chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Electric shock sensation, Electrocardiogram, Electroencephalogram, Fall, Fatigue
Clinical narrative: 1. Electric shocks up back of neck into head an hour after (with all three).  2. Lymphatic fluid swelling in left armpit within 12 hours, after 24  hours the swelling was huge and watery and had moved down. After 36 hours it looked like a large implant on the side of his torso.  3. Main event was upon waking on May 1st: woke up with the swollen area being sore and stretched it out. Got up to start the day and got lightheaded, sudden heart palpitations, seeing spots, so he got on his knees then passed out and fell to floor. Spouse then witnessed a full TONIC seizure, starting with his pupils dilating then rolling backwards into his head, entire body went rigid for 25-30 seconds while letting out a loud scream/howl, then going limp and breathing stopped for about three seconds. He then started panting and sweating profusely. He was non-responsive and could not move or speak. Was gaining more speech by the time paramedics arrived but was very confused and tired. Could not stand or walk on his own. Was transported by ambulance to nearest hospital emergency room.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Gait inability, Hyperhidrosis, Hyperventilation, Loss of consciousness
Clinical narrative: 1. Electric shocks up back of neck into head an hour after (with all three).  2. Lymphatic fluid swelling in left armpit within 12 hours, after 24  hours the swelling was huge and watery and had moved down. After 36 hours it looked like a large implant on the side of his torso.  3. Main event was upon waking on May 1st: woke up with the swollen area being sore and stretched it out. Got up to start the day and got lightheaded, sudden heart palpitations, seeing spots, so he got on his knees then passed out and fell to floor. Spouse then witnessed a full TONIC seizure, starting with his pupils dilating then rolling backwards into his head, entire body went rigid for 25-30 seconds while letting out a loud scream/howl, then going limp and breathing stopped for about three seconds. He then started panting and sweating profusely. He was non-responsive and could not move or speak. Was gaining more speech by the time paramedics arrived but was very confused and tired. Could not stand or walk on his own. Was transported by ambulance to nearest hospital emergency room.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphoedema, Magnetic resonance imaging, Mobility decreased, Muscle rigidity, Mydriasis
Clinical narrative: 1. Electric shocks up back of neck into head an hour after (with all three).  2. Lymphatic fluid swelling in left armpit within 12 hours, after 24  hours the swelling was huge and watery and had moved down. After 36 hours it looked like a large implant on the side of his torso.  3. Main event was upon waking on May 1st: woke up with the swollen area being sore and stretched it out. Got up to start the day and got lightheaded, sudden heart palpitations, seeing spots, so he got on his knees then passed out and fell to floor. Spouse then witnessed a full TONIC seizure, starting with his pupils dilating then rolling backwards into his head, entire body went rigid for 25-30 seconds while letting out a loud scream/howl, then going limp and breathing stopped for about three seconds. He then started panting and sweating profusely. He was non-responsive and could not move or speak. Was gaining more speech by the time paramedics arrived but was very confused and tired. Could not stand or walk on his own. Was transported by ambulance to nearest hospital emergency room.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Palpitations, Respiratory arrest, Screaming, Speech disorder
Clinical narrative: 1. Electric shocks up back of neck into head an hour after (with all three).  2. Lymphatic fluid swelling in left armpit within 12 hours, after 24  hours the swelling was huge and watery and had moved down. After 36 hours it looked like a large implant on the side of his torso.  3. Main event was upon waking on May 1st: woke up with the swollen area being sore and stretched it out. Got up to start the day and got lightheaded, sudden heart palpitations, seeing spots, so he got on his knees then passed out and fell to floor. Spouse then witnessed a full TONIC seizure, starting with his pupils dilating then rolling backwards into his head, entire body went rigid for 25-30 seconds while letting out a loud scream/howl, then going limp and breathing stopped for about three seconds. He then started panting and sweating profusely. He was non-responsive and could not move or speak. Was gaining more speech by the time paramedics arrived but was very confused and tired. Could not stand or walk on his own. Was transported by ambulance to nearest hospital emergency room.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Tonic convulsion, Unresponsive to stimuli, Urine analysis, Visual impairment
Clinical narrative: 1. Electric shocks up back of neck into head an hour after (with all three).  2. Lymphatic fluid swelling in left armpit within 12 hours, after 24  hours the swelling was huge and watery and had moved down. After 36 hours it looked like a large implant on the side of his torso.  3. Main event was upon waking on May 1st: woke up with the swollen area being sore and stretched it out. Got up to start the day and got lightheaded, sudden heart palpitations, seeing spots, so he got on his knees then passed out and fell to floor. Spouse then witnessed a full TONIC seizure, starting with his pupils dilating then rolling backwards into his head, entire body went rigid for 25-30 seconds while letting out a loud scream/howl, then going limp and breathing stopped for about three seconds. He then started panting and sweating profusely. He was non-responsive and could not move or speak. Was gaining more speech by the time paramedics arrived but was very confused and tired. Could not stand or walk on his own. Was transported by ambulance to nearest hospital emergency room.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cold sweat, Cough, Dyspnoea, Feeling cold
Clinical narrative: Pain at injection site for less than 24 hours.  Feeling flush-hot and then cold/clammy the 2nd day after shot.  One week after 4th dose,  felt slight headache , sore throat, tickle in throat and congested.  On the 8th day  after 4th dose, woke up feeling like I had the flu.  Took a home COVID test (Binax) and the result was positive.  Did a video conference with Dr at urgent care clinic.  She advised that I drink lots of fluids, get plenty of rest, take extra vitamin supplements, use over the counter medicine as needed to relieve symptoms.  I told her that my head felt like it was going to explode, the pressure was intense and I could not breathe through my nose.  I had taken a Sudafed the day before hoping that it would help with the congested feeling but it did not seem to phase it.  She prescribed me  Bromphen/pseudo/dextro HBR syrup to take if I started coughing and it would help with my congestion.   I took it Friday twice , several times on Saturday and just twice on Sunday.   I stayed in bed Friday, Saturday and most of Sunday.  I never ran a fever and on Sunday, the  12th I was finally able to breathe through my nose.  I coughed just a little bit but nothing ever came up and it never felt like it was in my chest.  It was more like clearing my throat.   On Monday, three days after I tested positive , I woke up and felt 90% better.  On Tuesday it was like I had never been sick.  I have noticed that I tire easily but everyday is better.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Influenza like illness, Injection site pain, Mobility decreased
Clinical narrative: Pain at injection site for less than 24 hours.  Feeling flush-hot and then cold/clammy the 2nd day after shot.  One week after 4th dose,  felt slight headache , sore throat, tickle in throat and congested.  On the 8th day  after 4th dose, woke up feeling like I had the flu.  Took a home COVID test (Binax) and the result was positive.  Did a video conference with Dr at urgent care clinic.  She advised that I drink lots of fluids, get plenty of rest, take extra vitamin supplements, use over the counter medicine as needed to relieve symptoms.  I told her that my head felt like it was going to explode, the pressure was intense and I could not breathe through my nose.  I had taken a Sudafed the day before hoping that it would help with the congested feeling but it did not seem to phase it.  She prescribed me  Bromphen/pseudo/dextro HBR syrup to take if I started coughing and it would help with my congestion.   I took it Friday twice , several times on Saturday and just twice on Sunday.   I stayed in bed Friday, Saturday and most of Sunday.  I never ran a fever and on Sunday, the  12th I was finally able to breathe through my nose.  I coughed just a little bit but nothing ever came up and it never felt like it was in my chest.  It was more like clearing my throat.   On Monday, three days after I tested positive , I woke up and felt 90% better.  On Tuesday it was like I had never been sick.  I have noticed that I tire easily but everyday is better.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Respiratory tract congestion, SARS-CoV-2 test positive, Throat clearing, Throat irritation
Clinical narrative: Pain at injection site for less than 24 hours.  Feeling flush-hot and then cold/clammy the 2nd day after shot.  One week after 4th dose,  felt slight headache , sore throat, tickle in throat and congested.  On the 8th day  after 4th dose, woke up feeling like I had the flu.  Took a home COVID test (Binax) and the result was positive.  Did a video conference with Dr at urgent care clinic.  She advised that I drink lots of fluids, get plenty of rest, take extra vitamin supplements, use over the counter medicine as needed to relieve symptoms.  I told her that my head felt like it was going to explode, the pressure was intense and I could not breathe through my nose.  I had taken a Sudafed the day before hoping that it would help with the congested feeling but it did not seem to phase it.  She prescribed me  Bromphen/pseudo/dextro HBR syrup to take if I started coughing and it would help with my congestion.   I took it Friday twice , several times on Saturday and just twice on Sunday.   I stayed in bed Friday, Saturday and most of Sunday.  I never ran a fever and on Sunday, the  12th I was finally able to breathe through my nose.  I coughed just a little bit but nothing ever came up and it never felt like it was in my chest.  It was more like clearing my throat.   On Monday, three days after I tested positive , I woke up and felt 90% better.  On Tuesday it was like I had never been sick.  I have noticed that I tire easily but everyday is better.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: COVID-19 PRIZER GRAY TOP WAS DILUTED WITH 1.8 ML OF DILUENT IN ERROE. PATIENT RECEIVED DILUTED DOSE
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Covid 19 Pfizer Gray Top was diluted with 1.8 ml of diluent. Patient received diluted dose
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: COVID-19 PFIZER GRAY TOP WAS DILUTED WITH 1.8 ML OF DILUENT IN ERROR PATIENT RECEIVED DILUTED DOSE
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: COVID-19 PFIZER GRAY TOP WAS DILUTED WITH 1.8ML OF DILUENT IN ERROR PATIENT RECEIVED DILUTED DOSE
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Covid 19 Pfizer Gray Top was diluted with 1.8 ml of diluent in error Patient received diluted dose
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: COVID-19 PFIZER GRAY TOP WAS DILUTED WITH 1.8 ML OF DILUENT IN ERROR PATIENT RECEIVED DILUTED DOSE
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Covid19 Pfizer Gray Top was diluted with 1.8 ml of diluent in error Patient received diluted dose
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Covid 19 Pfizer Gray Top was diluted with 1.8 ml of diluent in error. Patient received diluted dose.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Covid-19 Pfizer Gray Top was diluted with 1.8 ml of diluent in error Patient received diluted dose
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Covid 19 Pfizer Gray Top was diluted with 1.8 ml of diluent in error. Patient received diluted dose
Age: 59.0
Sex: M
Vaccine: COVID19, FLUR4, VARZOS
Symptoms: Product preparation issue, Underdose
Clinical narrative: Covid19 Pfizer Gray Top was dilute with 1.8 ml of diluent in error. Patient received diluted dose.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Covid19 Pfizer Gray Top was diluted with 1.8 ml of diluent in error Patient received diluted dose.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Covid19 Pfizer Gray Top was diluted with 1.8 ml of diluent in error Patient received diluted dose
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error, Product preparation issue
Clinical narrative: Covid19 Pfizer Gray Top was diluted with 1.8 ml of diluent in error Patient received diluted dose
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Rash
Clinical narrative: Kinrix/Proquad given 6/7/2022 . Patient began with Rash/redness  Left thigh 6/8; Patient was seen 6/9/2022 in office.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: died of a heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID 19", start date: 02Dec2020 (unspecified if ongoing), notes: He had been previously diagnosed with COVID 19 on or about 02Dec2020. The patient's concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant) with onset 09Apr2021, outcome "fatal", described as "died of a heart attack". The patient date of death was 09Apr2021. Reported cause of death: "died of a heart attack".  Clinical course: The patient received his first COVID 19 vaccine on 06Apr021. He died of a heart attack on 09Apr2021. He had been previously diagnosed with COVID 19 on or about 02Dec2020. He had no symptoms of indicating a heart issue prior to his heart attack. It has been thought by the reporter that it was important to report, in regards to efficacy and side effects of the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: died of a heart attack
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Rash, Rash macular, Rash pruritic
Clinical narrative: cankers sores in her mouth which bleed; All over body rash/Rash was down both arms, both thighs down to her knees, was wrapped around her waist, on her face (almost into her eyes), neck, and chest.; red as beat; Behind her neck and hairline she has welts; Itching from the rash; canker sores in her mouth; This case was reported by a consumer via call center representative and described the occurrence of stomatitis hemorrhagic in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Moderna Covid Vaccine (received MODERNA COVID Vaccine in November 2021).   On 7th February 2022, the patient received the 1st dose of Shingrix. In February 2022, 2 days after receiving Shingrix, the patient experienced stomatitis hemorrhagic (serious criteria GSK medically significant), generalized rash, red rash, welts, itchy rash and canker sore. The patient was treated with magic mouthwash (nos) (Magic Mouthwash). On an unknown date, the outcome of the stomatitis hemorrhagic, welts and canker sore were not recovered/not resolved and the outcome of the generalized rash, red rash and itchy rash were unknown.   It was unknown if the reporter considered the stomatitis hemorrhagic, generalized rash, red rash, welts, itchy rash and canker sore to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR092154   Additional Information: GSK Receipt Date: 10-JUN-2022  Reporter's comment: Reporter was the patient.   She stated she received Shingrix and believed it was given in her left arm. About 2 days later, she experienced an all over body rash.  Rash was down both arms, both thighs down to her knees was wrapped around her waist, on her face (almost into her eyes), neck, and chest.   She stated she was red as a beat.   Behind her neck and hairline she has welts  from the itching she had from the rash.    Shortly after the rash, she developed canker sores in her mouth.   The patient still had cankers sores in her mouth which bleed.  The patient uses Magic mouthwash to help alleviate symptoms.  The patient was going to see a dermatologist regarding the welts. The patient also stated that the pharmacist at her pharmacy told her that most of his patients report a red arm, a little bit of a fever, and a little pain from the Shingrix shot. Consumer gave consent to follow up with health care professional (pharmacy). The reporter consented to follow up. Additional Supportive Information: This case was linked with US2022AMR092154, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR092154:same reporter
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Aphthous ulcer, Pain, Pyrexia, Rash, Rash erythematous
Clinical narrative: cankers sores in her mouth which bleed; All over body rash/Rash was down both arms, both thighs down to her knees, was wrapped around her waist, on her face (almost into her eyes), neck, and chest.; red as beat; Behind her neck and hairline she has welts; Itching from the rash; canker sores in her mouth; This case was reported by a consumer via call center representative and described the occurrence of stomatitis hemorrhagic in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Moderna Covid Vaccine (received MODERNA COVID Vaccine in November 2021).   On 7th February 2022, the patient received the 1st dose of Shingrix. In February 2022, 2 days after receiving Shingrix, the patient experienced stomatitis hemorrhagic (serious criteria GSK medically significant), generalized rash, red rash, welts, itchy rash and canker sore. The patient was treated with magic mouthwash (nos) (Magic Mouthwash). On an unknown date, the outcome of the stomatitis hemorrhagic, welts and canker sore were not recovered/not resolved and the outcome of the generalized rash, red rash and itchy rash were unknown.   It was unknown if the reporter considered the stomatitis hemorrhagic, generalized rash, red rash, welts, itchy rash and canker sore to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR092154   Additional Information: GSK Receipt Date: 10-JUN-2022  Reporter's comment: Reporter was the patient.   She stated she received Shingrix and believed it was given in her left arm. About 2 days later, she experienced an all over body rash.  Rash was down both arms, both thighs down to her knees was wrapped around her waist, on her face (almost into her eyes), neck, and chest.   She stated she was red as a beat.   Behind her neck and hairline she has welts  from the itching she had from the rash.    Shortly after the rash, she developed canker sores in her mouth.   The patient still had cankers sores in her mouth which bleed.  The patient uses Magic mouthwash to help alleviate symptoms.  The patient was going to see a dermatologist regarding the welts. The patient also stated that the pharmacist at her pharmacy told her that most of his patients report a red arm, a little bit of a fever, and a little pain from the Shingrix shot. Consumer gave consent to follow up with health care professional (pharmacy). The reporter consented to follow up. Additional Supportive Information: This case was linked with US2022AMR092154, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR092154:same reporter
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic, Stomatitis haemorrhagic, Urticaria
Clinical narrative: cankers sores in her mouth which bleed; All over body rash/Rash was down both arms, both thighs down to her knees, was wrapped around her waist, on her face (almost into her eyes), neck, and chest.; red as beat; Behind her neck and hairline she has welts; Itching from the rash; canker sores in her mouth; This case was reported by a consumer via call center representative and described the occurrence of stomatitis hemorrhagic in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Moderna Covid Vaccine (received MODERNA COVID Vaccine in November 2021).   On 7th February 2022, the patient received the 1st dose of Shingrix. In February 2022, 2 days after receiving Shingrix, the patient experienced stomatitis hemorrhagic (serious criteria GSK medically significant), generalized rash, red rash, welts, itchy rash and canker sore. The patient was treated with magic mouthwash (nos) (Magic Mouthwash). On an unknown date, the outcome of the stomatitis hemorrhagic, welts and canker sore were not recovered/not resolved and the outcome of the generalized rash, red rash and itchy rash were unknown.   It was unknown if the reporter considered the stomatitis hemorrhagic, generalized rash, red rash, welts, itchy rash and canker sore to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR092154   Additional Information: GSK Receipt Date: 10-JUN-2022  Reporter's comment: Reporter was the patient.   She stated she received Shingrix and believed it was given in her left arm. About 2 days later, she experienced an all over body rash.  Rash was down both arms, both thighs down to her knees was wrapped around her waist, on her face (almost into her eyes), neck, and chest.   She stated she was red as a beat.   Behind her neck and hairline she has welts  from the itching she had from the rash.    Shortly after the rash, she developed canker sores in her mouth.   The patient still had cankers sores in her mouth which bleed.  The patient uses Magic mouthwash to help alleviate symptoms.  The patient was going to see a dermatologist regarding the welts. The patient also stated that the pharmacist at her pharmacy told her that most of his patients report a red arm, a little bit of a fever, and a little pain from the Shingrix shot. Consumer gave consent to follow up with health care professional (pharmacy). The reporter consented to follow up. Additional Supportive Information: This case was linked with US2022AMR092154, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR092154:same reporter
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: states the child was given the "entire vial of the product; states the child was given the "entire vial of the product; caller's son "received an entire vial of undiluted product"; fevers; abdominal pain; nausea; sore throat; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team. The reporter is the parent.  A 6-year-old male patient received BNT162b2 (BNT162B2), on 04Jun2022 at 11:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 6 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot: FK5127), administration date: 06Nov2021, when the patient was 5-year-old, for covid-19 immunisation; bnt162b2 (DOSE 2, SINGLE, Lot: FK5618), administration date: 27Nov2021, when the patient was 6-year-old, for covid-19 immunisation. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 04Jun2022, outcome "unknown"; FATIGUE (non-serious) with onset 04Jun2022, outcome "unknown"; PYREXIA (non-serious) with onset 04Jun2022, outcome "unknown", described as "fevers"; NAUSEA (non-serious) with onset 04Jun2022, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious) with onset 04Jun2022, outcome "unknown", described as "sore throat"; PRODUCT PREPARATION ERROR (non-serious) with onset 04Jun2022 at 11:30, outcome "unknown", described as "caller's son "received an entire vial of undiluted product""; OVERDOSE (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 04Jun2022 at 11:30, outcome "unknown" and all described as "states the child was given the "entire vial of the product". The events "fevers", "abdominal pain", "nausea", "sore throat" and "fatigue" required physician office visit. Therapeutic measures were taken as a result of pyrexia, abdominal pain, nausea, oropharyngeal pain, fatigue.  Additional information: per report, pharmacist gave pediatric vaccine to patient without adding the diluent to the vial first. patient is experiencing fevers, abdominal pain, nausea, sore throat, fatigue within the first 4 days after the vaccine. ae treatment was Clinic visit with PCP, Ibuprofen and Tylenol. if covid prior vaccination was Unknown. Patient has not tested covid post vaccination. Patient has no known allergies. Patient has not received any other vaccine in four weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received  Follow-up (08Jun2022): This is a spontaneous follow-up report received from a contactable Physician. This physician reported for a patient that: Updated information: New event fevers, abdominal pain, nausea, sore throat, fatigue was added. Treatment yes was added ,physician office visit was checked and RMH none was added  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: states the child was given the "entire vial of the product; states the child was given the "entire vial of the product; caller's son "received an entire vial of undiluted product"; fevers; abdominal pain; nausea; sore throat; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team. The reporter is the parent.  A 6-year-old male patient received BNT162b2 (BNT162B2), on 04Jun2022 at 11:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 6 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot: FK5127), administration date: 06Nov2021, when the patient was 5-year-old, for covid-19 immunisation; bnt162b2 (DOSE 2, SINGLE, Lot: FK5618), administration date: 27Nov2021, when the patient was 6-year-old, for covid-19 immunisation. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 04Jun2022, outcome "unknown"; FATIGUE (non-serious) with onset 04Jun2022, outcome "unknown"; PYREXIA (non-serious) with onset 04Jun2022, outcome "unknown", described as "fevers"; NAUSEA (non-serious) with onset 04Jun2022, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious) with onset 04Jun2022, outcome "unknown", described as "sore throat"; PRODUCT PREPARATION ERROR (non-serious) with onset 04Jun2022 at 11:30, outcome "unknown", described as "caller's son "received an entire vial of undiluted product""; OVERDOSE (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 04Jun2022 at 11:30, outcome "unknown" and all described as "states the child was given the "entire vial of the product". The events "fevers", "abdominal pain", "nausea", "sore throat" and "fatigue" required physician office visit. Therapeutic measures were taken as a result of pyrexia, abdominal pain, nausea, oropharyngeal pain, fatigue.  Additional information: per report, pharmacist gave pediatric vaccine to patient without adding the diluent to the vial first. patient is experiencing fevers, abdominal pain, nausea, sore throat, fatigue within the first 4 days after the vaccine. ae treatment was Clinic visit with PCP, Ibuprofen and Tylenol. if covid prior vaccination was Unknown. Patient has not tested covid post vaccination. Patient has no known allergies. Patient has not received any other vaccine in four weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received  Follow-up (08Jun2022): This is a spontaneous follow-up report received from a contactable Physician. This physician reported for a patient that: Updated information: New event fevers, abdominal pain, nausea, sore throat, fatigue was added. Treatment yes was added ,physician office visit was checked and RMH none was added  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Fatigue, Nausea, Oropharyngeal pain, Overdose
Clinical narrative: states the child was given the "entire vial of the product; states the child was given the "entire vial of the product; caller's son "received an entire vial of undiluted product"; fevers; abdominal pain; nausea; sore throat; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team. The reporter is the parent.  A 6-year-old male patient received BNT162b2 (BNT162B2), on 04Jun2022 at 11:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 6 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot: FK5127), administration date: 06Nov2021, when the patient was 5-year-old, for covid-19 immunisation; bnt162b2 (DOSE 2, SINGLE, Lot: FK5618), administration date: 27Nov2021, when the patient was 6-year-old, for covid-19 immunisation. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 04Jun2022, outcome "unknown"; FATIGUE (non-serious) with onset 04Jun2022, outcome "unknown"; PYREXIA (non-serious) with onset 04Jun2022, outcome "unknown", described as "fevers"; NAUSEA (non-serious) with onset 04Jun2022, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious) with onset 04Jun2022, outcome "unknown", described as "sore throat"; PRODUCT PREPARATION ERROR (non-serious) with onset 04Jun2022 at 11:30, outcome "unknown", described as "caller's son "received an entire vial of undiluted product""; OVERDOSE (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 04Jun2022 at 11:30, outcome "unknown" and all described as "states the child was given the "entire vial of the product". The events "fevers", "abdominal pain", "nausea", "sore throat" and "fatigue" required physician office visit. Therapeutic measures were taken as a result of pyrexia, abdominal pain, nausea, oropharyngeal pain, fatigue.  Additional information: per report, pharmacist gave pediatric vaccine to patient without adding the diluent to the vial first. patient is experiencing fevers, abdominal pain, nausea, sore throat, fatigue within the first 4 days after the vaccine. ae treatment was Clinic visit with PCP, Ibuprofen and Tylenol. if covid prior vaccination was Unknown. Patient has not tested covid post vaccination. Patient has no known allergies. Patient has not received any other vaccine in four weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received  Follow-up (08Jun2022): This is a spontaneous follow-up report received from a contactable Physician. This physician reported for a patient that: Updated information: New event fevers, abdominal pain, nausea, sore throat, fatigue was added. Treatment yes was added ,physician office visit was checked and RMH none was added  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product administration error, Product preparation error, Pyrexia
Clinical narrative: states the child was given the "entire vial of the product; states the child was given the "entire vial of the product; caller's son "received an entire vial of undiluted product"; fevers; abdominal pain; nausea; sore throat; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team. The reporter is the parent.  A 6-year-old male patient received BNT162b2 (BNT162B2), on 04Jun2022 at 11:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 6 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot: FK5127), administration date: 06Nov2021, when the patient was 5-year-old, for covid-19 immunisation; bnt162b2 (DOSE 2, SINGLE, Lot: FK5618), administration date: 27Nov2021, when the patient was 6-year-old, for covid-19 immunisation. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 04Jun2022, outcome "unknown"; FATIGUE (non-serious) with onset 04Jun2022, outcome "unknown"; PYREXIA (non-serious) with onset 04Jun2022, outcome "unknown", described as "fevers"; NAUSEA (non-serious) with onset 04Jun2022, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious) with onset 04Jun2022, outcome "unknown", described as "sore throat"; PRODUCT PREPARATION ERROR (non-serious) with onset 04Jun2022 at 11:30, outcome "unknown", described as "caller's son "received an entire vial of undiluted product""; OVERDOSE (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 04Jun2022 at 11:30, outcome "unknown" and all described as "states the child was given the "entire vial of the product". The events "fevers", "abdominal pain", "nausea", "sore throat" and "fatigue" required physician office visit. Therapeutic measures were taken as a result of pyrexia, abdominal pain, nausea, oropharyngeal pain, fatigue.  Additional information: per report, pharmacist gave pediatric vaccine to patient without adding the diluent to the vial first. patient is experiencing fevers, abdominal pain, nausea, sore throat, fatigue within the first 4 days after the vaccine. ae treatment was Clinic visit with PCP, Ibuprofen and Tylenol. if covid prior vaccination was Unknown. Patient has not tested covid post vaccination. Patient has no known allergies. Patient has not received any other vaccine in four weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received  Follow-up (08Jun2022): This is a spontaneous follow-up report received from a contactable Physician. This physician reported for a patient that: Updated information: New event fevers, abdominal pain, nausea, sore throat, fatigue was added. Treatment yes was added ,physician office visit was checked and RMH none was added  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness
Clinical narrative: fever; chills; like having the flu; weakness; Anatomical Location of Administration of Pfizer vaccine considered as suspect: Left forearm; receiving 1.8mL of the Pfizer COVID-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Physician, Consumer or other non HCP and Nurse) from medical information team.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 31May2022 at 15:00 as dose 4 (booster) 1.8 ml, single (Lot number: FK9729) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose:, Date: 19Mar2021, NDC number, lot number, expiration date: Unknown), administration date: 19Mar2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (2nd dose:, Date: 09Apr2021, NDC number, lot number, expiration date: Unknown), administration date: 09Apr2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (3rd dose:, Date: 24Oct2021, NDC number, lot number, expiration date: Unknown), administration date: 24Oct2021, when the patient was 60-year-old, for COVID-19 immunization. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 31May2022, outcome "unknown", described as "Anatomical Location of Administration of Pfizer vaccine considered as suspect: Left forearm"; OVERDOSE (non-serious) with onset 31May2022, outcome "unknown", described as "receiving 1.8mL of the Pfizer COVID-19 Vaccine"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "like having the flu"; ASTHENIA (non-serious), outcome "unknown", described as "weakness".  Additional information: Patient received their 4th dose of the Pfizer COVID-19 vaccine. While waiting for the paperwork the doctor came in and said caller and caller's husband were given an overdose of the vaccine. Caller and caller's husband were given a 1.8ml dose of the vaccine each, the whole vial, so 6 times what the dose should have been which should have been .3ml only. Caller is calling to report this. Doctors office let caller and caller's husband stay for an hour to make sure there were no allergic things, nobody has reached out to them since Tuesday. Had a fever and chills like having the flu, weakness, but milder than caller's symptoms. Confirmed this occurred after receiving the 4th dose.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200793526 same reporter/drug/event, different patient;
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Influenza like illness, Overdose, Product administered at inappropriate site
Clinical narrative: fever; chills; like having the flu; weakness; Anatomical Location of Administration of Pfizer vaccine considered as suspect: Left forearm; receiving 1.8mL of the Pfizer COVID-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Physician, Consumer or other non HCP and Nurse) from medical information team.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 31May2022 at 15:00 as dose 4 (booster) 1.8 ml, single (Lot number: FK9729) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose:, Date: 19Mar2021, NDC number, lot number, expiration date: Unknown), administration date: 19Mar2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (2nd dose:, Date: 09Apr2021, NDC number, lot number, expiration date: Unknown), administration date: 09Apr2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (3rd dose:, Date: 24Oct2021, NDC number, lot number, expiration date: Unknown), administration date: 24Oct2021, when the patient was 60-year-old, for COVID-19 immunization. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 31May2022, outcome "unknown", described as "Anatomical Location of Administration of Pfizer vaccine considered as suspect: Left forearm"; OVERDOSE (non-serious) with onset 31May2022, outcome "unknown", described as "receiving 1.8mL of the Pfizer COVID-19 Vaccine"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "like having the flu"; ASTHENIA (non-serious), outcome "unknown", described as "weakness".  Additional information: Patient received their 4th dose of the Pfizer COVID-19 vaccine. While waiting for the paperwork the doctor came in and said caller and caller's husband were given an overdose of the vaccine. Caller and caller's husband were given a 1.8ml dose of the vaccine each, the whole vial, so 6 times what the dose should have been which should have been .3ml only. Caller is calling to report this. Doctors office let caller and caller's husband stay for an hour to make sure there were no allergic things, nobody has reached out to them since Tuesday. Had a fever and chills like having the flu, weakness, but milder than caller's symptoms. Confirmed this occurred after receiving the 4th dose.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200793526 same reporter/drug/event, different patient;
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: fever; chills; like having the flu; weakness; Anatomical Location of Administration of Pfizer vaccine considered as suspect: Left forearm; receiving 1.8mL of the Pfizer COVID-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Physician, Consumer or other non HCP and Nurse) from medical information team.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 31May2022 at 15:00 as dose 4 (booster) 1.8 ml, single (Lot number: FK9729) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose:, Date: 19Mar2021, NDC number, lot number, expiration date: Unknown), administration date: 19Mar2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (2nd dose:, Date: 09Apr2021, NDC number, lot number, expiration date: Unknown), administration date: 09Apr2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (3rd dose:, Date: 24Oct2021, NDC number, lot number, expiration date: Unknown), administration date: 24Oct2021, when the patient was 60-year-old, for COVID-19 immunization. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 31May2022, outcome "unknown", described as "Anatomical Location of Administration of Pfizer vaccine considered as suspect: Left forearm"; OVERDOSE (non-serious) with onset 31May2022, outcome "unknown", described as "receiving 1.8mL of the Pfizer COVID-19 Vaccine"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "like having the flu"; ASTHENIA (non-serious), outcome "unknown", described as "weakness".  Additional information: Patient received their 4th dose of the Pfizer COVID-19 vaccine. While waiting for the paperwork the doctor came in and said caller and caller's husband were given an overdose of the vaccine. Caller and caller's husband were given a 1.8ml dose of the vaccine each, the whole vial, so 6 times what the dose should have been which should have been .3ml only. Caller is calling to report this. Doctors office let caller and caller's husband stay for an hour to make sure there were no allergic things, nobody has reached out to them since Tuesday. Had a fever and chills like having the flu, weakness, but milder than caller's symptoms. Confirmed this occurred after receiving the 4th dose.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200793526 same reporter/drug/event, different patient;
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness unilateral, Ear disorder, Hyperacusis, Nausea, Pain in extremity
Clinical narrative: I lost my hearing after having the vaccine on my left side; I now have a high pitch sound on my left ear; I have sensitivity to sound; 2nd booster dose.; 2nd booster dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59-year-old female patient received BNT162b2 (COMIRNATY), on 10Jun2022 at 16:00 as dose 4 (booster), single (Lot number: FP7135) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 3), for Covid-19 immunization; Covid-19 vaccine (Dose 2), for Covid-19 immunization; Covid-19 vaccine (Dose 1), for Covid-19 immunization. The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 10Jun2022 at 16:00, outcome "unknown" and all described as "2nd booster dose."; EAR DISORDER (non-serious) with onset 11Jun2022 at 07:35, outcome "unknown", described as "I have sensitivity to sound"; DEAFNESS (medically significant) with onset 11Jun2022 at 07:35, outcome "unknown", described as "I lost my hearing after having the vaccine on my left side"; TINNITUS (non-serious) with onset 11Jun2022 at 07:35, outcome "unknown", described as "I now have a high pitch sound on my left ear". Therapeutic measures were taken as a result of deafness, tinnitus, ear disorder.  Clinical Course: Caller called to report an adverse reaction she experienced with 2nd booster dose of the Pfizer Covid19 vaccine she received last Friday, 10June2022. I lost my hearing after having the vaccine on my left side, now have a high pitch sound on my left ear and have sensitivity to sound. Caller stated that she did not have any questions regarding the vaccine and that she wanted to report the adverse reaction she experienced with the booster dose. Transferring agent stated, "I do have a patient on the other line. This one is for the Pfizer COVID-19 vaccine second booster dose she said that she get this last Friday and has experienced adverse reaction for the vaccine, for the booster dose rather." Adverse reactions: Transferring agent stated, "She didn't say that to me and she just wanted to report it directly so, I transferred her immediately to you." On Paraphrasing: Consumer stated, "Yes, is this call being recorded? Good. I think it's horrible that Pfizer with all of the money they are making from this is using labor, from the third world country to get this information. Just once again more company greed. So, what would you like to know."  Follow-up attempts are completed. No further information is expected.