red. Then my lips began to feel like they had been sunburned badly. Then my forearms both started burning and also turned bright red. I was very anxious. Had two bouts of diarrhea. All this occurred within about a 20 minute time-frame. I chewed up 4 children's Benadryl (50mg) and the redness, burning and anxiousness subsided mostly. My heart rat was still over 100 bpm even after 6 hours. (Usually my HR is 68-70 bpm). I slept for 12 hours and the next day seemed fine. This has occurred two more times since that first time. The 2nd reaction being 5 days after that first one and the 3rd reaction being 5 days after that. Same reaction, same treatment and same outcome.
61 2021-04-19 confusional state Patient suffered a syncopal episode and confusion while under observation following her booster vacc... Read more
Patient suffered a syncopal episode and confusion while under observation following her booster vaccination. Patient has a history of diabetic related emergencies but this syncope/confusion resolved itself while under the care of on site paramedics. Patient was transported to a hospital of her choosing.
61 2021-04-19 euphoric mood, agitation, crying, feeling abnormal DAY ONE April 15, 2021. On Thursday April 15th at 10:00 a.m. I received the first dose of the Covid... Read more
DAY ONE April 15, 2021. On Thursday April 15th at 10:00 a.m. I received the first dose of the Covid 19 vaccine. They gave me the shot in my left arm. Within about 5 seconds, I started feeling nauseated and light headed like I was going to pass out. I asked to just sit there for awhile because I did not feel stable to stand up and go to the waiting area. I stayed seated for about 1-2 more minutes then the paramedics took me to the Medical area in a wheelchair. The paramedics checked my vitals. My blood pressure was 135 over ?? I don't remember. I told the medic my BP is normally 98/58. She said my BP was elevated. My pulse was in the high 80's. My temperature was 98.6 and my oxygen was 100. I started getting pain and pressure going up the back of my neck, into my head, eyes and ears. It was very painful and throbbing pressure. I felt dizzy and really high. It felt like I was floating on the top of the ceiling and the people were off in a distance. I was really woozy. I then got diarrhea. The nausea continued but I did not throw up. At times my thinking was spacey, so I talked to the paramedic to help me stay grounded. I narrated what was happening in my body. They did a glucose finger prick test because of my spaceyness, but it was normal. It was like my whole system was freaking out. I was there and then not there, feeling like I was floating. These symptoms continued for about 90 minutes and getting worse. The paramedics offered me to go to the hospital, but I thought eventually I would be fine. I did not want to go to the hospital and have a huge medical bill. At around 90 minutes, I started having pain in my heart left side, under my left breast on my left shoulder. The paramedics did an EKG and did not find anything but some irregular heartbeats. The heart beats felt like BA BOOM, then my heart would do a cartwheel. BA BOOM and another cartwheel. At this time, my husband arrived and took me to the hospital emergency room because the pain in my heart was getting worse. I stayed in the hospital emergency room until around 5:00pm on April 15th. They did another EKG and some lab work and did not find anything but low thyroid. I continued to feel drunk, nauseated, pain pressure and throbbing in my head neck, ears and eyes, diarrhea, and like I was High and going to pass out. The chest pain in my heart was off and on. It felt like muscle cramping in my heart, under my left breast and the left shoulder. I also got a pain in my left groin area, then behind my left knee. It was a sharp and throbbing pain for about an hour in each location, but eventually went away. While in the Emergency room, they tried to give me Ativan. I asked what it was for and they said Anxiety. I said I wasn't anxious; I was just having a reaction to my first Covid 19 vaccine. I said I did not want it because my body was already struggling to handle the Covid 19 vaccine. They said the doctor prescribed it. I said I had not seen a doctor, and they said it is protocol. The nurse then came in and wanted to give me a shot for nausea and I said no, I don't want any more chemicals in my body, it is really having a hard time already with the Covid vaccine. I went home, was wiped out, still feeling drunk/woozy/high, also nauseated, diarrhea, very dizzy, had a hard time walking. The pain, throbbing in my head, neck, ears and eyes was still there. By this time, I could not find clear thoughts, and could not make sense of things. I was very agitated and at the same time exhausted and only wanted to sleep. DAY TWO April 16, 2021 I woke up with a smashing head ache, neck ache, back ache and general feeling like Crap. The nausea and diarrhea were still there and had woken me in the middle of the night. I felt like a truck had hit me. I stayed in bed all day and tried to eat and drink as much as I could. I drank a lot of water that day. I felt horrible, but was able to stand without feeling like I was going to fall over. Had trouble finding clear thoughts at times. Still felt out of it and had chest pain off and on. Also had the BA BOOM heart beats and cartwheels in my heart. DAY THREE April 17, 2021 Very similar to day two. I felt weak, nauseated, diarrhea, pain all over, jittery, not able to have clear thoughts at times. It felt like my body was still on RED ALERT!!! I also had very shallow breathing on day 2, 3, 4 and 5. It tired me and I panted just getting up to go to the restroom. I am able to eat fine and keep food down. BA BOOM hear beats and cartwheels in my heart have lessened. DAY FOUR April 18, 2021 I felt a little better and made the mistake of thinking I was getting over the reactions and did too much. Shortness of breath. DAY FIVE April 19, 2021 I feel horrible again, Nausea is really strong as well as the diarrhea. I am feverish, sweaty and shaky. Shortness of Breath. Tight in my chest. I just took my temperature and it is normal, although I am hot, sweaty, feel feverish and shaky. I am exhausted. The headache is still here as well as the pains in my neck, ears and eyes. The aches in my body are still here. I have no energy. A wave of emotions is also here and I am weepy and crying. This is no fun. I am able to eat food OK and drink lots of water to counteract the diarrhea. DAY SIX April 20, 2021 Shortness of breath, very tight in my chest, having to take Benadryl and use my rescue inhaler to keep my breathing open. Feverish, chills, shakey, hot. Temperature 97.0 Blood pressure 90/66 Pulse 70. I feel like crap, just wiped out.
61 2021-04-19 insomnia, feeling abnormal Sore shoulder for three days-no treatment Bodyaches- for three day-Tylenol, rest, water Headaches- f... Read more
Sore shoulder for three days-no treatment Bodyaches- for three day-Tylenol, rest, water Headaches- for three day-Tylenol, rest, water Slept all Saturday following, most of Sunday, Some of Monday Insomnia Sunday night about four hours, Monday about two hours. Internal external mouth sores. Still healing from outside sores Brain Fog. Took about three weeks for brain fog to go away from first to second shot. Still have brain fog from second shot which what I am reporting on here.
61 2021-04-19 insomnia This was my second COVID dose, it felt completely different from the first one, which was given at a... Read more
This was my second COVID dose, it felt completely different from the first one, which was given at a different pharmacy. When it was being injected, it felt like the vaccine was pooling in my arm and the injection took much longer than the first one. My arm felt heavy within 30 minutes of getting the vaccine. About two hours later, I could not lift my arm more than 10% without terrible pain. I could not sleep even taking Advil. After three days, the intensity lessened some, but I still cannot lift my arm certain ways without a lot of pain and it is keeping me awake as it just aches. I cannot lay on that side either, as the pain becomes intolerable.
61 2021-04-19 sleep disorder Chills, restless sleep amd headache. Chills ended in the morning, 6 hours, headache and fatigue last... Read more
Chills, restless sleep amd headache. Chills ended in the morning, 6 hours, headache and fatigue lasted till evening, 12 hours +/-
61 2021-04-20 confusional state severe allergic reaction to the vaccine; sore arm; neck pain; getting lots of saliva; tongue started... Read more
severe allergic reaction to the vaccine; sore arm; neck pain; getting lots of saliva; tongue started swelling; rapid breathing, couldn't control her breathing; heart rate it got faster; started getting confused; shaky; wheezing; swelling of her throat; blood pressure dropped; This is a spontaneous report form a contactable consumer reporting for herself. A 61 years old female consumer received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; NDC number 59267-1000-01) on 29Mar2921 at 14:15, in left upper arm, for COVID-19 immunisation. No other vaccines were given on the same date or within 4 weeks. Medical history included allergic to hamsters (she found out that this one had the Chinese Hamster Ovary cells and she knew she had problems with those things), allergic to prednisone (crazy rash, itching), allergic to a lot of different things, sinus infection. Family history included allergy (the whole family had allergies). Concomitant medications included unspecified antibiotics for sinus infection (but it had cleared up by then) and unspecified allergy shots (but not a vaccine). The patient just wanted to report that she had a severe allergic reaction to the vaccine on 29Mar2021. Symptoms began minutes after getting vaccine. The patient experienced getting lots of saliva started with a couple of minutes of getting the shot, tongue started swelling, rapid breathing, couldn't control her breathing, heart rate it got faster, started getting confused, shaky, wheezing, swelling of her throat, blood pressure dropped, all on 29Mar2021. On 30Mar2021 the patient experienced sore arm and neck pain but she thought that was more of a vaccination saying it was working. Clinical course of the events included the following information: the patient had to stay for a while since she had allergies normally. She started getting lots of saliva and she thought that was her body saying, she did something, not a big deal. Around 15 minutes, she was at a grocery store, she started walking around, her tongue started swelling, rapid breathing, she couldn't control her breathing and heart rate, it got faster. She started getting confused, shaky, it wasn't too good. She made her way back to the place where the injections were done, they were trying to get her to use her epinephrine (EPIPEN). She took a diphenidramine (BENADRYL) while walking around looking for her husband and then took another and was wheezing. She thought BENADRYL would have helped. She should have taken her EPIPEN looking back, she thought BENADRYL would help. They heard wheezing, they contacted the other pharmacist, who contacted EMS then they came and took her to the emergency room on 29Mar2021 in the afternoon. When she was wheeled in, the doctor met her in the hall and he said they could give her a steroid shot. The patient stated she was allergic to prednisone, she got a crazy rash, itching, it's not just prednisone, it's an allergy. She got the shot at 14:15 and she was at the hospital by 15:00. The patient thought she was there for 5 hours and then she was sent home. Her blood pressure dropped. The only one she saw was 114/39 but her husband saw it went even lower than that. At the emergency room, they had the automatic thing strapped on so they watched her until it started going back up again. The vaccine shot was probably the easiest shot she had ever had. She had never had any problems. She did not research it very well in the beginning because she thought they should be good. The patient was told to not get the second vaccine. The events also required physician office visit. Allergic reaction symptoms resolved on 29Mar2021 but the swelling of her throat and heart rate lasted about four days, until 02Apr2021. Neck pain resolved on 01Apr2021. Sore arm resolved on 03Apr2021 or 04Apr2021. Blood pressure dropping resolved on an unspecified date in 2021. Information on the lot/batch number has been requested.
61 2021-04-21 disturbance in attention, feeling abnormal Sore left arm even tho shot was in right. Very foggy brain...lack of focus for a day after shot.
61 2021-04-21 loss of personal independence in daily activities Woke up early the night of the shot with severe pain in left are below shoulder where shot was given... Read more
Woke up early the night of the shot with severe pain in left are below shoulder where shot was given. My arm has been painful to move..I thought would eventually go away but never did. Three weeks later still very painful and makes my job even more painful to do. It's a continual ache and hard to move.
61 2021-04-21 sleep disorder I had done some weight lifting on Wednesday morning, the day before dose 2. May have aggravated a ne... Read more
I had done some weight lifting on Wednesday morning, the day before dose 2. May have aggravated a nerve in my back but had no sensation of this until acute pain from mid upper back across shoulder and down right arm. Began exactly 12 hours post vaccine. And woke me from deep sleep. Could not get relief for several days until I contacted provider and was given Flexeril and Aleve. Could not lay down or sleep due to position of nerve in my back. (Vaccine administered in Left arm. ) Have never had a problem previously like this in my back. I exercise regularly. I surmise that if this nerve was aggravated, the inflammation induced by the vaccine made this worse where no vaccine and I would not have had a problem. Friday followed with typical side effects of lethargy and tiredness. Experiencing slight mobility issues in right arm post 13 days vaccination.
61 2021-04-24 excessive sleepiness Having injection site pain; Nausea; Can hardly hold her head up; She slept all day yesterday, and sl... Read more
Having injection site pain; Nausea; Can hardly hold her head up; She slept all day yesterday, and slept all night; She just gets hot; Feeling unwell; blood pressure was out of control; lymph nodes are not as bad, they are hurting; She is having hot flashes; Tiredness/ she is still tired; Muscle and joint pain; swollen lymph nodes under arm; muscle and joint pain; Chills; Headaches; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old-female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: CR8732 or LR8732) first dose on 03Apr2021 08:30 on right arm at single dose for COVID-19 immunization. Medical history included ongoing High blood pressure (Has had a long time), Breast cancer (Has had 6 years) and covid in Feb2021. History of all previously immunizations was No. Prior vaccincations wtihin 4 weeks was No. AE's following prior vaccinations was No. Concomitant medications included anastrozole (ARIMIDEX, strength 20 mg) for breast cancer (Has not taken the last 3 days, Did not want to take with the shot), bisoprolol fumarate, hydrochlorothiazide (BISOPROLOL HCT) for Blood pressure (States that she was taking 5-6.25mg and increased dose to taking 10 in the morning and 5 at night) and ongoing Vitamins. States that in Feb2021 had Covid and had gotten over that and was discharged. States that she might have had mild Covid and with all of the variances coming out, she wanted to get the vaccine. States that she got her first dose on Saturday (03Apr2021) and didn't know if she hadn't waited long enough. Caller states that she has been having terrible reactions. Has been having injection site pain but even had that with the flu shot. States that she has been experiencing tiredness, headaches, muscle pain, chills, joint pain, and lymph nodes under her arm were swollen where she got the shot. Has also been experiencing nausea and can hardly hold her head up. States that she slept all day yesterday, and slept all night. Woke up this morning feeling a little bit better, then the side effects took a hold of her again. Caller states that cancer meds made her gain weight and hasn't been able to get rid of it. Noticed Tiredness yesterday (04Apr2021) when she woke up. States that she had the vaccine on Saturday the 03Apr2021 at 8:30am, started to have headache that night. States when she woke up yesterday (04Apr2021), she started experiencing all of the other symptoms, tiredness, headaches, muscle pain, chills, joint pain, and lymph nodes under her arm were swollen where she got the shot. States that when she woke this morning, had thought everything was a little better but, then it hit her again. Clarifies she is still tired, and the headache still has not gone away. This morning (05Apr2021) she is having hot flashes, not so much the chills. The chills are still there but not nearly as bad, she just gets hot. She has been experiencing nausea and feeling unwell. States that the lymph nodes are not as bad, they are hurting but, not as bad. States that it is hopefully doing what it is supposed to do. States that she has been taking only Tylenol but has not taking it yet today. States that she is super scared to get the second shot. If this happened with the first shot, is terrified for the second shot. States that she has been taking Tylenol every four hours and is such a lightweight that she has only been taking one Tylenol every four hours. Caller states that she is supposed to be back 24Apr2021 for second shot but does not know if she can go through with it. States that this was recently increased when her blood pressure was out of control when she had gotten Covid. States that she was taking 5-6.25mg and her dose was increased dose to taking 10 in the morning and 5 at night. States that she is not taking as prescribed but she was too chicken to take the 10mg. States she will be back to see her doctor on 16Apr2021. States that she hates taking any medicine. Tests: States that she had bloodwork done Friday (02Apr2021) but has no idea of the results. States she will be seeing her doctor 16Apr2021 to go over the results. Vaccination facility type was Hospital drive up. Vaccine administered at military facility was No. No events required to ER. Caller states she has contacted her doctor to find out about her future vaccination. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
61 2021-04-24 insomnia felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Heada... Read more
felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Headache; nausea; could not sleep for 6 days; Heart Racing; Body shaking; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6208), via an unspecified route of administration, administered in arm right on 12Mar2021 09:30 (at the age of 61-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included asthma, blood pressure and cholesterol; all from an unknown date. The patient had known allergies. No covid prior vaccination. No other vaccines in four weeks. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR); chlorphenamine maleate, phenylpropanolamine hydrochloride (NASAMEX); simvastatine; ibuprofen; losartan; and furosemide (FUROSE); all were taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 10:00, the patient experienced chest pain, rapid heartbeat, high blood pressure, dizziness, felt like she was going to faint and couldn't walk so dizzy. Her heart raced/heart racing for 5 days, headache, nausea and could not sleep for 6 days and body shaking. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events. Double the dose of losartan for blood pressure. Not tested covid post vaccination. The outcome of the events was recovered.
61 2021-04-24 irritability Headaches started 2nd day of 2nd vaccine. About day 8, I began having ear ringing along with headach... Read more
Headaches started 2nd day of 2nd vaccine. About day 8, I began having ear ringing along with headaches. It has been 36 days now and the headaches are still there but not as severe. The ear ringing tho; It is extremely irritating; Headaches started 2nd day of 2nd vaccine. About day 8, I began having ear ringing along with headaches. It has been 36 days now and the headaches are still there but not as severe. The ear ringing tho; This is a spontaneous report from a contactable consumer (patient). This 61- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: ER8733), via an unspecified route of administration, on 01Mar2021 at 12:00 AM (at the age of 61-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was reported as "other" and anatomically located on the left arm. Historical vaccine included: bnt162b2 (COMIRNATY, Solution for injection, Lot number EL9265,) dose 1 on 08Feb2021, for covid-19 immunization. No allergies to medications, food, or other products. The medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021, she experienced Headaches started 2nd day of 2nd vaccine. About day 8, I began having ear ringing along with headaches. It has been 36 days now and the headaches are still there but not as severe. The ear ringing thou is still present 24/7. It is extremely irritating and there is nothing i can do to make it better. Treatment was not received for the adverse event. The clinical outcome of the events was not recovered. On 05Apr2021, the patient was tested for COVID-19 via Nasal Swab since having the vaccine, with a negative result. No follow-up attempts are possible. No further information is expected.
61 2021-04-26 feeling abnormal when woke up today 4/27/21 at 7am, exhausted, muscle ache, headache, fever 101.3, foggy brain, 2 new... Read more
when woke up today 4/27/21 at 7am, exhausted, muscle ache, headache, fever 101.3, foggy brain, 2 new symptoms that I didn't get with first vaccine: VERY thirsty, bloodshot eyes
61 2021-04-27 confusional state Presented to emergency department with complaints of fatigue, cough, diarrhea, epigastric pain, conf... Read more
Presented to emergency department with complaints of fatigue, cough, diarrhea, epigastric pain, confusion, and malaise. Patient was admitted for hyperglycemia, suspected UTI and COVID-19 infection. Patient reported symptoms started around the same time of vaccination. Patient is still admitted at time of writing.
61 2021-04-27 insomnia I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pai... Read more
I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pain got worse; tired; earache; swelling; itching; stinging; peeling; hurt my throat; throat was swelling; couldn't sleep; rash; burning; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunization. Medical history included Asthma, HBP, High Cholesterol, prediabetes. Known allergies: Penicillin, Sulfa, Peanuts. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; atenolol, chlortalidone (ATENOLOL/CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRAL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10Apr2021, the patient experienced anaphylactic reactions, tired, earache, swelling, itching, stinging, peeling, hurt my, throat was swelling, couldn't sleep, rash, burning, the neck itching/burning and throat/ear pain got worse. It was reported that 09Apr2021- got her 1st Pfizer COVID shot. Left arm. Felt okay afterward, got a little tired later on. On Sunday, she woke up w/an earache on her left side, which moved down into her neck - near her lymph nodes. Later, her neck started swelling/itching/stinging/feeling warm, and it hurt her throat to swallow anything. She went to get Benadryl and anti-itch creams, but they didn't work. The neck itching/burning and throat/ear pain got worse, and at one point it felt like her throat was swelling and getting narrow, and she wondered if this was one of those anaphylactic reactions. So she took 2 Benadryl, and that seemed to help. That night she couldn't sleep for the neck heat, itching and throat pain. Monday AM (12Apr2021), she took her temp, which was 100.2. She did a Teladoc Zoom so the doc could see the situation, and he said that it could be a severe vaccine reaction, or some kind of infection. He prescribed prednisone & clindimycin. The rash left scars, which are peeling. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Prescription drugs. Outcome of the events was recovering.
61 2021-04-28 feeling abnormal, nightmare, insomnia First shot was fine - no symptoms. Second shot - severe flu type symptoms, headache, body aches, ch... Read more
First shot was fine - no symptoms. Second shot - severe flu type symptoms, headache, body aches, chills. Had trouble sleeping the following night of the vaccine with nightmares, unable to sleep at all, just plain felt miserable and had difficult time getting out of bed.
61 2021-04-29 amnesia Global amnesia. Husband took me to specialty hospital ER. Cat scan and exams done. Taken to their fa... Read more
Global amnesia. Husband took me to specialty hospital ER. Cat scan and exams done. Taken to their facility for observation, telemetry etc overnight
61 2021-04-29 anxiety Shortly after receiving the vaccine, Client complained of lightheadedness. She noticed it when she ... Read more
Shortly after receiving the vaccine, Client complained of lightheadedness. She noticed it when she started to get up to leave as she had sat there for 30 minutes. She does admit to having some anxiety about getting the shot as she has had an anaphylaxis reaction to both pyridium and macrobid requiring ED intervention. She carries an epipen with her. She is on Metoprolol as she throws quite a few PVCs. BP at 11:55 am 186/88- pulse-64 and ox reading 97%. Encouraged to drink some water to hydrate as has not drank much today. BP at 12:05 pm BP=184/84 and light headedness has resolved and able to leave. Card with contact information given to Client if any other side effect should be experienced. Encouraged her
61 2021-04-29 impaired work ability After my vaccine, I passed out. I went to the hospital for three days and they told me I had an ocul... Read more
After my vaccine, I passed out. I went to the hospital for three days and they told me I had an ocular migraine. I also had a post concussion syndrome and was out of work till 04-12-2021 with nausea and severe migraine headaches. I still have headaches today and I am on migraine medication.
61 2021-04-29 sleep disorder, feeling abnormal At 11:15 p.m. (10 hrs. after shot), I woke up nauseous, sat up in bed and felt weird, got up and mad... Read more
At 11:15 p.m. (10 hrs. after shot), I woke up nauseous, sat up in bed and felt weird, got up and made it to the foot of bed and passed out. When I came to, had my husband get me a cold rag, but then I felt diarrhea hit, I crawled to the hall to the bathroom, stood up and had the uncontrollable shakes so bad the whole toliet shook with me. After I finished in bathroom I went back to bed and literally shook for 1 1/2 hours and was up most of the night. This was my 2nd shot. On the 1st shot it made me feel like I was in a fog, like when you pass out and come to and your not all there. Took 3 hours to shake that one. I don't know what is in the freakin thing, but my body cant take this kind of stuff and I WILL NOT be doing any more of this quickly made, quickly approved vaccines. Count me out for any further ones. I'M DONE !!! I have never taken the flu shot ever so I WON'T be doing any more of these no matter how much the CDC pleads with me
61 2021-04-29 sleep disorder Patient received first dose of Pfizer Covid 19 vaccine on 03/12/21 in am and by 8pm same day, she wa... Read more
Patient received first dose of Pfizer Covid 19 vaccine on 03/12/21 in am and by 8pm same day, she was experiencing numbness and tingling in left arm, from acromian process to hand/fingers. She also report pain in arm, especially at night which wakens her. she is able to relieve the pain by stretching and extending left arm above her head. She has received second dose of Pfizer Covid 19 vaccine on 03/30/21 in right deltoid and has not experienced these symptoms. The symptoms reported in left upper extremity continue through today. 04/30/21.
61 2021-04-30 feeling abnormal She will be deceased, most likely, if she does.; arms really heavy, can hardly lift them; arms reall... Read more
She will be deceased, most likely, if she does.; arms really heavy, can hardly lift them; arms really heavy, can hardly lift them; She feels sick and unwell; face little swollen; chest pain; pressure in chest; ears ringing; Difficulty breathing; Migraine headache; heart palpitations; Chills; nausea; really red face, cheeks; back pain a lot worse; very high fever; This is a spontaneous report from a contactable consumer (patient) A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunisation . Age at vaccination :61 years. Medical history included ongoing epilepsy (started at 16 years old. Has not had a seizure in years, maybe 20 years) ,herniated disc and chronic back pain from 2003 and ongoing , Heart septal defect (repaired) and seizure disorder.Concomitant medication(s) included carbamazepine (CARBAMAZEPINE)at 200 mg, 1x/day taken for seizure from an unspecified start date and ongoing. The patient experienced "she will be dead, most likely, if she does" on an unspecified date , difficulty breathing on 10Apr2021 with outcome of unknown , very high fever (on 08Apr2021 with outcome of recovering , migraine headache on 10Apr2021 with outcome of recovering , heart palpitations on 10Apr2021 with outcome of not recovered , back pain a lot worse on 08Apr2021 with outcome of not recovered , ears ringing on 10Apr2021 with outcome of recovering , chills on 09Apr2021 with outcome of recovering , nausea on 09Apr2021 with outcome of not recovered , pressure in chest on 10Apr2021 with outcome of not recovered , chest pain on 14Apr2021 with outcome of not recovered , arms really heavy, can hardly lift them (non-serious) on 15Apr2021 with outcome of recovering , really red face, cheeks on 09Apr2021 with outcome of not recovered, face swelling on 14Apr2021 with outcome of not recovered and She feels sick and unwell on 14Apr2021 with outcome of not recovered. Clincal course was reported as follows:On 08Apr2021 she had her vaccine. She is running a fever and has every side effect on the template from the pharmacy. She is not doing good and should probably be in the hospital. She can not drive her self, or have anyone else drive her. She feels really bad and is afraid of a clot. This is from the first shot and she is not getting another. She will be dead, most likely, if she does.She can hardly lift her arms up. She did not see this in list of side effects and doesn't know what that is.She tried to make a claim with Covid compensation number, but was unable to connect with them. Her symptoms started 3 days ago. She did this in case she had to. She read she has to keep her fever down. She just took some Tylenol.She didn't look for few days at the paperwork provided to her after the vaccine. She was seeing side effects and she got nervous, this is why she didn't call earlier.She is having trouble breathing now and has never been so sick. Caller asking how long the side effects last and needs to talk with Medical Information.Her Mother recommended she receive the vaccine and told her of all these people coming across the boarder and that they may bring Covid with them.She had a septal defect repaired in her heart. She doesn't know if there could be something wrong with that, but her doctor and heart doctor said she is fine. They haven't found anything from the testing she had had.Her difficulty breathing is on and off. It started 2-3 days after, and she doesn't know with her heart palpitations and if there could be damage. That's why she called the Covid compensation.The first day, she had a very high fever and headache. She didn't take her temperature, but she knew it was a fever. Today it is not as high as it was, it's not bad.She had a migraine and took something for it and it went away for hours. She took aspirin, Bayer Back and Body, and her fever and headache went away for hours.She experiences heart palpitations. Every time she eats they get worse. She has reported this to her physician. Her Physician said to take Tylenol and gets exercise. She recommended she doesn't lay up and caller thinks she wanted her to go to the hospital. Caller's mother can't drive and her sister is dying of cancer. Caller lives near her mother but she can't drive. She's older and caller can't ask her to do that.Her palpitations are sometimes there.She has a back injury from someone hitting her from behind. It is extreme back pain. It worsens after she gets a vaccine. She gets on the heat pad. She doesn't have anything for it, just some patches.Her ears are not ringing now and might be getting better. She had chills, but they're better today.She had nausea. It's better today. Yesterday, when talking to her doctor caller was advised to exercise. That makes her feel worse. It's not a big thing. She feels sick and unwell.Her face is really red and maybe a little swollen. Her Physician was thorough and she even asked about it, and commented it sure is red.Caller lays in bed and keeps her feet up. She knows she's got to move around, her Physician told her to.Caller is concerned about a blood clot. She is having pressure and pain in her chest. It has been the same. What's new is chest pain yesterday and did not feel bad, but it is noticeable. She hopes it doesn't get worse. What is new is her arms feel really heavy and she can't hardly lift them.Her facial redness worsened with her fever. The Tylenol is working, her fever is going down, but her arms are still heavy, but better.Treatment received for arms really heavy, can hardly lift them and very high fever.Additional information:Vaccination Facility Type: Pharmacy/Drug Store . No COVID Prior Vaccinations
61 2021-04-30 feeling abnormal severe vertigo; fall down on the floor; nausea; horrible spinning; vomited; dizzy; generalized weakn... Read more
severe vertigo; fall down on the floor; nausea; horrible spinning; vomited; dizzy; generalized weakness; brain fog; a little tired; a little off; Fatigue; sore arm; couldn't eat; couldn't open her eyes; nystagmus; couldn't walk at all without help; This is a spontaneous report from a contactable consumer, reporting for herself. A 61-year-old female patient received the second dose of the bnt162b2 (BNT162B2; Lot Number: EN6208; Expiration Date: Jun2021), via an unspecified route of administration in the right arm on 19Mar2021 at 13:30 at a single dose for covid-19 immunisation. Medical history included ongoing celiac disease diagnosed in 2012 and has been gluten free ever since, allergies, and anxiety. Concomitant medications included zolpidem tartrate (AMBIEN) taken for sleep; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for allergies; alprazolam (MANUFACTURER UNKNOWN) taken for anxiety; vitamin d nos (MANUFACTURER UNKNOWN) taken for immune system health; and magnesium (MANUFACTURER UNKNOWN) taken for health. The patient previously received the first dose of the bnt162b2 (Lot number: EN6203) at 61 years of age on 26Feb2021 between 5:15PM and 5:30PM in the left arm at a single dose for covid-19 immunization and the flu vaccine (INFLUENZA) for immunization 15 years ago and experienced arm was sore. There were no other prior vaccinations within 4 weeks. On 19Mar2021, the patient experienced sore arm. On 21Mar2021, the patient experienced a little off, fatigue, brain fog, a little tired. On 31Mar2021, the patient experienced severe vertigo, fall down on the floor, nausea, vomited, horrible spinning, generalized weakness. In 2021, the patient experienced couldn't open her eyes, couldn't eat, nystagmus, could not walk at all without help. On an unknown date, the patient experienced dizzy. The events, severe vertigo, fall down on the floor, nausea, vomited, and horrible spinning, required emergency room and physician office (video) visits. The patient was hospitalized for severe vertigo, fall down on the floor, nausea, vomited, and horrible spinning from 31Mar2021 to 02Apr2021. The clinical course was as follows: the patient received the second dose on 19Mar2021 and she didn't really have any bad side effects, a sore arm, and a little tired on the second day, maybe a little off but was fine. 12 days later she was vacuuming and had severe vertigo, she was down on the floor, just horrible spinning, horrible nausea and laid on floor and vomited all day. Her doctor told her to go to the ER. They did all kinds of tests with unknown results on an unknown date and she could not open her eyes for 2 days, she was so violently spinning with vertigo, they gave her fluids. She went in on Wednesday and by Friday she was a little better, she could open her eyes, still had spinning and vertigo. It was like nystagmus, her eyes were, she just really couldn't open her eyes for the doctor, had generalized weakness and couldn't walk at all without help in the hospital. The only time she moved from one position was to go to the bathroom with assistance. In the ER, she could not get up out of bed the first night they were trying all ways of catharizing her. She could not even get out of the bed with the help, they had to carry her to the CAT scan with negative result on 31Mar2021. She had slightly improved but still had vertigo and she was not vomiting anymore, that was only the first couple days. She was sent home with medications for dizziness and nausea but they didn't do anything. Two weeks later she was still dizzy, had vertigo, it was way better than it was, she can open the windows a little bit but she was basically in a dark room for like the first week and a half. Not violent like it was the first couple of days. The events were further described as: she was a little sore on 19Mar2021, 20Mar2021, 21Mar2021, and maybe the 22Mar2021 her arm was still sore. She clarified the sore arm pretty much ended on the 22Mar2021. She was surprised she felt fine on 19Mar2021 and 20Mar2021 and on the evening of 21Mar2021, in the middle of the night between 20Mar2021 and 21Mar2021 she felt a little off and a little more tired. On 21Mar2021, she didn't feel great, fatigued and brain fog but was fine after that. She began feeling a little off and a little tired early morning on the 21Mar2021. That was pretty much gone by the 22Mar2021. The feeling tired and a little off and the brain fog and fatigue went away 22Mar2021. She vomited constantly, started suddenly and violently and was incapable of moving, all she did was vomit and lay on the floor. It was a complete 360, she was fine vacuuming a minute before and then suddenly got dizzy and went down and could never get up. She had to be taken from upstairs in her house and transported to the hospital. She was not really experiencing the nausea now, she was not completely herself but she can eat, she couldn't eat for the first couple of days and was on IV fluids and once she got out of the hospital was able to eat a little and now eating almost normally. It took a week to eat normally and she couldn't eat holiday dinner on 04Apr2021. From 31Mar2021 to 10Apr2021, every day the nausea has slightly been improving. She was not quite herself and still has vertigo and was making herself eat her meals. She vomited 30 times and in the hospital they gave her an IV to stop that and never vomited in hospital, maybe once in the ER. She confirmed the 31Mar2021 was the last time she vomited. She had not recovered completely from nausea. She used be running around all the time, she would walk 10 miles per week to exercise, yesterday she had a mammogram scheduled and she was just so wiped out for doing something for the first time and had to lie down for the whole rest of the day. She was hospitalized from 31Mar2021 until the evening of 02Apr2021 when they let her out. She was given medication for nausea and dizziness didn't do anything. She was given ondasetron (ZOFRAN), 4 mg and meclizine. Because of her weakness, the patient was checked to see if there was any brain bleed or brain stem problems that would explain the vertigo and did not find anything. The tests were negative for any brain problems on an unknown date. Lab data included: blood levels: low on vitamin d (probably because she was not absorbing nutrients as well) on an unknown date, endoscopy: unknown results on an unknown date, and MRI: negative on 01Apr2021. Therapeutic measures were taken as a result of severe vertigo, fall down on the floor, nausea, horrible spinning, vomited, and dizzy. The clinical outcome of the events, severe vertigo, nausea, generalized weakness, could not open her eyes, nystagmus, could not walk at all without help, was recovering. The clinical outcome of the events, fall down on the floor, horrible spinning, dizzy, was unknown. The clinical outcome of the events, a little off, fatigue, sore arm, brain fog, and a little tired, was recovered on 22Mar2021. The clinical outcome of the event, vomited, was recovered on 31Mar2021. The clinical outcome of the event, could not eat, was recovered in 2021. No follow-up attempts are needed. No further information is expected.
61 2021-05-01 anxiety ANXIETY, DRY COUGH, DIFFICULTY BREATHING. FIRST BP 195/86, SECOND BP 163/86. SYMPTOMS IMPROVED, REFU... Read more
ANXIETY, DRY COUGH, DIFFICULTY BREATHING. FIRST BP 195/86, SECOND BP 163/86. SYMPTOMS IMPROVED, REFUSED TRANSPORT, AMA SIGNED.
61 2021-05-03 impaired work ability I am an employee of a medical facility. After the 2nd Pfizer vaccination, which was administered at ... Read more
I am an employee of a medical facility. After the 2nd Pfizer vaccination, which was administered at the facility, I spent the next day in bed with mild flu like symptoms. I slept most of the day but on the second day I felt fine and went to work. I started noticing a ringing in my left ear upon waking on 2/10/2021. The tinnitus continues at this time. I did test positive for Covid-19 the week of Thanksgiving 2020 and was on Workman's comp for 20 days. I have tried to educate myself on tinnitus and noticed that most information says that there is no cure or real treatment. But after a recent article about those of us who have Tinnitus due to Covid-19 or the Vaccine, I will contact an ENT doctor to see if Steroids might work.
61 2021-05-05 anxiety, nervousness Second vaccine given at 1627. 1700 pt. Stating having tingling lips and feeling shaky. Taken to sit ... Read more
Second vaccine given at 1627. 1700 pt. Stating having tingling lips and feeling shaky. Taken to sit in observation area to sit and VSS BP178/92, HR 92, sat 98%. Benadryl, 25mg PO given with water. VSS 1705 BP191/88, HR 90 and sat 94%. 1710 162/91, 90, 99%, 1715 158/91,93,96%Patient put on cart with knees up and cont. To complain of dizziness and left neck stiffness. 1720 166/83,85HR,99% 1725 154/83, HR85, 99% 1728 157/91, HR 86, 98% 1732 156/94, HR 86, 99% 1737 175/87, HR 86, 99% Took patient into wheelchair, complaining of head spinning 1741 184/72, HR 90, 97% 1747 155/87, HR 90, 98% 1751 187/91, HR 95, 95% Patient was going to attempt to go to car, but continued with dizziness; EMS called. 1756 182/84, HR 97, 99% EMS arrived at 1800; took down history 1800 182/91, HR 99, 99% Patient transferred to cart and taken to hospital. Patient alert/oriented x3, anxious for the entire encounter.
61 2021-05-07 anxiety, feeling abnormal Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the bac... Read more
Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the back kind of by the lungs; She has been sick; Her mental status was also affected; What scared her was not feeling like she was getting enough oxygen; Nausea; Body pain/flu-like body pain in her muscles over her shoulders; Out of it; Pain in her back where her lungs are; Problems breathing/Her breathing still almost feels labored; Hot and cold sweats; Dizzy; Shaky; Weak; Tired; Headache; Anxious; Fever; Itchy; Arm hurt; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 61-year-old female patient received first dose BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (Batch/Lot Number: TW0151) as SINGLE DOSE for covid-19 immunization. Medical history included cancer, pneumonia, pain in her lungs, smoker and arthritis. The patient's concomitant medications were not reported. The patient experienced what scared her was not feeling like she was getting enough oxygen on an unspecified date, problems breathing/her breathing still almost feels labored on 11Apr2021, arm hurt on 09Apr2021, pain in her back where her lungs are on 11Apr2021, hot and cold sweats on 10Apr2021, dizzy on 10Apr2021, shaky on 10Apr2021, nausea on 13Apr2021, body pain/flu-like body pain in her muscles over her shoulders on 11Apr2021, out of it on 11Apr2021, weak on 10Apr2021, tired on 10Apr2021, headache on 10Apr2021, anxious on 10Apr2021, fever on 10Apr2021, itchy on 09Apr2021, feeling like maybe there is something wrong with her spleen on an unspecified date, the pain is in the left side of the back kind of by the lungs on an unspecified date, she has been sick on an unspecified date, her mental status was also affected on an unspecified date. Patient had the first dose of the Covid Vaccine on 09Apr2021 and gradually her arm hurt, she had hot sweats, she felt dizzy, was shaky, had nausea, and had body pain. The one thing she is concerned about was she had pain in her back where her lungs are and she was having problems breathing. She has a little bit of that still. She has also been out of it. Her breathing still almost feels labored, and this past weekend she thought she would go to the emergency room. Her main concern is this awful pain in her back while she was having problems breathing and getting enough oxygen. She felt weak, dizzy, and shaky. She got scared. She has been sick, she had cancer a long time ago. What scared her was not feeling like she was getting enough oxygen. The pain is in the left side of the back kind of by the lungs. It goes directly from the front to the back. On Monday it started feeling better. Today it is so much better. She will feel like she is not getting enough oxygen or giving a full breath and then this in her back. She remembers having pneumonia years ago and having pain in her lungs. That's why she knows the pain is in the back of her lungs. She has to say she is a smoker. She slowed down and couldn't smoke this week or during that. She kind of quit, that's her reality now. The pain comes and goes throughout the day but it is not as bad. She didn't have this shortness of breath and other things until a couple days after she got the vaccine. It gradually came up on her. She was not having trouble breathing, it was more slightly labored. It was not profound, just there. Sometimes when she is speaking after a while she gets tired and will have to take a moment and take a deep breath. It is so much better. She called her primary care physician and was anxious, and all he said was she would feel effects for 2 weeks. He wasn't very helpful. Her arm hurt the day that she had the shot. Even today there are little bits of pain but very light. 09Apr2021 through 11Apr2021 was when everything really hit. It was hard to lift up her arm. It was a little pain, it was no big deal. She would have the AC on and blast it when she had the hot and cold sweats. She was using napkins because she was sweating profusely. It felt like she obviously had a reaction to the vaccine. It's normal she guesses. She didn't expect it for the first dose. The 11th, 12th, 13th, and 14th it was really bad. Her whole body was sweating and would get wet. She'd be hot and then cold. She was anxious because she was having problems breathing. She still gets a little bit of hot and cold sweats, but nothing compared to what she went through. As the days go on she is slowly getting better. She was dizzy not just during the day, at night she couldn't sleep because of it. She has gradually gotten better. Yesterday she tried to do some gardening but felt so weak she had to come back inside. When she gets up she feels weak and a little bit of lack of air. She has labored breathing. She was real itchy. The shakiness, dizziness, and anxiety all came on and were horrible. She doesn't know if the nausea was because she couldn't eat and had to take her regular medication. It was very light nausea. She had flu-like body pain in her muscles over her shoulders. Her headache was major too during all of this. The headache is something that comes and goes still. It is a weird kind of headache. She had a fever and got like flu all over body pain. She doesn't know how to explain how she felt out of it. She doesn't know if it was the fact she was so sick. She had a feeling of did she do that. She couldn't make decisions. She would need to take the garbage out and go back to the garbage and think what did she come here for. Her mental status was also affected. The weakness gradually got really bad, and she still hasn't recovered from it. She still feels weak and tired when trying to do things. She was tired the day after she got the vaccine. The first day she thought it was nothing and she was fine. Gradually it got real bad when she was sick. She didn't feel that flu-ish feeling but was weak and tired. She got dizzy and she had the brain fog thing. She was having really bad headaches during the same time. The weakness and tiredness go hand in hand. She takes a mineral for her thoracic spine, but she takes that more for elderly arthritis. She doesn't have any conditions that she thinks played a role. She has been feeling like maybe there is something wrong with her spleen. Took Tylenol for her fever. Mentioned fever would go away and come back. The patient underwent lab tests and procedures which included body temperature: 102, 99 and 100.1 (unit unspecified) all on unspecified dates. Therapeutic measures were taken as a result of fever and itchy. Outcome of the event problems breathing/her breathing still almost feels labored, arm hurt, pain in her back where her lungs are, hot and cold sweats, dizzy, out of it and headache was recovering. Outcome of the event fever was recovered on 13Apr2021, itchy was recovered with sequelae on 14Apr2021, body pain/flu-like body pain in her muscles over her shoulders was recovered on 16Apr2021, nausea was recovered on 16Apr2021, shaky was recovered on 19Apr2021. Outcome of the event weak and tired was not recovered. Outcome of all the other events was unknown.
61 2021-05-08 memory impairment, confusional state Patient started having numbness and joint pain in her left arm within one hour of administration. By... Read more
Patient started having numbness and joint pain in her left arm within one hour of administration. By that evening, she had pain in all her joints. Joint pain lasted 3-4 days. She had vertigo when standing. Experienced confusion and forgetfulness for 24-36 hours.
61 2021-05-09 feeling abnormal Mild/moderate loss of bladder control Off balance Injection site pain Headache/ stabbing pain in lef... Read more
Mild/moderate loss of bladder control Off balance Injection site pain Headache/ stabbing pain in left temple area,a little in the right temple/"spacey" feeling Lower back pain/General muscle weakness Chills/ low grade fever Nausea Congestion/cough Lasted 24-48 hours
61 2021-05-09 loss of personal independence in daily activities Day after injection- diarrhea for two days and sore arm. Five days after injection left arm so sore ... Read more
Day after injection- diarrhea for two days and sore arm. Five days after injection left arm so sore I couldn't use it. Prescribed Motrin 600. Pain gone in two days.
61 2021-05-09 sensation of foreign body Respiratory symptoms - Burning pain when inhaling in lower trachea and upper chest. Feeling of weig... Read more
Respiratory symptoms - Burning pain when inhaling in lower trachea and upper chest. Feeling of weight on upper chest. Breathing was not obstructed. Chills but not fever, hypothermia (97.1 F), body aches, dizziness, spots and floaters in vision, tiredness, slight nausea. Note this related find from internet research: A team of researchers have found that exposure to the SARS-CoV-2 spike protein alone was enough to induce COVID-19-like symptoms, including severe inflammation of the lungs. https://medicalxpress.com/news/2021-04-sars-cov-spike-protein-lung.html Messenger RNA vaccines work by instructing cells to create "spike proteins." These proteins simulate part of the SARS-CoV-2 cell structure and trick the body into believing it's infected with the virus.
61 2021-05-10 agitation Patient arrived at the hospital 6 days after her vaccination. She had been experiencing 4 days of i... Read more
Patient arrived at the hospital 6 days after her vaccination. She had been experiencing 4 days of increased agitation and 3 days of altered gait.
61 2021-05-10 anxiety, panic reaction Anxiety; Panicked Feeling; Panicked Feeling; upset/mad; Chills; This is a spontaneous report from a ... Read more
Anxiety; Panicked Feeling; Panicked Feeling; upset/mad; Chills; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Apr2021 09:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history included panicked feeling and stopped on unknown date. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 for COVID-19 Immunization and experienced Sore Arm. The patient stated she seemed alright on 20Apr2021. She had chills in the evening 20Apr2021 and took Tylenol and drank water like she was told. this morning on 21Apr2021 she had anxiety. A panicked feeling. She hasn't felt that way in years and felt that how she was feeling now was most likely due to the vaccine. She became upset she even got the vaccine and stated she was mad. The events outcome was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
61 2021-05-10 feeling abnormal bled a bit; pain in left finger joints/ joint aches; sudden heaviness in arm; chills; severe fatigue... Read more
bled a bit; pain in left finger joints/ joint aches; sudden heaviness in arm; chills; severe fatigue; over all unwell/uneasy feeling; Nausea started about the 5th hour; feeling feverish, but never had a real fever; odd little pains in the left side of her neck; tension type headache; foggy; blood vein and possibly a nerve was hit; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 03Feb2021 (lot number: EL9265) at 10:00 at single dose for COVID-19 immunisation. The relevant medical history included arthritis, breathing issues - asthma/copd still being tested, hypertension, liver issues and known allergies: Ct contrast, Dilaudid, Flagyl combined with doxycyline or cephlexinc. Concomitant medications were reported as none. At injection, a blood vein and possibly a nerve was hit. She felt the nurse followed all proper protocol for finishing the injection and notifying RN in charge. On 03Feb2021 at 2:00 PM, the patient had immediate pain in left finger joints and sudden heaviness in arm within a couple of minutes. It bled a bit. She was still having some issues with the hand, but the injection site was fine. She was concerned about the number of symptoms, the severeness and the length of time they had lasted. This was very worrisome and unexpected from all other accounts by others and everything she had read on the first vaccine. She was feeling 'off' within 2 hours, by the 4th hour She had developed chills, severe fatigue and over all unwell/uneasy feeling. Nausea started about the 5th hour and she started feeling feverish, but never had a real fever, odd little pains in the left side of her neck, but that subsided. Developed tension type headache, joint aches, foggy. This continued for about 4 1/2 days. Unable to function without Tylenol every 5hr. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.
61 2021-05-11 sleep disorder I have an appointment with an ENT next Monday. The ringing is non-stop. I have to sleep with noise a... Read more
I have an appointment with an ENT next Monday. The ringing is non-stop. I have to sleep with noise at night so that I can get to sleep.
61 2021-05-12 nervousness, anxiety Client began to feel anxious and shaky after receiving the vaccine. Fire Rescue at the scene to eval... Read more
Client began to feel anxious and shaky after receiving the vaccine. Fire Rescue at the scene to evaluate client. Clients BP was elevated but all other vitals stable. Client states hx of high BP and did not take BP meds this morning. Client began to feel much better and blood pressure came down. Per Fire Rescue no further evaluation needed. Client exited park at 2:30pm.
61 2021-05-13 euphoric mood Patient looked lethargic during her 15-minute monitoring period. She stated she felt like she couldn... Read more
Patient looked lethargic during her 15-minute monitoring period. She stated she felt like she couldn't breath, "she felt high." Administered oxygen. Provider instructed to give EpiPen 0.3mL. Patient transported to hospital.
61 2021-05-13 excessive sleepiness slept for 2-3 days; Body was Sore; First Dose: Diarrhea; worn out; Arm was sore; This is a spontaneo... Read more
slept for 2-3 days; Body was Sore; First Dose: Diarrhea; worn out; Arm was sore; This is a spontaneous report received from a contactable consumer (patient's husband). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Jan2021 13:45 at 61 years old (Lot Number: EL1284) as single dose for covid-19 immunisation. Medical history included ongoing seizure, seizures began when she was 5 years old, minor seizures. Seizures were under control in 1984, possibility configuration it is the right cocktail; Nerve injury; swelling on the wound leg; Blood pressure abnormal. Family history was none, states her Dad died last year, he was old, died of old age and natural causes. As people get older their body falls apart, nothing that is cancerous. States her Mother died of her heart, something to do with the heart and that was before they got married in 1984, he never met her mom. Concomitant medications included ongoing gabapentin taken for Nerves, she has been taking that for the last 7 years, states she has a wound on her left leg and that was being treated by a wound doctor for the last 7 years, states he got tired of what the wound doctor was doing so he drove her to (withheld) to be treated. Caller states the wound doctor at (withheld) made a suggestion on how to bandage it up and medicate it and it went from 8Jan2021 length was 7.5mm by 10mm and with (withheld) suggestion yesterday it was 1mm by 0.7 mm, so half the size of a penny, states he anticipated within the next week or two weeks that it will be healed; ongoing valproate semisodium (DIVALPROEX) taken for seizure, states she has been taking for at least 20 years; ongoing furosemide taken for Water Pill, states she takes it to reduce swelling on the wound leg; states he gives it to her on the odd day of the month; ongoing metoprolol taken for Blood pressure abnormal, start and stop date were not reported; ongoing zinc taken for an unspecified indication, start and stop date were not reported; ongoing acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported; ongoing pramipexole taken for seizure, start and stop date were not reported, states she takes it at 6pm, because it makes her drowsy and so the best time is at night time when she goes to bed; ongoing Vitamin C taken for an unspecified indication. No other vaccines were administered on same Date of the Pfizer Suspect, every year they get the flu shot and everything is normal. Caller states his wife got her first shot on 09Jan2021. States the effects started immediately, her arm was sore and then the next day (10Jan2021) her body was sore and she had diarrhea for 2-3 days and she also slept for 2-3 days, she was worn out. On the 3rd or 5th day she said she feels good, lets go. Caller states, then they were okay. The outcome of the events was recovered on 12Jan2021.
61 2021-05-14 excessive sleepiness Second blood clot that traveled to her brain which caused her to have a stroke; Blood clot in her ri... Read more
Second blood clot that traveled to her brain which caused her to have a stroke; Blood clot in her right leg; Weight Loss from 258 pounds, down to 208 pounds, back up to 214 pounds.; She has to learn how to walk again, she is in a wheelchair now; Having Problems Swallowing from the Stoke; Speech went down to 25% and now she is at 50%, because of the Stroke; high blood pressure; slept five days; Arm was Sore; Body was Sore; Diarrhea; Slept and was Totally Exhausted; This is a spontaneous report received from a contactable consumer (husband of the patient) and a contactable other healthcare professional. This consumer reported similar events with different doses of the same product; this case refers to dose 2; only this case is serious. A 61-year-old adult female received the second dose of BNT162B2 (solution for injection, Lot EL3246 expiry information not provided) as a single dose via an unspecified route on 30Jan2021 at 13:45 (at 61-years-old) for COVID-19 immunization. Relevant medical history included ongoing seizures (1964; began at 5 years old, minor seizures; under control in 1984, possibility configuration it is the right cocktail), and wound on her left leg (that was being treated by a wound doctor for the last 7 years). Concomitant medications included gabapentin; 300mg three times a day by mouth (6am, 2pm and bedtime) ongoing from 2014 for nerves; valproate semisodium (DIVALPROEX; 500mg two tablets in the morning and one tablet at 6pm ongoing from 2010 for seizures furosemide 20mg every 48 hours (odd days); States she takes it to reduce swelling (diuresis)on the leg wound leg; states he gives it to her on the odd day of the month from an unspecified date; metoprolol (50mg) one tablet twice a day (6am and 6pm), for Blood pressure management; ascorbic acid, zinc (VITAMIN C WITH ZINC; 500mg/50mg) once daily from an unspecified date for an unspecified indication; acetylsalicylic acid (ASPIRIN) 81mg once daily from an unspecified date for an unspecified indication; and pramipexole 0.5mg once daily at 6pm ongoing from an unspecified date for seizures. The patient previously received COVID-19 immunization with the first dose of BNT162B2 (solution for injection; Lot EL1284) on 09Jan2021 (at 61-years-old) and experienced arm was sore, slept for two to three-days, body was sore, and diarrhea. The consumer reported that on 30Jan2021, the patient experienced her arm was sore, her whole body was sore for about five days, she had diarrhea for five days, and she for slept five days and was totally exhausted. The consumer then reported that on 22Feb2021, she developed a blood clot in her right leg. The reporter explained that her leg swelled up and turned dark blue, almost black. The consumer reported that the patient was immediately rushed to the hospital. Caller states they did all sorts of tests and confirmed she had a blood clot in her right leg. States she was hospitalized from 22Feb2021 through 26Feb2021, so for five days. Caller states the leg went back to normal color, the swelling went down and she felt good. Caller states they came home on 26Feb2021, and she was up moving around, and everything was wonderful. On an unspecified date in Feb2021, around the time of the first blood clot, the patient was diagnosed with high blood pressure. Caller states on 12Mar2021 she had a second blood clot that traveled to her brain which caused her to have a stroke. Caller states when they got to the hospital they said she had a stroke from a blood clot that was somewhere in her system and it traveled to her brain. Caller states she was hospitalized from 12Mar2021 through 16Mar2021 when she was released from the hospital. Caller states she was too sick to go home so she was transferred to Rehab Center. She was there from 16Mar2021-27Apr2021. Caller states on 27Apr2021, she was transferred for rehab. Caller states at the center they only give rehab once a day for 30 minutes and he only works five days a week. Now she gets three hours of physical therapy a day and it is seven days a week. States they are working to get her to walk again and she is receiving speech therapy. States she has to learn how to walk again. Caller states her lowest weight was 208lbs, and they weighed her in yesterday and she was at 214lbs. Caller states with the stroke when she was at the hospital, they put her on baby food because she was having problems swallowing. While at rehab center she went from baby food to mechanical food. On 27Apr2021 she went to regular food. Speech because of the stroke went down to 25% and now she is at 50% and she is also getting one hour of speech therapy at hospital. Caller states they recognized it is important to get as much therapy as possible in the first 90 days, they call it a boot camp and patients are limited to 90 days to repair the damage. After 90 days, that is it. States that is why it was important to transfer her to hospital to heal and get back to normal. Caller states she is in a wheelchair and they are trying to get her to stand up. Caller states at the hospital they were able to get her to take 2 steps. At Hospital they were able to get her to do special training and he was able to get her to take 4 steps. Caller states he has no idea where she is with the walking right now. States she did not do anything on the 27Apr2021, because that was arrival date. Therapy started yesterday on 28Apr2021 at Hospital. The consumer also reported that the patient's current weight is 214 pounds, from 258 when she took the shot and down to 208 pounds on an unspecified date in 2021. Treatment for the events included occupational, physical and speech therapies, as well as apixaban (ELIQUIS), rivaroxaban (XARELTO), and spironolactone 25mg once a day; takes in the evening at 6:00p.m. ongoing from 12Mar2021 for hypertension. The outcome of the events arm was sore, body was sore, diarrhea, and slept and was totally exhausted and slept five days was recovered on 04Feb2021. The outcome of the event blood clot in right leg was recovered on 26Feb2021. The outcome of the event second blood clot that traveled to her brain which caused her to have a stroke was recovered with sequelae on an unspecified date in 2021. The outcome of the event Having Problems Swallowing from the Stoke was recovered on 27Apr2021. The outcome of the events speech went down to 25%, back up to 50%, and weight loss from 258 pounds, down to 208 pounds, back up to 214 pounds was recovering. The outcome of the event high blood pressure was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021484454 PFIZER (Same reporter/patient/different doses/events)
61 2021-05-16 amnesia muscular joint pain in spine that goes up to the neck; memory loss
61 2021-05-16 feeling abnormal, amnesia, mental impairment patient stated on her survey that she experienced brain fog, loss of memory and hard to concentrate.
61 2021-05-16 sleep disorder, feeling abnormal, nervousness Pt reports after receiving her vaccines and for the past 3 weeks she is still in a lot of physical p... Read more
Pt reports after receiving her vaccines and for the past 3 weeks she is still in a lot of physical pain, difficult to walk, and lots of muscle and joint pain in the side she received the vaccine. She has not been able to sleep and her brain feels foggy, states the her memory has been affected severely. Pt also reports still having diarrhea, vomiting and coughs sometimes. At time of call pt also reports she is feeling shaky. Pt states all these symptoms she is experiencing is all because of the vaccine. Pt reports she took Tylenol, and did not help. Pt reports that she called her MD today and was told she should still get her second vaccine.
61 2021-05-17 impaired work ability RASH STARTED ABOUT A WEEK AFTER THE 2ND SHOT. BUMPS ON LEFT UPPER ARM AND BACK OF NECK, THEN BUMPS S... Read more
RASH STARTED ABOUT A WEEK AFTER THE 2ND SHOT. BUMPS ON LEFT UPPER ARM AND BACK OF NECK, THEN BUMPS STARTED ON RIGHT ARM. TOOK BENADRYL FOR THE ITCHING AND RUBBED CALAMINE LOTION ON THE BUMPS. BUMPS WOULD STOP ITCHING BUT COME BACK. COULD NOT CONTINUE TAKING BENADRYL BECAUSE IT CAUSES MY HEART TO RACE. STOPPED USIG THE CALAMINE BECAUSE IT WAS NOT HELPING. TRIED RUBBING ALCOHOL AND IT GAVE SOME RELIEF. THIS IS THIRD WEEK AND STILL GETTING NEW BUMPS ON MY ARMS AND NOW MY LEGS. I HAVE NOT BEEN TO A DOCTOR YET BUT DID REPORT IT TO MY SUPERVISOR AT WORK BECAUSE I HAVE TAKEN TIME OFF DUE TO THE PAIN.
61 2021-05-17 sleep disorder The day (4/25) I received the 2nd vaccine, I was more tired than the first one. On the next day, Mon... Read more
The day (4/25) I received the 2nd vaccine, I was more tired than the first one. On the next day, Monday I felt really tired and little feverish, but no fever. I rested all day. I had vertigo that night I don't remember which side. The next day, Tuesday I was still tired. On Wednesday I felt ok. On Thursday, I felt tired again and when I rested I had vertigo on my right side. Then on Saturday, I was cold before I slept, I wore a sweatshirt to sleep. During the night I started sweating, felt like night sweats. I don't remember when tinnitus got worst. I only remember the vertigo. Currently tinnitus in my right ear is noticeably louder and has been getting me up. I just had vertigo yesterday 5/17 while resting in the afternoon as the night before I did not have enough sleep.
61 2021-05-18 confusional state, feeling abnormal Patient expressed concern that first vaccine she acquired some blurred vision about 2 hours after th... Read more
Patient expressed concern that first vaccine she acquired some blurred vision about 2 hours after the vaccine and complained of being tired and slight headache. She was advised at that point to strongly consider following up with her Provider and not getting the booster today. She stated she has a new position in the school system and should get the booster and does not wish to follow up with her PCP. She said she was fine and wanted again to get the vaccine booster. Vaccine booster, Pfizer Lot: ER8727, was given in pts left deltoid at 10:55. Pt tolerated injection well and walked 10 feet to chair in waiting area, where she was visible to me. Around 11:05, this RN called patient's name and approached pt, as she was noted to be staring into space and not responding to audible cue of her name. She could appropriately answer her name but had to be redirected to the question of her last name x 2. She appeared confused to place and time. Her friend, was called to her side as per patient's request. After some coaxing, she was assisted with ambulation to a stretcher in the clinic. At that time she appeared to have an unsteady gait. Her VSs at 1110 were BP-191/109, HR 88, O2 96%. She was able to follow commands with some cuing. She was also able to lift both arms and legs to gravity with moderate strength to resistance. Pupils were equal, reactive and 3mm. She denied any numbness or tingling anywhere, but did complain of a "weird" sensation in her left posterior scalp. No facial droop noted. Her eyes were noted to be blood shot and she stated they had a burning sensation noted. VSs at 1115 BP 169/103. HR 82, O2 95% VSs at 1120 BP 180/95, HR 78, O2 95%, at this time patient was advised of the concern of her elevated blood pressure and that we would continue to monitor for about 10 more minutes to see if it would improve. Cognition now almost back to baseline per friend who was at the patient's side. Patient denied history of high blood pressure in the past, but also states she does not routinely follow up with a Provider. VSs at 1125 BP 192/85. HR 78, O2 94%, at this time patient advised of concern for high blood pressure and associated symptoms she was experiencing and was advised by myself, her friend and Vaccine Clinic RN, to be taken to the ED for a Provider to look at her and a possible evaluation. Pt sat upright on the stretcher and refused to go to the ER. Her friend asked multiple times if she would like a family member to be called and come pick her up if she was going to refuse going to the ER. Patient then stated she was fine and had to go to the bathroom. Pt escorted by myself to bathroom, gait appeared steady and pt no longer starring into space. Pt accompanied to the bathroom. Pt accompanied by friend and myself to waiting area and stated she has an appointment tonight to follow up with a Provider at 1830 for psoriatic arthritis and possible steroids. I asked if I would be able to call and talk to this provider to ensure a better transition of care into the community due to not going to the ER. Pt agreed and came back to sit down with me in the vaccine clinic. Dr. was called and I spoke to him reviewing the aformentioned event to inlcude the patient's VSs. He agreed that when blood pressure initially 191/109 she should've gone to the ER. He then said since the BP was now192/85 that he was okay with her leaving, driving herself back home and seeing him at 1830 tonight, where he would address her hypertention. Pt was then with steady gait and back to baseline, per friend, escorted back to waiting room nd to her car, where she stated she was going to drive directly back to home. Pt was instructed multiple times if she had any sensation of confusion, dizziness, blurred vision to pull her car over and call 911, also if issues once home to go to ER. She verbalized multiple times her understanding of this information and again did not want her sister called to come and pick her up.
61 2021-05-19 feeling abnormal, amnesia TIA/Mini stroke; Blood pressure went up to 240/130; Loss of memory; Everything is foggy; Lips and to... Read more
TIA/Mini stroke; Blood pressure went up to 240/130; Loss of memory; Everything is foggy; Lips and tongue started tingling; Stinging lips; She is not taking the second vaccine. She reported that the card has a reminder to return date to go back in April and states she did not go and is not going to get the 2nd dose; This is a spontaneous report from a contactable consumer (the patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in left arm on 21Mar2021 10:30 (at the age of 61 years old), 1st dose, single for COVID-19 immunization. Medical history included diabetes and ankle problem from an unknown date and unknown if ongoing, and bariatric sleeve from 2018 to an unknown date. Concomitant medications included all her normal medications and medications for high blood pressure (not specified). The patient reported that she was administered with the first dose of the vaccine on 21Mar2021 and on the same day, her lips and tongue started tingling during the observation period after the administration. The patient also reported a few days later on 02Apr2021 that she had a transient ischemic attack (TIA), which was also described as mini stroke. The patient also reported that she has not been administered the 2nd dose. She is not taking the second vaccine. She reported that the card has a reminder to return date to go back in April and states she did not go and is not going to get the 2nd dose. She also complained since day one on 21Mar2021 about the stinging lips and tingling tongue. She was hospitalized with the mini stroke, she was admitted 02Apr2021 and discharged 04Apr2021. Another thing was loss of memory on 02Apr2021, from the time the ambulance picked her up and took her to the local hospital she recalls that, but she doesn't recall that hospital to being transferred 6-7 hours later. She stated she doesn't recall anything, it's like a blank. She was transferred from one hospital to another and the 1st hospital she recalled getting there, her mom worked there, but she doesn't recall the 6 hours in between or the ambulance ride to a different town. She stated everything is foggy. She still has problems remembering, it's better but she still has problems remembering like if she is talking to somebody and gets sidetracked, she doesn't recall what she was saying. The patient reported that her blood pressure went up to 240/130 on 02Apr2021 when the ambulance picked her up. She reported that since 2018 her blood pressure was always normal until after the vaccination. The patient underwent a heart monitor, brain scan EEG, an MRI and echocardiogram/EKG on an unknown date, with unknown results. The outcome of the events "Stinging lips" and "Lips and tongue started tingling" was recovered on 02Apr2021, and unknown outcome for other events.
61 2021-05-19 sleep disorder Sunday after 2nd dose of vaccination (May 9) I started having numbness and tingling in my arms legs,... Read more
Sunday after 2nd dose of vaccination (May 9) I started having numbness and tingling in my arms legs, face and neck and experiencing nausea. When I sleep at night if I lay in one position for too long my day starts to burn in that area. I am having trouble sleeping. The nausea continues to come and go as does the numbness and tingling and burning issues at night. It seems to be getting worse every day and I am getting tired and weak.
61 2021-05-21 feeling abnormal itching; brain is on hold; localized injection site urticaria; generalized prickle sensation; Bilate... Read more
itching; brain is on hold; localized injection site urticaria; generalized prickle sensation; Bilateral Wheezing; hoarse voice; Generalized Urticaria; Generalized erythema; coughing so bad she vomited: first dose; broke out in a rash; croupy cough; rhinorrhea/runny nose; This is a spontaneous report from a contactable nurse (patient). This 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in right arm on 22Mar2021 08:00 (lot number EP7534) at single dose for COVID-19 immunisation. Medical history included Latex allergy, Penicillin allergy. Patient previously experienced allergies with allopurinol (ELAVIL) and amitriptyline. Concomitant medications included triamcinolone acetonide (KENALOG), famotidine (PEPCID), and multivitamins. Patient reported that when she first got her vaccine, she broke out in a rash on 23Mar2021, nothing productive, no fever no nothing. She took care of the rash with a little prednisone, antihistamines. She stated the day she got her first one was 22Mar2021. Her arm got red the next day 23Mar2021, nice little whelp around it, her arm started getting kind of bumpy and a little itchy, then she noticed it on her back and her chest then around her waist, just patches, whelps. She started on Hydrocortisone and it just never went away. Then after, started 29Mar2021 or 30Mar2021, she got a croupy cough, the coughing lasted a few weeks, it ended sometime in the end of Apr. She thought it was seasonal allergies, but the coughing was so bad she was actually vomiting from it. She stated she actually thought she had COVID but she didn't run a fever and didn't lose taste or smell, just the way she was coughing and it was in her chest. She stated just some coughing, no fever, no production of anything, just coughing, very raspy. She had a dose pack, she took it, took Benadryl, Antihistamines, the rash was still there, but not as bad. She states the first one stayed on her back and chest and a little bit on her arms, back, arms and so forth. Then the second shot (in her left arm, LOT: ER8732), she was head to toe in a rash and she got the second shot 12Apr2021 in the left arm at 08:00. The rash never even went away, it just got worse. She stated it was serious enough because of all the medication, Benadryl, antihistamines, Atarax. The patient also experienced runny nose in Mar2021. She stated it's like her brain is on hold since the shot. She stated the coughing so bad she vomited started the first of Apr. The cough had just gotten so hard, no matter what kind of cough medicine she took, it just did not help it. She stated flat out croupy cough. Cough Medicine: she just did the Mucinex DM for the congestion and she did Dayquil and Nyquil that type of thing. She stated when she got on the steriods, that did help with that. She stated she was on her fourth dose of steriods, oral steriods, she had one IM dose. She had to go to doctor to get an IM steriod and other three have been oral. The treatment medication included: Hydrocortisone (EXP: Nov2023, LOT: 20W319, NDC:0031713-03): Cortisone 10. It's the cream she's been using, the itch relief cream, to help relieve the itching. She's been using regular Hydrocortisone cream, she's used a lot of that. Prednisone (LOT: UJ200503B, EXP: Mar2022, NDC: 42806-400-21) pack currently on, she stated this is the third pack of tabs. Prednisone shot: she went to the doctor office and got a prednisone shot the week before last, so last Wednesday on 28Apr2021 or 29Apr2021. Two previous steroid packs. Benadryl (LOT: P83332, EXP: Jun2021): 25 mg tablets, takes two of them about every 3-4 hours. Loratadine (LOT: 0BE2611A, EXP: Oct2021, NDC: 49348-818-56): 10 mg tablets, she takes them first thing in the morning, by mouth. She stated it's been tough between taking magnesium sulfate (EPSOM) salt baths and avena sativa (OATMEAL) baths. Patient was not seen in the emergency department, no hospitalization required. Respiratory: Bilateral Wheezing, Dry cough, hoarse voice, rhinorrhea. Dermatological/Mucosal: Generalized Urticaria, Generalized erythema, generalized pruritus with skin rash, generalized prickle sensation, localized injection site urticaria. Patient did not receive any recent vaccines for any other conditions prior to the event being reported, did not receive any recent vaccines for SARS-COV2 other than the Pfizer- BioNTech COVID-19 Vaccine prior to the event being reported, did not receive any other vaccines around the time of Pfizer- BioNTech COVID-19 Vaccine vaccination. Lab data included COVID test: unknown result on unspecified date. The outcome of event rash, itching was not recovered, outcome of cough, vomiting, rhinorrhoea was recovered in Apr2021, outcome of other events was unknown.; Sender's Comments: Based on information available, the reported serious event rash was likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to the temporal relationship and known safety profile of this product.
61 2021-05-24 feeling abnormal Patient has had Bells Palsy 2 times prior. 1976 H1N1 vaccine / 2009 after having been infected with... Read more
Patient has had Bells Palsy 2 times prior. 1976 H1N1 vaccine / 2009 after having been infected with H1N1. No Fever at all during 14 days May 12- facial pain, body aches, head aches. May 15- all symptoms continued facial swelling, loss of feeling to touch of face. Pain traveling down neck. Left side of face dropping. Hands very cold and cramping. May 17 - body aches and headaches leave. All other symptoms and facial pain continues. Tingling of skin on knees begins. May 21 - knees and thighs begin to feel numb and tingly. This feeling of not right continues to increase and spread. May 24 - all facial pain increased. Legs and arms tingly and numbing feeling unsteady. May 25- flushing and rash appears. Arms are heavy and all other symptoms continue.
61 2021-05-26 feeling abnormal severe brain fog; intense cramping; she got red really fast and almost a strange itching inside her ... Read more
severe brain fog; intense cramping; she got red really fast and almost a strange itching inside her body; felt she had Covid; Mild diarrhea; body aches; fever; Headaches; This is a spontaneous report received via medical information from a contactable consumer (patient). A 61-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 30Mar2021 (Batch/Lot Number: ER8737) at the age of 61-year-old, as single dose for covid-19 immunisation. Medical history included ongoing thyroid disorder has had for years, ongoing hypertension started about 8 years ago, ongoing immune system disorder ( Her spleen has been removed, and she is immune compromised). The patient was immune compromised and has no spleen and she had Covid and has Covid long haulers. The patient's concomitant medications were not reported. The patient received the second dose of Covid vaccine received on 20Apr2021, at 09:00, right arm injection. After the 1st dose of Covid vaccine she felt she had Covid. Mild Covid again, for about 4 days. She experienced fever, body aches, and some mild diarrhea the same day of vaccination. The patient did not confirm if she just felt like she had Covid again or tested positive for COVID-19 after first dose. She had diarrhea until she received the second dose of the vaccine then got ulcers in her mouth, body swelling, and had headaches with both doses. The patient stated that fever started after the 1st shot, within 4 hours, It was fast. She was sitting with a friend and she got red really fast and almost a strange itching inside her body. She told her friend she needed to lie down. Her friend told her she didn't look good. It happened so quick. It started on 30Mar2021 and she recovered completely. Body aches started on 30Mar2021 but not until the evening and lasted until it ended with the fever. She recovered completely. She was a long hauler and this was a whole different ball of wax. Patientdidn't feel it when she had Covid. Mild diarrhea started in the middle of the night on 30Mar2021 and she doesn't think it ever ended. It spun around, It was now constant diarrhea and continues from the first dose. It waswater and with intense cramping and is constant. She is on the BRAT diet. It won't hold so she is living on Gatorade and white rice. Headache started with the first dose. The headache came in after the first dose and was very mild. It left just like the symptoms did. The headache started when the fever started and it started quickly and it hasn't left. Patient also complained severe brain fog. The patient experienced felt she had covid (suspected covid-19) on 30Mar2021 with outcome of unknown, mild diarrhea on 30Mar2021 with outcome of unknown , body aches on 30Mar2021 with outcome of recovered , fever (non-serious) on 30Mar2021 with outcome of unknown , headaches on an unspecified date with outcome of unknown, severe brain fog (feeling abnormal) on an unspecified date with outcome of not recovered , pruritus on 30Mar2021 with outcome of recovered , intense cramping on an unspecified date with outcome of unknown.
61 2021-05-26 insomnia Severe pain in upper neck, left shoulder, left arm; Severe pain in upper neck, left shoulder, left a... Read more
Severe pain in upper neck, left shoulder, left arm; Severe pain in upper neck, left shoulder, left arm; Severe pain in upper neck, left shoulder, left arm; pain to left shoulder and left arm where the shot was given/Severe muscle pain on injection arm; Left wrist ache; was not sleeping; severe muscle pain; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 10:00 (Batch/Lot Number: EN6208) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included nerve injury from an unknown date and unknown if ongoing, intervertebral disc operation from 2019 to an unknown date, nuchal rigidity (Can't turn neck to the left past a certain point) from an unknown date and was ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2m (Lot number: EN6198) on 12Apr2021 (at the age of 61-year-old) for covid-19 immunisation; the past drug includes naproxen which worked well. The patient developed pain to left shoulder and left arm where the shot was given a week later/ Severe muscle pain on injection arm, on an unknown date in May2021, severe pain in upper neck, left shoulder, left arm on 07May2021, experienced left wrist ache, was not sleeping on an unknown date in May2021. It was reported that patient used ice packs on it and taking Naproxen around the clock, but nothing touches it. Starts to feel like she was getting better, but really was not. The patient had no cold or flu symptoms. It was reported that patient visited chiropractor on 01May2021 for this crick in her neck. States she did not have COVID arm and did not have redness or swelling on the injection arm. It was also reported that patient had severe muscle pain on an unknown date in May2021. The patient has been taking Naproxen (Kroger brand, Formulation: 220mg caplets, NDC: 30142-617-90, Lot: 9ER0418, Exp: Dec2020) at a dose of three caplets in the morning. A couple of nights did two caplets 12-14 hours later; Lidocaine Patches (NDC: 0603188010; Lot: 74098; Exp: Jun2017; Formulation: 5%, 700mg patches) at a dose of patch on last night where the main part of the pain was at, which was the injection site, put one patch on the left arm and one patch on the upper part of the left shoulder near her back, left patches on overnight, about six hours. The outcome of the events pain to left shoulder and left arm where the shot was given/Severe muscle pain on injection arm, Severe pain in upper neck, left shoulder, left arm was not resolved, left wrist ache was resolved on May2021 and was not sleeping, severe muscle pain was unknown. No follow-up attempts are needed. No further information is expected
61 2021-05-26 loss of personal independence in daily activities, disturbance in attention Patient became rigid and fell down and could not get up, she can no longer stand unassisted. She has... Read more
Patient became rigid and fell down and could not get up, she can no longer stand unassisted. She has become incontinent and now has to where a diaper, and leans to her right side while sitting and standing. She cannot focus for very long. And she becomes rigid and stiff for periods of time. She is no longer able to bath herself or care fir her basic needs. Even with intense therapy hasn?t reached her baseline.
61 2021-05-27 feeling abnormal body swelling; Swollen joints; Ulcers in her mouth; Migraine headache; Constant diarrhea; Brain fog;... Read more
body swelling; Swollen joints; Ulcers in her mouth; Migraine headache; Constant diarrhea; Brain fog; This is a spontaneous report from a contactable consumer reporting for herself. A 61-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine in Hospital, via an unspecified route of administration, administered in right arm on 20Apr2021 09:00, at 61 years of age, (Batch/Lot number ER8737) as single dose for COVID-19 immunization. Medical history included thyroid disorder from an unknown date and ongoing (she has had it for years), hypertension started about 8 years before this report and ongoing, immunodeficiency from an unknown date and ongoing, her spleen has been removed and she is immune compromised and has had COVID. The patient reported that after the first dose of Pfizer-BioNTech COVID-19 mRNA Vaccine administered on 30Mar2021 at 09:00, she had mild diarrhea, body aches, fever and headaches and she felt she had COVID. The patient's concomitant medications were not reported. In Apr2021 the patient experienced body swelling, assessed as medically significant, swollen joints, ulcers breaking out inside her mouth and a 24 hour migraine headache. Ulcers started about 3 days in from the 2nd dose, they come and go. She keeps them at bay by using Listerine. She understands that whatever is happening in her lower gastrointestinal tract is coming up into her mouth. The patient added she is a neuro-muscular therapist and had an understanding of how her body works. The body swollen started a week after the shot (also reported as immediately after the shot). It continues at the time of the report and it is persisting. The patient stated "she has a little bit of COVID brain". Moreover, the mild diarrhea after the first dose changed to constant diarrhea after the second dose. It is water and with intense cramping and is constant. She reported she is on the BRAT diet. "It won't hold so she is living on Gatorade and white rice". Over the past week, her joints in her hands and in her body have become swollen. Horribly swollen to the point she couldn't get her pants on because her knees and ankles were so swollen. Her hands last week started swelling and the pores around her joints look like blisters. The patient added she has had severe brain fog since an unknown date which was ongoing at the time of the report. The headache has not left as well, the outcome of all the events was unknown at the time of the report. The patient has not been to the Emergency Department or her Physicians office, but was going at the day of the report. No follow-up attempts are needed. No further information is expected.
61 2021-06-02 anxiety Pt reported severe anxiety and syncope when receiving injectable medication and blood draws. Pt was ... Read more
Pt reported severe anxiety and syncope when receiving injectable medication and blood draws. Pt was agreeable to receive vaccine and a plan was made ahead of time to administer to her in her vehicle with the seat laid flat. Upon receiving the vaccine, the pt immediately stated, " I don't feel good" and began to hyperventilate and complaint of tingling in all extremities. Pt then vomited and an EMS crew on standby was notified to evaluate the patient. The patient was eventually transported to the ER due to near syncope and hypotension.
61 2021-06-03 restlessness Began to feel hot.; Upper extremities became to feel tingly or prickly internally/ tingling traveled... Read more
Began to feel hot.; Upper extremities became to feel tingly or prickly internally/ tingling traveled to my legs; Antsy, fidgety and felt like bouncing off the walls.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EP7534) via an unspecified route of administration in left arm on 16Mar2021 at 07:15 (at an age of 61-years-old) as a single dose for COVID-19 vaccination. Medical history included allergic to penicillin. 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 were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 16Mar2021 at 07:30, approximately 10 minutes after the vaccination the patient had upper extremities felt tingly or prickly internally and began to feel hot. Then the tingling travelled to his legs, almost like the feeling when legs fall asleep. About an hour later felt like drank a pot of coffee, the patient was antsy, fidgety and felt like was bouncing off the walls. The clinical outcome of upper extremities felt tingly or prickly internally and began to feel hot, tingling travelled to the legs, almost like the feeling when legs fall asleep was recovered on an unknown date; while for the event antsy, fidgety and felt like was bouncing off the walls were recovered on 16Mar2021. No follow-up attempts are needed. No further information is expected.
61 2021-06-03 sleep disorder Cough; Body aches; I am tired because I have been sleeping a lot; Injection site pain; Chills; I am ... Read more
Cough; Body aches; I am tired because I have been sleeping a lot; Injection site pain; Chills; I am tired because all I do I have been sleeping a lot; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0187) via an unspecified route of administration on 29May2021 in upper right arm as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 30May2021, the patient experienced cough, some body aches, she was tired, she got the pain at the injection site which she knew was common anyway, little bit of chills but nothing major. She was tired because all she did was sleeping a lot. She just wanted to know if she could take amphetamines (treatment), if it could help alleviate some of those side effects. She wanted to know if it was safe to do that or not. The outcome of all events was unknown. Consumer was informed about Pfizer Medical Information Department. Information on Lot/Batch number was available. Additional information has been requested.
61 2021-06-06 sleep disorder Around 7:00-8:00 that evening, approximately four hours after recieving the vaccine, I started havi... Read more
Around 7:00-8:00 that evening, approximately four hours after recieving the vaccine, I started having shooting pain in my head. It was mild at first, then harder and more frequent as the evening went on. It did that until late the next morning and was completely gone by around noon. This wasn't a 'headache' or migraine. It was shooting pain like none I had ever had in my head. I had a knee revision years ago and it also affected the knee through the night with that same type of pain. I wasn't as concerned about the knee, but, the head was concerning. I didn't report it because I didn't know I had to register to check in.
61 2021-06-07 anxiety She is worried it is a kind of blood clot.; She is worried it is a kind of blood clot.; Swollen lymp... Read more
She is worried it is a kind of blood clot.; She is worried it is a kind of blood clot.; Swollen lymph nodes in right leg; This is a spontaneous report from a contactable consumer(Patient). A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 23May2021 as 2nd DOSE, Single for covid-19 immunization. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, obesity. No family medical history reported. The patient's concomitant medications were not reported. Patient previously took historical vaccine of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm left on 02May2021 as single dose for covid-19 immunization. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. It was reported that, on 26May2021, after getting the second dose of the Covid vaccine, she had swollen lymph nodes in her right leg. She was worried and asks what to do and She asked if she needs to go to Urgent Care. she is worried it is a kind of blood clot. She asks if Pfizer will call her doctor and then call her. All she had were swollen lymph nodes. They are getting big and big. She confirms they are getting bigger. No relevant tests reported. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
61 2021-06-07 depression feeling very very low and depressed and moody/ sadness, not myself/ events worsened yesterday its se... Read more
feeling very very low and depressed and moody/ sadness, not myself/ events worsened yesterday its seems; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration on the left arm on an unspecified date (at the age of 61-years-old) as second dose, single dose for COVID-19 immunization. Medical history included ongoing depression (that was reported as currently and have this for several years on medication). Concomitant medications included venlafaxine hydrochloride (EFFEXOR), bupropion hydrochloride (WELLBUTRIN SR), quetiapine, atorvastatin (LIPITOR), amlodipine, levothyroxine sodium (SYNTHROID) and hydrochlorothiazide; all taken for an unspecified indication, start and stop dates were not reported. On an unspecified date in 2021 (reported as Saturday, yesterday), the patient experienced feeling very very low, depressed, moody, sadness and not herself. The events were reported as seemed to have worsened. The patient was not sure if the events were reaction to the second vaccine she had on Thursday and stated that it may be the vaccine was effecting. The event seriousness was unspecified by the reporter. There was no investigation assessment. No treatment was given as a result of the events. The outcome of the event was not recovered. The patient was querying if this could be experienced by the medication that she was taking. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
61 2021-06-07 impaired work ability he received Pfizer vaccine 2/5 and got symptoms a few weeks after the vaccine. She experienced a lo... Read more
he received Pfizer vaccine 2/5 and got symptoms a few weeks after the vaccine. She experienced a lot of chest pain at work and went to healthcare facility and was diagnosed with pleurisy. She received steroid treatment and a steroid shot and then received another 3 rounds of steroids - this was through February, March, and April. She saw a pulmonologist 5/20 and CT scan done again and CXR. She was diagnosed with pulmonary edema and elevated calcium levels. She was started on some pain medicine at that time and a steroid. After she came off steroids, was in a lot of pain and had to stop working. Diagnosed with recurrent pericarditis.
61 2021-06-07 memory impairment Stomach cramps increased; Upset stomach; Memory is not good/sometimes she remember things that amaze... Read more
Stomach cramps increased; Upset stomach; Memory is not good/sometimes she remember things that amazes her and sometimes she cannot remember what happened yesterday; Pain in lower abdomen; This is a spontaneous report from a contactable consumer (patient) and physician. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0167), dose 2 via an unspecified route of administration, administered in Arm Left on 29Apr2021 12:00 as 2nd dose, single dose for COVID-19 immunization; palbociclib (IBRANCE), via an unspecified route of administration from Apr2016 (Batch/Lot number was not reported) to 27May2021, at 125mg caplets oral with water for 21 days on and seven days off once a day for stage IV metastatic breast cancer. The patient's medical history and concomitant medications were not reported. No patient history. Family Medical History Relevant to AE(s): None. No other products. History of all previous immunization with the Pfizer vaccine considered as suspect: None. 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. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0153), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date 12:05 as 1st dose, single dose for COVID-19 immunization and had stomach cramps. The patient stated that she was on Ibrance. The patient stated that she had second shot on 29Apr2021. Since the second vaccine, she had so much trouble with her stomach. The patient stated that this had been an ongoing thing. Her stomach cramps increased, and she had pain in her lower abdomen. The patient stated that she had the first shot three weeks before the second shot and had stomach cramps. The patient stated that stomach would not settle down. The patient stated that she would get some good days. The patient stated that last week on Thursday that she was in downward spiral and could not get out of it. The patient stated that she was being careful with what she ate. The patient stated that she stopped the Ibrance. The patient stated that this week was her seven days off and she would call today to ask for next month but wanted to take a reduced amount. The patient stated that when she saw her oncologist that she asked if people ever stop taking Ibrance and was told no that if one has a reoccurrence that it may not work as well. The patient stated that she did not ask for a reduction at that time but intends to. It was a temporary stop. The patient stated that this was more about Ibrance than the vaccine. The patient stated that she had pain in lower abdomen that started 10 days ago. The patient stated that she gets upset stomach from time to time but that it had been pretty constant since the first week in May. The patient stated that sometimes she remembers things that amazes her and sometimes she cannot remember what happened yesterday. The patient stated that other factors were involved (memory) at that time that her husband was ill. The patient stated that the stomach cramps started again 6 days after second vaccination and resolved last week. Recovered with lasting effects of upset stomach. The patient stated that she changed from capsules to caplets in 2020. The patient was treated with Mylanta. The patient stated that she had a video call scheduled with her nurse practitioner. Is eating soft foods and keeps drinking water. Relevant Tests: None. The event did not result in Emergency Room/Physician Office. The outcome of the events stomach cramps increased was recovered with sequelae, pain in lower abdomen, upset stomach was recovered, memory is not good/sometimes she remember things that amazes her and sometimes she cannot remember what happened yesterday was unknown. Follow-up attempts are possible. Further information is expected.
61 2021-06-08 poor quality sleep Pt received first Pfizer COVID vaccine dose at approximately 0800 on 5/27/2021. Injection administe... Read more
Pt received first Pfizer COVID vaccine dose at approximately 0800 on 5/27/2021. Injection administered in left deltoid. Pt states that she took two Tylenol before going to bed the night of 5/27/2021. Felt fine prior to going to bed except for injection site pain. She was awakened by chest pain, muscles pain, joint pain and swelling and malaise at 0200 on 05/28/2021. She states she did not have a fever and felt cold but no chills. States the chest pain lasted about 30 minutes. Unable and afraid to go back to sleep after this episode. Joint and muscle pain resolved after about 2 days.
61 2021-06-09 feeling abnormal, depressed mood flushing on my face three times like heated /top of my head to chin and is like some covered it but ... Read more
flushing on my face three times like heated /top of my head to chin and is like some covered it but it was more like flush; felt little bit weird; Heart racing; felt little off; head is drawling; hives; This is a spontaneous report from a contactable consumer. A 61-years-old female consumer (patient) reported for herself that she received first dose of BNT162B2 (COMIRNATY, solution for injection; Batch/Lot Number: EN6206; expiry date, UPC number and NDC number were reported as unknown) via an unspecified route of administration on 20Mar2021 in left arm as a single dose for covid-19 immunization. Medical history, other products, investigation assessment and concomitant medications were not reported. On 20Mar2021, the patient experienced slight reaction in morning after 10 mins of first shot which included flushing on face like three times and it was heated (from top of head to chin and was like some covered it). Her doctor said flushing was like something that drained out of her face like heat. She was not able to describe it. 15 mins after taking the shot she felt little off and weird, had hives, her heart was raising (doctor couldn't recognize her pulse), and her head was drawling. The events occurred 2 to 3 times in a row. She stayed at the vaccination centre for 30 minutes and after that she felt fine. She reported that she had little diet and too much caffeine half the day, received first dose and had mild reactions but was fine after an hour. She asked if she could take second dose and does the events get worse after second dose. The patient did not receive any treatment. The action taken in response to the event for BNT162B2 was unknown. The outcome of all the events was recovered on 20Mar2021. No follow-up attempts are possible. No further information is expected.
61 2021-06-09 feeling abnormal Feeling some nausea almost daily. Feel like marbles are between my skin (like on my foot, hand, un... Read more
Feeling some nausea almost daily. Feel like marbles are between my skin (like on my foot, hand, underarm, head) but cannot feel them it just feel like something is there. High allergic reaction to my cat. (have had my cat for 6 years, now got hives). Just overall not feeling well. Feel itchy like I'm about to have a reaction. Like heightened response to allergens.
61 2021-06-10 feeling abnormal Within 30 minutes, Heart began to flutter and head began to swim, Took home Blood pressure which was... Read more
Within 30 minutes, Heart began to flutter and head began to swim, Took home Blood pressure which was 193/90. Had pressure on left side back by bar strap. Face skin color was fluctuating between very pale to Normal. Went to ER within one hour of vaccine. Blood pressure was 207/95, heart rate fluctuating between 50-80 within 2-4 minutes. EKG and others tests were performed which were normal. I was monitored for 3 hours, when blood pressure went down to 166/?? I was released to go home. No medications were given. Was told to see my primary doctor and start with a cardiologist. At 10:00, I started sweating profusely and my blood pressure was 123/66. Next day I felt the heart flutter or felt like heart was jiggling in chest several times, BP was higher than normal at 2:00 in after noon BP was 181/88. Blood pressure slowly went down when checked every 2 hours. I also had a weird headache. Today I saw my primary doctor, who advised to take an additional losartan if BP Systolic goes above 175. The heart flutters are less, but I just experienced three episodes this afternoon,(2 days after vaccine). Headache is still the same. (Not good) BP at doctors was 145/88. A cardiologist appt was made for next week.
61 2021-06-12 anxiety, fear I received the shot and 5 minutes later I wasn't feeling well - lightheaded, tingly hands almost imm... Read more
I received the shot and 5 minutes later I wasn't feeling well - lightheaded, tingly hands almost immediately and after that I broke out in a sweat. 10 minutes after that my stomach started to hurt and I threw up a few times. 20 or so minutes after the shot my blood pressure dropped to 65/40 and the people administering the shot made the decision to call an ambulance and I was taken to the hospital.
61 2021-06-14 sleep disorder Immediately after the shot, my shoulder became very painful. I noticed that the band-aid from the in... Read more
Immediately after the shot, my shoulder became very painful. I noticed that the band-aid from the injection was located very high on my arm, right at the shoulder joint towards the back. My arm stayed painful, and I couldn't sleep. I couldn't move my arm normally. I read that arm pain was a normal side effect, so I waited. After 7-8 days, on April 3, I went to the urgent care for a virtual visit. I was seen by a PA. She had my husband rotate my arm in several ways, and it would move normally except if directly out to the side and up over my head. I couldn't raise my arm past horizontal, and my shoulder was very painful. She recommended Ibuprofen, ice, and movement. I did those things, but my arm still was not able to move normally. It felt stuck when I tried to raise it. I went in on April 30 for an in-person visit with my doctor. She examined my shoulder and recommended physical therapy and that I see an orthopedist. I had some difficulty getting authorizations in place in a timely manner, and eventually was able to see an orthopedist for a virtual visit on June 1. He recommended physical therapy and to call back for an MRI if it doesn't resolve after 6 weeks. I had my first physical therapy appointment with a clinic on June 8. I am currently doing daily PT and seeing the PT weekly.
61 2021-06-16 impaired work ability Firs stop shot 3/27/2021, second 4/17/2021Lightheaded, accelerated INR of 4.7within 48 hrs. Of first... Read more
Firs stop shot 3/27/2021, second 4/17/2021Lightheaded, accelerated INR of 4.7within 48 hrs. Of first shot.Low grade fever on and off sometimes accompanied wit chills. Increasing fatigue and leg weakness, eventually shortness of breath, pain in center of chest when breathing, couldn?t lay down due to pain in neck and chest, diagnosed with pericarditis May 31 2021. Out of work since may 28 2021
61 2021-06-20 nervousness COMPLAINED ABOUT BEING NERVOUS AND SLIGHT NAUSEA, STATING SHE ALWAYS HAS THAT. PATIENT TOOK HER OWN... Read more
COMPLAINED ABOUT BEING NERVOUS AND SLIGHT NAUSEA, STATING SHE ALWAYS HAS THAT. PATIENT TOOK HER OWN ZOFRAN SHE HAD WITH HER.
61 2021-06-23 sleep disorder, depression, memory impairment, confusional state After the first shot on 03242021 I experienced overall fatigue. Though I drove the 30 minutes to th... Read more
After the first shot on 03242021 I experienced overall fatigue. Though I drove the 30 minutes to the first shot, I could not drive the same distance to the second due to fatigue. After the second shot, the fatigue worsened. Pain in my joints and muscles increased. My inability to walk beyond a few steps resulted in my using a cane at all times. My grip worsened and I dropped most objects I picked up. The pain had continued to increase throughout my body. I could not sleep, I became depressed. My thought processes became confused and my memory cloudy. I spoke to the Rheumatologist on June 3 out of concern and he scheduled Xrays. By 06232021 the confusion symptom started to wane.
61 2021-06-24 excessive sleepiness Yesterday she slept for 36 hours; her head was just killing her; Headache; This is a spontaneous rep... Read more
Yesterday she slept for 36 hours; her head was just killing her; Headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-years-old female patient received bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in Arm Left on 11Jun2021 15:40 (Batch/Lot Number: EW0191; Expiration Date: 30Sep2021) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation at clinic (61-years-old at the time of vaccination). The patient medical history concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included first dose of bnt162b2 for covid-19 immunisation. It was reported that, she had her second Pfizer shot on Friday(11Jun2021) and at night she had such a bad headache, yesterday (12Jun2021) she slept for 36 hours and her head was just killing her. She did not knew was that normal or not. Consumer was informed about the Pfizer medical information department. The clinical outcome of the events was unknown. Information on lot/batch number was available. Additional information has been requested.
61 2021-06-29 anxiety felt anxious; hot; had a fast heart beat for a minute; This is a spontaneous report from a contactab... Read more
felt anxious; hot; had a fast heart beat for a minute; This is a spontaneous report from a contactable consumer. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) (at the age of 61- year-old) as single dose for covid-19 immunisation. The patient had received first dose of vaccine on an unknown date. The patient medical history was not reported. The patient's concomitant medications were not reported. History included she has an allergy to Penicillin. After a few minutes of vaccine administration, the patient felt anxious, then really hot, she was fanning herself, had a fast heart beat for a minute, after a minute it went away and she didn't tell anyone. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
61 2021-06-29 sleep disorder Severe shoulder pain and upper arm pain. Restricted range of motion. Prior to vaccine had zero issue... Read more
Severe shoulder pain and upper arm pain. Restricted range of motion. Prior to vaccine had zero issues with shoulder. Arm was sore and kept getting worse each day...shoulder pain began around day 3. Continually got worse. Affected sleeping, anything to do with arm and shoulder usage, woke me up twice a night. In the morning when I got up, pain so severe I could not lift shoulder out of position without assistance. Pain was all day and all night. Pain is severe up still and range of motion affected.
61 2021-06-30 feeling abnormal terrible rash / It is spreading and not getting better, it is all over her body, stomach, face.; My ... Read more
terrible rash / It is spreading and not getting better, it is all over her body, stomach, face.; My eyes started to getting itchy now, this is blinding my eyesight. I can't go to work; itchy and miserable; itchy and miserable; it started on the arm that consumer got the vaccination; This is a spontaneous report from a contactable Consumer (Patient). A 61-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EWO180) via an unspecified route of administration on an unspecified date (61 years age at the time of vaccination) as dose 2, single for COVID-19 immunization. The patient medical history had chemotherapy and radiation (further not clarified) in the past and high blood pressure. The concomitant medications were not reported. The patient previously received the first dose of the covid vaccine, consumer thought that it was a low dose and felt tired. But nothing really traumatic. It was not so bad. Consumer stated that consumer took the second vaccination, probably now, after eight to nine days, consumer have a terrible series of rash throughout my body. Consumer can't think of anything else it would be coming from and it started on the arm that consumer got the vaccination, and it seems to be travelling around my body and it went from my arm to my stomach to the other side. It's terribly itchy. It is on my face. When probed for the date of first shot: The last one was on June 5th I believe. The first one was on 15May. The second one was on 05Jun and the both was on right date. Consumer had chemotherapy and radiation (further not clarified) in the past and high blood pressure. Maybe it was not approved for people with chemotherapy in the past and radiation. I mean this is pretty miserable and consumer don't want to miss work for it. If this is going, my eyes started to getting itchy now, this is blinding my eyesight. Consumer can't go to work. The outcome of the events was unknown. Follow attempts are needed; Additional information has been requested.
61 2021-06-30 sleep disorder was so sick with fluids in her lungs, and she was gurgling and trying to cough it up; Terrible side ... Read more
was so sick with fluids in her lungs, and she was gurgling and trying to cough it up; Terrible side effects she is very sick and got bad stuffs; she is bedridden; got helped to her do everything; Terrible side effects she is very sick and got bad stuffs; she is bedridden; got helped to her do everything; his wife was up all night; his wife has thrown up a few times; having body aches; Rash; This is a spontaneous report from a contactable consumer (patient husband). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and Expiration date: Unknown), via an unspecified route of administration in left arm on 18Mar2021 (at the age of 61-year-old) as a single dose for COVID-19 immunization at hospital. Medical history included patient got crushed up in a car wreck and lost 53% of her pancreas and had a bad heart valve. Concomitant medications were reported as none. Patient did not receive any other vaccines on the same day as the COVID shot. On 18Mar2021, after her first dose of Covid shot, she was up all night last night because she was so sick with fluids in her lungs, and she was gurgling and trying to cough it up and she stated that she was going to get better, but she was still in bed today. Reporter stated that his wife had fluid in her lungs and stuff, that maybe her heart couldn't push it out and did not get out of bed yesterday to sit on the couch and see the grandkids, but she wanted to be in bed. She was ok but had terrible side effects she was very sick and got bad stuffs, she was bedridden and got helped to her do everything. She had thrown up a few times and was just really sick and also experienced rash on an unspecified date in 2021. He stated that he hopes his wife does not have any permanent damage from this, as she just had a lot of things already, his wife was sick and disabled, having body aches, and is not planning on getting the second dose and he stated his wife does think that she will get well again. Patient did not receive any treatment for the events. The outcome of the events was unknown. Information on the lot/batch number has been requested.
61 2021-07-01 feeling abnormal feeling of "like euugh"; tiredness; she probably had the Covid 19 virus; had very little discomfort... Read more
feeling of "like euugh"; tiredness; she probably had the Covid 19 virus; had very little discomfort with the injection; low grade fever 99F; a little cough; frontal lobe headache; sinus issue; scratchy throat; runny nose; head congestion; sinus pressure; ear pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6199), via unspecified route of administration in arm left on 12Mar2021 at 13:30-14:00 (as reported) (at the age of 61-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included she reported she was in good health. Her blood pressure was borderline and below. She was a little overweight, they tell her she is overweight. She was the type of person who can get the flu shot, no problems. She never had the shingles shot. She does have seasonal allergies and they do happen this time of year. She is going to get checked for arthritis because it runs in her family. She just lost her mother. Her mother had cancer this past year, she didn't die from the cancer. They were secluded at that time. Then the Covid 19 virus came and her family was even more secluded. As far as other allergies, she has an allergy to pollen, and a form of Penicillin. The form of Penicillin she took and had a reaction to was Cephalexin about 25 years ago and she got a rash and itchy hives. She reports that reaction wasn't like she wasn't able to breathe, it was more like what's wrong. The concomitant medications of the patient included calcium and magnesium and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient experienced scratchy throat, runny nose, head congestion, sinus pressure, ear pain, low grade fever 99f, a little cough, frontal lobe headache, sinus issue on 12Mar2021 and feeling of like euugh, tiredness, her blood pressure is borderline and below, a little overweight and she probably had the covid 19 virus on an unspecified date. The patient reported that she experienced pretty heavy seasonal allergy-like symptoms. She mentioned that she experienced a scratchy throat 4 hours later, a runny nose, head congestion in the night, sinus pressure, and ear pain due to her head filling with fluid. She also mentioned that she lied down with a general feeling of like euugh and tiredness. She mentioned that this was normal symptoms when she gets seasonal allergies every year but she cannot rule out that this was possibly caused by the vaccine because the timing was just too near her vaccination. As of calling, she was feeling better but still has congestion. She was concerned on getting the 2nd dose because this might happen again to her or maybe worse. She said that people have told her that they did not experience side effects during the 1st dose but had experienced side effects on the 2nd dose. Her symptoms started that night after she received her first Covid 19 vaccine. She went into her normal allergy thing that she gets every year. Clarified she has seasonal allergies that occur every year. She asked some friends and they told her she probably had the Covid 19 virus and she thinks it was more seasonal allergy symptoms. She had head congestion, clear to white mucus, her head was congested. She did have a low grade fever of 99F just one night, the night she received her vaccine. She also had a scratchy throat, the head congestion, a little cough, not the nasty type of mucus. She did not see these symptoms that she was having listed as common side effects. She was asking if these are symptoms we can have. She was getting a little fearful of getting the next Covid 19 vaccine. She does not know what to do. She does not want that anxiety over getting the second Covid 19 vaccine, scheduled to receive it 04Apr2021. she reports she wakes up now and still has a runny nose. She received the Covid 19 vaccine on Friday, 12Mar2021. By Friday night she was totally congested with sinus pressure. She was blowing her nose. It went into her ears, it feels like a whole lot of fluid. It causes ear pain. She still has the symptoms. One night she took Claritin. She's not big on taking medicines. She was still so congested. Every morning she was waking up with it. The scratchy throat started about 3 hours after she received the Covid 19 vaccine. And about 8-10 hours after the vaccine she had a frontal lobe headache, the kind of headache when she gets her seasonal allergies. It's not an allover headache, it's definitely concentrated on her sinuses. Her sinuses feel like they are filling up. It's very much a sinus issue. Feels like the same kind of allergies that she's had for the last 2 years. And it goes into her ears and gives her earache pain. She had very little discomfort with the injection. The patient was not hospitalized. The patient underwent lab tests and procedures which included blood pressure measurement: borderline (her blood pressure is borderline and below) on an unknown date and body temperature increased: 99 fahrenheit on 12Mar2021. Therapeutic measures were taken as a result of AE that included the patient had also taken Tylenol Extra Strength. They were 500mg and she only took one. She took that on 13Mar2021 at 12:00PM. She took maybe a total of 4 Tylenol all together and she felt better so she did not take it anymore. She took them sparingly. Maybe a total of 6 in 2 weeks. The outcome of the events scratchy throat, runny nose, head congestion, sinus pressure, low grade fever 99F, a little cough and frontal lobe headache was reported as resolving and outcome of the events ear pain, feeling of like euugh, tiredness, sinus issue vaccination site discomfort and she probably had the Covid 19 virus was reported as unknown.
61 2021-07-01 feeling abnormal Hives on left wrist; started feeling a little funny when she first got the vaccine; Felt really tire... Read more
Hives on left wrist; started feeling a little funny when she first got the vaccine; Felt really tired; Raspy voice; This is a spontaneous case from a female contactable consumer (patient herself). A 61-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8736) via an unspecified route of administration in left arm on 10May2021 as dose 1, single (at the age of 61-years-old) and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0173) via an unspecified route of administration in left arm on 07Jun2021 as dose 2, single for COVID-19 immunization. Vaccine was not administered at Military Facility. Patient history included ongoing seasonal allergies, hypertension, benign tumor in breast (found at 16 years old), type II diabetes from 2014, thyroid, non-smoker, fibroid tumor (surgically removed in 2003), anemia, overweight (but was losing weight) parasites, hay fever. In early 2000s, her glucose was 80 which was normal. UTI infections for which patient took ciprofloxacin in the past. Patient experienced typical dizziness from the Ciprofloxacin. Patient was allergic to trees, foods and cats, dust and grass that is freshly cut, beef, corn, strawberries, ragweed and blooming flowers/plants. Her allergies have tremendously improved the older she has gotten. In the 1990s, they were really bad. She was eating scallops and other seafood. She knows she was getting contaminated food. She picked up these parasites which eat the glucose and other nutrients out of her body. She went from one doctor to another, only 2 doctors found the parasites. These parasites are microscopic and some of them could be pinworms, but also could look like hookworms, pinworms, and different types of parasites. She believed she developed Type II Diabetes because the parasites were eating glucose and nutrients out of her body. She was previously eating well, three meals a day. She confirms she was diagnosed for diabetes in 2014. She was severely anemic in 2003. She knows if the anemia goes on for 6 months, she can have vital organ failure. She had not been tested lately for anemia. Patient family history included patient said her brother was allergic to the penicillin family. Her brother had Covid. He tested seventh in the county for Covid last year. He also took the vaccine this year. The concomitant medications were not reported. The patient stated when she first got the vaccine, she started feeling a little funny. She broke out in hives on her wrists about an hour after both injections. She clarified that the hives were only on the wrist of the arm where she got the vaccine. When she tried to tell people she broke out in hives immediately within an hour after receiving the vaccine, people were doubting her. She makes the comment that we all have a different chemical make-up and she is allergic to a lot of things. She did have a reaction. The reactions that she mostly had were that she got tired and she did get hives around her wrist. She comments that she has had hives around her wrist before, but mostly it had been a reaction to food that she was allergic to. She had been tested by allergists with standard tests. She explained they used to do injections and now they do the back test. She had broken out in hives around her wrist before, this was not the first time. She had 3 other health conditions that gets her attention. Patient was not sure if the stress and the spike in her blood pressure could have anything to do with the hive breakout or if it was an anaphylactic reaction. When she came down with the second tumor, she became severely anemic and she gained 100 pounds. She clarifies the tumor was the size of a golf ball, 3.5cm fibroid. She became severely anemic and had a hemoglobin count of 7.6. She told to the healthcare team she suspected a tumor. Instead of listening to her, she was tested for diabetes and other things, and were not on the right track. Those tests were coming back negative. So, she did gain a lot of weight and she is taking the weight off, but it had took a long time. Her underlying conditions could have led to her death, and her doctors did not get her to any other professionals. The hives on her wrist started again a day before (07Jun2021), but she actually broke out in hives the first time after the first injection. Patient stated the first dose was in the beginning of May, about 3 or 4 weeks ago. She later confirmed the first dose was on 10May2021. She confirmed she broke out in hives the same day she received her doses, within the hour. She confirmed the hives were on her wrist of her left arm, where she had the injection. She confirms there were no hives on the right wrist. The hives were still ongoing today, but they were going down. She can still see the hives and feel the bumps under her skin. However, they looked like they were going down. She has had hives before so she knows what they were. Patient stated she felt really tired and she woke up in hives. She had a little bit of a raspy throat. Her throat did not hurt, but her voice was a little bit raspy a day before (May2021). However, she also had seasonal allergies. Her allergies were bad in April and May and also bad in September and October. So, one part could be the allergies. However, she thought it was strange she broke out on the same arm where she had the injection. The adverse events did not result in physician office or emergency room visit. Patient did not receive any treatment for the adverse events. The outcome of the event hives was not resolved while of the other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
61 2021-07-01 insomnia Less sleepy the following day after; Extreme sleepiness; Still tired the next day; This is a spontan... Read more
Less sleepy the following day after; Extreme sleepiness; Still tired the next day; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), via an unspecified route of administration in the left arm on 20Mar2021 at 13:30 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included suffered with chronic system neurological Lyme disease (10 years ago) and concurrent condition included hypothyroid. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medication included levothyroxine sodium (LEVOXYL) for an unknown indication from an unknown date. The patient previously received the first dose of BNT162b2(PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot no: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. 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 vaccines within 4 weeks prior to the COVID-19 vaccine. On 21Mar2021, the patient experienced extreme sleepiness and tiredness. On 22Mar2021 the patient experienced less sleepy. The patient reported that she had extreme sleepiness the following day, was still tired the next day, but less so and less sleepy the following day after that. The patient did not received 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 extreme sleepiness, tired and less sleepy were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
61 2021-07-11 loss of personal independence in daily activities One week following after the vaccination, my arthritis has gotten worse. I'm having cramps in my leg... Read more
One week following after the vaccination, my arthritis has gotten worse. I'm having cramps in my legs. The cramps in my legs had me go to the doctor. Doctor also notice I had more swelling were my arthritis is. I'm started taking the supplements, calcium, potassium, and magnesium, it's a combination to deal with the leg cramps. And the doctor gave me an osteopathic adjustment. The AE are disabling and impairing my function. I am also having muscle cramps in my abdomen.
61 2021-07-13 anxiety, abnormal dreams, nervousness Strange and crazy dreams/It's like you can't tell reality from a dream. This is very scary to me. I'... Read more
Strange and crazy dreams/It's like you can't tell reality from a dream. This is very scary to me. I'm worried I might do something in my sleep like leave my house or anything; This is very scary to me; Strange and crazy dreams/It's like you can't tell reality from a dream. This is very scary to me. I'm worried I might do something in my sleep like leave my house or anything; Seems almost like this vaccine is messing with your brain; Woke up screaming; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 61-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ENG207), via an unspecified route of administration, administered in right arm on 19Mar2021 at 15:30 (Age at vaccination was 61 years) as single dose for covid-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing. No concomitant medications were reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ENG198) in right arm on 24Feb2021 at 04:00 (Age at vaccination was 61 years) as single dose for COVID-19 immunization. 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. The patient reported that on 19Mar2021 at 11:30 PM, she was having strange and crazy dreams. This started the night of her second dose. she woke up during the night and remember strange dreams. Last night she woke up screaming. She had never done this before. It was like you can't tell reality from a dream. This was very scary to her. She worried that she might do something in sleep like left her house or anything. This seems almost like this vaccine was messing with our brain. She did not see this listed as a side effect. Her daughter was having strange dreams as well since her second dose of the Pfizer vaccine. This had to be related to this vaccine. This was causing her lots of concern about this vaccine. She was asking for explanation why this was happening and how long it will last. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the all events was not recovered. No follow-up attempts are needed. No further information is expected. (Follow-up 28Jun2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included: confirmation on receipt of inquiry. (Follow-up 28Jun2021): This is a follow-up spontaneous report contactable consumer. This 61-years-old female consumer (Patient) reported for herself that: clinical information added. No Follow-up attempts are needed. No further information is expected.
61 2021-07-13 impaired work ability I had a low fever, severe chills, pink eye, tiredness, dry skin, hair loss, sore throat, dizziness, ... Read more
I had a low fever, severe chills, pink eye, tiredness, dry skin, hair loss, sore throat, dizziness, mental fatigue, extra dry lips--lasted 24 hours and required a day off work. I experienced the same symptoms exactly (timing, duration, and severity) after the second dose on 05/21/2021 (also Pfizer, Lot EW 0178) AND after my "immunity day" of 06/04/2021. I was very surprised at the third instance, but my work supervisor, who took the same brand of vaccine with similar timing and at the same Fairgrounds, had the same thing happen.
61 2021-07-13 irritability, anxiety, panic attack tired and exhausted; Panic/anxiety; Panic/anxiety; feels like her ribs are killing her; Back hurts; ... Read more
tired and exhausted; Panic/anxiety; Panic/anxiety; feels like her ribs are killing her; Back hurts; Arms hurt the front of her breasts; Her feet, ankles, calves and back hurt; Bones feel hurt; injection site is just sore; Lethargic; When I get up it actually hurt to walk all my ankles on my feet now; the site is very red and very sore and swollen; I had all kind of things going on but did not feel as weak as I felt the next couple of days; I still was not feeling right/I just did not feel well; Joint pain/Joint were bothering; Chills/extreme chills to my bones; body and muscle aches/Pain in my muscle; the site is very red and very sore and swollen; body and muscle aches; Slept the entire week/she just wanted to sleep; Touching of my skin it hurts; Everything was irritating her/it's irritating, wearing cloths irritated, the sheet irritate it, my thigh, joint, hip, knees, shoulder, the back of my arm, elbows, forearm; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6206), via an unspecified route of administration on 12Mar2021(at 61-years-old) as single dose for covid-19 immunization. Medical history included , thoracic outlet syndrome She had a pectoral flap moved up to her chest , thyroid disorder, autoimmune thyroiditis, renal stone removal from 08Feb2021 to an unknown date She had a kidney stone removed and had complications with that and he called the other day and said she has a UTI, which is a reoccurring , ongoing urinary tract infection , heart valve replacement from an unknown date and unknown if ongoing , coronary artery bypass from an unknown date and unknown if ongoing , coronary artery disease from an unknown date and unknown if ongoing. Concomitant medication(s) included ranolazine (RANEXA) taken for an unspecified indication, start and stop date were not reported; semaglutide (OZEMPIC) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (EUTHYROX) taken for an unspecified indication, start and stop date were not reported; empagliflozin (JARDIANCE) taken for an unspecified indication, start and stop date were not reported. The patient previously took Percocet [oxycodone hydrochloride; oxycodone terephthalate; paracetamol] for cardiac operation, warfarin. The patient reported that she had the first dose of the vaccine on 12Mar2021. It started about 3 o'clock in the morning (13Mar2021). She was experiencing something she had never experienced before. Later that night and more towards the morning she had joint pain. She noticed this first in her ankles and feet, she only noticed that because she had to go to let her dog out. Then the next day, she had pain in her muscle she had chills to the bone, and she just started with body and muscle aches and that was all last week and she slept the entire week. She had the chills really bad. The site was very red and very sore and swollen. She was like that Saturday, joint pain and chills and then she called a friend of her who got first shot but she got Moderna and she said she had symptoms similar to that (hence submitted as split case), said that was not big deal, that means it working so she was like okay. Then on Sunday she still was not feeling right. She got up and took Xanax. She took her normal medication. She took Xanax for anxiety (Intent: Treatment) and took 5 mg percocet (Oxycodone) for joint pain in order to function, get up and get around and do stuff with her husband who was only home on the weekend. So anyhow she did that on Sunday. She ended up coming to bed early and she fell asleep and the entire week last week she did not do anything she just stayed in bed and she just felt very lethargic. The patient actually fell asleep trying to talk to her husband on the phone, she means on video chat because we video chat every night while we he was awake. So, she thought she was just tired, so she stopped video chat with him and just started talking to him every night and this was last week, and I was really tired. She was in her bed. She had one of the beds where pop comes up and legs come up because she had underlying condition. A big deal underlying condition and all last week she stayed in bed all week and she just slept and when she gets up it actually hurt to walk all her ankles on her feet now. It feels like just touching of her skin, this was been going on since yesterday maybe Friday, just touching of my skin it hurts, it was irritating, wearing cloths irritated, the feet irritate it, her thigh, joint, hip, knees, shoulder, the back of her arm, elbows, forearm, and just tried to massage them and just tried to get through it yesterday. The patient took yet again an anxiety medication within addition to my other medication. She took anxiety medication and an Oxycodone. So that she can go to viewing her husband's friend passed and people were like what's wrong with you, you look like you could fall asleep. They did not stay long, came back home and climbed back in bed and that was where she was all day yesterday. She had not taken anything thus far and literally the sheets she got up last night and as she tried to slide out of bed, it literally hurts rubbing the sheet back of my leg and then getting up out of her bed going in into the bathroom because she had other issues, bladder issues. So, this morning she still had some issues and her husband said could it be the result of the covid, the vaccine you got, and she said you know what I never even thought of that, so she started reading some paperwork and it was like joint pain. She was like well she got more than joint pain or muscle pain that she got joint muscle and chills. She was still feeling the same way. Her back hurts just lying on the bed and hurts. When she gets up to move it feels like her ribs are killing her, her arms hurt the front of her breasts. This was something new and prolonged. Walking to the kitchen her feet, ankles, calves and back hurt and her nightgown is hurting her skin. Her bones feel hurt, and her calves hurt. The injection site was just sore. The patient did not have chill at the time of report but jacked up the heat in her house. The patient normally keeps it at 68 all year around whether a heat or cold she turned up the heat and stayed in bed and at the time of report she was under sheet blanket and heavy comfort. The patient asked could any of this related to the shot. It was reported that she tests her own INR and it went down to 2.2, it was up to 2.8 and for some reason it dropped down to 2.2 in middle of the week and I am due to test tomorrow and for some reason the doctor called but that his test was done before she got the shot. The patient stated that she supposed to figure out the drug interaction, possible drug interaction maybe as she takes other drugs. The patient reported that she still experiencing symptoms and it could be due to the Pfizer vaccination. The patient asked that how long can she expect these symptoms to last. She asked if the symptoms reported in the clinical trials with people with underlying conditions. The patient underwent lab tests and procedures which included international normalized ratio: 2.2 it was up to 2.8 and for some reason it dropped down to 2.2 in middle of the week. The patient received treatment. The clinical outcome of the events tired and exhausted, panic/anxiety, back hurts, calves and back hurt, bones feel hurt, lethargic, when i get up it actually hurt to walk all my ankles on my feet now, touching of my skin it hurts, irritability, the site is very red and very sore and swollen was unknown whereas the remaining events was not recovered. No follow-up attempts are possible. No further information is expected
61 2021-07-15 disturbance in attention, feeling abnormal I had really bad brain fog. I didn't know who I was or where I was. I couldn't concentrate on anythi... Read more
I had really bad brain fog. I didn't know who I was or where I was. I couldn't concentrate on anything. It lasted a little over thirty days before I was able to concentrate and have a better handle on my surroundings. I talked to my doctor and my neurologist about it, but I was not seen because they did not know what to do.
61 2021-07-15 fear, mental impairment, memory impairment, anxiety, confusional state, disturbance in attention The symptoms I describe began before Tuesday, June 29 but on that everything got much worse and each... Read more
The symptoms I describe began before Tuesday, June 29 but on that everything got much worse and each day it gets more noticeable and worse. I noticed an EXTREME increase in my inability to think clearly. I get confused easily, I forget work items to complete, I forget to call people. When I'm typing, I'm striking the wrong keys throughout the day, several times per hour. I'm not speaking clearly or making sense. I have more difficulty listening. Just writing this report, I'm having trouble typing (I've made at least 20 errors trying to hit the correct keys) and I'm not able to write clearly. People have noticed and I'm worried about my job because I'm making too many mistakes. I'm scared.
61 2021-07-16 confusional state Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Patient reports she was diagnosed as having a vasovagal syncope to the pfizer covid vaccine at the ER
61 2021-07-17 nightmare Claustrophobia got much worse resulting in nightmares and inability to ride in elevators prior to va... Read more
Claustrophobia got much worse resulting in nightmares and inability to ride in elevators prior to vaccination
61 2021-07-18 depressed mood, insomnia, anxiety I have had Tinnitus since the age of 22 in my right ear and was able to live with it. After my first... Read more
I have had Tinnitus since the age of 22 in my right ear and was able to live with it. After my first injection the tinnitus in creased in tone. But after the second shot the next day it was far worst. My left ear started ringing. The ringing was so loud it was unbearable. Both ears was ringing a different tone. I could not sleep at night, my anxiety increased and I became more depressed.
61 2021-07-18 feeling abnormal 61 y/o female patient refers feelings of dizziness and "strangeness in her body" after receiving the... Read more
61 y/o female patient refers feelings of dizziness and "strangeness in her body" after receiving the second dose of pfizer vaccine.
61 2021-07-25 sleep disorder Patient reports having shooting arm pain up her left arm and neck the day after her vaccination. Dif... Read more
Patient reports having shooting arm pain up her left arm and neck the day after her vaccination. Difficulty sleeping and pain in her arm.
61 2021-07-27 feeling abnormal feels crummy; Chills; a little headache; Low grade fever; a lump under her arm/has a lump under her ... Read more
feels crummy; Chills; a little headache; Low grade fever; a lump under her arm/has a lump under her right arm, this is also the injection site arm/swollen lymph node; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Right on an unspecified date as single dose for covid-19 immunization (age at vaccination: 61-year-old). Previously the patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Right on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date post vaccination, the patient woke up with chills in the morning, a little headache and a low-grade fever. The patient also reported that there is a lump under her arm, her right arm, the same arm she received her vaccine in. The lump is not at the injection site, it is under her armpit. The patient also felt crummy. The outcome of the events was reported as unknown at the time of report. Information on the lot/batch number has been requested.
61 2021-07-27 feeling abnormal wheezing; out of breath/i had trouble catching my breath; felt terrible like i had COVID; This is a ... Read more
wheezing; out of breath/i had trouble catching my breath; felt terrible like i had COVID; This is a spontaneous report from a contactable consumer reported for herself. A 61-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ewo188), dose 1 via an unspecified route of administration, administered in Arm Left on 17May2021 14:00 (at the age of 61-years-old) as a single dose for covid-19 immunization. Medical history included cerebrovascular accident (stroke 5 years ago), drug hypersensitivity- known allergies: penicillin, covid-19 (Prior to vaccination, the patient was diagnosed with COVID-19). Concomitant medication(s) and received within 2 weeks of vaccination included baclofen fluoxetine oxybutynin clonidine benazepril. The patient had no other vaccine within four weeks. On 17May2021 22:00, the night she had vaccine she was wheezing and out of breath when used the bathroom. The next 2 days had trouble catching breath and felt terrible like had COVID again. She had it at christmas for 2 weeks. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment. The seriousness of the event was considered as non-serious by reporter. Outcome of the event was recovered, at the time of this report.
61 2021-07-27 insomnia headache; nausea; chills/shivering; fever; sweating; body aches; unable to sleep due to body aches; ... Read more
headache; nausea; chills/shivering; fever; sweating; body aches; unable to sleep due to body aches; pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 10Mar2021 13:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included kidney disease, recent surgery Jan2021 for brain aneurysm from Jan2021 (Other medical history), Penicillin (Known allergy: Penicillin) and COVID-19 (Covid prior vaccination). Concomitant medication included clopidogrel bisulfate (PLAVIX) and acetylsalicylic acid (ASPIRIN (E.C.) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. Patient did not test covid post vaccination. Patient experienced headache, nausea, chills/shivering, fever, sweating, body aches, unable to sleep due to body aches, pain at injection site on 11Mar2021 02:30 AM. Patient did not received treatment for the adverse events. The outcome of the events was recovering. No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
61 2021-07-27 loss of personal independence in daily activities One week after receiving the vaccine, I suddenly became dizzy and was taken to the ER. My blood pres... Read more
One week after receiving the vaccine, I suddenly became dizzy and was taken to the ER. My blood pressure was elevated. I suffered with waves of dizziness for a week, which prevented me from leaving my house. When I saw my medical provider, she put me on Meclizine and a steroid. They did no good. I was tired and napped each day (I do not take naps normally). The dizziness was replaced with lightheadedness and the fatigue continued, allowing me to function outside the home, but I was only able to work 1/2 days for two additional weeks. In total, it took about 5 weeks for the lightheadedness and fatigue to pass, gradually getting better to the point that I felt normal.
62 2021-01-04 excessive sleepiness Persistent vomiting from 3am to about noon on Monday. Fever of 38.4 ' C. Headache, chills, fatigue.... Read more
Persistent vomiting from 3am to about noon on Monday. Fever of 38.4 ' C. Headache, chills, fatigue. Slept most of the day. Took acetaminophen when able to drink. Drank ginger tea and ate dry toast in the evening. Tuesday, HA controlled with Acetaminophen and Ibuprofen. Able to eat and increase fluids. Consulted with my PCP who suggested I enter my information. Feeling stronger as time passes. I believe another nights sleep will help.
62 2021-01-05 anxiety swelling and joint pain in the little finger on left arm; swelling and joint pain in the little fing... Read more
swelling and joint pain in the little finger on left arm; swelling and joint pain in the little finger on left arm; She got a bruise at the injection site; It bled a little bit when she put it in; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231), via an unspecified route of administration on the left arm, on 28Dec2020 at 14:15 at a single dose for Covid-19 immunization. Medical history included environmental allergies, she has allergies and can have an asthmatic attack from cat dander and perfume, blood pressure (abnormal) and sleep (disorder). Concomitant medications included ongoing lisinopril for blood pressure, colecalciferol (VITAMIN D), acetylsalicylic acid (BABY ASPIRIN), paracetamol (TYLENOL). The patient previously took novocaine but was allergic. She got all this information when she got the vaccine on Monday at (place name) in (state name). It tells all the side effects from the first injection. She wanted to report that it is the same arm that she got the vaccine in. She has swelling and joint pain in the little finger on left arm. It says you can have joint pain, but nothing about swelling. She thought she better report it. This was her first shot. She is supposed to get the second one on 18Jan2021. She wanted to make sure she can take it. She received the vaccine on 28Dec2020. She laid around that day. Today is the first day she doesn't have arm pain and swelling at the injection site. It was the first time she has had arm pain. She has never had that with flu shot. The arm pain started within the 15 minutes she was observed. It hurt like hell until that day. She got a bruise at the injection site. It bled a little bit when she put it in. Swelling and joint pain in the little finger on left arm: she doesn't know if it was later that day. She can't remember. She really noticed it yesterday. She has never had joint pain or swelling. She doesn't have any problems with arthritis. Now her little finger is bigger than the rest of her fingers. It hurts because of the swelling. She doesn't want to take anything. It might be fluid. She has a high pain tolerance. She keeps bending it thinking it will get better. It isn't as bad, but its still swelled up. At first she thought it was better, but it is still pretty swollen. To her this is a reaction. She was thinking if she took paracetamol before, it wouldn't hurt as bad, but she can't remember if she took it that morning. She takes 500mg before bed for the heck of it at night. It helps her sleep better. She has allergies and can have an asthmatic attack from cat dander and perfume. They think she was allergic to the preservative in the flu shot, but she has never had any trouble with the flu shot since. She has environmental allergies. They thought she was allergic to Novocaine once at the dentist office. Who knows, it only happened once. She's been to the dentist many times and who knows what they injected and why she reacted that way. She felt like she was going to pass out. They don't give it to her anymore. She doesn't know what was in it. She is worried since this vaccine is emergency authorization. She doesn't want to get the next one and have a worse reaction. She is not sure if she should be worried. The events of swelling and joint pain in the little finger on left arm were assessed as medically significant. Outcome of the event of 'swelling of fingers' was not recovered, the other events were unknown.; Sender's Comments: There is a reasonable possibility that the event joint pain was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the event swelling with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
62 2021-01-07 confusional state At 12 hrs after injection vomiting and severe chills for an hour. 15 hrs after injection severe bod... Read more
At 12 hrs after injection vomiting and severe chills for an hour. 15 hrs after injection severe body aches for an hour. 18 hrs after injection was mild-moderate headache and moderate tiredness and confusion for another 4-6 hrs.
62 2021-01-07 sleep disorder My body had started itching and I didn't know why. I had not eaten anything new or changed any sha... Read more
My body had started itching and I didn't know why. I had not eaten anything new or changed any shampoo or soap. Finally on Thursday night I realized maybe it is the shot that is giving me all the itching. My whole body was flushed I kept scratching my arms and legs, especially around my ankle, knee, under arm and goin area. I took an allergy pill and called Kaiser and spoke with an advice nurse. she mentioned that taking an allergy pill will relief some of the itching. I fell asleep around after midnight normally I go to bed around 9:30. I also called pfizer and explained and the person took all my information and symptoms.
62 2021-01-08 confusional state Confusion, Headache, Myalgia, fatigue, chills Narrative: Felt "loopy" with sharp vision initially.... Read more
Confusion, Headache, Myalgia, fatigue, chills Narrative: Felt "loopy" with sharp vision initially. Over 3 day period developed varying degrees of chills, headache, muscle aches. Fatigue on first day.
62 2021-01-10 feeling abnormal, impaired work ability shaking; weak; cough; shortness of breath; very ill/ sick; horrible chills; I had a 103 degree fever... Read more
shaking; weak; cough; shortness of breath; very ill/ sick; horrible chills; I had a 103 degree fever for 4 days, horrible chills that were just debilitating; ached everywhere/ severe aches; site soreness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via an unspecified route of administration at left upper arm on 18Dec2020 at single dose for COVID-19 immunization. Medical history included auto immune problems, diabetes, thyroid condition, all ongoing since age 28; pemphigusvulgarism since Sep2020 and ongoing. No concomitant medications. Patient is a frontline worker. She received the vaccine on 18Dec2020 at (Name) where she works. 9 days later she got very ill. she didn't know if it's unrelated. She wanted to know if there is anything she need to be watching out for in order to get her second vaccine on Friday. She was so sick and she did have some autoimmune problems. She was really healthy. On 26Dec2020, she had a 103 degree fever for 4 days, horrible chills that were just debilitating. She was just shaking. She ached everywhere, she had severe aches since 26Dec2020. She got tested for Covid and it was negative on 28Dec2020, she had no cough and no vomit. She stayed in bed and drank lots of fluids and toughed it out. By New Year's Day (reported as 30Dec2020) her fever broke but she was so weak and didn't work. She was back at work now. Also, she experienced site soreness from the injection since 19Dec2020. She did have a cough or any shortness of breath. She felt awful. She had recovered. She was just a little nervous because everything she read said the reaction was more severe with second injection. She planned on getting the second shot. She would have a repeat Covid test on 07Jan2020. Reporter seriousness for fever 103: Medically significant. Reporter seriousness for severe aches: Medically significant. Reporter considered the causality of the event site soreness was related with bnt162b2, of the events fever 103 and severe aches was unknown. The outcome of the event fever was recovered on 30Dec2020, of event ache was recovered on 31Dec2020, of event chills was recovering, of event vaccination site pain was recovered on an unspecified date in Dec2020, of events cough and shortness of breath was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fever, pain 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, 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.
62 2021-01-11 anxiety Approximately 20 minutes after vaccine administration, patient reported feeling swelling of throat a... Read more
Approximately 20 minutes after vaccine administration, patient reported feeling swelling of throat and tonsils. Patient did sip water and was verbally communicative and was texting on phone with pale, anxious appearance with not obvious shortness of breath noted. 911 was called to Center per vaccine clinic protocol at which ems initiated IV and took patient to ED.
62 2021-01-11 fear, amnesia some memory loss; locked jaw/unable to open mouth; her arm hurt; pain went in her jaws; she was real... Read more
some memory loss; locked jaw/unable to open mouth; her arm hurt; pain went in her jaws; she was really scared; Excruciating pain on left ear; swelling in arm; This is a spontaneous report from a contactable other healthcare professional. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: ES1685, Expiry date: 01Mar2021) via intramuscular (left deltoid) on 28Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She stated she is very healthy and don't have any medical conditions. She further stated that it was a scary moment, she don't want to take any chances, she was really frightened (28Dec2020). She made a complaint to let know her experience with the vaccine. Her cousin took the vaccine and told her she needed to report these events. The patient stated she experienced side effects after the first dose of the vaccine: Excruciating pain on left ear, locked jaw, her left upper arm was hurting on 28Dec2020. The pain went in her jaws and she was unable to open her mouth on 28Dec2020. She took 2 Benadryl and it relieved her. She saw on television if you experienced any side effects to take Benadryl. She also took Tylenol for the pain. She also had swelling in arm on an unspecified date in Dec2020. She also experienced some memory loss described as short-term memory loss on 30Dec2020. She stayed in bed after the vaccine, she was really scared, and stated she had memory loss and she don't have any memory problems. She was unable to remember if her car was black. She was looking for a white car. She drives a black car. She stayed in bed all day on Tuesday. Patient was asking what will happen if she does not take the second vaccine. The same morning while she was waiting to get the vaccine, a co-worker sent her a video of a woman who had received a COVID vaccine. She does not know which one. The woman experienced Bell's Palsy. The woman was crying and her face was turning side ways. She stated some people were talking negatively about the vaccine. She stated doesn't want her face to be deformed. She stated what are the cons of not taking the second vaccine. Reporter assessed the events as non-serious. Outcome of the events some memory loss and locked jaw/unable to open mouth was recovered on 30Dec2020, outcome of the events excruciating pain on her left ear, pain went in her jaws, her arm was hurt was recovering. Outcome of swelling in arm and she was really scared was unknown.
62 2021-01-11 feeling abnormal 20 mins later numbness in face a head. Blood vessel popped in right eye. Dizziness feeling out of so... Read more
20 mins later numbness in face a head. Blood vessel popped in right eye. Dizziness feeling out of sorts. Feels like flu shot.
62 2021-01-11 excessive sleepiness, feeling abnormal, disturbance in attention Nausea; Diarrhea; Jitteriness; foggy head or brain; she can't concentrate /she didn't pay it any att... Read more
Nausea; Diarrhea; Jitteriness; foggy head or brain; she can't concentrate /she didn't pay it any attention; sleeping a lot; sick; Headache; body aches; This is a spontaneous report from a contactable nurse. A 62-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration on 05Jan2021 08:15 at single dose for COVID-19 immunisation. Anatomical location of administration of vaccine was right deltoid. Medical history was not reported. The patient previously took omeprazole (PRILOSEC) and experienced drug hypersensitivity and lip swelling. Concomitant medication included atorvastatin (LIPITOR). The patient experienced headache on Jan2021, body aches on Jan2021, nausea on 06Jan2021, diarrhea on Jan2021, jitteriness on Jan2021, foggy head or brain on Jan2021, sleeping a lot on Jan2021, sick on Jan2021, she can't concentrate /she didn't pay it any attention on Jan2021. The outcome of headache and she can't concentrate /she didn't pay it any attention was recovering, of pain, jitteriness, foggy head or brain was not recovered, of sleeping a lot and sick was unknown. Nausea, and diarrhea recovered on 07Jan2021.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events headache, pain, nausea, diarrhea, feeling jittery, feeling abnormal, disturbance in attention and hypersomnia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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.
62 2021-01-11 sleep disorder approximately 2 hours after my vaccination, I started with a very severe headache and felt extremel... Read more
approximately 2 hours after my vaccination, I started with a very severe headache and felt extremely tired. I had difficulty staying awake. I slept about 2 hours. When I woke up my headache was gone and I was no longer tired. I went to bed and slept well until a headache woke me up the next morning however it was not as severe as the previous night. I was a bit lethargic but not too bad. My headache continued until the evening of 1.11.21 however I was not lethargic and was able to work. Today is 11.12.21 and I feel fine. I had no injection site discomfort to speak of.
62 2021-01-12 anxiety Dizziness, Headache, Palpitations, HYPERtension, anxiety and stated SOB Narrative:
62 2021-01-13 feeling abnormal, nervousness, fear was afraid; she was nervous; vomiting; Fatigue; felt chills/chill became a bone chill, and she was f... Read more
was afraid; she was nervous; vomiting; Fatigue; felt chills/chill became a bone chill, and she was freezing; felt chills/chill became a bone chill, and she was freezing; randomly felt miserable/she felt like her body was purging/feeling "blah"; she wasn't really eating; Feeling sick; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730), via an unspecified route of administration in her right upper arm on 22Dec2020 16:00 at single dose for COVID-19 immunization. Vaccination Facility Type is hospital and which was not a facility. Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing and it was maybe 10 years ago that she was diagnosed, and she was treated for her diabetes. There were no concomitant medications. There was no history of all previous immunization with the Pfizer vaccine (within 4 weeks) or additional vaccines administered on Same Date of the Pfizer Suspect. The patient received the first dose of the COVID-19 vaccine 22Dec2020 and is due for her second dose this upcoming Tuesday, 12Jan2021. She asked if it would be safe to receive the second dose at a different time, due to personal plans. She said after she received the first dose of the COVID-19 Vaccine on 22Dec2020, she was feeling sick in Dec2020. She said she had vomiting, chills, and randomly felt miserable, fatigue from 23Dec2020. She said she was nervous about getting the second dose of the COVID-19 Vaccine on Tuesday, 12Jan2021. She said she had plans around that time period and she was afraid she was going to be sick after she receives the second COVID-19 Vaccine dose. She asked if the second COVID-19 Vaccine dose had to be administered in the timeframe that was scheduled. The patient reported she felt chilled when she woke up the next morning, 23Dec2020. She said at first she thought she felt chilled because it was cold outside. She said after she arrived at work on 23Dec2020, the chill became a bone chill, and she was freezing. She said she realized the chill was not a normal cold feeling. She said by mid-morning on 23Dec2020, she began to vomit, and went home and went to bed. She said she got sick 2 more times that day. She said she went to work on Thursday, 24Dec2020, and randomly got sick. She said she wasn't really eating at that point (Dec2020), so it was not like she got sick before or after she ate something. She said she continued to get randomly sick through holiday, 25Dec2020. She said she felt like her body was purging. She said she was feeling "blah", but she was not bedridden or out of commission. She said she had no fever that she knew of. She said her symptoms resolved right after holiday, clarifying she started to feel like herself, saying she felt good. The patient declined any treatment and reported she didn't think her symptoms were that severe, though her family wanted her to go to the doctor. There was nothing had changed in her routine prior to receiving the first dose of the COVID-19 Vaccine. Reported she had blood work every 4 months, and her last blood work was probably done in Oct2020 or Nov2020. The events did not require a visit to emergency room or physician office. The outcome of the event feeling sick, she wasn't really eating, were resolved in Dec2020, outcome of fatigue, felt chills/chill became a bone chill, and she was freezing were resolved on 23Dec2020, outcome of vomiting, randomly felt miserable/she felt like her body was purging/feeling "blah" were resolved on 25Dec2020, outcome of fear and nervous were unknown.
62 2021-01-13 impaired work ability I had to leave work as I was achy, fatigued and had a headache
62 2021-01-14 impaired work ability On the evening of the vaccine day, recipient woke up with Fever, Chills, Body aches, and Fatigue. Ca... Read more
On the evening of the vaccine day, recipient woke up with Fever, Chills, Body aches, and Fatigue. Called off of work.
62 2021-01-14 sleep disorder, feeling abnormal Advised received first covid vaccine 12/21/2020 w/o issues. Received 2nd Pfizer vaccine on 1/11/21. ... Read more
Advised received first covid vaccine 12/21/2020 w/o issues. Received 2nd Pfizer vaccine on 1/11/21. Within minutes her tongue was tingling with sensation of feeling full-felt funny. 30 min later had frontal/jaw headache. 60 min later chills with goose bumps all over while working (works as resp technician at NMCP). While walking to car, her upper arm and front of thighs hurt as if exercised too much. Self treated with Advil and tylenol. --- Next day 1/12 0100am awoke with severe bilateral shoulder joint pain extending to shoulder blades, stabbing abdominal/stomach pain, nausea, urge to vomit. she returned to sleep but awoke 6am with nausea and severe diarrhea and fatigue. She c/o nasal congetion, sinus fullness and severe post nasal drip x 24 hours. S/s persisted and left work early now with severe bilateral ankle pain. She was off Wed/Thursday. Wed 1/13 her shoulder pains eased but now with severe back pain. Wed evening noted tongue swelling sensation again (has pictures) and took oral benadryl and ice chips. She went to sleep. Thursday 1/14 bilateral knee pain/joint with increased nausea again - treated with zofran. Friday 1/15 returned to work, pain in knees made gait wobbly = treated with advil. Notified ID MD and director on tongue swelling and constantly trying to clear throat = sent to ER where treated with oral decadron and M Toradol for pain. She was sent home with prednisone dose pack and compazine. Recommended f/u with HCP for further testing to r/o possibility of a mast cell disorder of familial hypertrytassemia due to her history of multiple allergies/insect allergies--
62 2021-01-15 impaired work ability, excessive sleepiness Jan 12, 11:30am - Dizziness, headache, muscle aches, weakness, cold feeling, flushed. Temperature = ... Read more
Jan 12, 11:30am - Dizziness, headache, muscle aches, weakness, cold feeling, flushed. Temperature = 102.4 F. Had to leave work. Slept for 18 hours, Symptoms continued for 48 hours.
62 2021-01-17 anxiety Patient experience heart palpitations and was experiencing anxiety before and during vaccination. Af... Read more
Patient experience heart palpitations and was experiencing anxiety before and during vaccination. After sitting for 30 minutes after getting the vaccine patient felt more calm.
62 2021-01-19 impaired work ability Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling ... Read more
Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling in chest. No sob. Early on 1/8/21 in the AM, had 2 runs afib, that responded to metoprolol. She reported the afib to her cardiologists. Called again on 1/19/21 to report continued fevers, fatigue, body aches, nausea, and chills that caused her to call off on 1/17/21. Ordered COVID-19 PCR.
62 2021-01-20 nervousness Felt itchy and shaky after vaccine. Left after 30 min. She later developed hives and was seen at E... Read more
Felt itchy and shaky after vaccine. Left after 30 min. She later developed hives and was seen at ED. Per ED notes, approx 1 hour after vaccine, she developed mild erythematous rash over upper chest/ collarbone region. Slightly itchy. She took benadryl PO x 1 with resolution of itching and rash within 1-2 hours. Patient has noted she is needing to clear her throat more often, feeling like it is "a little mucousy". She does not have a frank cough. She denies SOB, chest pain, difficulty breathing, stridor, wheezing or nasal congestion. She does not feel her mouth, lips, face or tongue are swollen. She has no difficulty swallowing. She denies abdominal pain, vomiting, and diarrhea. Denies myalgias, headaches, chills or fevers at this time. Discussed can use additional antihistamine as needed for further rash. Does not need epi IM at this time. Reviewed common side effects for 2nd vaccine to expect in next 24 hours. Reviewed elevated BP and asked to recheck at PCP or next medical visit to monitor for possible hypertension
62 2021-01-21 impaired work ability Extreme fatigue-unable to function-head congestion lasted approximately 48 hours slept approximately... Read more
Extreme fatigue-unable to function-head congestion lasted approximately 48 hours slept approximately 36 of those hours
62 2021-01-21 sleep disorder, loss of personal independence in daily activities A little over 12 hours after receiving my 2nd dose at 8:42 am, I woke up at approximately 11:15 pm t... Read more
A little over 12 hours after receiving my 2nd dose at 8:42 am, I woke up at approximately 11:15 pm to find that my tongue and throat were swelling. I immediately took 1 25mg benadryl and went to the Emergency Room (ER). After many questions and examination of my mouth. I was given another benadryl, prednisone, and famotidine. I waited and was observed for approximately 2.5 hours in the ER. At that time it was obvious that the medication was effective and I was comfortable leaving the ER to return home. I had prescriptions for more prednisone and famotidine to take for 5 days. On Wednesday, I felt well enough to go to work at my school, though I did light duty. On Thursday, I was also at school and also attended a physical therapy session and exercise class. I talked at length with my PT about my experience and she could tell that I was feeling good (presumably from the prednisone) and cautioned me about not overdoing things during exercise. I felt like my tongue was beginning to swell and the PT mentioned that my words sounded a bit funny (she was the only one to comment on this). I then went to dinner at my daughters house and began to feel tired from the benadryl. Upon arriving home and getting ready for bed, my husband and I both noticed how flushed my chest and face had become during the day. My throat and tongue were still somewhat swollen and my throat was beginning to hurt. During the day on Thursday, I had registered with the local Covid information website and had received an email stating that I should feel free to call the triage phone number if I needed. At approximately 9:45 pm I called and talked with a nurse who urged me to return to the ER because of the flushing and continued swelling. In the ER I was seen by a different doctor who was concerned not so much about the swelling, but about the white streaks in my throat and had me swabbed for strep throat. That test was negative. He said he had read my chart from Tuesday night and felt that the medication that had been prescribed was appropriate and that he didn't feel anything needed to be changed. He asked about how bad my throat felt and wrote a prescription for Magic Mouthwash and I asked for an EpiPen, which he also prescribed. We arrived home at approximately 12:00 am, but it was still difficult to lie down and sleep. I had already decided that I would not go to school on Friday and stay home and rest. I needed to pick up my prescriptions when the pharmacy opened and I ran a few other errands while I was out, but returned home and slept most of the afternoon. I have not been very energetic this evening, but decided that I wanted to get this form filled out. At approximately 10:00 PM on Friday evening, I hope that I am able to sleep better than I have the last several nights.
62 2021-01-22 insomnia Insomnia, body aches, chills, low grade fever. I was okay by noon on Thursday.
62 2021-01-24 feeling abnormal Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; ... Read more
Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; Swelling; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included ibuprofen and paracetamol (TYLENOL). The patient was not pregnant at the time of vaccination. 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. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: Ek5730, expiry date not reported) in the right arm on 18Dec2020 15:00 at single dose for COVID-19 immunisation. On 08Jan2021 at 18:00, the patient experienced brain fog, headache, muscle spasm at injection site, severe fatigue, joint pain, driving difficult and swelling. It was unknown if treatment was received for the adverse events. Clinical outcome of the events was not recovered.
62 2021-01-24 loss of personal independence in daily activities joint pain; bad back spasms in the middle of the back radiating up through right should to right arm... Read more
joint pain; bad back spasms in the middle of the back radiating up through right should to right arm; Sweating; arm pain; she couldn't do anything with her right hand. She "couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing".; arm shoulder blade rib cage are sore; arm shoulder blade rib cage are sore; This is a spontaneous report from a contactable consumer (patient, healthcare tech in the ER). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Jan2021 at single dose for COVID-19 immunization. Medical history included spondylosis. Concomitant medications were not reported. patient calls today to report symptoms following administration of the covid vaccine. Caller reports that she got the vaccine on Friday. Reports that on Saturday she started to have joint pain everywhere on Sunday she felt a little better. Reports that on Monday she got up and had really bad back spasms in the middle of the back radiating up through right should to right arm. She went to work, only worked for 2 hours and then checked into the ED. They did an EKG because she was sweating and was with arm pain. They did X-rays and gave her steroids and gave her a pain shot stating it didn't do anything, states they put her on steroids to come home with, muscle relaxers to stop spams. Reports that on Monday night she couldn't do anything with her right hand. She couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing. The spasms won't stop, everything; arm shoulder blade rib cage was sore. Went back to the ER on Tuesday, they did a thoracic and cervical MRI, nothing looked different or wrong. they told her to stay on steroids and keep taking muscle relaxers, with ibuprofen and Tylenol. She also asks, what should her do, and if her history of spondylosis triggering this reaction. Patient was recovering from joint pain, was not recovered from bad back spasms in the middle of the back radiating up through right should to right arm and arm shoulder blade rib cage are sore. Outcome of the events was unknown. Identification of the case safety report serious was No. Information on the Lot/Batch number has been requested.
62 2021-01-25 confusional state ON 1/20/21 DEVELOPED FATIGUE, CONFUSION, AND VOMITING. FOLLOWED UP WITH PCP.
62 2021-01-26 anxiety, agitation Patient reported on 1-27-21 at 11:40am to Employee Health office that on 1-8-21 3:15pm received COVI... Read more
Patient reported on 1-27-21 at 11:40am to Employee Health office that on 1-8-21 3:15pm received COVID dose #1 at staff COVID vaccination clinic - waited 15 minute observation then returned to workstation. About 20 minutes after vaccination began experiencing light headedness, anxiousness, agitation and heart racing. Symptoms increased over next 1-2 days then diminished over the following week. Did not report symptoms. Stated "feeling like myself now"
62 2021-01-27 feeling abnormal migraines; arm is sore where the injection; she could hear like blood going through her, and if she ... Read more
migraines; arm is sore where the injection; she could hear like blood going through her, and if she moved it got faster and faster; Chills; muscle aches; not feeling well; Headache; fever; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (BNT162B2, manufacture: Pfizer), via an unspecified route of administration on 21Dec2020 by injection once to right arm (Lot Number: EJ1685) at SINGLE DOSE, via an unspecified route of administration on 11Jan2021 (Lot Number: EL3302) at SINGLE DOSE for covid-19 immunization (reported as healthcare worker, medical receptionist). Medical history included Other Conditions No. There were no concomitant medications. The patient experienced fever on 11Jan2021, headache on 12Jan2021, chills on 12Jan2021 23:30 , muscle aches on 12Jan2021 06:00, not feeling well on 12Jan2021 , migraines and arm is sore where the injection on an unspecified date. The caller had her second vaccine (later clarified as COVID vaccine) on 11Jan2021, and had the same symptoms as on the first one. They were not as bad, and she thought the first one was pretty bad. She previously reported her symptoms with the first vaccine. Symptoms with the second were fever, headache, chills, of course, and muscle aches, her arm weighs a ton, and not feeling well. Fever was noted when she was sleeping, it is now 99.6, but it was was 103. Headache was noted in the early morning, it was not a normal headache, it was the worst thing, and she is prone to migraines, but this was not even like that, she could hear like blood going through her, and if she moved it got faster and faster, one time, she stood still and it was like ahhh! Chills started about 11:30 last night, they went away this morning, about 11AM. Muscle aches started at 6AM yesterday, and are finally gone, as of proba