chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer(patient). A 41-year-old female patient (non-pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6202), via an unspecified route of administration on arm left on 27Feb2021 11:45 AM at single dose for COVID-19 immunization. The patient medical history included Polycystic Ovarian Syndrome and allergies to Sulfa Drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines in 4 weeks. The patient Concomitant medications included ethinylestradiol, norethisterone (VYFEMLA), Prazosin, Buspirone, Metformin. On 27Feb2021 12:30 PM, the patient experienced Extreme fatigue, headache, achy joints, sore injection site, nausea. The lab test included PCR (Nasal swab), result: Negative on 05Feb2021. The patient did not receive any treatment for the events. The outcome of the events was reported as Recovering. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia, Inflammation, Rash pruritic
Clinical narrative: My voice has changed, mean to say it's higher; It is red and inflamed; It (rash) is red and inflamed; This is a spontaneous report received from a contactable pharmacist (Patient).   A 81-years-old male patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included ongoing atrial fibrillation. The patient's concomitant medications were not reported. Patient stated that his voice has changed, it seems very, mean to say it's higher. he donot know if that is from it but the main thing he was calling about was a rash that I developed. Patient was treated with Benadryl for the itchy rash and he started a dose of Methylprednisolone. Reporter stated that the rash was red and inflamed. The outcome of the events was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Sinusitis
Clinical narrative: prone to sinus infections; Tested positive for COVID; This is a spontaneous report from a contactable Nurse. A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EL9262), dose 1 via an unspecified route of administration, administered in left deltoid on 08feb2021 at 3:15 PM as single dose for covid-19 immunisation. Medical history included sinusitis, diverticulitis. Concomitant medication(s) included levothyroxine sodium (LEVOXYL) taken for thyroid disorder, docusate sodium (COLACE) taken for diverticulitis; calcium carbonate, Vitamin D 2000 units, colecalciferol (vitamin d 2000). Her husband started not feeling well 1.5 weeks post vaccination. She specified her husband was also sneezing and she didn't have symptoms beside maybe a sinus congestion when waking up in the morning, which she has regularly. She said they are both prone to sinus infections (non serious), and her husband had a "sinus infection" with a "negative covid-19 test back in november. Due to having contact with her husband who had tested positive for COVID she also got tested for COVID. She mentioned she only goes out walking 3-4 miles each day, or bicycle 6-7 miles a day in the gym downstairs in their apartment complex. She has no symptoms whatsoever. She was not sleeping a lot with her husband because he was already in a different room due to his sleeping habits. She had a rapid COVID test done on 20Feb2021 and it was negative. On Saturday at the Urgent care she asked were the Rapid PCR test could be done. The rapid test was done via nasal swab. She had an oral COVID test done yesterday 21Feb2021 and it was positive. She has not had the second dose of the vaccine yet. The event assessed as medically significant. The outcome of the events was unknown.; Sender's Comments: Based on the temporal relationship, A possible contributory role of the suspect product to the development of Sinusitis cannot be excluded.,Linked Report(s) : US-PFIZER INC-2021218654 same reporter/drug, similar event, different patient
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Urticaria
Clinical narrative: tickle in my throat; I had hives all over my chest; This is a spontaneous case is received from a contactable consumer or other non hcp reported for herself. A 24-years-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: UNKNOWN), via an unspecified route of administration, administered in Arm Left on 20Feb2021 15:15 (at the age of 24-years-old) as single dose for COVID-19 immunization. Medical history was none. Patient had no known allergies. Patient did not receive any other vaccine in two weeks of vaccination. Patient received unspecified other medications in two weeks of vaccination. Patient was not tested for covid prior to vaccination. It was reported that, on 20Feb2021 23:00, patient felt nothing physically until the evening after vaccination. She noticed around 11 PM that she had hives all over her chest (collarbone to bust to armpit) and on her back directly across from the front. They looked like red freckles almost. No pain, no itching, just hives. They were still on her body just less red. Now they look like freckles. Not sure when they developed. Thinking back, she did develop a tickle in her throat within 5 minutes. Patient was not tested for covid post vaccination. Outcome of the events was reported as recovering.   Information about Lot/Batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Hypoacusis, Tinnitus
Clinical narrative: it felt like my head would pop off at one point; hearing muffled; left ear was clogged and ringing; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregnant female patient received dose of bnt162b2 (PFIZER BIONTECH COVID mRNA VACCINE, solution for injection, Lot Number: EN6205), via an unspecified route of administration, administered in arm Left on 27Feb2021 at 12:00 as SINGLE DOSE for covid-19 immunization. Medical history included Acid Reflux and known allergies to Bananas. The patient had no other vaccine in four weeks. Concomitant medication(s) in two weeks included rabeprazole (RABEPRAZOLE) taken 20 mg dose for an unspecified indication, start and stop date were not reported.The patient reported that about 28 hours after the vaccination her left ear was clogged and ringing and then both ears were clogged, and it felt like her head would pop off at one point. The patient was literally thought that she was going deaf. This had never happened to her before. It has gotten better at about 34 hours in, but left ear still feels clogged and hearing muffled. On 28Feb2021 at 16:00, the patient experienced hearing muffled and it felt like my head would pop off at one point and left ear was clogged and ringing. The patient not had covid prior vaccination; not tested covid post vaccination. The patient did not receive any treatment for the events. The outcome of the events is recovering.   No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: Bronchitis; This is a spontaneous report from a Pfizer-sponsored program VyndaLink Patient Support Hub from a contactable consumer A 82-years-old female patient received tafamidis (VYNDAMAX), NDC number: 0069873030 via an unspecified route of administration from 2020 (Batch/Lot number was not reported) and ongoing, at 61 mg, 1x/day for cardiac amyloidosis and bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19Feb2021 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunisation. Medical history included body height decreased, carpal tunnel syndrome, cardiac amyloidosis (she has several heart conditions including cardiac amyloidosis). The patient's concomitant medications were not reported. The patient experienced bronchitis on 21Feb2021 with outcome of recovering. The action taken in response to the event for tafamidis was unknown. Therapeutic measures taken as a result of bronchitis are aspirin, lozenges and fluids.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Rash, Rash macular, Rash pruritic
Clinical narrative: itchy rash; eyes are itchy; blotches on both arms, under arms, some on her breasts, and buttocks, and some on knees and on her elbows; Rash; This is a spontaneous report received from a contactable consumer reported for herself. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection,Lot number: EN6201) via an unspecified route of administration in left arm on 15Feb2021 as single dose for COVID-19 immunization. Patient medical history and Concomitant medications were not reported. No other products or investigation assessment was reported. On 20Feb2021,the patient experienced itchy rash, eyes are itchy, rash, blotches on both arms, under arms, some on her breasts, and buttocks, and some on knees and on her elbows, stated her eyes were itchy and where the rash was itching. Age at time of onset of reaction/event was reported as 81. Stated that she was due for her second dose on 8Mar2021. Reporter wanted to know if the rash will happen again with her second dose. The patient was not recovered from the event.  Follow up attempts are completed. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I had a terrible pain in my leg between the knee and the groin; This is a spontaneous report from a contactable consumer or other non hcp. A 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9269), first dose via an unspecified route of administration, administered in left arm on 21Feb2021 as SINGLE DOSE for covid-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date approximately 14 hours later after her vaccination, early morning, she had a terrible pain in leg between the knee and the groin and it lasted for couple of minutes but it was very severe and she didn't know whether she should report this or not."  She stated "my height is 5 feet 6 inch, I think I am shrunk and my weight is 210, more or less". Outcome of the event was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Erythema, Flushing, Neck pain
Clinical narrative: the muscles in my neck got sorer; Diarrhoea; my legs were really red; flushed; Dizziness; This is a spontaneous report from a contactable consumer. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Feb2021 11:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included irregular heartbeat, known allergies to sulfa drugs, wheat, dairy, eggs, and beans. Concomitant medication included metoprolol and gabapentin. It was reported that, on 26Feb2021, she received the shot about 11:30 AM she had to use the restroom and noticed that her legs were red and flushed at that point. She did not notice any rash. She had a couple of waves of dizziness which were short lived over the next couple of hours. she ran errands and ate lunch. She was fine after that. On 27Feb2021, she slept well and woke up OK. However, after breakfast, she was quite dizzy. She was able to walk around and when she dropped something on the floor, she was able to pick it up. she did have to pay attention to do these things. As the morning progressed, the muscles in her neck got sorer and sorer. she also had some diarrhea, which was not unusual for her. she called her doctor and spoke to a nurse, who said these mild reactions are not unusual and instructed her to document the symptoms. If they got worse, she was to call again, of course. All day, she was spacy and a bit dizzy; but she did take her dog for a mile walk. She has been under the weather all day. No fever, no rash and tired. The patient experienced my legs were red, flushed and dizziness on 26Feb2021, the muscles in my neck got sorer and diarrhoea on 27Feb2021. Outcome of the events was recovered.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bacterial vaginosis, Chest discomfort, Eye pruritus, Fatigue
Clinical narrative: tightness in chest; joint pain; headache; nausea; swollen lymph nodes; fatigue; itchy eyes; bacterial vaginosis; This is a spontaneous report from a contactable consumer. A 43-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 13Feb2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included amlodipine besilate (AMLODIPINE BESILATE) taken for an unspecified indication,phentermine (PHENTERMINE) taken for an unspecified indication,metoprolol tartrate (METOPROLOL TARTRATE) taken for an unspecified indication, ascorbic acid (VIT C) taken for an unspecified indication, ergocalciferol (VIT D) taken for an unspecified indication. The patient experienced bacterial vaginosis with outcome of recovering. The patient had tightness in chest, joint pain, headache, nausea, swollen lymph nodes, fatigue, itchy eyes on 09Feb2021 with outcome of recovered.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Nausea
Clinical narrative: tightness in chest; joint pain; headache; nausea; swollen lymph nodes; fatigue; itchy eyes; bacterial vaginosis; This is a spontaneous report from a contactable consumer. A 43-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 13Feb2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included amlodipine besilate (AMLODIPINE BESILATE) taken for an unspecified indication,phentermine (PHENTERMINE) taken for an unspecified indication,metoprolol tartrate (METOPROLOL TARTRATE) taken for an unspecified indication, ascorbic acid (VIT C) taken for an unspecified indication, ergocalciferol (VIT D) taken for an unspecified indication. The patient experienced bacterial vaginosis with outcome of recovering. The patient had tightness in chest, joint pain, headache, nausea, swollen lymph nodes, fatigue, itchy eyes on 09Feb2021 with outcome of recovered.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer. A 74-year-old female patient (not pregnant) received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection), dose 2 via an unspecified route of administration on 11Feb2021 (Batch/Lot Number: Unknown) at the age of 74 years old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for covid-19 immunisation. No known allergies. No other vaccine in four weeks. On 12Feb2021, patient had headache for 2 days after getting the second dose of the vaccine. No treatment received for the event. No covid prior vaccination and no covid tested post vaccination. The outcome of the event was recovered on 14Feb2021.  Information about the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: I have a rash; hives; itchy; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 02 patients (Husband and wife). This is 2nd of 02 reports. This consumer (Patient's wife) reported for a male patient (Husband). A male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash, would call it hives, very itchy. Consumer further stated, her husband and she had got the same thing. they got shot and stuff together. And he had got the same, he got them two weeks ago. He had still got them, they are lessening. The outcome of events was recovering.  Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021218620 same drug/same event, different patient.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid 24 after second dose in vaccination series; Tested positive for Covid 24 after second dose in vaccination series; This is a spontaneous report from a contactable nurse. This 41-year-old female nurse (not pregnant) reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: EN5318), intramuscular, administered in Arm Right on 03Feb2021 as single dose for COVID-19 immunization. Medical history included known allergies: Sulfa drugs (drug hypersensitivity) from an unknown date and unknown if ongoing. Concomitant medication(s) included estradiol (ESTRADIOL) 1 mg daily taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: E3249), intramuscular, administered in Arm Right on 13Jan2021 as single dose for COVID-19 immunization. The patient reported that she tested positive for covid 24 after second dose in vaccination series on 27Feb2021. No treatment received for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Feb2021. Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported vaccination failure and COVID-19 cannot be ruled out.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: dull ache; Headache; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 22Feb2021 (Batch/Lot Number: EL9267) as SINGLE DOSE for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced headache on 22Feb2021, dull ache on an unspecified date. The reporter stated that she got her first dose yesterday, 22Feb2021. She says her adverse effect was that at 03:00PM or 03:30PM she was fine, then she took a nap and at 06:00PM she woke up with a big headache that she got to go away with an ice pack and a pill, then that night she had a dull headache. She says she didn't take another pill until the next morning, the headache is still here, it is a dull ache, it is not as worse as last night, it is annoying more than anything. Documented as provided. Caller says she took TYLENOL last night about 06:00PM then took another one this morning at 09:00AM. She says that the TYLENOL is 500mg, Extra Strength. UPC: Caller says this is not on the bottle, maybe it was on an outer box that was discarded a long time ago. LOT: SLA002, EXP: Jul2024. The events was considered as a non-serious. Therapeutic measures were taken as a result of headache and, dull ache. The outcome of the events was reported as unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Arthralgia, Bowel movement irregularity, Chemical burn of oral cavity, Chills
Clinical narrative: This is a spontaneous report from a contactable physician. A 76-year-old male patient received BNT162B2 (BNT162B2), dose 1 intramuscular on 25 Feb 2021 (Batch/Lot Number: EN6198) at single dose for COVID-19 immunization administered at clinic. Medical history included hypertension, blood cholesterol increased, myocardial infarction, colon cancer (had surgery for that and also had chemotherapy), coronary artery disease (30% blocked coronary artery), covid-19 from 19May2020 to an unknown date. Concomitant medication(s) included lisinopril for hypertension; amlodipine; rosuvastatin for blood cholesterol increased; evolocumab (REPATHA), subcutaneously at 140 mg (twice a month) for blood cholesterol increased. The patient reported, he was diagnosed positive with COVID-19 on 27May2020 from which he seem to have recovered without any residues of symptoms or side effect. He received first Pfizer COVID vaccination at noon time this past Thursday 25Feb in a vaccination clinic set up, the following day Friday the 26 he woke up the next morning and entire body was so sore from head to toe and could hardly get himself out of bed, but when he got up, he was having difficulty walking, so anyway he stayed in bed all day on 26 and 27. He initially had a slight temperature, some chills, slight cough, runny nose and those symptoms except for the cough seem to have resolved, what hasn't resolved is about every 30 or 40 minutes or so he had been having to urinate ever since 26Feb2021 night, his mouth has been constantly very dry. Still urinating every half hour 45 minutes and ongoing. Mouth has been very dry and had a couple of areas where it seems like maybe he had bit his lip or something, maybe when he was sleeping. It was nothing like that in mouth anymore but the mouth is still constantly so dry like dehydrated and no matter how much of fluid he drank that doesn't seem to help it and what in fact has also caused was on yesterday morning he had been a little constipated on Friday night and then yesterday morning had a severe case of diarrhea. Now he had not had another bowel movement since yesterday morning as no appetite and feeling so lousy, and so tired and fatigued. He had been feeling even much worse since getting the vaccine. He still feels very fatigued, very sore all over, very tired, still have the slight cough and he would say that's about it. Outcome of events for cough, pain and tiredness was not recovered and for the rest of the events it was unknown. No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Constipation, Cough, Decreased appetite, Dehydration, Depression
Clinical narrative: This is a spontaneous report from a contactable physician. A 76-year-old male patient received BNT162B2 (BNT162B2), dose 1 intramuscular on 25 Feb 2021 (Batch/Lot Number: EN6198) at single dose for COVID-19 immunization administered at clinic. Medical history included hypertension, blood cholesterol increased, myocardial infarction, colon cancer (had surgery for that and also had chemotherapy), coronary artery disease (30% blocked coronary artery), covid-19 from 19May2020 to an unknown date. Concomitant medication(s) included lisinopril for hypertension; amlodipine; rosuvastatin for blood cholesterol increased; evolocumab (REPATHA), subcutaneously at 140 mg (twice a month) for blood cholesterol increased. The patient reported, he was diagnosed positive with COVID-19 on 27May2020 from which he seem to have recovered without any residues of symptoms or side effect. He received first Pfizer COVID vaccination at noon time this past Thursday 25Feb in a vaccination clinic set up, the following day Friday the 26 he woke up the next morning and entire body was so sore from head to toe and could hardly get himself out of bed, but when he got up, he was having difficulty walking, so anyway he stayed in bed all day on 26 and 27. He initially had a slight temperature, some chills, slight cough, runny nose and those symptoms except for the cough seem to have resolved, what hasn't resolved is about every 30 or 40 minutes or so he had been having to urinate ever since 26Feb2021 night, his mouth has been constantly very dry. Still urinating every half hour 45 minutes and ongoing. Mouth has been very dry and had a couple of areas where it seems like maybe he had bit his lip or something, maybe when he was sleeping. It was nothing like that in mouth anymore but the mouth is still constantly so dry like dehydrated and no matter how much of fluid he drank that doesn't seem to help it and what in fact has also caused was on yesterday morning he had been a little constipated on Friday night and then yesterday morning had a severe case of diarrhea. Now he had not had another bowel movement since yesterday morning as no appetite and feeling so lousy, and so tired and fatigued. He had been feeling even much worse since getting the vaccine. He still feels very fatigued, very sore all over, very tired, still have the slight cough and he would say that's about it. Outcome of events for cough, pain and tiredness was not recovered and for the rest of the events it was unknown. No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dry mouth, Fatigue, Gait disturbance, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable physician. A 76-year-old male patient received BNT162B2 (BNT162B2), dose 1 intramuscular on 25 Feb 2021 (Batch/Lot Number: EN6198) at single dose for COVID-19 immunization administered at clinic. Medical history included hypertension, blood cholesterol increased, myocardial infarction, colon cancer (had surgery for that and also had chemotherapy), coronary artery disease (30% blocked coronary artery), covid-19 from 19May2020 to an unknown date. Concomitant medication(s) included lisinopril for hypertension; amlodipine; rosuvastatin for blood cholesterol increased; evolocumab (REPATHA), subcutaneously at 140 mg (twice a month) for blood cholesterol increased. The patient reported, he was diagnosed positive with COVID-19 on 27May2020 from which he seem to have recovered without any residues of symptoms or side effect. He received first Pfizer COVID vaccination at noon time this past Thursday 25Feb in a vaccination clinic set up, the following day Friday the 26 he woke up the next morning and entire body was so sore from head to toe and could hardly get himself out of bed, but when he got up, he was having difficulty walking, so anyway he stayed in bed all day on 26 and 27. He initially had a slight temperature, some chills, slight cough, runny nose and those symptoms except for the cough seem to have resolved, what hasn't resolved is about every 30 or 40 minutes or so he had been having to urinate ever since 26Feb2021 night, his mouth has been constantly very dry. Still urinating every half hour 45 minutes and ongoing. Mouth has been very dry and had a couple of areas where it seems like maybe he had bit his lip or something, maybe when he was sleeping. It was nothing like that in mouth anymore but the mouth is still constantly so dry like dehydrated and no matter how much of fluid he drank that doesn't seem to help it and what in fact has also caused was on yesterday morning he had been a little constipated on Friday night and then yesterday morning had a severe case of diarrhea. Now he had not had another bowel movement since yesterday morning as no appetite and feeling so lousy, and so tired and fatigued. He had been feeling even much worse since getting the vaccine. He still feels very fatigued, very sore all over, very tired, still have the slight cough and he would say that's about it. Outcome of events for cough, pain and tiredness was not recovered and for the rest of the events it was unknown. No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Jealous delusion, Loss of personal independence in daily activities, Malaise, Micturition urgency, Myalgia
Clinical narrative: This is a spontaneous report from a contactable physician. A 76-year-old male patient received BNT162B2 (BNT162B2), dose 1 intramuscular on 25 Feb 2021 (Batch/Lot Number: EN6198) at single dose for COVID-19 immunization administered at clinic. Medical history included hypertension, blood cholesterol increased, myocardial infarction, colon cancer (had surgery for that and also had chemotherapy), coronary artery disease (30% blocked coronary artery), covid-19 from 19May2020 to an unknown date. Concomitant medication(s) included lisinopril for hypertension; amlodipine; rosuvastatin for blood cholesterol increased; evolocumab (REPATHA), subcutaneously at 140 mg (twice a month) for blood cholesterol increased. The patient reported, he was diagnosed positive with COVID-19 on 27May2020 from which he seem to have recovered without any residues of symptoms or side effect. He received first Pfizer COVID vaccination at noon time this past Thursday 25Feb in a vaccination clinic set up, the following day Friday the 26 he woke up the next morning and entire body was so sore from head to toe and could hardly get himself out of bed, but when he got up, he was having difficulty walking, so anyway he stayed in bed all day on 26 and 27. He initially had a slight temperature, some chills, slight cough, runny nose and those symptoms except for the cough seem to have resolved, what hasn't resolved is about every 30 or 40 minutes or so he had been having to urinate ever since 26Feb2021 night, his mouth has been constantly very dry. Still urinating every half hour 45 minutes and ongoing. Mouth has been very dry and had a couple of areas where it seems like maybe he had bit his lip or something, maybe when he was sleeping. It was nothing like that in mouth anymore but the mouth is still constantly so dry like dehydrated and no matter how much of fluid he drank that doesn't seem to help it and what in fact has also caused was on yesterday morning he had been a little constipated on Friday night and then yesterday morning had a severe case of diarrhea. Now he had not had another bowel movement since yesterday morning as no appetite and feeling so lousy, and so tired and fatigued. He had been feeling even much worse since getting the vaccine. He still feels very fatigued, very sore all over, very tired, still have the slight cough and he would say that's about it. Outcome of events for cough, pain and tiredness was not recovered and for the rest of the events it was unknown. No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rhinorrhoea
Clinical narrative: This is a spontaneous report from a contactable physician. A 76-year-old male patient received BNT162B2 (BNT162B2), dose 1 intramuscular on 25 Feb 2021 (Batch/Lot Number: EN6198) at single dose for COVID-19 immunization administered at clinic. Medical history included hypertension, blood cholesterol increased, myocardial infarction, colon cancer (had surgery for that and also had chemotherapy), coronary artery disease (30% blocked coronary artery), covid-19 from 19May2020 to an unknown date. Concomitant medication(s) included lisinopril for hypertension; amlodipine; rosuvastatin for blood cholesterol increased; evolocumab (REPATHA), subcutaneously at 140 mg (twice a month) for blood cholesterol increased. The patient reported, he was diagnosed positive with COVID-19 on 27May2020 from which he seem to have recovered without any residues of symptoms or side effect. He received first Pfizer COVID vaccination at noon time this past Thursday 25Feb in a vaccination clinic set up, the following day Friday the 26 he woke up the next morning and entire body was so sore from head to toe and could hardly get himself out of bed, but when he got up, he was having difficulty walking, so anyway he stayed in bed all day on 26 and 27. He initially had a slight temperature, some chills, slight cough, runny nose and those symptoms except for the cough seem to have resolved, what hasn't resolved is about every 30 or 40 minutes or so he had been having to urinate ever since 26Feb2021 night, his mouth has been constantly very dry. Still urinating every half hour 45 minutes and ongoing. Mouth has been very dry and had a couple of areas where it seems like maybe he had bit his lip or something, maybe when he was sleeping. It was nothing like that in mouth anymore but the mouth is still constantly so dry like dehydrated and no matter how much of fluid he drank that doesn't seem to help it and what in fact has also caused was on yesterday morning he had been a little constipated on Friday night and then yesterday morning had a severe case of diarrhea. Now he had not had another bowel movement since yesterday morning as no appetite and feeling so lousy, and so tired and fatigued. He had been feeling even much worse since getting the vaccine. He still feels very fatigued, very sore all over, very tired, still have the slight cough and he would say that's about it. Outcome of events for cough, pain and tiredness was not recovered and for the rest of the events it was unknown. No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Rash pruritic
Clinical narrative: Eczema; Rash on my leg, on the top of my front side and it was like itchy; This is a spontaneous report from a contactable consumer. This 63-years-old female consumer reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: E19266), via an unspecified route of administration on 16Feb2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 21Feb2021, the patient got like a little rash on her leg, on the top of her front side and it was like very itchy. She thought it was little bit of eczema. The patient took cortisone cream over the counter for the event. The outcome of the event eczema was resolved In 2021 whereas other event was resolving.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Dry mouth
Clinical narrative: with the second dose, swollen and cracked lips; dry mouth; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9262), dose 2 via an unspecified route of administration in left arm on 10Feb2021 13:15 (at 74-years age) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. With the 1st dose, patient's lips were swollen and cracked and with the second dose, swollen and cracked lips, dry mouth on 12Feb2021. No treatment received for reported adverse event. Patient not tested for COVID-19 after the vaccination. The event outcome was reported as not resolved.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test, Urinary tract infection
Clinical narrative: urinary tract infection; 21Feb2021 tested positive for covid-19; 21Feb2021 tested positive for covid-19; had been sick and got sicker; This is a spontaneous report from a Pfizer-sponsored program  via consumer (patient). A 74-years-old male patient received the first dose of BNT162B2 (Solution for injection, Lot number EL9262) on 26Jan2021. The patient experienced for a couple of weeks not feeling well with headaches, shortness of breath and congestion. On 21Feb2021, the patient tested positive for covid-19. Patient has been in bed and sick ever since. He has been sick for a total of over 3 weeks. Between 16Feb2021 and 22Feb2021 he had been sick and got sicker. The patient asked if it is ok to get the second dose on 09Mar2021. The events were treated with an antibiotic for a urinary tract infection. The outcome of the events was unknown. The patient was unable to make it back for the second vaccine on 17Feb2021 due to weather and power outages in his area then got the Covid virus during that time which postponed the second vaccine for the second time. They rescheduled the second dose for the following Monday, 22Feb2021. The patient underwent lab test which included COVID-19 test and the patient was tested positive for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID on 07Jan2021 which was two days before my second dose; tested positive for COVID on 07Jan2021 which was two days before my second dose; This is a spontaneous report from a contactable patient. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 19Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received her Pfizer vaccine dose 1 on 19Dec2020. She tested positive for COVID on 07Jan2021 which was two days before her second dose of the vaccine. Her hospital was not sure whether she need just a second dose of the vaccine or if she should start the process over. Patient look forward to hearing your guidance on this matter. The outcome of the events was unknown.  Information on lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Incomplete course of vaccination, Product dose omission issue, Pyrexia
Clinical narrative: Laboratory tests results confirmed that she was infected by the COVID-19 virus/she found to be an asymptomatic patient for COVID-19 infection; Laboratory tests results confirmed that she was infected by the COVID-19 virus/she found to be an asymptomatic patient for COVID-19 infection; she did not received the second dose of the Pfizer's COVID-19 vaccine; she did not received the second dose of the Pfizer's COVID-19 vaccine; Fever; This is a spontaneous report from a non-contactable consumer . This female consumer reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE (Solution for injection) via an unspecified route of administration as a single dose for COVID-19 immunization in the first week of January. The consumer reports that in Jan she was installed at a nursery home and there were multiple cases of COVID-19 infection that affected the staff and the members installed there. Two days after that she had fever but she was not admitted in the hospital despite the laboratory tests results confirmed that she was infected by the COVID-19 virus. The consumer reports that she found to be an asymptomatic patient for COVID-19 infection. The consumer reports that she was transferred to another nursery residence and because of that and her quarantine after being infected with the COVID-19 virus she did not received the second dose of the Pfizer's COVID-19 vaccine which led to missed dose and incomplete course of vaccination. The outcome for the events was unknown.  The consumer reports that she spoke with agent  before being transferred to Pfizer. AE for the missed second dose of the Pfizer's COVID-19 vaccine due to COVID-19 quarantine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-1 test
Clinical narrative: Laboratory tests results confirmed that she was infected by the COVID-19 virus/she found to be an asymptomatic patient for COVID-19 infection; Laboratory tests results confirmed that she was infected by the COVID-19 virus/she found to be an asymptomatic patient for COVID-19 infection; she did not received the second dose of the Pfizer's COVID-19 vaccine; she did not received the second dose of the Pfizer's COVID-19 vaccine; Fever; This is a spontaneous report from a non-contactable consumer . This female consumer reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE (Solution for injection) via an unspecified route of administration as a single dose for COVID-19 immunization in the first week of January. The consumer reports that in Jan she was installed at a nursery home and there were multiple cases of COVID-19 infection that affected the staff and the members installed there. Two days after that she had fever but she was not admitted in the hospital despite the laboratory tests results confirmed that she was infected by the COVID-19 virus. The consumer reports that she found to be an asymptomatic patient for COVID-19 infection. The consumer reports that she was transferred to another nursery residence and because of that and her quarantine after being infected with the COVID-19 virus she did not received the second dose of the Pfizer's COVID-19 vaccine which led to missed dose and incomplete course of vaccination. The outcome for the events was unknown.  The consumer reports that she spoke with agent  before being transferred to Pfizer. AE for the missed second dose of the Pfizer's COVID-19 vaccine due to COVID-19 quarantine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Rash, Vaccination site pruritus
Clinical narrative: Rash; itching from the injection site; pain on right arm; swelling on the Right arm; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (BNT162B2, Lot Number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Right on 20Feb2021 13:15 as SINGLE DOSE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing Verbatim: Asthma, hypersensitivity from an unknown date and unknown if ongoing Verbatim: Allergy. On 22Feb2021, the patient experienced rash, itching from the injection site, pain on right arm, swelling on the right arm. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of rash. The outcome of the event rash was recovering, and rest event outcome was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: anxiety; This is a spontaneous report from a contactable consumer via Pfizer Company Representative. A 33-year-old male patient received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Lot Number: EL9265) at the age of 32 years old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient began having anxiety the day after receiving his second dose of the Covid-19 vaccine. Event took place after use of product. The outcome of the event was unknown.  Information about the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient developed Covid-19; patient developed Covid-19; This is a spontaneous report from a Non contactable pharmacist. A male patient of an unspecified age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. The pharmacist reported that after patient received the 1st dose of the BioNTech Covid-19 Vaccine, the patient developed Covid-19 and pharmacist wants to know if it would still be okay if the patient receives the 2nd dose of the BioNTech Covid-19, 42 days or more after the 1st dose. The outcome of the event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.; Sender's Comments: Based on the known safety profile of the drug and a plausible temporal relationship, a causal association between the reported event and the suspect drug bnt162b2.
Sex: F
Vaccine: COVID19
Symptoms: Bone neoplasm
Clinical narrative: Tumor in spine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's daughter) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 29Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history included hip pain (prior to the first dose of the vaccine). The patient's concomitant medication included paracetamol (TYLENOL) for hip pain. The patient received the first dose of the Pfizer vaccine on 29Jan2021. The patient started taking 4 mg dexamethasone daily since 03Feb2021 (also reported as 02Feb2021 or 03Feb2021) for a tumor in spine on an unspecified date. The event was considered non-serious by the reporter. The patient received the second dose of the vaccine on 18Feb2021. The patient's daughter wanted to know if this will affect the efficacy of the vaccine as she has been seeing conflicting sources about it. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt sick; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that second vaccine was scheduled today. Caller did not go because she felt sick. Inquiring was it okay to miss the vaccine after 21 days. The outcome of the event was unknown.  Information about the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a Pfizer sponsored program  Support from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for Covid-19 immunisation. The patient took her second dose yesterday and caught fever today and she wanted to know if she could take Ibuprofen. The outcome of the event was unknown.  Information on the lot batch number has been requested.