chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, Headache, Hot flush, Ovulation pain, Pregnancy test
Clinical narrative: woke u pwith a pain in my left armpit.; the day after shot #2 i was achy all over head to toe (like mild flu) I rested; itchiness on and off where injections took place; This is a spontaneous report from a contactable consumer. A 46-Year-old female patient received Pfizer Covid 19 (BNT162B2) (Batch/Lot number: EL9269, Expiration date: Unknown), on 12Feb2021 around 12.15pm on left Arm as Dose 2 single for covid 19 immunization (age at vaccination: 46 Year old). Medical history included Headaches. Concomitant medications included vitamin d, multi vitamin, calcium, relpax, advil. Patient previously received first dose of BNT162B2 (Batch/Lot number: EL3247) around 12.15pm on left Arm as Dose 1 single for covid 19 immunization on 22Jan2021. On 13Feb2021 patient experienced achy all over head to toe (like mild flu) I rested. That night patient woke up with a pain in left armpit. All achiness and pain went away the following morning and Itchiness on and off where injections took place. No therapeutic treatments were received. On an unspecified date the outcome of the events were reported as recovered/resolved.  Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Premenstrual syndrome
Clinical narrative: woke u pwith a pain in my left armpit.; the day after shot #2 i was achy all over head to toe (like mild flu) I rested; itchiness on and off where injections took place; This is a spontaneous report from a contactable consumer. A 46-Year-old female patient received Pfizer Covid 19 (BNT162B2) (Batch/Lot number: EL9269, Expiration date: Unknown), on 12Feb2021 around 12.15pm on left Arm as Dose 2 single for covid 19 immunization (age at vaccination: 46 Year old). Medical history included Headaches. Concomitant medications included vitamin d, multi vitamin, calcium, relpax, advil. Patient previously received first dose of BNT162B2 (Batch/Lot number: EL3247) around 12.15pm on left Arm as Dose 1 single for covid 19 immunization on 22Jan2021. On 13Feb2021 patient experienced achy all over head to toe (like mild flu) I rested. That night patient woke up with a pain in left armpit. All achiness and pain went away the following morning and Itchiness on and off where injections took place. No therapeutic treatments were received. On an unspecified date the outcome of the events were reported as recovered/resolved.  Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Pain, Pruritus
Clinical narrative: woke u pwith a pain in my left armpit.; the day after shot #2 i was achy all over head to toe (like mild flu) I rested; itchiness on and off where injections took place; This is a spontaneous report from a contactable consumer. A 46-Year-old female patient received Pfizer Covid 19 (BNT162B2) (Batch/Lot number: EL9269, Expiration date: Unknown), on 12Feb2021 around 12.15pm on left Arm as Dose 2 single for covid 19 immunization (age at vaccination: 46 Year old). Medical history included Headaches. Concomitant medications included vitamin d, multi vitamin, calcium, relpax, advil. Patient previously received first dose of BNT162B2 (Batch/Lot number: EL3247) around 12.15pm on left Arm as Dose 1 single for covid 19 immunization on 22Jan2021. On 13Feb2021 patient experienced achy all over head to toe (like mild flu) I rested. That night patient woke up with a pain in left armpit. All achiness and pain went away the following morning and Itchiness on and off where injections took place. No therapeutic treatments were received. On an unspecified date the outcome of the events were reported as recovered/resolved.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Deformity thorax, Hookworm infection, Rash
Clinical narrative: Bell's Palsy; Stroke; TIA; Coma; Quarter of his hearing and eyesight gone; Quarter of his hearing and eyesight gone; Rash on cheek, scalp, groin, lower legs, and forearms; Weakness and was bedridden; Weakness and was bedridden; Teeth fell out; Lost weight; Sternum is projected; This is a spontaneous report from a contactable consumer (patient himself). 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 12Apr2021 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient begins call, by talking about his mother and her career as a nurse. The patient states he was slowly dying from the Pfizer vaccine, reclarified later as the Pfizer Covid 19 vaccine. On an unspecified date, patient experienced with Bell's Palsy, Rash on cheek, scalp, groin, lower legs, and forearms, Weakness and was bedridden, Coma, Teeth fell out, Quarter of his hearing and eyesight gone, Sternum was projected, Lost weight, TIA, Stroke. ADR as follows: 35 hours after the vaccine, on an unspecified date, he woke up with Bell's Palsy and his face will never be the same, rash on his cheek, scalp, groin, lower legs and forearms, weakness and was bedridden. He became homeless, then was in a coma, his teeth fell out and quarter of his hearing and eyesight was gone, his sternum was projected, he lost weight and he stated he will be dead by the end of the year. He got a TIA 3.5 months, after the vaccine. He had his car impounded with all of his possessions and had a stroke and needs financial assistance. Also stated Pfizer, lines the pockets of the medical system, they have legal immunity, he was pro-vaccine. He had been to 11 doctors, but Pfizer had lined their pockets, and those of the medical system. Investigation Assessment was not Provided. The outcome of all events was unknown.  No further details were obtained.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Bedridden, Bell's palsy, Blindness, Cerebrovascular accident
Clinical narrative: Bell's Palsy; Stroke; TIA; Coma; Quarter of his hearing and eyesight gone; Quarter of his hearing and eyesight gone; Rash on cheek, scalp, groin, lower legs, and forearms; Weakness and was bedridden; Weakness and was bedridden; Teeth fell out; Lost weight; Sternum is projected; This is a spontaneous report from a contactable consumer (patient himself). 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 12Apr2021 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient begins call, by talking about his mother and her career as a nurse. The patient states he was slowly dying from the Pfizer vaccine, reclarified later as the Pfizer Covid 19 vaccine. On an unspecified date, patient experienced with Bell's Palsy, Rash on cheek, scalp, groin, lower legs, and forearms, Weakness and was bedridden, Coma, Teeth fell out, Quarter of his hearing and eyesight gone, Sternum was projected, Lost weight, TIA, Stroke. ADR as follows: 35 hours after the vaccine, on an unspecified date, he woke up with Bell's Palsy and his face will never be the same, rash on his cheek, scalp, groin, lower legs and forearms, weakness and was bedridden. He became homeless, then was in a coma, his teeth fell out and quarter of his hearing and eyesight was gone, his sternum was projected, he lost weight and he stated he will be dead by the end of the year. He got a TIA 3.5 months, after the vaccine. He had his car impounded with all of his possessions and had a stroke and needs financial assistance. Also stated Pfizer, lines the pockets of the medical system, they have legal immunity, he was pro-vaccine. He had been to 11 doctors, but Pfizer had lined their pockets, and those of the medical system. Investigation Assessment was not Provided. The outcome of all events was unknown.  No further details were obtained.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coma, Deafness, Deformity thorax, Rash, Tooth loss
Clinical narrative: Bell's Palsy; Stroke; TIA; Coma; Quarter of his hearing and eyesight gone; Quarter of his hearing and eyesight gone; Rash on cheek, scalp, groin, lower legs, and forearms; Weakness and was bedridden; Weakness and was bedridden; Teeth fell out; Lost weight; Sternum is projected; This is a spontaneous report from a contactable consumer (patient himself). 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 12Apr2021 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient begins call, by talking about his mother and her career as a nurse. The patient states he was slowly dying from the Pfizer vaccine, reclarified later as the Pfizer Covid 19 vaccine. On an unspecified date, patient experienced with Bell's Palsy, Rash on cheek, scalp, groin, lower legs, and forearms, Weakness and was bedridden, Coma, Teeth fell out, Quarter of his hearing and eyesight gone, Sternum was projected, Lost weight, TIA, Stroke. ADR as follows: 35 hours after the vaccine, on an unspecified date, he woke up with Bell's Palsy and his face will never be the same, rash on his cheek, scalp, groin, lower legs and forearms, weakness and was bedridden. He became homeless, then was in a coma, his teeth fell out and quarter of his hearing and eyesight was gone, his sternum was projected, he lost weight and he stated he will be dead by the end of the year. He got a TIA 3.5 months, after the vaccine. He had his car impounded with all of his possessions and had a stroke and needs financial assistance. Also stated Pfizer, lines the pockets of the medical system, they have legal immunity, he was pro-vaccine. He had been to 11 doctors, but Pfizer had lined their pockets, and those of the medical system. Investigation Assessment was not Provided. The outcome of all events was unknown.  No further details were obtained.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Transient ischaemic attack, Weight decreased
Clinical narrative: Bell's Palsy; Stroke; TIA; Coma; Quarter of his hearing and eyesight gone; Quarter of his hearing and eyesight gone; Rash on cheek, scalp, groin, lower legs, and forearms; Weakness and was bedridden; Weakness and was bedridden; Teeth fell out; Lost weight; Sternum is projected; This is a spontaneous report from a contactable consumer (patient himself). 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 12Apr2021 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient begins call, by talking about his mother and her career as a nurse. The patient states he was slowly dying from the Pfizer vaccine, reclarified later as the Pfizer Covid 19 vaccine. On an unspecified date, patient experienced with Bell's Palsy, Rash on cheek, scalp, groin, lower legs, and forearms, Weakness and was bedridden, Coma, Teeth fell out, Quarter of his hearing and eyesight gone, Sternum was projected, Lost weight, TIA, Stroke. ADR as follows: 35 hours after the vaccine, on an unspecified date, he woke up with Bell's Palsy and his face will never be the same, rash on his cheek, scalp, groin, lower legs and forearms, weakness and was bedridden. He became homeless, then was in a coma, his teeth fell out and quarter of his hearing and eyesight was gone, his sternum was projected, he lost weight and he stated he will be dead by the end of the year. He got a TIA 3.5 months, after the vaccine. He had his car impounded with all of his possessions and had a stroke and needs financial assistance. Also stated Pfizer, lines the pockets of the medical system, they have legal immunity, he was pro-vaccine. He had been to 11 doctors, but Pfizer had lined their pockets, and those of the medical system. Investigation Assessment was not Provided. The outcome of all events was unknown.  No further details were obtained.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest discomfort, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: Acute pericarditis; This spontaneous case was reported by an other health care professional and describes the occurrence of PERICARDITIS (Acute pericarditis) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 008C21A) for COVID-19 vaccination.     The patient's past medical history included Erectile dysfunction, Coronary artery disease, Anemia, Stroke and Femoral-popliteal shunt. Concurrent medical conditions included Peripheral vascular disease, Hypertension, Osteoarthritis and Smoker.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PERICARDITIS (Acute pericarditis) (seriousness criteria hospitalization and medically significant). In 2021, PERICARDITIS (Acute pericarditis) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  The patient had high risk as patient was homeless.  Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of coronary artery disease, anemia, hypertension and use of concomitant medication are contributory factors to the events.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Significant follow-up included updated reporter information, patient information, vaccine information and adverse event information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of coronary artery disease, anemia, hypertension and use of concomitant medication are contributory factors to the events.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Somnolence, X-ray
Clinical narrative: Acute pericarditis; This spontaneous case was reported by an other health care professional and describes the occurrence of PERICARDITIS (Acute pericarditis) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 008C21A) for COVID-19 vaccination.     The patient's past medical history included Erectile dysfunction, Coronary artery disease, Anemia, Stroke and Femoral-popliteal shunt. Concurrent medical conditions included Peripheral vascular disease, Hypertension, Osteoarthritis and Smoker.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PERICARDITIS (Acute pericarditis) (seriousness criteria hospitalization and medically significant). In 2021, PERICARDITIS (Acute pericarditis) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  The patient had high risk as patient was homeless.  Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of coronary artery disease, anemia, hypertension and use of concomitant medication are contributory factors to the events.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Significant follow-up included updated reporter information, patient information, vaccine information and adverse event information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of coronary artery disease, anemia, hypertension and use of concomitant medication are contributory factors to the events.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pericarditis
Clinical narrative: Acute pericarditis; This spontaneous case was reported by an other health care professional and describes the occurrence of PERICARDITIS (Acute pericarditis) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 008C21A) for COVID-19 vaccination.     The patient's past medical history included Erectile dysfunction, Coronary artery disease, Anemia, Stroke and Femoral-popliteal shunt. Concurrent medical conditions included Peripheral vascular disease, Hypertension, Osteoarthritis and Smoker.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PERICARDITIS (Acute pericarditis) (seriousness criteria hospitalization and medically significant). In 2021, PERICARDITIS (Acute pericarditis) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  The patient had high risk as patient was homeless.  Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of coronary artery disease, anemia, hypertension and use of concomitant medication are contributory factors to the events.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Significant follow-up included updated reporter information, patient information, vaccine information and adverse event information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of coronary artery disease, anemia, hypertension and use of concomitant medication are contributory factors to the events.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Headache, Injection site pain, Nausea, Pain
Clinical narrative: Then about 10:30 pm I started vomiting. And continued vomiting all night long/Around 9:30 am finally quit vomiting; The nausea was awful/feel very nauseous.; The nausea was awful; The second shot was way worse; Running a fever/My fever was over 102.1; Aching/My whole body ached; Head hurting/my head felt like it was going to explode; This is a spontaneous report from a contactable consumer (patient herself). A 54-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 59267-1000-01), via an unspecified route of administration, administered in left arm on 22Jul2021 10:00 (age at vaccination: 54 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included food allergy to hazelnuts and almonds. There were no concomitant medications. The patient previously took sulfamethoxazole and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation on 01Jul2021 00:00 in the left arm and experienced headache, neck pain and malaise. The second dose of vaccine was administered in the pharmacy. There were no other medications the patient received within 2 weeks of vaccination. On 22Jul2021 21:30, the patient experienced was awful/felt very nauseous, the second shot was way worse, running a fever/ fever was over 102.1 ((because that was taken after vomiting, brushing my teeth, and drinking cold water), aching/her whole body ached, head hurting/ head felt like it was going to explode, then on the same date about 22:30, she started vomiting and continued vomiting all night long/around 9:30 am finally quit vomiting but continued to feel nauseous. On 22Jul2021, the patient underwent lab tests and procedures which included body temperature was over 102.1. The patient did not receive treatment for the adverse events. The patient was not diagnosed with covid-19 prior to vaccination nor was tested for covi-19 since the vaccination. The outcome of vomiting was recovered on 23Jul2021 09:30 and all the other events were not recovered. The device date was 23Jul2021.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Then about 10:30 pm I started vomiting. And continued vomiting all night long/Around 9:30 am finally quit vomiting; The nausea was awful/feel very nauseous.; The nausea was awful; The second shot was way worse; Running a fever/My fever was over 102.1; Aching/My whole body ached; Head hurting/my head felt like it was going to explode; This is a spontaneous report from a contactable consumer (patient herself). A 54-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 59267-1000-01), via an unspecified route of administration, administered in left arm on 22Jul2021 10:00 (age at vaccination: 54 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included food allergy to hazelnuts and almonds. There were no concomitant medications. The patient previously took sulfamethoxazole and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation on 01Jul2021 00:00 in the left arm and experienced headache, neck pain and malaise. The second dose of vaccine was administered in the pharmacy. There were no other medications the patient received within 2 weeks of vaccination. On 22Jul2021 21:30, the patient experienced was awful/felt very nauseous, the second shot was way worse, running a fever/ fever was over 102.1 ((because that was taken after vomiting, brushing my teeth, and drinking cold water), aching/her whole body ached, head hurting/ head felt like it was going to explode, then on the same date about 22:30, she started vomiting and continued vomiting all night long/around 9:30 am finally quit vomiting but continued to feel nauseous. On 22Jul2021, the patient underwent lab tests and procedures which included body temperature was over 102.1. The patient did not receive treatment for the adverse events. The patient was not diagnosed with covid-19 prior to vaccination nor was tested for covi-19 since the vaccination. The outcome of vomiting was recovered on 23Jul2021 09:30 and all the other events were not recovered. The device date was 23Jul2021.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Condition aggravated, Feeling abnormal, Headache, Nausea
Clinical narrative: Then about 10:30 pm I started vomiting. And continued vomiting all night long/Around 9:30 am finally quit vomiting; The nausea was awful/feel very nauseous.; The nausea was awful; The second shot was way worse; Running a fever/My fever was over 102.1; Aching/My whole body ached; Head hurting/my head felt like it was going to explode; This is a spontaneous report from a contactable consumer (patient herself). A 54-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 59267-1000-01), via an unspecified route of administration, administered in left arm on 22Jul2021 10:00 (age at vaccination: 54 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included food allergy to hazelnuts and almonds. There were no concomitant medications. The patient previously took sulfamethoxazole and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation on 01Jul2021 00:00 in the left arm and experienced headache, neck pain and malaise. The second dose of vaccine was administered in the pharmacy. There were no other medications the patient received within 2 weeks of vaccination. On 22Jul2021 21:30, the patient experienced was awful/felt very nauseous, the second shot was way worse, running a fever/ fever was over 102.1 ((because that was taken after vomiting, brushing my teeth, and drinking cold water), aching/her whole body ached, head hurting/ head felt like it was going to explode, then on the same date about 22:30, she started vomiting and continued vomiting all night long/around 9:30 am finally quit vomiting but continued to feel nauseous. On 22Jul2021, the patient underwent lab tests and procedures which included body temperature was over 102.1. The patient did not receive treatment for the adverse events. The patient was not diagnosed with covid-19 prior to vaccination nor was tested for covi-19 since the vaccination. The outcome of vomiting was recovered on 23Jul2021 09:30 and all the other events were not recovered. The device date was 23Jul2021.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Then about 10:30 pm I started vomiting. And continued vomiting all night long/Around 9:30 am finally quit vomiting; The nausea was awful/feel very nauseous.; The nausea was awful; The second shot was way worse; Running a fever/My fever was over 102.1; Aching/My whole body ached; Head hurting/my head felt like it was going to explode; This is a spontaneous report from a contactable consumer (patient herself). A 54-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 59267-1000-01), via an unspecified route of administration, administered in left arm on 22Jul2021 10:00 (age at vaccination: 54 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included food allergy to hazelnuts and almonds. There were no concomitant medications. The patient previously took sulfamethoxazole and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation on 01Jul2021 00:00 in the left arm and experienced headache, neck pain and malaise. The second dose of vaccine was administered in the pharmacy. There were no other medications the patient received within 2 weeks of vaccination. On 22Jul2021 21:30, the patient experienced was awful/felt very nauseous, the second shot was way worse, running a fever/ fever was over 102.1 ((because that was taken after vomiting, brushing my teeth, and drinking cold water), aching/her whole body ached, head hurting/ head felt like it was going to explode, then on the same date about 22:30, she started vomiting and continued vomiting all night long/around 9:30 am finally quit vomiting but continued to feel nauseous. On 22Jul2021, the patient underwent lab tests and procedures which included body temperature was over 102.1. The patient did not receive treatment for the adverse events. The patient was not diagnosed with covid-19 prior to vaccination nor was tested for covi-19 since the vaccination. The outcome of vomiting was recovered on 23Jul2021 09:30 and all the other events were not recovered. The device date was 23Jul2021.  Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: He had a sore arm; Things smelled different but did not lose sense of smell; Intermittent nosebleeds; Headache; It was just one patient who got an entire vial of vaccine/ it was full vial of .45mL of undiluted vaccine that was administered for the 6x overdose.; It was just one patient who got an entire vial of vaccine/ it was full vial of .45mL of undiluted vaccine that was administered for the 6x overdose.; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 17-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown, age at vaccination 17 years), via an unspecified route of administration on 23Jul2021 as DOSE 1, 0.45 ML SINGLE for covid-19 immunization. The patient's medical history includes severe obesity from Jun2021 and ongoing Severe obesity due to excess calories and BMI > 99 percentile for age in pediatric patient. Concomitant medications include METFORMIN for severe obesity from Mar2021 and ongoing. Caller reported it was just one patient who got an entire vial of vaccine on an unspecified date 2021. The patient got first dose of Pfizer vaccine (unspecified vaccine) on 23Jul2021, but they got all six doses from the 3 ml instead of just one. Reporter sent them to the emergency room because, don't know how they are going to react to all the six doses one time, but wanted to know if Pfizer had any additional information report, if it happened before. Upon follow-up on 03Aug2021, Nurse confirmed it was full vial of .45mL of undiluted vaccine that was administered for the 6x overdose on 23Jul2021. Patient went to ER for monitoring. The ER sent him home and on an unspecified date his mother reported he had a sore arm, things smelled different but did not lose sense of smell, intermittent nosebleeds, and headache on an unspecified date. The update was provided on 27Jul2021, but the symptoms happened before the mother called, so the nurse was not sure of the exact onset for each. Clinical outcome of all symptoms was recovered or resolved on unspecified date in 2021 and the outcome of other events was unknown.  Information about lot/batch number has been requested.  Follow-up (23Jul2021): New information received from a contactable other hcp (Nurse) included: patient's gender (male), relevant medical history, event onset date, concomitant medications.  Follow up(03Aug2021): This is a follow up-spontaneous report from a contactable Nurse in response to HCP letter sent via follow-up letter which included that: Additional events coded along with outcome (he had a sore arm; things smelled different but did not lose sense of smell, intermittent nosebleeds, and headache); verbatim of overdose updated (it was just one patient who got an entire vial of vaccine/ it was full vial of .45mL of undiluted vaccine that was administered for the 6x overdose) and coded as Product preparation issue and other relevant information.  Information about lot/batch number will be requested during follow up.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body mass index, Epistaxis, Headache, Overdose, Pain in extremity
Clinical narrative: He had a sore arm; Things smelled different but did not lose sense of smell; Intermittent nosebleeds; Headache; It was just one patient who got an entire vial of vaccine/ it was full vial of .45mL of undiluted vaccine that was administered for the 6x overdose.; It was just one patient who got an entire vial of vaccine/ it was full vial of .45mL of undiluted vaccine that was administered for the 6x overdose.; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 17-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown, age at vaccination 17 years), via an unspecified route of administration on 23Jul2021 as DOSE 1, 0.45 ML SINGLE for covid-19 immunization. The patient's medical history includes severe obesity from Jun2021 and ongoing Severe obesity due to excess calories and BMI > 99 percentile for age in pediatric patient. Concomitant medications include METFORMIN for severe obesity from Mar2021 and ongoing. Caller reported it was just one patient who got an entire vial of vaccine on an unspecified date 2021. The patient got first dose of Pfizer vaccine (unspecified vaccine) on 23Jul2021, but they got all six doses from the 3 ml instead of just one. Reporter sent them to the emergency room because, don't know how they are going to react to all the six doses one time, but wanted to know if Pfizer had any additional information report, if it happened before. Upon follow-up on 03Aug2021, Nurse confirmed it was full vial of .45mL of undiluted vaccine that was administered for the 6x overdose on 23Jul2021. Patient went to ER for monitoring. The ER sent him home and on an unspecified date his mother reported he had a sore arm, things smelled different but did not lose sense of smell, intermittent nosebleeds, and headache on an unspecified date. The update was provided on 27Jul2021, but the symptoms happened before the mother called, so the nurse was not sure of the exact onset for each. Clinical outcome of all symptoms was recovered or resolved on unspecified date in 2021 and the outcome of other events was unknown.  Information about lot/batch number has been requested.  Follow-up (23Jul2021): New information received from a contactable other hcp (Nurse) included: patient's gender (male), relevant medical history, event onset date, concomitant medications.  Follow up(03Aug2021): This is a follow up-spontaneous report from a contactable Nurse in response to HCP letter sent via follow-up letter which included that: Additional events coded along with outcome (he had a sore arm; things smelled different but did not lose sense of smell, intermittent nosebleeds, and headache); verbatim of overdose updated (it was just one patient who got an entire vial of vaccine/ it was full vial of .45mL of undiluted vaccine that was administered for the 6x overdose) and coded as Product preparation issue and other relevant information.  Information about lot/batch number will be requested during follow up.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Parosmia, Product preparation issue
Clinical narrative: He had a sore arm; Things smelled different but did not lose sense of smell; Intermittent nosebleeds; Headache; It was just one patient who got an entire vial of vaccine/ it was full vial of .45mL of undiluted vaccine that was administered for the 6x overdose.; It was just one patient who got an entire vial of vaccine/ it was full vial of .45mL of undiluted vaccine that was administered for the 6x overdose.; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 17-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown, age at vaccination 17 years), via an unspecified route of administration on 23Jul2021 as DOSE 1, 0.45 ML SINGLE for covid-19 immunization. The patient's medical history includes severe obesity from Jun2021 and ongoing Severe obesity due to excess calories and BMI > 99 percentile for age in pediatric patient. Concomitant medications include METFORMIN for severe obesity from Mar2021 and ongoing. Caller reported it was just one patient who got an entire vial of vaccine on an unspecified date 2021. The patient got first dose of Pfizer vaccine (unspecified vaccine) on 23Jul2021, but they got all six doses from the 3 ml instead of just one. Reporter sent them to the emergency room because, don't know how they are going to react to all the six doses one time, but wanted to know if Pfizer had any additional information report, if it happened before. Upon follow-up on 03Aug2021, Nurse confirmed it was full vial of .45mL of undiluted vaccine that was administered for the 6x overdose on 23Jul2021. Patient went to ER for monitoring. The ER sent him home and on an unspecified date his mother reported he had a sore arm, things smelled different but did not lose sense of smell, intermittent nosebleeds, and headache on an unspecified date. The update was provided on 27Jul2021, but the symptoms happened before the mother called, so the nurse was not sure of the exact onset for each. Clinical outcome of all symptoms was recovered or resolved on unspecified date in 2021 and the outcome of other events was unknown.  Information about lot/batch number has been requested.  Follow-up (23Jul2021): New information received from a contactable other hcp (Nurse) included: patient's gender (male), relevant medical history, event onset date, concomitant medications.  Follow up(03Aug2021): This is a follow up-spontaneous report from a contactable Nurse in response to HCP letter sent via follow-up letter which included that: Additional events coded along with outcome (he had a sore arm; things smelled different but did not lose sense of smell, intermittent nosebleeds, and headache); verbatim of overdose updated (it was just one patient who got an entire vial of vaccine/ it was full vial of .45mL of undiluted vaccine that was administered for the 6x overdose) and coded as Product preparation issue and other relevant information.  Information about lot/batch number will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Burning sensation, Chills, Dysphagia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0162), via an unspecified route of administration, administered in the right arm on 17Apr2021 14:45 (at the age of 34 years old) as dose 2, single for COVID-19 immunization. Medical history included seasonal allergies, known allergies: dairy, egg, known allergies: cat and known allergies: penicillin, all from an unknown date and unknown if ongoing. The patient is not pregnant. Concomitant medications included hydroxyzine hcl and ibuprofen, both taken for unspecified indications, start and stop dates were not reported. The patient previously took neosporin, azithromycin, reglan [metoclopramide] and zofran [ondansetron] and experienced allergy for all. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8730), via an unspecified route of administration, administered in the right arm on 27Mar2021 15:00 (at the age of 34 years old) as dose 1, single for COVID-19 immunization. The patient experienced server joint pain (especially in hips & rt shoulder ongoing), painful skin sensitivity (especially on face & scalp, now spread to limbs; ongoing), headache, nausea, fever, chills, shaking, pins & needles, allergic reaction type rash on arms, back & neck muscle pain and swollen lymph nodes in both sides of neck on 17Apr2021 15:00. The reporter assessed all events as serious (resulted in disability or permanent damage). Treatment received for the adverse events included pain medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device date was reported as 10Aug2021. The outcome of all events was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Eye pain, Facial pain, Feeling cold, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0162), via an unspecified route of administration, administered in the right arm on 17Apr2021 14:45 (at the age of 34 years old) as dose 2, single for COVID-19 immunization. Medical history included seasonal allergies, known allergies: dairy, egg, known allergies: cat and known allergies: penicillin, all from an unknown date and unknown if ongoing. The patient is not pregnant. Concomitant medications included hydroxyzine hcl and ibuprofen, both taken for unspecified indications, start and stop dates were not reported. The patient previously took neosporin, azithromycin, reglan [metoclopramide] and zofran [ondansetron] and experienced allergy for all. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8730), via an unspecified route of administration, administered in the right arm on 27Mar2021 15:00 (at the age of 34 years old) as dose 1, single for COVID-19 immunization. The patient experienced server joint pain (especially in hips & rt shoulder ongoing), painful skin sensitivity (especially on face & scalp, now spread to limbs; ongoing), headache, nausea, fever, chills, shaking, pins & needles, allergic reaction type rash on arms, back & neck muscle pain and swollen lymph nodes in both sides of neck on 17Apr2021 15:00. The reporter assessed all events as serious (resulted in disability or permanent damage). Treatment received for the adverse events included pain medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device date was reported as 10Aug2021. The outcome of all events was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Injection site pain, Joint noise, Loss of personal independence in daily activities, Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0162), via an unspecified route of administration, administered in the right arm on 17Apr2021 14:45 (at the age of 34 years old) as dose 2, single for COVID-19 immunization. Medical history included seasonal allergies, known allergies: dairy, egg, known allergies: cat and known allergies: penicillin, all from an unknown date and unknown if ongoing. The patient is not pregnant. Concomitant medications included hydroxyzine hcl and ibuprofen, both taken for unspecified indications, start and stop dates were not reported. The patient previously took neosporin, azithromycin, reglan [metoclopramide] and zofran [ondansetron] and experienced allergy for all. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8730), via an unspecified route of administration, administered in the right arm on 27Mar2021 15:00 (at the age of 34 years old) as dose 1, single for COVID-19 immunization. The patient experienced server joint pain (especially in hips & rt shoulder ongoing), painful skin sensitivity (especially on face & scalp, now spread to limbs; ongoing), headache, nausea, fever, chills, shaking, pins & needles, allergic reaction type rash on arms, back & neck muscle pain and swollen lymph nodes in both sides of neck on 17Apr2021 15:00. The reporter assessed all events as serious (resulted in disability or permanent damage). Treatment received for the adverse events included pain medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device date was reported as 10Aug2021. The outcome of all events was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Myalgia, Nausea, Neck pain, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0162), via an unspecified route of administration, administered in the right arm on 17Apr2021 14:45 (at the age of 34 years old) as dose 2, single for COVID-19 immunization. Medical history included seasonal allergies, known allergies: dairy, egg, known allergies: cat and known allergies: penicillin, all from an unknown date and unknown if ongoing. The patient is not pregnant. Concomitant medications included hydroxyzine hcl and ibuprofen, both taken for unspecified indications, start and stop dates were not reported. The patient previously took neosporin, azithromycin, reglan [metoclopramide] and zofran [ondansetron] and experienced allergy for all. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8730), via an unspecified route of administration, administered in the right arm on 27Mar2021 15:00 (at the age of 34 years old) as dose 1, single for COVID-19 immunization. The patient experienced server joint pain (especially in hips & rt shoulder ongoing), painful skin sensitivity (especially on face & scalp, now spread to limbs; ongoing), headache, nausea, fever, chills, shaking, pins & needles, allergic reaction type rash on arms, back & neck muscle pain and swollen lymph nodes in both sides of neck on 17Apr2021 15:00. The reporter assessed all events as serious (resulted in disability or permanent damage). Treatment received for the adverse events included pain medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device date was reported as 10Aug2021. The outcome of all events was not recovered. No follow-up attempts are needed. No further information is expected.