Pfizer

Gastrointestinal symptom reports

Female, 60 - 75 years

Age Reported Symptoms Notes
60 2021-01-01 nausea, difficulty swallowing Dizziness, nausea, sweating, throat swelling, hard to swallow, dry mouth, headache, shaky, feeling h... Read more
Dizziness, nausea, sweating, throat swelling, hard to swallow, dry mouth, headache, shaky, feeling hot/cold
60 2021-01-01 vomiting Starting at 0100 am I noticed chills, body aches, vomited, then felt crappy all day. Thursday night ... Read more
Starting at 0100 am I noticed chills, body aches, vomited, then felt crappy all day. Thursday night 12/31 symptoms worsened with above & headache
60 2021-01-03 diarrhea, abdominal discomfort, nausea 12/18/20 08:00PM Mild headache; 12/19/20 headache resolved; chills, loose bowel movement, fatigue. ... Read more
12/18/20 08:00PM Mild headache; 12/19/20 headache resolved; chills, loose bowel movement, fatigue. 12/20/20 loose bowel movement, rash on back and disappeared face red lips swollen. 12/21/20 symptoms continued medications taken Benadryl. Imodium; rash resolved and loose bowel movements later in the day. Abd discomfort, pain and nausea present since vaccine given.
60 2021-01-03 nausea, vomiting Debilitating frontal headache, accompanied by nausea and vomiting, and fatigue for 16 hours
60 2021-01-03 nausea Flu-like symptoms - nausea, sweat. Arm sore immediately after injection - sore for 2 days.
60 2021-01-03 vomiting * Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, ... Read more
* Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, cold and unable to get warm even with multiple blankets * Severe dizziness and vomiting * Headache not relieved by Ibuprofen; took 25 mg Benadryl at midnight
60 2021-01-04 abdominal pain lower, nausea nausea/waves of nausea; lower abdominal pain; headache; This is a spontaneous report from a contacta... Read more
nausea/waves of nausea; lower abdominal pain; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (BNT162B2; reported as COVID19 Vaccine; lot number: EJ1685; expiration date: Mar2021), via an unspecified route of administration right arm on 18Dec2020 15:00 at single dose for Covid-19 vaccination. Medical history included IBS (irritable bowel syndrome), hysterectomy at age 42 and she doesn't have periods (amenorrhea). The patient family medical history included her family are all dead and has been for a long time. The patient's concomitant medications were not reported. It was reported that vaccinations within 4 weeks included shingles vaccination 5 weeks before covid-19 vaccine wherein the patient first singles shot was fine. Her second shingles shot made her sick, body aches, and fever for about 24 hours. She received it from a pharmacy inside a store. The reporter mentioned that she took her first covid vaccine shot and was able to experience nausea, headache lower abdominal pain. She inquired if there was information on until when she will be experiencing this or how long the symptoms will last. She mentioned that she had headaches and waves of nausea, and before nausea, she had lower abdominal pain. She doesn't know if abdominal pain was coincidental. She had a hysterectomy, so she doesn't have periods. She lives with IBS, but this abdominal pain was different. Immediately after COVID-19 Vaccine within about 20 minutes after injection (18Dec2020 15:20), she had headaches and she still has been having headaches. She had strange lower abdominal pain that lasted a minute and a half then shortly after that started having waves of nausea. She added that the waves of nausea began 24 hours after the COVID-19 Vaccine (19Dec2020 15:00). The outcome of the event headache was not recovered, as for nausea was unknown while the outcome of the other event was recovered on Dec2020.
60 2021-01-04 vomiting, abdominal discomfort, diarrhea Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation... Read more
Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation and the soreness in tongue; vomiting severely 5 times; could not eat and breathe; could not eat and breathe; abdomen was upset; cramps and pain; cramps and pain; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 60-years-old at a single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for high cholesterol from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: palpitations (non-serious) on 22Dec2020 with outcome of unknown , weakness (non-serious) on 22Dec2020 with outcome of unknown, sore throat (non-serious) on 22Dec2020 with outcome of unknown, burning sensation and the soreness in tongue (non-serious) on 22Dec2020 with outcome of unknown, vomiting severely 5 times (non-serious) in Dec2020 with outcome of unknown, could not eat and breathe (non-serious) in Dec2020 with outcome of unknown, abdomen was upset (non-serious) in Dec2020 with outcome of unknown, cramps and pain (non-serious) in Dec2020 with outcome of unknown, diarrhea (non-serious) in Dec2020 with outcome of unknown. The nurse stated she received the COVID vaccine on 21Dec2020. The nurse stated she did not have any adverse reaction immediately on the first day but on the second day, after 24 hours, she started to have "little bit palpitations that too for a short period of time and a little bit weakness for a short period of time and sore throat. It is not just soring or swelling but it is burning sensation and, on my tongue, also I feel the same thing, burning sensation and the soreness. That was for a small period of time but on my tongue, it is still there, and my throat is still there and last night I experienced vomiting severely 5 times. After the vomiting, I could not eat and breathe." Then, the nurse slept about 3-5 hours, and woke up and her abdomen was upset. The nurse had cramps and pain and when she went to the bathroom and she had huge diarrhea, 2 times."
60 2021-01-04 vomiting Vomiting, chills, headache. Began 18 hours post injection. Lasted for 12 hours. Continued to have ch... Read more
Vomiting, chills, headache. Began 18 hours post injection. Lasted for 12 hours. Continued to have chills and excessives sleepiness for 48 hours.
60 2021-01-05 nausea 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 nausea 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 2021-01-05 nausea INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINES... Read more
INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINESS, TIREDNESS, MUSCLE PAIN, CHILLS ALL BY 13:30PM AND LASTED FROM 1.04.21 AND CURRENTLY ON 1.06.21 STILL TIRED, DIZZY, HEADACHE, CHILLS AND ITCHY BUT IS BETTER THAN ON 1.04.21.
60 2021-01-05 nausea 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 2021-01-06 diarrhea Severe Body aches cough fever 100.8 chills diarrhea
60 2021-01-06 nausea 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 2021-01-06 retching, decreased appetite Received 2nd dose at 10:30 am at Hospital. I went to work as usual at 1:45 pm though 10:00 pm. wit... Read more
Received 2nd dose at 10:30 am at Hospital. I went to work as usual at 1:45 pm though 10:00 pm. without any issues. Came home, had 2 glasses of wine, as usual, at 1:00 a.m. feeling body aches and headache continued sleeping, woke up at 9:00 a.m. with dry heaves with phlegm with small streaks of blood, rapid heart rate, fatigue with body aches, pain in location of injection, occasional headache, loss of appetite. The body aches, fatigue continued the following day, appetite returned slightly. Thankful these were my scheduled days off from work. Third day after injection body aches dissipating able to go out of the house to do errands.
60 2021-01-07 abdominal pain Chest pain Abdominal pain Fever, severe chills, diaphoresis Seizure like activity for two night
60 2021-01-07 diarrhea Diarrhea Headache Narrative:
60 2021-01-07 nausea, diarrhea, abdominal pain Sudden onset nausea; Swelling at injection site.; abdominal cramps; single episode loose stool; This... Read more
Sudden onset nausea; Swelling at injection site.; abdominal cramps; single episode loose stool; This is a spontaneous report from a contactable nurse, the patient. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0140), via an unspecified route of administration on 30Dec2020 at 09:15 (at the age of 60-years-old) as a single dose, in the right arm for COVID-19 vaccination. Medical history included lymphedema, lipedema, depression, osteoporosis, osteoarthritis, hypothyroid, malabsortion with vitamin deficiencies, anemia, and allergy to latex. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, however it was reported the patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took thimerisol and influenza vaccine both from unknown dates to unknown dates for unknown indications and experienced allergy. On 30Dec2020 at 10:00, the patient experienced sudden onset nausea, abdominal cramps, single episode loose stool, and swelling at injection site. The patient did not receive any treatment for the events. The clinical outcome of the events sudden onset nausea, abdominal cramps, single episode loose stool, and swelling at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
60 2021-01-07 nausea, diarrhea very dizzy/ felt like her Blood pressure dropped/she felt like she was going to faint; she felt real... Read more
very dizzy/ felt like her Blood pressure dropped/she felt like she was going to faint; she felt really really sick/ didn't feel good/felt very bad; Sweating; Nauseous; loose stool; her injection site had a lump and was red; a little pain in her arm/ it was just a little sore; her injection site had a lump and was red; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) via an unspecified route of administration on 29Dec2020 11:30 at single dose in the arm for COVID-19 immunization. There were no relevant medical history and no concomitant medications. The patient received the vaccine 29Dec2020 at 11:30 am. She went to work at 11 at night and only had a little pain in her arm. At 4 am on 30Dec2020, she felt really sick. She felt like her blood pressure dropped. She was very dizzy. She was scared. She didn't feel good. She felt like she was going to faint and was sweating. She was going to try to finish her work and go home. She went to the house, and was very sick. She got into bed because she believed she needed rest. At 3 pm on 30Dec2020, nothing was wrong. She was going to rest more. That night time on 30Dec2020, she felt better. She had also got nauseous. She stated the symptoms only lasted a day, and also said the side effects only lasted from 4 o'clock to 8 o'clock when she got home. She did go to the bathroom and experienced loose stool. She felt very bad when she laid down in bed. By 10 o'clock pm (30Dec2020) she felt better. The patient said she had no problem moving her arm as it was just a little sore. When she got home from work her husband noticed her injection site had a lump and was red. Her arm recovered in a week's time. The patient stated she would go for her second shot on 13Jan2021. The symptoms which started on 30Dec2020 04:00 (dizzy/felt like her blood pressure dropped/she felt like she was going to faint, feeling sick/bad, sweating, nauseous, loose stool) were resolved on 30Dec2020. The events pain in her arm and injection site lump and red were resolved on an unspecified date in Jan2021. Information about lot and batch number was requested.
60 2021-01-07 nausea Significant nausea that came on about 24 hours after the injection. No vomiting. Symptoms are signif... Read more
Significant nausea that came on about 24 hours after the injection. No vomiting. Symptoms are significantly improved and subsiding at the time of this report.
60 2021-01-08 nausea, vomiting SkinRash & NauseaVomiting
60 2021-01-09 diarrhea Chills, extreme weakness, and excruciating bone and muscle pain, diarrhea lasting 48 hours. Improve... Read more
Chills, extreme weakness, and excruciating bone and muscle pain, diarrhea lasting 48 hours. Improved with Meloxicam. The keratitis flared up. Developed keratitis after the first dose on 12/17/2020. Lot EK5730. The keratitis presented with dry eyes, photophobia and reduced reading ability. I am treated with steroid drops and artificial tears.
60 2021-01-10 diarrhea 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 2021-01-10 diarrhea 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 difficulty swallowing Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after receiving vaccination patient became tired and expe... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after receiving vaccination patient became tired and experienced a headache. The next day at 2:15pm the patient reported a temperature of 99.0 degrees Fahrenheit, not being as tired, but starting at 9:30 am that morning experiencing "tongue being tied" and having difficulty communicating described as "know what they want to say but it... doesn't come out" that lasted three hours. The patient denied problems walking or being confused. The patient was immediately referred to the emergency department for evaluation. Upon arrival to the emergency department patient had clear speech speaking in complete sentences and ambulating independently with a steady gait. Physical and neurological exams both normal: no aphasia and no focal neurological deficits, normal strength and sensation throughout. Initial vital signs within normal ranges except blood pressure 149/88 mmHg. Patient remained asymptomatic and stable throughout emergency department stay. Repeat vital signs were within normal ranges and patient was discharged to home with a diagnosis of transient ischemic attack. On follow-up visit with primary care physician four days after vaccination patient reports feeling much better and no new symptoms reported.
60 2021-01-10 nausea, decreased appetite nausea,weakness,chills , fever , muscle and joint pain , no appetite
60 2021-01-10 nausea 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 nausea dizziness around 8:00pm, fatigue, severe headache, neck & shoulder pain, body aches, joint pain, nau... Read more
dizziness around 8:00pm, fatigue, severe headache, neck & shoulder pain, body aches, joint pain, nauseous, mild shortness of breath
60 2021-01-10 nausea Fever 102.2, chills, body aches, nausea.
60 2021-01-11 nausea, frequent bowel movements Arm pain; Full body aches; Headaches; Frequent bathroom use (not diarrhea more of a mix); Mild wheez... Read more
Arm pain; Full body aches; Headaches; Frequent bathroom use (not diarrhea more of a mix); Mild wheezing; Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing asthma (asthmatic) which had been under control for years. The patient's concomitant medications were not reported. In Jan2021, the patient had arm pain; full body aches; headaches; had frequent bathroom use (not diarrhea "more of a mix"); mild wheezing; and nausea. The patient had received paracetamol (TYLENOL) as treatment for the arm pain. The outcome of the events, 'arm pain', 'full body aches', 'headaches', 'frequent bathroom use', 'mild wheezing' and 'nausea', was unknown. Information on the lot/batch number has been requested.
60 2021-01-11 nausea 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 2021-01-11 vomiting, nausea 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 2021-01-14 decreased appetite Patient reports chills, fever, muscle aches, headache, 100.1 within 24 hours. Also report loss of ap... Read more
Patient reports chills, fever, muscle aches, headache, 100.1 within 24 hours. Also report loss of appetite, fatigue.
60 2021-01-14 nausea Chills; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A 60-... Read more
Chills; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246), via an unspecified route of administration on 08Jan2021 11:45 AM at single dose on the right arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), on 18Dec2020 12:00 PM on right arm. COVID-19 vaccine was administered in the hospital. The patient experienced chills, nausea and headache on 09Jan2021 01:30 AM. No treatment received for the events. The events were assessed as non-serious. Outcome of the events was recovered in Jan2021. The patient has not been tested for COVID-19 since the vaccination.
60 2021-01-14 nausea 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 2021-01-17 abdominal pain upper limping one side of foot; wanted to pass out; numbness to right side of face; every muscle in her bo... Read more
limping one side of foot; wanted to pass out; numbness to right side of face; every muscle in her body hurts; stomach is cramping; This is a spontaneous report from a contactable consumer. A 60-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) , via an unspecified route of administration on 04Jan2021 at the first single dose at Arm Left for covid-19 immunisation . Medical history reported as none. There were no concomitant medications. The patient experienced wanted to pass out, numbness to right side of face, every muscle in her body hurts, stomach is cramping on 08Jan2021, limping one side of foot on 11Jan2021. The outcome of event wanted to pass out was unknown; outcome of event numbness to right side of face, stomach is cramping, limping one side of foot was not recovered; outcome of event every muscle in her body hurts was recovering;
60 2021-01-18 nausea 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 2021-01-18 nausea fever (100,4, 101 and 100); I was a little ache like a flu; I was a little ache like a flu; Felt rea... Read more
fever (100,4, 101 and 100); I was a little ache like a flu; I was a little ache like a flu; Felt really hot in my face; I just kind of felt little nauseous; Little bit of chills; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history included ongoing hypertension. Concomitant medication included amlodipine besilate at 5 mg once a day for hypertension, acetylsalicylic acid (BABY ASPIRIN) at 81 mg once a day, vitamins and metoprolol succinate at 50 mg twice a day for hypertension. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. On Jan2021, the patient reported that: " I was running a fever like above 100.4, I was a little ache like a flu" and " I woke up and I just felt really hot in my face, I just kind of felt little nauseous and a little bit of chills and I took my temperature and it was like a 100, so I went to work and I did take a TYLENOL, 2 extra strength TYLENOL around 9:00 and I felt much better and now I am feeling like a fever is coming back so I took my temperature and I was getting like chills again and I took my temperature and it is 101". The patient outcome of the events was unknown.
60 2021-01-18 vomiting, decreased appetite, appendicitis, abdominal pain, nausea Lot number for the first dose was EK5730. After receiving the 2nd dose on the 01/11/2021 went to lun... Read more
Lot number for the first dose was EK5730. After receiving the 2nd dose on the 01/11/2021 went to lunch and in the evening started feeling nausea and was throwing and abdominal pain. Went to work sick Tuesday and Wednesday low grade fever, nausea and abdominal pain, wasn't eating was to sick to eat. Thursday early morning hours the pain was unbearable so she went to the ER and the cat scan. It was determined that she had appendicitis and they removed my appendix same day. Feels so much better now.
60 2021-01-18 vomiting, diarrhea 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 2021-01-19 decreased appetite, difficulty swallowing Within 5 minutes of getting injected, felt heat over entire body, from top of head to toes, heart ra... Read more
Within 5 minutes of getting injected, felt heat over entire body, from top of head to toes, heart rate increased. Nurses came over and took VS. BP 180/100, P128, Throat scratchy and hard to swallow. Monitored continuously and had epinephrine ready but didn't inject as about 10 minutes later symptoms started to subside. Stayed in hospital for longer period (unsure of exact time) and then went home. Over the next 2 days, felt listless, weak and no appetite.
60 2021-01-19 difficulty swallowing, nausea 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 decreased appetite 1. Fever lasting 30 hours. It began approximately 11 hours after my shot, and ended 30 hours later.... Read more
1. Fever lasting 30 hours. It began approximately 11 hours after my shot, and ended 30 hours later. Fever ran about 102 degrees most of the time. 2. Chills 3. Loss of appetite and body aches lasting approximately 3 days 4. Hives in armpits, worse on the side of the injection. I noticed it 48 hours after the injection, and I still have them 1 week later. They are much better, but still visible and itchy. 5. Sensitive and painful gums
60 2021-01-20 diarrhea, vomiting Sore arm vomiting diarrhea muscle pain pain in the neck to the shoulders
60 2021-01-20 nausea taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the co... Read more
taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the corners of my mouth; sore arm; nausea; headache; This is a spontaneous report from a contactable consumer. This consumer reported for that the 60-year-old female patient who received first dose of bnt162b2 (Pfizer Pfizerbiontech covide-19 Vaccine EUA), via an unspecified route of administration on 03Jan2021 10:00 AM on Left arm at single dose for covid-19 immunisation. She is not pregnant. Medical history included Known allergies: Penicillin sulfa. No other vaccine in four weeks. Concomitant medications included in two weeks: escitalopram oxalate (LEXAPRO), valaciclovir hydrochloride (VALTREX). The patient experienced Day 1 sore arm, nausea, headache from 05Jan2021 12:00AM, Day 2 nausea from 06Jan2021, Day 3 rash around the corners of my mouth from 07Jan2021, Day 4 bumps on roof of mouth from 08Jan2021, Day 5 red spots on roof of mouth from 09Jan2021, Day 6 Continued red spots went to Doctor, Day 7 taking new meds for allergic reaction from 11Jan2021, Day 8 headache mouth improving. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. Treatment was received included Doxycycline. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
60 2021-01-23 nausea developed muscle tremors, ataxia, unable to walk, nausea
60 2021-01-24 abdominal discomfort 12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours l... Read more
12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours later turned into sweating/heat. Mild upset stomach throughout. Soreness/brusing at injection site. After 18 hours headache persisted with mild body aches and upset stomach. Still soreness /brusing at injection site. 24 hours after injection very mild backache. No headache. Soreness at injection site. No other issues.
60 2021-01-24 abdominal pain Chills (freezing), aches and pain all over, headache, felt feverish with no fever, painful arm at s... Read more
Chills (freezing), aches and pain all over, headache, felt feverish with no fever, painful arm at site of injection with swelling- took total of 4 tylenol over a course of 20 hours- symptoms lasted about 20 hours- arm swelling and pain lasted about 3 days
60 2021-01-24 nausea, vomiting Pain through whole body and tremoring; Pain through whole body and tremoring/ whole body was sore; T... Read more
Pain through whole body and tremoring; Pain through whole body and tremoring/ whole body was sore; Things started looking funny/ Funny feeling in her ears; Deaf and couldn't hear; Leg cramps in both legs and toes curled out/ muscle spasming; Dizzy; nauseous; Threw up twice; Bruise at injection site; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3246) via an unspecified route of administration on the arm left on 05Jan2021 around 12:00 PM at single dose for COVID-19 immunization. The patient used to get legs cramps when she was pregnant with her twins, but it was only one leg. The patient stated she delivered six children, was in car accidents, and had surgeries. And the patient stated the pain from the COVID-19 Vaccine was beyond any other pain she has experienced. The patient needed glasses to read patient card. And stated her eyesight was going. The patient was pretty healthy. There were no concomitant medications. The patient had no prior vaccinations within 4 weeks. And the patient did not receive additional vaccines on same date that administered BNT162B2. The patient experienced deaf and couldn't hear on 06Jan2021 09:00, leg cramps in both legs and toes curled out on 05Jan2021 19:00, dizzy on 05Jan2021, nauseous on 05Jan2021, threw up twice on 05Jan2021, things started looking funny on 06Jan2021 09:00, pain through whole body and tremoring on 06Jan2021 10:00, bruise at injection site on Jan2021. All the events (except for event bruise at injection site) were reported as seriousness as life threatening. Clinical course: the patient worked nightshift. Laid down that afternoon to take a nap and got up around 10:00. Around 05Jan2021 19:00 PM had sever leg cramps in both legs where her toes were curled out. Leg cramps after vaccine wouldn't go away and it was in both legs. Just wouldn't go away. Around 05Jan2021 21:00 PM it went away. The patient was dizzy, nauseous, and threw up twice on the night of 05Jan2021, and going into 06Jan2021. The patient went to the couch in the hotel room and started going deaf. She couldn't hear anything on 06Jan2021 around 09: 00 AM. Things started looking funny on 06Jan2021 around 09: 00 AM. Woke up at 09:35. Hour after that there was pain through her whole body and everything was hurting at 10:00 AM on 06Jan2021. The patient was tremoring at 10:00 AM on 06Jan2021. Couldn't reach the phone to dial 9-11. Thought she was going to die. Last until about noon and then started to go away. Doesn't know if it is safe to take the second vaccine. Doesn't know if these are thing that should have happened to her. She started to get real concerned. Went into hotel room and started feeling dizzy again. Stopped haring things. Funny feeling in her ears. Was seeing things, got dizzy, and everything got dark. Everything lasted until 12:00 PM on 06Jan2021. Everything was good now. The patient had a bruise where injection was in Jan2021. Stated it was nothing compared to what she went through. Woke up around 10:00 AM. Then went back to sleep and got up around 18:00 PM. She felt fine. Her whole body was sore from the muscle spasming. The outcome of the event bruise at injection site was unknown, of the event leg cramps in both legs and toes curled out was recovered around 05Jan2021 21:00, the outcome of other remain events was recovered on 06Jan2021 12:00. The reporter considered (method of assessment: Global Introspection) that all the events were related to BNT162B2.; Sender's Comments: All the reported events were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, it is worth noting that the 60-year-old female patient had car accidents history and had surgeries. All the events started when she worked nightshift, including leg cramps in both legs and toes curled out, nauseous, threw up twice, pain through whole body, tremoring and transient deafness. Patient did not get rest after vaccination may a risk factor to the onset of the events. 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.
60 2021-01-24 nausea 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 2021-01-24 vomiting, nausea Awoke in the early morning hours of 1/23/21 with severe vertigo, almost fell over twice while walkin... Read more
Awoke in the early morning hours of 1/23/21 with severe vertigo, almost fell over twice while walking to the bathroom. Vertigo caused severe nausea and vomiting, with inability to drink or eat for 36 hours. I became dehydrated. Went to the ED and was admitted overnight for vertigo, orthostatic hypotension, dehydration.
60 2021-01-25 nausea 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 2021-01-26 decreased appetite 26th 0130-can't move, all joints bones-Can't get out of bed. No eating. Poor voiced quality. She's... Read more
26th 0130-can't move, all joints bones-Can't get out of bed. No eating. Poor voiced quality. She's been vomiting. When I asked her the Lot# and manufacturer-she said-stop yelling- don't get frustrated-began to cry-I softy asked the question again Lot# and Manufacturer. Told to go see her PCM.
60 2021-01-26 diarrhea, nausea C/o muscle aches, calf cramps, (B) feet numbness, cough, nausea, diarrhea, all began after #2 vaccin... Read more
C/o muscle aches, calf cramps, (B) feet numbness, cough, nausea, diarrhea, all began after #2 vaccine. No problems with #1 vaccine Tx antiemetic, H2 blocker, anti histamine, Tylenol push fluids
60 2021-01-26 nausea weird taste in mouth; like a burnt oatmeal taste; Nausea; This is a spontaneous report from a contac... Read more
weird taste in mouth; like a burnt oatmeal taste; Nausea; This is a spontaneous report from a contactable nurse. A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1283, expiry date not reported), intramuscular on 09Jan2021 12:00 at a single dose in the left arm for COVID-19 immunization. Medical history included had known allergies to sulfa and patient had the COVID virus back in Oct2020 to an unknown date. The patient was not pregnant at the time of vaccination. Concomitant medication included celecoxib (CELEBREX). The patient had the first dose of BNT162B2 on an unknown date for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. Patient wanted to report a side effect and was reading a little about it. She had her second dose of the Pfizer Covid-19 vaccine last Saturday, 09Jan2021 and has like a weird taste in her mouth on 11Jan2021. It's like a burnt oatmeal taste. Patient wanted to know if anyone has ever reported that. Patient reported nausea with weird taste in my mouth, not a loss of taste but taste of burnt oatmeal. Patient had the COVID virus back in Oct2020 and she didn't have taste or smell at all then and now she has a taste so it's not like she has COVID again. No treatments received in related to the events reported. Since the vaccination, the patient has not been tested for COVID19. The outcome of the events "weird taste in mouth; like a burnt oatmeal taste" and nausea was not recovered. Information on the batch/lot has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021025273 Pfizer
60 2021-01-26 nausea Fatigue but only in evening. Able to work. Irregular heart beat (not normal intermittent PVC) that c... Read more
Fatigue but only in evening. Able to work. Irregular heart beat (not normal intermittent PVC) that caused chest discomfort. Nothing concerning, just more curious. With second vaccine, developed chills within one hour and went to bed. Upon awakening, had headache, nausea, chills, kidney area pain, chest discomfort from irregular heart beat. This resolved for about 18 hours, then started again and lasted for 1 week. Chest pain became sharp at times spreading to arm with mild shortness of breath. Having had a full heart workup last year, did not pursue tests. wanted to see if would pass on it's own. After one week, only have occasional chest discomfort. Arrhythmia has returned to baseline occasional PVC. No further chills, headache, nausea or other pains.
60 2021-01-26 nausea Nausea
60 2021-01-27 abdominal pain arm pain; light headedness; abdominal pain; swollen, tender lymph node left axillary area; swollen, ... Read more
arm pain; light headedness; abdominal pain; swollen, tender lymph node left axillary area; swollen, tender lymph node left axillary area; This is a spontaneous report from a contactable nurse (patient). A 60-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK4176; expiration date: unknown), via an unspecified route of administration left arm on 08Jan2021 08:30 at a single dose for covid-19 immunization. The patient medical history was not reported. The patient has no known allergies. There were no concomitant medications. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 18Dec2020 10:30 at a single dose for covid-19 immunization. The patient experienced arm pain, light headedness, abdominal pain and swollen, tender lymph node left axillary area on 08Jan2021 04:00 PM. The patient received treatment for the adverse events includes acetaminophen (TYLENOL) and ibuprofen (MOTRIN). The outcome of the events was recovered on in Jan2021.
60 2021-01-27 nausea Muscle pain; Chills; Nausea; This is a spontaneous report from a contactable consumer. A 60-year-old... Read more
Muscle pain; Chills; Nausea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in left upper arm on 11Jan2021 around 3:45-4:00pm at a single dose for COVID-19 vaccination. Medical history included hypothyroidism. Concomitant medication included levothyroxine from 2006 for hypothyroidism. The patient was administered the first dose of Pfizer-BioNTech COVID Vaccine on 11Jan2021 at work. On 12Jan2021, the patient experienced muscle pain, chills, nausea. The outcome of the events was not recovered. The patient underwent rapid COVID-19 nasal swab test and the result was negative on 12Jan2021. Second dose scheduled to be administered on 01Feb2021 with no dose change made. Information on the Lot/batch number has been requested.
60 2021-01-28 diarrhea day 5 vertigo just morning dizziness all day better the next day. very tired no energy feeling cru... Read more
day 5 vertigo just morning dizziness all day better the next day. very tired no energy feeling crummy, migraines by day 6, 7 and 8... worst than normal and lasting longer than normal. usually get relief after 1 dose but it would take at least 2 before feeling somewhat better. some diarrhea, body aches. pain in my left arm and side around lung area. had chest x-ray on 1-11-21 clear. this all lasted until 1-27 or 1-28 felling a lot better today 1-29-21.... these are all the symptoms i had when i had covid in Nov. it was like having it all over again......
60 2021-01-28 nausea, abdominal pain Moderate Swelling and pain under right axilla Redness swelling at site Nausea Aches Abdominal pain ... Read more
Moderate Swelling and pain under right axilla Redness swelling at site Nausea Aches Abdominal pain Headache
60 2021-01-28 nausea Headache; chills; shaking; weakness; tiredness; nausea; Joint pain; muscle pain; This is a spontaneo... Read more
Headache; chills; shaking; weakness; tiredness; nausea; Joint pain; muscle pain; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:15 (at the age of 60-years-old) at a single dose for COVID-19 immunization. Medical history included arthritis (knees), sulfa drugs allergy, poison ivy allergy (severe), and COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) and furosemide (LASIX). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain on 16Jan2021 at 13:00. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative (test name: Binex) on 12Jan2021 and COVID-19 test: unknown results (post vaccination) on an unspecified date. Therapeutic measures were taken as a result of the events, which included naproxen sodium (ALEVE); it was reported that the treatment did not work. The clinical outcome of headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain was unknown. The batch/lot number for the vaccine, BNT162B2, was provided and has been requested during follow up.
60 2021-01-31 nausea nose bleed/kind of "blew like a quarter size of blood clot"; congestion in her throat; headache; tir... Read more
nose bleed/kind of "blew like a quarter size of blood clot"; congestion in her throat; headache; tired, very tired and just wanted to sleep; nausea, some nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140 and expiry date unknown) via unspecified route of administration on 14Jan2021 at single dose for Covid-19 immunization on her job (nursing home). Medical history included blood pressure high. Concomitant medications vitamins. The patient took that COVID-19 vaccine shot yesterday (later clarified the date as 14Jan2021) on her job. The patient informed that she was okay the first day, but yesterday (15Jan2021) last night she had some new problems and she wanted to talk about and see it's a clinical sign. The patient informed that it was headache, tired, very tired and just wanted to sleep. The patient had no swelling/no swelling in arm, nausea, some nausea and even she has been just feeling unwell. The patient informed that today (16Jan2021) this morning, she was having nosebleed until the last time she felt like congestion in her throat and she kind of "blew like a quarter size of blood clot". The patient blew her nose and it bled a while, but then a quarter size blood clot come out and since then it wasn't bleeding, her nose was not bleeding. The patient did not receive treatment due to the events. The patient underwent lab tests and procedures which included COVID testing; swab the nose: negative on 13th or maybe 14th (Jan2021). The outcome of the events headache, tired, very tired and just wanted to sleep, nausea, some nausea, feeling unwell, nose bleed/kind of "blew like a quarter size of blood clot", congestion in her throat was unknown.
60 2021-01-31 vomiting, nausea 6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days... Read more
6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days later 12 hrs after vaccination: Nausea, vomiting, headache, body aches, fever (100.7 at peak), chills. Lasted approximately 36 hours. 48 hours after vaccination: vaccinated arm has tingling sensation and weakness when raised, armpit lymph nodes tendor/sore - still have this symptom 3 days later. Took Aleve to alleviate symptoms. It lessened them somewhat but I was still not able to function fully for several days.
60 2021-02-01 diarrhea Fatigue; headache; earache; sore throat; fever of 101.4 for 24 hours; Diarrhea; Could do nothing but... Read more
Fatigue; headache; earache; sore throat; fever of 101.4 for 24 hours; Diarrhea; Could do nothing but sleep; administration date=15Jan2021 (dose number: 2); administration date=23Dec2020 (dose number=1); This is a spontaneous report from a contactable other health professional (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on 15Jan2021 at 13:30 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included allergies when younger, known allergies to wheat, dairy, cats, and mold. There were no concomitant medications. The patient previously took levofloxacin (LEVAQUIN) and nitrous oxide and experienced allergies; also had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231) on 23Dec2020 at 11:30 for COVID-19 immunization. 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. On 15Jan2021, the patient experienced fatigue, headache, earache, sore throat, and fever of 101.4 for 24 hours, and diarrhea. The patient could do nothing but sleep. The patient did not receive any treatment for the reported events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.
60 2021-02-01 diarrhea Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On ... Read more
Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On 1/25/21 I also had fever (highest was 101.4), chills, weakness, and aching bones. I also had a terrible headache that started 1/20 and lasted until 1/ 28 or 1/29. There was the normal injection site soreness on the evening of the first day.
60 2021-02-01 nausea Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, s... Read more
Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, sensitive to touch, movement and unable to lift arm beyond 45 degree angle. 17 hours after vaccine chills, fever of 102, muscle aches, severe headache, fatigue. 53 hours after vaccine, fever 101, severe headache, muscle aches, fatigue. Arm pain much less severe.
60 2021-02-01 nausea 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 nausea, abdominal discomfort 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 2021-02-02 nausea Pt reports feeling "out of body", lightheaded, impending doom, nauseated and diaphoretic.
60 2021-02-02 vomiting Severe vertigo: onset 1 hour after injection followed by vomiting x3- Benedryl taken
60 2021-02-03 nausea 11pm evening of shot woke with body aches. Approx. 2am woke again with extreme chills, headache & na... Read more
11pm evening of shot woke with body aches. Approx. 2am woke again with extreme chills, headache & nausea. Somewhat lethargic throughout the day but no symtoms other than slight headache. Woke the next morning at 3am with extreme chills again. Seem to feel ok but not 100% today.
60 2021-02-03 nausea Starting about 30 minutes after the injection she had nausea and occasional dizziness. About 12 hour... Read more
Starting about 30 minutes after the injection she had nausea and occasional dizziness. About 12 hours later she began having fever, chills and muscle aches. Fever improved with Motrin.
60 2021-02-03 nausea nausea and dizziness/dizziness and nausea went pretty extreme; nausea and dizziness/dizziness and na... Read more
nausea and dizziness/dizziness and nausea went pretty extreme; nausea and dizziness/dizziness and nausea went pretty extreme; This is a spontaneous report from a contactable consumer (husband of patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 13Jan2021, 2 days after vaccination, patient experienced nausea and dizziness, that went away. Until yesterday, 19Jan2021, her dizziness and nausea went pretty extreme. She was scheduled for a second dose in about 2 weeks, on 09Feb2021. Outcome of events was not recovered. Information on the lot/batch number has been requested.
60 2021-02-04 diarrhea, vomiting After less then 48 hours I woke up with diarrhea. Then I started throwing up followed by severe chil... Read more
After less then 48 hours I woke up with diarrhea. Then I started throwing up followed by severe chills & body aches, a fever & a headache
60 2021-02-04 nausea 6 hours after shot became extremely dizzy and nauseous.
60 2021-02-06 vomiting, abdominal pain upper 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 nausea Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female pat... Read more
Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: En5318; Expiration date was not reported) on 22Jan2021 (10:45) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization. Medical history included multiple (MS), blood clots and pulmonary embolism. Concomitant medications included rivaroxaban (XARELTO) and omeprazole. The patient previously took clarithromycin (BIAXIN), and had drug allergies. The patient was not pregnant at the time of vaccination. On 23Jan2021 (16:00), the patient had nausea. The patient did not receive any treatment for the event, nausea. The outcome of the event, nausea, was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination.
60 2021-02-07 nausea Started to feel achy, then it got worse; very painful. Some nausea, chills, headache, lethargic. Mos... Read more
Started to feel achy, then it got worse; very painful. Some nausea, chills, headache, lethargic. Most symptoms gone in 20 hrs. After that a few days feeling sluggish.
60 2021-02-07 nausea Fever 100.2F; chills, nauseous, weakness
60 2021-02-09 abdominal pain upper, abdominal discomfort, abdominal pain upper, abdominal discomfort Next day bad headache, two days later bad GI upset, stomach pain inflammation ; 2nd vaccine Psfizer
60 2021-02-09 diarrhea positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous re... Read more
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer reported for herself. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EL3249, exp.date May2021 on 15Jan2021 16:00 at single dose for COVID-19 immunization, via unspecified route of administration at the left arm. The patient had get earlier in January a DPT (diphtheria, pertussis, and tetanus) vaccine in the left arm. The patient had have a Pneumonia and Shingles vaccines in the last 2 years and she had no problems in past with vaccines, but stated she did get a little bit of swelling and had to put heat to the area with vaccines, but never had a fever afterwards. The patient had not medical history. Concomitant medications were not reported. No other vaccines given the same day. Since 16Jan2021, he started having symptoms, fever, cough and Diarrhea. On 17Jan2021 the patient was positive to SARS-CoV-2 test. On 19Jan2021 she received monoclonal antibody therapy. The outcome of the event was not recovered.
60 2021-02-10 nausea, diarrhea Could not raise my arm the next morning with out extreme pain from the site to the arm pit to the ne... Read more
Could not raise my arm the next morning with out extreme pain from the site to the arm pit to the neck. Then my arm pit was swollen, hot and the swelling went down my arm. I also had diarrhea, Nausea, slight head ache, chills, body ache with a temp of 101.5. Went to the doctor yesterday because of my armpit swelling, hot to touch and it had a red band. She said where they gave it was not in a muscle. It was given sub Q & that it went into my lymph gland and leaked down my arm to swell. Right now I just have on and off nausea , pain in my lymph glands in my arm pit. The swelling and pain has gone down and the other symptoms have faded away.
60 2021-02-14 diarrhea Soreness at site of injection; loose bowels; This is a spontaneous report from a contactable consume... Read more
Soreness at site of injection; loose bowels; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported for 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247) via unspecified route of administration on 26Jan2021 at 02:30 PM in left arm at single dose for COVID-19 immunization in the workplace clinic. There was no other vaccine administered in four weeks. Medical history included gluten intolerant. No Known allergies. Concomitant medication included calcium, ergocalciferol (VIT D), ibuprofen (ADVIL), multivitamin. The patient was not pregnant at the time of vaccination. The patient did not have COVID prior to vaccination. The patient experienced soreness at site of injection and loose bowels on 27Jan2021 at 07:15 AM. No treatment was received for adverse effects. The patient was not tested for COVID post vaccination. The outcome of events was not recovered. No follow-up attempts possible. No further information expected.
60 2021-02-14 diarrhea Intermittent cramping and diahrrea from midnight Sunday through Monday 2/15 (so far)
60 2021-02-14 nausea 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 2021-02-15 abdominal discomfort, diarrhea 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 abdominal discomfort, nausea 8:30 pm - extreme shivering, teeth chattering, extremities freezing cold, particularly the feet; sev... Read more
8:30 pm - extreme shivering, teeth chattering, extremities freezing cold, particularly the feet; severe body aches; injection site throbbing; upset stomach and a feeling of nausea. Temperature 100.2 at 8:45. Took temp every hour. By midnight temp reached 102.7. Head ache started. Couldn?t sleep on my left side because of the extreme pain around the injection site and down my left arm. Finally fell asleep around 2:30 and woke at 5:30. Fever was gone. Temp read 98.9. Body aches still present but not as severe. Arm pain had eased but head ache remained most of the day. Felt much better but just very tired.
60 2021-02-15 decreased appetite 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 abdominal pain upper, nausea, indigestion 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 2021-02-16 nausea 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 2021-02-17 decreased appetite, nausea lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded... Read more
lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded to the point of nearly passing out; cold sweat; loss of appetite; pain in upper shoulder/back area; pain in upper shoulder/back area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL-9265), via an unspecified route of administration on 29Jan2021 12:30 in left arm, at single dose for covid-19 immunization. Medical history included chronic low BP, hypothyroidism, HRT, nasal allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), multivitamin NOS (MULTIVITAMIN). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and known allergies: Augmentin, being treated for nasal allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, general feeling of being unwell, lightheaded to the point of nearly passing out; cold sweat, loss of appetite, pain in upper shoulder/back area, on 01Feb2021 06:30. No treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.
60 2021-02-17 nausea Head ache, body aches, fever, chills, nausea, fatique
60 2021-02-18 nausea Fever, pain in the arm where I got the shot. nauseated
60 2021-02-21 difficulty swallowing During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations... Read more
During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations/dizziness with BP of 157/99, requested transfer to ED for further evaluation. Began experiencing scratchy sensation to throat, difficulty swallowing with hoarseness of voice 5 minutes after vaccination. Received epinephrine 0.5mg IM once, protonix 40mg IV once, and solu-medrol 125mg IVPB once in ED. Patient was observed in ER for 3 hours and reported having EpiPen and Benadryl at home, was discharged with Prednisone 20mg, 2 tablets daily for 3 days.
60 2021-02-23 nausea I only had 1 dose on 2/16/2021 and got the reaction 1 week later 2/23/2021.. Not sure if that's pos... Read more
I only had 1 dose on 2/16/2021 and got the reaction 1 week later 2/23/2021.. Not sure if that's possible but wanted to report it anyway. body ache, joint discomfort, migraine headache all day, fever, chills & nausea - this started about 10am on 2/23/2021 and lasted until 2am the following morning 2/24/2021. I took 600 mg of motrin every 6 hrs and 600 mg of tylenol every 4 hrs. I feel fine today
60 2021-02-25 abdominal distension, abdominal discomfort Eyelids and face swollen, itching on the jaw, tingling sensation and possible stomach upset and some... Read more
Eyelids and face swollen, itching on the jaw, tingling sensation and possible stomach upset and some shortness of breath.
60 2021-02-26 nausea IMMEDIATE Strange warmth/tingling down left arm and then further down body Dizziness Headache Fatig... Read more
IMMEDIATE Strange warmth/tingling down left arm and then further down body Dizziness Headache Fatigue brief chills LATER & NEXT DAY Pain left arm Muscile aches, especially legs Brief episode of nausea Slight fever
60 2021-02-27 decreased appetite Headache, Low grade fever, cough, loss of appetite, hot flashes, Lost my voice. Didn't feel well Fri... Read more
Headache, Low grade fever, cough, loss of appetite, hot flashes, Lost my voice. Didn't feel well Friday night, started coughing and feeling unwell. I had a fever in the morning and had lost my voice but wasn't coughing anymore. Today no fever but no voice and I just don't feel well. No appetite today either.
60 2021-02-27 decreased appetite 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 2021-02-27 nausea At 48 hours After vaccines I developed a headache nauseous Hot the following day I was sore all over... Read more
At 48 hours After vaccines I developed a headache nauseous Hot the following day I was sore all over still having a headache still nauseous my ribs hurt my hand hurt four days today still not well tired weak headache! So sick ! I do not wish to have the second dose! I really thought I was gonna die
60 2021-02-27 nausea That evening starting to feel flu like symptoms. Today I feel like I have the stomach flu-body aches... Read more
That evening starting to feel flu like symptoms. Today I feel like I have the stomach flu-body aches, headache, sore arm, nausea, 102 fever, joint pain
60 2021-02-28 vomiting, nausea excessive vomiting, nausea, headache, aches, fatigue
60 2021-03-01 abdominal pain upper Left upper abdominal pain after receiving COVID vaccine radiating to left jaw rapid response, had pa... Read more
Left upper abdominal pain after receiving COVID vaccine radiating to left jaw rapid response, had patient remove mask and reported facial drooping. Transferred to ED for acute, painless, unilateral facial paralysis with no forehead sparing most likely secondary to Bell?s Palsy. Patient was monitored and discharged with prescriptions for valacyclovir 1000mg tid and prednisone 50mg qday x 7 days
60 2021-03-01 decreased appetite, nausea 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 2021-03-01 diarrhea, nausea I started to get mild nausea within about 15 mins. then a chemical taste in my mouth. Later I ... Read more
I started to get mild nausea within about 15 mins. then a chemical taste in my mouth. Later I was getting some sputum or phlegm coming up,, no cough, on short of breath no nasal discharge. During the night I woke up because the phlegm was much worse and abundant I wanted to sleep so at first was swallowing it, then it was so much that I got up and went to the bathroom. That is when I noticed that the palms of my hands were scarlet red. on both hands and not on the wrists or any where else. by morning it was gone but I did have diarrhea and still a cold mild nausea feeling in my stomach. Yesterday , 3 days later, still had diarrhea and nausea and was tired,,symptoms are not severe, but since these are not typical symptoms for me. I figured they will go away, but also I figured that I should communicate the reaction . I am scheduled for my 2nd shot in 3 weeks,
60 2021-03-02 decreased appetite Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appet... Read more
Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appetite, fatigue, could not lift arm.
60 2021-03-02 difficulty swallowing 5 minutes after receiving the vaccine, patient became flushed. She also stated that she had a sore t... Read more
5 minutes after receiving the vaccine, patient became flushed. She also stated that she had a sore throat without SOB or difficulty swallowing. She was able to drink water without difficulty. Her airway was patent and oropharynx was normal on exam. She had no stidor on exam. Patient was advised to seek care at the ED, but she did not.
60 2021-03-03 nausea SORE ARM, VERY TIRED, SEVERE HEADACHE, SORE MUSCLES ALL OVER, CHILLS, KNEE AND HIP JOINT PAIN, NAUSE... Read more
SORE ARM, VERY TIRED, SEVERE HEADACHE, SORE MUSCLES ALL OVER, CHILLS, KNEE AND HIP JOINT PAIN, NAUSEA, SWOLLEN LYMPH NODES UNDER BOTH ARMS, FEELING UNWELL
60 2021-03-04 diarrhea, vomiting Pt experienced diarrhea at 0300 today with vomiting. Pt had body ache and feeling weak, Temperature ... Read more
Pt experienced diarrhea at 0300 today with vomiting. Pt had body ache and feeling weak, Temperature was 101 at 0930 this morning. Pt has minimal coughing at this time. Current temperature is 99.9 The pt denies any SOA prior or currently at this time. The pt was informed to eat small amount of crackers as tolerated and fluids as tolerated. Get plenty of rest. Should sx's worsen or SOA occur, then call for an ambulance for assistance.
60 2021-03-04 difficulty swallowing Pt in 30 min waiting area. At 10:36 am reported tongue feeling funny. Upon assessment tongue was t... Read more
Pt in 30 min waiting area. At 10:36 am reported tongue feeling funny. Upon assessment tongue was thick , interfering with speech. BP: 186/93, Heart Rate : 66, Oxygen Saturation 99%, Temperature 97.6 F. Epinephrine 0.3 mL administered on left thigh at 10:42 am and 911 called. Pt reported inability to swallow and chest tightening at 10:51 am. Ambulance arrived.
60 2021-03-04 nausea, vomiting 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 2021-03-04 nausea 4 hours after vaccine, had the following Reaction : -Big Chills -Nausea -Small amount of swelling o... Read more
4 hours after vaccine, had the following Reaction : -Big Chills -Nausea -Small amount of swelling on Face, Ankles, & Wrists -Very tired = fatigue / sleep
60 2021-03-04 painful swallowing Sore throat, and chest feels heavy. Hurts to swallow. No treatment. I am currently monitoring my is... Read more
Sore throat, and chest feels heavy. Hurts to swallow. No treatment. I am currently monitoring my issue. If symptoms worsen I will go to ER
60 2021-03-07 diarrhea 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 difficulty swallowing Lip tingling, palpitation, flushing and wheezing/slight SOB within 15-30 mins and sensation that she... Read more
Lip tingling, palpitation, flushing and wheezing/slight SOB within 15-30 mins and sensation that she was unable to swallow while driving home. Used rescue inhaler when she reached home for relief. Symptoms now resolved. H/O asthma
60 2021-03-08 decreased appetite fever, chills, back pain, fatigue, loss of appetite, foggy
60 2021-03-08 diarrhea several bouts of diarrhea after the Pfizer Covid Vaccine (1st One)
60 2021-03-08 difficulty swallowing throat tightness, elevated HR, difficulty swallowing, chest pressure. Evaluated by EMS-Cleared
60 2021-03-08 difficulty swallowing This is a 60-year-old female who just received her second Pfizer dose of the Covid vaccine earlier t... Read more
This is a 60-year-old female who just received her second Pfizer dose of the Covid vaccine earlier today when she says she felt immediately a flushing of her left arm where she had received the vaccination and then some tingling and abruptly followed with difficulty swallowing tongue enlargement, and feeling like she had to "search for my air". This required her to turn her head leftward to assist in her breathing. She has no associated pruritus. She was given an intramuscular injection of epinephrine at the clinic where she received the vaccination and EMS was activated. She did not demonstrate any changes in her phonation or signs of stridor and there was no wheezing or signs of facial or oral swelling on arrival of paramedics. She received additional intramuscular injection of epinephrine and IV Benadryl and Solu-Medrol at that time followed by an albuterol inhalation treatment and transported here as a medical alert. She reports the symptoms are similar to what she is experienced with multiple bee sting allergic reactions in the past. She is never required intubation. She never develops any facial swelling or urticaria.
60 2021-03-09 difficulty swallowing within a couple of minutes after receiving the shot, I felt a sudden flash of warmth throughout my b... Read more
within a couple of minutes after receiving the shot, I felt a sudden flash of warmth throughout my body. Then my heart started racing. This lasted about a minute. I just sat there since I wasn't sure if this was normal. I started to feel like my heart was going back to normal so I just sat there for the specified 15 minutes. After I left and was driving home, I stated to feel a shortness of breath and difficulty getting air. I also felt like a hard to swallow. I was about 1 mile from venue so this happened with 30 minutes of receiving the shot. This only lasted what seemed like a short time and then I started to feel like I could get my breath. By the time I returned home I was breathing ok but my lips were a little tingly. I felt fine by 5:00 pm.
60 2021-03-09 nausea 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 nausea mild headache, sore arm at injection site, mild nausea, mild weakness. sore arm immediately after in... Read more
mild headache, sore arm at injection site, mild nausea, mild weakness. sore arm immediately after injection lasting 2 days. Headache, nausea and weakness day after vaccination lasting 24 hours.
60 2021-03-10 diarrhea Enlarged lymph nodes following 1st shot-- Diagnostic Mammogram and ultrasound; Severe Diarrhea for ... Read more
Enlarged lymph nodes following 1st shot-- Diagnostic Mammogram and ultrasound; Severe Diarrhea for 48hrs following 2nd shot. Pain in arm for about 4 days following both shots
60 2021-03-11 diarrhea, nausea 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 2021-03-11 diarrhea, vomiting, nausea Fatigue starting at 20:25 on 1/27/2021. Ended on arising on 1/29/2021 at 0530 Nausea with vomiting... Read more
Fatigue starting at 20:25 on 1/27/2021. Ended on arising on 1/29/2021 at 0530 Nausea with vomiting starting at 2200 on 1/27/2021. Continued thru the night and early morning hours stopped at approximately 0930 on 1/28/2021 Diarrhea starting after midnight on 1/28/2021 Ended at 0700 on 1/28/2021
60 2021-03-11 nausea Patient administered Covid Vaccine (Pfizer, 1st dose) at approximately 2:46PM. At approximately 150... Read more
Patient administered Covid Vaccine (Pfizer, 1st dose) at approximately 2:46PM. At approximately 1505 pt c/o nausea and ran outside. Pt awake, alert, respirations easy and unlabored, no distress noted. No vomiting occurred. Pt stated history of throat swelling and facial swelling/rash after PCN. 1510: Pt stated nausea resolved. Pt Diabetic and had not eaten lunch. Juice and crackers given, pt tolerated well with no difficulty. Respirations remain easy and unlabored, no distress. 1517: Pt clearing throat, c/o throat swelling, able to manage oral secretions, speaking in complete sentences. Pt to triage area via wheelchair by RN. BP 171/80 | Pulse 77 | Resp 17 | LMP 02/01/2013 (LMP Unknown) | SpO2 98% 1523: Pt awake, alert, c/o difficulty breathing. RN called for assistance 1526: 911 called. BP 184/84 | Pulse 82 | Resp 20 | LMP 02/01/2013 (LMP Unknown) | SpO2 100% 1528: RN called ED MD, Dr., verbal order received for Epinephrine 0.3 mg subcutaneous one time now. 1530: Epinephrine given per MD order. 1532: EMS crew on scene, Sac City 7, assessing patient, full report given by RN. During transfer of care, pt started shaking, full body, eyes closed, assisted to supine position on gurney by EMS crew, no injuries occurred, very short duration- pt aroused. Pt and her personal belongings to ED by EMS crew.
60 2021-03-11 vomiting, nausea Headache, vomiting, nausea. No fever, but very tired
60 2021-03-13 abdominal discomfort, vomiting, nausea, decreased appetite Nausea and vomiting, dizziness, stomach upset, no appetite, headache
60 2021-03-13 diarrhea Severe diahrrea, lightheadedness, headache, legs ached- started around 4:00 pm No treatment
60 2021-03-13 nausea, retching 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 2021-03-13 nausea Chills, headache, nausea, body aches and fatigue
60 2021-03-14 diarrhea swollen lymph nodes; tiredness; diarrhea; This is a spontaneous report from a contactable consumer (... Read more
swollen lymph nodes; tiredness; diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 10Feb2021 09:15 at single dose for COVID-19 immunisation in workplace clinic. The patient's medical history included AFib, hypertension, known allergies: TB test (allergies to medications, food, or other products: TB test). Concomitant medications included apixaban, digoxin, metoprolol, enalapril; the patient received all the drugs within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), in left arm on 20Jan2021 09:15 AM at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On an unspecified date in 2021, the patient experienced swollen lymph nodes, tiredness, diarrhea. The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the events was recovering.
60 2021-03-14 nausea Fever, nausea, whole body aches, pain in arm, armpit, back, chest, dizziness, palpitations, headache... Read more
Fever, nausea, whole body aches, pain in arm, armpit, back, chest, dizziness, palpitations, headache.
60 2021-03-15 abdominal pain upper Headache, Myalgia, stomach pain, fatigue Narrative:
60 2021-03-15 diarrhea, abdominal pain About 13 hours after receiving vaccine I awoke close to midnight feeling ill. I spent the next 3 hou... Read more
About 13 hours after receiving vaccine I awoke close to midnight feeling ill. I spent the next 3 hours having bouts of diarrhea every 5 to 10 minutes along with chills and feeling hot and abdominal pain. This morning on the 16 of March I feel okay with some fatigue and sore right shoulder at injection site.
60 2021-03-15 difficulty swallowing my tongue was tingling and was slightly swollen; difficulty swallowing saliva but could swallow wate... Read more
my tongue was tingling and was slightly swollen; difficulty swallowing saliva but could swallow water; my tongue was tingling and was slightly swollen; I felt some tingling in my face; I felt light headed right after the shot; 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 VACCINE; Formulation: Solution for injection; Lot Number: EM9810), via an unspecified route of administration in the left arm on 04Feb2021 at 16:15 (at the age of 60-years-old) as a single dose for COVID-19 vaccination. Medical history included depression, anxiety and the patient was diagnosed with COVID-19 prior to vaccination. No allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included 6 prescribed meds daily plus vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. Upon vaccination on 04Feb2021 at 16:15, patient felt light headed right after the shot. She waited 15 minutes and started driving home. she felt some tingling in her face. By the time she got home, 35 minutes after the shot, her tongue was tingling and was slightly swollen. She had some difficulty swallowing saliva but could swallow water. Her tongue was still slightly swollen the next morning but did not tingle. No seriousness criteria was reported. The patient did not receive any treatment for the events. The outcome of events was recovered on an unspecified date of Feb2021.
60 2021-03-15 nausea Headache, nausea, fatigue
60 2021-03-15 nausea 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 vomiting, diarrhea 15 hours after vaccination sever diarrhea and vomiting, which lasted 8 hours. Chills and shaking. Fe... Read more
15 hours after vaccination sever diarrhea and vomiting, which lasted 8 hours. Chills and shaking. Fever that climbed to 102.7 and lasted 24 hours. Took acetaminophen. Fever back to normal on 3/16/2021, four days after the vaccination.
60 2021-03-16 abdominal discomfort left arm soreness, headache, upset stomach, tired
60 2021-03-16 decreased appetite 12 hours post vaccine, began to experience extreme chills, hyperventilation, breathing difficulties,... Read more
12 hours post vaccine, began to experience extreme chills, hyperventilation, breathing difficulties, and fever of 103. Couldn't talk due to chills without extreme stuttering. Ended up being transported to a local ER for care where I remained for approximately 7 hours. Was given IV fluids and Toporol to control fever. Fever persisted for 72 hours, loss of appetite and extreme fatigue. Now 7-days post 2nd shot and still experiencing fatigue.
60 2021-03-16 diarrhea 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 2021-03-16 difficulty swallowing The event began with me feeling extremely cold and unable to warm up. It later progressed to needle... Read more
The event began with me feeling extremely cold and unable to warm up. It later progressed to needle like sensations where ever touched. I do not remember the next week. Per my husband I had a sustained temp of 102 and was difficult to keep hydrated. My O2 sats remained stable. The following week I became unable to drink anything thicker than water. This has improved but continues to this day. My husband is a physician.
60 2021-03-16 nausea Fifteen minutes after vaccination pt c/o lightheadedness; symptoms progressed w moderately severe he... Read more
Fifteen minutes after vaccination pt c/o lightheadedness; symptoms progressed w moderately severe headache and nausea. She was hemodynamically stable no signs of any allergic reaction. There are concerns her V-P shunt is not working properly. After lying in a recumbent position for 30+ minutes headache worsened. We elected to transport to ER, via ambulance so she was recumbent during transport.
60 2021-03-16 nausea Dizzyness, nausea, severe headache, painful arm, sore throat, fatigue.
60 2021-03-16 nausea Beginning on the second day after the patient first vaccine she began experiencing fever up to 102.5... Read more
Beginning on the second day after the patient first vaccine she began experiencing fever up to 102.5, body aches, headache, profound fatigue, chills and nausea. She came to my clinic as this is her 9th (ninth) day of experiencing fevers and fatigue. The other symptoms have resolved.
60 2021-03-17 nausea, vomiting, diarrhea, abdominal pain upper This is a 60 year old female was brought into emergency department as cardiac arrest. Patient was s... Read more
This is a 60 year old female was brought into emergency department as cardiac arrest. Patient was seen at care now urgent care with the complain of epigastric pain associated with nausea vomiting and intermittent diarrhea. Patient received her initial COVID vaccine 2 days ago. History is obtained from urgent care chart. As per notes patient started nausea vomiting 6 hours post COVID vaccine administration. Patient was seen in urgent care for epigastric pain and nausea vomiting. Patient was found unresponsive at 0902 by tech. No carotid pulses palpated. CPR was started. Patient was brought into the emergency department with Lucas on. Patient was given 5 epinephrine prior to arrival. CPR was in progress. Patient was asystole. Resuscitation was continued in the ED. Patient was intubated in the ED by physician assistant 5 epinephrine 2 bicarb and 1 calcium chloride was given in the ED. Cardiac Ultrasound didn't show any cardiac activity. Asystole on the monitor. No corneal reflex people are fixed and dilated. Patient was pronounced at 1007 am
60 2021-03-17 nausea After about 10 minutes felt head pressure and light headedness. Reclined patient - lightheadedness r... Read more
After about 10 minutes felt head pressure and light headedness. Reclined patient - lightheadedness resolved; slight nausea when leaving - felt much better
60 2021-03-17 nausea Strong nausea for about an hour. It seems to be dissipating.
60 2021-03-18 diarrhea, abdominal distension, vomiting I started throwing up and had diarrhea by around 10 pm, did that about 4 times, my stomach was so bl... Read more
I started throwing up and had diarrhea by around 10 pm, did that about 4 times, my stomach was so bloated, it was weird. The next day, couldn?t get out of bed, all I had yesterday was diarrhea and felt like someone kicked me in the ribs. Today I am having a hard time taking a deep breathe or coughing without my ribs hurting so bad. My stomach feels better. Haven?t eaten anything, I am more concerned about under my breast hurt so much when I take a deep breathe or cough. I haven?t gone to doctor because I just wonder if it hurts so much there because if the vomiting
60 2021-03-18 diarrhea Arm was sore at bedtime. By the morning, I could barely move my right fingers. Very sore and tired ... Read more
Arm was sore at bedtime. By the morning, I could barely move my right fingers. Very sore and tired the day after. I was incredibly sore everywhere - back,chest, hips, legs, neck... very hard to move. Around 5 PM the day after the vaccination, I became violently ill. Diarrhea, chills, feverish, sweating. etc. This lasted until about 3 AM on the 18th.
60 2021-03-18 difficulty swallowing pt. called stating she recieved her first COVID vacc. past weekend, now having swollen lymph nodes a... Read more
pt. called stating she recieved her first COVID vacc. past weekend, now having swollen lymph nodes and trouble swallowing. Pt. was advised to go to UC or ER. Pt. presenting today for Swollen glands (had 1st dose vaccine on Saturday, Monday started having swollen glands in neck
60 2021-03-18 nausea Body aches; fever (100.5); chills; nausea; headache; This is a spontaneous report from a contactable... Read more
Body aches; fever (100.5); chills; nausea; headache; This is a spontaneous report from a contactable consumer, the patient (patient). A 60 -years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration in the left arm on 12Feb2021 at 14:15 as a single dose, for COVID-19 immunization. Historical Vaccine includes BNT162B2, Dose 1, Lot number EL8982, Administered on 22Jan2021 at 14:30 in the right arm. Medical history included Allergy: Egg intolerance. Concomitant medication includes Prempro, and multi vitamin. The facility in which the vaccine was administered No other vaccines were given within 4 weeks. On 13Feb2021 at 13:00 the patient experienced Body aches, fever (100.5), chills, nausea, headache. No treatment was given for the events. Lab data includes Body temperature 100.5 on 13Feb2021. The clinical outcome of the events Body aches, fever (100.5), chills, nausea, headache were not recovered.
60 2021-03-18 nausea Day 1 (3/7): sore arm, mild headache, fatigue, nausea Day 2 (3/8): more sore arm, mild headache, fat... Read more
Day 1 (3/7): sore arm, mild headache, fatigue, nausea Day 2 (3/8): more sore arm, mild headache, fatigue Day 3: unable to lift left arm, headache Day 4: sore arm, 3" oval shaped red spot next to shot spot: swollen, raised, itch Day 5: arm better, red spot still itch Day 6: able to lift arm, less sore, red spot smaller, still itch, shot spot still itch too Day 7: arm almost back to normal, red spot diasppeared Day 8: all 10 toes red, swollen, extremely itch, unbearable especially at night Day 9 - 10: different toes itch more each night Day 11 (3/17): visited urgent care - diagnosed fungal infection Day 11: visited Primary Care Physician : referral to visit Podiatrist Day 13 (3/19): visited Podiatrist - diagnosis COVID Pfizer Vaccine side effect, prescription: Betamethasone
60 2021-03-18 vomiting, abdominal pain, nausea 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 2021-03-19 nausea, abdominal pain, diarrhea, vomiting Pt was admitted 6 weeks post second covid vaccination with c/o sudden onset of generalized abdominal... Read more
Pt was admitted 6 weeks post second covid vaccination with c/o sudden onset of generalized abdominal pain, nausea, vomiting and diarrhea resulting in 2 syncopal episodes. CBC showed leukocytosis with neutrophilia which resolved. She was treated with IV fluids and antiemetics and was discharged on 3/19/2021
60 2021-03-19 nausea Fatigue malaise headache nausea on March 19 all day ... fine on March 20
60 2021-03-19 nausea swelling where shot was given and could not lift my arm for 2 days. Nausea for 2 days and really ... Read more
swelling where shot was given and could not lift my arm for 2 days. Nausea for 2 days and really tired.
60 2021-03-19 nausea Headache, injection site pain, nausea, tiredness, joint pain
60 2021-03-19 nausea Fever , chills, headache, body ache, nausea
60 2021-03-19 retching, nausea 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 2021-03-20 decreased appetite I felt fine when I woke up. My left arm was very sore which also was the case after first vaccine. A... Read more
I felt fine when I woke up. My left arm was very sore which also was the case after first vaccine. Around 10 am I developed chills and just did not feel great. My husband took my temp and the highest it got was 102.6 which is high for me since my baseline is 97.6 or so. I did not have a great appetite and felt very stiff when I moved around. I pushed fluids and took 3 naps Saturday. I have a low grade fever of 99 today but feel much better. Did take 2 naps and slept well last night. Took Advil with each meal and doing so today.
60 2021-03-20 nausea, diarrhea nausea & lightheadedness (10 minutes), diarrhea (one instance), fatigue (2 days), headache (1,5 days... Read more
nausea & lightheadedness (10 minutes), diarrhea (one instance), fatigue (2 days), headache (1,5 days), sore injection site (1 day)
60 2021-03-20 nausea Same symptoms as when I had Covid in November 2020. Extreme fatigue, headache, nausea, sinus congest... Read more
Same symptoms as when I had Covid in November 2020. Extreme fatigue, headache, nausea, sinus congestion, severe flu-like symptoms. These lasted 48 hours.
60 2021-03-20 nausea Fever (fluctuated between 99 and 102 degrees), chills, achy body, nausea, headache for approximately... Read more
Fever (fluctuated between 99 and 102 degrees), chills, achy body, nausea, headache for approximately 12-15 hours did not feel well. The next morning (Sunday 3/21) woke up nauseous and had trouble breathing. Went outside for cold air and breathing was OK.
60 2021-03-20 nausea COVID Vaccine clinic. Per chart review, pt received COVID vaccine at 1426. At approximately 1505 p... Read more
COVID Vaccine clinic. Per chart review, pt received COVID vaccine at 1426. At approximately 1505 pt c/o nausea and ran outside. Pt awake, alert, respirations easy and unlabored, no distress noted. No vomiting occurred. Pt stated history of throat swelling and facial swelling/rash after PCN. 1510: Pt stated nausea resolved. Pt Diabetic and had not eaten lunch. Juice and crackers given, pt tolerated well with no difficulty. Respirations remain easy and unlabored, no distress. 1517: Pt clearing throat, c/o throat swelling, able to manage oral secretions, speaking in complete sentences. Pt to triage area via wheelchair by RN. BP 171/80 | Pulse 77 | Resp 17 | LMP 02/01/2013 (LMP Unknown) | SpO2 98% 1523: Pt awake, alert, c/o difficulty breathing. RN called for assistance, attempted to located on site MDs. 1526: No MDs on site, 911 called. BP 184/84 | Pulse 82 | Resp 20 | LMP 02/01/2013 (LMP Unknown) | SpO2 100% 1528: RN called ED MD, Dr., verbal order received for Epinephrine 0.3 mg subcutaneous one time now. 1530: Epinephrine given per MD order. 1532: EMS crew on scene, Sac City 7, assessing patient, full report given by RN. During transfer of care, pt started shaking, full body, eyes closed, assisted to supine position on gurney by EMS crew, no injuries occurred, very short duration- pt aroused. Pt and her personal belongings to ED by EMS crew.
60 2021-03-21 decreased appetite Loss of appetite morning after vaccine, headache, body aches, chills, face flushed. Fever started af... Read more
Loss of appetite morning after vaccine, headache, body aches, chills, face flushed. Fever started afternoon. 99.4. Took Tylenol but it gradually rose to 102.3. Took 3 hours for fever to go down. By 5:30 fever was gone & I was feeling better. Next day I felt great but by three days later I had a fever blister & very sore, dry and stuffy nose which lasted two weeks. And headache as well. I?m thinking because of stuffy nose. I did have Covid last March/April 2020 so I have heard that I would have side effects.
60 2021-03-21 diarrhea Due to 4 days progressive worsen skin lesion. Lesion as erythema multiform, generalized on hand, for... Read more
Due to 4 days progressive worsen skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg; Oral ulcer; Chill; Body ache; Joint pain; Joints swelling; Diarrhea; This is a spontaneous report from a contactable other healthcare professional (HCP). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201), via unspecified route of administration in the left arm on 17Feb2021 as single dose for COVID-19 immunization. Medical history included hyperlipidemia. The patient had no known allergies. The patient is not pregnant. There were no vaccine in four weeks. Other medications in two weeks included cholesterol med. The previously received the first dose of BNT162B2 on 26Jan2021 12:00 intramuscular at left arm (lot number: EL9262) for COVID-19 immunization. The patient was seen at urgent care on 04Mar2021 due to 4 days progressive worsened skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg from 28Feb2021 (12:00 AM). Patient presented with chill, body ache, joint pain, joints swelling and diarrhea since second dose of vaccine on 17Feb2021. She also has oral ulcer at the same time when rash started on 28Feb2021. Vital sign was stable, no shortness of breath (SOB) and no chest pain. Events resulted in Doctor or other HCP office/clinic visit. The treatment for the events included Hydroxyzine 25 mg prn. It was unknown if patient had COVID prior vaccination or if COVID tested post vaccination. The outcome of the events was not recovered.; 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 Erythema multiforme cannot be 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.
60 2021-03-21 nausea Chills, musculoskeletal pain, headache, sinus pain, nausea, tooth sensitivity
60 2021-03-21 nausea extreme fatigue, headache, nausea, muscle aches, joint pain, low grade fever, chills, swollen lymph ... Read more
extreme fatigue, headache, nausea, muscle aches, joint pain, low grade fever, chills, swollen lymph nodes in neck and under arm, treatment was motrin 600 mgs q6hrs from 2/18/21-02/22/21 returned to work on 02/23 lymph nodes still slightly enlarged as of today, 03/22/21
60 2021-03-21 nausea After about 20 minutes felt head pressure and lightheadedness, Reclined patient, light headedness re... Read more
After about 20 minutes felt head pressure and lightheadedness, Reclined patient, light headedness resolved. Slight nausea when leaving felt much better. VS 168/90; 73; 97%SaO2
60 2021-03-21 stomatitis Sialadenitis (salivary gland inflammation); glossitis (tounge inflammation); inflammation of the muc... Read more
Sialadenitis (salivary gland inflammation); glossitis (tounge inflammation); inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; Tingling; prickly sensation on tongue when eating; cold items felt opposite of what they should, more like burning sensation; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6202), via an unspecified route of administration in the left arm on 27Feb2021 12:45 as single dose for COVID-19 immunization. Medical history included known allergies to Sulph. The patient was not pregnant. Concomitant medications included aceclofenac (BIOFLEX [ACECLOFENAC]), calcium (CITRICAL [CALCIUM]) and vitamin D (VITAMIN D [VITAMIN D NOS]). On 01Mar2021 08:00, the patient experienced sialadenitis (salivary gland inflammation), glossitis (tounge inflammation), inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips. Tingling, prickly sensation on tongue when eating, cold items felt opposite of what they should, more like burning sensation were also reported. Onset of symptoms Monday morning, symptoms peaked Wednesday evening through midday Thursday, greatly improved by Friday morning. The patient had a COVID test on Friday to be sure and it was negative. There were no treatment for events. No COVID prior vaccination. The patient had a COVID test type post vaccination-Nasal Swab (Covid 2 PCR) on 05Mar2021 which was negative. The patient had The outcome of the events was recovered on unspecified date in Mar2021.
60 2021-03-22 abdominal discomfort, nausea, vomiting EUA Phizer-BioNtech vaccine reaction. patient reported vomiting associated with nausea and abdominal... Read more
EUA Phizer-BioNtech vaccine reaction. patient reported vomiting associated with nausea and abdominal discomfort s/p getting the covid
60 2021-03-22 nausea Flu-like symptoms: headache, fatigue, dizziness, nausea, swollen lymph nodes, sore arm beginning th... Read more
Flu-like symptoms: headache, fatigue, dizziness, nausea, swollen lymph nodes, sore arm beginning the evening of injection. All symptoms, except sore arm, gone by morning. No treatment given.
60 2021-03-22 nausea At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fing... Read more
At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fingers. Pain to the back of my neck, a flush of warmth to my upper body and difficulty breathing. Felt like a truck ran over my chest. I was weak, dizzy and nauseous as well. The tingling sensation also affected both my legs. The RN took to their infirmary area and began taking my vitals. Vitals seems normal, Blood Pressure and Pulse were high. I am asthmatic but did not bring my inhaler with me. Because of my difficulty breathing, they decided to inject me with Benadryl which is all they had. After about twenty minutes, my breathing started to calm down and blood pressure began coming down as well.
60 2021-03-22 nausea 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 nausea DIzzyness and mild nausea
60 2021-03-22 nausea Severe headache 101 temp Nausea Intense pain at injection site Intense body pains
60 2021-03-23 abdominal discomfort, diarrhea Received the first vac on 3/12 at 8:30 a.m.. I started feeling achy and tired by 4pm. By the next da... Read more
Received the first vac on 3/12 at 8:30 a.m.. I started feeling achy and tired by 4pm. By the next day, I had diarrhea and stomach upset starting by mid day. Since then, I have had daily diarrhea, lethargy, weakness, off and on headache, body aches (especially joints) and overall feeling of unwell.
60 2021-03-23 diarrhea I was submitting my events daily on website and two days it tells me my session has expired and won'... Read more
I was submitting my events daily on website and two days it tells me my session has expired and won't let me report anything. On Sunday night, March 21st, I started with very painful joint and muscle aches with fatigue. The next morning I felt terrible and could barely function, I had a bought with diarrhea that lasted almost the entire day and had no energy. I developed a large lump on my left clavicle area that seemed to be filled with fluid. My knees I had replaced are still very painful today ( 7 days post vaccine). I phoned my Dr. yesterday and they told me to take 1000mg of Tylenol 3 times a day. I am doing this now for the second day with some relief. I feel this is very unusual to feel this way 7 days after the vaccine. On day 1-2 the only symptoms were a sore arm from the vaccine. Saturday was actually a good day with no symptoms, the other symptoms started on Sunday. I feel like my heartbeat is irregular also but my BP is good. I would like to be able to to report daily on v-safe like I was the first few days.
60 2021-03-23 diarrhea Headache, eyes burned, diarrhea
60 2021-03-23 diarrhea Symptoms were minor--soreness at injection site for 2 days, loose stool the day after injection, and... Read more
Symptoms were minor--soreness at injection site for 2 days, loose stool the day after injection, and minor headache and fatigue on the day after injection through the following day (2 days after injection).
60 2021-03-23 nausea 20 hours of terrible body aches, headache, chills, nausea. Fever (that got up to 100.2) for 12 hours... Read more
20 hours of terrible body aches, headache, chills, nausea. Fever (that got up to 100.2) for 12 hours.
60 2021-03-24 nausea, diarrhea this was my 2nd dose. late afternoon & was feeling unenergetic. late that eve I felt achy, took 400m... Read more
this was my 2nd dose. late afternoon & was feeling unenergetic. late that eve I felt achy, took 400mg ibuprofen before going to bed around 11pm. by 1 am on 3/24 I was running a fever, shivering & my inj arm was very sore/felt heavy. Took 400 more ibuprofen, fever reduced before too long. Also felt slightly nauseous during the night & into the day of 3/24. around 2 pm got a bad headache. more ibuprofen, still felt a little nauceous, tho that subsided in early a.m. 3/25. Also was coughing quite q bit most of 3/24, but that may have been due to allergy stuff. experienced some mild diarrhea on 2 occassions 3/24. Symptoms are fairly well abated by 10a.m. 3/25.
60 2021-03-24 nausea Fever, 100 F. Chills Nausea Sore Arm
60 2021-03-25 diarrhea gradual onset of diarrhea and fever 2 days after injection for a duration of 4 days. fever of 101, c... Read more
gradual onset of diarrhea and fever 2 days after injection for a duration of 4 days. fever of 101, chills diarrhea and inflammation under left arm and breast.
60 2021-03-25 diarrhea seven minutes after injection my skin felt flushed and hot around my upper back, neck, shoulders, I ... Read more
seven minutes after injection my skin felt flushed and hot around my upper back, neck, shoulders, I felt dizzy and then had diarrhea this continued off and on for several hours...in the ER they gave me steroid, saline solution for dehydration and pepcid. I had a headache and chills while in the ER. Went home and felt fine that night other than mild headache.
60 2021-03-25 nausea, vomiting, diarrhea Nausea, Vomit/Diarrhea, Chills (very cold head to toes), body/joints ache, stiff throat
60 2021-03-25 nausea things went black; my blood pressure was alarmed was over 200 checked other arm same called there te... Read more
things went black; my blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high; severe dizziness; severe headache nausea; weakness; severe headache nausea; This is a spontaneous report from a contactable other healthcare professional (patient). An 60-year-old non-pregnant female patient received bnt162b2 (COVID 19, brand: Pfizer, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Feb2021 11:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included Stent in LAD (Left anterior descending coronary artery). Concomitant medications included losartan potassium, lorazepam (ATIVAN), acetylsalicylic acid (BABY ASPIRIN) and furosemide. It was reported that, within 15-20 minutes went to stand up severe dizziness and things went black started to get severe on 07Feb2021 at 11:15 AM. On 07Feb2021 at 11:15 AM, Headache, nausea Nurse Practitioner that gave shot took her blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high and she could not stand up due to weakness dizziness apparently they called Paremedic/EMT advised in her best interest to be seen in Emergency department. they did not how ever ask if she belonged to a ambulance company which she do so know she have a bill of about 1,500 with ambulance company. was in the ED for about 4 hours till blood pressure can down. was given medication for nauseas, felt like she was hit by a truck. Patient had Cardiac montering/medication. No covid prior to vaccination. No covid tested post vaccination. Outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The events assessed as possibly related to the suspect drug BNT162B2______ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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 2021-03-25 nausea 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 abdominal pain upper, vomiting, diarrhea The first day body discomfort, arm pain, today vomiting and diarrhea chronically, mild stomach pain.... Read more
The first day body discomfort, arm pain, today vomiting and diarrhea chronically, mild stomach pain. Discomfort all day from the morning and vomits and diarrhea from 3 in the afternoon. Body pain.
60 2021-03-26 diarrhea 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 2021-03-26 nausea 100? Fever, total body aches, nausea, inflammation, some shortness of breath, chest tightening, fati... Read more
100? Fever, total body aches, nausea, inflammation, some shortness of breath, chest tightening, fatigue, headache.
60 2021-03-26 nausea Within four hours of shot, low grade fever, 101.4, chills, nausea, exhaustion. Asleep by 9:00p.m., s... Read more
Within four hours of shot, low grade fever, 101.4, chills, nausea, exhaustion. Asleep by 9:00p.m., slept 13 hours, On March 17, woke at 10 am. Nausea, fever, chills gone, but totally exhausted with burning sensation at shot site and soreness in upper right arm. Remained in bed all day, asleep by 6 pm. Remained exhausted through March 23. Any physical activity caused shortness of breath and further tiredness. Exhaustion dissipated by March 24, 2021
60 2021-03-26 retching, diarrhea with profuse bleeding Severe cramping, bloody diarrhea, dry heaves. It calmed for a week, now I have cramping and bloody ... Read more
Severe cramping, bloody diarrhea, dry heaves. It calmed for a week, now I have cramping and bloody diarrhea again.
60 2021-03-26 vomiting Pain in left arm for about 30 min. followed by numbness in hand, then ring finger fingertip complete... Read more
Pain in left arm for about 30 min. followed by numbness in hand, then ring finger fingertip completely white that lasted about 10 min. Once color returned I soon became dizzy and weak feeling in my legs followed with vomiting. I then felt a little better with mild light headedness.
60 2021-03-27 diarrhea Diarrhea, tired, fever 101.3
60 2021-03-27 nausea Headache muscle pain tiredness nausea chills Overall not feeling well
60 2021-03-27 nausea 3/25/21 2:00 AM sore throat congestion 3/26/21 3:09 AM. Awoke with chills 101.5 fever, sore throat n... Read more
3/25/21 2:00 AM sore throat congestion 3/26/21 3:09 AM. Awoke with chills 101.5 fever, sore throat nausea aches cough Continue with very sore throat, fatigue nausea congestion dry cough nasal congestion
60 2021-03-27 vomiting, nausea 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 abdominal discomfort I have taken Pfizer-BioNTech COVID-19 Vaccine EUA Three days later I have muscle pain, ear infectio... Read more
I have taken Pfizer-BioNTech COVID-19 Vaccine EUA Three days later I have muscle pain, ear infection, headache, stomach very up set, feeling not well
60 2021-03-28 decreased appetite Severe headache beginning around 9:00 PM after vaccination. Extreme fatigue for approximately 48 ho... Read more
Severe headache beginning around 9:00 PM after vaccination. Extreme fatigue for approximately 48 hours. Some fever and chills. Lack of appetite.
60 2021-03-28 nausea Swollen Lymph Nodes, chills, headache, nauseous stomach, pain radiating in left boob & left back, an... Read more
Swollen Lymph Nodes, chills, headache, nauseous stomach, pain radiating in left boob & left back, and tireness
60 2021-03-29 abdominal pain patient states a few seconds after receiving the vaccine she was light headed, and had a low grade ... Read more
patient states a few seconds after receiving the vaccine she was light headed, and had a low grade headache. Later on that evening she began to have 1/10 central abdominal pain. C/o coughing spasm in the middle of the night that went away after a few minutes. Also c/o moderate fatigue.
60 2021-03-29 difficulty swallowing, nausea felt nausea and dizziness on day of vaccine. 2-3 days after sore throat, hard to swallow, 5 days aft... Read more
felt nausea and dizziness on day of vaccine. 2-3 days after sore throat, hard to swallow, 5 days after vaccine lost voice and/or voice change. no fever at any time
60 2021-03-30 constipation, indigestion Moderate indigestion; constipation; This is a spontaneous report from a contactable consumer(patient... Read more
Moderate indigestion; constipation; This is a spontaneous report from a contactable consumer(patient herself). A 60-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection; batch/lot number and expiry date were not reported), via an unspecified route of administration on 24Jan2021, 12:00pm (at the age of 60-years-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took acetaminophen and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient has not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. At 4:00pm (16:00) of 25Jan2021, the patient experienced moderate indigestion and constipation. Treatment was not received for the events. The outcome of these events was recovering. The events were reported as non-serious by the reporter. Information on the lot/batch number has been requested.
60 2021-03-30 diarrhea diarrhea - has been ongoing all day, from about 9:45am through at least 4:15pm.
60 2021-03-30 nausea Muscles around hip replacement were affected for 2-3 days. Sore muscles in the buttocks, hip and qua... Read more
Muscles around hip replacement were affected for 2-3 days. Sore muscles in the buttocks, hip and quad. It only affected this site. It went away but I found it odd. I got the usual bit of nausea, wooziness, fatigue and sore arm, but those were expected
60 2021-03-30 nausea Pt. stated she felt nauseous 10 Minutes after getting vaccinated. She also stated she suffers from ... Read more
Pt. stated she felt nauseous 10 Minutes after getting vaccinated. She also stated she suffers from migraines and when she is about to get a migraine she feels nauseous. She stated she has her migraine medication at work and she will take it as soon as she gets there. At 9:30am she stated she feels better. At 9:33am pt. stated she was ready to go.
60 2021-03-31 decreased appetite Headache, tiredness, stiff neck, chills, no appetite, slight dizziness, slight buzzing in head
60 2021-03-31 diarrhea Low grade fever; itchy throat and face/slight hives, cold compress; few hours Tues: fatigue; Wed: ok... Read more
Low grade fever; itchy throat and face/slight hives, cold compress; few hours Tues: fatigue; Wed: okay; Thurs: all day diarrhea; Fri: morning diarrhea; Sat. okay; Sun and Monday; Sneezing and runny nose; Tues: runny nose
60 2021-03-31 nausea, abdominal discomfort Nausea, sweating,sick to my stomach, sick for about 4 hours and started to feel better after laying ... Read more
Nausea, sweating,sick to my stomach, sick for about 4 hours and started to feel better after laying down
60 2021-03-31 nausea, decreased appetite That night felt tired with chills and body aches. The next day I had a fever of 102.2, horrible body... Read more
That night felt tired with chills and body aches. The next day I had a fever of 102.2, horrible body aches, joint pain, chills, headache, nausea, zero appetite, fatigue. Felt like a bad flu. By Monday the fever was gone but was very weak, nauseous, with joint pain. Didn?t feel like myself for several days-almost a week.
60 2021-03-31 nausea, diarrhea I had every single side effect listed. Severe headache starting almost immediately, lasting 5 days.... Read more
I had every single side effect listed. Severe headache starting almost immediately, lasting 5 days. Fever of 102, gradually coming down, over 5 days. Severe dry coughing, lasting 6 days and continuing. Severe muscle aches, lasting 6 days so far. Diarrhea lasting 1 day. Nausea, lasting 3 days.
60 2021-03-31 nausea Site soreness immediately following vaccine which dissipated quickly. HOWEVER, 4 days AFTER vaccine ... Read more
Site soreness immediately following vaccine which dissipated quickly. HOWEVER, 4 days AFTER vaccine experienced extreme vertigo, dizziness, nausea which required an ER visit. Side effects still lingering next day.
60 2021-03-31 nausea mild fever (99 degrees to 100 degrees); chills, headache, fatigue, nausea
60 2021-03-31 stomatitis Headache chills fever upper respiratory cough, muscle aches, earache, stomach ache, pain at inject... Read more
Headache chills fever upper respiratory cough, muscle aches, earache, stomach ache, pain at injection site and itching
60 2021-03-31 vomiting, nausea 3/29/21 around 6pm -Light-headed, dizziness, off-balance when walking, numbness on right side of fac... Read more
3/29/21 around 6pm -Light-headed, dizziness, off-balance when walking, numbness on right side of face, nausea and vomit once. Went to ER around 12:30am on 3/30/21. Admitted to the Hospital from 3/30/21-3/31/21.
60 2021-04-01 nausea, vomiting Chills, sweating, nausea (twice vomited)
60 2021-04-01 nausea EXTREME fatigue and nausea. I'm still feeling tired and it's been a week since I received my first ... Read more
EXTREME fatigue and nausea. I'm still feeling tired and it's been a week since I received my first shot.
60 2021-04-01 nausea body aches slight nausea weary
60 2021-04-01 vomiting, nausea Shot 3/3/2021 9:05am, headache started around 7:00pm, overnight also had fever and chills. 3/4-Heada... Read more
Shot 3/3/2021 9:05am, headache started around 7:00pm, overnight also had fever and chills. 3/4-Headache and fever continued, also had nausea and vomiting. On 3/5/3021, other symptoms resolved, but woke with double vision due to 6th cranial nerve palsy. This is the fourth acute occurrence of the nerve palsy. As of today, 4/2/2021, the double vision is still acutely present.
60 2021-04-02 diarrhea Tachycardia, hypertensive episode within 2 minutes. Diarrhea, flushing, and palpitations about an ho... Read more
Tachycardia, hypertensive episode within 2 minutes. Diarrhea, flushing, and palpitations about an hour later, and later that afternoon. Diarrhea, dizziness, fatigue, and palpitations the afternoon of 4/2/2021.
60 2021-04-02 nausea, vomiting, diarrhea Nausea, vomiting, diarrhea, headache, shortness of breath, dizziness, extreme tiredness
60 2021-04-02 nausea, vomiting Sore arm within 8 hours. Headache within 24 hours which became increasing severe. At 32 hours afte... Read more
Sore arm within 8 hours. Headache within 24 hours which became increasing severe. At 32 hours after the vaccine, severe headache, chills, nausea and vomiting. The headache lasted up to 47 hours after the vaccine and then started to become better. By noon 48 hours after the vaccine, I felt better but still a little shaky.
60 2021-04-02 nausea Headache, metallic taste, nausea. BP 156/81 (pulse 59). Final BP 160/76 (pulse 52). Sent to ED, but ... Read more
Headache, metallic taste, nausea. BP 156/81 (pulse 59). Final BP 160/76 (pulse 52). Sent to ED, but left upon arrival, as she felt OK.
60 2021-04-02 nausea After 30 minutes , Pt C/O throat dryness, cough, SOB nausea and anxiety
60 2021-04-03 abdominal pain upper Day 1 - within 5 minutes I felt extremely sleepy and my eyelids were heavy 15 - 2... Read more
Day 1 - within 5 minutes I felt extremely sleepy and my eyelids were heavy 15 - 20 minutes of receiving the vaccine, I was experiencing itchiness - like hives or from allergic reaction (I had them previously from allergy test reactions and allergic reactions). It was generally all over, but then I started itching under my arms. At that point, we informed the medical person who was monitoring our waiting section. He asked if I had any Benadryl, and I responded that I did. I took 12 ml (?) of Benadryl liquid and the effects subsided somewhat. I slept and when I woke up, I was itchy again and my stomach was cramping. I took more Benadryl and over the next 5 days got better.
60 2021-04-03 decreased appetite, nausea Nausea; Decreased appetite; Fatigue; Severe chills 8 days post 2nd does.; This is a spontaneous repo... Read more
Nausea; Decreased appetite; Fatigue; Severe chills 8 days post 2nd does.; This is a spontaneous report from a contactable consumer. This 60-years-old (at the time of vaccination) female consumer reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9264) via an unspecified route of administration from 06Feb2021 to 06Feb2021 at single dose (dose number; 2) on left arm for covid-19 immunisation. Patient's medical history and concomitant medications (if other vaccine in four weeks; no) were not reported. Patient experienced severe chills 8 days post 2nd dose, could not get warm on 15Feb2021, nausea and loss of appetite and severe fatigue for 24 hrs on an unknown date. Treatment for adverse event was reported as no. If covid prior vaccination; no, if covid tested post vaccination; yes, covid test type post vaccination; nasal swab, covid test name; PNR, covid test date; 16Feb2021, covid test result; pending. The outcome of events was recovered for chills while for other events was unknown. Information about batch number has been requested.
60 2021-04-03 diarrhea chills; body aches; under arm/neck/torso/inner thigh rash; diarrhea; This is a spontaneous report fr... Read more
chills; body aches; under arm/neck/torso/inner thigh rash; diarrhea; This is a spontaneous report from a contactable consumer (patient reported herself) reported in response to non-HCP letter sent in cross-referenced case. A 60-Year-old female patient received second dose of BNT162B2 (COVID 19, Pfizer/BioNTech, Formulation: Solution for injection, Lot number: EL3247, Expiration Date: May2021) via an unspecified route of administration on 16Feb2021 02:45 PM at single dose to her left arm for Covid-19 immunization. Facility type vaccine: Workplace clinic. The patient's medical history was not reported. Known allergies included gluten intolerant. Historical vaccine details included: product: COVID Pfizer, vaccine date: 26Jan2021, lot number: EL3247, vaccine location: arm left, Expiration Date: May2021, time the vaccination was given: 14:24 (24hour clock), anatomical location of administration of Pfizer vaccine considered as suspect: arm left, events: soreness at site of injection and loose bowels; fine now; did not receive any treatment. Concomitant medications included lisinopril, MULTIVITAMIN, ongoing ergocalciferol (VIT D), ongoing calcium and ibuprofen (ADVIL) from an unspecified date to an unspecified date. Covid was not tested prior or post vaccination. On 17Feb2021 01:45 PM, the patient experienced chills, body aches, under arm/neck/torso/inner thigh rash and diarrhea. Outcome of the events was not recovered.
60 2021-04-03 nausea 12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post... Read more
12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post: malaise; 5th-10th day post: coronary vasospasms, malaise, arrhythmia; took nitroglycerin patches, nitro bid paste; 11th day: met with rheumatologist, started medrol dose pack, improved spasms for a short time, 13th day: afib symptoms and Apple Watch reading noted by patient; 15th day spasms began again and increased symptoms of afib: saw doctor in office for EKG showing afib; met with cardiologist ordered increase in diltiazem and second medrol dose pack; first 48 hrs on second dose pack improved spasms, by 3rd day spasms significantly increased and constant afib w headache, dizziness, malaise. Visited ER, admitted. cardio version. Reduced dilitiazem, reduced ramipril, increased isosorbide. Continued symptoms with waxing and waning of spasms and atrial fibrillation . Although this is a pre-existing chronic condition, Afib without relief is not normal. Spasms without resolution not normal nor have I experienced an episode of this duration ever.
60 2021-04-03 nausea Pt reports onset on nausea and palpitations approximately 10 hours after receiving first dose of vac... Read more
Pt reports onset on nausea and palpitations approximately 10 hours after receiving first dose of vaccine. Pt reports Emergency room visit, where she states she was diagnosed with atrial fibrillation. Pt reports she underwent 3 days of hospitalization, converting spontaneously without treatment to normal sinus rhythm.
60 2021-04-04 abdominal discomfort 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 abdominal discomfort Dizziness, Vertigo, light-headedness which has lasted into 4 weeks post 2nd vaccine
60 2021-04-04 abdominal pain upper, diarrhea On the 3rd day I was sick to my stomach (cramping and diarrhea) and ran a fever of about 102. I had ... Read more
On the 3rd day I was sick to my stomach (cramping and diarrhea) and ran a fever of about 102. I had chills and was a bit achy. This lasted two days.
60 2021-04-04 abdominal pain, nausea Woke up at 2 AM with severe chest pain, no dyspnea, but she felt like she was going to die. Chills, ... Read more
Woke up at 2 AM with severe chest pain, no dyspnea, but she felt like she was going to die. Chills, back pain (from the front of the chest to the back), slight nausea. Sore arm the next day, chest continued to hurt over the next 24 hours, developing lower right groin pain ~ 32 hours after injection onset. Diaphoretic 36-48 hours afterwards, severe abdominal pain when waking up in the morning . 53 hours s/p injection, pt now feeling queasy.
60 2021-04-04 decreased appetite, nausea, diarrhea, abdominal pain upper 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 2021-04-04 diarrhea, abdominal pain upper, decreased appetite Sharp stabbing stomach pain without nausea or diarrhea. Burning, achy joint pain followed by chills,... Read more
Sharp stabbing stomach pain without nausea or diarrhea. Burning, achy joint pain followed by chills, fever ,headache and general weakness. Lack of appetite due to stomach pain. Continued for 48 hours. Slow improvement on 4/4. Still having moderate, intermittent stomach pain and now diarrhea. Poor appetite, feel flushed, without fever. Still headache,weakness and fatigue
60 2021-04-04 diarrhea, nausea, vomiting Two hours after receiving vaccination had extreme nausea and diarrhea. Nausea and vomiting lasted u... Read more
Two hours after receiving vaccination had extreme nausea and diarrhea. Nausea and vomiting lasted until 8 pm. Vomiting at least 30 times. Diarrhea lasted into the next day, all day, until I took two ammonium.
60 2021-04-04 nausea, abdominal pain, abdominal pain upper, vomiting, diarrhea Cold Feet, Nausea, Vomiting, Diarrhea/abdominal cramps. The diarrhea and abdominal cramps/stomachach... Read more
Cold Feet, Nausea, Vomiting, Diarrhea/abdominal cramps. The diarrhea and abdominal cramps/stomachache are still happening as I write this report today April 5, 2021.
60 2021-04-04 nausea, abdominal pain Scratchy throat, cough within 10 minutes of vaccine administration; some nausea, abdominal cramps an... Read more
Scratchy throat, cough within 10 minutes of vaccine administration; some nausea, abdominal cramps and headache. Also felt burning during vaccine administration. Given oral benadryl with improvement. Observed one hour total after vaccine. Called 2 hours post vaccine with almost complete resolution of all symptoms. instructed to not get second dose and follow up with PCP/allergist.
60 2021-04-04 nausea Morning of April 4th: Nauseous, Fever (100 F), High Blood Sugars -Took 2 Tylenol pills - Felt better... Read more
Morning of April 4th: Nauseous, Fever (100 F), High Blood Sugars -Took 2 Tylenol pills - Felt better early afternoon Late Afternoon April 4th: Dizzy, Nauseous, Light Headed, Collapsed and was unconscious for 2ish minutes - Called 911 -> Medics ran heart and bp tests which were all normal and did not consent to go to hospital Evening April 4th: Chills, Fever spiked to 100F, Nauseous, Light headed -Took 2 Tylenol pills - Did not take Ciprofloxacin evening dose Morning April 5th: Fever hovering around 100F, more color in face and up and moving around -Reported incident to doctor & pharmacist where Ciprofloxacin came from - Pharmacist contact information
60 2021-04-04 nausea Nausea - Not Diaphoretic Reports being "lightheaded" No Emesis No Syncope No rash Reports being co... Read more
Nausea - Not Diaphoretic Reports being "lightheaded" No Emesis No Syncope No rash Reports being cold Reports tightness in throat - EMS activated
60 2021-04-04 vomiting, nausea Severe headache, vomiting, nausea, body aches. Most severe symptoms lasting 24 hours. Milder sympto... Read more
Severe headache, vomiting, nausea, body aches. Most severe symptoms lasting 24 hours. Milder symptoms persisting 48 hours beyond.
60 2021-04-04 vomiting soreness extreme dizziness 4 days after with vomiting , unable to keep food down. headaches still v... Read more
soreness extreme dizziness 4 days after with vomiting , unable to keep food down. headaches still vomiting second day with no fever but on and off chills
60 2021-04-05 nausea Received shot on Friday afternoon. On Saturday morning had sore arm at injection site. Then develo... Read more
Received shot on Friday afternoon. On Saturday morning had sore arm at injection site. Then developed very achy shoulder, with ache spreading up neck and down back on left side. Some fatigue as well. Aches dissipated after a couple of hours, but fatigue continued and worsened on Sunday and continued into Monday. Also on Monday, woke up nauseated, and it continued, on and off, throughout the day until bedtime. Nausea gone on Tuesday, but still a bit more tired than usual.
60 2021-04-05 nausea Became nauseated has itchy throat and chest tightness with in 5 mins of receiving the vaccine
60 2021-04-05 vomiting, diarrhea Liquid diarrhea, vomiting, chills, fever from Friday morning until this morning Tuesday (4 days so f... Read more
Liquid diarrhea, vomiting, chills, fever from Friday morning until this morning Tuesday (4 days so far).
60 2021-04-05 vomiting, nausea 12 hours following injection, nausea leading to vomiting and heat flush. Fine immediately following... Read more
12 hours following injection, nausea leading to vomiting and heat flush. Fine immediately following vomiting.
60 2021-04-06 decreased appetite Fever ranging from 99.5-101.5, fatigue, loss of appetite, rash, began 24 hours after the shot and co... Read more
Fever ranging from 99.5-101.5, fatigue, loss of appetite, rash, began 24 hours after the shot and continued for 48 hours. Used Advil, which could have been the cause of the rash but I am not certain. I often get rashes when I have a virus, and and Advil seems to make them worse. It was a little unusual in that it spread to my legs and back, as well as my face and torso. It was completely gone after 4 days.
60 2021-04-06 difficulty swallowing My throat was itchy in between that half hour my voice started to change; my throat felt worse; I ha... Read more
My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I still have problem swallowing a little bit; My throat was itchy in between that half hour my voice started to change; my throat felt worse; This is a spontaneous report from a contactable consumer (reporting for herself). A 60-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included anxiety, depression, neuralgia, heart, blood pressure issue and lot of allergies. Concomitant medication included levothyroxine; atorvastatin calcium (CHOLESTAT [ATORVASTATIN CALCIUM]); pantoprazole; ciprofloxacin hydrochloride, tinidazole (FLOXAZOLE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); lubiprostone (AMITIZA); thioctic acid (ALPHA LIPOIC ACID); baclofen; linezolid (ZENIX [LINEZOLID]); ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]); rosuvastatin calcium (CRESTOR); docusate sodium (STOOL SOFTENER); benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) taken for heart; desvenlafaxine succinate (PRISTIQ) taken for anxiety, depression; citalopram; venlafaxine hydrochloride (EFFEXOR) taken for anxiety; escitalopram oxalate (LEXAPRO); cyclobenzaprine; gabapentin taken for neuralgia; metoprolol taken for heart; amlodipine taken for blood pressure issue; magnesium oxide. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Feb2021 for COVID-19 immunization and experienced pulse rate would not go down. On 15Mar2021, it was reported that they had it done at the hospital, then after 15 minutes, her throat was itchy the may say another half hour in between that half hour, her voice started to change and her throat felt worse. They walk me down to the ER my throat was hurting then slowly they gave me Epi Pen and they injected in an IV with steroids. The have wheezing in her lungs and spent the night in hospital for observation. They did all kind of blood work, when she was placed in ER. The patient reported that she still have problem swallowing a little bit and voice changes after talking. The outcome of the event "still have problem swallowing a little bit" was not recovered while the outcome of the other events was unknown. Information on the lot/batch number has been requested.
60 2021-04-06 vomiting IMMEDIATELY AFTER VACCINATION I HAD DIZZINESS, VOMITING, MENTAL BLACKOUT, HIGH BLOOD PRESSURE, TOTAL... Read more
IMMEDIATELY AFTER VACCINATION I HAD DIZZINESS, VOMITING, MENTAL BLACKOUT, HIGH BLOOD PRESSURE, TOTAL FATIGUE, HEADACHE. THAT WAS SEEN BY PARAMEDICS
60 2021-04-07 nausea, abdominal pain upper, diarrhea 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 nausea Severe headache unresponsive to OTC analgesics, body aches, chills, coughing, burning sensation in c... Read more
Severe headache unresponsive to OTC analgesics, body aches, chills, coughing, burning sensation in central chest, severe fatigue, nausea continuing for 5 days starting the second day after the initial dose.
60 2021-04-07 nausea Chills, fever, headach muscle aches, nausea
60 2021-04-07 nausea nausea; This is a spontaneous report from a contactable other HCP (patient). A 60-year-old female pa... Read more
nausea; This is a spontaneous report from a contactable other HCP (patient). A 60-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included (BNT162B2, covid vaccine) via unspecified route and unspecified date for covid-19 immunisation and experienced fatigue. Patient states that she is having occasional fatigue. Patient did have a Covid vaccine and the first injection she took during her on week and just had fatigue. The second dose was during her off week and she states she slept for three days and had nausea on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch no. cannot be obtained.
60 2021-04-07 stomatitis Flu like symptoms for two days after. Developed red rash on top of both forearms, Hives in various p... Read more
Flu like symptoms for two days after. Developed red rash on top of both forearms, Hives in various places on body. Sores inside mouth.
60 2021-04-08 abdominal pain ~12 hours after vaccination, began experiencing chills, lower back pain, bilateral side/abdominal cr... Read more
~12 hours after vaccination, began experiencing chills, lower back pain, bilateral side/abdominal cramping (gas-like), and rapid heart rate with elevated blood pressure (normal 120s/80 but up to 146/84), was advised to come to EC for evaluation but patient declined
60 2021-04-08 diarrhea, vomiting Vomiting, diarrhea, fever, headache that lasted 2 days. This was horrible, I very rarely ever get s... Read more
Vomiting, diarrhea, fever, headache that lasted 2 days. This was horrible, I very rarely ever get sick. I do not want to get the second shot, especially since it's been reported that the second shot is worse.
60 2021-04-08 nausea The patient received her second Pfizer vaccine at 1401 pm, was monitored in the observation area for... Read more
The patient received her second Pfizer vaccine at 1401 pm, was monitored in the observation area for 15 minutes per pre-vaccination screening, and was discharged to home at 1421 pm without incidence with her spouse who was discharged at 1435 pm. At approximately 1445, the spouse states that the patient lost consciousness in the vehicle and that he panicked and brought her back to the clinic site because he couldn't remember where the hospital was. The patient was found to be sitting in the clinic alert and oriented, pale, diaphoretic, and nauseated. Vital signs were checked at 1457 with B/P of 124/71, O2 sat 99%, HR 80, and blood glucose of 149. After being monitored for 15 minutes in her vehicle, the patient stated she was feeling better and was escorted to the restroom via wheelchair. The patient stated that she felt like she could go home but was advised to call 911 immediately if symptoms returned or she started having any other reactions. The patient and spouse both verbalized understanding and agreement.
60 2021-04-08 nausea 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 nausea, vomiting I woke up Wednesday morning extremely dizzy and nauseous. I was unable to open my eyes because of h... Read more
I woke up Wednesday morning extremely dizzy and nauseous. I was unable to open my eyes because of how dizzy I was. I violently threw up for 2 hours . I was carried back to my bed by my husband. When I tried to roll over onto my side, I threw up again. I was unable to move on Wednesday. I actually thought that dying was easier. This sickness last 24 hrs. The next day I got out of bed around 11am and still suffered mild nausea. I am still a bit light headed today even when I woke up.
60 2021-04-09 nausea Thursday April 8, 8:15pm arm starts to ache; 8:30pm feel a little nauseous; 11:30pm feel dizzy (like... Read more
Thursday April 8, 8:15pm arm starts to ache; 8:30pm feel a little nauseous; 11:30pm feel dizzy (like the bed is moving under me) while I'm laying down. Friday April 9: 5:20am headache, body aches, nausea and fatigue; stayed in bed. 4:15pm went out to feed the cats and felt dizzy and kept loosing my balance; 5:30pm feel bad again: dizzy, headache and exhausted; That night my head ached and I felt mildly unwell. Saturday April 10: I feel better all around but I'm still getting dizzy and loosing my balance; also I still have a slight head ache. By 11:00 am, I'm feeling much better - just about normal.
60 2021-04-09 nausea tightness in chest; Headache; dizziness; shortness of breath; nausea; itching; severe pain in both k... Read more
tightness in chest; Headache; dizziness; shortness of breath; nausea; itching; severe pain in both knees; numbness in both thighs; This is a spontaneous report from a contactable consumer (patient). A 60-year-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 21Mar2021 14:30 (Batch/Lot number was not reported) at the age of 60 years old, as single dose for covid-19 immunization. Medical history included sleep apnea, history of breast cancer left side lumpectomy, chemotherapy, radiation, asthma, osteoarthritis, vestibular disorder, allergies to unspecified medications and food, and GERD (gastrooesophageal reflux disease). The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included lisinopril (LISINOPRIL); hydrochlorothiazide; hydroxyzine; and meloxicam (MELOX); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 03:00, the patient experienced tightness in chest, headache, dizziness, shortness of breath, nausea, itching, severe pain in both knees, and numbness in both thighs. The events resulted in: doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The events were treated with Benadryl, solution medrol pf, sodium chloride. The patient has not recovered from the events. The patient has not been tested for COVID post vaccination. The events were reported as non-serious. Information on the lot/batch number has been requested.
60 2021-04-09 nausea Experience exact symptoms of Covid19 virus as when I had it in Dec/2020. nausea, fever, cough, and b... Read more
Experience exact symptoms of Covid19 virus as when I had it in Dec/2020. nausea, fever, cough, and body aches. It lasted 24 hours.
60 2021-04-09 vomiting, diarrhea vomiting; diarrhea/Lingering diarrhea into second day; ringing in my left ear. LOUD!; excessive urin... Read more
vomiting; diarrhea/Lingering diarrhea into second day; ringing in my left ear. LOUD!; excessive urination; eyes feeling like they were popping out; tunnel vision; 104 fever; severe chills and quaking; severe chills and quaking; the worst headache in my life/slight headache on the back of my head, and continued into today; felt like broken shins; hip joints on fire; This is a spontaneous report from a contactable consumer herself (patient). A 60-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Mar2021 (Batch/Lot Number: EN6204) Solution for injection as Single Dose for covid-19 immunisation. Medical history included asthma, mild HP (Hypersensitivity pneumonitis) and I am fat. Concomitant medications included lovastatin, eszopiclone (LUNESTA), lisinopril and gabapentin. The patient previously took first dose of BNT162B2 (EN6198), on Left arm on 27Feb2021 for Covid-19 immunization. On 23Mar2021 02:00 patient experienced 104 fever, severe chills and quaking, the worst headache in my life, what felt like broken shins another friend said she had this as well, hip joints on fire, eyes feeling like they were popping out, vomiting after hours 26, tunnel vision, excessive urination, diarrhea started at hour 28. Lingering diarrhea into second day, slight headache on the back of her head, and continued into today, ringing in her left ear. The patient underwent lab tests and procedures which included body temperature: 104 on 23Mar2021. Patient did not test covid post vaccination. Patient did not have covid prior vaccination. The outcome of all events was recovered with sequelae.
60 2021-04-09 vomiting, nausea, diarrhea 1) I hour after 2nd dose was dizzy 2) 2 hours after had vertigo, hands felt like vibrating for 2-3 m... Read more
1) I hour after 2nd dose was dizzy 2) 2 hours after had vertigo, hands felt like vibrating for 2-3 minutes, nauseous, vomiting, diarrhea, elevated tinnitus 3) taken to ER at Hospital and sat there with no treatment for several hours. Symptoms were resolving on own. Given an IV and Benadryl. 4) started again (similar to after 1st dose) on Meclizine 5) after light exercises this morning got dizzy, vertigo and nauseous- lasted for over 4 hours!!
60 2021-04-09 vomiting 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 abdominal pain upper Dizziness, achy all over, fever, sick to stomach, hot and cold, extremely weak and fatigued, still u... Read more
Dizziness, achy all over, fever, sick to stomach, hot and cold, extremely weak and fatigued, still upset stomach and weakness today but getting better
60 2021-04-10 diarrhea, vomiting, nausea, indigestion Chills, nausea, vomiting, diarrhea - Wednesday night 04/07/21 Very severe heartburn, body aches, hea... Read more
Chills, nausea, vomiting, diarrhea - Wednesday night 04/07/21 Very severe heartburn, body aches, headaches, pain behind eyes - Thursday all day 04/08/21 Headaches - back of neck, pain behind the eyes, side of face - Friday and Saturday all day 04/09/21 and 04/09/21
60 2021-04-10 nausea Feeling feverish and achey, hot but not registering any high temperature. Headache. Nauseous and i... Read more
Feeling feverish and achey, hot but not registering any high temperature. Headache. Nauseous and itching at injection site. This all started at 12 hours after the shot, almost to the minute. I have been taking Ibuprofen for the aches and headache, drinking water and eating small meals, trying to rest.
60 2021-04-10 nausea Headache, nausea, body aches, extremely tired0
60 2021-04-10 nausea approximately 12 hours after vaccination 4/10 woke up with severe muscle aches, arms, shins, ankles ... Read more
approximately 12 hours after vaccination 4/10 woke up with severe muscle aches, arms, shins, ankles and headache. Also felt nauseous. In morning had very slight fever and sore throat. Overnight on 4/10 woke up with extreme tightening feeling in center of chest Today 4/11 have rash on arm where I received vaccination in an area that covers an oval about 5 x 8". Took Ibuprofen in am for pain then tylenol for slight fever and pain. have marked rash to see if it spreads.
60 2021-04-11 decreased appetite, nausea, vomiting Within 12 hours of receiving the vaccine, I became very nauseous and remained so through the next da... Read more
Within 12 hours of receiving the vaccine, I became very nauseous and remained so through the next day (4/7). I could not eat anything and by 3pm on 4/7 I threw up. I could not keep food down through 4/9 - my stomach was acidy and I was throwing up bile. I did not have a fever. On 4/9 I went to the Urgent Care and was advised to take an anti nausea medicine and get some Pepcid and try electrolyte drinks until I could keep down solid food. I slept and only had liquids on 4/10 and 4/11. Today - 4/12, I am able to keep down crackers. I have never had a reaction like this (except when I had stomach flu - and then I had a fever). Even today I am very weak. I believe it is related to the COVID vaccine.
60 2021-04-11 difficulty swallowing, diarrhea, nausea Arm pain immediately afterwards. Beginning at 18 hours after vaccination: excruciating headache, nau... Read more
Arm pain immediately afterwards. Beginning at 18 hours after vaccination: excruciating headache, nausea, diarrhea, elevated temperature/flushing, chills, fatigue, swelling and redness at injection site. Unable to eat or drink anything for 12 hours. Symptoms started to ameliorate after taking 1,000mg of acetaminophen around 28 hours after injection. 48 hours after vaccination, most symptoms had passed except for some residual headache and fatigue. Short fainting spell at 49 hours but did not pass out.
60 2021-04-11 nausea, vomiting MSG LEFTTC 4-9-21 STATES HAS NAUSEA/VOMITING. STATES HAD CALLED PCP. 4-12-21 10AM RETURNED TC:NO AN... Read more
MSG LEFTTC 4-9-21 STATES HAS NAUSEA/VOMITING. STATES HAD CALLED PCP. 4-12-21 10AM RETURNED TC:NO ANSWER.
60 2021-04-11 nausea u1st Pfizer vaccine on 3/17/21 the next day I only has pain with swollen area in left arm around sho... Read more
u1st Pfizer vaccine on 3/17/21 the next day I only has pain with swollen area in left arm around shot location. My 2nd Pfizer vaccine on 4/7/21 the next day around 4pm I started all the symptoms until chills, aches and pains, fever, and nausea, This was severe Thursday evening and most of Friday. Friday night I had swollen lymph nodes in the armpit and near the collarbone on my shot arm. This was very uncomfortable. Saturday the chills, aches and pains, fever, and nausea started to go away. Sunday mostly swollen lymph nodes and aches and pain in joints. Sunday night swollen lymph nodes stared to go down. Monday am still a bit tired but feeling better
60 2021-04-11 vomiting 4/6/21 headaches lasting days 4/8/21 sore throat 3 days 4/10/21 severe vomiting for 10 hours , dizzy... Read more
4/6/21 headaches lasting days 4/8/21 sore throat 3 days 4/10/21 severe vomiting for 10 hours , dizzy, severe headache, body aches no fever 96.7°
60 2021-04-11 vomiting Bleeding at injection site. Seven minutes after being seated for observation, I fainted and vomited... Read more
Bleeding at injection site. Seven minutes after being seated for observation, I fainted and vomited while I was out for 5 minutes. An ambulance was called and took vitals for the 20 minutes after I awoke and vitals were all good, so I declined going to the hospital.
60 2021-04-12 abdominal discomfort Rash at injection site, severe itching at injection site, continued headaches, stomach issues, metal... Read more
Rash at injection site, severe itching at injection site, continued headaches, stomach issues, metal taste in mouth, fatigue.
60 2021-04-12 abdominal pain Sweats Abdominal Cramps Body Aches Severe Fatigue Swelling and Redness and Induration and Warmth and... Read more
Sweats Abdominal Cramps Body Aches Severe Fatigue Swelling and Redness and Induration and Warmth and Tenderness to Palpation at site of injection after the second shot All symptoms started about 8 hours after the second dose and have continued to today. Today is the first day the symptoms seem to be decreasing in severity a little. Symptoms are worse at the end of the day.
60 2021-04-12 nausea, vomiting Nausea, vomitting
60 2021-04-12 nausea 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 nausea Called 911, hospital dianosed with Vertigo. woke up in bed during night turned to right side and g... Read more
Called 911, hospital dianosed with Vertigo. woke up in bed during night turned to right side and got dissy and nausus, happened twice called 911, hispital dianosed with vertigo , ct scan showed no clots in neck or brain, said could be iner ear, follow up with family doctor. was givenMeclizine 25 mg tablets, Ondansetron ODT 4mg tablets
60 2021-04-13 nausea I got extremely dizzy at 4:00am on Sunday after getting the shot about noon on Friday (so roughly 40... Read more
I got extremely dizzy at 4:00am on Sunday after getting the shot about noon on Friday (so roughly 40 hours later.) The vertigo was so severe that I had to lay on my back and try no to move my head any direction. Getting up even to go to the bathroom resulted in nausea because of the intense dizziness. The dizziness/vertigo lasted until about 9:00am Monday morning (so nearly 30 hours.) I actually still have some residual dizziness when I move my head a certain way, but it goes away quickly and doesn't cause nausea. (I was worried I'd have a similar reaction to the second shot, but I only had some fatigue and a sore arm with the second shot.)
60 2021-04-13 nausea Fever, aches, headache, chills, sweating, nausdia, body ache, sore arm
60 2021-04-13 nausea I felt fine following vaccination so kept appointment to donate blood 3 days later. I've donated man... Read more
I felt fine following vaccination so kept appointment to donate blood 3 days later. I've donated many, many times in past without any side effects. It was uneventful. The following AM, I felt exhausted, dizzy, had mild headache, thirsty, and had minimal nausea. And when I tried to do my daily walk of 3 miles, I was SOB on hills so I stopped. I had no F/C, cough, CP, palpitations or resp symptoms at rest. I pushed fluids and rested. I held my BP meds thinking I was a bit dehydrated and maybe my BP was low. After 4 days of no improvement, I went to see my internist. Exam, ECG and CBC, Chem 7 were all normal. BP was mildly elevated so I restarted my meds. These symptoms slowly resolved over next several days and now I feel back to normal. So I don't know if these were delayed side effects to COVID vaccine or due to the blood donation. I'm a bit worried about receiving the #2 vaccine.
60 2021-04-14 abdominal pain One week after receiving the first vaccine, I developed severe headaches. I got my booster 21 days l... Read more
One week after receiving the first vaccine, I developed severe headaches. I got my booster 21 days later. One week after receiving the booster, I started having severe headaches, severe neck, back and abdominal pain. I went to the ED the morning of 3/5/21, was admitted to the hospital and release on 3/8/21. It is in the H&P from Health facility.
60 2021-04-14 decreased appetite 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 2021-04-14 diarrhea chills, joint pain, muscle aches, low-grade fever, fatigue starting at 4:00 pm 4/12/2021 through 2:0... Read more
chills, joint pain, muscle aches, low-grade fever, fatigue starting at 4:00 pm 4/12/2021 through 2:00 am 4/14/2021 diarrhea 4/14/2021 6:00 am - 2:00 pm
60 2021-04-15 nausea 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 2021-04-15 nausea SOB and wheezing much improved and nausea subsided. Pulse OX remained 96% or above. Team member all... Read more
SOB and wheezing much improved and nausea subsided. Pulse OX remained 96% or above. Team member allowed to leave and return to work. ,Team member had some brief nausea after vaccine given however it passed and she left the vaccine site after 15 minute, Team member rested on stretcher for 15 minutes Hr decreased to 90 SOB and wheezing much improved and nausea subsided. Pt had Shortness of Breath, Wheezing.
60 2021-04-15 vomiting, colitis, diarrhea, indigestion Severe digestion problems -- vomiting and diarrhea. Continued for several days so went to hospital ... Read more
Severe digestion problems -- vomiting and diarrhea. Continued for several days so went to hospital where CT showed inflammation of colon. Received IV and antiobiotics; released after three days. No fever or other symptoms. Mostly better now.
60 2021-04-16 abdominal pain upper, diarrhea, nausea Nausea Chill - Bone Chilling/Chattering Teeth/Cold more at extremities/cold to the touch Headache Ac... Read more
Nausea Chill - Bone Chilling/Chattering Teeth/Cold more at extremities/cold to the touch Headache Achy All over Achy joints Exhausted/Extremely Tired Diarrhea
60 2021-04-16 nausea, vomiting Nausea vomiting throughout the day and continuous the next night, sense on impending doom
60 2021-04-16 nausea Pt c/o anxious and claustrophobic, & nausea. "I just want to get out of here, I want to go outside."
60 2021-04-16 vomiting, nausea Body chills/aches, followed by an elevated temperature (102), naesua/vomiting, headaches, and lethar... Read more
Body chills/aches, followed by an elevated temperature (102), naesua/vomiting, headaches, and lethargy. Fever broke approximately 12 hours after I began to experience body chills with my body temperature returning to normal 28 hours after receiving the 2nd dose.
60 2021-04-17 nausea 1st IM Pfizer vaccination on 4-8-21, no issues until awakened at 4am on 4-13-21 with severe dizzines... Read more
1st IM Pfizer vaccination on 4-8-21, no issues until awakened at 4am on 4-13-21 with severe dizziness-room spinning, very mild nausea, still mild dizziness until midafternoon - no other issues until 4-18-21 at 5 am, once again awakened by severe dizziness, room spinning out of control- incapacitating dizziness continued well into next 12 hours of the day accompanied by severe nausea and headache, nausea improved with ondansetron and dizziness improved with meclizine after hours of not being able to ambulate.
60 2021-04-17 vomiting Extreme muscle soreness, low grade temp. Within 30 hours excessive vomiting started & continued for ... Read more
Extreme muscle soreness, low grade temp. Within 30 hours excessive vomiting started & continued for over 12 hours, resulting in dehydration, leading to trip to ER.
60 2021-04-17 vomiting Fever 101.0; chills; fatigue, throwing up, soreness at injection site
60 2021-04-18 abdominal pain, decreased appetite, nausea, abdominal distension Following my first Covid 19 Pfizer vaccine 03/11/21: **Note, I went through 1 1/2 days dull ache i... Read more
Following my first Covid 19 Pfizer vaccine 03/11/21: **Note, I went through 1 1/2 days dull ache in arm no concerns > days 2--5 went through a HYPER-WELL (no age aches, prior-hurt finger didn't ache, energy, ladies room habits back to what I reported to daughter "age 20!" for these four days, amazing, enjoyable, then > day 6 very early am woke up with swollen neck lymph nodes half-palm sized rocks on neck, breathing difficulties (lungs not neck), bad dull intrusive headache (different pain from Migraine, or low-hydration pain), cough dry and have called this my HYPER-CRASH because I could barely walk, backward C-shape abdomen hurt (dull ache big always + frequent stabbing pains from below bra bottom line to left abdomen down side then curving to my right across bottom abdomen at both leg-attaches-to-abdomen locations. Difficulty breathing, pain, extreme swelling over upper abdomen when I even drank water to swallow morning Hydrochlorothiazide pill and would stay swollen for 4-8 hours with continued surprise to me gulps of air throughout period, weak, nausea but not vomiting, dizzy, unable to walk more than a few steps at a time, fever taken and wavered from 95 to 99 degrees (my usual body registered 97.8 degrees) but never over 99 degrees, and only over 97.8 degrees perhaps three times very little above it and only for a few hours. >>I went to Urgent Care in person no better at all on 3/24/21/roughly day 12 after vaccine shot 3/11/21 (Urgent Care) which took blood and urine tests determining roaring infection and blood in tests and a CT CONTRAST scan should be ordered by my PCP asap at appt PCP already scheduled 3/26/21 but she couldn't order CONTRAST version the PCP would need to and she prescribed three antibiotics to take over next 2 weeks >> I went to PCP 3/26/21/day 14 after vaccine shot and he ordered CT Scan but insurance required pre-auth and they refused it at first so PCP referred me to GI SPECIALIST who again referred me for CT CONTRAST test, which I did have on Friday afternoon 4/16/21 (Clinic), and I await the results today 4/19/21. Today I continue to have pain abdomen, though softer and throbbing, same C-shaped region, HUGE issue even drinking water with Hydrochlorothiazide pill only for many hours as abdomen swells at bottom bra-line center in a palm size mound for hours, and back hurts badly, solid headache which may be only right side of head more than left but I am taking nothing for any symptoms afraid of GI issue. NOTING AGAIN: Yes I was diagnosed roughly 2015 with a single incidence of diverticulitis/osis by GI SPECIALIST in Town and went through series of Colonoscopies and tests, but tests only determined incidental few polyps removed over all tests and no incidents at all since that. Knowing what I know of my body and health, the trigger seemed to be the first shot of Covid 19 Pfizer vaccination which remarkably seemed to react first with a few days of better health than I have had for decades (eating, moving, energy etc. for my age), where after days of extreme great health and energy (where I went nowhere, and still did not push myself much) my body then crashed to unable to move much or even breath normally for many days after and with a multi-level infection in my gut that needed three antibiotics and after those I still hurt in the same locations. I cannot confidently rule out the Vaccine as the cause, and what I know of my body suggests in fact some "overdrive" function in my system was triggered and then caused the crash that resulted in infection and that continues to interfere with my walking, eating, moving, breathing, and even drinking a small glass of water today. Final note: PCP confirmed I should take the second Vaccine Pfizer shot, which I did on 4/1/21 - same site, Lot #EW0150, after which second vaccine shot I had the same two days of dull arm pain, and I continued to finish the antibiotics until finished (but pain though softer continues to today). I did not experience a #-Days HYPER-WELL episode then HYPER-CRASH after this second vaccine shot, only the arm ache, but throughout was still very unwell (breathing, pain, no activity, weak, unable to eat, swelling, headache, cough intermittent, back hurts, etc.) throughout, and same to this day 4/19/21 as I await CT CONTRAST results. I felt compelled to share I feel this was triggered by the first Vaccine shot, and would not have happened had I not had the Vaccine shot. Thank you.
60 2021-04-18 abdominal pain, diarrhea 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 diarrhea, abdominal discomfort, vomiting, abdominal pain upper, appendicitis appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; enti... Read more
appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; entire intestinal tract and stomach became hard; extended and felt like it was on fire and was extremely painful; vomiting along with diarrhea; vomiting along with diarrhea; pain and burning in my stomach and back; pain and burning in my stomach and back; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 12:15 (Batch/Lot Number: EP6955) as single dose (at the age of 60-year-old) for COVID-19 immunisation, administered at Pharmacy or Drug Store. Medical history included known allergies: Sulfa drugs, aspirin cordisone. Patient had not COVID prior vaccination. Patient was not pregnant. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, cortisone and experienced drug hypersensitivity. No other vaccine in fourweeks. On 29Mar2021 19:30 the patient experienced she felt tired, sore arm, entire intestinal tract and stomach became hard, extended and felt like it was on fire and was extremely painful, vomiting along with diarrhea, pain and burning in my stomach and back. On 31Mar2021 the patient experienced appendix had ruptured, diagnosed with appendicitis, could barely stand. The patient was hospitalized for appendix had ruptured and diagnosed with appendicitis for 2 days. The events were considered serious as per hospitalization, disability, life threatening. Therapeutic measures were taken as a result of appendix had ruptured and diagnosed with appendicitis: appendectomy. COVID was not tested post vaccination. Course of events was as follows: She had the shot on 29Mar2021 at 12:15, 4 hrs after she felt tired and had sore arm. 7 hours after, her entire intestinal tract and stomach became hard and extended and felt like it was on fire and was extremely painful. 4 hrs later she started vomiting along with diarrhea. The vomiting continued non stop along with the pain and burning in her stomach and back. On 31Mar2021 morning the pain settled into the right lower stomach and became so painful she could barely stand. She went to the ER and was diagnosed with appendicitis. She had surgery that night and found my appendix had ruptured. The OR nurse told he she was the 2nd lady that day who's appendix had ruptured after having their First COVID vaccine and there had been others. She believed this was absolutely the direct result of the vaccine. She queried why were we not warned of this violent side effect of the vaccine. The outcome of events was recovering.
60 2021-04-18 nausea 4/4/ Patient returned to the ED with SOB, cough and home pulse ox readings in the 80's. She was star... Read more
4/4/ Patient returned to the ED with SOB, cough and home pulse ox readings in the 80's. She was started on O2 at 2L NC and was admitted on IV Remdesivir and Decadron. By 4/8, she was able to be weaned off O2 and completed 4 days of Remdesivir and Decadron therapy. She refused rx to complete 10 day course of Decadron due to concerns regarding hyperglycemia and her diabetes.
60 2021-04-18 nausea Vertigo, dizziness, nausea
60 2021-04-18 vomiting left side headache, left eye pain, severe vomiting, full body pain, neck pain, chills as of Sunday s... Read more
left side headache, left eye pain, severe vomiting, full body pain, neck pain, chills as of Sunday some had subsided but not all. tylenol of no use!
60 2021-04-19 diarrhea, faeces discoloured, abdominal pain, flatulence I experienced the known, Headache, body/joint pain, injection site pain....what followed was severe ... Read more
I experienced the known, Headache, body/joint pain, injection site pain....what followed was severe abdominal pain followed by frequent diarrhea & high levels of gas. This started approx 10 hours after my second injection(on Wed 4/14/21)and lasted until midday 4 days (Sunday 4/18/21). I did not run a temperature. After waiting for it to go away (48 hours), I called COVID-19 line and they said to go to BRAT diet. I did that & added Pedialyte to replenish electrolytes & help with the extreme fatigue(over and above my usual MS fatigue). I also treated the extreme gas with gas-x chewable tablets. The diarrhea was like prepping for a colonoscopy, nothing stayed in my system & the stools were very loose & yellow in color.
60 2021-04-19 diarrhea, nausea Dose 1: Redness, swelling at injection site, Headache, dizzy, nauseous, fever over 100 degrees F. Ev... Read more
Dose 1: Redness, swelling at injection site, Headache, dizzy, nauseous, fever over 100 degrees F. Everyday or every other day. Diarrhea, muscle aches, joint aches, neck pain, fatigue all lasting 2-3 weeks. Still had 100 degree fever the night before Dose 2. Told nurses at Super Station about all the side effects from first dose and they had me take a Benadryl before 2nd shot, stay 30 min. for observation, then they told me to take Tylenol when I got home, which I did. Taking 2-3 more over the next day or so. Did not get redness or swelling at shot site, did have headache, fever, fatigue, muscle and joint pain, but much more muted than with the first dose with no medication. I continue to have a fever of 100 degrees about every 2-3 days. Some days I have diarrhea or feel headachy and have to be in bed most of the day. Usually fever is first symptom on those days. It's been 3 weeks since last dose and my fever was 100 yesterday and spent 15 hours in bed.
60 2021-04-19 nausea, abdominal pain upper 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 nausea severe headache, swelling of eyelids, naseau, muscle pai nin legs
60 2021-04-19 nausea Fatigue, headache, fever, nausea. Reports symptoms still ongoing.
60 2021-04-19 vomiting, nausea APPROXIMATELY 4 DAYS AFTER GETTING THE FIRST SHOT OF THE COVID-19 VACCINE, MS. THREATT EXPERIENCED N... Read more
APPROXIMATELY 4 DAYS AFTER GETTING THE FIRST SHOT OF THE COVID-19 VACCINE, MS. THREATT EXPERIENCED NAUSEA, BODY ACHES, VOMITING (FOR FOUR DAYS), AND A CHANGE IN TASTE BUDS. SHE SAYS SHE NO LONGER CAN DRINK ANYTHING BUT WATER AND CLEAR LIQUIDS AND THAT FOOD SUCH AS MEAT AND BREAD ARE NO LONGER ABLE TO BE EATEN.
60 2021-04-20 gastrointestinal disorder 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 nausea Onset of severe chills and headache approximately 8 hours after the injection of the second vaccine.... Read more
Onset of severe chills and headache approximately 8 hours after the injection of the second vaccine. Extreme fatigue, nausea and chills lasted 24 hours plus after injection. Still feel weak, nauseated and have headached 48 hours after injection.
60 2021-04-21 abdominal pain, abdominal discomfort, abdominal pain upper, diarrhea, vomiting The day following the vaccination, I had a fever, intense chills, and a mild headache. I have had an... Read more
The day following the vaccination, I had a fever, intense chills, and a mild headache. I have had an upset stomach since the second vaccination, with intermittent stomach pain. Last night (04/22/2021, starting around 7:30 PM), I had intense lower abdominal pain, loose stool, vomiting, and an intense chill. The symptoms came on suddenly (over the period of a half hour). After vomiting, I was seized by sudden, intense, lower-back pain immediately followed by full-body tremors. The tremors started with my legs, then went to my hands and finally my arms. I have never had a problem with tremors or seizures before. The back pain and tremors fully subsided after 10 minutes. I did not visit a doctor, since it is doubtful that they would definitively blame the Covid vaccine, and I would be stuck with a large hospital bill. However, the symptoms were too peculiar to be attributed to a random illness. I do believe they are a side effect from the second vaccine dose. This morning I feel tired and am a pound lighter, but I am quickly recovering.
60 2021-04-21 nausea Severe migraine, heart palpitations and nausea lasting 24 hours
60 2021-04-21 nausea Cold sores around mouth and chin. Accompanied by severe nausea. They are still breaking out so unsu... Read more
Cold sores around mouth and chin. Accompanied by severe nausea. They are still breaking out so unsure how bad yet or if hospital is needed.
60 2021-04-21 nausea Developed fatigue and nausea two days after vaccine. Began to have skin irritation the same day. Dev... Read more
Developed fatigue and nausea two days after vaccine. Began to have skin irritation the same day. Developed a rash five days after vaccine and was diagnosed with shingles six days after vaccination. Took Enbrel and methotrexate two days after vaccination.
60 2021-04-22 decreased appetite Injection site pain, extreme tiredness, ?hangover? headache/awful headache, joint pain, 101 degree f... Read more
Injection site pain, extreme tiredness, ?hangover? headache/awful headache, joint pain, 101 degree fever, feeling unwell, no appetite (but not nauseous) X 1-1/2 days Sore arm/difficulty raising arm X several days; tolerable
60 2021-04-22 diarrhea, nausea, vomiting Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Mediu... Read more
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Diarrhea-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Nausea-Medium, Systemic: Vomiting-Severe, Error: Incorrect Reconstitution
60 2021-04-22 indigestion 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 2021-04-22 nausea, decreased appetite At time of injection- immediate warm sensation in stomach, neck and face. Slight flush color in face... Read more
At time of injection- immediate warm sensation in stomach, neck and face. Slight flush color in face. Itching in face and forehead however NO signs of hives or labored breathing. Intake if fluids. No Benadryl or Epi-pen required. Symptoms diminished and left facility in 10-15 minutes. 2-3 hours later- body aches, mild nausea and mild headache. NO Tylenol 1 am- woke from sleep- Headache . Took 2 Tylenol. Went to sleep. Woke at 6 am- string body aches, nausea, and very sore arm. NO headache. Took Tylenol. Stated in bed with fluids until 2 pm. Little appetite. Slight headache in evening. Achey feeling subsided . Next day - Mild body aches and nausea. Took one Tylenol. No appetite.
60 2021-04-22 nausea Chills, weakness, nausea
60 2021-04-22 vomiting severe headache- took Maxalt, went away vomiting- began 12 hours after injection painful arm, especi... Read more
severe headache- took Maxalt, went away vomiting- began 12 hours after injection painful arm, especially when lifting arm up
60 2021-04-23 diarrhea Severe dizziness, rare front or left headache with pain, pain in both eyes and left eyelid tremor, d... Read more
Severe dizziness, rare front or left headache with pain, pain in both eyes and left eyelid tremor, diarrhea, muscle and joint pain, stiff fingers, feet and leg muscles, rash all over the body, fatigued and shortness of breath, tiredness.
60 2021-04-23 nausea Chills; body aches; fever; nausea; This is a spontaneous report from a contactable consumer (patient... Read more
Chills; body aches; fever; nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration in the left arm on 11Feb2021 at 08:45 AM (at the age of 60-year-old) as a single dose for COVID-19 immunization at Workplace clinic. Medical history included allergies to medications, food, or other products was Sulfa drugs. Prior to the vaccination, the patient was diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications received within 2 weeks of vaccination included citalopram at 20 mg. Patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for Covid-19 immunization. On 12Feb2021 at 12:00 AM, on the second day, the patient experienced chills, body aches, nausea and fever. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the chills, body aches, nausea and fever were recovering. No follow-up attempts are Possible. No further information can be obtained.
60 2021-04-23 nausea Day after shot (Saturday 10 April) - nausea, headache, 101.5 fever, body aches, arm soreness, tired... Read more
Day after shot (Saturday 10 April) - nausea, headache, 101.5 fever, body aches, arm soreness, tiredness 2nd day after shot (Sunday 11 April) - slight headache, tiredness, red rash around injection site and itching. My arm was also swollen and more sensitive to touch than movement. The itching wasn't bad enough that I needed to take any meds. I just wanted to report this adverse reaction to the second shot.
60 2021-04-24 nausea, abdominal discomfort, abdominal pain upper 3/19/21: patient is a 60yo female who presented with complains of facial droop. The sister reports t... Read more
3/19/21: patient is a 60yo female who presented with complains of facial droop. The sister reports the patient complained about headache in the left temporal area around 8-9pm, reports having the same pain throughout the week but today was stronger, and the sister noticed she had facial droop and was unable to open her left eye. The patient also reports abdominal discomfort the the epigastric region and LUQ that started today and was associated with nausea. She denies diarrhea or fever. Of note patient reports having Covid Pfeizer vaccine yesterday and 5 minutes later being were unable to speak with edema in her lips and tongue, associated with SOB. She was taken to a ER, was given epipen, albuterol, benadril, prednisone and was discharged home at night with improvement on her symptoms. Patient discharge note on 3/22/21: Admitted for facial paresthesias in setting of arnold-chiari malformation, HTN, HLD, after covid vaccine, neuro work up neg, discharged home on 3/22/21.
60 2021-04-24 nausea, diarrhea, vomiting possible hearing loss; episodes of elevated tinnitus (pre-existing); vertigo; dizzy; hands felt like... Read more
possible hearing loss; episodes of elevated tinnitus (pre-existing); vertigo; dizzy; hands felt like vibrating; nauseous; threw up; diarrhea; chills; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 60 years of age), dose 2 via an unspecified route of administration, administered in arm left on 05Apr2021 13:00 (Batch/Lot Number: EP7533) as a single dose for COVID-19 immunisation. Medical history included tinnitus and penicillin allergy, both from an unknown date and unknown if ongoing. Concomitant medications included ciclosporin (RESTASIS) and vitamin d nos (VITAMIN D NOS), both taken for an unspecified indication, start and stop date were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number: EL9629) (at 60 years of age), dose 1 in the left arm on 08Mar2021 13:00 for COVID-19 immunisation. The patient was not pregnant. The patient did not receive any other vaccine in four weeks prior to covid vaccine. The patient had no covid prior to vaccination. The patient has not been covid tested post vaccination. The patient experienced repeated night time episodes of elevated tinnitus (pre-existing), possible hearing loss, vertigo, dizzy, hands felt like vibrating, nauseous, threw up, diarrhea, and chills, all on 05Apr2021 14:00 PM with outcome of recovered/resolved with Sequel. The events resulted to Emergency room/department or urgent care. No treatment received for the events.
60 2021-04-24 nausea feeling nauseated; warm; This is an initial spontaneous report from a contactable consumer(patient).... Read more
feeling nauseated; warm; This is an initial 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 was not reported) first dose via unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunization. The patient medical history stated she had COVID-19 back in October. The patient concomitant medications were not reported. Patient wanted to know if the reaction happens right away when they ask us to wait for 15 mins. Patient wanted to know if vaccine have the virus in it. Patient wanted to know what if she does not take the second dose. On Apr 2021 patient stated that she received the Pfizer COVID vaccine on 07Apr and feeling nauseated, warm, patient has celiac sprue and wanted to know about the ingredient/ gluten in it. The outcome of the event was unknown. Information on the lot/ batch number has been requested.
60 2021-04-24 nausea Fever, chills, muscle aches, malaise, site pain extending down arm and into shoulder, headache, naus... Read more
Fever, chills, muscle aches, malaise, site pain extending down arm and into shoulder, headache, nausea. Adverse events lasted 2 days. Treated with tylenol.
60 2021-04-25 diarrhea Headache started after 2nd dose?started Wednesday evening. Diarrhea on Thursday. Headache continued.... Read more
Headache started after 2nd dose?started Wednesday evening. Diarrhea on Thursday. Headache continued. Night sweats on Thursday to the point of waking up soaked. Friday headache continued, no energy. Saturday felling slightly better and by Sunday appetite returned. Treated with IBP and Tylenol plus rest.
60 2021-04-26 nausea 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 2021-04-26 nausea I had all this pain at the injection side; tired; headache; chill; throat pain; fever; nausea; swoll... Read more
I had all this pain at the injection side; tired; headache; chill; throat pain; fever; nausea; swollen lymph nodes; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/expiration date: unknown) via an unspecified route of administration on 23Feb2021 (at age of 60 years) at single dose for COVID-19 immunization. Patient relevant medical history included chronic obstructive pulmonary disease (COPD). Patient concomitant medications were not reported. After receiving covid-19 vaccine patient started running really high temperature and pain at the vaccination side, really tired, headache, chill, throat pain, fever, nausea, Patient said swollen lymph nodes, throat has been sore on unspecified date. Patient stated that run temperature but took Tylenol and it took it down it was high, but I still have the soreness. Patient also mentioned having COVID 19 infection months ago. Treatment received for events was unknown. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
60 2021-04-26 vomiting, nausea 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 vomiting This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt1... Read more
This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 12:30 (at the age of 60-years-old) (Batch/Lot Number: ER-8730) as SINGLE DOSE for covid-19 immunization. Medical history included Hypothyroid, High Blood Pressure. Concomitant medications included levothyroxine sodium (SYNTHROID); losartan potassium (LOSARTIN); amlodipine; hydrochlorothiazide; all taken for unspecified indications, start and stop dates were not reported. On 27Mar2021 13:30, the patient experienced Bleeding at the site, fainting and vomiting while passed out for 5 minutes. The patient believes the injection was too high and she hit a vein. It was further reported that the patient is not a squeamish person and have never had reactions to any shots or blood draws in the past. The event fainting and passed out was assessed as serious (medically significant). Therapeutic measures were taken as a result of bleeding at the site. The patient did not receive treatment for the events fainting, passed out, and vomiting. The outcome of the events was recovered.
60 2021-04-27 difficulty swallowing 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 nausea, appendicitis, abdominal pain Received Vaccine on 12/19/20 around 5pm. next day Sunday on 5/20/20 in the evening had, nausea, a... Read more
Received Vaccine on 12/19/20 around 5pm. next day Sunday on 5/20/20 in the evening had, nausea, abdominal pain, headache, fatigue symptoms worsened to include chills and fever went to Emergency room 12/21/20 evening, had high Blood pressure and fever. had labs done, bedside ultrasound, and Abdominal CT. was diagnosed with Acute Appendicitis. I just learned that Appendicitis was one of the serious adverse side effects of the Pfizer Vaccine.
60 2021-04-29 diarrhea After 1st vaccine it was just like I had COVID all over again - severe headache lasting 48 hours, sw... Read more
After 1st vaccine it was just like I had COVID all over again - severe headache lasting 48 hours, sweaty/cold, diarrhea. After 2nd vaccine severe body aches, extreme fatigue, sweaty/cold and diarrhea.
60 2021-04-29 vomiting Cerebral venous sinus thrombosis Patient received vaccine in March (exact date is unknown but around... Read more
Cerebral venous sinus thrombosis Patient received vaccine in March (exact date is unknown but around March 8-12 per husband); in mid-April patient started reporting intermittent low intensity headaches. On April 23, patient had severe headache and vomiting, went to urgent care and was thought to have sinusitis and started on antibiotics and discharged home. On April 24th, patient became more drowsy with worsening headache and unresponsive. On April 25, she was taken to outside hospital and was noted to have abnormal brain MRI. She was transferred to our facility on April 26 after clinical worsening. Imaging revealed venous sinus thrombosis in deep cerebral veins and patient was intubated due to worsening mentation. Imaging also revealed a venous stroke with hemorrhage in her left thalamus and diffuse brain edema. Treatment includes extraventricular drain placement, anticoagulation (heparin), hypertonic saline to manage brain edema. We also did extensive workup but no history of hormone therapy, contraceptive pills, underlying cancers. Tumor markers are negative. Hypercoagulable panel and rheumatologic panel are negative. Body imaging did reveal multiple uterine fibroids but no other cancer. Patient remains in the ICU, on the ventilator, heavily sedated for management of refractory intracranial hypertension.
60 2021-04-30 diarrhea, nausea 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 2021-04-30 difficulty swallowing Caller states the patient had an anaphylactic reaction twice that caused her to go to the emergency ... Read more
Caller states the patient had an anaphylactic reaction twice that caused her to go to the emergency room; couldn't swallow; right side of the patient's face swelled up and her lips were numb; right side of the patient's face swelled up and her lips were numb; face numb; hands itching; tongue had swelled up; voice was scratchy; This is a spontaneous report from a contactable consumer, Reporter's sister via Pfizer-sponsored. A 60-year-old female patient received the second dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Ex-piry Date: Unknown) via an unspecified route of administration on 01Mar2021 on an unknown ana-tomical location as a single dose for COVID-19 immunization. Caller provided that her sister got the vaccine for COVID Prevention and because the patient has a handicapped, bedridden husband who has MS and is immune compromised, and it was to help prevent him from getting sick. Caller reported that the patient received the product during the daytime, all the women at the patient's job, which was home health payroll, everyone left to get the vaccine during work hours, like in the AM at around lunch time. Patient's medical history and concomitant medications were unknown. Patient has not received any prior vaccinations within 4 weeks. Patient had no other vaccines on the same day as the suspect product. Patient received first dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Expiry Date: Unknown) on 08Feb2021 with no reaction. She worked for a health agency and the whole office went and got it. Caller provided that her sister had a reaction the first time, on 03Apr2021, where her sister woke up with itching started in her hands and ended up migrating to her whole body. By morning patient's tongue had swelled up, couldn't swallow and her voice was scratchy, like the caller couldn't understand her sister's speech well. Caller provided that her sister went to the ER and said there was a whole team giving her urgent care, medication, and such. Caller reported that her sister said the ER didn't find anything in her bloodwork, and the caller did not think the patient was being treated for any other medical conditions, and caller did not think her sister is on any medications, but caller said to not quote her on that. Caller knew her sister had a weight problem, but she did not know if her sister needed blood pressure medication or anything. Caller reported her sister said that the bloodwork from the ER did not find any-thing, and the patient was not admitted to the hospital. Caller reported that at this time, her sister's adverse events were no longer ongoing as her sister was given Steroids, like Prednisone, Benadryl and Famotidine, and she took those products as recommended by the doctor. Caller did not know the end date of her sister's events; all she knew was that the reaction initially started on 03Apr2021. Caller stated that her sister was allergic to nothing, and she has never had incidences of itching like that, where the itching was so bad that she was stripping down and the patient's daughter was patting the patient down with witch hazel. Caller stated that ER released the patient and gave her some medications and such. Caller stated that a day or so later, there was a second round of reaction: the right side of the patient's face swelled up and numb and her lips were numb, like when people have a dental procedure. Lips were numb for a while. Upon completion of the medications she was given, the reactions stopped. Patient regularly saw the family doctor. She would go back to see her Doctor on Thursday. HCP Information was unknown to the caller, but caller stated that her sister had been recommended to go to her PCP and get an Epi Pen. Caller stated that knock on wood, so far, her sister was holding her own, and it had not happened again. Caller stated that she was reporting the data that her sister gave to her after having the Pfizer vaccination. Caller stated the patient had an anaphylactic reaction twice that caused her to go to the emergency room. No relevant tests were done. Caller stated that she had the dates that she had her shots and where she had her shot at. Caller stated somebody called and reported it already. Caller stated she was trying to press three but never could figure out which prompts was. Caller stated they said if she called this number, they would tell her at the medical information department if this occurrence has happened to other people, like statistics. Caller stated they tried to call this number, but it was too long of a wait. Caller stated that she did not have the vaccination card, she never asked for them. Caller does not have card with her at time of call for LOT, NDC, Expiry date. Caller stated that she knew that all the COVID vaccines are just in the Emergency Use Authorization stage and in clinical trials, but caller really thought that all manufacturers should be advertising that they would like feedback from patients. Caller has not heard anything from any of the manufacturers saying that people are welcome to reach out and report side effects. Caller states that she only knew to call because she used to be a Home Health Worker, and she thought this is an important data. Caller has never seen on any of her 19 TV channels about calling to report. Caller stated that the girl who first answered her call, read a clinical data sheet about joint pain being seen in 23% of patient's and not knowing a percentage for anaphylactic reactions, caller was wondering if this was true. Caller verified that she just wanted to ask basically that patient was not alone, if other people might have had that happen too. Caller stated that she tried to call, and it would ask another question and it would say press 1 or 2, then it would ask other questions and it would say press 1 or 2, she never got an option 3. Caller asked: how much percentage, has anyone reported this side effects weeks after the second dose. Caller was wondering if this reaction could have been from the vaccine. Investigation Assessment: No. The outcome of the events were unknown. Information on the lot/batch number has been requested.
60 2021-04-30 nausea Pt received Pfizer vaccine at 12:15 pm and at 12:23 pt became nauseated. Pt taken to vaccination cli... Read more
Pt received Pfizer vaccine at 12:15 pm and at 12:23 pt became nauseated. Pt taken to vaccination clinic observation room to lay on cot 1:1 with MD supervision. Pt was given a bottle of water to sip and rest until nausea passes. PT had no other complaints other than a headache which she had prior to vaccination. PT gets frequent migraines and has a scheduled aimovig injection for tomorrow 5/2/21. Pt in no visible distress, no difficulty breathing and o complaints other than nausea. PT was monitored for 30 minutes and released by physician. Pt stated had no dizziness or other symptoms at time of discharge. PT was educated and instructed to call 911 if symptoms of allergic reaction occur at home and to follow up with PCP if nausea comes back.
60 2021-04-30 nausea has mild tinnitus prior to being vaccinated, but started having really bad tinnitus a week later to ... Read more
has mild tinnitus prior to being vaccinated, but started having really bad tinnitus a week later to the date after receiving first dose Pfizer Covid 19 Vaccine; nausea and vertigo kind of feelings; nausea and vertigo kind of feelings; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Expiry Date: 31Jul2021, Lot Number: ER8733) in right upper arm on 30Mar2021 at single dose at 60-year-old for COVID-19 immunization. Medical history included, on a low dose blood pressure medication. Mild tinnitus prior to being vaccinated. There were no additional vaccines administered on Same Date of the Pfizer Suspect, did not even get the flu shot. There were no prior vaccinations within 4 weeks. Concomitant medications were not reported. Past drugs included steroids make blood pressure go up that was all. States like zithromax (Z-paks) or dexamethasone or whatever, makes blood pressure go up. Patient took the Covid vaccine 2 weeks ago. One week after taking the vaccine she contracted tinnitus. She is calling to inform Pfizer she feels they should put this on the list of side effects so patients can have the option of receiving the Pfizer vaccine or not. She went to a specialist and the doctor stated he has seen several patients that this has happened to. She would like to speak with someone about this. She is in good health and is on a low dose blood pressure medication (she would not give name of medication). Patient was a consumer who received the Pfizer Covid 19 Vaccine dose one on 30Mar2021. Reports wearing KN95 masks and haven't gone anywhere. One week later on 06Apr2021, after receiving the first dose Pfizer Covid 19 Vaccine caller started having really bad tinnitus. Caller reports she has mild tinnitus prior to being vaccinated, but started having really bad tinnitus a week later to the date after receiving first dose Pfizer Covid 19 Vaccine. Caller states she doesn't know how much, like how much of her personal life she wants to give. Just thought her husband is the superintendent and was calling to report the side effects, wanted to be a good citizen. Caller reports trying to be responsible and feel like caller is doing the right thing. Caller is going to sit down now. Was walking around the kitchen while on hold, was on hold for a while. Caller reports having a history of tinnitus, but very mild. All of a sudden, the tinnitus got really like the volume turned up, and has just been like that since. Reports also having nausea and vertigo kind of feelings on 06Apr2021. Tinnitus is very profound. Reports the vertigo and nausea kind of feelings come with the tinnitus. Reports the tinnitus, nausea and vertigo kind of feelings have been the same since last Tuesday. Caller states she has so many KN95, so many masks, because her husband is the superintendent. The KN95 masks are all they have worn for the past year. Inquires if caller should still be wearing KN95 mask even after being vaccinated. Caller states she is just making conversation, she uses KN95 masks all the time, the mask question has nothing to do with what the caller is reporting. Caller's husband is so organized being who he is, caller has the time in the calendar. Caller got to the administration site at 16:55. There was no adverse event required a visit to Emergency room or Physician office. Patient talked to the Doctor on the phone about how to deal with the symptoms. Patient was scheduled for second dose Pfizer Covid 19 Vaccine not this Wednesday, but the next Wednesday. There was no adverse event following prior vaccinations. The only thing that caller has bad reactions to are steroids, caller did not do well with steroids. Caller is unable to provide NDC/lot/expiration for the steroids. States, no just like caller's whole life, steroids make caller's blood pressure go up that's all. States like Z-paks or Dexamethasone or whatever, makes blood pressure go up. Caller is not able to provide NDC/lot/Expiration for the Z-pak or Dexamethasone drugs. States no, just been caller's whole life steroids tend to make blood pressure rise. No family medical history relevant reported, stated her Mom is dead and father just passed away. Caller request an email that she spoke to agent. Caller asks how this information will be used, if it even matter caller reported events. Caller requests specific information on what happens to Safety reports and how many adverse events are reported. Caller states she probably will not call again, was just being a good citizen and reporting events. Outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.
60 2021-04-30 nausea Fatigue and malaise. Then on 4/6/21 experienced intense skin sensitivity/pain (especially on back) ... Read more
Fatigue and malaise. Then on 4/6/21 experienced intense skin sensitivity/pain (especially on back) and chills, followed by a papule type rash on elbows, hands, fingers, back, and at the gluteal fold. Rash on fingers and back were also itchy. The rash had subsequently resolved, but it returned again accompanied by skin sensitivity/pain on my back along with nausea and lightheadedness on 4/29/21. It has not resolved as of this day.
60 2021-04-30 vomiting, diarrhea, nausea DVT blood clot; ankle was still swollen and uncomfortable; ankle was still swollen and uncomfortable... Read more
DVT blood clot; ankle was still swollen and uncomfortable; ankle was still swollen and uncomfortable/discomfort; nights were the worst for the pain; pulse ox was low; d-dimer was very high; fainted; Fracture of ankle/two fractures on her ankle; severely nauseous; Vomiting; Diarrhea; deathly sick; This is a spontaneous report from a contactable consumer, reporting for herself. A 60-year-old female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: ER8727), via an unspecified route of administration in the left arm on 26Mar2021 at 14:00 at a single dose for covid-19 immunisation. Medical history included osteoporosis at least 10 years, terrible nausea, mild case of covid from Nov2020 to an unknown date. There were no concomitant medications. The patient previously took alendronate from 2008 to an unknown date and experienced very sick, nausea, diarrhoea and zoledronic acid (RECLAST) from Dec2017 and experienced nausea and vomiting. On 27Mar2021 at 2:00, the patient experienced deathly sick, fainted, fracture of ankle/two fractures on her ankle, severely nauseous, vomiting, and diarrhea. On an unknown date, the patient experienced dvt blood clot, ankle was still swollen and uncomfortable/discomfort, the nights are the worst for the pain, pulse ox was low, and d-dimer was very high. The event, deathly sick, was life-threatening. The clinical course was as follows: the patient had the first dose of the vaccine on 26Mar2021 at 14:00 in the afternoon in her left arm. Twelve hours after the first dose, later in the night about 02:00 AM she woke up deathly sick; and severely nauseous. She remembered she was going to the bathroom then she must have fainted because they were taking her to the hospital. She went to the ER and they found she had a fractured ankle. She was not admitted to the hospital. She was in the ER from about 03:00 AM to noon the next day. There must have been something in there; she knew there must be something in the vaccine because of her reaction. Adds a few years ago, something like this happened before. She had osteoporosis and had similar reactions with other products she had tried for osteoporosis; she had terrible nausea. The other products she tried included: in 2008 she took alendronate, it made her very sick but not as severe as this time, she never fainted. She had nausea and diarrhea. Then in Dec2017 she had zoledronic acid. She went for an infusion at the hospital then went shopping, and was fine until the early morning, when she woke up with nausea and vomiting. In the ambulance, they gave her ondasetron (ZOFRAN) for the nausea so the vomiting stopped. With regard to her ankle, first they thought it was a DVT blood clot. They did the xray and saw actually two fractures on her ankle but she does not need surgery. She saw the orthopedic doctor the other day and he said her ankle was healing but she still will have no weight bearing for 6 weeks and she was in a boot. Adds her ankle was still swollen and uncomfortable. She hated to take medications and they gave her oxy but she didn't want to take it. She was taking ibuprofen but that messed up her stomach. The nights are the worst for the pain and discomfort. Doctor at the hospital and primary care agreed she should not have the second dose. She did have mild case of COVID in Nov2020 and they are hoping she had antibodies from the infection and the first dose. Her primary care doctor was reviewing the blood work she had done at the hospital and told her they were surprised the hospital didn't admit her for observation because her pulse ox was low and there was another test that she was questioning because the d-dimer was very high. They did a chest x ray with unknown results. The doctor was questioning why they didn't do something else to rule out a blood clot. Therapeutic measures were taken as a result of the events, deathly sick, DVT blood clot, fainted, fracture of ankle/two fractures on her ankle, severely nauseous, vomiting, diarrhea, ankle was still swollen and uncomfortable/discomfort, nights were the worst for the pain, pulse ox was low, and d-dimer was very high. The clinical outcome of the events, deathly sick, fainted, severely nauseous, vomiting, diarrhea, was recovered on 27Mar2021. The clinical outcome of the events, DVT blood clot and nights were the worst for the pain, pulse ox was low, and d-dimer was very high, was unknown. The clinical outcome of the event, fracture of ankle/two fractures on her ankle, was recovering. The clinical outcome of the event, ankle was still swollen and uncomfortable/discomfort, was not recovered. No follow-up attempts are needed. No further information is expected.
60 2021-05-02 decreased appetite, nausea 4/9/21 Pt had URI symptoms. She was seen at a Minute Clinic. Tested negative for Sars-Co-V-2 4/12 Ha... Read more
4/9/21 Pt had URI symptoms. She was seen at a Minute Clinic. Tested negative for Sars-Co-V-2 4/12 Had continued symptoms. Test positive for SARS-CoV-2 4/15 Treated with mAB 4/17 Presented to ED w/nausea and decreased appetite. Vitals stable. No hypoxemia. +electrolyte imbalance K+ was 2.9. Given IFV and K repletion and discharged to home 4/19 Started on Zpack and Decadron as outpt 4/21 Returned to ED with increasing SOB and reported home pulse ox 75-82% w/ exertion. In ED, sats in low 90's. Tachypnea with RR24-28. CTA + for PNA and new PE Discharge summary : Pulmonary embolus Likely secondary to COVID-19 infection; HRT possibly contributing Chest CTA showed a small subsegmental pulmonary embolus in the left lower lobe. Flattening of the interventricular septum possibly indicating acute right heart strain Lovenox 1 mg/kg twice daily in the hospital and transitioned to Eliquis at discharge Patient currently on estrogen placement therapy-discontinued Covid-19 Virus Infection Date of onset of symptoms: 4/9/2021 Symptoms present on admission: Productive cough, dyspnea Date of covid positive test: 4/12/2021 Vaccination status: First dose given on 3/31/2021 Special isolation anticipated end date: 4/22/2021 if symptomatically improving Imaging: Chest CTA with interval worsening of diffuse interstitial infiltrates Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: Continue oral Decadron 6 mg daily Consultants following: None Inflammatory markers: LDH 306, ferritin 507, CRP 54.3 and D-dimer 2.07 Disharged on codeine cough syrup and Tessalon for persistent cough
60 2021-05-02 nausea Waves of body shaking chills for a day and a half. Nausea, heavy legs, headache, muscle aches.
60 2021-05-02 nausea One week after 2nd dose of COVID vaccine, extremely dizzy and nauseous.
60 2021-05-02 vomiting, nausea Pfizer-BioNTech COVID-19 Vaccine EUA: patient with seizure disorder reports seizure one day followin... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient with seizure disorder reports seizure one day following vaccination. No loss of conscioussness or speech. Seizure reported as arm weakness, incontinenece, and vomiting. Afterwards rested all day and able to eat and drink. Patient also reports fatigue, myalgias, arthralgias, and nausea. Symptoms improving and no additional seizures documented.
60 2021-05-03 appendicitis Appendicitis 3/22/2021 Emergency Appendectomy
60 2021-05-03 difficulty swallowing Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic... Read more
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: syncope-Mild, Additional Details: Patient reported throat tightness and difficulty breathing. immediately after patient lost consciousness. patient was repositioned and one injection of epinephrine was given. paramedics came within 10 minutes and carted her off to hospital.
60 2021-05-03 nausea Patient received 2nd dose of Pfizer Vaccine. Patient reported to Vaccinator that she had experienced... Read more
Patient received 2nd dose of Pfizer Vaccine. Patient reported to Vaccinator that she had experienced sudden onset of nausea and vomiting and chest tightness post 1st dose and was taken by EMS to Hospital after 1st dose. Per patient she was given clearance by her PCP to receive 2nd dose of Pfizer Vaccine. Within 5 minutes of receiving dose, patient with sudden nausea, sharp headache, and complaining of chest pain. EMS called, and patient transported to ER. Vital Signs Stable: 124/71, HR 80, 100% on Room Air upon transfer.
60 2021-05-04 diarrhea Fever ? Cough ? Fatigue ? Headache ? Diarrhea
60 2021-05-04 nausea, vomiting pt. c/o of nausea and vomitting (vomited x1 the liquid drink that was injested earlier as reported b... Read more
pt. c/o of nausea and vomitting (vomited x1 the liquid drink that was injested earlier as reported by the patient) Patient reported slight dizziness. Vitals: BP:116/74 Pulse: 84 RR:19 o2 sat 98% RA Advised to rest on gurney in sit up position and take sips of water for the nausea. Monitored Vital signs. pt no signs of SOB and no change of LOC. Pt. alert and verbally responsive 10:07am Vitals: BP:124/79 Pulse: 69 RR:18 o2 97% RA Pt. went home and pt. stable and relief with symptoms noted.
60 2021-05-04 nausea blood pressure (BP) went over 269/149, it made my blood pressure go up.; left side of middle back ha... Read more
blood pressure (BP) went over 269/149, it made my blood pressure go up.; left side of middle back had some excruciating pain; Nauseous; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I got a mark on my arm, my arm started swelling; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0164/expiration date: 30Jun2021), via an unspecified route of administration, on 16Mar2021 (at the age of 60 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6208/expiration date: not provided), via an unspecified route of administration, on 16Mar2021 (at the age of 60 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION and experienced a headache. Relevant ongoing medical history included Diabetes Type II from about 5 years ago in 2016, fibromyalgia diagnosed about 6 years ago in 2015, and high blood pressure. Concomitant medication included gabapentin from an unspecified date at 600mg 3x/day for fibromyalgia, empagliflozin (JARDIANCE) from an unspecified date at 10mg 1x/day for Diabetes Type II, clonidine from an unspecified date at 30 mg, 2x/day for high blood pressure and labetalol from an unspecified date at 200 mg, 2x/day for high blood pressure. On an unspecified date in Mar2021, the patient experienced her blood pressure (BP) went over 269/149, it made my blood pressure go up, which required hospitalization overnight. Also on an unspecified date in Mar2021, the patient experienced a mark on her arm, and her arm started swelling. On 16Mar2021, the patient experienced major body ache, described as it started hurting the minute she put it in her arm, excruciating pain and pain in the neck down the arm, and she was nauseous. She described that she couldn't get out of the bed because of so much body pain. On 21Mar2021, the patient experienced her left side of middle back had some excruciating pain. The clinical course was as follows: I had a major body ache with the second vaccine. I did not have any problem except the headache with the first one but I took second one on this past Friday, I got very nauseous, it started hurting the minute she put it in my arm, which is on the left side. I got a mark on my arm, my arm started swelling. Saturday morning I couldn't get out of the bed because of so much body pain, Sunday my left side my middle back I had some excruciating pain I rushed to the doctor to the ER, my BP went over 269/149 and they had to give me pain medicine and BP medicine to reduce the blood pressure. I made it to the doctor and I'm getting medicine for the pain. I woke up in the morning there's pain in the neck down the arm and it's aching, the side I got the shot, the side is hurting, excruciating pain in my arm. I had to go to the ER straight to my doctor's office, they wouldn't let me drive or anything straight to the ER where they administered 2 doses of pain medicine and 3 doses of blood pressure, the pain was so intensive it made my blood pressure go up, the doctor said all of this was coming from the vaccine." Relevant lab data on an unspecified date in Mar2019 included blood pressure 269/149. The patient received treatment for the events blood pressure high, body pain, neck pain, pain in arm, and back pain. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446955 same reporter/patient/drug, different event in separate dose
60 2021-05-04 vomiting, abdominal discomfort sickness to her stomach; fibromyalgia flared up; heaviness in the muscle of her arm; vomiting; This ... Read more
sickness to her stomach; fibromyalgia flared up; heaviness in the muscle of her arm; vomiting; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, lot number: EN6206), via an unspecified route of administration in left arm on 08Mar2021 at single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, fibromyalgia, diabetes diagnosed almost 10 years before, obese, knee replacements 10 years before on both knees, and Sjogren's disease. Concomitant medications included loratadine from 13Mar2021, hydrochloorthiazide for Sjogren's disease from little over a year before, fluoxetine, cetirizine hydrochloride (ZYRTEC) for years like 20 years for asthma, and montelukast sodium (SINGULAIR) for years for asthma. Patient previously received varicella zoster vaccine (shingles shot) 2 years before. The patient experienced sickness to her stomach, fibromyalgia flared up, heaviness in the muscle of her arm and vomiting within 24 hours after the vaccination. After the 1st dose she was really sick and it affected her fibromyalgia and rheumatoid arthritis and she was just a mess and ended up vomiting and this took about three days which was normal. Patient was on a lot of medicines that counter act anything the Pfizer COVID Vaccine could do to her regarding side effects and thought the vaccine was too much for her body. Patient took several different asthma medicines and made the reported event not as severe. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
60 2021-05-05 appendicitis Appendicitis
60 2021-05-05 diarrhea, vomiting Woke up with headache, chills, and vomiting. Diarrhea.
60 2021-05-06 decreased appetite Extreme fatigue, fever 100.2, hands & face very swollen, no appetite.
60 2021-05-06 nausea, difficulty swallowing, diarrhea, retching, vomiting Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eye... Read more
Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eyes it is swollen; She was having severe diarrhea; having severe dry heaves; vomiting bile; It had dehydrated her/lead to dehydration; Her throat closing up and it being sore from vomiting and dry heaving; couldn't swallow to get any fluids in; Her throat closing up and it being sore from vomiting and dry heaving; she was struggling with having a dry mouth; puffiness; Headache; severe muscles aches/Muscles pain; feeling nauseous; Was a little warm on her arms/ it was warm to the touch; it just looked like a bee sting and it wasn't super sore; sensitive to the touch; It had big red spots; had a little tiredness; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 16Apr2021 at 10:00 (at age of 60 years old, Lot Number: EW0ISO) as single dose for covid-19 immunization. Medical history included she had lupus, sjogren's syndrome. The patient's concomitant medications not reported. The patient previously took Pneumonia Vaccine on 04Mar2021 (Anatomical Location: Left arm); took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 at 10:00 (at age of 60 years old, Lot Number: the lot number starts with ER something and then it ends with a 3) as single dose for covid-19 immunization; took azathioprine for lupus and had allergic reaction; took belimumab (BENLYSTA), subcutaneous from an unspecified date (Lot Number: PV7G; Expiration Date: Jun2023, NDC: 49401-088-01, Number on the side: 0147098) to an unspecified date, self injection once a week for lupus. She gets it through the VA and it is subcutaneous use and the manufacturer is company. she was immunocompromise, she had lupus, so she was off of her medication (BENLYSTA) for a month per the CDC guidelines. She wanted to let Pfizer know that as well. For her first COVID vaccine she was originally scheduled to go 6 to 7 days after she had her pneumonia shot and they told her that she would have to wait 2 weeks before having her COVID shot and she did. Other than that she had followed the guidelines and she had been able to take her regular medications but she had to stop her Benlysta because of her immune system and everything. She had been following through on what the CDC has said. Patient stated that she just did a follow up with her doctor because of what happened after her second Pfizer COVID vaccine and her doctor recommended her to let Pfizer know about the side effects that she was having. On Friday 16Apr2021 she had her shot at 10 AM and it was no big deal, it was a little warm on her arms. She stated that it just looked like a bee sting and it wasn't super sore, it was warm to the touch and sensitive to the touch. It had big red spots and there has really been no change since it began. It looks about the size of a bee sting and it was still there. She had a little tiredness and she was not hungry but when she woke up at 06:40 the next morning (17Apr2021) on Saturday she was having severe dry heaves and vomiting bile and she could not get it under control. It had dehydrated her and she was having severe muscles aches. She had the severe dry heaves and the vomiting that lead to dehydration and then she went to the emergency room and she got replenished and they had given her something for feeling nauseous and eventually she was released 3 to 4 hours later. They gave her pills as well so she was doing well now and she hasn't done anything since she went to the emergency room with the vomiting and feeling nauseous. She went there about 1030 to 1040. Before she went she couldn't stop and she told herself that if it didn't stop on the 5th time then she was going to go to the emergency room and it got really bad so she had to call 911 to come and get her. Then she was having severe diarrhea on Sunday (18Apr2021) and the only way she could stop that was for her husband to pick up antidiarrheal pills. That only went away because of the medicine from the pharmacy. She had the over the counter medicine and she took Imodium. She hasn't been eating a lot so she hasn't had a bowel movement since she took that medication. When she had diarrhea there was no substance, it was very watery. And now today (unspecified date) she was having another reaction that she was seeing and it was just itching on her hands and her feet. She had been continuing to take the Benadryl and something that they gave her in the emergency room and she had taken Tylenol for the little headache that she has had. She had a slight headache and she was still taking Tylenol like they had recommended. This began the same time as she was vomiting on 17Apr2021 when she was going through all of that she had the slight headache. But her biggest concern was during this time when initially on Saturday (17Apr2021), her throat closing up and it being sore from vomiting and dry heaving, she was having the dry heaves her airway closed shut and she couldn't swallow to get any fluids in. Her concern was that the back of her throat was killing her and it was totally closed up so she had to go to the emergency room. She had recognized this because in the past she has had a medication where she had an allergic reaction (she thinks it is the medication that they gave her for lupus because she has been on several different things. She thinks azathioprine but she can't recall exactly but she thinks that might of been the one that did it to her) and it had closed her esophagus up the same way like this. This time it got worse to where she couldn't even swallow water no less a pill. This was on 17Apr2021. When she went to the emergency room they gave her the hydrocortisone to take it down and she actually had felt better while she was waiting for the saline drop. She was able to swallow when her airway was opened again by the time they treated it with the hydrocortisone. Around 16:00 she was better when she left the emergency room that same day 17Apr2021. She doesn't really have a sore throat, it is pretty fine. It seems to be okay she thinks that once the dry heaves and all that stopped it helped to relax that. She was a little raspy from the whole thing and she was struggling with having a dry mouth but that even had been resolved as far as her throat. She had no other reactions than what she explain but she also had a lot of muscles pain but that was to be excepted because it says that on all that she has read. She had had all of the reactions listed except for fever. She had had chills and then when clammy and then was clammy and had chills. She had all of those side effects listed on the sheet and when she went on Saturday following her vaccine to the emergency room most of the side effects were treated in emergency room. They gave her Pepcid, hydrocortisone through her IV and gave her Zofran for the vomiting and they said to keep taking acetaminophen. They gave her cetirizine for allergy or the itching or whatever and they also gave her famotidine which she thinks is Pepcid. Since being off the lupus drug she was getting her symptoms again such as sensitivity to light, inflammation and the dry heaves didn't help so under her eyes it was swollen and she just takes it as it was because she was not on her medication and she had something else injected inside of her. Also, she had Sjogren's disease too so her eyes were already drier than normal and she had had puffiness since 17Apr2021 when she was vomiting. She just wanted to make sure that Pfizer got that information because she didn t see that listed. The only side effect she was related was the swollen glands and she has glands in her throat but she wanted to be sure that Pfizer had that data just in case if it could help someone else. Again, she wants to reiterate that with her first dosage she had no problems. She couldn t even see the mark and all of this is stemming from the second dose of the COVID vaccine. The outcome of the events "Dry heaves, Bilious vomiting, Dehydration, Her throat closing up and it being sore from vomiting and dry heaving, Unable to swallow, Dry mouth, Nauseous" was recovered on 17Apr2021. The outcome of events "Feeling of warmth, Vaccination site pain, Hyperaesthesia, Vaccination site erythema, Tiredness" not recovered. The outcome of the event "Headache" was recovering. The outcome of other events was unknown. No follow up attempts are needed. No further information is expected.
60 2021-05-07 nausea High fever of 107.5 degree Fahrenheit; Dizziness; Nausea; Headache; Fatigue; Joint and muscle pain; ... Read more
High fever of 107.5 degree Fahrenheit; Dizziness; Nausea; Headache; Fatigue; Joint and muscle pain; Joint and muscle pain; Blurred vision; Persistent cough; My glands started hurting; My ears hurt specially on the right where the shot was given everything is the worse; Sore throat; Jaw pain; my neck under my chin is swollen and painful; my neck under my chin is swollen and painful; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; This is a spontaneous report from a contactable consumer(patient). A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW016) via an unspecified route of administration in right arm on 19Apr2021 at 17:15 as SINGLE DOSE for covid-19 immunization. Patient was 60 years old at the time of vaccination. Medical history included rheumatoid arthritis, COPD, chronic empyema, asthma, chronic bronchitis, gastritis, irritable bowel syndrome, blood pressure high and digestive disorder, all from an unknown date and unknown if ongoing. Concomitant medications included quetiapine fumarate (SEROQUEL), POTASSIUM CHLORIDE, albuterol sulfate (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), FLUNISOLIDE, FLUOXETINE, HYDROCHLOROTHIAZIDE, IPRATROPIN, METOPROLOL, MONTELUKAST, PANTOPRAZOLE, FAMOTIDINE and LOSARTAN, all taken on unspecified date for unknown indication. In Apr20, the patient had high fever of 107.5 degree fahrenheit, dizziness, nausea, headache, fatigue, joint and muscle pain, blurred vision, persistent cough, my glands started hurting, my ears hurt specially on the right where the shot was given everything was the worse, sore throat, jaw pain and neck pain, my neck under my chin is swollen and painful, abscess in my gum and swelling and blisters in my mouth. On unspecified date, the patient underwent lab tests and procedures which included body temperature 107.5 degree F, blood test which she does every year and she had a follow up every 6 months. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
60 2021-05-07 nausea 12 hours after the 2nd injection I developed sudden severe nausea that lasted 24 hours non-stop. I w... Read more
12 hours after the 2nd injection I developed sudden severe nausea that lasted 24 hours non-stop. I was also very thirsty and had chills. The nausea stopped as suddenly as it started but I had fatigue for a few days afterward. I had slight left arm pain. I had fatigue for several days after I recovered from the nausea.
60 2021-05-09 abdominal discomfort Positive Covide`19 on 5/7/2021 Symptoms: c/o sinus congestion, productive cough, stomach" feels lik... Read more
Positive Covide`19 on 5/7/2021 Symptoms: c/o sinus congestion, productive cough, stomach" feels like I'm getting diarrhea," subjective fever, HA, chills, body aches started with morning. Temp 99.6 now,
60 2021-05-09 abdominal pain, decreased appetite Immediate feeling of pain that shot down arm of left arm ("tendonitis-feeling") after receiving vacc... Read more
Immediate feeling of pain that shot down arm of left arm ("tendonitis-feeling") after receiving vaccine. Developed odd lower back and abdominal cramping 4 days later accompanied with loss of appetite. Provider thinks possible colitis but unsure.
60 2021-05-10 nausea nausea. patient counseled to see PCP. Pt. declined further eval by EMS and hospital transport.
60 2021-05-10 nausea After 15 minutes, lightheaded as ready to leave. Is DM, BS 126 before came; ate lunch; takes 75U. BP... Read more
After 15 minutes, lightheaded as ready to leave. Is DM, BS 126 before came; ate lunch; takes 75U. BP 100/60--bit low for her; pulse 80, pulse ox 98. No hives, itching, trouble breathing. Monitoring, gave water, juice, cracker. BP 118/60. Still lightheaded plus nausea. Rapid response; agreed to be monitored in ED; went by cart.
60 2021-05-10 retching, vomiting, diarrhea, nausea Chest pain and couldn't hardly breathe and hard to get up off the bed; Chest pain and couldn't hardl... Read more
Chest pain and couldn't hardly breathe and hard to get up off the bed; Chest pain and couldn't hardly breathe and hard to get up off the bed; Sweats; Hot and Cold; Chills; Sweats; Hot and Cold; Chills; Sweats; Hot and Cold; Chills; Body Aches where can't walk; Body Aches where can't walk; Fatigue; Nauseated and Can't Eat; Vomiting Dry Heaves; Nauseated and Can't Eat; Vomiting Dry Heaves; Nauseated and Can't Eat; Vomiting Dry Heaves; Nauseated and Can't Eat; Vomiting Dry Heaves; Dehydrated and Dry Mouth and Mucous; Dehydrated and Dry Mouth and Mucous; Dehydrated and Dry Mouth and Mucous; Fever 102F; Weak and Can't Hardly Walk; Diarrhea; Blurred Vision in Both Eyes; Right Arm Pain; Headache; Lightheadedness; flu bug, virus in her body; This is a spontaneous report received from a contactable consumer (patient). A 60 years old female patient received the first dose of bnt162b2 (Pfizer COVID 19 vaccine) via unspecified route of administration in right arm on 09Apr2021 09:10 AM at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as no. No history of all previous immunization with the Pfizer vaccine considered as suspect ad no additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. No family medical history. The patient experienced diarrhea on 18Apr2021, blurred vision in both eyes on 18Apr2021, sweats; hot and cold; chills on 19Apr2021, body aches where can't walk on 19Apr2021, really bad fatigue on 19Apr2021, nauseated and can't eat; vomiting dry heaves on 19Apr2021, dehydrated and dry mouth and mucous on 19Apr2021, fever on 19Apr2021, weak and can't hardly walk on 19Apr2021, chest pain and couldn't hardly breathe and hard to get up off the bed from 20Apr2021 to 20Apr2021, right arm pain from 09Apr2021 to 12Apr2021, headache from 09Apr2021, lightheadedness comes and goes from 09Apr2021. Right after the shot her headache started and the soreness in the arm. The patient stated she didn't know how to ride out her headaches, they were so severe like bricks in her brain. For diarrhea, the patient stated it is like water and she is going to the bathroom right now. For Nausea, the patient stated if she eats or drinks anything she is throwing up, further clarifies that nothing comes up but dry heaves. For fever, the patient stated her temperature was 102F 19Apr2021 night, 100F 20Apr2021 morning, and it is 101F at the reporting time. The patient stated she had a cold rag on her forehead. For weakness, she has to use a cane to get up and move around because of the weakness. The patient received none treatment. The events did not require a visit to Emergency Room or Physician Office. The PCP stated he is treating it like flu bug and said she just has to ride it out. The patient stated she was supposed to go back for her second shot 28Apr2021, but she is hesitant because she can't take care of her children because she is sick. The patient stated she didn't know if she was going to take the second vaccine and didn't know what to do for her side effects. The patient asked, with these symptoms, if recommended she get the second shot, because it is like a virus in her body. The outcome of the events sweats; hot and cold; chills was resolving. The outcome of the event chest pain and couldn't hardly breathe and hard to get up off the bed, right arm pain was resolved. The outcome of the other events was not recovered. Diarrhea, blurred vision in both eyes worsened. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
60 2021-05-10 vomiting Fatigue; Started feeling sick again on 30Mar2021 and she could not move and ended up vomiting; start... Read more
Fatigue; Started feeling sick again on 30Mar2021 and she could not move and ended up vomiting; started feeling sick again on 30Mar2021 and she could not move and ended up vomiting; Vomiting/throwing up; Vomiting/throwing up; Rash; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 60 years old, administered in arm left on 29Mar2021 (Lot Number: ER8734) at single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus which diagnosed almost 10 years ago, obesity, sjogrens disease, knee replacements which done like 10 years ago on both knees and she did not know the exact dates of the knee replacements, asthma. Concomitant medications included loratadine taken for an unspecified indication from 13Mar2021 and ongoing; hydrochlorothiazide taken for sjogrens disease from an unspecified start date and ongoing; fluoxetine taken for an unspecified indication as antidepressant from an unspecified start date and ongoing; cetirizine hydrochloride (ZYRTEC) taken for asthma from an unspecified start date and ongoing; montelukast sodium (SINGULAIR) taken for asthma from an unspecified start date and ongoing. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 60 years old, administered in arm left on 08Mar2021 (Lot Number: EN6206) for covid-19 immunisation, and experienced sickness to her stomach, fibromyalgia flared up, heaviness in the muscle of her arm and vomiting within 24 hours after the vaccination. The patient also previously took shingles shot for immunization. The patient experienced vomiting/throwing up on 30Mar2021, rash on 30Mar2021, fatigue on an unspecified, started feeling sick again on 30mar2021 and she could not move and ended up vomiting on 30Mar2021. After the 2nd dose within 24 hours the patient started feeling sick again on 30Mar2021 and she could not move and ended up throwing up and got a rash that appeared on her left arm; stated she had both doses of the Pfizer COVID Vaccine in her left arm and the rash is a little above where the vaccine doses were administered. She had the 2nd Pfizer COVID vaccine on 29Mar2021 and has been coming in and out of feeling good and bad since then and for the rash she has she used the Triamcinolone Acetone cream and the rash seems to subside and then flares back up and when the rash flares back up she gets sick again. Stated the Triamcinolone Acetone cream is 0.1% with lot 0LT0435, expiry date Sep2022. She just got over this this weekend and was sick on Friday, was ok on Saturday and then on Sunday she could not move and was sick. The rash had gotten larger than when it first appeared and when it does flare it itches and was hot and she also has Sjogrens disease in that rheumatology thing and has had the shingles shot 2 years ago; states she has no name of the shingles shot to provide but had it 2 years ago in September. The patient stated this was not shingles and she had the shingles shot and this does not look like shingles to her. She stated she takes several different asthma medicines (cetirizine hydrochloride and montelukast sodium) and made the reported event not as severe and the rash is not as severe. The outcome of the event rash was not recovered, of the other events was unknown. No follow-up attempts are needed. No further information is expected.
60 2021-05-11 difficulty swallowing throat closed up and my tongue feels thick; throat closed up and my tongue feels thick; I couldn't ... Read more
throat closed up and my tongue feels thick; throat closed up and my tongue feels thick; I couldn't swallow; severe itching in the shot area; severe itching in chest area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0170) via unspecified route on right shoulder (right arm) unknown single for COVID-19 immunization on 23Apr2021 at 60-year-old. Medical history and concomitant medication were not reported. 15 minutes after the patient took the shot (23Apr2021), patient throat closed up and tongue felt thick, the patient couldn't swallow but the patient was medical services at the bin where the patient had the shot. After about 30 or 40 after minutes (23Apr2021), maybe 30 minutes after the shot, the patient started doing lot of itching, severe itching in the shot area in the shoulder in chest area, severe itching was given some diphenhydramine hydrochloride (BENADRYL) and it did a help so but still had itching in chest area. Outcome of the event severe itching in chest area was not resolved, outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.
60 2021-05-11 nausea, vomiting 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 2021-05-11 nausea Severe joint pain, mild nausea, lethargy, and Headache for 5 days. The headache still mildly persist... Read more
Severe joint pain, mild nausea, lethargy, and Headache for 5 days. The headache still mildly persists and I have no history of headaches.
60 2021-05-11 nausea 24 hours after second shot I had a sever migraine, nausea, pain in joints/bones, and fatigue. My lu... Read more
24 hours after second shot I had a sever migraine, nausea, pain in joints/bones, and fatigue. My lungs also had a minimal amount of pressure/discomfort
60 2021-05-13 difficulty swallowing My throat was itchy/my throat felt worse; My throat was itchy in between that half hour my voice sta... Read more
My throat was itchy/my throat felt worse; My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I am allergic to them/ Severe reactions and had to be hospitalized overnight; had problem swallowing a little bit and voice changes after talking; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Age at Vaccination 60 year), as single dose for covid-19 immunisation. Medical history of the patient included anxiety, depression, nerve pain, ongoing blood pressure (hypertension), change in personality and cardiac disorder. Concomitant medication of the patient included levothyroxine, atorvastatin calcium (cholestat [atorvastatin calcium]), pantoprazole, 1300mg fluconazole (Fluxizol), 81mg aspirin, lubiprostone (Amitiza), alpha lipoic acid, baclofen, linezolid (Zenix [linezolid]), centrum silver, 10mg rosuvastatin calcium (Crestor), 100mg docusate sodium (stool softener), amlodipine and magnesium oxide for blood pressure. Patient was on Benazepril HCTZ for heart, Pristiq for anxiety or depression, citalopram for pain (something to do with pain I can't remember), Effexor for Anxiety, Lexapro, Levaquin, and Sulfa for rashes. Patient got it from her bladder infection. Cyclobenzaprine (I can't remember), Gabapentin, change in personality and nerve pain. Metoprolol for heart. Patient was not taking any of these medications now she got several allergies from them. Patient had a lot of allergies. She was on lot of medications. But it was not what she was taking any these medications on the same, so she was like what was going on. Patient not taking the medication (Unspecified Medication), she was allergic to them, but she was taking other medication. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number, PF12ER6200), via an unspecified route of administration, administered in Arm Left on 22Feb2021 (Age at Vaccination 60 year), as single dose for covid-19 immunisation. On 15Mar2021, the patient had severe reactions and had to be hospitalized overnight. Within mild reaction for 15 minutes and within 40 minutes severe. Patient went to have it done at the hospital they walked her down to the ER they get to give her an epi Pen injection into IV." When again probed for the concern, Patient stated, she had it done at the hospital, they after 15 minutes her throat was itchy they may say another half hour in between that half hour her voice started to change and her throat felt worse they walk her down to the ER her throat was hurting then slowly they gave her Epi Pen and they injected in an IV with steroids. Patient had wheezing in her lungs and she spent the night in hospital for observation. Patient stated that she still had problem swallowing a little bit and voice changes after talking. Patient wanted to know it was like how she supposed to find out what she was allergic. Patient further stated, "Because she want to you know she need an update how was it bad so she want to had to go all this what she was allergic. Event outcome for the events swallowing difficult and for voice alteration it was not recovered and for other events it was unknown. Information about lot/batch number has been requested.
60 2021-05-14 nausea None stated.
60 2021-05-14 vomiting, abdominal pain, blood in stool This is a spontaneous report from a contactable consumer (patient). This 60-year-old female (no preg... Read more
This is a spontaneous report from a contactable consumer (patient). This 60-year-old female (no pregnant) patient received 2nd dose of BNT162B2 on 14Apr2021 03:45 PM on Left arm at single dose for covid-19 immunization. Medical history was Myasthenia Gravis. Past drug was allergies to Z pack. Historical Vaccine was 1st dose of BNT162B2 on 24Mar2021 03:45 PM on Left arm for covid-19 immunization. No other vaccine in four weeks. Other Medications in Two week included Olmesartan, Calcium. On the second day of the second dose of Pfizer (15Apr2021), she had the expected side effects, such as chills, muscle pain during the day. But, around 11 p.m. she suddenly started having abdominal pain, then throwing up, cold sweats, shivering, dizziness. She was taken to ER that night. The ER doctor did a CT, lab work but didn't find anything remarkable, so she was sent home. The next day (16Apr2021) she found blood in the toilet when she had bowel movement, so she went to see family doctor. He confirmed it's blood. He then set up an appointment for her to see a specialist the next Monday, since it's Friday afternoon. The bleeding got worse at night (16Apr2021), so she went to that ER again. She was then admitted to the hospital due to the big drop of red blood cell count. Later, the specialist did a colonoscopy on her and the result showed ischemic colitis. She was released from the hospital on 18Apr2021. This is very surprising to her as she had never had GI problems before. Events results in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (2 days). Outcome of the event was Recovering. No covid prior vaccination. No covid tested post vaccination. Information on the lot/batch number has been requested.
60 2021-05-14 vomiting SARS-CoV-2 test positive; Vomiting; She was still sick; This is a spontaneous report from a contacta... Read more
SARS-CoV-2 test positive; Vomiting; She was still sick; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 10:00 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization.There patient's medical history included blood clot.The patient's concomitant medications were not reported. The patient experienced sars-cov-2 test positive and Vomiting on 21Apr2021, she was still sick on Apr2021. Caller was calling about the Pfizer Covid-19 Vaccine. She was having a problem. She was due to schedule her second COVID Pfizer Vaccine on 03May2021. Caller states that she was still sick, she is still sick with it. She was going to go on 03May2021 but she was vomiting and she could not make it for her second shot. Now, she was trying to contact the place she went to which was care center in (With held). She did not have a number to call to reschedule. he lost her registration card. She did not know how to go about getting the second vaccine. Caller clarifies that she received her first dose of the vaccine three weeks ago this past Monday on 12Mar2021. Call handler clarifies infor-mation and caller asks what she said and then states she meant she received the first vaccine 12Apr2021. On 12Apr2021, caller received her first vaccine. On 21Apr2021, caller got a test for COVID and was diagnosed with COVID. Caller states they went to use urgent care on 21Apr2021 and her and her husband tested positive. caller does not provide address. Caller states that her husband has an e-mail address because she does not know how to use the computer. Caller states that it was okay to use this e-mail address. caller provides name and facility name, does not provide address or any contact information. Caller states she is not fully sure if that is the spelling of the doctor's name. Caller adds she was afraid to go to get her second vaccine because she was vomiting. Caller adds that she had vomiting a couple of times during - caller interrupts sentence - and states she had it but she does not have it no more. Caller adds she had vomiting on Monday and two other times but that was all. The last ten day, but she can not remember what days it was. Caller clarifies that she received a COVID-19 test and they put a swab in her nose. That was very uncomfortable. caller states she does not know. She misplaced her card and she can not find it. Her husband and her looked all over for it.Caller does not have any additional details. caller adds that she just wanted to get the COVID vaccine. She adds just so that she does not get sick. She was anxious to get it like everyone else was. She ended up getting sick. Caller adds she has never been so sick in her life and would not wish this on her worst enemy.Caller clarifies that she means with the vomiting. caller states she does not have any medical concerns. caller was not sure which COVID-19 test she received. Caller adds that she did not go to the emergency room. She went to an urgent care and does not know the name or contact information. She only knows that, she states she was just vomiting, They performed two culture and She had to wait 20 minutes and then they sent another one out. Caller confirms both were positive.Caller adds she was just concerned about where and when she can get her second shot. She wanted to see where she should go. The paper she was given is how she got Pfizer's number and that is where they wrote 03Mar2021 for her sec-ond dose. They did not give her local numbers or anything like that where she could go. Caller was advised that Pfizer cannot schedule appointments for the vaccinations. Caller states she was just glad she got to talk to a person and that she knows where to call. Caller advised to contact her physician or local health authority and states she will do so.The patient underwent lab tests and procedures which included culture: positive (they did two) on unspecified date, unspecified COVID19 test: positive on 21Apr2021.Therapeutic measures were taken as a result of sars-cov-2 test positive,vomiting she was still sick.the doctor just told her to take Tylenol. he has taken Tylenol. It was 500 mg tablets.The doctor she saw there also told her to take vitamins. She is now taking Vitamin C 1000 mg, zinc 50 mg, and Vitamin D3. Caller adds the Vitamin D3 is 50 mcg, whatever that means. The doctor also put her on a baby aspirin in case she gets a blood clot or something - like a low dose aspirin. Caller adds there is also one more thing, it is a probiotic.The outcome of she was still ill was not recovered and outcome of rest of the events was unknown. No follow-up attempts are needed. information about lot/batch number cannot be obtained.
60 2021-05-15 difficulty swallowing Patient reported symptoms ~ 2mins after receiving vaccine per administering clinician. Patient noted... Read more
Patient reported symptoms ~ 2mins after receiving vaccine per administering clinician. Patient noted to have coughing. Patient reported lip numbness and mild shortness of breath. Patient then continued to say that she was having difficulty swallowing. EMS was contacted. Patient awake, alert, oriented. Patient refused EPI administration at vaccine site. Patient taken by EMS to ED. Per medical record patient received IV antihistamines and steroids and was observed.
60 2021-05-15 nausea starting 1st day of injection pain at injection site and radiating up to shoulder with swe... Read more
starting 1st day of injection pain at injection site and radiating up to shoulder with swelling around the site area. Nausea . starting days 2 & 3 pains increased up further on left side of the arm to neck (left side only) , switched from taking Ibuprofen 800mg throughout the day after day 3 - 4 body aches and pains in left leg/thigh muscles , switched to Tylenol 1000mg everyday from day 1 rubbing down multiple time daily with rubbing alcohol , nightly alcohol with Epsom bath soaks. pains for about 2 weeks before relief. May 11 no pain just still tiredness . Yesterday and today believe all resolved .
60 2021-05-18 decreased appetite Twelve days after 1st covid vaccine dose profuse sweating and increased heart rate 148. Two days lat... Read more
Twelve days after 1st covid vaccine dose profuse sweating and increased heart rate 148. Two days later no energy or appetite and decreased exercise intolerance
60 2021-05-19 abdominal discomfort sensitive stomach. She reports that this can happen not only with the Pfizer vaccine; significant he... Read more
sensitive stomach. She reports that this can happen not only with the Pfizer vaccine; significant hearing loss; ringing in the ears; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 12Apr2021 (Lot number was not reported) as single dose (at age of 60-year-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. On unknown date in Apr2021 patient experienced significant hearing loss, ringing in the ears, also reported as ear ringing like crazy and lost significant hearing. On unknown date she experienced sensitive stomach (she reported that this can happen not only with the pfizer vaccine). Patient stated that after receiving the first dose of Pfizer COVID-19 Vaccine, 10 hours later she developed a ringing in the ears (also reported as her ears started buzzing like ringing like crazy) to which she has seen her health care professional (HCP) and an ear specialist and has under gone hearing tests and states "has significant hearing loss" to which she is on steroids to help, she would like to know if Pfizer had any documented cases on this and what she needed to do about this. She has been going to an ear specialist and he said that she lost significant hearing in that ear where she heard the noise. For treatment, they are doing an injection into her ear. She is still having to go for injections but it does not sound like anything. She researched the internet and there is a whole group of people who experienced this with the Pfizer and Moderna and the other vaccine. Patient added that a doctor did not want to give an opinion or say anything. They did not know if this was permanent or will go away. Patient stated that a lot of people are out there, there are a lot of people with the same problem. She does not know which vaccines they got. She is halfway vaccinated because she is afraid to take the second one. She read comments of people who took the second, and people say it was worse. They discussed with doctors that it should go away eventually. Some say it went away in 9 weeks, some still had the hearing problem and it is uncomfortable. Patient added that it is all day ringing in the air, in her left ear. She went to the emergency room because it was so unbearable, and they did not know what to do. Patient did not take any medications like she did not have any issues, no blood pressure or nothing. Patient said that she cannot take steroids by mouth because she has a sensitive stomach. She reports that this can happen not only with the Pfizer vaccine, it happened with people taking Moderna, Astra Zeneca and Johnson and Johnson reported that. It is all over the internet. A bunch of people are having this problem. Therapeutic measures were taken as a result of significant hearing loss and ringing in the ears. Outcome of the events was unknown. Patient skipped the second dose because she does not want to make it worse. Information on the lot/batch number has been requested.
60 2021-05-19 nausea, abdominal pain Abdominal pain and significant nausea, malaise
60 2021-05-19 nausea Since having COVID in November 2020 still experiencing shortness of breath and ringing in ears. Afte... Read more
Since having COVID in November 2020 still experiencing shortness of breath and ringing in ears. After the shot , Felt fine first day, next morning woke up nauseous and dizzy, achy in muscles , especially in legs, pain in knees. Worsen shortness of breath with even short distances . Ringing in ears louder and high pitched. Brain fog. Each day the symptoms got worse, more intense. By the 8th day, pain in muscles so bad , had to be helped to walk or use a cane. Breathing was gasp for breath within short distances.Stayed in bed for several days and muscle pain got better. Breathing got better.
60 2021-05-19 vomiting Pt also had received covid vaccine at~934am. Hx of HTN and DM (nonadherent to BP meds). then around ... Read more
Pt also had received covid vaccine at~934am. Hx of HTN and DM (nonadherent to BP meds). then around 9:57am, pt c/o be Vomiting, Diaphoresis, HA, Chest pain 3/10. Pt was offered by staff to call ED but pt decline. Pt will go to ED with family member for further evaluation. During ED visit, it was found by provider that patient has been out of her blood pressure medications for over a year. Pt was prescribed amlodipine and recommended for pt to follow-up with PCP at discharge
60 2021-05-23 nausea, abdominal pain upper, appendicitis appendicitis. Nausea for maybe the week prior, feeling tired, unwell. Sunday, May 2, 2021 at noon... Read more
appendicitis. Nausea for maybe the week prior, feeling tired, unwell. Sunday, May 2, 2021 at noon stomach pain. Moved into lower right side. Went to emergency department at 9 p.m. as pain was intense. CAT scan done. Inflamed appendix. Appendectomy done the next morning.
60 2021-05-23 vomiting, nausea naseaa, headaCHE, VOMITiNG, HEart paLPATIATIONS, BLURRY VISION, TIA
60 2021-05-25 diarrhea, vomiting Chills; fever; shaking; Diarrhea; vomiting; This is a spontaneous report from a contactable consumer... Read more
Chills; fever; shaking; Diarrhea; vomiting; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non pregnant female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no. EN6208) via an unspecified route of administration in the right arm on 12Mar2021(at the age of 60 years old as a single dose for COVID-19 immunisation. The patient's medical history not reported. Concomitant medications for an unknown indication. The patient did not have any allergies to medications, foods or other products. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19. On12Mar2021 The patient was experienced diarrhea and vomiting 15 hours after the vaccination which continued for 12 hours. The patient also experienced chills, shaking and fever that climbed to 102.7 from 24 to 48 hours after the vaccination. The patient also reported that it took another 48 hours for the fever to end. The patient did not undergo any lab tests and procedures. The patient had not received any treatment for the events Diarrhea, vomiting, chills and shaking were recovering and the event fever was recovered at the time of report. No follow-up attempts are needed. No further information is expected
60 2021-05-25 indigestion 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 2021-05-25 nausea Nausea; High fever 101; Mussel aches; This is a spontaneous report from a contactable consumer, the ... Read more
Nausea; High fever 101; Mussel aches; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200], as first dose via an unspecified route of administration, in left arm on 14Mar2021 at 01:00 AM (at the age of 60-years-old) as single dose for COVID-19 immunization. The patient's medical history included diabetic, ulcerative colitis and non alcoholic steatohepatitis (NASH) also the patient was allergic to Morifine. The patient was diagnosed with COVID-19 prior to vaccination. The patient received prescribed medicines (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021, the patient experienced high fever 101, muscle aches (reported as mussel aches) and nausea. The patient did not receive any treatment for the reported events. The clinical outcome of the events high fever 101, muscle aches and nausea were resolved with sequelae. No follow-up attempts are needed. No further information is expected.
60 2021-05-25 nausea Injection site pain; Nausea; Fever (unknown temperature); Chills; Body aches; Bad headache; This is ... Read more
Injection site pain; Nausea; Fever (unknown temperature); Chills; Body aches; Bad headache; This is spontaneous report from contactable consumer, the patient. A 60-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL3248), dose number 2, via an unspecified route of administration in the right arm on 15Mar2021 at 01:00 PM, (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown, whether the patient was diagnosed with COVID-19, prior to vaccination. Since the vaccination the patient was not tested for COVID-19. The patient had no current illness. Past drug history included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL3248), dose number 1 via an unspecified route of administration in the right arm on 22Feb2021 at 01:15 PM, as a single dose for COVID-19 immunisation. Medical history included allergy to ibuprofen and breast cancer. Concomitant medications included daily vitamin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), 81 mg aspirin (MANUFACTURER UNKNOWN) all for unknown indication. On 15Mar2021 at 01:00 PM, the patient experienced bad headache, body aches, fever (unknown temperature), chills, nausea and injection site pain. The injection site pain was minimized. No therapeutic measures were taken for the events. The clinical outcome of bad headache, body aches, fever (unknown temperature), chills and nausea were unknown. The clinical outcome of injection site pain was resolving. Action taken with BNT162B2 was not applicable No follow-up attempts are needed. No further information is expected.
60 2021-05-25 vomiting, diarrhea Tongue swelling, facial numbness, rash to both arms, tachycardia, headache, eye pain, elevated b/p 2... Read more
Tongue swelling, facial numbness, rash to both arms, tachycardia, headache, eye pain, elevated b/p 210/103, dizziness, and shaky. Epinephrine given with relief of swelling within 20 min. Two hours later reports vomiting and diarrhea.
60 2021-05-26 nausea no energy; Sore arm; spike of asthma; chills; tiredness; fever; body ache; headache; nausea; This is... Read more
no energy; Sore arm; spike of asthma; chills; tiredness; fever; body ache; headache; nausea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Lot /Batch Number: EN6205), Dose 2 via an unspecified route of administration on left arm on 04Mar2021 at 10:15 (at the age of 60 years) as a single dose for COVID-19 immunization. Medical history included heart attack, diabetes, obesity, asthma and Sulfa allergic. The patient's past medical history included BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot/Batch Number: EN6201) dose 1 on 13Feb2021 at 10:00 as a single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient took Nasal swab test for COVID-19 and was tested negative at 04Feb2021. Concomitant medications include Meloxicam ER (Manufacturer Unknown), Metformin (Manufacturer Unknown), Spironolac (Manufacturer Unknown), Pantoprazole (Manufacturer Unknown), Metoprolol tartrate (MANUFACTURER UNKNOWN), Atorvastatin (Manufacturer Unknown), Clopidogrel (Manufacturer Unknown), Losartan (Manufacturer Unknown), Montelukast (Manufacturer Unknown). The patient experienced no other adverse event except for sore arm until 11Mar2021. On 11Mar2021 around 03:30am it started with chills but moved on and would cycle through between chills, fevers up to 102.4, headaches, body aches, tiredness, spikes in asthma, nausea, and just an overall feeling of feeling bad and 6 days later the patient feels ok, just no energy. Patient not taken any treatment for reported events. Therapeutic outcome of reported events was recovering at the time of report. No follow-up attempts are needed. No further information is expected.
60 2021-05-26 nausea It was swollen up pretty big/My arm swelled up. It almost looked like I had a big muscle; Feeling re... Read more
It was swollen up pretty big/My arm swelled up. It almost looked like I had a big muscle; Feeling really sick; Her arm was hurting/Sore arm; I did have COVID, the virus; Slight headache; Weak; I don't even feel that well right now with the first shot; So I think this was an allergic reaction to the medicine because its not real clear; She was pale and dizzy/kind of dizzy; She was pale and dizzy; Nauseated; She's tired/I just feel tired; I just feel like I am dragging; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0176) dose 1 via an unspecified route of administration in the left arm on 04May2021 (at the age 60 years old), as single dose for COVID-19 immunization. The patient's medical history included patient had a pulled tendon for which she was wearing a boot, hypothyroidism for which the patient was taking Synthyroid since 1991, COVID-19 in Dec2020 and was sick from Dec2020 to Jan2021, it took patient a month to get over it. The patient's concomitant medication included Diclofenac Sodium delayed release tablets 75mg, two times a day for 2 pulled tendons in her foot. On 05May2021, patient's arm was hurting/Sore arm. On 06May2021, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle, feeling really sick. On an unspecified date in May2021, patient did have COVID, the virus, patient was pale and dizzy/kind of dizzy, felt nauseated, tired/ just feel tired like patient was dragging, slight headache, weak, patient didn't even feel that well right now with the first shot and patient thought that this was an allergic reaction to the medicine because it was not real clear. Patient was started on Diclofenac Sodium 75mg two tabs daily- started on Tuesday, the same day she got her Pfizer Vaccine. On an unspecified date, patient had ultrasound of the leg to check for clots, but she did not have any. The patient reported that her arm was still really sore, and she was not as nauseous and pale as she was last night but then was tired and slept all night. She just felt tired. The patient did not receive any treatment for the adverse events. Patient wanted to know if this could be a reaction between the medication (Diclofenac Sodium) and the vaccine and also wanted to know if she was allergic to something in the vaccine and how many days side effects might last, patient did not know anyone who got sick after the first dose. Patient was scheduled for the second dose of the vaccine on 26may2021. Outcome of the pale and nauseated was recovering, patient's arm was hurting/sore arm, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle not recovered was not recovered while for the other events was unknown. Patient reported that her 83-years-old mother got Moderna and her arm was a little sore after the first dose and nothing after the second shot. No follow-up attempts are needed. No further information is expected.
60 2021-05-26 vomiting, diarrhea, nausea allergic reaction; she couldn't get warm; chills; rash all over; swelling in her arms and legs; diar... Read more
allergic reaction; she couldn't get warm; chills; rash all over; swelling in her arms and legs; diarrhea; Extremely tired; headache; Nausea; her blood pressure was taken and it was 165/40.; her blood pressure was taken and it was 165/40.; throwing up; dizzy; Numb on body on right side; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 1 via an unspecified route of administration, administered in arm left on 04May2021 08:30 (Lot Number: EW0172) as 1st dose, single for covid-19 immunisation. The patient medical history was reported as none. There were no concomitant medications. Patient had investigation assessment. No additional administered vaccines. No Prior vaccinations within 4 weeks. The patient had an allergic reaction to the first dose of the Pfizer covid 19 vaccine and wanted to know if she should take the other one. The patient had throwing up, numb on body on right side, dizzy, nausea on 04May2021; headache and extremely tired on 05May2021; diarrhea on 06May2021; rash all over, swelling in arms and legs, chills on 08May2021; her blood pressure was taken and it was 165/40 mmHg on 04May2021, she couldn't get warm on an unspecified date. Events did not require a visit to emergency room or physician office. The outcome of events rash all over, swelling in arms and legs, chills was not recovered; event throwing up was recovered on 04May2021; numb on body on right side was recovered on 06May2021; events diarrhea, headache and extremely tired was recovered on 07May2021; events dizzy and nausea was recovered in May2021; of other events was unknown.
60 2021-05-28 difficulty swallowing 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 nausea This vaccine triggered my meniere?s. It has proceeded to to get worse. I have been dizzy now for 4 w... Read more
This vaccine triggered my meniere?s. It has proceeded to to get worse. I have been dizzy now for 4 weeks along with a headache and nausea. It is very debilitating and cannot continue to cope this way. I need to get back to a normal life.
60 2021-05-30 abdominal pain Server abdominal pain around incision area. Cat scan revealed nothing wrong. Gabapentin prescribed f... Read more
Server abdominal pain around incision area. Cat scan revealed nothing wrong. Gabapentin prescribed for the pain. Systems disappeared 4 weeks later
60 2021-05-31 nausea body and headache; chills; body and headache; low grade fever; nautiated for 48 hours; Very weak for... Read more
body and headache; chills; body and headache; low grade fever; nautiated for 48 hours; Very weak for 2 days after.; This is a spontaneous report from a contactable consumer (Patient). A 60-year-old non pregnant female patient received second dose of BNT162B2 (Formulation: Solution For injection, Batch/Lot Number was not reported) via an unspecified route of administration, administrated in left arm on 17Feb2021 as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. The concomitant medications included in two weeks Lisinopril was taken.No known allergies.The patient previously took first dose of BNT162B2 (Formulation: Solution For injection, Batch/Lot Number was not reported) via an unspecified route of administration, administrated in left arm on 28Jan2021 13:30 as 1ST dose, single for COVID-19 immunization and experienced chills, headache and 101 fever. Took some Ibprofane temp went down and was fine the next day. 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.On 17Feb2021, the patient experienced with 8 hours later, chills, body and headache, low grade fever and nauseated for 48 hours. very weak for 2 days after. No treatment was received for the events. The outcome of the events was recovered in Feb 2021. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
60 2021-06-02 abdominal discomfort, appendicitis One week later (overnight Apr 18/19) I woke during the night with fever (highest 101F) and lower rig... Read more
One week later (overnight Apr 18/19) I woke during the night with fever (highest 101F) and lower right side abdominal pain. I called my primary care dr on Apr 19 at 10.15am. Due to prior history of intestinal surgery and resection July and Aug 2015, Dr advised me to go to Hospital ER for a CT scan. During some 7 hours in the ER, blood work, urinalysis, EKG and CT scan were done. The urinalysis showed possible UTI (though no other symptoms) and appendicitis was suspected from the CT scan. I also got a migraine during the hours in the ER. IV antibiotics and med for migraine were started and I was moved to a room. I saw surgeon and his team over the next two days. Another CT scan - with contrast drink - was done on Apr 20, and from this Dr advised the inflamed appendix was visible. Again due to my prior abdominal surgery and potential scar tissue Dr advised that removing the appendix in this state was at a bit higher risk. He suggested continuing IV antibiotics in the hospital for 48hrs and if the appendix responded well to finish oral antibiotics at home and then schedule appendectomy in approximately 6-8 weeks. This is now the plan. I am going for another CT scan with contrast drink next week in advance of potential appendectomy the week of June 14.
60 2021-06-02 abdominal discomfort Upset stomach; Sore arm; Headache; Tired; This is a spontaneous report from a contactable consumer, ... Read more
Upset stomach; Sore arm; Headache; Tired; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 16Mar2021 at 11:15 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 23Feb2021 at 11.45 as a single dose for COVID-19 immunisation. Concomitant medication included Celebrex for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient was not diagnosed with covid-19 prior to vaccination. Since the vaccination, patient had not tested positive for COVID-19. On 16Mar2021 at 19.00, patient experienced sore arm, headache, tired, upset stomach. Clinical outcome of the events sore arm, headache, tired, upset stomach was recovering. No follow-up attempts are needed. No further information is expected.
60 2021-06-02 vomiting, diarrhea 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 2021-06-03 difficulty swallowing odd sensation in her mouth; difficulty swallowing; mouth full of saliva; Her face, neck and chest we... Read more
odd sensation in her mouth; difficulty swallowing; mouth full of saliva; Her face, neck and chest were all very red and flushed; Her face, neck and chest were all very red and flushed; This is a spontaneous report from a contactable consumer (patiemt). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration on 04Mar2021 13:00 (at the age of 60-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included shellfish allergy from 2011 and ongoing (patient had an Epi-pen prescription on her patient portal information but she has never filled or used that prescription), pneumonia in 2017 and 2018 (occurred 2 years in a row, probably around 2017 and 2018), bronchitis from 2016 (one year bronchitis without Pneumonia, may have been 2016), prediabetic (Onset date: Probably 2015), obesity (Onset Date: Probably 2000), compromised immune status, blood pressure and thyroid. Concomitant medications included lisinopril taken for blood pressure from 2016 and ongoing; atenolol taken for blood pressure from an unspecified start date and ongoing; amlodipine taken for blood pressure from an unspecified start date and ongoing; hydrochlorothiazide taken for blood pressure from an unspecified start date and ongoing; levothyroxine taken for thyroid from 2016 and ongoing. On 04Mar2021 about at 13:50 the patient experienced odd sensation in her mouth, difficulty swallowing, mouth full of saliva, and her face, neck and chest were all very red and flushed. The patient stated that it was a slight reaction. The patient reported that she received her first dose of Pfizer COVID-19 Vaccine on 04Mar2021. She waited the 30 minutes and then left. As she was driving home felt she felt an odd sensation in her mouth, had difficulty swallowing and her mouth filled with saliva; so she pulled over and she looked in the mirror she was all red, her face, neck and chest were very flushed. She just did some breathing and tried to relax. She called her doctor and waited to hear back from her but didn't yesterday. She tried to drink water and just relax; she did not feel like she had to go to the emergency room. Her doctor got back to her today and had a teleconference. The patient did not have other vaccinations within four weeks prior to the first administration. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
60 2021-06-07 diarrhea Hypersensitivity; I feel like I have a arthritis like rheumatoid arthritis in my hands; little tende... Read more
Hypersensitivity; I feel like I have a arthritis like rheumatoid arthritis in my hands; little tender on the arm; little tender on the arm and it is swollen and little itchy; itchiness on the arm; little tender on the arm and it is swollen and little itchy; itchiness on the arm/ feet are swollen; mild chills; body aches; weird muscle; fatigue; Diarrhea; had marking on my legs actually in elbow area; had like ulcers in my mouth; I lost in the meantime, currently now I am 108 pounds; Bone Ache; blistering in the mouth; blisters; sandpaper like rash on the hands and the feet's; mild rash and itchiness on the arm; This is a spontaneous report from a contactable consumer reported for self. This 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 17Feb2021 Arm Left at the age of 60-year-old as 2nd dose, single (Lot # EN6201) for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Anatomical location: Left Arm for covid-19 immunisation. The patient had it, 2nd one was then on 17Feb2021, 10 days later had a guess what you call hypersensitivity because that is the thing can relate to and the they had at the urgent care (emergency room visit) and then the hospital (further not clarified) because had therapy in multiforme. Symptoms on 27Feb2021 and then had gone through an urgent care that following Tuesday and Thursday went back. So, thought it was from that. She had the initial little tender on the arm and it is swollen and little itchy and then had mild chills and body aches initially and did not take, that is better than other people are having with headaches and everything else but it was 10 days later that had this multiforme beginning of this blisters (27Feb2021), sandpaper like rash on the hands and the feet's (27Feb2021), blistering in the mouth (27Feb2021) and had that everything multiforme all over body it is in neck and head. After the 2nd shot on 17Feb2021. She have been mild rash and itchiness on the arm and then little bit of mild chills and mild body ache, it was nothing serious or anything took a steroid and then 10 days later have little bit of sensitivity on index finger and middle finger and then from the next day had marking on legs actually in elbow area, thought it was mosquito bit because of the experienced of itchiness and then it progressed and migrated upward had sandpaper and blisters on face, hands and feet. The rash was on under, it progressed from the ankle and up through the shoulder and had the blister and sandpaper, rash feeling on hands and on feet and then had like ulcers in her mouth. She also had weird muscle and bone aches, body aches and fatigue and diarrhea and everything but she still had she felt like she had a arthritis like rheumatoid arthritis in hands and feet are swollen. She lost in the meantime, currently now was pounds. Treatments included a corticosteroid shot (Further not clarified) and took steroid for the 5 days at the hospital (further clarification unknown) they give her the shot, corticosteroid shot and then took the pills for the 5 days. Outcome of the events was unknown.
60 2021-06-08 decreased appetite, nausea 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 vomiting, diarrhea 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 2021-06-09 nausea, vomiting Approximately 10 minutes after receiving vaccine, patient became very hot and sweaty, nauseous, and ... Read more
Approximately 10 minutes after receiving vaccine, patient became very hot and sweaty, nauseous, and dizzy. We laid her down flat on the floor with a pillow and got her some water. We checked her blood pressure, and it was approximately 90/58. Patient says her BP usually runs very low. She stated she had just been for a 4 mile run in 90+ degree heat, had not eaten much that morning, and had not drank much water. After about 20 minutes, she began vomiting. After about 40 minutes from time of vaccine, her son picked her up and took her to a nearby ER at her request. I called her the following day, and she had recovered.
60 2021-06-09 vomiting, nausea Superficial thrombophlebitis of the forearm distal to injection site. Persistent nausea and vomitin... Read more
Superficial thrombophlebitis of the forearm distal to injection site. Persistent nausea and vomiting following injection
60 2021-06-12 constipation, abdominal pain, diarrhea 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 nausea, vomiting Severe headache, vomiting, nauseous, swollen arm
60 2021-06-15 nausea 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 diarrhea, nausea Really bad headache; Nauseous; Diarrhea; Maybe she was hyperventilating; She's feeling a little sick... Read more
Really bad headache; Nauseous; Diarrhea; Maybe she was hyperventilating; She's feeling a little sick; Having a problem breathing a little bit; 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 VACCINE, solution for injection, Lot Number: EW0181), via an intramuscular route on 08Jun2021 at 10:45 (at the age of 60-years) as single dose in the right arm for covid-19 immunisation. The patient's medical history included high cholesterol, temporal arteritis. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atorvastatin (LIPITOR) with dose 20 mg, daily for high cholesterol, Fish Oil with dose 2000 mg, daily for unspecified indication, venlafaxine hydrochloride (EFFEXOR) with dose 150 mg, daily for depression. The patient previously took Prednisone for temporal arteritis since 24Dec2020 and she had been holding off on getting the COVID 19 vaccine until she was taking a lower dose of the Prednisone. She's taking 8mg of Prednisone. The Prednisone is in a pharmacy bottle. The Prednisone 5mg tablet is in a yellow pharmacy bottle. She took her Prednisone every day at 2:30PM. Her doctor told her on 07Jun2021, that she was ok to get the COVID 19 vaccine. She was taking 60mg of Prednisone but she's weaning off of the Prednisone. She has gained weight while taking the Prednisone. On unspecified date at 14:30 (4 hours after vaccination), the patient experienced really bad headache, nauseous, having a problem breathing a little bit, maybe she was hyperventilating and She's feeling a little sick. She had diarrhoea when she first got home after getting the COVID 19 vaccine. She's scared. She hadn't reached out to her doctor or gone to the emergency room. She doesn't wanted to got the COVID 19 virus. She was been quarantined for a year. Patient reported that she took Ibuprofen and her headache is going away. She thinks she's feeling better now. She's still a little nauseous. And her breathing, maybe she was hyperventilating because of the nausea. She is starting to feel better. The outcome of the events really bad headache, breathing, maybe she was hyperventilating was recovering and other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
60 2021-06-16 indigestion, vomiting, diarrhea Seven hours after the vaccine I began vomiting, followed by diarrhea and indigestion that lasted for... Read more
Seven hours after the vaccine I began vomiting, followed by diarrhea and indigestion that lasted for two days May 28th and 29th 2021.
60 2021-06-16 nausea feeling like legs were made of jello.; Very hot; flushed face; weak; Merely nauseated; This is a spo... Read more
feeling like legs were made of jello.; Very hot; flushed face; weak; Merely nauseated; 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: EN6203), via an unspecified route of administration in the left arm on 05Mar2021 at 12:45 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included hashimoto's thyroiditis. Patient had allergies to penicillin. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN) for an unknown indication. On 05Mar2021 at 13:30, patient experienced very hot, flushed face and weak and feeling like legs were made of jello. This lasted for approximately 3 hours. On 05Mar2021, patient experienced merely nauseated. On 17Mar2021, patient underwent lab tests nasal swab (PCR) and result was negative. No therapeutic measures were taken for the reported events. The clinical outcome of the events very hot, flushed face and weak, feeling like legs were made of jello and merely nauseated was recovered/ resolved on 05Mar2021. No follow-up attempts are needed. No further information is expected.
60 2021-06-17 diarrhea When she took her Pfizer vaccine on 5/29/2021, she had a feeling of pressure around her heart that m... Read more
When she took her Pfizer vaccine on 5/29/2021, she had a feeling of pressure around her heart that made her anxious on Day 2 and Day 3, Lymph node under her left arm was swollen the size of a credit card for Days 3 & 4 post vaccine. Had a fever on Day 4 & 5 after the Covid Vaccine. Would wake up in the night with her bed soaked with sweat and she would have to change her clothes. She had a horrible smell in her nostrils. Had diarrhea.
60 2021-06-18 diarrhea, abdominal pain upper Stomachache; diarrhea very liquid stools; Feel flu like symptoms; Achy; Chills; Very sleepy; This is... Read more
Stomachache; diarrhea very liquid stools; Feel flu like symptoms; Achy; Chills; Very sleepy; This is a spontaneous report from a contactable Consumer, the patient. A 60-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown) (at the age 60 years) via an unspecified route of administration, on the left arm, on 18Mar2021 at 13:30 as a single dose for COVID-19 immunisation. The patient medical history includes diabetes, high blood pressure, thyroid and glaucoma. Concomitant medications include Bystolic [MANUFACTURER UNKNOWN], amlodipine [MANUFACTURER UNKNOWN], synthroid [MANUFACTURER UNKNOWN], allopurinol [MANUFACTURER UNKNOWN], and spiron [MANUFACTURER UNKNOWN], for unknown indications. The patient was allergic to Pineapples, stations and ceclore. 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 not been tested for COVID-19. On 19Mar2021 at 10:00 AM, the patient experienced achy, chills, diarrhoea very liquid stools, flu-like symptoms, stomach-ache and very sleepy. No treatment was received to treat adverse events. The clinical outcome of the events stomach-ache, watery diarrhoea, flu-like symptoms, ache, chills, and sleepy was reported as not resolved at the time of reporting. Information about lot/batch number cannot be obtained. No further information is expected.
60 2021-06-18 vomiting, abdominal pain upper Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; Within 1 ho... Read more
Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; Pain in the right side of her leg and in her stomach; Caller stated she has been vomiting mainly from the draining that is choking her.; Throat tightened up and glands swell; Barely able to breath, shortness of breath; Pain in right side, below her breast; Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; She was so sick; Caller stated she has been vomiting mainly from the draining that is choking her.; Headaches; Pain in the right side of her leg and in her stomach; Burning in her chest and throat/ pain was in the right side of the chest; Burning in her chest and throat/ throat has been like its on fire; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 02Jun2021 (Batch/Lot Number: EW0177) as 1ST DOSE, SINGLE for covid-19 immunisation. Time the Vaccination Was Given: Between 12:00 and 1:00pm. Medical history included when she was a child, she had bronchial asthma. Has not had any problems in years. Prior Vaccinations (within 4 weeks): No, has been years. Has not even had the flu shot in 3 years. The patient's concomitant medications were not reported. Caller stated she had the first dose of the Pfizer covid 19 vaccine and stated she is having a reaction. Caller stated it feels like she has covid. Caller stated she got the vaccine 3 days ago and within 1 hour had tightness in her chest, wheezing and her throat started to tighten up. All she could do was wheeze. Her throat started tightening up and her glands started swelling. Caller stated she then had draining down the back of her throat. Caller reported burning in her chest and throat. Caller reported pain in the right side of her leg on 02Jun2021 and in her stomach. Caller stated she has been vomiting on 02Jun2021 mainly from the draining that is choking her. Caller stated she is still draining but not vomiting. Caller reported she is having headaches. Caller was concerned about what she should do, go to her doctor or go to the ER. Caller wanted to know how long the symptoms should last. Caller stated she is 52 hours out from the vaccine, Throat tightened up and glands swell, Barely able to breath, shortness of breath, pain on 02Jun2021. She was so sick. She was barely able to breathe within an hour and has been in pain. It is now a struggle, with shortness of breath. Her throat has been like its on fire, and lungs filled with a huge amount of drainage in the back of her throat. Is having right leg pain and pain in her stomach. It is not severe pain, but there is some pain there, is having a lot of burning sensation with the drainage. It now feels like she has Covid now. She read in the paperwork that this could not cause Covid. She was perfectly fine when she had the vaccine. She has no allergies. Does not know what to do. It has been 48 hours. She was perfectly fine until an hour later. She contacted the pharmacy and they didn't do anything. She then contacted this number to report this. Her biggest concern was the severe drainage. There were globs of drainage down the back of her throat. Her chest tightened prior to that and she was wheezing. She has not had bronchial asthma since she was a child. Has had no flus, or nothing. Had the pain after the burning in her chest, the pain was in the right side of the chest. Pain in right side of leg: Hasn't stopped completely. Still has pain in the right leg and in the chest. It is barely any better. It is probably because it is in one spot in the calf on her right leg. The pain in the right side, below her breast. The pain seems to be in the right side. Pain in stomach: Seems to be both sides. Has gotten better some, in the stomach. Vomiting: Was vomiting from all the drainage, it was choking her. It started within 2 hours. She is still experiencing the drainage, but not the vomiting. Has also been experiencing headaches. Shortness of breath: Was the same time as the tightness in the chest. It was within an hour after she left. They kept her there 15 minutes and she was fine when she left. Within the hour, she could barely breathe. She didn't know if she should go to the emergency room or if it would get better in a few days. The shortness of breath and wheezing is not worse, but is constant and really hard. Her breathing is really labored. She is not having pain, other than the tightness and wheezing, which she can hear. It is like she had asthma for years, or pneumonia. Outcome of events Wheezing, Chest burning, Throat burning sensation, headache, and Shortness of breath, pain of was not recovered, of Pain in leg, Stomach pain was recovering, of Vomiting was recovered in Jun2021, of others was unknown.
60 2021-06-19 nausea Heartbeat 120 on April 27 and May 18 at night after both shots went away the next day. Dizziness and... Read more
Heartbeat 120 on April 27 and May 18 at night after both shots went away the next day. Dizziness and Nausea right after 1st shot. Sore arm 1st shot.
60 2021-06-20 nausea, diarrhea, abdominal pain upper 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 2021-06-21 diarrhea, vomiting I had pulsing/fluttering around my heart. Arm pain. Lymph pain. Severe vomiting and diarrhea.
60 2021-06-21 nausea Patient describes nausea and mild dizziness . Patient being sent home with mother who is driver . ER... Read more
Patient describes nausea and mild dizziness . Patient being sent home with mother who is driver . ER precautions given . Patient advised to follow-up with PCM for persistent symptoms.
60 2021-06-23 difficulty swallowing 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 2021-06-23 GERD Joint pain, difficulty breathing, fatigue, extreme thirt, headaches, acid reflex.
60 2021-06-24 nausea her voice feels a little weak; having problems breathing; lot of Phlegm; coughing a lot; fingers sta... Read more
her voice feels a little weak; having problems breathing; lot of Phlegm; coughing a lot; fingers started tingling; waves of nausea; light headedness; She started to itch; 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 VACCINE, formulation: Solution for injection, Lot number: EN8203 and expiration date 30Aug2021), via an unspecified route of administration in left arm on 01Mar2021 at 14:30 (age at vaccination 60-year-old) as single dose for COVID-19 immunization. Medical history included type 1 diabetes mellitus, hashimoto's disease, high cholesterol and high blood pressure. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. On 01Mar2021, with a few minutes just driving to the waiting spot she was having problems breathing. There was plenty of staff there in the hospital parking lot to help. They were monitoring her oxygen and her heart also on 01Mar20210, patient experienced lot of phlegm, coughing a lot, fingers started tingling, waves of nausea, light headedness and on 03Mar2021, patients voice felt a little weak. She was treated with Benadryl and an inhaler. The outcome of event having problems breathing, fingers started tingling, light headedness, waves of nausea was recovered on 01Mar2021. The outcome of event lot of Phlegm and coughing a lot was recovering at the time of reporting. The outcome of itching and her voice feels a little weak was unknown. No follow-up attempts are possible. No further information is expected.
60 2021-06-26 flatulence, burping, decreased appetite Patient states loss of apatite, flatulence, burping, feeling hot and sweating since day after Vaccin... Read more
Patient states loss of apatite, flatulence, burping, feeling hot and sweating since day after Vaccine
60 2021-06-28 abdominal discomfort, vomiting, nausea, difficulty swallowing, abdominal pain Within 4 hours of receiving the vaccine, I developed chills and an fever of 101.5. I had muscle ache... Read more
Within 4 hours of receiving the vaccine, I developed chills and an fever of 101.5. I had muscle aches, pains, stomach upset, and nausea. At night I had difficulty breathing so I had to take extra medicine for my asthma. My temperature had went down to 100. I had severe body pains, abdominal pains, and vomiting. I was told to take Tylenol and stay hydrated by my doctor. He sent me to ER on March 11th. I went to ER and they ruled out a Covid or flu infection and any other infections. They said it was caused by the vaccine. They administered IV fluids, pain medicines, and vomiting medicines. 9 hours later after waiting, I decided to leave the ER and continued with taking pain and vomiting medicines. The symptoms lasted for 16 days. I met with my PCP and decided to get the 2nd shot three weeks later. I got similar symptoms as 1st shot with 2nd dose. Off and on I have been having adnominal discomfort. I have been having a hard time swallowing and chewing food. June 2nd I seen my PCP, and he said there was a problem with food processing into my stomach. He sent me to a gastroenterologist on June 22nd and they are scheduling a procedure to take a look into my esophagus and stomach to see the issue.
60 2021-06-28 abdominal pain upper Day of First shot: headache, sore arm, extreme exhaustion, feeling that some virus or illness was c... Read more
Day of First shot: headache, sore arm, extreme exhaustion, feeling that some virus or illness was coming on, intermittent chills. 36 hours after first shot: sore arm, headache, stomach ache (upper and lower), cramping, swollen gland on front of neck (just one gland). Had all of these symptoms on my second shot too, but not as bad. I did not have a swollen throat/neck gland, BUT had shortness of breath/asthma reaction on my second shot, and chest & sinus congestion. The intermittent asthma/shortness of breath, (haven't had in a long time), was without wheezing. I used my albuterol rescue inhalor and it seems to help me get through these boughts. The asthma came on at about 29-36 hrs and has lasted 6 days so far.
60 2021-06-28 nausea At 6pm the evening of my 2nd dose I started feeling nausea. Within an hour later I had a slight feve... Read more
At 6pm the evening of my 2nd dose I started feeling nausea. Within an hour later I had a slight fever of 99.8 degrees and had terrible headaches like I suffered when I had the Covid back in 12/04/2020. My symptoms from the 2nd shot lasted until Sunday. June 27th, 2021 up till 6:30 pm
60 2021-06-29 decreased appetite, nausea 24 hours post vaccine developed fever (101); Nausea; lack of appetite; muscle aches (entire body); F... Read more
24 hours post vaccine developed fever (101); Nausea; lack of appetite; muscle aches (entire body); Fatigue; This is a spontaneous report received from a contactable health care professional, the patient. A 60-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: FR2613) via an unspecified route of administration in the right arm on 19Mar2021 at 16:00 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to sulpha. The concomitant medications included losartan (MANUFACTURER UNKNOWN), felodipine (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), CRESTOR and CARVIDEX; all for unknown indications from unknown dates. 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. Since the vaccination, the patient was tested for COVID-19, but the result was unknown. On 20Mar2021 at 16:00, the patient experienced fever of 101 (units unspecified), nausea, lack of appetite, muscle aches (entire body) and fatigue. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was treated with TYLENOL for the reported events. The clinical outcome of the events fever, nausea, lack of appetite, muscle aches and fatigue were resolved on an unknown date in Mar2021. No follow-up attempts possible. No further information expected.
60 2021-06-29 diarrhea, nausea Headache, nausea, diarrhea, tiredness
60 2021-06-29 nausea, abdominal discomfort 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 2021-06-29 nausea Headache; Nausea; Feeling unwell; Fever; This is a spontaneous report from a contactable consumer, t... Read more
Headache; Nausea; Feeling unwell; Fever; 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 BIONTECH, Lot Number: Er8727) via an unspecified route of administration in the left arm on 19Mar2021 at 13:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto, depression and allergy to shellfish. The patient received unspecified medications within 2 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 19Mar2021, the patient experienced headache, nausea, feeling unwell and fever on that night but no fever at the time of the report. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department, or urgent care. The clinical outcome of the events headache, nausea and feeling unwell was resolving while the outcome of fever was resolved on an unknown day in Mar2021. No follow-up attempts are needed. No further information is expected.
60 2021-06-29 vomiting Dizziness; vomiting, unable to move; unable to move; This is a spontaneous report from a contactable... Read more
Dizziness; vomiting, unable to move; unable to move; This is a spontaneous report from a contactable consumer, the patient. . A 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration in the right arm on 13Mar2021 at 18:15 (at the age of 60-years-old) as a single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. The Patient did not have any allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient experienced Dizziness, vomiting and unable to move on unknown date (reported date 12Mar2021 at 09:15). It was unknown if patient received treatment for the events. The clinical outcome of the Dizziness, vomiting and unable to walk was not recovered. Information about lot number cannot be obtained. No further information expected
60 2021-06-30 diarrhea, decreased appetite, nausea, vomiting This is a spontaneous report from a contactable consumer or other non health care professional. A 60... Read more
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: 9W0187), intramuscular, administered in upper Arm Left on 17Jun2021 14:15 (Age at vaccination: 60 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that she don't know if she has high blood pressure or diabetes at that time. Patient did not received any vaccinations prior to COVID vaccine. It was reported that she haven't took any medicine since Thursday morning (further not clarified). On 17June2021 the patient experienced fever went highest as 104 but it's down to 101 today, lot of pain, headache, muscle ache, tiredness, chills, joint pain, Feeling unwell, severe nausea, pain in her ear, severe vomiting, really draining she haven't eaten anything since Thursday at 6 pm, everything keeps 'coming', diarrhea, pain in 'neck area'. Consumer stated that I don't have my, the card with me, I am downstairs on the couch I don't have the card in front of me and I don't have enough energy to go upstairs to get it. Consumer stated, "I got the Pfizer shot (COVID Shot) on Thursday and Thursday evening I have been having the problems and it's still going today 20Jun2021 and I got the call from the pharmacist and he concerns about the side effects, I am not sure what caused all of this 'up again', I was fine before the shot and now that evening different things started happening, not feeling well." Patient did not had swelling. Consumer was suggested to share information and a safety report will be filed by the call handler which is going to be forwarded and if consumer want to speak to someone then call back attempt can be done in order to get a person. The patient underwent lab tests procedures which included body temperature was 104 , body temperature was 101 on 20Jun2021. Patient did not received any treatment for the events. last night something to control diarrhea Ammonia AD, that was the only thing that she took, to stop the diarrhea. But the pain was still there, diarrhea stopped. The patient was recovered from diarrhea in Jun2021,Outcome of Lot of pain was not recovered ,the outcome of the rest of the events was unknown.. Consumer was informed about the role of Pfizer Medical Information and offered the number. Information on the lot/ batch number has been requested.
60 2021-06-30 diarrhea, nausea, abdominal pain upper Fever; Body aches; Shakes; Fatigue; Joint pain; Headache; Weakness; Chills; Sore arm; Nausea; Stomac... Read more
Fever; Body aches; Shakes; Fatigue; Joint pain; Headache; Weakness; Chills; Sore arm; Nausea; Stomach cramps; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in left arm on 19Mar2021 at 15:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had only known allergy with z-pak. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included atorvastatin calcium (LIPITOR), estradiol (ESTRACE), simvastatin (ZOCOR) and multivitamins, all for unknown indication received within 2 weeks of vaccination and was unknown if ongoing. The patient experienced fever, body aches, shakes, fatigue, joint pain, headache, weakness, chills, sore arm, nausea, stomach cramps and diarrhea on 20Mar2021 at 06:00. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, body aches, shakes, fatigue, joint pain, headache, weakness, chills, sore arm, nausea, stomach cramps and diarrhea was resolving at the time of reporting. Information about lot/ batch number cannot be obtained. No further information expected.
60 2021-06-30 nausea Headache; Dizziness; Fatigue; Nausea; Swollen lymph node; Sore arm; This is a spontaneous report fro... Read more
Headache; Dizziness; Fatigue; Nausea; Swollen lymph node; Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 20Mar2021 at 10:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included losartan (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and labetalol (MANUFACTURER UNKNOWN), all for unknown indication within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 20Mar2021, at 19:00, the patient experienced headache, dizziness, fatigue, nausea, swollen lymph nodes, sore arm. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events headache, dizziness, fatigue, nausea, swollen lymph nodes and sore arm was resolved on an unknown date in Mar2021. Information about lot/batch number cannot be obtained. No further information is expected.
60 2021-07-01 abdominal pain, vomiting, diarrhea Possible anaphylactic shock, acute kidney injury, shock liver, hypotension, rash, thrombocytopenia. ... Read more
Possible anaphylactic shock, acute kidney injury, shock liver, hypotension, rash, thrombocytopenia. Full body rash, abdominal pain, vomiting, diarrhea, RLE pain, fever, dizziness, body aches, headache. Sx onset 06/26/2021 after receiving COVID vaccine #2 the same day. Pt went to medical facility on 06/30/2021 and was sent to ED. Pt admitted to ICU 06/30 - 07/02. Transferred to general medical floor on 07/02/2021.
60 2021-07-01 abdominal pain 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 2021-07-02 diarrhea, nausea, vomiting face/hand sensation/Tingling; Elevated tinnitus; Night sweats; Sweats; light-headed; Vertigo; Dizzy;... Read more
face/hand sensation/Tingling; Elevated tinnitus; Night sweats; Sweats; light-headed; Vertigo; Dizzy; Nausea; vomiting; diarrhea; hands sizzling; chills; Tinnitus/Tinnitus in other ear; This is a spontaneous report from a contactable consumer (patient) reported in response to Non-HCP letter sent in cross referenced case. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EP7533, Expiration Date: not reported) via intramuscular, administered in left arm on 05Apr2021 at 13:00 as dose 2, single for COVID-19 immunization. Prior vaccination within 4 weeks was none. Medical history included vitamin d deficiency, dry eye, and Injury. Concomitant medication included vitamin d [vitamin d nos] taken for vitamin d deficiency and ciclosporin (RESTASIS) taken for dry eye. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) on 08Mar2021 at 13:00, and experienced vertigo, dizzy, hearing loss, tinnitus, nauseous, diarrhea, chills, sweating, Hands felt like vibrating, and vomiting. The patient experienced vertigo, dizzy, nausea, vomiting, diarrhea, hands sizzling, chills and tinnitus/tinnitus in another ear on 05Apr2021 at 14:00. On 10Apr2021, the patient experienced light-headed. On 15Apr2021, the patient experienced sweats and on 19Apr2021, night sweats. Elevated tinnitus on 20Apr2021, face/hand sensation/tingling on 24Apr2021. The patient underwent lab tests and procedures which included blood test: all else normal, eosinophil count: low Eosinophil absolute- low, full blood count: normal, lymphocyte count: low and neutrophil count: high on 05Apr2021. The events recovered but reoccurred again. The patient did not received treatment for the events. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
60 2021-07-02 nausea 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 2021-07-02 nausea Within 1 hour of receiving the 1st of 2 vaccine doses my mouth became extremely dry; Extremely thirs... Read more
Within 1 hour of receiving the 1st of 2 vaccine doses my mouth became extremely dry; Extremely thirsty; Suffered from a mild headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration on left arm 20Mar2021 at 12:15 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. The patient medical history included colon issues. The patient had allergies which included codeine, cipro and flu meds. The patient did not receive any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Mar2021 at 13:30 the patient reported her mouth became extremely dry and extremely thirsty within 1 hour of receiving the first of 2 vaccine doses. Patient did not get enough to drink. Later on the same day patient suffered from a mild headache and nausea. Therapeutic measures were not taken as a result of the events. The outcome of the events mouth became extremely dry, extremely thirsty, mild headache and nausea were recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
60 2021-07-05 stomatitis fever, sore arm at site, flu-like symptoms for 32 hours following the vaccine Today (7/6/21) I have... Read more
fever, sore arm at site, flu-like symptoms for 32 hours following the vaccine Today (7/6/21) I have dry mouth, dry eyes, sores on torso, tender thyroid, cracking skin, constant metallic taste in mouth, food tastes awful and irritates my mouth. Water helps to calm but symptoms never go away.
60 2021-07-06 diarrhea Feels like Covid pneumonia all over again; Feels like Covid pneumonia all over again; Feels like Cov... Read more
Feels like Covid pneumonia all over again; Feels like Covid pneumonia all over again; Feels like Covid pneumonia all over again; Sore arm; Extreme chills; Body and muscle ache; Body and muscle ache; Diarrhea; This is a spontaneous report from a contactable consumer (patient herself). This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number EW0182), via an unspecified route of administration in left arm on 10May2021 10:45 as single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient medical history included COVID-19. Concomitant medication included (paracetamol) TYLENOL. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via unspecified route in left arm on 19Apr2021 24:00 (Batch/Lot number EW0171) as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 11May2021 23:00 the patient experienced with felt like COVID pneumonia all over again, sore arm, extreme chills, feels like ice in blood, Body and muscle ache and diarrhea. Treatment received was reported as no. The outcome of events was recovering.
60 2021-07-06 diarrhea Developed persistent diarrhea about 3-4 days after second dose vaccine.
60 2021-07-06 nausea AFTER RECEIVING MY FIRST DOSE I WENT TO WAIT IN THE WAITING ROOM AND BEGAN HAVING A RACING HEARTBEAT... Read more
AFTER RECEIVING MY FIRST DOSE I WENT TO WAIT IN THE WAITING ROOM AND BEGAN HAVING A RACING HEARTBEAT ABOUT 10 MINUTES AFTER THE SHOT. I BEGAN TO FEEL DIZZY, MY HEART WAS RACING, MY PULSE SHOT UP FROM 64 TO 154 PER MY WATCH AND MY MOUTH GOT DRY. I ASKED FOR A NURSE AND THEY ESCORTED ME BACK TO A ROOM. I WAS FEELING LIKE I WAS GOING TO PASS OUT SO THEY LOWERED ME ON THE THE TABLE. THEY CHECKED MY PULSE AND 02. MY MOUTH WAS DRY AND MY LEGS AND HANDS WERE TINGLING. MY HEART WAS POUNDING AND I FELT SICK TO MY STOMACH. THEY CHECKED MY BP WHICH IS USUALLY LOW AND IT WAS REALLY HIGH. I WAS FEELING WEAK AND UNABLE TO STAND SO THEY TOLD ME THEY WERE TRANSPORTING ME TO THE ER. I WAS SHAKING, FREEZING, MY MUSCLES WERE CRAMPING IN MY ARMS AND LEGS. MY HEART CONTINUED TO RACE, I WAS DIZZY AND REALLY WEAK. I HAVE CONTINUED TO HAVE A RACING HEART BEAT AT RANDOM TIMES DURING THE DAY, STILL FEEL DIZZY AND FATIGUED. MY HEART ALSO POUNDS AT RANDOM TIMES DURING THE DAY. I AM NOT FEELING WELL.
60 2021-07-07 nausea Lightheaded, dizzy, shakey, nausea, unable to look at any screens
60 2021-07-08 nausea Itching, bloody nose, palpitations, headaches for the week following, one severe, nausea
60 2021-07-08 nausea Headache; Fever; chills; Body ache; Nausea; Swollen armpit; This is a spontaneous report from a con... Read more
Headache; Fever; chills; Body ache; Nausea; Swollen armpit; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EP7534), via an unspecified route of administration in the left arm on 23Mar2021 at 09:30, (At the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, atrial tachycardia, thyroid disease and Hashimotos disease. Concomitant medications taken within 2 weeks prior to vaccination include Levothyroxine (MANUFRATURER UNKNOWN) and Diltiazem hydrochloride (CARTIA) both for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EN6203), via an unspecified route of administration in the left arm on 02Mar2021 at 10:00 as a single dose for COVID-19 immunisation. The patient was allergic to codeine and demerol. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccine. On 23Mar2021, the patient experienced headache, fever, chills, body aches, nausea and swollen left armpit. The adverse event had not resulted in doctor or other healthcare professional office/clinic visit/ emergency visit/ department or urgent care. The patient did not take any medication for headache, nausea, chills, fever, swollen arm, general body pain. The clinical outcome of the events headache, nausea, chills, fever, swollen arm, general body pain was recovering at the time of this report. No follow-up attempts possible. No further information expected.
60 2021-07-11 nausea, diarrhea, vomiting 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 vomiting rheumatoid arthritis; was really sick and it affected her fibromyalgia; she was just a mess and ende... Read more
rheumatoid arthritis; was really sick and it affected her fibromyalgia; she was just a mess and ended up vomiting and this took about three days; feeling sick; This case has been considered invalid initially upon follow up information case was processed as valid file The initial case was missing the following minimum criteria: Other-Info not qualifying for AE reporting Medical Information. Upon receipt of follow-up information on (20Apr2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 1st of two reports. This 60-year-old female consumer reported for herself that: a 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6206, Expire Date: unknown) via an unspecified route of administration, in the left arm on 08Mar2021 as dose 1, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8734, Expire Date: unknown) via an unspecified route of administration, in the left arm on 29Mar2021 as dose 2, single for covid-19 immunisation. Medical history included ongoing Diabetes, Sjogren's disease, obese and knee replacements like 10 years ago on both knees and she did not know the exact dates of the knee replacements. Concomitant medications included loratadine taken for rash from 13Mar2021 and ongoing; hydrochlorothiazide taken for sjogren's syndrome, fluoxetine taken for antidepressant therapy; montelukast sodium (SINGULAIR) taken for asthma, cetirizine hydrochloride (ZYRTEC ALLERGY) taken for rash. No additional vaccines administered on same date of the pfizer suspect. The patient did not receive any vaccines within four weeks prior to the vaccination. Caller stated she had a reaction to the Pfizer COVID vaccine and had the 1st dose on 08Mar2021 and after the 1st dose she was really sick and it affected her fibromyalgia and rheumatoid arthritis and she was just a mess and ended up vomiting and this took about three days which was normal. Stated after the 2nd dose within 24 hours she started feeling sick again on 30Mar2021 and she could not move and ended up throwing up and got a rash that appeared on her left arm; stated she had both doses of the Pfizer COVID Vaccine in her left arm and the rash was a little above where the vaccine doses were administered. Stated she had the 2nd Pfizer COVID vaccine on 29Mar2021 and had been coming in and out of feeling good and bad since then and for the rash she had, she used the Triamcinolone Acetone cream and the rash seems to subside and then flares back up and when the rash flares back up she got sick again. Stated the Triamcinolone Acetone cream is 0.1% with lot 0LT0435, expiry date Sep2022 and NDC number. Stated the rash has gotten larger than when it first appeared and when it did flare it itches and was hot and she also has Sjogrens disease in that rheumatology thing and has had the shingles shot 2 years ago; stated she had no name of the shingles shot to provide but had it 2 years ago in September and it was at Walgreens. Stated she just got over this weekend and was sick on Friday, was ok on Saturday and then on Sunday she could not move and was sick. Caller stated the 1st dose of the Pfizer Vaccine was administered on 08Mar2021 with lot EN6206; 2nd dose administered on 29Mar2021 with lot number ER8734; states the patient card has no expiry date or NDC written on it; stated she has had no treatment for the reported events and had not gone into the HCP office but wanted to. Stated her husband got nervous when he looked on the site and saw there were problems with the Pfizer COVID Vaccine in Israel about bringing up shingles in people and he read this in an article; caller stated her husband was concerned about her and thought maybe she had shingles and caller stated this was not shingles and she had the shingles shot and this did not look like shingles to her. Caller stated her husband himself had shingles and he got a little nervous and she herself was going to go to urgent care and did not feel like going that route; stated she had no other treatment. Stated she was having a bad reaction and sees enough doctors and went often enough if this was a real problem she would bring it up and the further away from testing the longer the distance was between her feeling ill; no further details stated by the caller. Stated she took quite a bit of medications and takes Hydrochlorothiazide for her Sjogrens disease and began taking that a little over a year ago and takes 300mg once per day by mouth. Stated she was on an antidepressant and takes Fluoxetine 60mg once per day by mouth and all the names of these medications a was going crazy in her head; stated she began taking Fluoxetine about 10 years ago. Stated she was on a lot of medicines that counter act anything the Pfizer COVID Vaccine could did to her regarding side effects and thinks the vaccine was too much for her body; no further details provided by the caller except she states she took several different asthma medicines and made the reported event not as severe and the rash was not as severe. Caller clarifies to state the medications she took for asthma that made the reported events less severe are Zyrtec 10mg tablets and she took it once per day and had been on it for years like 20 years; she takes Singulair 10mg once per day and had been on that for years and had two new medications just prescribed to her that was Loratidine 10mg once daily that she started taking on 13Mar2021 and then clarified this was the only new one prescribed and she also used nose sprays; no further details provided by the caller. Caller asks that based on what she had told medical, was she doing the right things for this and was she treating this the right way by letting it run its course; caller aware that Pfizer cannot offer medical advice or treatment recommendations and she was referred to her HCP. Adverse events not required in a visit to ER or MD office. Outcome of all events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076803 same reporter/drug/event, different patients
60 2021-07-12 abdominal pain, abdominal pain, nausea Symptomatic, started on 7/9/21 with cough, runny nose, muscles aches, nausea, loss of smell & taste,... Read more
Symptomatic, started on 7/9/21 with cough, runny nose, muscles aches, nausea, loss of smell & taste, sore throat, nasal congestion, fever, headache, fatigue abdominal pain, & ear ache.
60 2021-07-12 difficulty swallowing 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 2021-07-12 vomiting I had a severe headache like a migraine the night before and then in the morning it was really sever... Read more
I had a severe headache like a migraine the night before and then in the morning it was really severe. I couldn't stop throwing up. The night before I took the butalb-acetamin-caff. I went to an urgent care facility, and they sent me directly to the emergency room.
60 2021-07-13 diarrhea, abdominal pain upper, constipation Diarrhea, severe stomach cramps. Started 11 days after the first dose. Had a tele-medicine visit wi... Read more
Diarrhea, severe stomach cramps. Started 11 days after the first dose. Had a tele-medicine visit with a nurse at my primary doctor's office. They did blood work and several fecal tests - all lab results were normal. The gastrointestinal problems lasted about 3 weeks, with alternating bouts of diarrhea and constipation. Slowly over the past few months I have returned to normal.
60 2021-07-17 abdominal pain, diarrhea pain in injection side; cherry angioma; fatigue; muscle weakness; chills; fever; diarrhea; skin rash... Read more
pain in injection side; cherry angioma; fatigue; muscle weakness; chills; fever; diarrhea; skin rash (urticaria); on day five start of abdominal pain; 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 no: EN6205) via an unspecified route of administration in the right arm on 13Mar2021 at 11:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included cholinergic urticaria, lactose and fructose intolerance. The patient's allergic history included rhinitis, animal fur, mites, dust, NSAIDS (Nonsteroidal Anti-Inflammatory Drugs) causes urticaria. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 18Mar2021, the patient experienced abdominal pain. On 20Mar2021 at 10:00, the patient experienced pain in injection side, fatigue and muscle weakness, chills, fever, diarrhoea, skin rash (urticaria), cherry angioma. Since the vaccination, the patient had been tested negative for COVID-19 on 21Mar2021. As a corrective measure the patient received cetirizine for all the events. The clinical outcomes of the events, pain in injection side, fatigue and muscle weakness, abdominal pain, chills, fever, diarrhoea, skin rash (urticaria), cherry angioma were recovering. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Patient's Postal Code added, Verbatim was updated for medical history. Relevant Med History Rhinitis was deleted as it is the reaction of animal fur, mites, dust allergy, Lab data "Rapid Diagnostic RNA test" deleted as it can be combined with PCR (Nasal Swab), Vaccine Facility Information added.
60 2021-07-17 nausea, diarrhea Pain/heaviness in left arm; Sweats; Chills; Diahrea; Nausea; Weakness; Fatigue for 3 weeks; This is ... Read more
Pain/heaviness in left arm; Sweats; Chills; Diahrea; Nausea; Weakness; Fatigue for 3 weeks; This is a spontaneous report received from a contactable health care professional (patient). This is the 1st of 2 reports, for the 1st dose. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231) via an unspecified route of administration on the left arm on 07Jan2021 at 17:00, as single dose for COVID-19 immunisation (age at vaccination 60-years-old). Medical history was reported as asthma, hypothyroidism, neuro damage in spine and wrists, vertigo, migraines (none in past 5-6 years), arthritis, and mood disorder. Concomitant medications included bromide, vilanterol trifenatate (ANORO); levothyroxine sodium (UNITHROID); paliperidone; valproate semisodium (DEPAKOTE). The patient previously took Darvon [dextropropoxyphene hydrochloride] and was allergic to it. 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 08Jan2021 at 14:00, the patient experienced pain/heaviness in left arm, sweats, chills, diarrhea, nausea (nausea for 3 days), weakness, and fatigue (fatigue for 3 weeks). The patient received treatment for the reported events as an injection of a medication with high NSAID (non-steroidal anti-inflammatory drugs) levels. Patient visited the doctor or other healthcare professional office/clinic visit for adverse event. The events outcome were recovered with sequalae. No follow-up attempts are needed. No further information is expected.
60 2021-07-17 nausea 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 nausea Chills; Fever; Nausea; Headache; General body pain / Body aches; Extreme tiredness; This is a sponta... Read more
Chills; Fever; Nausea; Headache; General body pain / Body aches; Extreme tiredness; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 at 11:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no past medical history, however, the patient had allergies to penicillin, sulfonamide, codeine and clindamycin. The concomitant medications include red yeast rice (MANUFACTURER UNKNOWN), zyrtec (MANUFACTURER UNKNOWN), CoQ10 (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), vitamin E (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN) all for an unspecified indication from an unspecified date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 12:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 04:30, the patient experienced chills, fever, nausea, headache, general body pain (body aches) and extreme tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the reported events. The clinical outcome of the events chills, fever, nausea, headache, general body pain (body aches), extreme tiredness was recovered on an unspecified date. No follow-up attempts are needed. No further information is expected.
60 2021-07-18 nausea Severe vertigo and nausea with any movement , but most severe when putting head down. Symptoms star... Read more
Severe vertigo and nausea with any movement , but most severe when putting head down. Symptoms started 3 days after the first vaccine , lasted 2 weeks . Vertigo and nausea returned much worse the morning after getting the second vaccine and symptoms continued for 3 weeks. Currently still has slight vertigo and imbalance intermittently.
60 2021-07-19 diarrhea, abdominal pain Increased Migraines , Decreased hearing, Abdominal pain, chills, headache, loose stool.
60 2021-07-19 gastrointestinal disorder, diarrhea, decreased appetite Diarrhea. No appetite. Flu-like symptoms: Headache; Weak; No energy; I am currently having digestive... Read more
Diarrhea. No appetite. Flu-like symptoms: Headache; Weak; No energy; I am currently having digestive issues.
60 2021-07-20 abdominal pain upper Pain in upper abdomen, sudden cardiac arrest on 5/3/21
60 2021-07-21 nausea, diarrhea 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 2021-07-22 abdominal distension, gastrointestinal disorder, loss of appetite Hypertension after second vaccine noted. B4 vaccine avg at home bp 115/70, after vaccine noted as h... Read more
Hypertension after second vaccine noted. B4 vaccine avg at home bp 115/70, after vaccine noted as high as 180/90. Avg after vaccine 150/90. Had to go to cardiologist and received medication bystolic 5mg. Gastrointestinal issues: after second dose severe bloating, no bowel movements, could not eat solid food for over 10 days. My primary physician ordered ct scan with contrast. Outcome no blockages or masses. Still bloating but am moving bowels.
60 2021-07-22 nausea, vomiting Slight sore arm; Severe headache; chills; nausea; vomiting; This is a spontaneous report from a cont... Read more
Slight sore arm; Severe headache; chills; nausea; vomiting; This is a spontaneous report from a contactable healthcare professional, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150), via an unspecified route of administration in the left arm on 01Apr2021 at 10:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis, alopecia areata (not chronic but recent) and penicillin allergy. Concomitant medications included loratadine (CLARITIN), ascorbic acid; calcium; minerals nos, retinol; tocopheryl acetate; vitamin b nos; vitamins nos; zinc (CENTRUM SILVER) and others (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 08:00, the patient experienced slight sore arm, severe headache, chills, nausea and vomiting. The headache started within 24 hours of the vaccine. It became worst and most severe approximately around 32 hours after the vaccination. The severe headache and chills lasted for approximately 26 hours after they started. 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 patient did not receive any treatment for the events slight sore arm, severe headache, chills, nausea and vomiting. The clinical outcome of the events slight sore arm, nausea and vomiting was resolved on an unspecified date in Apr2021. The clinical outcome of the events severe headache and chills was resolved on 03Apr2021 at 10:00. No follow-up attempts are needed. No further information is expected.
60 2021-07-22 nausea Splitting headache; Extreme fatigue; Hot flashing; Felt nausea; This is a spontaneous report from a ... Read more
Splitting headache; Extreme fatigue; Hot flashing; Felt nausea; 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: PAA16596S/06/2022), via an unspecified route of administration in the left arm on 15Mar2021 at 11:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included Meniere's disease. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC), multivitamin (MANUFACTURER UNKNOWN), ubidecarenone (COQ10) and vitamin D not otherwise specified (NOS) (MANUFACTURER UNKNOWN) all since an unknown date for an unknown indication. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021 at 11:05, within 5 minutes of vaccination, the patient felt nausea and had nausea all day for 48 hours. Four hours after the shot, at 15:00, extreme fatigue had kicked in and experienced hot flashing. On 16Mar2021, the morning the patient woke up with a splitting headache that lasted for 24 hours. On 17Mar2021, the patient felt great and free of symptoms. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events felt nausea, extreme fatigue, hot flashing, and splitting headache were recovered on 17Mar2021. No follow-up attempts are needed. No further information is expected.
60 2021-07-27 diarrhea pneumonia; loss of consciousness; difficulty in breathing; feeling weak; diarrhea; Arm fracture; Fal... Read more
pneumonia; loss of consciousness; difficulty in breathing; feeling weak; diarrhea; Arm fracture; Fall; This is a solicited report received from a contactable consumer (patient) based on the information received by Pfizer. (MFR Control No. # 21K-163-3955081-00). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 26Apr2021 (Batch/Lot Number: ER8730) as single dose for covid-19 immunisation; adalimumab (HUMIRA 40MG/0.4ML, Solution for injection in pre-filled pen), subcutaneous from 03Apr2020 (Batch/Lot number was not reported) to Mar2021, at Citrate Free (40 mg,1 in 2 wk), subcutaneous from Mar2021 (Batch/Lot number was not reported) and ongoing, at 40 mg for Ulcerative Colitis. Medical history included tobacco user: one pack of cigrette per day (Started 1978), abstains from alcohol. Concomitant medications included tizanidine; carvedilol (COREG); pregabalin; atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported; apixaban (ELIQUIS). The patient previously took hydrocodone. The patient experienced loss of consciousness on May2021 with outcome of recovered on May2021, pneumonia on 05May2021 with outcome of recovered in 2021, feeling weak on 27Apr2021 with outcome of unknown, difficulty in breathing on 27Apr2021 with outcome of unknown, diarrhea on Mar2021 with outcome of recovered in 2021, arm fracture on 27Feb2021 with outcome of recovering, fall on 27Feb2021 with outcome of recovering. Clinical course: In 2021, the patient experienced chest tube had been drained and removed. On 27Feb2021, the patient experienced broken right arm in two different places and fell. In Mar2021, the patient experienced diarrhea. in May2021, the patient experienced loss of consciousness. on 05May 2021, the patient experienced pneumonia. in May 2021, the loss of consciousness resolved. in 2021, the pneumonia and diarrhea resolved. Covid-19 vaccine was also considered suspect. the patient shared that she fell in 27Feb2021 and broke her right arm so she went to the emergency room. Her x-ray revealed that she broke her arm in two different places. she was then asked to meet with an orthopedic surgeon and was scheduled for an out-patient procedure to repair her broken arm with pins and plates on the second week of Mar2021. she was sent home and was given hydrocodone for pain. she also added that the physician placed her humira on hold two weeks prior and after the procedure. because of humira was placed on hold, she experienced diarrhea for a week until it resolved. she received her first dose of her covid-19 vaccine in 26Apr2021. she noticed that she started feeling weak and had difficulty in breathing the next morning. she was rushed to the hospital in 05May2021 because her weakness and difficulty of breathing worsened. a series of unrecalled tests had been performed including chest x-ray which showed that she had pneumonia. she was then admitted and was hooked up to a machine because she had difficulty in breathing. she added that she could not recall any other treatments or diagnostic tests that was done to her because she was unconscious for three weeks and was monitored in the intensive care unit. she added that her chest tube had been drained and removed the day she got released in the hospital. she was sent home in 25May2021. alternative etiology of pneumonia, weakness, loss of consciousness, difficulty breathing were reported as covid-19 vaccine.it was unknown if patient was enrolled in a covid-19 vaccine trial. The action taken in response to the events for bnt162b2 was not applicable, for adalimumab was unknown. Causality for humira 40mg/0.4ml(adalimumab)-the reporter's causality for the event(s) of loss of consciousness, broken right arm in two different places, pneumonia, fell and diarrhea with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of chest tube had been drained and removed was not provided. Programs opinion is that there is no reasonable possibility that the events of loss of consciousness, broken right arm in two different places, chest tube had been drained and removed, pneumonia, fell and diarrhea are related to humira 40mg/0.4ml(adalimumab). COVID-19 VACCINE (COVID-19 VACCINE)(Injection) (COVID-19 VACCINE), Causality: Loss of consciousness-Causality as per reporter (Drug/Vaccine): Probable; Arm fracture-Causality as per reporter (Drug/Vaccine): Not Related; Pneumonia-Causality as per reporter (Drug/Vaccine): Probable; Fall-Causality as per reporter (Drug/Vaccine): Not Related; Diarrhea-Causality as per reporter (Drug/Vaccine): Not Related. The reporter's assessment of the causal relationship of the events (feeling weak, difficulty in breathing) with the suspect products 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 needed. No further information is expected.; Sender's Comments: Based on the plausible temporal relation, the association between the events of loss of consciousness, pneumonia, asthenia and dyspnoea and the suspect product of BNT162B2 cannot be completely ruled out. The confounding factor for the event of pneumonia is the co-suspect drug Humira Due to implausible temporal association, the events of diarrhoea, arm fracture and fall are assessed as unrelated to BNT162B2 The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
60 2021-07-27 diarrhea the aches and pains were severe and affected all of her joints; cramping up in her calves and it hur... Read more
the aches and pains were severe and affected all of her joints; cramping up in her calves and it hurts; sight issues; She could barely move; arthritis; she has real sensitivity to light; She still has pain in her knees when she walks, it's almost like her knees want to give out. Severe pain in hips; severe pain was also in her back, hips and neck; severe pain was also in her back, hips and neck; aches and pains; Diarrhea; Severe fatigue; a little bit of swelling; pain at the site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0169; Expiration Date: Aug2021, at the age 60-year-old), dose 1 via an unspecified route of administration, administered in arm left on 27Apr2021 13:00 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Prior vaccinations (within 4 weeks), adverse events following prior vaccinations, patient's medical history (including any illness at time of vaccination), family medical history relevant to adverse events and relevant tests: none. Caller stated she had the shot and a reaction with the first shot and haven't had the second. She clarified she was referring to the covid 19 shot. On 27Apr2021, she had the first vaccine. The day of the vaccine, she experienced normal swelling, a little bit of swelling (not much), and pain at the site, which was normal. The pain went away but she doesn't know it went away. No treatment received. Then, after a few days, she started out with aches and pains but then it got to the point, the aches and pains were severe and affected all of her joints. She could barely move. Her husband had to help her on and off the toilet and that lasted a good week. She also mentions she had diarrhea. She doesn't know. It was probably a couple days later after receiving the vaccine. She was still having diarrhea, but it had improved. She has been taking Imodium. Patient reported that 2 days after she got the shot, she was severely fatigued and that's when the aches and pains started. Caller doesn't know the exact date. If she stands for more than 5 minutes, she has cramping up in her calves and it hurts. She confirms she has recovered with lasting affects. She adds she also has arthritis which might be a factor. She clarifies the aches and pains started on third day. She believes the third day, she is not exactly sure. The aches and pains got worse. When she says severe fatigue, she means she was in bed all day. Time of onset: She would say the fatigue started the 2nd or 3rd day. She provides the start date as: 29Apr2021. The severe fatigue is better than it was but hasn't gone away. She makes the comment she doesn't know why she reacted so bad to the first vaccine. She mentioned she was supposed to go on 18May2021 and get second shot, but she cancelled it. She explains this is one of the reasons she is calling. She needs to know should she get the second shot. Patient wanted to be protected against covid the best she could, her husband has major heart issues and she can't have him being exposed to the virus and she needs to get a shot. She's scared. DSU agent stated we suggest caller reach out to her primary care provider if she has questions on whether or not to get the second vaccine we wouldn't be able to provide her with any medical advice over the phone. Caller stated her doctor said not to take the second shot because she had such a severe reaction to the first one. Her main problem is that she is having sight issues. She has her husband read off the product information from her vaccine record card because she can't really see it. She has always been near sighted but this is to the point, she has real sensitivity to light, that's her main concern right now. First, she had severe pain and then had sight issues. She explained the sight issues started about two weeks in after receiving the first dose, it was right after the severe pain. It has persisted. She has an appointment on Thursday to see her ophthalmologist. She mentions its hard to get into her ophthalmologist. The severe pain started on the 4th day after receiving the first dose, around 30Apr2021. The severe pain lasted a good week, week and a half. She still has pain in her knees when she walks, it's almost like her knees want to give out. Other than that, it's better. She mentions the severe pain was also in her back, hips and neck. Her doctor prescribed diclofenac, 50 mg. She mentions she can see this dose because its bolded and its bigger. No emergency visit. The doctor said to call and see what Pfizer had to say about the second shot because she is really nervous. The outcome of event a little bit of swelling was resolved, diarrhea, fatigue was was not recovered and outcome of all other events was unknown. No follow-up attempts are needed. No further information is expected.
60 2021-07-27 difficulty swallowing excruciating pain in the bones; sharp neck pain; Headache; sore throat; Difficulty swallowing and br... Read more
excruciating pain in the bones; sharp neck pain; Headache; sore throat; Difficulty swallowing and breathing; Difficulty swallowing and breathing; Swollen and blistered on the right leg; Swollen and blistered on the right leg; itch and hurt; itch and hurt; 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 was not reported) dose 2 via an unspecified route of administration in Arm Right on 04May2021 10:00 (at the age of 60 years old) as single for COVID-19 immunisation at Hospital. Medical history included lupus erythematosus, rheumatoid arthritis, fibromyalgia. Concomitant medication received within two weeks included baclofen (SOLOFEN), clonazepam (KLONOPIN), trazodone hydrochloride (TRAZODON) all taken for an unspecified indication, start and stop date were not reported and Plasma Capilar. The patient previously took tramadol and experienced allergies, ultacit and experienced allergies, ultram and experienced allergies. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Arm Right on 13Apr2021 08:00 (at the age of 60 years old) as single for COVID-19 immunisation. Patient did not have COVID prior to vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced excruciating pain in the bones, sharp neck pain, headache, sore throat, difficulty swallowing and breathing, swollen and blistered on the right leg, itch and hurt on 06May2021 16:00. Event reported as, After three days excruciating pain in the bones. Still sharp neck pain. Headache and sore throat. Difficulty swallowing and breathing. Swollen and blistered on the right leg. They itch and hurt. The pain in the neck is excruciating. Adverse events resulted in emergency room/department or urgent care. Treatment given for adverse events included toradol, sodomedrol, ataraxia, norflex. Patient did not tested for COVID post vaccination. Outcome of all the events were not recovered. Information about/lot batch number is requested.
60 2021-07-27 nausea, vomiting Nauseous; Night sweats; Chills / more of the chills; Headache; Aching all over; Off balance/ head fe... Read more
Nauseous; Night sweats; Chills / more of the chills; Headache; Aching all over; Off balance/ head felt like it was swimming off balance; Throwing up; 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: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 at 15:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), buspirone (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and fluoxetine (MANUFACTURER UNKNOWN) all for unknown indications from an unknown dates. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 15:00, the patient started experiencing chills and headache. By the night, the patient experienced aching all over, throwing up and off balance. On 01Apr2021, the patient experienced more of the chills, nauseous and head felt like it was swimming off balance. On an unknown date in Apr2021, the patient experienced night sweats. The patient experienced headache the whole time. The patient did not receive any treatment for the events. The clinical outcome of the events chills, headache, loss of balance, night sweats and nauseous was resolved on an unknown date in Apr2021.The clinical outcome of the events general body pain and vomiting resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
60 2021-07-27 nausea Body aches; Fever; Nausea; Headache; This is a spontaneous report from a contactable consumer, the p... Read more
Body aches; Fever; Nausea; Headache; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 01Apr2021 at 08:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and mild depression. The patient not had known allergies to medications, food or other products. Concomitant medications included levothyroxine sodium (SYNTHROID) and lexoprin(MANUUFACTURER UNKNOWN), both from an unknown date, for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 11Mar2021 at 08:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 02:00, the patient experienced fever, nausea, headache and body aches. No therapeutic measures were taken as a result of reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, nausea, headache and body aches was recovered on an unspecified date in Apr2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
60 2021-07-27 nausea Dizzy immediately following injection; Tired; Nauseous; Sore arm; This is a spontaneous report from ... Read more
Dizzy immediately following injection; Tired; Nauseous; Sore arm; 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: ER8736) via an unspecified route of administration in the right arm on 29Apr2021 at 11:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included scoliosis. The patient did not receive any medication within two weeks of vaccination. The patient previously received unspecified medication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021, the patient experienced dizzy immediately following injection, tired, nauseous and sore arm. The clinical outcome of the events dizzy immediately following injection, tired, nauseous and sore arm was recovered on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
60 2021-07-27 nausea Severe dizziness; nausea; severe headache; This is a spontaneous report from a contactable consumer,... Read more
Severe dizziness; nausea; severe headache; 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: EP7533) via an unspecified route of administration in the left arm on 31Mar2021 at 16:45 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disorder and latex allergy since an unknown date. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 17:30, the patient experienced severe dizziness, nausea and severe headache. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Patient did not receive any treatment for the events. The clinical outcome of the events severe dizziness, nausea and severe headache were recovered on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
60 2021-07-27 nausea Tiredness; muscle pain; chills; joint pain; Headache; Fever; injection site pain; Nausea; feeling un... Read more
Tiredness; muscle pain; chills; joint pain; Headache; Fever; injection site pain; Nausea; feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 03Apr2021 at 17:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. It was reported that the patient had no allergies to medications, food, or other products. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Concomitant medications included progesterone (MANUFACTURER UNKNOWN), dextromethorphan hydrobromide and guaifenesin (ROBITUSSIN DM) and azithromycin (MANUFACTURER UNKNOWN) started on an unknown date for an unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 6:00, the patient experienced tiredness, muscle pain, chills, joint pain, headache, fever, vaccination site pain, nausea and malaise. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tiredness, muscle pain, chills, joint pain, headache, fever, vaccination site pain, nausea and malaise were recovered on an unknown date in 2021. No follow-up attempts are needed; information about the lot number cannot be obtained.
60 2021-07-27 vomiting, diarrhea Body aches; Diarrhea; Severe headache; Vomiting; This is a spontaneous report from a contactable hea... Read more
Body aches; Diarrhea; Severe headache; Vomiting; This is a spontaneous report from a contactable healthcare professional, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient did not had any allergies to medications, food, or other products. The patient received unspecified other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0202) via an unspecified route of administration in the left arm on 03Mar2021(at the age of 59-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced severe headache, vomiting, diarrhoea and body aches for four days. The patient received treatment for the reported events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events of headache, general body pain, vomiting and diarrhoea was recovered on 04Apr2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
60 2021-07-28 abdominal pain upper 2nd dose was EW0162, 4/15/2021;~3 wk after first dose had episode of epigastric pain, malaise, light... Read more
2nd dose was EW0162, 4/15/2021;~3 wk after first dose had episode of epigastric pain, malaise, light headedness for ~3 hrs. Got 2nd dose ~4 days later. Then 5/14, had ER visit for above epigastric pain, malaise, lightheadedness then 5/22-5/25; had ER visit after similar episode but also developed whole body hives, low blood pressure event, suspected to be mastocytosis, however bone marrow biopsy later suggested against this. 5/31 similar episode started, required epi at home and led to another 3 day hospitalization.
60 2021-07-28 diarrhea 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.
60 2021-07-28 diarrhea Headache; Diarrhea; Bronchospasm; Chills; Fatigue; This is a spontaneous report from a non-contactab... Read more
Headache; Diarrhea; Bronchospasm; Chills; Fatigue; This is a spontaneous report from a non-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: EW0150) via an unspecified route of administration in the arm left on 01Apr2021 at 08:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, migraine, diverticulitis, sepsis. The patient had previously experienced milk allergy, fish allergy and allergy to nuts (walnuts allergy). The patient previously took Cipro and Flagyl and experienced drug allergy to Cipro and Flagyl. Concomitant medications taken within two weeks included aciclovir (ACYCLOVIR), propranolol (MANUFACTURER UNKNOWN) and testosterone cipionate (DEPOTESTOSTERONE) all from unknown date for unknown indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 11Mar2021 at 10:00 (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 four weeks prior to the vaccination. On 01Apr2021 at 14:00, the patient experienced headache, diarrhea, bronchospasm chills and fatigue. Therapeutic measures were taken as a result of the adverse events and included treatment with Ibuprofen from an unknown date. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, diarrhea, bronchospasm chills and fatigue was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
60 2021-07-28 nausea I was so sick on 03Jun2021; Could not eat, had to stay in bed & whole Day & Night/I could not get ou... Read more
I was so sick on 03Jun2021; Could not eat, had to stay in bed & whole Day & Night/I could not get out of bed.; Could not eat, had to stay in bed & whole Day & Night/I could not get out of bed.; sweating; migraine; Headache; nausea; hair still falling; shaking; I was aching worse on 2nd shot; This is a spontaneous report from a contactable Nurse (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0172), via intramuscular route of administration on 03Jun2021 at 09:10 AM (at the age of 60-year-old) as dose 2, single for COVID-19 immunization. Medical history included COVID-19 from 18Feb2021 to an unknown date (my hairs still falling out after had covid by hands full as of 18Feb2021. I had Covid & so sick. I could not get out of bed). The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EP753), via intramuscular route of administration on 12May2021 at 09:00 AM (at the age of 60-year-old) as dose 1, single for COVID-19 immunization and experienced shaking, I was aching all over. The patient experienced shaking, I was aching worse on 2nd shot, hair still falling on an unspecified date in 2021, sweating, migraine, headache, nausea, could not eat, had to stay in bed & whole day & night/I could not get out of bed on an unspecified date in Jun2021, I was so sick on 03Jun2021. Pertinent Details: shaking, I was aching worse on 2nd shot & had to go to bed when got up at 10 AM and sweating, migraine, headache & nausea. Could not eat, had to stay in bed & whole Day & Night. My hairs still falling out after had covid by hands full as of 18Feb2021. Family medical History: Patient husband (withheld) took Moderna & no symptoms at all. But patient was so sick on 03Jun2021. Patient never want to take that shot again because patient felt like I did when I had Covid & so sick. Patient could not get out of bed. The patient underwent lab tests and procedures which included COVID test: had covid (my hairs still falling out after had covid by hands full as of 18Feb2021) on 18Feb2021, blood test was kidney, liver, heart all good and thyroid good (everything good & doctor still don't know why my hair is falling out in hands full) on 01Jun2020. The patient received Tylenol, Chicken soup as a treatment for the event shaking. Outcome of the events I was aching worse on 2nd shot, hair still falling was not recovered; sweating, migraine, headache, nausea, could not eat, had to stay in bed & whole day & night/I could not get out of bed was unknown; shaking was recovered on an unspecified date in 2021, I was so sick was recovered on 03Jun2021. Follow-Up: Follow-up attempts are completed. No further information is expected.
60 2021-07-28 nausea Injection site pain; Tiredness; Headache; Muscle pain; Chills; Nausea; Feeling unwell; This is a spo... Read more
Injection site pain; Tiredness; Headache; Muscle pain; Chills; Nausea; Feeling unwell; 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: EW0161) via an unspecified route of administration in the arm left on 27Apr2021 at 13:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient received unspecified medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 09:00, the patient experienced injections site pain, tiredness, headache, muscle pain, chills, nausea and feeling unwell. The clinical outcomes of the events injections site pain, tiredness, headache, muscle pain, chills, nausea, feeling unwell were recovering. No follow-up attempts are needed; No further information is expected.
61 2020-12-31 nausea Body ache, head ache, fever, nausea, liwer leg muscle spams/cramping
61 2021-01-01 nausea, diarrhea Approximately 48 hours after receiving vaccine, I developed nausea and extreme diarrhea. This laste... Read more
Approximately 48 hours after receiving vaccine, I developed nausea and extreme diarrhea. This lasted 2.5 days
61 2021-01-03 diarrhea Reports the following symptoms: Left shoulder pain, diarrhea, nasal congestion, sore throat, cough, ... Read more
Reports the following symptoms: Left shoulder pain, diarrhea, nasal congestion, sore throat, cough, Itching all over body, scalp pain and tenderness. 12/28 Began feeling better, mild cough persists. 1/4: Feels as though she has "bad flu" fever of 101 F.
61 2021-01-04 nausea NAUSEA AND HEADACHE
61 2021-01-04 nausea VACCINE SAT AT 1:30 PM, SUNDAY 9:00 AM FEELING TIRED NAUSEATED, TEMP UP TO101 THROUGH THE DAY, HEADA... Read more
VACCINE SAT AT 1:30 PM, SUNDAY 9:00 AM FEELING TIRED NAUSEATED, TEMP UP TO101 THROUGH THE DAY, HEADACHE,PAIN IN LEFT ARM AT INJECTION SITE. TEMP SEEMED TO BREAK THAT EVENING 98.0 . MONDAY INJECTION SITE VERY RED AND RAISED, ITCHY, ABOUT 1 TO 1 1/2 INCHES IN SIZE. TODAY TUESDAY SAME SIZE ITCHY NOT RAISED .
61 2021-01-04 vomiting, nausea Received COVID vaccine, severe headache started 5 minutes after the administration. Jittery, nauseat... Read more
Received COVID vaccine, severe headache started 5 minutes after the administration. Jittery, nauseated. Continued to have worsening symptoms. Nausea/Vomiting, muscle twitching, severe headache, increased heart rate went to ED on 1/5 at 0100.
61 2021-01-06 diarrhea Woke up this morning (the day after receiving the vaccine) with chills, fever of 101.9 & diarrhea. C... Read more
Woke up this morning (the day after receiving the vaccine) with chills, fever of 101.9 & diarrhea. Called my manager at work. Went back to bed. Around 8am took 2 Tylenol extra strength 225 caplets, 500mg each. 3 hours later temp down to 99.2. My normal is 97.6
61 2021-01-06 diarrhea Fever 101.7 Chills, Body Aches, Generalized Weakness, Head Ache, Diarrhea
61 2021-01-07 abdominal discomfort, decreased appetite Headache, Myalgia, Arthralgia, decreased appetite, general malaise, some abdominal discomfort
61 2021-01-07 abdominal pain upper SEVERE HEADACHE, MILD DIZZINESS, RUNNY NOSE , EAR ACHE, STOMACH ACHE, COLDS,COUGH
61 2021-01-07 abdominal pain, nausea Severe chills /tremors 14 hours following the second injection that lasted uncontrollably for one ho... Read more
Severe chills /tremors 14 hours following the second injection that lasted uncontrollably for one hour, headaches, fatigue, abdominal pain that cleared 1/7 in the afternoon. The nausea was so bad I could not eat. Vomited only one time. I missed one day of work, slept the whole day, and night, too.
61 2021-01-07 decreased appetite Chills; dry cough; no appetite; fatigue; pain at injection site; general malaise; general aches; tem... Read more
Chills; dry cough; no appetite; fatigue; pain at injection site; general malaise; general aches; temperature 102; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer-BioNTech ;lot number: EK9231) intramuscularly at right arm on 02Jan2021 at 07:45 A.M. at a single dose (dose number: 1) for COVID-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19 on 07Dec2020. No known allergies (no allergies to medications, food, or other products) and no other medical history. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medications the patient received within 2 weeks of vaccination were none. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events included chills, temperature 102, general aches, fatigue, pain at injection site, dry cough, general malaise, no appetite. Temperature elevated till 03Jan2021, 6pm. Symptoms similar to what she experienced when diagnosed with covid-19 on 07Dec2020. All events with start date on 02Jan2021 at 06:00 P.M. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Since the vaccination, the patient had not been tested for COVID-19.
61 2021-01-07 difficulty swallowing 1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after... Read more
1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after receiving the vaccine, at 2 PM started with itching of scalp, arms, legs, rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck. Took 50 mg Benadryl w/ some relief. 630 PM symptoms reoccur, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER at 830 PM
61 2021-01-07 frequent bowel movements Headache Malaise and frequent stools but not considered diarrhea Narrative: She states that she had ... Read more
Headache Malaise and frequent stools but not considered diarrhea Narrative: She states that she had immediate pain at the injection site. On Saturday at 7AM, she developed malaise and frequent stools but would not classify them as diarrhea as well as a headache. She has never had a fever. Today, she continues to feel weak but reports that she is improving.
61 2021-01-07 nausea, diarrhea Swollen stiff arm at the site of the injection; Swollen stiff arm at the site of the injection; Naus... Read more
Swollen stiff arm at the site of the injection; Swollen stiff arm at the site of the injection; Nausea; Diarrhea; shivering; Sweating; Body ache; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: PFL72TRA9899), intramuscular in left arm, on 31Dec2020 at 07:00, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (diagnosed prior to vaccination). There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. On 31Dec2020 at 8 PM (also reported as after exactly 12 hours; possibly discrepant), the patient experienced swollen stiff arm at the site of the injection, severe episode of nausea, diarrhea, shivering, sweating, and severe body ache. Treatment received for the adverse events included paracetamol (TYLENOL). The events were considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.
61 2021-01-07 nausea, vomiting, diarrhea Headache; Nausea; Vomiting; Diarrhea; I just ache all over; This is a spontaneous report from a cont... Read more
Headache; Nausea; Vomiting; Diarrhea; I just ache all over; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; Solution for injection; lot number: EJ1685; expiration date: not known), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. Medical history included hypertension. The patient's concomitant medications were not reported. The patient had been feeling fine after her last vaccination when she took it at a hospital on 29Dec2020 until today (01Jan2021), in which she experienced headache, nausea, vomiting, diarrhea, and she just ache all over. The patient stated it was not serious and just wanted to make sure she was not supposed to be doing something. The patient did not receive treatment for these reported events. The outcome of the events was unknown.
61 2021-01-07 nausea fever 101, arm soreness, body aches, fatigue, nausea, congestion and dry cough
61 2021-01-07 nausea patient reports fasting high blood sugar >200 12+ hours after vaccination - she is diabetic on oral ... Read more
patient reports fasting high blood sugar >200 12+ hours after vaccination - she is diabetic on oral metformin and has never had elevated blood sugar >140 with fasting; controlled HgA1C at 6.1%; felt dizzy, nauseated, HA and sweaty as if she may pass out - never passed out
61 2021-01-07 nausea Chills. Nausea. Headache. Body aches. Flushed face
61 2021-01-08 nausea 01/08/21 02:30am on set of headache, 01/08/21 05:15am nausea Headache, called in for work due to thi... Read more
01/08/21 02:30am on set of headache, 01/08/21 05:15am nausea Headache, called in for work due to this being so bad, 01/08/21 08:54am hip pain/throbbing, took motrin. reported difficulty to bear weight, stayed in bed all day. 01/09/20 01:00pm reports much improved continues with slight pain today, but able to ambulate and function without problems.
61 2021-01-09 nausea Headache, nausea, body aches, joint pain, fatigue.
61 2021-01-10 abdominal discomfort 1-24 hours AFTER vaccination: headache, fatigue, body aches, chills, fever (102) 24-48 hours AFTER v... Read more
1-24 hours AFTER vaccination: headache, fatigue, body aches, chills, fever (102) 24-48 hours AFTER vaccination: headache, fatigue, cough, GI distress, fever (100) 48-72 hours AFTER vaccination: headache, elevated temperature (99.7)
61 2021-01-10 diarrhea, abdominal discomfort Diagnosed with COVID-19, Fatigue, Bodyaches(severe), Myalgia, Fever, Diarrhea, GI Discomfort
61 2021-01-10 diarrhea injection site soreness and swelling, sore are with in 1 hour, lasted 48 hours, diarrhea started 13... Read more
injection site soreness and swelling, sore are with in 1 hour, lasted 48 hours, diarrhea started 13 hours after injection lasted 72 hours. headache started 12 hours after injection lasted 60 hours tiredness started 4 hours after injection lasted 48 hours I only took tylenol
61 2021-01-10 diarrhea I had diarrhea, numbness in my face, high blood pressure. 9 days of symptoms. The symptoms started a... Read more
I had diarrhea, numbness in my face, high blood pressure. 9 days of symptoms. The symptoms started a few days after.
61 2021-01-11 nausea, diarrhea Headache, nausea, diarrhea, malaise. Improving.
61 2021-01-11 nausea fever; nausea; general feeling of unwell; soreness at site; redness; whole upper arm was swollen aft... Read more
fever; nausea; general feeling of unwell; soreness at site; redness; whole upper arm was swollen after the injection; This is a spontaneous report from a contactable other HCP (patient, Respiratory Therapist) reported that a 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE , Batch/lot number: EJ1685) via an unspecified route of administration on 21Dec2020 around 6:00 PM in left upper arm at 0.3mL single dose for COVID Prevention. The patient's medical history was covid at the end of Apr/May2020 with shortness of breath, seasonal allergies and allergies to "some anitbiotics." The concomitant medications was reported as none, received no other vaccines on the same day as the COVID vaccine. The patient experienced soreness at site, redness and swelling, fever, nausea, general feeling of unwell 3 days. Patient stated, "I had covid at the end of April/May with shortness of breath. I thought I would have less reaction from the vaccine. I know someone who was out of work for a while week after the vaccine." States that she read that the 2nd dose is supposed to have worse side effects than the first. If she had bad side effects from the 1st dose, will the 2nd be worse? Also asking if the side effects are the immune system reacting or just an allergic reaction. Patient was anxious about getting her second COVID shot on 11Jan2021. Patient stated that she had all the side effects listed, for three days. Patient stated that she didn't mind the side effects at the time, she had fever, soreness at the injection site, nausea, and a general feeling of unwell, but Patient stated that she could not work like that. Patient stated that her question was, statistically she has read that the side effects from the second shot are supposed to be worse than the first shot, but she was wondering, if she had bad side effects from the first shot, will her side effects be worse after the second, or will they maybe be lessened because she already had bad side effects. Patient reported that she did fill out the VSafe significant because she had to work on the third day after her shot, which was Christmas Eve, and work, was so busy and she did not feel well. Patient stated that she does have two days scheduled off work after her next injection, but it is the third day that she was worried about because she does not want to work feeling like that. Patient stated that the arm soreness started that same day (21Dec2020). At first, Patient reported that the arm soreness resolved, but then she states that it is still a little sore to the touch. So Patient confirmed that it is ongoing but improved. Patient reportsed that the fever started the day after the injection, 22Dec2020 and it has resolved. Patient reported that the last day she recorded a fever was on 24Dec2020. Patient stated that she woke up on 24Dec2020 and her temperature was normal, so she went to work and she did not feel so well at work, but they were so busy that she barely noticed, and then when the Patient went home that night, she took her temperature and it was 100 degrees Fahrenheit. Patient reported that the nausea started on 22Dec2020, which was mild at times, but then she got to where she did not want to eat. Patient reported that the nausea has resolved but she was not entirely sure when it resolved because she had been so busy at work on 24Dec2020, and it was hard to tell what she was feeling because she was non-stop busy that day. Patient stated that she was nauseous for a full three days, and she remembered that she did not eat much on the 24th either. So Patient stated that her nausea may have resolved on the third day after her injection, but it is unknown to her what day exactly that it resolved. Patient was also experiencing the general feeling of unwell from 22Dec2020 for a few days, but stated that by 25Dec2020 she felt okay. Patient also included that her left arm was also swollen, like her whole upper arm was swollen after the injection in Dec2020. Patient stated that she also experienced redness, there was a like a red mark that was further down her arm than the injection site in Dec2020. The outcome of soreness at site was recovering. Patient confirmed that both the swelling and redness had resolved in Dec2020.The outcome of fever was recovered on 24Dec2020. The outcome of general feeling of unwell and nausea was recovered on 25Dec2020.
61 2021-01-11 vomiting developed dizziness and vomiting day of vaccine administration
61 2021-01-12 abdominal pain, diarrhea, nausea 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 2021-01-12 nausea Nausea, chest pain, difficulty breathing following first dose of Pfizer COVID-19 vaccine 0.3 mL IM i... Read more
Nausea, chest pain, difficulty breathing following first dose of Pfizer COVID-19 vaccine 0.3 mL IM in right deltoid. Went to outside ED and placed on BiPAP. Given diphenhydramine, epinephrine, and steroid (unknown doses). Prescribed outpatient epinephrine in case of flare of reaction once stabilized.
61 2021-01-12 nausea Extreme fatigue, hard chills, fever of 100 for several hours, nausea, generalized weakness. Chills ... Read more
Extreme fatigue, hard chills, fever of 100 for several hours, nausea, generalized weakness. Chills and extreme fatigue lasted 4 hours. Low grade fever lasted 12 hours.
61 2021-01-13 diarrhea, nausea Headache for3 days Nausea for 3 days Muscle weakness for 3 days. Joint pain for 3 days. Red rash at ... Read more
Headache for3 days Nausea for 3 days Muscle weakness for 3 days. Joint pain for 3 days. Red rash at injection site. Swelling at injection site. Diarrhea for 2 Days
61 2021-01-13 nausea Pt received vaccine at 0730 on 1/11/2021. She developed fever, chill, body aches and headache at mid... Read more
Pt received vaccine at 0730 on 1/11/2021. She developed fever, chill, body aches and headache at midnight the same day. The following day shew had a fever a high as 103. She continued to feel fatigued, achy, headache, slightly nauseated and weak. Her symptoms improved over the course of the last 2 days. She is fever free today
61 2021-01-13 nausea At time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed a... Read more
At time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested for about 45 mins before I felt well enough to drive. All better after about 2 hours.Next day, tired, sweaty, nauseous, lightheaded when standing.
61 2021-01-13 nausea Fever to 102 F. Chills. Total body aches. Severe headache. Nausea. All began around midnight, 1... Read more
Fever to 102 F. Chills. Total body aches. Severe headache. Nausea. All began around midnight, 16 hours post-shot. Worsened throughout the night and began to diminish about 8 hours later. After about 12 hours had only slight fever, more manageable headache, was achy all over and fatigued. Back to baseline 36 hours after onset of symptoms.
61 2021-01-14 abdominal pain upper but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; but then... Read more
but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; Got the vaccine early Friday afternoon and had a sore arm; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the vaccine early Friday (08Jan2021) afternoon and had a sore arm but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever. The patient asked if that normal for side effects to occur 2 days later. The outcome of the events was unknown. Information on the lot/batch number has been requested.
61 2021-01-14 abdominal pain, diarrhea Chills; Diarrhea; Again today 24 hours later she had abdominal cramping that was almost debilitating... Read more
Chills; Diarrhea; Again today 24 hours later she had abdominal cramping that was almost debilitating; Abdominal cramps; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on the right arm on 07Jan2021 07:00 at single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient experienced abdominal cramps on 07Jan2021 13:30, diarrhea and chills for 20 or 30 minutes and then it all went away on 08Jan2021. Again today 24 hours later, she had abdominal cramping that was almost debilitating. Had Covid 19 Test up the nose test, thinks it was PCR that was negative on 06Nov2020. The outcome of events was recovered on 08Jan2021.
61 2021-01-16 decreased appetite "Pfizer-BioNTech COVID-19 Vaccine EUA", Injection site pain, Severe tiredness, mild headache, muscle... Read more
"Pfizer-BioNTech COVID-19 Vaccine EUA", Injection site pain, Severe tiredness, mild headache, muscle pain, fever, loss of appetite, HR in lower 90's, pulse OX in low 90's.
61 2021-01-17 constipation, abdominal pain, vomiting, nausea Headaches, Chills, worst nausea and abdominal pain I?ve ever had in my life, vomiting
61 2021-01-17 nausea, decreased appetite, vomiting Was cold, took a shower, got out , couldn't get warm. Freezing and shaking, nausea, tingling in left... Read more
Was cold, took a shower, got out , couldn't get warm. Freezing and shaking, nausea, tingling in left side of face, joint pain, headache and neck pain. Lasted about 3 hours, shaking stopped but had chills that lasted all night. The next day, no appetite but when she ate something, she vomited. Worse things were shakes, headache and neck pain and vision. . Had vision problems. Eyes were swollen and jittery and hard to focus. The swelling went away but still unable to focus. Everything has gone except vision issue.
61 2021-01-17 nausea Nausea & Headache
61 2021-01-17 vomiting, diarrhea Received Vaccine on 1/2/2021 at 10AM , at 3PM employee felt itchy, took a nap, and at 8PM she had a ... Read more
Received Vaccine on 1/2/2021 at 10AM , at 3PM employee felt itchy, took a nap, and at 8PM she had a circular redden skin rash on her arms, legs, and torso. Temperature: 99 degrees. Employee took Tylenol and Claritin for rash, complained of diarrhea, vomiting, and weakness of both knees within 24 hours all symptoms were gone.
61 2021-01-18 abdominal discomfort fatigue; headache; body aches; chills; cough; GI distress; high fever (102); This is a spontaneous r... Read more
fatigue; headache; body aches; chills; cough; GI distress; high fever (102); This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration in the left arm, on 08Jan2021 at 17:00, at a single dose, for COVID-19 immunization. Relevant medical history included diabetes type 2, high blood pressure, hyperlipidemia, and glaucoma. Concomitant medications included orphenadrine (K-FLEX), empagliflozin (JARDIANCE), losartan, atorvastatin calcium (LIPITOR), and insulin. The previously took metformin and experienced allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient is not pregnant at the time of vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021, at 18:00, the patient experienced fatigue, headache, body aches, chills, cough, gastrointestinal (GI) distress, and high fever (102). The patient did not receive treatment for the events. Outcome of the events was recovering. Information on the lot/batch number has been requested.
61 2021-01-18 abdominal pain upper, diarrhea, nausea nausea diarrhea extreme stomach pain
61 2021-01-18 difficulty swallowing itching of scalp, arms, legs; rash; abdominal hives; facial swelling; difficulty swallowing; swellin... Read more
itching of scalp, arms, legs; rash; abdominal hives; facial swelling; difficulty swallowing; swelling back of neck; inj site very sore; fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK923) , via an unspecified route of administration on 29Dec2020 09:45 at the first single dose at arm left for covid-19 immunisation. Medical history included known allergies: Sulfa. The concomitant drug was unspecified. The patient previously took cipro and experienced drug hypersensitivity. On 29Dec2020, the patient expected side effect of inj site very sore and fatigue for 24 hours. On 06Jan2021 14:00, the patient started with itching of scalp, arms, legs ,rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck, took 50 mg Benadryl w some relief. 630 PM symptoms reoccurred, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of the back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER. The patient received Prednisone 50 mg orally and for the 4 days. The outcome of event inj site very sore and fatigue was recovered on 30Dec2020; the outcome of events was recovered.
61 2021-01-18 nausea, decreased appetite 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 2021-01-18 nausea, diarrhea DIARRHEA 01/09, 01/10, 01/11, HEADACHE 01/09THRU 01/19 VERY TIRED 01/09 THRU 01/19 NAUSEA 01/09 TH... Read more
DIARRHEA 01/09, 01/10, 01/11, HEADACHE 01/09THRU 01/19 VERY TIRED 01/09 THRU 01/19 NAUSEA 01/09 THRU 01/19 SORE ARM 01/09 THRU 01/19
61 2021-01-18 nausea 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 vomiting, nausea chills shakes nausea vomiting cough sob sore throat maliase
61 2021-01-19 diarrhea, diarrhea with profuse bleeding, nausea Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours... Read more
Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours after injection (I took 2 Tylenol and took a 3 hour nap) o Tired o Left Eye twitch o Blurred double vision o Headache o Nauseous ? Side Effects started about 5 - 6 hours after injection (I took 2 Tylenol a Benadryl and used my Ventolin inhalator) o Tired o Watering eyes o Sore tongue o Headache o Nauseous o Heavy feeling in chest ? Side Effects started some time during the night after injection o Muscle cramping in both legs and opposite arm of injection site o Low fever 100.3 Sunday side Effects (I took 2 Tylenol and took a 3-4 hour nap) o Tired o Left Eye twitch o Watering eyes o Sore tongue o Excessive thirst o Swollen neck glands o Nauseous (only after eating) o Muscle cramping in both calves o Blurry vision in the evening o Runny nose Monday side Effects (Went to work) o Tired o Left eye lid twitch o Swollen neck glands o Nauseous o Runny nose o Achy body o Diarrhea Tuesday side Effects (Went to work) o Left eyelid twitch o Swollen neck glands o Runny nose o Sore throat o Diarrhea BLOODY Wednesday side Effects (went to work) o Swollen neck glands o Runny nose o Sore throat Note: I have several Allergies that require me to take an allergy pill every day. I also use an inhaler as needed. My symptoms were not any worse than when I have a bad allergic reaction, I have received shots of Epinephrine for my allergies and did not feel one was necessary.
61 2021-01-19 difficulty swallowing After waiting 15 mins I developed a dry throat and walked to my car (8-10 mins later). Began to dev... Read more
After waiting 15 mins I developed a dry throat and walked to my car (8-10 mins later). Began to develop difficulty swallowing by the time I reached my car. Waited a few minutes and it did not abate and continued worsen,. Went to hospital's ER and was seen by Dr. At that time, my voice had become coarse and gravely. Was given oral steroid and a Benadryl. Symptoms lessened a bit and were gone after about 2 hours. While at first I thought my breathing wasn't affected, after symptoms cleared, I realized that my breathing was easier. Symptoms did not reoccur.
61 2021-01-19 nausea Dose 2 given at 1208 on 1/20/2021. At 1232 pt noticed flushing in the arms b/l, persistent pins and ... Read more
Dose 2 given at 1208 on 1/20/2021. At 1232 pt noticed flushing in the arms b/l, persistent pins and needles in arms, hands, and feet b/l, with "slight tingle" in lips. Unusual taste in mouth (that happened after 1st dose as well). Small wave of nausea. Sensation of heat in chest. At 1301 on 1/20/2021, 50 mg of IM Benadryl administered to RD (Lot # 080010, Exp 8/20/2022) by NP. At 1320, arms were less flushed, however b/l pins and needles persistent in both arms and feet, with "tingling" still in lips. Pt will wait until symptoms improve further to d/c to home. NP checking in continuously.
61 2021-01-19 vomiting Slightly sore left deltoid, cleared up in a few days. 16 hours after shot, experienced the dramatic... Read more
Slightly sore left deltoid, cleared up in a few days. 16 hours after shot, experienced the dramatic sensation of tilting while sitting on a couch. Had I been driving, this would likely have caused an accident. This is the first time I have ever experienced this feeling. There were 2 or 3 other episodes of feeling like I was falling. 2 of this happened while lying down. They were sudden sensations that made me gasp. Spent most of 1 week in bed with fatigue, vertigo, and 2 times vomiting. Vomiting occurred day 2 post vaccine. Fatigue was continuous for about a week. At day 16 now, certain movements still illicit vertigo. All vertigo symptoms have lasted under 1 minute. However, some have been back to back, such as after repositioning multiple times in bed. Ears have felt very full for almost 2 weeks. Certain head positions or movements, still illicit sensations of the room moving. There was no specific headache, but my head did not feel good for about 2 weeks. There was no fever, but there was chilling one night, a couple of days after the vaccine. I don't know if getting 2nd vaccine is wise.
61 2021-01-20 abdominal discomfort Extremely tired dizzy feeling of vomiting upset stomach
61 2021-01-20 diarrhea Diarrhea about 6hrs after injection chills fever body aches and dull headache continued for about a... Read more
Diarrhea about 6hrs after injection chills fever body aches and dull headache continued for about another 24 hrs
61 2021-01-20 nausea, abdominal pain upper, diarrhea 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 2021-01-20 nausea 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 2021-01-21 nausea 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 nausea Had when I woke up at 6 am set on Jan 22, 2021 still ongoing Sore throat, severe headache, nausea, ... Read more
Had when I woke up at 6 am set on Jan 22, 2021 still ongoing Sore throat, severe headache, nausea, muscle ache, light headness, dizzy. January 22, 2021 temp 100.1 tympanic
61 2021-01-21 vomiting, nausea Headache 8:00pm to current 4:00pm 1-22-21 Nausea 6:00 am 1-22-21 to 3:00 pm Vomiting 8:00 am to 1:30... Read more
Headache 8:00pm to current 4:00pm 1-22-21 Nausea 6:00 am 1-22-21 to 3:00 pm Vomiting 8:00 am to 1:30 pm. Took zofran
61 2021-01-24 abdominal discomfort 12 hours after shot Headache, stomach upset, fever 100.6, body aches x 36 hours
61 2021-01-24 nausea, vomiting Chills. Fever. Nausea. Vomiting. Fainted
61 2021-01-25 nausea Headache, nausea
61 2021-01-25 vomiting No problems with first vaccine. Started having severe head aches 2 days after the vaccine. Back Ache... Read more
No problems with first vaccine. Started having severe head aches 2 days after the vaccine. Back Ache after 5 days on the right side. Throwing up 6 days after for 3 days. Went to the hospital 10 days later for four days was taken by ambulance because she was to ill to drive.
61 2021-01-26 decreased appetite 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 indigestion, vomiting Intense indigestion followed but intense vomiting; Intense indigestion followed but intense vomiting... Read more
Intense indigestion followed but intense vomiting; Intense indigestion followed but intense vomiting; This is a spontaneous report from a contactable Nurse reporting for herself. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1685), via an unspecified route of administration at right arm on 23Dec2020 15:00 at single dose, then received the second dose of BNT162B2 (lot number: E10140), via an unspecified route of administration at left arm on 11Jan2021 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included hypertension, and depression, and allergy to latex. Concomitant medication included desvenlafaxine succinate (PRISTIQ), hydrochlorothiazide, olmesartan medoxomil (BENICAR HCT). Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced intense indigestion followed but intense vomiting on 25Dec2020 11:00. Occurred 48hours after 1st injection and 56 hours after 2nd. Was much more intense after 2nd injection. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date in Jan2021.
61 2021-01-26 nausea, vomiting, indigestion Chills, low grade fever right away. Next 9 days--severe stomach burning, nausea, unable to hold flu... Read more
Chills, low grade fever right away. Next 9 days--severe stomach burning, nausea, unable to hold fluids down, "metal taste"--by day 9 went from 103 kg to 92 kg. Slowly got better after this with time and Pepto Bismol.
61 2021-01-27 decreased appetite, abdominal discomfort A little over 48 hours into my COVID19 shot (Pfizer), I got sick. I was freezing cold, slight headac... Read more
A little over 48 hours into my COVID19 shot (Pfizer), I got sick. I was freezing cold, slight headache, no appetite, and tired/achy. I slept for 3 hours and woke up a little after 8 p.m. Temperature was 100.5. After calling work and notifying my doctor, I drank a Powerade and went to bed. This morning, I feel almost normal. Slight headache (maybe from lack of food) and my stomach is still a little upset.
61 2021-01-27 diverticulitis Client was being treated with antibiotics by her PCP for diverticulitis flare up. It had not been r... Read more
Client was being treated with antibiotics by her PCP for diverticulitis flare up. It had not been resolved on the date of her death which occurred 01/27/21, She was found unresponsive by staff, 911 contacted, and paramedics pronounced her deceased at 7:48 AM. After consultation with PCP manner of death was noted as cardiac arrest. PCP was to sign off on death certificate.
61 2021-01-27 difficulty swallowing 10 -15 minutes after shot: Swelling of tongue; drainage from nose and back of throat;gourde voice; t... Read more
10 -15 minutes after shot: Swelling of tongue; drainage from nose and back of throat;gourde voice; trouble swallowing : elevated blood pressure Told nurse 25 minutes later.given benedryl injection Things improved and an hour later tongue began to swell again and blood press increased Paramedics called and they transported me to the ER where I was given an Epi injection and steroids. Monitored for three hours and sent home with prescription for steroids: epi pen; and zyrtec Still experiencing fatigue , headache and lots of drainage off and on
61 2021-01-27 nausea tired; sweaty; nauseous light headed when standing; rush of hotness through entire body; severe naus... Read more
tired; sweaty; nauseous light headed when standing; rush of hotness through entire body; severe nausea/nauseous light headed when standing; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Lot number: 3302), via an unspecified route of administration in right arm on 13Jan2021 13:00 at single dose for covid-19 immunization. Medical history was none. Concomitant medication included escitalopram, vitamin d. At the time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested about 45 mins before feeling well enough to drive. All better after about 2 hours. Next day (14Jan2021), tired, sweaty, nauseous light headed when standing. No treatment received. No pregnant at the time of vaccination. The outcome of the events was unknown.
61 2021-01-27 nausea headaches; achy feeling; nausea; felt hot; This is a spontaneous report from a contactable consumer ... Read more
headaches; achy feeling; nausea; felt hot; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3249) via an unspecified route of administration in the left arm on 12Jan2021 09:15 AM at a single dose for COVID vaccine. Medical history included rheumatoid arthritis. Concomitant medications included leflunomide, paroxetine, and ergocalciferol (VITAMIN D) (other medications in two weeks). The patient had no other vaccine in four weeks. The patient had known allergies to sulfamethoxazole/trimethoprim (SEPTRA) and mefloquine. It was reported that the patient had 4 days of headaches and achy feeling on 12Jan2021. During her 30-minute wait after the injection, she experienced some nausea and felt hot on 12Jan2021. Treatment was not received for the events. The patient had no COVID prior vaccination. She did not have COVID tested post vaccination. The outcome of the events was recovering.
61 2021-01-27 nausea FEVER, CHILLS, NAUSEA, FATIGUE, FLU-LIKE SYMPTOMS, TREATED WITH TYLENOL 650MG BID, EFFECTIVE - SYMT... Read more
FEVER, CHILLS, NAUSEA, FATIGUE, FLU-LIKE SYMPTOMS, TREATED WITH TYLENOL 650MG BID, EFFECTIVE - SYMTPOMS RESOLVED
61 2021-01-27 nausea FEVER, CHILLS, FATIGUE, NAUSEA; 12HR; TREATED WITH TYLENOL 650MG BID; EFFECTIVE
61 2021-01-27 nausea Fever 101; pain in both thigh; chills; nausea; headache; This is a spontaneous report from a contact... Read more
Fever 101; pain in both thigh; chills; nausea; headache; This is a spontaneous report from a contactable nurse (patient herself). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 13:00 at single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). Concomitant medications were none. 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 vaccinated at a hospital. 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 had no allergies to medications, food, or other products. On 14Jan2021 01:00, the patient experienced fever 101, pain in both thighs, chills, nausea and headache. No treatment was received for the adverse events. Clinical outcome of the events was recovered with sequelae on Jan2021.
61 2021-01-29 diarrhea 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 2021-01-29 nausea Numbness around my mouth, chills, and nausea
61 2021-01-30 nausea 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 2021-01-30 vomiting Metallic taste in her mouth. Violent shaking for 11.5 hours and pulled muscles in her stomach and b... Read more
Metallic taste in her mouth. Violent shaking for 11.5 hours and pulled muscles in her stomach and back. Injection site hot. Fingers on that side were white Dizziness. H/A. Vomiting
61 2021-01-31 diarrhea, nausea headache in the frontal lobe nausea diarrhea dizzy
61 2021-01-31 diarrhea 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 2021-01-31 nausea, diarrhea Headache, Chills, Nausea, Diarrhea, Malaise
61 2021-01-31 nausea Patient's reaction(s) noted during COVID vaccine observation period: At 1700, patient had left obs... Read more
Patient's reaction(s) noted during COVID vaccine observation period: At 1700, patient had left observation area, gotten to car, drove away but returned because she was experiencing nausea and headache. Patient was seated, used wet cloth to forehead and back of neck. VS: B/P 127/86, HR 98, O2 sat 98%, Temp 98.0. At 1715 VS: B/P 124/76, HR 88, O2 sat 98%, temp 98.1. At 1730 VS: B/P 121/91, Hr 86, O2 sat 98%,. Still c/o headache, refused tylenol. Nausea still present but slightly improved. Reassured by staff and husband and taking sips of Sprite 1745 B/P 118/64, HR 85, )2 sat 98%, nausea improving still has H/A, states these symptoms have occurred in past with other events. 1800 B/P 117/69, HR 89, O2 sat 98%. Was walked out to car, denies lightheadedness or shortness of breath. States other symptoms are improving. Disposition: Declined going to ED. Left to go home with no further concerns.
61 2021-01-31 nausea Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Other- CHEST TIGHTNESS,TROUBLE BREATHI... Read more
Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Other- CHEST TIGHTNESS,TROUBLE BREATHING-Medium
61 2021-01-31 vomiting Chills & Vomiting
61 2021-02-01 nausea very sore Painful arm at injection site; Started chilling; ran a fever between 102- 103 degrees; hea... Read more
very sore Painful arm at injection site; Started chilling; ran a fever between 102- 103 degrees; headache; felt nauseous; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration in left arm on 18Jan2021 10:00 at first single dose for COVID-19 immunization. Medical history included high blood pressure (BP) on medication, known allergies: Penicillin (PCN), levaquin, covid-19 on 18Nov2020. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient had a very sore painful arm at injection site, no redness, started chilling and ran a fever between 102- 103 degrees during the night and into the next day. Had headache felt nauseous. Events start date/time: 19Jan2021 02:00 AM. By 6 pm the next day the patient started to feel a little better. The patient tested positive for covid 19 in 18Nov2020. Covid was not tested post vaccination. No treatment was received for the events. Outcome of the events was recovering.
61 2021-02-01 vomiting, diarrhea, stomatitis lost 22lbs; teeth hurting; can't eat; sores in mouth; cold chills; Headache/it's mainly in the back ... Read more
lost 22lbs; teeth hurting; can't eat; sores in mouth; cold chills; Headache/it's mainly in the back of her head; Diarrhea; Throwing up/threw up 4 times; low grade temp of 100; This is Spontaneous report from a contactable consumer reporting for self. A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration in Right arm on 14Jan2021 10:00 at single dose for covid-19 immunisation. Patient received 1st dose of bnt162b2 on 24Dec2020, Lot number: EL0140; She only had a little aches with the first dose. States that she has had Covid before. There were no concomitant medications. She got the 2nd covid vaccine and felt like she got Covid all over again, diarrhea, throwing up, cold chills, and headaches started on 15Jan2021 at around 2:00AM, low grade temp of 100 on 15Jan2021, then she got sores in her mouth and now her teeth hurt. States that maybe it's from the fever. States that she can't eat because it hurts. She lost 22lbs because she couldn't eat. She has been gargling with half warm water and half peroxide. States that she threw up 4 times, but she doesn't even remember how many times she had diarrhea. After she was done throwing up she finally sat down and took her temperature, so it was probably around 4:00-5:00 AM. States that she still has a headache; it's mainly in the back of her head. Outcome of event diarrhea, throwing up, low grade temp of 100, chills was recovered, of headache was recovering, of can't eat and lost 22lbs was unknown, of others was not recovered.
61 2021-02-02 abdominal pain upper Patient reported stomach cramping and had 5 bowel movements after vaccine. Stated was nervous for t... Read more
Patient reported stomach cramping and had 5 bowel movements after vaccine. Stated was nervous for the shot. Took blood pressure 137/80. No diarrhea bowel movements were normal. Monitored pt and she felt better and reported still a little cramping but much better.
61 2021-02-03 abdominal discomfort a few days after the 1st I had intestinal discomfort, two days later I was passing only mucus, two d... Read more
a few days after the 1st I had intestinal discomfort, two days later I was passing only mucus, two days later blood was mixed with the mucus. two days later it was mostly blood. After the 2nd dose, the bleeding increased and went to 100% blood. The bleeding lasted a total of 18 days. My GI appointment was a few days later.
61 2021-02-03 diarrhea Diarrhea; Chills; Slight headache; Very body tired; This is a spontaneous report from a contactable ... Read more
Diarrhea; Chills; Slight headache; Very body tired; This is a spontaneous report from a contactable other HCP reported for herself that a 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: p9231), via an unspecified route of administration at the age of 61-years, on 22Jan2021 17:00 (05:00 PM) at single dose in left arm for COVID-19 immunization, in hospital. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient had slight headache on 23Jan2021 and was very body tired. On 24Jan2021 10:00 AM, she had diarrhea and chills. No treatment received for the adverse events. The events were considered as non-serious. Outcome of the events was recovering/resolving. Since the vaccination, the patient has not been tested for COVID-19.
61 2021-02-03 diarrhea Headaches, dizziness, loose stool, upper body pain, 8/10 for 15 minutes (Felt like a heart attack an... Read more
Headaches, dizziness, loose stool, upper body pain, 8/10 for 15 minutes (Felt like a heart attack and then gone completely after 10 minutes)
61 2021-02-04 difficulty swallowing Difficulty swallowing, tongue swelling, headache, Epi pen 0.3mg, 25 mg Benadryl Improvement in tong... Read more
Difficulty swallowing, tongue swelling, headache, Epi pen 0.3mg, 25 mg Benadryl Improvement in tongue swelling
61 2021-02-04 nausea Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, diz... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, dizziness, chest pressure, and profound weakness. Brought to Emergency Department by crisis RN where she remains achy with weakness, fatigue and had no energy. Pt reports "feeling tired" and "my speech is slower". On exam, slight R facial droop noted, tongue noted to be leaning towards the right, pronator drift noted in R arm. Code Brain activated with real time audio video interaction. MRI completed with normal results. Symptoms resolved. Stroke team ok with discharge to home with f/u with PCP.
61 2021-02-06 nausea, abdominal pain 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 indigestion indigestion
61 2021-02-07 nausea Sore arm. Nausea. Fatigue
61 2021-02-08 abdominal pain, nausea, abdominal discomfort On 2/5 am felt dizzy and nauseated. On 2/6 am felt dizzy and nauseated On 2/7 had child, abdominal ... Read more
On 2/5 am felt dizzy and nauseated. On 2/6 am felt dizzy and nauseated On 2/7 had child, abdominal cramping and pain , Temp 99.3 On 2/8 stomach uncomfortable, fatigue and muscle aches. 2/9 feel tired
61 2021-02-08 nausea Chills, fever up to 101.2 F, body aches, and nausea, lasting 40 hours.
61 2021-02-09 nausea, vomiting splitting headaches; chronic nausea; Vomiting is explosive and unpredictable; metallic taste in mout... Read more
splitting headaches; chronic nausea; Vomiting is explosive and unpredictable; metallic taste in mouth for 3 days.; This is a spontaneous report from a contactable other hcp, the patient. This 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730), dose number 1, via an unspecified route of administration in the right arm on 29Dec2020 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunization. Medical history included type 1 diabetes mellitus from 1974 to an unknown date (T1DM dx 1974) and aortic valve replacement from 1990 and unknown if ongoing (AVR 1990 and 1992). Concomitant medication included insulin (INSULIN), simvastatin (SIMVASTATIN) and lisinopril (LISINOPRIL). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 31Dec2020, the patient experienced metallic taste in mouth for 3 days. On 07Jan2021 at 13:00, the patient experienced splitting headaches, chronic nausea began and vomiting which was explosive and unpredictable. No therapeutic measures were taken as a result of the events. The clinical outcomes of the metallic taste in mouth for 3 days, splitting headaches, vomiting and chronic nausea were not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
61 2021-02-09 nausea I had flu like symptoms headache and dizziness with both doses. The symptoms of the first dose stopp... Read more
I had flu like symptoms headache and dizziness with both doses. The symptoms of the first dose stopped at day 3. After the second dose, 3 weeks later, the symptoms appeared later but held on to day 5 or 6, except the more extreme dizziness which I still have. It is worse on some days and there is some nausea in the mornings with headache. I have never had vertigo but this is what I imagine it to be.
61 2021-02-10 abdominal pain upper Chills, body aches, headache, stomach ache Duration = 60 hours
61 2021-02-10 nausea Injection Site Pain, tiredness, headache severe, muscle pain, chills, joint pain, fever, nausea, fee... Read more
Injection Site Pain, tiredness, headache severe, muscle pain, chills, joint pain, fever, nausea, feeling unwell, cough
61 2021-02-11 nausea Left arm pain at injection site x 3 weeks, nausea, heart palpitations x 1 1/2 weeks
61 2021-02-12 nausea, vomiting Patient reports feeling unwell after injection. She felt like "throat was swollen." Also reports h... Read more
Patient reports feeling unwell after injection. She felt like "throat was swollen." Also reports having nausea/vomiting, fatigue and headache that persisted until 2/9/2021 (approximately 2-3 days after injection). She did not eat Saturday and Sunday (day of the injection and day after injection). She was finally feeling able to eat on 2/9/2021. She also reported sensation of heart going "fast" up to 93 on Sunday (2/7/2021). She denies any fevers or diarrhea. She also developed soreness in left arm at area of injection site, but did not have any redness at injection site.
61 2021-02-13 vomiting, diarrhea Wokke up around 3:00 a.m. 3 nights after vaccine. Violent vomiting 3-4 times, then diahhrea for abou... Read more
Wokke up around 3:00 a.m. 3 nights after vaccine. Violent vomiting 3-4 times, then diahhrea for about half hour. Thought I had food poisoning. Sever headache shortly after. Sunday, slight fever, listless, some muscle aches, joint pain. Sunday night, headaches returned. Monday, slight fever, muscle aches, swollen lymph nodes under right armpit. Some mild muscle aches and joint pain. Monday night, headache again. Tuesday, same symptoms. Wednesday, some joint pain, swollen lymph node, otherwise fine.
61 2021-02-14 nausea Severe all arm pain for short period of time, chills, headache, fatigue, swollen lymph nodes and con... Read more
Severe all arm pain for short period of time, chills, headache, fatigue, swollen lymph nodes and continuing nausea.
61 2021-02-16 diarrhea, nausea 61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief compl... Read more
61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine (Pfizer) on 1/28/21. Upon arrival to triage she was obviously dyspneic with significantly low oxygen saturations. O2 sats on arrival were 65%, improved to mid 90's with O2 6 liters per NC. Admitting diagnosis: hypoxic respiratory failure post COVID vaccine. Lab work shows an elevation of the BUN and creatinine at 31 and 1.71 which is slightly higher than her usual baseline levels. BNP is elevated at 2 448 with a mildly elevated troponin. Procalcitonin is also elevated. Patient's white blood cell count is 11.07. Full viral panel including COVID-19 is not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, Thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 2/8/2021 and then VV ECMO cannulation on 2/13/2021. EGD done 2/14/2021 as unable to pass the TEE probe during cannulation prior day (unable to complete due to abnormal anatomy). Acute pupil exam change in the early am hours of 2/15/2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. GOL engaged and patient not an organ donation candidate. Therefore discussion with sister at bedside resulted in decision for cessation of life support. Patient expired shortly after support withdrawn and pronounced dead on 2/15/2021 at 11:11 AM.
61 2021-02-16 diarrhea diarrhea
61 2021-02-16 nausea, diarrhea Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101... Read more
Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101 - 2 days headache - 5 days nausea - still have diarrhea - 6 days Sore and stinging left arm (received vaccine), sore upper and lower back and neck. Felt like I was kicked in those areas - still have Fatigue - 6 days, lessening Toes bright red at the top and are painful, areas on bottom of toe as well - still have
61 2021-02-16 nausea almost like she also had some mild hearing loss; nausea; exacerbation of migraine with paresthesia a... Read more
almost like she also had some mild hearing loss; nausea; exacerbation of migraine with paresthesia and tinnitus/ headaches/migraines; exacerbation of migraine with paresthesia and tinnitus; exacerbation of migraine with paresthesia and tinnitus/ increased tinnitus; some abdominal tightness; This is a spontaneous report from a contactable pharmacist (patient herself) via Medical Information team. A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3302, NDC number/expiration date was unknown), via an unspecified route of administration on the left arm (also reported as upper left arm) on 13Jan2021 at 09:00 at a single dose for COVID-19 immunization; the patient was a healthcare worker and was trying to protect herself. The vaccination facility type was reported as a drive thru site. Relevant medical history included previous neurological problems, which included history of underlying migraine with paresthesia/chronic paresthesia (ongoing) and tinnitus. The patient had no family medical history relevant to the adverse events (AEs). There were no concomitant medications. The patient had no other vaccine received on the same day of the Pfizer suspect or 4 weeks prior. She never had any problems with vaccines in the past. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Initially, the patient was asking if there were any reports of paresthesia, serious neurologic adverse events, tinnitus, hearing loss, or abdominal tightness in the studies for the Pfizer-Biontech Covid-19 vaccine. After the patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 13Jan2021, she experienced an exacerbation of migraine with paresthesia and tinnitus. She also reported experiencing some abdominal tightness on an unspecified date in Jan2021. The patient reported she was scheduled for her second dose of the Pfizer COVID-19 vaccine, but had concerns because she was still experiencing tinnitus and it was "almost like she also had some mild hearing loss" on an unspecified date. The patient further reported that she was due for the next dose the following day at the time of the report (03Feb2021). She had previous neurological problems and did not know if this did exacerbate things or not. She had migraines, tinnitus, and paresthesia and was wondering how many other patients with neurological problems reported this and was this a common side effect or adverse event reported. One doctor told her not to get the second dose and another one told her to get it and she wanted to know what she should do. The patient had headaches/migraines on the evening of vaccination on 13Jan2021 that were fairly mild and 3 days after that on 16Jan2021, they got bad and was accompanied with nausea with increased tinnitus. The migraines and nausea had gone, and the chronic paresthesia was the same as she always had, but the tinnitus was a lot louder and worse. The patient also mentioned that her migraines usually go away, but this one had lingered. The AEs did not require any visit to an emergency room or a physician office. There were no investigation assessment. The patient recovered from the event "nausea" on an unspecified date, she was recovering from the event "exacerbation of migraine/ headaches/migraines," she was not recovered from the events "exacerbation of paresthesia and tinnitus/increased tinnitus, while the outcome of the events "almost like she also had some mild hearing loss and some abdominal tightness" was unknown. The reporter assessed the events "migraine, tinnitus, paresthesia, and nausea" as serious, other medically important conditions. The relatedness of drug to the reactions/events "migraine, tinnitus, paresthesia, and nausea" was unknown as per the reporting pharmacist (Method of assessment: Global Introspection).; Sender's Comments: The 61-year-old female had relevant medical history included previous neurological problems. The reported neurological events and partial hearing loss were more likely due to pre-existing conditions, and less likely related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). Event nausea was likely due to the first dose of bnt162b2. 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 2021-02-18 nausea 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 2021-02-18 nausea Over a 3 day period, I had chills, fever, entire body aches (I could barely move), nausea, EXTREME l... Read more
Over a 3 day period, I had chills, fever, entire body aches (I could barely move), nausea, EXTREME labored breathing. Symptoms were more severe than the actual covid virus I had.
61 2021-02-18 nausea 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 2021-02-19 nausea Patient presented for COVID vaccination today, first dose. Prior to receiving dose, she mentioned to... Read more
Patient presented for COVID vaccination today, first dose. Prior to receiving dose, she mentioned to RN that she has a history of vasovagal syncope following her shingles vaccine. She routinely has flu vaccines without any adverse reaction. RN requested I standby and observe while patient receives vaccine. Within minutes of receiving vaccine, patient endorses prodromal symptoms lightheadedness, hot flashes, then lost consciousness while seated in the chair. After approximately 1 minute, the patient did regain consciousness. She was given orange juice and crackers and felt well enough to ambulate to a chair in the observation area. Vital signs were WNL and she was monitored closely in the observing area. She continued to complain of "queasiness" often stating that she just feels that she would like to go lay down and nap in her car. Rechecked her blood pressure which dropped to 94/64, patient states she usually runs low but systolic within the low 100's. She was taken to a private hallway where she laid down on a stretcher. Blood sugar checked reading 121. She was given more water but she was uninterested in any more food, as she questions if the orange juice and the crackers were the cause of the queasiness. Blood pressure was rechecked and she was again WNL. Given her persistent fatigue and "queasiness", team lead contacted ED charge nurse to discuss case. The recommendation was to have the patient further evaluated. Discussed with team lead, and it was agreed upon that this was best course of action given her persistent symptoms. EMS was called. Per EMS report, patient's blood pressure did rise which patient attributed to excitement/anxiety surrounding the situation. Patient ultimately declined EMS transfer to ED. Her husband arrived to drive her home. Discussed the importance of monitoring symptoms for the next 48 hours. If she has any worsening "queasiness", weakness, fatigue, nausea/vominting, throat swelling, wheezing, dyspnea then she is to call 911 immediately. Patient verbalizes understanding and is agreeable to emergency services should any of these problems occur.
61 2021-02-21 vomiting Vomiting, rash, dizziness, weakness
61 2021-02-22 vomiting, nausea nausea, vomiting, headache, tired, chills, pain in injection site
61 2021-02-23 abdominal pain upper Extreme lower stomach pain; Could not move for 3 days; dehydration; fatigue; speech issues; This is ... Read more
Extreme lower stomach pain; Could not move for 3 days; dehydration; fatigue; speech issues; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location/vaccination location: arm left) on 29Jan2021 13:30 at SINGLE DOSE for COVID-19 immunisation. Medical history included bad back, penicillin allergy, and covid prior vaccination all from unknown dates and unknown if ongoing. The patient has not had other vaccine in four weeks. Patient was not pregnant. Concomitant medication included oxycodone hydrochloride (OXYCONTIN). The patient experienced extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues (all events assessed as serious - disability) all on 05Feb2021 17:00. Patient's clinical course is as follows: One week after the shot, patient had extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues then continued for 2 more days. No treatment was provided for the events. It was reported that patient was COVID tested post vaccination. The patient underwent lab tests and procedures which included nasal swab with result of negative on 20Jan2021. Facility type vaccine was reported as nursing home. Outcome of the events was recovering. Information on the lot/batch number has been requested.
61 2021-02-23 diarrhea, nausea chest x-ray shows numerous bilateral patchy opacities; catastrophic brain bleed; Brainstem reflexes ... Read more
chest x-ray shows numerous bilateral patchy opacities; catastrophic brain bleed; Brainstem reflexes were lost; Patient died; shortness of breath; nausea; diarrhea; worsening shortness of breath/numerous bilateral patchy opacities; immunosuppressed status; This is a spontaneous report from a contactable pharmacist and a contactable other health professional. A 61-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular at arm right on 28Jan2021 (at the age of 61 years) at single dose for COVID-19 immunization. The patient medical history included bilateral lung transplant on 23Jun2017, lymphangioleiomyomatosis, hepatocellular carcinoma, antibody mediated rejection of lung transplant , bronchiolitis obliterans syndrome, grade 0P, major depressive disorder, RLS (restless legs syndrome), chronic insomnia, long term current use of systemic steroids OSA (obstructive sleep apnea), iron deficiency anemia, bilateral sciatica, hoarseness of voice, memory change, laryngeal stridor, pure hypercholesterolemia senile nuclear cataract, bilateral myopia of both eyes, osteoporosis without current pathological fracture, alopecia, immunosuppressed status, all from an unknown date and unknown if ongoing. Concomitant medication included acyclovir (formulation: capsule, strength: 200 mg) oral at 200 mg twice daily, salbutamol (ALBUTEROL HFA) as needed (MCG/ACT inhaler take 2 puffs by inhalation every 4 hours as needed) for wheezing (shortness of breath), atorvastatin (LIPITOR, formulation: tablet) oral at 80 mg once a day, azithromycin (ZITHROMAX, formulation: tablet)oral at 250 mg (every Monday, Wednesday, Friday), bupropion hydrochloride (WELLBUTRIN XL, formulation: tablet, strength: 150 mg) oral at 150 mg once a day, calcium citrate/cholecalciferol (CALCIUM + VITAMIN D, formulation: tablet) oral at 2 dose form once a day (every morning), everolimus (ZORTRESS, formulation: tablet, strength: 1 mg) oral at 2 mg twice a day, fluticasone propionate/salmeterol xinafoate (ADVAIR, strength: 500 ug/ 20 ug) twice daily (1 puff by inhalation), gabapentin (NEURONTIN, formulation: capsule, strength:100 mg) oral at 300 mg daily (by mouth nightly), loratadine (CLARITIN, formulation: tablet, strength: 10 mg) oral at 10 mg as needed, metoprolol tartrate (LOPRESSOR, formulation: tablet, strength: 25 mg)oral at 50 mg twice daily, minoxidil (ROGAN, strength: 5%) topical apply 1 cap full every other day to affected area on scalp for alopecia, ondansetron (ZOFRAN, formulation: tablet, strength: 4 mg) oral at 4 mg as needed for nausea, pantoprazole sodium sesquihydrate (PROTONIX, formulation: tablet, strength: 40 mg) oral at 40 mg once a day, prednisone (DELTASONE, formulation: tablet, strength: 5 mg) oral at 5 mg daily (every morning), sertraline hydrochloride (ZOLOFT, formulation: tablet, strength: 100 mg) oral at 100 mg twice a day (every morning), sulfamethoxazole/trimethoprim (BACTRIM) 400-80 mg per tablet (1 tablet by mouth every Monday, Wednesday, Friday), tacrolimus (formulation: capsule) at 3 mg daily (2 mg every morning and 1 mg at night), salbutamol sulfate (PROVENTIL HFA) as needed for wheezing (shortness of breath), salbutamol sulfate (VENTOLIN HFA) as needed for wheezing (shortness of breath) , salbutamol sulfate (PROAIR HFA) as needed for wheezing (shortness of breath), ascorbic acid/ferrous fumarate/folic acid/ retinol (PRENATAL, formulation: tablet) oral daily. The patient previously took NSAIDs and voriconazole and experienced drug allergies. It was reported that the patient presented to emergency department (ED) on 04Feb2021 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine. Full viral panel including COVID-19 was not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 08Feb2021 and then VV ECMO cannulation on 13Feb2021. Acute pupil exam changes in the early am hours of 15Feb2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. The events were all serious. The patient outcome of the events was fatal. The patient died on 15Feb2021. It was not reported if an autopsy was performed.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. However, the reported event may possibly represent intercurrent medical conditions in this patient. 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.; Reported Cause(s) of Death: Chest x-ray shows numerous bilateral patchy opacities; Catastrophic brain bleed; Brainstem reflexes were lost; shortness of breath; nausea; Diarrhea; Worsening shortness of breath/numerous bilateral patchy opacities
61 2021-02-23 nausea 1. Facial numbness 2. Nausea 3. Pain in back of neck 4. Headache
61 2021-02-24 abdominal pain Pain on right-side of back all the way to front of chest and under breast and part of right shoulder... Read more
Pain on right-side of back all the way to front of chest and under breast and part of right shoulder. Week prior felt sensation of "pins and needles" on back. Patient reports 1 blister spot on chest. Patient went to urgent care and was diagnosed with shingles. Doctor prescribed Valtrex and Ibuprofen.
61 2021-02-25 diarrhea, nausea [COVID-19 mRNA vaccine (Pfizer-BioNtech] treatment under Emergency Use Authorization (EUA)
61 2021-02-25 difficulty swallowing chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helpe... Read more
chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helped. Limited range of motion noted on L arm, could not lift arm ROM more than 30 degrees 12 hours after vaccine still had chills, and fever. Then started to itching on both hands, noticed and uncontrollable itching. Took Benadryl 25mg and feel asleep. hives and itching was gone by the time she woke up. Severe fever and body aches 22 hours after vaccine administration. Temperature was 101.8. Throat felt "sore, with some little difficulty swallowing", took Tylenol 1200mg and Vit C 2000mg and Vit D 10,000 IU and Zinc 100mg. Today, 48 hours after vaccine administration, having systemic hives, and eyes are puffy and swollen, R eye more than left, upper lid is swollen. Took Claritin 10mg and Famotidine 20mg. Hives are better but not fully resolved, but itching is persistent. Still discomfort noted in swallowing.
61 2021-02-27 nausea Had chills, nausea and ringing in the head/ears about 4 hours after the first shot. The chills and n... Read more