chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Aching arm for 2 hours; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in arm on 27Jan2021 at 08:00 (at the age of 79 years old) as single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease from 35+ years, gluten sensitivity from 35+ years, chronic fatigue came down on 24Nov2019 and no treatment for chronic fatigue syndrome. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021, patient experienced aching arm for 2 hours in evening then ok. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Sep2020. The outcome of events was recovered on 27Jan2021.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis
Clinical narrative: had a flare up of Diverticulitis; This is a spontaneous report from a contactable consumer or other non-health care professional. A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 25Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications of the patient were not reported. It was reported that the patient received Pfizer covid vaccine on 25Apr2021 and had a flare up of Diverticulitis, her HCP told her to postpone getting the second dose. It had been 3 months since postponed second dose of Pfizer covid vaccine. Reporter wants to know was it ok to receive second dose of Pfizer covid vaccine then due to the time and asked if she could receive HPV vaccine and the Pfizer covid vaccine or would she had to wait. The outcome of event was Unknown.  Information about lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Chills, Illness, Pyrexia, SARS-CoV-2 test
Clinical narrative: I had moderate vaginal bleedings each and every morning; This abnormal spotting was going on, non stop, for 3 months.; fully sick for a week; fever; chills; This is a spontaneous report from a contactable consumer (Patient). A 32-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 09Apr2021 as dose 2, single for covid-19 immunization (Vaccinated at 32-years age). Medical history included known allergies: Strawberry. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Ep7534), via an unspecified route of administration in arm left on 16Mar2021 as dose 1, single for covid-19 immunization (Vaccinated at 32-years age). Facility where the most recent Covid-19 vaccine was administered was Workplace clinic. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with Covid-19. Patient did not received any other vaccines within 4 weeks prior to the Covid vaccine. On 03May2021, the patient had moderate vaginal bleedings each and every morning, this abnormal spotting was going on, non stop, for 3 months, fully sick for a week, fever, chills. It was reported that after the periods following her second shot (09Apr2021) she had moderate vaginal bleedings each and every morning. This abnormal spotting was going on, non stop, for 3 months. She saw an obgyn who tested her for about anything without finding anything. No progesterone amount would stop it. never had hormonal issues before, so this was concerning. The bleeding stopped after three months. She was fully sick for a week following the second shot (done having about all the side effects advertised, chills, fever, etc). Since the vaccination, patient has been tested for Covid-19. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included biopsy: unknown result, Nasal Swab: negative on 15Jul2021, scan: unknown result, x-ray: unknown result. Events were assessed as medically significant by the reporter. Therapeutic measures were taken as a result of all events. Treatment received for the adverse event included testing, biopsy, xray, scan, progesterone. Outcome of all the events was unknown.  Information on the Batch/lot number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Scan, Vaginal haemorrhage, X-ray
Clinical narrative: I had moderate vaginal bleedings each and every morning; This abnormal spotting was going on, non stop, for 3 months.; fully sick for a week; fever; chills; This is a spontaneous report from a contactable consumer (Patient). A 32-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 09Apr2021 as dose 2, single for covid-19 immunization (Vaccinated at 32-years age). Medical history included known allergies: Strawberry. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Ep7534), via an unspecified route of administration in arm left on 16Mar2021 as dose 1, single for covid-19 immunization (Vaccinated at 32-years age). Facility where the most recent Covid-19 vaccine was administered was Workplace clinic. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with Covid-19. Patient did not received any other vaccines within 4 weeks prior to the Covid vaccine. On 03May2021, the patient had moderate vaginal bleedings each and every morning, this abnormal spotting was going on, non stop, for 3 months, fully sick for a week, fever, chills. It was reported that after the periods following her second shot (09Apr2021) she had moderate vaginal bleedings each and every morning. This abnormal spotting was going on, non stop, for 3 months. She saw an obgyn who tested her for about anything without finding anything. No progesterone amount would stop it. never had hormonal issues before, so this was concerning. The bleeding stopped after three months. She was fully sick for a week following the second shot (done having about all the side effects advertised, chills, fever, etc). Since the vaccination, patient has been tested for Covid-19. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included biopsy: unknown result, Nasal Swab: negative on 15Jul2021, scan: unknown result, x-ray: unknown result. Events were assessed as medically significant by the reporter. Therapeutic measures were taken as a result of all events. Treatment received for the adverse event included testing, biopsy, xray, scan, progesterone. Outcome of all the events was unknown.  Information on the Batch/lot number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Polymerase chain reaction, SARS-CoV-2 antibody test, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: her getting covid even though she received both doses of the vaccine; her getting covid even though she received both doses of the vaccine; This is a spontaneous report from a contactable consumer(patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 26Mar2021(age at vaccination:66 years) (Batch/Lot Number: EN6199) as DOSE 2, SINGLE for covid-19 immunization and BNT162b2 dose 1 via an unspecified route of administration in left arm on 05Mar2021(Age at vaccination:65 years) (Batch/Lot Number: EN6204) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. Caller received both doses of Pfizer Covid 19, vaccine first dose on 05Mar2021 and 2nd dose on 26Mar2021. On 24Jun2021, The patient experienced cough, congestion, scratchy throat, watery eyes. It wasn't until 28Jun2021 she had cough and congestion with lots of mucus. She had watery eyes that lasted for 5-6 days and scratchy throat that lasted for 4-6 days. She had a rapid Covid test. She did it twice to confirm that she was getting the right information. Patient has completed both doses of the vaccine. On 18Jul2021 she tested rapid test twice in a row and was positive. She had a PCR on the 20Jul2021 which was negative, and an antibody test was positive. She went to the doctor and asked for a steroid shot. The doctor did not want to give her a shot. She gave her a prescription for Prednisone 20mg twice daily for 5 days. She started it on 28Jun2021. After three days she was not getting any better. She called and asked for something else. The doctor ordered an antibiotic for 7 days and an inhaler. The doctor didn't think it was anything an antibiotic would take care. The doctor thought it was viral. Her doctor didn't think she needed to be tested because she was vaccinated. Caller was concerned because she was getting a hefty cough and a lot of mucous. It didn't go away with the antibiotic or steroid. Outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: his co-worker tested positive for COVID-19 after returning from a trip to country. He had received the full 2 dose of the Pfizer COVIS-19 Vaccine prior to going to country; his co-worker tested positive for COVID-19 after returning from a trip to country. He had received the full 2 dose of the Pfizer COVIS-19 Vaccine prior to going to country; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration, on an unknown date, as dose 1 and dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient tested positive for COVID-19 after returning from a trip a (Withheld). He had received the full 2 doses of the Pfizer COVID-19 Vaccine prior to going to (Withheld). It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19, Since the vaccination, the patient been tested for positive COVID-19. Treatment for adverse event was unknown. The outcome of the event was unknown.  Information on batch/lot number has been requested.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dyskinesia, Headache, Heart rate increased, Insomnia
Clinical narrative: Fast heart beat; slowed breathing; intense headache; every muscle in my body hurts especialy my lower back/with muscles and lower back throbing; cant sleep; violently jerk; my face eyes nose itch bad for about 10 minutes and then go away; every muscle in my body hurts especialy my lower back/with muscles and lower back throbing; This is a spontaneous report from a contactable consumer (patient).   A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number was not reported), via an unspecified route of administration, administered in right arm on 19Jul2021 10:00, (at age of 54 year old), as dose 1, single for COVID-19 immunisation.  Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date. No known allergies. Concomitant medications included methadone, roflumilast (DALIRESP), Breztri all taken for an unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID. The patient did not receive any other vaccines within 4 weeks prior to the COVID.  On 22Jul2021, 06.00, patient experienced fast heartbeat, slowed breathing, intense headache, every muscle in his body hurts especially his lower Back. He could not sleep, but 2 hours before, he woke up with muscles and lower back throbbing. Also, at the time of reporting, patient reported as he was sitting and watching tv, holding remote and out of nowhere he would violently jerk and his face, eyes, and nose itch bad for about 10 minutes and then went away. No treatment was given for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event face, eyes, and nose itch bad was recovered, where of all other events was not recovered.  Lot number/Batch has been requested.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Respiratory rate decreased
Clinical narrative: Fast heart beat; slowed breathing; intense headache; every muscle in my body hurts especialy my lower back/with muscles and lower back throbing; cant sleep; violently jerk; my face eyes nose itch bad for about 10 minutes and then go away; every muscle in my body hurts especialy my lower back/with muscles and lower back throbing; This is a spontaneous report from a contactable consumer (patient).   A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number was not reported), via an unspecified route of administration, administered in right arm on 19Jul2021 10:00, (at age of 54 year old), as dose 1, single for COVID-19 immunisation.  Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date. No known allergies. Concomitant medications included methadone, roflumilast (DALIRESP), Breztri all taken for an unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID. The patient did not receive any other vaccines within 4 weeks prior to the COVID.  On 22Jul2021, 06.00, patient experienced fast heartbeat, slowed breathing, intense headache, every muscle in his body hurts especially his lower Back. He could not sleep, but 2 hours before, he woke up with muscles and lower back throbbing. Also, at the time of reporting, patient reported as he was sitting and watching tv, holding remote and out of nowhere he would violently jerk and his face, eyes, and nose itch bad for about 10 minutes and then went away. No treatment was given for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event face, eyes, and nose itch bad was recovered, where of all other events was not recovered.  Lot number/Batch has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Limb discomfort, Vaccination site joint movement impairment
Clinical narrative: couldn't move my arms; couldn't move my arms; This is a spontaneous report from a Regulatory Authority received from a contactable Healthcare Professional. A 53-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on an unspecified date, at 53 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization and palbociclib (IBRANCE), oral from Mar2021 and ongoing (Batch/Lot number was not reported), at 125 mg, cyclic daily for 21 days on and 7 days off for breast cancer. Medical history included breast cancer from an unknown date and unknown if ongoing. The patient's concomitant medications included exemestane daily in conjunction with palbociclib. The patient reported that the first vaccine dose was really bad and she couldn't move her arms since an unknown date. The patient reported that the most recent blood work (date unknown) "looked okay". In response to the events palbociclib dose was not changed. At the time of the report the events outcome was unknown.  Information about batch/ lot number has been requested.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cerebrovascular accident, Computerised tomogram, Condition aggravated, Dizziness
Clinical narrative: stroke; She had blood clots in her heart up until her brain; hand went numb and tingling; hand went numb and tingling; she has not had energy/she feels weak/dizzy; she has not had energy/she feels weak; Dizzy; This is a spontaneous report from a contactable consumer. This consumer reported for a 91-Year-old female patient that patient received first dose of bnt162b2 (BNT162B2; Formulation: Solution for injection) via unknown route of administration from unknown date in Mar2021(at the age of 91-Years) on unknown location for COVID-19 immunization. No prior Vaccinations (within 4 weeks). No AEs following prior vaccinations. Patient's Medical History (including any illness at time of vaccination) was reported as None. Patient's family medical history was not reported. Concomitant medications were not reported. It was reported that patient experienced stroke (required emergency Room, and physician office visit and patient was hospitalized, for two nights and three days.), she had blood clots in her heart up until her brain (required emergency Room, and physician office visit and patient was hospitalized, for two nights and three days.), hand went numb and tingling (required emergency Room, and physician office visit and patient was hospitalized, for two nights and three days). Her mother's first shot was in March, her second shot was in April. She has been perfectly healthy up until this point. Ever since she got the shot in April, she has not had energy, she feels weak, and she has been dizzy worsened, no treatment received, and the same doctor tells her to rest. She has not had energy, no treatment received, and she has went to doctor she has been resting more. A week ago, yesterday she was standing at the pantry and her right hand went numb and tingling so she rushed over and took her to the urgent care and the doctor said he thinks she is having a stroke and she took her to hospital, and they found out on the second day they did an MRI and cat scan and an ultrasound of the heart. The MRI showed she had two strokes. So, they kept her in the hospital she had blood clots in her heart up until her brain. She got the covid vaccine and now she has two blood clots. The outcome of the events for stroke, she had blood clots in her heart up until her brain, hand went numb and tingling was unknown, and for she has not had energy/she feels weak, Dizzy was not recovered.  Information on the lot/ batch number has been requested.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging, Paraesthesia, Thrombosis, Ultrasound scan
Clinical narrative: stroke; She had blood clots in her heart up until her brain; hand went numb and tingling; hand went numb and tingling; she has not had energy/she feels weak/dizzy; she has not had energy/she feels weak; Dizzy; This is a spontaneous report from a contactable consumer. This consumer reported for a 91-Year-old female patient that patient received first dose of bnt162b2 (BNT162B2; Formulation: Solution for injection) via unknown route of administration from unknown date in Mar2021(at the age of 91-Years) on unknown location for COVID-19 immunization. No prior Vaccinations (within 4 weeks). No AEs following prior vaccinations. Patient's Medical History (including any illness at time of vaccination) was reported as None. Patient's family medical history was not reported. Concomitant medications were not reported. It was reported that patient experienced stroke (required emergency Room, and physician office visit and patient was hospitalized, for two nights and three days.), she had blood clots in her heart up until her brain (required emergency Room, and physician office visit and patient was hospitalized, for two nights and three days.), hand went numb and tingling (required emergency Room, and physician office visit and patient was hospitalized, for two nights and three days). Her mother's first shot was in March, her second shot was in April. She has been perfectly healthy up until this point. Ever since she got the shot in April, she has not had energy, she feels weak, and she has been dizzy worsened, no treatment received, and the same doctor tells her to rest. She has not had energy, no treatment received, and she has went to doctor she has been resting more. A week ago, yesterday she was standing at the pantry and her right hand went numb and tingling so she rushed over and took her to the urgent care and the doctor said he thinks she is having a stroke and she took her to hospital, and they found out on the second day they did an MRI and cat scan and an ultrasound of the heart. The MRI showed she had two strokes. So, they kept her in the hospital she had blood clots in her heart up until her brain. She got the covid vaccine and now she has two blood clots. The outcome of the events for stroke, she had blood clots in her heart up until her brain, hand went numb and tingling was unknown, and for she has not had energy/she feels weak, Dizzy was not recovered.  Information on the lot/ batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: And then "immediately" developed Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: AM9810, Expiration date: Jun2021) via an unspecified route of administration in left arm on 8Mar2021 10:00 (at the of 64-years-old) as first dose single for COVID-19 immunization. No medical history and concomitant medications were reported. Patient had no other vaccinations the same day as her Pfizer COVID-19 vaccine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Mar2021, the patient experienced Bell's palsy symptoms a day or two after getting her first dose of the vaccine. Patient was treated with Prednisone and it did clear up, she didn't have it anymore because she took all of it. Patient did not undergo any lab test. The outcome of Event was recovered on an unspecified date in 2021.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Depressed mood, Dysstasia, Impaired work ability, Neuralgia
Clinical narrative: blood clots; She's been bedridden now for 3 days; she's in bed she can't even standup long enough to brush her teeth cause she got nerve pain in her legs that she got a blood clot; she's in bed she can't even standup long enough to brush her teeth cause she got nerve pain in her legs that she got a blood clot; had to quit her jobs its awful; she's really depressed; This is a spontaneous report from a contactable consumer. This contactable consumer reported for a female patient of an unknown age received second dose of BNT162B2 (Solution for injection, batch/ lot number: unspecified), via an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (Solution for injection, batch/ lot number: unspecified), via an unspecified date as historical vaccine as single dose for COVID-19 immunisation. Caller stated "It is in regard to my older sister and she had some it's been 3 months since she got her 2nd vaccination. She's been bedridden now for 3 days, 3 days after she got her second Pfizer shot. Like I said after 3 months she's in bed she can't even stand up long enough to brush her teeth cause she got nerve pain in her legs that she got a blood clot from like I said it happened 3 days after she got her second shot. I am only trying to give the doctors something to go on because the pain she's in I can't even believe her doctors are letting her go for 3 months without being able to move. Her and her husband had to quit her jobs its awful and I'm worried about her both physically and mentally she's really depressed." The outcome of the adverse events was unknown.  The lot number for the vaccine, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots; She's been bedridden now for 3 days; she's in bed she can't even standup long enough to brush her teeth cause she got nerve pain in her legs that she got a blood clot; she's in bed she can't even standup long enough to brush her teeth cause she got nerve pain in her legs that she got a blood clot; had to quit her jobs its awful; she's really depressed; This is a spontaneous report from a contactable consumer. This contactable consumer reported for a female patient of an unknown age received second dose of BNT162B2 (Solution for injection, batch/ lot number: unspecified), via an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (Solution for injection, batch/ lot number: unspecified), via an unspecified date as historical vaccine as single dose for COVID-19 immunisation. Caller stated "It is in regard to my older sister and she had some it's been 3 months since she got her 2nd vaccination. She's been bedridden now for 3 days, 3 days after she got her second Pfizer shot. Like I said after 3 months she's in bed she can't even stand up long enough to brush her teeth cause she got nerve pain in her legs that she got a blood clot from like I said it happened 3 days after she got her second shot. I am only trying to give the doctors something to go on because the pain she's in I can't even believe her doctors are letting her go for 3 months without being able to move. Her and her husband had to quit her jobs its awful and I'm worried about her both physically and mentally she's really depressed." The outcome of the adverse events was unknown.  The lot number for the vaccine, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer (husband) via Pfizer sponsored program Pfizer regulatory authority.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VAC-CINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date in May2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 30May2021, the patient was affected by Bell's Palsy. This was exactly after 2 weeks after her 2nd Pfizer COVID shot. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation and no reaction were reported. The reporter wrote to you previously as well, but reporter did not receive any reply from your side. Yesterday, reporter contacted the Neurologist and he suggested reporter to write to you again informing about the situation. It seems to be an acute Bell's Palsy and reporter requested to take this matter on an urgent basis. The outcome of the event was unknown at the time of reporting.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100953159 Same reporter/ drug/ event for different patients
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle discomfort, Neurological symptom
Clinical narrative: The next morning experienced "weird" muscular and neurological reactions; The next morning experienced "weird" muscular and neurological reactions; This is a spontaneous report from a contactable consumer.   A 53-year-old female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Lot/Batch number, not reported), via on an unspecified route of administration on 11Jul2021 (age at vaccination was 53-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 12Jul2021, the next morning of vaccination, the patient experienced weird muscular and neurological reactions. These side effects lasted 36 hours. Reporter stated that she sought medical care from her PCP yesterday and they could not recommend whether she should get the second dose of the vaccination series on Saturday or not, therefore patient seeking this information from Pfizer. At the time of this report event outcome was recovered on an unknown date in Jul2021.   Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Lymph node pain, Pain, Pain in extremity
Clinical narrative: having burning pain in lymph nodes under her left arm; having burning pain in lymph nodes under her left arm that is getting worse; pain that radiated into her left leg / having burning pain in lymph nodes under her left arm; pain is so bad; This is a spontaneous report from a contactable consumer or other non hcp (parent) reported for her daughter (patient). A 30-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm left on 24Jul2021 as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The reporter reported the patient had left side pain that radiated into her left leg on Sunday but it subsided. Previous day she began having burning pain in lymph nodes under her left arm that is getting worse.  She got the vaccine in her left arm. She fought getting the vaccine because she heard it causes fertility issues but finally decided to get it. She had to leave work because the pain was so bad. The reporter asked was this normal. Had it been reported before and how long would it last. The outcome of the events was reported as not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracted COVID-19; contracted COVID-19; This is a spontaneous report from a non-contactable consumer (patient). A 52-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on Mar2021 (end of March) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date of 2021, patient contracted COVID-19. It had already been 4 months past her first dose, and she wanted to know if she can still take the second dose of the vaccine with this situation. Patient was concerned since one doctor told her that she should start the vaccination series all over again and the other doctor told her that it was okay to go ahead with the second dose. The outcome of both the events 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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: have both now been diagnosed with COVID; have both now been diagnosed with COVID; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: was not reported; Expiration Date: was not reported), dose 1 via an unspecified route of administration on 08Jul2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced have both now been diagnosed with COVID-19 and feeling sick on an unspecified date. Caller stated both her and her son received their first dose of the Pfizer COVID-19 vaccine on 08Jul2021 and have both now been diagnosed with COVID-19. Caller was looking for information about when her and she son can get the second dose. She was still feeling sick so would like to know when she can receive her second dose and it's going to be after the three-week mark is that going to be a problem. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on an unspecified date. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100958348 same reporter/drug, different event/ patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: have both now been diagnosed with COVID; This is a spontaneous report from a contactable consumer. This consumer reported for a 21-year-old male patient (Reporter's son) received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, Batch/ lot number was not reported), via unspecified route on 08Jul2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 patient experienced Covid-19, Caller is looking for information about when her and son could get the second dose, patient was feeling better now and their Primary care physician said he could go ahead and proceed and get his scheduled second dose on 29Jul2021, the patient had COVID-19 Test on15Jul2021 and result was positive. The outcome of event was recovered in Jul2021.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100958348 same reporter/drug, different event/ patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: After second dose caller had COVID; After second dose caller had COVID; This is a spontaneous report from a contactable consumer (patient himself) via a Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in January2021 as dose 1, single; second 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 unknown date in February 2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, the patient after second dose the patient had covid. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on an unknown date in 2021.Patient treated with monoclonal antibodies. The reporter states that he really wants to know if the booster is going to be the same as the other two doses because he had no effects from them whatsoever. COVID-19 and circulating mutations, the companies provided an update on booster dosing on 09Jul2021. Please note that the use of a 3rd or booster dose is not recommended or authorized and Pfizer does not suggest the use of the vaccine in any manner other than as described in the authorized EUA Prescribing Information authorized product monograph. Initial data from the ongoing study of booster doses demonstrated a consistent tolerability profile and high neutralization titers against the wild-type virus (the naturally occurring non-mutated virus) and the Beta variant. It is thought that the effects seen against the Beta variant may also be seen in the Delta variant. We are doing studies to confirm this. We expect to publish the data soon in a peer-reviewed journal and submit to regulatory authorities like the FDA in the coming weeks. Note to frontline: This FAQ should only be used if an HCP or non-HCP specifically asks about the Pfizer statement on booster doses. For HCPs with general inquiries about booster doses, please refer to the SRD titled "Administration of More Than a 2-Dose Series (Booster Dose)". Non-HCPs should be referred to their HCP for further discussion. The outcome of the events was unknown. There was no product quality complaint (PQC) present.  The lot number for the vaccine was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100957896 Pfizer
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Lymphadenopathy, Swelling face, Vaccination site swelling
Clinical narrative: bell's Palsy; she experienced swelling of her left underarm where she got her shot.; Lymphadenopathy; experienced facial swelling (left side of her face); This is a spontaneous report from a non-contactable physician via Medical Information Team.   A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration in the left arm on an unspecified date in Jan 2021 as dose 1, single for COVID-19 immunization. Medical history included covid-19 from Jul2020 to an unknown date. The patient's concomitant medications were not reported. The patient got her first dose of the Pfizer Covid 19 vaccine back in Jan and after her first dose On an unspecified date patient experienced swelling of her left underarm where she got her shot. Stated it was lymphadenopathy. patient also experienced facial swelling (left side of her face) and bell's Palsy. she went to her doctor and she was given Prednisone 50mg for 5 days as she was diagnosed of bells Palsy. patient wanted more information specific to Bells Palsy and patient was asking if she could get the second dose of the vaccine. The clinical outcome for the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.  ; Sender's Comments: based on the strong temporal relationship the events bells palsy , lymphadenopathy,facial swelling and the suspect vaccine BNT162B2 cannot be ruled out completely. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Blood thyroid stimulating hormone, Blood thyroid stimulating hormone decreased, Body temperature, Iodine uptake
Clinical narrative: thyroiditis subacute; Blood thyroid stimulating hormone decreased; Iodine uptake decreased; Lymphocyte count decreased; Monocyte count increased; Red blood cell sedimentation rate increased; Serum ferritin increased; Thyroxine free increased; Tri-iodothyronine free increased; Pyrexia; This is a spontaneous report from a non-contactable consumer. A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as dose 2, single (at the age of 44-years-old) for COVID-19 immunization. Medical history included Gilbert's syndrome; Ragweed allergy; COVID-19, showed as past COVID-19 infection (acute infection excluded via antigen test). Concomitant medication included ascorbic acid, colecalciferol, potassium, selenium; all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (Batch/Lot number and Expiration date: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single was taken for covid-19 immunization. The patient experienced thyroiditis subacute, Blood thyroid stimulating hormone decreased, Iodine uptake decreased, Lymphocyte count decreased, Monocyte count increased, Pyrexia or Fever of 40 centigrade for 36 hours, Red blood cell sedimentation rate increased, Serum ferritin increased, Thyroxine free increased, Tri-iodothyronine free increased. The patient underwent lab tests and procedures which included antibody test: covid on showed past COVID-19 infection (acute infection excluded via antigen test), blood thyroid stimulating hormone: decreased, body temperature: 40 centigrade for 36 hours, iodine uptake: decreased, lymphocyte count: decreased, monocyte count: increased, red blood cell sedimentation rate: increased, serum ferritin: increased on, thyroxine free: increased, tri-iodothyronine free: increased, radioactive iodine uptake test (RAIU): almost zero TC99 uptake in the thyroid; all on unspecified date. Outcome of the events was not recovered.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Iodine uptake decreased, Lymphocyte count, Lymphocyte count decreased, Monocyte count, Monocyte count increased
Clinical narrative: thyroiditis subacute; Blood thyroid stimulating hormone decreased; Iodine uptake decreased; Lymphocyte count decreased; Monocyte count increased; Red blood cell sedimentation rate increased; Serum ferritin increased; Thyroxine free increased; Tri-iodothyronine free increased; Pyrexia; This is a spontaneous report from a non-contactable consumer. A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as dose 2, single (at the age of 44-years-old) for COVID-19 immunization. Medical history included Gilbert's syndrome; Ragweed allergy; COVID-19, showed as past COVID-19 infection (acute infection excluded via antigen test). Concomitant medication included ascorbic acid, colecalciferol, potassium, selenium; all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (Batch/Lot number and Expiration date: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single was taken for covid-19 immunization. The patient experienced thyroiditis subacute, Blood thyroid stimulating hormone decreased, Iodine uptake decreased, Lymphocyte count decreased, Monocyte count increased, Pyrexia or Fever of 40 centigrade for 36 hours, Red blood cell sedimentation rate increased, Serum ferritin increased, Thyroxine free increased, Tri-iodothyronine free increased. The patient underwent lab tests and procedures which included antibody test: covid on showed past COVID-19 infection (acute infection excluded via antigen test), blood thyroid stimulating hormone: decreased, body temperature: 40 centigrade for 36 hours, iodine uptake: decreased, lymphocyte count: decreased, monocyte count: increased, red blood cell sedimentation rate: increased, serum ferritin: increased on, thyroxine free: increased, tri-iodothyronine free: increased, radioactive iodine uptake test (RAIU): almost zero TC99 uptake in the thyroid; all on unspecified date. Outcome of the events was not recovered.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Red blood cell sedimentation rate, Red blood cell sedimentation rate increased, Serum ferritin, Serum ferritin increased
Clinical narrative: thyroiditis subacute; Blood thyroid stimulating hormone decreased; Iodine uptake decreased; Lymphocyte count decreased; Monocyte count increased; Red blood cell sedimentation rate increased; Serum ferritin increased; Thyroxine free increased; Tri-iodothyronine free increased; Pyrexia; This is a spontaneous report from a non-contactable consumer. A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as dose 2, single (at the age of 44-years-old) for COVID-19 immunization. Medical history included Gilbert's syndrome; Ragweed allergy; COVID-19, showed as past COVID-19 infection (acute infection excluded via antigen test). Concomitant medication included ascorbic acid, colecalciferol, potassium, selenium; all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (Batch/Lot number and Expiration date: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single was taken for covid-19 immunization. The patient experienced thyroiditis subacute, Blood thyroid stimulating hormone decreased, Iodine uptake decreased, Lymphocyte count decreased, Monocyte count increased, Pyrexia or Fever of 40 centigrade for 36 hours, Red blood cell sedimentation rate increased, Serum ferritin increased, Thyroxine free increased, Tri-iodothyronine free increased. The patient underwent lab tests and procedures which included antibody test: covid on showed past COVID-19 infection (acute infection excluded via antigen test), blood thyroid stimulating hormone: decreased, body temperature: 40 centigrade for 36 hours, iodine uptake: decreased, lymphocyte count: decreased, monocyte count: increased, red blood cell sedimentation rate: increased, serum ferritin: increased on, thyroxine free: increased, tri-iodothyronine free: increased, radioactive iodine uptake test (RAIU): almost zero TC99 uptake in the thyroid; all on unspecified date. Outcome of the events was not recovered.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Thyroiditis subacute, Thyroxine free, Thyroxine free increased, Tri-iodothyronine free, Tri-iodothyronine free increased
Clinical narrative: thyroiditis subacute; Blood thyroid stimulating hormone decreased; Iodine uptake decreased; Lymphocyte count decreased; Monocyte count increased; Red blood cell sedimentation rate increased; Serum ferritin increased; Thyroxine free increased; Tri-iodothyronine free increased; Pyrexia; This is a spontaneous report from a non-contactable consumer. A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as dose 2, single (at the age of 44-years-old) for COVID-19 immunization. Medical history included Gilbert's syndrome; Ragweed allergy; COVID-19, showed as past COVID-19 infection (acute infection excluded via antigen test). Concomitant medication included ascorbic acid, colecalciferol, potassium, selenium; all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (Batch/Lot number and Expiration date: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single was taken for covid-19 immunization. The patient experienced thyroiditis subacute, Blood thyroid stimulating hormone decreased, Iodine uptake decreased, Lymphocyte count decreased, Monocyte count increased, Pyrexia or Fever of 40 centigrade for 36 hours, Red blood cell sedimentation rate increased, Serum ferritin increased, Thyroxine free increased, Tri-iodothyronine free increased. The patient underwent lab tests and procedures which included antibody test: covid on showed past COVID-19 infection (acute infection excluded via antigen test), blood thyroid stimulating hormone: decreased, body temperature: 40 centigrade for 36 hours, iodine uptake: decreased, lymphocyte count: decreased, monocyte count: increased, red blood cell sedimentation rate: increased, serum ferritin: increased on, thyroxine free: increased, tri-iodothyronine free: increased, radioactive iodine uptake test (RAIU): almost zero TC99 uptake in the thyroid; all on unspecified date. Outcome of the events was not recovered.  No follow up attempts are possible, information about lot/batch number cannot be obtained.