chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Come down with an infection, she is almost bed ridden; sick/his wife is sick/My wife is down with a sickness; Come down with an infection, she is almost bed ridden; She has lost some weight in the last couple of weeks; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient's husband) reported for a female patient. An 84-year-old female patient received first dose of BNT162B2 (Solution for injection, Lot number: EL9261 expiration date: unknown) via an unspecified route of administration on 21Jan2021, as a single dose for Covid-19 immunization. The patient did not have any medical history. Concomitant medications were not reported. On an unspecified date, the patient fell sick (reported as "My wife is down with a sickness"). On 04Feb2021, she was diagnosed with an infection (reported as come down with an infection). It was stated that she was almost bed ridden and on an unknown date in 2021, she had lost some weight in the couple of weeks prior to this report. It was stated that she had an appointment for second dose of vaccine scheduled on 09Feb2021, unfortunately she had come down with an infection 'chronic' (further not clarified), she had received the diagnosis from her doctor. She was almost bed ridden at the time of this report, hopefully improving. It was also stated that she would not be able to go for that second session on 09Feb2021, and needed to reschedule appointment a little later, the reporter asked could she go as far as a week beyond such as like 15Feb2021 or 16Feb2021. The reporter stated that do not know her weight, she has lost some weight in the couple of weeks but that was okay. She was taking an antibiotic Bactrim (Further clarified as treatment) for this infection, on a 5 day schedule which would end on a day next to this report. The patient went to the doctor on 04Feb2021 Thursday, underwent laboratory test blood work on 04Feb2021 the result showed the infection (unspecified). The reporter did not think this was a side effect from the vaccine, and stated this was, could be, reporter was guessing it could be. It was reported that, "I am going to say it's very much in the vicinity of 145 pounds. She has lost some weight in the last couple of weeks but that's okay, I would say that 140, I am going to say 140 instead of 145". The outcome of the events of fell sick, come down with an infection, almost bed ridden and lost some weight was unknown.    Follow-up attempts completed. No further information expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Erythema, Gingival bleeding, Gingival discolouration, Gingival swelling
Clinical narrative: his teeth got swollen, then red and purple after; left shin was a little red; left foot red, purple, and swollen/right foot red and purple; left foot red, purple, and swollen/right foot not as swollen; This is a spontaneous report from a contactable consumer or other non Healthcare Professional. A 57-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9264),via an unspecified route of administration on 05Feb2021 as single dose for COVID-19 immunisation. Patient medical history included paralysis since 28Aug1996, patient concomitant medications were not reported. On 06Feb2021, The patient reported that his left foot red, purple, and swollen; patient right foot red and purple (it was reported that right foot not as swollen). The patient reported that he got his first shot last Friday, 05Feb. He says that he is a police officer that has been paralyzed for 24 years and after he got the first dose last Friday, on Saturday his left foot swelled, then Sunday it swelled some more. Patient said he walks with therapy using an exoskeleton and they noticed also that it was purple, red, and swollen. Patient said a couple days later his right foot started turning purple and red, but was not as swollen. He says that he has heard that for people who suffer from blood flow problems with circulation there was a problem after the shot, this is something he has never had in 24 years so he would like to know if it is related to the injection. No further details about others who were receiving vaccine provided. Patient reported that it was only his feet, though his left shin was a little red yesterday. Patient said that his second injection was coming up, and he would like to know, is that going to do it again, because he can't do therapy when that happens. Patient reported that his swelling was bad but then it got better. He says after the half hour drive to the hospital for therapy both feet got worse, and this morning his left is still swollen but his feet are better, he will see at the end of the day what it is like. Patient said that his doctor's office took blood tests and did an ultrasound for the circulation of his leg, the patient underwent lab tests and procedures (on unspecified dates) which included Blood test: possible blood or leg infection and Ultrasound scan: possible blood or leg infection. Investigations: Patient reported that his doctor said that his labs were clear and that his ultrasound was clear. Therapeutic measures were taken, patient was prescribed antibiotics for a possible blood or leg infection. No further details provided about the antibiotics prescribed for treatment. The outcome of the events left foot red, purple, and swollen/right foot not as swollen were recovering, however clinical outcome of other events were unknown.  Follow-up attempts completed. No further information expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Localised infection, Peripheral swelling, Skin discolouration, Tooth disorder, Ultrasound scan
Clinical narrative: his teeth got swollen, then red and purple after; left shin was a little red; left foot red, purple, and swollen/right foot red and purple; left foot red, purple, and swollen/right foot not as swollen; This is a spontaneous report from a contactable consumer or other non Healthcare Professional. A 57-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9264),via an unspecified route of administration on 05Feb2021 as single dose for COVID-19 immunisation. Patient medical history included paralysis since 28Aug1996, patient concomitant medications were not reported. On 06Feb2021, The patient reported that his left foot red, purple, and swollen; patient right foot red and purple (it was reported that right foot not as swollen). The patient reported that he got his first shot last Friday, 05Feb. He says that he is a police officer that has been paralyzed for 24 years and after he got the first dose last Friday, on Saturday his left foot swelled, then Sunday it swelled some more. Patient said he walks with therapy using an exoskeleton and they noticed also that it was purple, red, and swollen. Patient said a couple days later his right foot started turning purple and red, but was not as swollen. He says that he has heard that for people who suffer from blood flow problems with circulation there was a problem after the shot, this is something he has never had in 24 years so he would like to know if it is related to the injection. No further details about others who were receiving vaccine provided. Patient reported that it was only his feet, though his left shin was a little red yesterday. Patient said that his second injection was coming up, and he would like to know, is that going to do it again, because he can't do therapy when that happens. Patient reported that his swelling was bad but then it got better. He says after the half hour drive to the hospital for therapy both feet got worse, and this morning his left is still swollen but his feet are better, he will see at the end of the day what it is like. Patient said that his doctor's office took blood tests and did an ultrasound for the circulation of his leg, the patient underwent lab tests and procedures (on unspecified dates) which included Blood test: possible blood or leg infection and Ultrasound scan: possible blood or leg infection. Investigations: Patient reported that his doctor said that his labs were clear and that his ultrasound was clear. Therapeutic measures were taken, patient was prescribed antibiotics for a possible blood or leg infection. No further details provided about the antibiotics prescribed for treatment. The outcome of the events left foot red, purple, and swollen/right foot not as swollen were recovering, however clinical outcome of other events were unknown.  Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Blood test, Dyspnoea, Investigation
Clinical narrative: Short of breath; I am having difficulty is shortness of breath; It's nauseating pain that I am having in my stomach; It's nauseating pain that I am having in my stomach; Very strong stomach discomfort; This is a spontaneous report from a contactable consumer reporting for himself. A 79-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 27Jan2021 (Batch/Lot Number: EL9261) as dose 1, single (age at vaccination: 79-year-old) for covid-19 immunization. Medical history included Blood pressure high from an unknown, knee surgery from 25Jan2021. Concomitant medication included clonidine 0.1 mg, taken for hypertension, start and stop date were not reported. On unknown date in 2021 (reported as couple days after I got my shot), the patient experienced "short of breath; I am having difficulty is shortness of breath, it's nauseating pain that I am having in my stomach, very strong stomach discomfort, And I can't shake it". Consumer stated, he had his COVID 19 Shot, first one and he think it was done last month on the 28th he believes (clarified as 27Jan2021). Because his next follow-up shot was going to on the 19th of this month that will be on 19Feb2021. And his symptoms were that he was short of breath and he was also having very strong stomach discomfort. And its nauseating pain that he was having in his stomach. And he could not shake it. And he doesn't know if there was something to do with the vaccine or something completely different. So, he was just wondering. He had gone through some lab test in last 2 weeks because he just had knee surgery, he had a knee surgery. And he that, his knee surgery was on the 25th of last month, it was 25Jan2021 when his knee surgery done. Lab test were apparently well, they were good, there was no reason for him not to have his knee surgery. He did pass COVID 19 nasal test for negativity, before the operation. And so, he had his blood work done and everything else was done before the surgery. Patient told the events were started couple days after he got his shot and was still experiencing. Patient did not take any medication for treatment because he doesn't know what it was. The only thing that was recommended to him was to eat some yogurt. The only other thing that he was having difficulty in shortness of breath, also that he noticed after getting the shot. The patient underwent lab tests and procedures which included blood test: unknown result, Lab test: they were good, sars-cov-2 test: negativity on an unknown date in 2021. The outcome for all events was not resolved.  Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test
Clinical narrative: Short of breath; I am having difficulty is shortness of breath; It's nauseating pain that I am having in my stomach; It's nauseating pain that I am having in my stomach; Very strong stomach discomfort; This is a spontaneous report from a contactable consumer reporting for himself. A 79-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 27Jan2021 (Batch/Lot Number: EL9261) as dose 1, single (age at vaccination: 79-year-old) for covid-19 immunization. Medical history included Blood pressure high from an unknown, knee surgery from 25Jan2021. Concomitant medication included clonidine 0.1 mg, taken for hypertension, start and stop date were not reported. On unknown date in 2021 (reported as couple days after I got my shot), the patient experienced "short of breath; I am having difficulty is shortness of breath, it's nauseating pain that I am having in my stomach, very strong stomach discomfort, And I can't shake it". Consumer stated, he had his COVID 19 Shot, first one and he think it was done last month on the 28th he believes (clarified as 27Jan2021). Because his next follow-up shot was going to on the 19th of this month that will be on 19Feb2021. And his symptoms were that he was short of breath and he was also having very strong stomach discomfort. And its nauseating pain that he was having in his stomach. And he could not shake it. And he doesn't know if there was something to do with the vaccine or something completely different. So, he was just wondering. He had gone through some lab test in last 2 weeks because he just had knee surgery, he had a knee surgery. And he that, his knee surgery was on the 25th of last month, it was 25Jan2021 when his knee surgery done. Lab test were apparently well, they were good, there was no reason for him not to have his knee surgery. He did pass COVID 19 nasal test for negativity, before the operation. And so, he had his blood work done and everything else was done before the surgery. Patient told the events were started couple days after he got his shot and was still experiencing. Patient did not take any medication for treatment because he doesn't know what it was. The only thing that was recommended to him was to eat some yogurt. The only other thing that he was having difficulty in shortness of breath, also that he noticed after getting the shot. The patient underwent lab tests and procedures which included blood test: unknown result, Lab test: they were good, sars-cov-2 test: negativity on an unknown date in 2021. The outcome for all events was not resolved.  Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Glossitis, Limb discomfort, Pain in extremity, Swollen tongue
Clinical narrative: Underneath part of my tongue was felt irritated and it was slightly swollen, it was more irritated/ Experienced the some irritation under my tongue; Underneath part of my tongue was felt irritated and it was slightly swollen, it was more irritated; Soreness; Discomfort in my arm; This is a spontaneous report from a contactable consumer (patient). This is first of the two cases. A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318, Expiration date: Unknown) via intramuscular route, administered in Upper Arm on 02Feb2021 at 11:00 AM (age of 75-year-old at vaccination) as an 1st dose, single for COVID-19 immunization. The patient also received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported) via intramuscular route, administered in Upper Arm on 23Feb2021 at 11:00 AM (age of 75-year-old at vaccination) as an 2nd dose, single for COVID-19 immunization. The vaccination facility was reported as other and not military facility. The patient's medical history was reported as none. The patient's concomitant medication(s) included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient was not vaccinated with any other vaccine 4 weeks prior to Covid-19 vaccination. On 02Feb2021, (Tuesday), the patient experienced soreness, she was fine just had some discomfort in my arm, and she took some Tylenol, and she was fine. Soreness continued to the next day and was much better. Her husband also had the same reaction and yesterday. On 04Feb2021 (during the night), the patient had underneath part of her tongue was felt irritated and it was slightly swollen, just very slightly but it was more irritated. She drank some water, it did not seem to do anything, she switched with some glycerin and still nothing. So, she took 2 Benadryl, and she went back to sleep and this morning it was slightly better but still little irritated and she had some cereal for breakfast and at this point it was quite a bit better. She had not taken any more medication, she thought if she should take a little more Benadryl just to get it out of her system whatever it is." She noticed it last night about 3 O'clock in the morning, and right now it's almost back to normal totally." She wanted to know if she should take any more Benadryl, or she just let it go since she was better. Three days after second vaccine, she experienced some irritation under my tongue. She took some Benadryl and was fine a few hours later. The patient had not undergone any relevant lab test or any procedures. No investigation assessment was reported. The outcome of the events was recovering.  Follow-up attempts are completed. No further information was expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I was fine just had some discomfort in my arm and I took some Tylenol and I was fine. My husband also had the same reaction/just a little soreness in his arm; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (Reporter's husband). This is second case out of the two cases.  A 77-years-old male patient received bnt162b2 (BNT162B2, Batch/Lot Number: EN5318), via an unspecified route of administration on 02Feb2021 as unknown, single dose for COVID-19 immunisation. Medical history included myocardial infarction : Mild heart attack , blood pressure abnormal from an unknown date. The patient's concomitant medications were not reported. On 02Feb2021, the patient experienced discomfort in the arm, had a little soreness in the arm. Additional Information was reported by the reporter that patient had Mild heart attack last Sep but now he is fit as fiddle and also reported that her husband, I don't know if it's same. Yes his is same, it says lot number, product name, EN5318. Reporter also stated that "Well because we are old. Outcome of the event was recovered on an unspecified date.    Follow up (04Feb2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported for a 77-year-old patient (Reporter's husband) that included patient's weight, height, medical history, product batch no, product start date, event with outcome.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Nasal congestion, Pain in extremity, Pyrexia
Clinical narrative: I work up this morning with a stuffy nose and had a minor fever through the night (99.2).; Also woke up feeling a little drained overall; my arm is sore overall; I work up this morning with a stuffy nose and had a minor fever through the night (99.2).; This is a spontaneous report from a contactable consumer(Patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Feb2021 as, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 05Feb2021 the patient stated that I work up this morning with a stuffy nose and had a minor fever through the night (99.2) Also woke up feeling a little drained overall. I received my shot at the Pfizer Site. As with many shots my arm is sore overall. I do not have a fever anymore, but my nose still is a little stuffy. On 04Feb2021 the patient underwent lab tests and procedures which included body temperature: 99.2.  The outcome of the event I work up this morning with a stuffy nose and had a minor fever through the night (99.2) was not recovered, while outcome of I work up this morning with a stuffy nose and had a minor fever through the night (99.2) recovered on 05Feb2021, and outcome of the evets fatigue and pain in extremity was unknown.   Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nervousness
Clinical narrative: feels dragged out and a little shaky; feels dragged out and a little shaky; This is a spontaneous report from a contactable Consumer or other non-health professional (patient).  A 78-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via intramuscular route of administration, administered in right arm on 02Feb2021 at 14:30 hours as 1st dose, single dose (at the age of 78-years-old) and on 23Feb2021 at 14:30 hours as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Feb2021, patient felt good. On 04Feb2021, patient feels dragged out and a little shaky. Patient stated that in two weeks she has to go back for second. She and her husband got their first shot on Tuesday, 02Feb2021. They felt good the net day. Today she feels dragged out and a little shaky. Patient asked was that normal. The case was classified as non-serious. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (23Mar2021): This is a follow-up spontaneous report from a contactable consumer. This 78-year-old consumer reported in response to Non-HCP coversheet and questionnaire sent.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: I had a bad reaction and I have been not right ever since then you know; This is a spontaneous report form a non-contactable consumer (patient). A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. On an unspecified date, patient had a bad reaction, patient had been not right ever since then. Patient wanted to know how long that thing going to last on me like that, how long I am going to be like this. Why it did not go back to normal because I was not normal. The patient got a card after taking last shot. Patient was informed about Pfizer Medical information department. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Nausea
Clinical narrative: Nauseous; The one that is distressing is I started getting this diarrhea and it had got watery, pasty, and very frequent; The one that is distressing is I started getting this diarrhea and it had got watery, pasty, and very frequent; I am pretty tired out and I was tired the first day; This is a spontaneous report received from a contactable consumer (patient). A 68-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EL9262, Expiry date was not reported), via an unspecified route of administration on 02Feb2021 as 1st, dose single for COVID-19 immunisation. The patient medical history was not reported. The patient was taking other unspecified medications however the details were not provided (It's a long list, patient don't have it). It was reported that, the patient called you because she got the COVID shot on Tuesday morning. And by the evening, yesterday and today, patient have had a couple of symptoms. But the one that was distressing was patient started getting this diarrhea and it had got watery, pasty, and very frequent on an unspecified date in Feb2021. So, the patient pretty tired out and she was tired the first day. When she woke up yesterday and she didn't know if they were coming from, but she figured it out and it appeared that it was the reaction to the medicine or the vaccine. It was further stated that, actually, it started late Tuesday night and then it was constant yesterday, and then she woke up with very severe this happening, this diarrhea. And she didn't lay down till now and it's a little better, but it's really taken a lot out of me. Patient have been nauseous in Feb2021. The patient finally took Imodium this afternoon for the treatment of diarrhoea and distress abdominal. The patient stated that she was still experiencing diarrhea. The outcome of the event the one that is distressing is i started getting this diarrhea and it had got watery, pasty, and very frequent was not recovered and the events i am pretty tired out and i was tired the first day and nauseous was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report received from a contactable Nurse (daughter). Follow up (04Feb2021): This is a follow up spontaneous report from a contactable Nurse was processed together along with initial information.   A 75-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, batch/lot number and Expiration date was not reported), via an unspecified route of administration, on 25Jan2021 (at the age of 75 years), as a single dose for covid-19 immunisation. The patient medical history included blood pressure, kidney stones. Concomitant medications were unknown (Nurse stated, "Not that I know of, he is taking allergy medicine, I think ."). On an unknown date (a day or two after vaccination) in Jan2021, the patient had experienced dizziness ever since he got it, he is able to drive but caller is concerned (he is 75 years old male). He has been continuing dizzy from nine days. Caller wanted to know about dizziness and how long it lasts. The patient was kind of ignored and did not had any treatment. Outcome of the event was reported as not recovered. The causality was reported as the nurse stated, "It is just said like maybe it is caused with vaccine. He is 75 years old and I don't know, it could be his heart, I don't know (not clarified). The dizziness, when I look it at on Pfizer, it says that there may be like a severe reaction and that will be within 24 to 48 hours, and he is still experiencing."  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable nurse (patient's daughter) via Medical Information Team. A 72-year-old female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as unknown, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient's daughter stated that her mother had sore arm after she got the shot. She wanted to know about dizziness and how long it lasts. The outcome of the event was unknown.   Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Lethargy, Lymphadenopathy, Pain
Clinical narrative: Posterior auricular lymphadenopathy; Moderate to severe pain lasting; Severe lethargy; Left axillary swelling without pain; Chills; Joint pain; This is a spontaneous report from a contactable nurse (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES).  A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262) via an unspecified route of administration on 01Feb2021 at 12:45 (at the age of 41-year-old), as dose 2, single, in left arm for COVID-19 immunization at Urgent care center. The patient's medical history included hypertension, anxiety and attention deficit hyperactivity disorder (ADHD). Patient had no known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246) via an unspecified route of administration on 12Jan2021 at 12:45 as single dose in left arm for COVID-19 immunization. On 01Feb2021 at 19:00, 6 hours 15 minutes after the second dose of vaccine, the patient experienced left axillary swelling without pain, and 8 hours after the second dose, the patient experienced chills and joint pain for 1-2 hours. 20 hours post injection, the patient had severe lethargy for 36 hours. On 06Feb2021 at 19:00, the patient experienced posterior auricular lymphadenopathy with moderate to severe pain lasting more than 24 hours and was ongoing. At this time adverse events was not medically attended, however, if ice and Motrin 800mg are ineffective, she would be seeking medical care on 08Feb2021. The patient had not received any treatment medications for the other resulted events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all the events was not resolved.  Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Posterior auricular lymphadenopathy; Moderate to severe pain lasting; Severe lethargy; Left axillary swelling without pain; Chills; Joint pain; This is a spontaneous report from a contactable nurse (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES).  A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262) via an unspecified route of administration on 01Feb2021 at 12:45 (at the age of 41-year-old), as dose 2, single, in left arm for COVID-19 immunization at Urgent care center. The patient's medical history included hypertension, anxiety and attention deficit hyperactivity disorder (ADHD). Patient had no known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246) via an unspecified route of administration on 12Jan2021 at 12:45 as single dose in left arm for COVID-19 immunization. On 01Feb2021 at 19:00, 6 hours 15 minutes after the second dose of vaccine, the patient experienced left axillary swelling without pain, and 8 hours after the second dose, the patient experienced chills and joint pain for 1-2 hours. 20 hours post injection, the patient had severe lethargy for 36 hours. On 06Feb2021 at 19:00, the patient experienced posterior auricular lymphadenopathy with moderate to severe pain lasting more than 24 hours and was ongoing. At this time adverse events was not medically attended, however, if ice and Motrin 800mg are ineffective, she would be seeking medical care on 08Feb2021. The patient had not received any treatment medications for the other resulted events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all the events was not resolved.  Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: hardly a sore arm; This is a spontaneous report from a contactable consumer (patient himself). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 02Feb2021 (Lot Number: EN5318, Expiration Date: 31May2021) as unknown, single for COVID-19 immunisation. Medical history was none and there were no concomitant medications. On an unspecified date of Feb2021, the patient experienced hardly a sore arm. The patient thought it was a good idea to get the vaccine. He did not have anything except hardly a sore arm. The patient underwent lab tests and procedures which included sars-cov-2 test: positive, for it hadn't been 90 days since he had COVID that he got the vaccine on an unspecified date of Dec2020. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: he reported that his arm is a little sore at the injection site; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 05Feb2021 (Batch/Lot number: Not reported) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, at dinner, patient reported that his arm was a little sore at the injection site. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: has a very bad migraine headache; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264), via an Intramuscular route of administration in left arm on 04Feb2021 at 09:30 (at 65-years age) as a 1st dose, single for COVID-19 immunization. Medical history included ongoing Blood pressure, ongoing Hypothyroid, ongoing Migraines. Concomitant medication(s) included metoprolol taken for blood pressure; Olmesartan taken for blood pressure; levothyroxine sodium (SYNTHROID) taken for hypothyroidism. Vaccination facility was in Health Clinic. Patient had a very bad migrane headache on Feb2021. Patient called because she had a terrible migraine after first vaccination. Patient needed to know if she could take Maxalt the day after. She did take it (Maxalt) because headache was bad. By the afternoon she was okay. Patient did not have a reaction on the 2nd vaccine. The outcome of the event was recovered in Feb2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; This is a spontaneous report from a non-contactable consumer. An female patient (daughter)of unspecified age received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nausea after the second dose (with no vomiting). The outcome of the event was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Possible hair loss; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, stress (patient has many underlying health conditions, type 2 diabetes, high blood pressure, stress) and surgery (major surgery to repair broken cervical vertebrae). The patient's concomitant medications were not reported. On an unspecified date, several weeks after first dose of Pfizer BioNTech COVID-19 vaccine, the patient experienced possible hair loss. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: urinary tract infection; This is a spontaneous report from a contactable consumer reporting for herself. An elderly female patient of unknown age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on 02Feb2021 as single dose for covid-19 immunization. Medical history included allergies to cats and dogs, and osteoporosis. The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot# EN5318 and expiration date not reported) dose 1 on an unspecified date for covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications in two weeks. The patient experienced urinary tract infection on 03Feb2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measure taken as result of event: treatment included Nitrofurantoin Mono/Mac. On an unspecified date in 2021, the patient had resolved from the event.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart issue; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had a significant reaction and went to emergency room with a heart issue. The outcome of the heart issue was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Nausea, Pain
Clinical narrative: Temp climbed to102; chills came on; Fever broke at 630 am; Continued having body aches and dry heaving; Continued having body aches and dry heaving; Continued having body aches and dry heaving; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported, Temperature started at 11:30, shot was given at 4:00 pm. Temp climbed to 102 and then chills came on. Fever broke at 6:30 am with Tylenol. Continued having body aches and dry heaving, retching. Her doctor prescribed Zofrane because the nausea and dry heaving was awful. Down in bed for 2 days. (Missed 2 days of work). Outcome of event for fever was recovering; body aches and dry heaving was not recovered and for the other events it was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Retching
Clinical narrative: Temp climbed to102; chills came on; Fever broke at 630 am; Continued having body aches and dry heaving; Continued having body aches and dry heaving; Continued having body aches and dry heaving; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported, Temperature started at 11:30, shot was given at 4:00 pm. Temp climbed to 102 and then chills came on. Fever broke at 6:30 am with Tylenol. Continued having body aches and dry heaving, retching. Her doctor prescribed Zofrane because the nausea and dry heaving was awful. Down in bed for 2 days. (Missed 2 days of work). Outcome of event for fever was recovering; body aches and dry heaving was not recovered and for the other events it was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Nausea, Pain
Clinical narrative: Temp climbed to102; chills came on; Fever broke at 630 am; Continued having body aches and dry heaving; Continued having body aches and dry heaving; This is a spontaneous report from a non-contactable consumer. This consumer reported for female patient (reporter's daughter in law) that a 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history included rarely drinks. Concomitant medications was not reported. The reporter stated, the patient experienced, temperature started at 11:30, shot was given at 16:00. Temp climbed to 102 and then chills came on. Fever broke at 6:30 am with Tylenol. Continued having body aches and dry heaving. Her doctor Prescribed Zofrane because the nausea and dry heaving was awful. Down in bed for 2 days. (Missed 2 days of work). Has never smoked. She is in great shape. Rides her bike every day. Therapeutic measures were taken as a result of fever broke at 6:30 am, continued having body aches and dry heaving, continued having body aches and dry heaving and nausea. Outcome of events for body aches and dry heaving and nausea was not recovered and for the other events it was unknown.   No follow-up attempts are possible. Information about batch/Lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Temp climbed to102; chills came on; Fever broke at 630 am; Continued having body aches and dry heaving; Continued having body aches and dry heaving; This is a spontaneous report from a non-contactable consumer. This consumer reported for female patient (reporter's daughter in law) that a 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history included rarely drinks. Concomitant medications was not reported. The reporter stated, the patient experienced, temperature started at 11:30, shot was given at 16:00. Temp climbed to 102 and then chills came on. Fever broke at 6:30 am with Tylenol. Continued having body aches and dry heaving. Her doctor Prescribed Zofrane because the nausea and dry heaving was awful. Down in bed for 2 days. (Missed 2 days of work). Has never smoked. She is in great shape. Rides her bike every day. Therapeutic measures were taken as a result of fever broke at 6:30 am, continued having body aches and dry heaving, continued having body aches and dry heaving and nausea. Outcome of events for body aches and dry heaving and nausea was not recovered and for the other events it was unknown.   No follow-up attempts are possible. Information about batch/Lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: rash and itching below the injection site; rash and itching below the injection site; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date for covid-19 immunization. The patient experienced rash and itching below the injection site on an unspecified date. Outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she experienced arm soreness for a day after receiving the Pfizer covid vaccine; This is a spontaneous report from a Non-contactable consumer. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Medical history included asthma, food, cardiac failure, psoriasis and she's taking several meds to manage these conditions. The patient's concomitant medications were not reported. This morning she experienced arm soreness for a day after receiving the Pfizer covid vaccine. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtain. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nasopharyngitis
Clinical narrative: Feel little stinks; Headache; Feel like tired; Chilling; Muscles pain; Cold; This is a spontaneous report from a contactable consumer or other non hcp. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Feb2021 (at the age of 35 years old), 2nd dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient got the shots of COVID-19, yesterday (03Feb2021) was her second shot and feels little stinks, she has headache, feel like tired, chilling, muscles pain and cold. And she wants to know if it is, on it paper it is normal but for her but like for like her family. The number 82, so the name of the shot they told her, she has a number, and it is 82, she don't know if it is that one. Therapeutic measures were taken as a result of muscles pain. The outcome of the events was unknown.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.