chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Pyrexia, Somnolence, Urine analysis
Clinical narrative: was like sleepy; A little bit of fever; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on Dec2020 (at the age of 24-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included HIV infection recently diagnosed. The patient's concomitant medications were not reported. The patient reported that it was in December and started having, the symptoms were kind of same. I take the vaccine; I was off for two days after and I was like sleepy and I had just a little bit of fever and stuff like that. But not bad. The patient underwent lab tests and procedures which included blood test: result unknown on an unspecified date and urine analysis: result unknown an unspecified date.  The outcome of the event were recovered on an unspecified date.   Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First dose: sore left arm/Second dose: sore left arm; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support by a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 (Batch/Lot Number: EN6206) as dose 1, single (at the age of 60 year) for covid-19 immunisation, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single (at the age of 60 year) for covid-19 immunisation. The consumer reported no medical history that was relevant, but she does take thyroid medication and has taken that for years. The patient did not have vaccine in four weeks. With the Covid 19 vaccine she had a sore left arm with the first Covid 19 vaccine. It was an extremely painful left arm. She put ice on her arm after her injection. It was extremely painful. When she went to get her second Covid 19 vaccine she brought ice with her. The second Covid 19 vaccine was not as bad as the first Covid 19 vaccine but was still sore in her left arm. She received both Covid 19 vaccines in her left arm. With the first Covid 19 vaccine her sore arm lasted about 2 days and on the third day the pain started subsiding. She did not have to go to the doctor or hospital for treatment for her sore arm after receiving the Covid 19 vaccine. She states she and her husband have the same primary care doctor. When probing adverse events with other vaccines she reports she gets her other vaccines like she's supposed to and has never had any problems. Therapeutic measures were taken as a result of first dose: sore left arm/second dose: sore left arm. The outcome of the event was not recovered.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Feeling abnormal, Gastrointestinal sounds abnormal, Headache
Clinical narrative: shooting pain in the head; brain fog; fatigue; clammy feet; hollow sound in the stomach; clotting platelet elevated after she got the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported for a 87-years-old female patient (reporter's mother) that:  A 87 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at an (Age at the vaccination 87years old) dose number unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. On an unspecified date, the patient had experienced strange side effects - shooting pain in the head, brain fog, fatigue, clammy feet , hollow sound in the stomach (you can hear its amplification) - Her mother takes chemotherapy every night for 5 years now because of lung cancer - She is 115 pounds and asking if the booster dose will be the same amount as the initial 2 doses- Asking if the booster dose is highly advised for her mother and if she needs it - She confirmed that her mother is not immunocompromised according to her doctor. Patient mentioned that she had a normal platelet count in February and all of a sudden her clotting platelet elevated after she got the vaccine. At the time of reporting, the outcome of the events were unknown.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count increased
Clinical narrative: shooting pain in the head; brain fog; fatigue; clammy feet; hollow sound in the stomach; clotting platelet elevated after she got the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported for a 87-years-old female patient (reporter's mother) that:  A 87 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at an (Age at the vaccination 87years old) dose number unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. On an unspecified date, the patient had experienced strange side effects - shooting pain in the head, brain fog, fatigue, clammy feet , hollow sound in the stomach (you can hear its amplification) - Her mother takes chemotherapy every night for 5 years now because of lung cancer - She is 115 pounds and asking if the booster dose will be the same amount as the initial 2 doses- Asking if the booster dose is highly advised for her mother and if she needs it - She confirmed that her mother is not immunocompromised according to her doctor. Patient mentioned that she had a normal platelet count in February and all of a sudden her clotting platelet elevated after she got the vaccine. At the time of reporting, the outcome of the events were unknown.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Subcutaneous abscess
Clinical narrative: I have developed an abscess in my arm pit that requires draining; This is a spontaneous report from a contactable other healthcare professional (patient). A 46-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 05Apr2021 (at the age of 46-years-old) as dose number unknown, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Prior to vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient not been tested with covid-19. The patient stated that she had developed an abscess in her arm pit that requires draining on 14Aug2021. The event led to the physician office visit. Therapeutic measures were taken as a result of event that included had to have it drained and now another apt drain. The outcome of the event was reported as not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event Subcutaneous abscess and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Extra dose administered, Off label use, Pneumonia
Clinical narrative: Pneumonia; 3rd single dose of BNT162b2; 3rd single dose of BNT162b2; And then went to the A-Fibrillation; This is a spontaneous report from a contactable consumer (patient's wife).  An 84-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular injection in the left arm, on 19Aug2021, at around 10:30 - 11:00 AM (Batch/Lot Number: FC3182), at the age of 84 years old,  as 3rd single dose, for COVID-19 immunisation. Medical history included Crohn's disease, pneumonia approximately 10 years prior to the initial reporting (approximately in 2011), or maybe more. Concomitant medication included vedolizumab (ENTYVIO) every 6 weeks 2-6 weeks, for Crohn's disease. Prior vaccinations included flu vaccine yearly, but not received in 2021 at the time of the initial reporting. The patient received the 1st single dose of BNT162b2 (lot number: EL3246) on 03Jan2021, and the 2nd single dose (lot number: EL9262) on 26Jan2021, all as intramuscular injections in the arm, at the age of 84 years old. The patient had very, very minor reactions to the 1st and 2nd doses. The patient's wife stated that on 20Aug2021, within a day from having the 3rd single dose, her husband who was 100% well, developed pneumonia, for which he was hospitalized on 21Aug2021, and then went to the A-Fibrillation (as reported). She thought this was directly related to the booster shot. The reporter had no information regarding the treatment received due to pneumonia. The patient had not recovered from pneumonia at the time of the reporting, while the outcome of atrial fibrillation was not provided.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer. This consumer reported for 5 patients. This report refers to the male (other guest's husband) she was at dinner with.  A male patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown), via an unknown route, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. In Aug2021, after vaccination, the patient was tested positive for COVID. This consumer reported stated she was with three people on 24Jul2021, inside at dinner. She was with person who was coughing their brains out but had a mask on, another person who wasn't wearing a mask, and the third person who only had one shot. All three tested positive for COVID and she was the only one who didn't. She clarified she still has immunity obviously, and she doesn't want to get another shot. The consumer clarifies the female person who was coughing her brains but was wearing a mask and was sitting across from the reporting consumer. This person's husband had COVID and didn't know it but was cured. His symptoms resolved in 2 days but was shedding the virus apparently. She clarifies this person's husband was not wearing a mask and was talking a mile a minute, he had just gotten over COVID that week and was fine. He had gone back to work and everything. Apparently, the male that had COVID that week was still shedding the virus because the other male guest at the dinner was in the hospital for 2 weeks. The reporting consumer confirms they all three people at the dinner with her tested positive for COVID. The patient had recovered from the event on unknown date in 2021.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Blister, Blood test, Hypersensitivity, Inappropriate schedule of product administration
Clinical narrative: broke out in horrible itchy rash along with blistering and oozing spots all over the entire body; broke out in horrible itchy rash along with blistering and oozing spots all over the entire body; broke out in horrible itchy rash along with blistering and oozing spots all over the entire body; broke out in horrible itchy rash along with blistering and oozing spots all over the entire body; first dose on 01Apr2021/second dose on 15Apr2021; showed some kind of elevation in antibodies for allergic reaction; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 15Apr2021 at 12:00 (Batch/Lot number was not reported; at the age of 54 years old) as dose 2, single for COVID-19 immunisation. Medical history included vitamin B deficiency controlled with monthly shot, anemic, and high BP. Concomitant medications included ibuprofen (MOTRIN) and losartan potassium (LOSARTIN).  The patient previously took Vicodin and experienced allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; at the age of 54 years old) in the left arm on 01Apr2021 at 12:00pm for COVID-19 immunisation.  The patient reported that she broke out in horrible itchy rash along with blistering and oozing spots all over the entire body on 19Apr2021. The only place it did not appear was on her face.  The patient went to urgent care twice within two-week span because got worse and worse. The patient was sent for bloodwork after visit in 2021, and doctor said the patient showed some kind of elevation in antibodies for allergic reaction. In 2021, the primary care doctor referred the patient to a dermatologist and was biopsied newest spot on the knee, sent it to pathology for review, also more lab work was done for third time showing an unknown conclusion. At that point of 3rd round of steroids, antibiotics, creams, ointments, the patient was referred to (University name).  At visit, doctors said they never seen a severe reaction like the patient has. The patient showed pictures of the progression of her awful reaction to this and brought all the past results from other doctors which had no clue how to diagnose because vaccine being too new. In summary, the patient was one of the unlucky few, a guinea pig. The patient had no COVID prior vaccination and has not been tested for COVID post vaccination. The events resulted in doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. Other treatments included drugs, anti-itch pills, steroids, creme, and ointments. The patient is recovering from the events. The events were assessed as serious (Disability or permanent damage).   Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Rash macular, Rash pruritic, Skin weeping
Clinical narrative: broke out in horrible itchy rash along with blistering and oozing spots all over the entire body; broke out in horrible itchy rash along with blistering and oozing spots all over the entire body; broke out in horrible itchy rash along with blistering and oozing spots all over the entire body; broke out in horrible itchy rash along with blistering and oozing spots all over the entire body; first dose on 01Apr2021/second dose on 15Apr2021; showed some kind of elevation in antibodies for allergic reaction; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 15Apr2021 at 12:00 (Batch/Lot number was not reported; at the age of 54 years old) as dose 2, single for COVID-19 immunisation. Medical history included vitamin B deficiency controlled with monthly shot, anemic, and high BP. Concomitant medications included ibuprofen (MOTRIN) and losartan potassium (LOSARTIN).  The patient previously took Vicodin and experienced allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; at the age of 54 years old) in the left arm on 01Apr2021 at 12:00pm for COVID-19 immunisation.  The patient reported that she broke out in horrible itchy rash along with blistering and oozing spots all over the entire body on 19Apr2021. The only place it did not appear was on her face.  The patient went to urgent care twice within two-week span because got worse and worse. The patient was sent for bloodwork after visit in 2021, and doctor said the patient showed some kind of elevation in antibodies for allergic reaction. In 2021, the primary care doctor referred the patient to a dermatologist and was biopsied newest spot on the knee, sent it to pathology for review, also more lab work was done for third time showing an unknown conclusion. At that point of 3rd round of steroids, antibiotics, creams, ointments, the patient was referred to (University name).  At visit, doctors said they never seen a severe reaction like the patient has. The patient showed pictures of the progression of her awful reaction to this and brought all the past results from other doctors which had no clue how to diagnose because vaccine being too new. In summary, the patient was one of the unlucky few, a guinea pig. The patient had no COVID prior vaccination and has not been tested for COVID post vaccination. The events resulted in doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. Other treatments included drugs, anti-itch pills, steroids, creme, and ointments. The patient is recovering from the events. The events were assessed as serious (Disability or permanent damage).   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, Fatigue, Illness, Malaise, Weight
Clinical narrative: lost weight; I am exhausted/I am very tired; I was really sick; not feeling great; extra dose administered; This is a spontaneous report from a contactable consumer (patient, self-reported). A patient of unspecified age and gender received third dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 18Aug2021, as a single dose for COVID-19 immunization, second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an un-specified route of administration, on an unspecified date, as a single dose for COVID-19 immunization and after second shot had a reaction and you know it felt, flu like symptoms, and first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that the patient had third shot (further clarification unknown hence not captured in tab) and after second shot the patient had a reaction and you know it felt, flu like symptoms whatever and the patient was anticipating the same type of thing when the patient had the shot last Wednesday and today on Monday was the first day actually feel somewhat decent and other than fact that the patient was exhausted, lost weight, everything on 23Aug2021. The patient wanted to know like has this happened before the people the patient like felt like the patient was really sick and had it for so long, was that something that has happened before. The patient stated that the patient was concerned the patient mean it was possible to get sick at same time that seems strange and was perfectly fine you know when got it and right now the patient felt like the patient didn't have fever today (further not clarified hence not captured in tab), it was the first time the patient was very tired and all wanted to know was if you supposed to documenting this all but I also wanted to know the patient was sure you have heard many thousands of peoples and the patient wanted to know if this was that something unusual obviously it was not the usual thing ok you wanna connect me to with them. The patient stated that the patient was not feeling great so did not feel like doing that. The patient underwent lab test and procedure included weight which was decreased on an unspecified date. Outcome of the events was unknown.  The lot number for the vaccine, BNT162B2 was not provided and will be re-quested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: lost weight; I am exhausted/I am very tired; I was really sick; not feeling great; extra dose administered; This is a spontaneous report from a contactable consumer (patient, self-reported). A patient of unspecified age and gender received third dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 18Aug2021, as a single dose for COVID-19 immunization, second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an un-specified route of administration, on an unspecified date, as a single dose for COVID-19 immunization and after second shot had a reaction and you know it felt, flu like symptoms, and first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that the patient had third shot (further clarification unknown hence not captured in tab) and after second shot the patient had a reaction and you know it felt, flu like symptoms whatever and the patient was anticipating the same type of thing when the patient had the shot last Wednesday and today on Monday was the first day actually feel somewhat decent and other than fact that the patient was exhausted, lost weight, everything on 23Aug2021. The patient wanted to know like has this happened before the people the patient like felt like the patient was really sick and had it for so long, was that something that has happened before. The patient stated that the patient was concerned the patient mean it was possible to get sick at same time that seems strange and was perfectly fine you know when got it and right now the patient felt like the patient didn't have fever today (further not clarified hence not captured in tab), it was the first time the patient was very tired and all wanted to know was if you supposed to documenting this all but I also wanted to know the patient was sure you have heard many thousands of peoples and the patient wanted to know if this was that something unusual obviously it was not the usual thing ok you wanna connect me to with them. The patient stated that the patient was not feeling great so did not feel like doing that. The patient underwent lab test and procedure included weight which was decreased on an unspecified date. Outcome of the events was unknown.  The lot number for the vaccine, BNT162B2 was not provided and will be re-quested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Hyperhidrosis, Nasal congestion, Nasopharyngitis
Clinical narrative: I had a break through; got tested with the PCR test and its positive for SARS Covid-2; I had a break through; got tested with the PCR test and its positive for SARS Covid-2; Cold/ I thought like I had a pretty bad cold coming on; Congestion; Runny nose; Sneezing; kind of feeling achy; Tired; sinus; bad cold sinus infection; Sweaty; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 59 years), dose 1 via an unspecified route of administration on 18Feb2021 as dose 1, single, and dose 2 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 59 years),via an unspecified route of administration on 10Mar2021 as dose 2, single for COVID-19 immunisation. The medical history was not reported. Concomitant medication(s) included levothyroxine sodium (SYNTHROID). The patient received first dose on 18Feb of this year and second dose on 10Mar of this year at the and she recently returned from travel exactly about a week ago on the 14th of August. She thought like she had a bad cold coming on you know sinus, congestion, runny nose often sneezing just kind of feeling achy and it just continued throughout the week and then on, when was that, about 5 days and with it persisting she went and got tested with the PCR test and its positive for SARS Covid-2. So, she was like it was very mild and concerns consistently most of that was 10 days before it was off. It just felt like a very bad, bad cold sinus infection, never any fever just sweaty, tired but she was symptoms free more or less for about 2 days now but it definitely a breakthrough case but mild in severity. The events started on 14Aug2021. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Aug2021. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained, no further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea, SARS-CoV-2 test, Sinusitis, Sneezing
Clinical narrative: I had a break through; got tested with the PCR test and its positive for SARS Covid-2; I had a break through; got tested with the PCR test and its positive for SARS Covid-2; Cold/ I thought like I had a pretty bad cold coming on; Congestion; Runny nose; Sneezing; kind of feeling achy; Tired; sinus; bad cold sinus infection; Sweaty; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 59 years), dose 1 via an unspecified route of administration on 18Feb2021 as dose 1, single, and dose 2 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 59 years),via an unspecified route of administration on 10Mar2021 as dose 2, single for COVID-19 immunisation. The medical history was not reported. Concomitant medication(s) included levothyroxine sodium (SYNTHROID). The patient received first dose on 18Feb of this year and second dose on 10Mar of this year at the and she recently returned from travel exactly about a week ago on the 14th of August. She thought like she had a bad cold coming on you know sinus, congestion, runny nose often sneezing just kind of feeling achy and it just continued throughout the week and then on, when was that, about 5 days and with it persisting she went and got tested with the PCR test and its positive for SARS Covid-2. So, she was like it was very mild and concerns consistently most of that was 10 days before it was off. It just felt like a very bad, bad cold sinus infection, never any fever just sweaty, tired but she was symptoms free more or less for about 2 days now but it definitely a breakthrough case but mild in severity. The events started on 14Aug2021. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Aug2021. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained, no further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: I had a break through; got tested with the PCR test and its positive for SARS Covid-2; I had a break through; got tested with the PCR test and its positive for SARS Covid-2; Cold/ I thought like I had a pretty bad cold coming on; Congestion; Runny nose; Sneezing; kind of feeling achy; Tired; sinus; bad cold sinus infection; Sweaty; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 59 years), dose 1 via an unspecified route of administration on 18Feb2021 as dose 1, single, and dose 2 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 59 years),via an unspecified route of administration on 10Mar2021 as dose 2, single for COVID-19 immunisation. The medical history was not reported. Concomitant medication(s) included levothyroxine sodium (SYNTHROID). The patient received first dose on 18Feb of this year and second dose on 10Mar of this year at the and she recently returned from travel exactly about a week ago on the 14th of August. She thought like she had a bad cold coming on you know sinus, congestion, runny nose often sneezing just kind of feeling achy and it just continued throughout the week and then on, when was that, about 5 days and with it persisting she went and got tested with the PCR test and its positive for SARS Covid-2. So, she was like it was very mild and concerns consistently most of that was 10 days before it was off. It just felt like a very bad, bad cold sinus infection, never any fever just sweaty, tired but she was symptoms free more or less for about 2 days now but it definitely a breakthrough case but mild in severity. The events started on 14Aug2021. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Aug2021. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained, no further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate decreased, Syncope
Clinical narrative: Low heart rate / about 45; vasovagal syncope; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 12Apr2021 at 16:00 (Batch/Lot number was not reported) (at the age of 20 years old) as single dose for covid-19 immunisation. Medical history included allergy to latex. The patient was not pregnant at the time of vaccination. Patient did not have COVID-19 prior to vaccination. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 02Mar2021 at 3pm, via an unspecified route of administration, administered in left arm (lot number: unknown) (at the age of 20 years old) for covid-19 immunisation. Concomitant medication included etonogestrel (NEXPLANON) taken for an unspecified indication, start and stop date were not reported. On 13Apr2021 at 11:00, the patient experienced low heart rate and vasovagal syncope. Heart rate at about 45. Heart rate remained under 60 for 48 hours post vaccine. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was treated with IV (as reported). Patient was not tested for COVID-19 post vaccination. The patient underwent lab tests which included heart rate: about 45 on 13Apr2021 11:00. Outcome of the events was recovered.    The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via unspecified route of administration in right arm on 10Feb2021 02:00 PM (at the age of 48-year-old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history included atrial fibrillation (AFiB). The patient did not have COVID prior vaccination. The patient's concomitant medications received within two weeks included multiple vitamin (unspecified), vitamin D, escitalopram oxalate (LEXAPRO) and flecainide, all from unspecified date. The patient previously received amoxicillin sodium/clavulanate potassium (AUGMENTIN), sertraline (ZOLOFT), ceftriaxone/beta-lactamase inhibitor (BACTRUM), IVP dye (as reported) and they were reported as known allergies. No other vaccines were administered within four weeks. On 18Feb2021 the patient experienced myocarditis. The event resulted in emergency room/department or urgent care visit and patient was hospitalized for 2 days. Treatment received due to the event included heart catherization, steroids and fluids. The patient was not tested for COVID post vaccination. The outcome of the event was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Hyperhidrosis, Rhinorrhoea
Clinical narrative: Sweating more; Chest flutters around heart; Runny nose; This is a spontaneous report from a contactable consumer(patient) or other non-healthcare professional. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0186) as dose 1 single, administered in left arm on 07Aug2021 (at the age of 58-year-old) for COVID-19 immunization. The patient medical history included an allergic reaction to when she had the Tuberculosis shot, and there were two medications in one shot. The patient had a bad reaction in her left arm and it was hot to touch. She got the shot when she turned 50 or something as reported. NDC/LOT/EXP Unknown. The concomitant medications were not reported. About a week after she had the first dose the patient experienced chest flutters around the heart, sweating more, and a runny nose. The patient said that she does not know if that was normal or not. The patient said that she was not a sickly person. Never had a flu shot in her life. Patient was sweating more. It began about a week later and has perspiration on her forehead and gets so hot that she must turn the AC up and then she gets too hot. It was up and down. She could feel sweat on her face and not the whole body, just in the head and forehead she was feeling so hot. The runny nose was at the same time as sweating. She did not have a cold or runny nose before the shot. The chest flutter was not constant, comes and goes. Sometimes when it happened, there was a little pinch. The patient's second dose of COVID 19 immunization was due on 28Aug2021. Outcome: It is starting to taper off, it's not as much. The event outcome for sweating more and chest flutter was not recovered, and runny nose was unknown at the time of reporting.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Cardiac flutter, Chest discomfort, Chest pain, Erythema
Clinical narrative: Sweating more; Chest flutters around heart; Runny nose; This is a spontaneous report from a contactable consumer(patient) or other non-healthcare professional. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0186) as dose 1 single, administered in left arm on 07Aug2021 (at the age of 58-year-old) for COVID-19 immunization. The patient medical history included an allergic reaction to when she had the Tuberculosis shot, and there were two medications in one shot. The patient had a bad reaction in her left arm and it was hot to touch. She got the shot when she turned 50 or something as reported. NDC/LOT/EXP Unknown. The concomitant medications were not reported. About a week after she had the first dose the patient experienced chest flutters around the heart, sweating more, and a runny nose. The patient said that she does not know if that was normal or not. The patient said that she was not a sickly person. Never had a flu shot in her life. Patient was sweating more. It began about a week later and has perspiration on her forehead and gets so hot that she must turn the AC up and then she gets too hot. It was up and down. She could feel sweat on her face and not the whole body, just in the head and forehead she was feeling so hot. The runny nose was at the same time as sweating. She did not have a cold or runny nose before the shot. The chest flutter was not constant, comes and goes. Sometimes when it happened, there was a little pinch. The patient's second dose of COVID 19 immunization was due on 28Aug2021. Outcome: It is starting to taper off, it's not as much. The event outcome for sweating more and chest flutter was not recovered, and runny nose was unknown at the time of reporting.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Hyperhidrosis, Insomnia, Joint range of motion decreased, Neck pain
Clinical narrative: Sweating more; Chest flutters around heart; Runny nose; This is a spontaneous report from a contactable consumer(patient) or other non-healthcare professional. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0186) as dose 1 single, administered in left arm on 07Aug2021 (at the age of 58-year-old) for COVID-19 immunization. The patient medical history included an allergic reaction to when she had the Tuberculosis shot, and there were two medications in one shot. The patient had a bad reaction in her left arm and it was hot to touch. She got the shot when she turned 50 or something as reported. NDC/LOT/EXP Unknown. The concomitant medications were not reported. About a week after she had the first dose the patient experienced chest flutters around the heart, sweating more, and a runny nose. The patient said that she does not know if that was normal or not. The patient said that she was not a sickly person. Never had a flu shot in her life. Patient was sweating more. It began about a week later and has perspiration on her forehead and gets so hot that she must turn the AC up and then she gets too hot. It was up and down. She could feel sweat on her face and not the whole body, just in the head and forehead she was feeling so hot. The runny nose was at the same time as sweating. She did not have a cold or runny nose before the shot. The chest flutter was not constant, comes and goes. Sometimes when it happened, there was a little pinch. The patient's second dose of COVID 19 immunization was due on 28Aug2021. Outcome: It is starting to taper off, it's not as much. The event outcome for sweating more and chest flutter was not recovered, and runny nose was unknown at the time of reporting.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Rhinorrhoea, Vaccination site erythema, Vaccination site pain
Clinical narrative: Sweating more; Chest flutters around heart; Runny nose; This is a spontaneous report from a contactable consumer(patient) or other non-healthcare professional. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0186) as dose 1 single, administered in left arm on 07Aug2021 (at the age of 58-year-old) for COVID-19 immunization. The patient medical history included an allergic reaction to when she had the Tuberculosis shot, and there were two medications in one shot. The patient had a bad reaction in her left arm and it was hot to touch. She got the shot when she turned 50 or something as reported. NDC/LOT/EXP Unknown. The concomitant medications were not reported. About a week after she had the first dose the patient experienced chest flutters around the heart, sweating more, and a runny nose. The patient said that she does not know if that was normal or not. The patient said that she was not a sickly person. Never had a flu shot in her life. Patient was sweating more. It began about a week later and has perspiration on her forehead and gets so hot that she must turn the AC up and then she gets too hot. It was up and down. She could feel sweat on her face and not the whole body, just in the head and forehead she was feeling so hot. The runny nose was at the same time as sweating. She did not have a cold or runny nose before the shot. The chest flutter was not constant, comes and goes. Sometimes when it happened, there was a little pinch. The patient's second dose of COVID 19 immunization was due on 28Aug2021. Outcome: It is starting to taper off, it's not as much. The event outcome for sweating more and chest flutter was not recovered, and runny nose was unknown at the time of reporting.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Hyperhidrosis, Rhinorrhoea
Clinical narrative: chest flutters / still experiencing the flutters; runny nose; sweating / sweating on her forehead; staying hot; when the flutters happen there's a little pain/ very painful, extended into neck, armpit and lower arm that kept her up at night.; a little tightening that comes and goes; arm was swollen; couldn't lift the shoulder or arm up; it was red where the needle went in; it was red where the needle went in at the injection site, very painful; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; kept her up at night; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Aug2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of the Pfizer BioNTech Covid 19 vaccine on 07Aug2021 and is due for her second dose on 28Aug2021. About a week after in Aug2021 she developed a runny nose and developed flutters, chest flutters. Her nose was starting to dry out but was still experiencing the flutters and has been sweating on her forehead and staying hot. She said it didn't feel like a fever and hadn't taken her temperature but she did sweat and that she got hot. She had the flutters throughout the day, not constant, it came and went. She got the shot in the left arm. Sometimes when the flutters happen there was a little pain with it, a little tightening that came and went. However, there's not always pain that's associated with it. The sweating happened first and then she got the flutters. Her husband got the vaccine and had no problems. She had a TDaP shot in her left arm back on 15Oct2012 for immunization and had a severe reaction. She had done fine with other tetanus shots in the past but she said she was told that after age 40 you receive a combination and that's the one she had this reaction with. Her arm was swollen, couldn't lift the shoulder or arm up, it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm that kept her up at night. The outcome of chest flutters was not resolved, the outcome of other events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Cardiac flutter, Chest discomfort, Chest pain, Erythema
Clinical narrative: chest flutters / still experiencing the flutters; runny nose; sweating / sweating on her forehead; staying hot; when the flutters happen there's a little pain/ very painful, extended into neck, armpit and lower arm that kept her up at night.; a little tightening that comes and goes; arm was swollen; couldn't lift the shoulder or arm up; it was red where the needle went in; it was red where the needle went in at the injection site, very painful; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; kept her up at night; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Aug2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of the Pfizer BioNTech Covid 19 vaccine on 07Aug2021 and is due for her second dose on 28Aug2021. About a week after in Aug2021 she developed a runny nose and developed flutters, chest flutters. Her nose was starting to dry out but was still experiencing the flutters and has been sweating on her forehead and staying hot. She said it didn't feel like a fever and hadn't taken her temperature but she did sweat and that she got hot. She had the flutters throughout the day, not constant, it came and went. She got the shot in the left arm. Sometimes when the flutters happen there was a little pain with it, a little tightening that came and went. However, there's not always pain that's associated with it. The sweating happened first and then she got the flutters. Her husband got the vaccine and had no problems. She had a TDaP shot in her left arm back on 15Oct2012 for immunization and had a severe reaction. She had done fine with other tetanus shots in the past but she said she was told that after age 40 you receive a combination and that's the one she had this reaction with. Her arm was swollen, couldn't lift the shoulder or arm up, it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm that kept her up at night. The outcome of chest flutters was not resolved, the outcome of other events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.