chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, UNK, COVID19, UNK, UNK, UNK
Symptoms: Alopecia, Malaise, Rash, SARS-CoV-2 test, Skin exfoliation
Clinical narrative: SKIN GOT FLAKES OFF; SKIN GOT CRUSTY; ALLERGIC TO SUNSCREEN (RASH ON THE RIGHT SIDE OF NECK); This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received neutrogena rapid wrinkle repair moisturizer spf30 (cream, topical, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication; neutrogena rapid wrinkle repair night moisturizer (cream, topical, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication; and neutrogena fresh foaming cleanser (form of admin unknown, topical, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced skin got flakes off, skin got crusty, and allergic to sunscreen (rash on the right side of neck). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with neutrogena rapid wrinkle repair moisturizer spf30, neutrogena rapid wrinkle repair night moisturizer, and neutrogena fresh foaming cleanser was not reported. The outcome of the skin got flakes off, skin got crusty and allergic to sunscreen (rash on the right side of neck) was not reported. This report was non-serious. This case, involving the same patient is linked to 20211014842.
Sex: U
Vaccine: COVID19, UNK, COVID19, UNK, UNK, UNK
Symptoms: Application site hypersensitivity, Scab, Skin exfoliation
Clinical narrative: SKIN GOT FLAKES OFF; SKIN GOT CRUSTY; ALLERGIC TO SUNSCREEN (RASH ON THE RIGHT SIDE OF NECK); This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received neutrogena rapid wrinkle repair moisturizer spf30 (cream, topical, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication; neutrogena rapid wrinkle repair night moisturizer (cream, topical, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication; and neutrogena fresh foaming cleanser (form of admin unknown, topical, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced skin got flakes off, skin got crusty, and allergic to sunscreen (rash on the right side of neck). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with neutrogena rapid wrinkle repair moisturizer spf30, neutrogena rapid wrinkle repair night moisturizer, and neutrogena fresh foaming cleanser was not reported. The outcome of the skin got flakes off, skin got crusty and allergic to sunscreen (rash on the right side of neck) was not reported. This report was non-serious. This case, involving the same patient is linked to 20211014842.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Dysstasia, Eye movement disorder, Muscle tightness
Clinical narrative: seizure; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old male patient received first dose of bnt162b2 (COMIRNATY; Lot Number: 301558A), via an unspecified route of administration, administered in left arm on 15Oct2021 between 3:15-3:20PM (at the age of 13-years-old) as dose 1, single for COVID-19 immunisation.  Medical history included allergic to penicillin. Historical vaccine included HPV vaccine on 28Aug2021. The patient's concomitant medications were not reported. The patient experienced seizure on 15Oct2021. It was reported that patient received the first dose of the Pfizer BioNTech Covid-19 Vaccine on 15Oct2021, and within 7 minutes, experienced a seizure. The patient not prone to seizures and has never experienced a seizure before. Patient's twin brother experienced no problems after vaccination, but the reporter noted that his twin was 120 pounds, while her son who seized was only 74 pounds. She explained her son was standing up with her. The went and got the vaccine. The pharmacist told them to wait 15 minutes so she went and checked out a few items at the grocery store and came back. Her other twin son was perfectly fine. Her son, the patient, asked if he could sit on the floor and she told him no because the floor was dirty and there were no seats available. Then, her son was saying what if I did this as he laid back and she thought he was joking at first, but his eyes started rolling back and his body was twitching. He was unresponsive. Another person saw this and had the pharmacist call. There was a lovely retired nurse doing some grocery shopping and the retired nurse had checked his pulse and his breathing and everything was okay. The patient had a CT scan, EKG, and everything seems to be clear. They were admitted into the Emergency Room, but patient was never admitted into the hospital. She mentions they checked his blood sugar and that was it. Everything seemed to be fine. He was discharged from the ER. The event required also physician office visit. The reporter stated also that people were saying maybe he fainted seeing the needle, but she would think if he fainted it would have happened rather quickly after the injection and not 7 minutes afterwards. Plus, her son was not scared of needles. He said that the COVID shot didnt hurt as bad as the HPV shot he had back in August. The outcome of event was recovered on an unspecified date in Oct2021.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Seizure, Syncope
Clinical narrative: seizure; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old male patient received first dose of bnt162b2 (COMIRNATY; Lot Number: 301558A), via an unspecified route of administration, administered in left arm on 15Oct2021 between 3:15-3:20PM (at the age of 13-years-old) as dose 1, single for COVID-19 immunisation.  Medical history included allergic to penicillin. Historical vaccine included HPV vaccine on 28Aug2021. The patient's concomitant medications were not reported. The patient experienced seizure on 15Oct2021. It was reported that patient received the first dose of the Pfizer BioNTech Covid-19 Vaccine on 15Oct2021, and within 7 minutes, experienced a seizure. The patient not prone to seizures and has never experienced a seizure before. Patient's twin brother experienced no problems after vaccination, but the reporter noted that his twin was 120 pounds, while her son who seized was only 74 pounds. She explained her son was standing up with her. The went and got the vaccine. The pharmacist told them to wait 15 minutes so she went and checked out a few items at the grocery store and came back. Her other twin son was perfectly fine. Her son, the patient, asked if he could sit on the floor and she told him no because the floor was dirty and there were no seats available. Then, her son was saying what if I did this as he laid back and she thought he was joking at first, but his eyes started rolling back and his body was twitching. He was unresponsive. Another person saw this and had the pharmacist call. There was a lovely retired nurse doing some grocery shopping and the retired nurse had checked his pulse and his breathing and everything was okay. The patient had a CT scan, EKG, and everything seems to be clear. They were admitted into the Emergency Room, but patient was never admitted into the hospital. She mentions they checked his blood sugar and that was it. Everything seemed to be fine. He was discharged from the ER. The event required also physician office visit. The reporter stated also that people were saying maybe he fainted seeing the needle, but she would think if he fainted it would have happened rather quickly after the injection and not 7 minutes afterwards. Plus, her son was not scared of needles. He said that the COVID shot didnt hurt as bad as the HPV shot he had back in August. The outcome of event was recovered on an unspecified date in Oct2021.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood glucose, Computerised tomogram, Electrocardiogram, Heart rate, Investigation
Clinical narrative: seizure; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old male patient received first dose of bnt162b2 (COMIRNATY; Lot Number: 301558A), via an unspecified route of administration, administered in left arm on 15Oct2021 between 3:15-3:20PM (at the age of 13-years-old) as dose 1, single for COVID-19 immunisation.  Medical history included allergic to penicillin. Historical vaccine included HPV vaccine on 28Aug2021. The patient's concomitant medications were not reported. The patient experienced seizure on 15Oct2021. It was reported that patient received the first dose of the Pfizer BioNTech Covid-19 Vaccine on 15Oct2021, and within 7 minutes, experienced a seizure. The patient not prone to seizures and has never experienced a seizure before. Patient's twin brother experienced no problems after vaccination, but the reporter noted that his twin was 120 pounds, while her son who seized was only 74 pounds. She explained her son was standing up with her. The went and got the vaccine. The pharmacist told them to wait 15 minutes so she went and checked out a few items at the grocery store and came back. Her other twin son was perfectly fine. Her son, the patient, asked if he could sit on the floor and she told him no because the floor was dirty and there were no seats available. Then, her son was saying what if I did this as he laid back and she thought he was joking at first, but his eyes started rolling back and his body was twitching. He was unresponsive. Another person saw this and had the pharmacist call. There was a lovely retired nurse doing some grocery shopping and the retired nurse had checked his pulse and his breathing and everything was okay. The patient had a CT scan, EKG, and everything seems to be clear. They were admitted into the Emergency Room, but patient was never admitted into the hospital. She mentions they checked his blood sugar and that was it. Everything seemed to be fine. He was discharged from the ER. The event required also physician office visit. The reporter stated also that people were saying maybe he fainted seeing the needle, but she would think if he fainted it would have happened rather quickly after the injection and not 7 minutes afterwards. Plus, her son was not scared of needles. He said that the COVID shot didnt hurt as bad as the HPV shot he had back in August. The outcome of event was recovered on an unspecified date in Oct2021.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Seizure
Clinical narrative: seizure; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old male patient received first dose of bnt162b2 (COMIRNATY; Lot Number: 301558A), via an unspecified route of administration, administered in left arm on 15Oct2021 between 3:15-3:20PM (at the age of 13-years-old) as dose 1, single for COVID-19 immunisation.  Medical history included allergic to penicillin. Historical vaccine included HPV vaccine on 28Aug2021. The patient's concomitant medications were not reported. The patient experienced seizure on 15Oct2021. It was reported that patient received the first dose of the Pfizer BioNTech Covid-19 Vaccine on 15Oct2021, and within 7 minutes, experienced a seizure. The patient not prone to seizures and has never experienced a seizure before. Patient's twin brother experienced no problems after vaccination, but the reporter noted that his twin was 120 pounds, while her son who seized was only 74 pounds. She explained her son was standing up with her. The went and got the vaccine. The pharmacist told them to wait 15 minutes so she went and checked out a few items at the grocery store and came back. Her other twin son was perfectly fine. Her son, the patient, asked if he could sit on the floor and she told him no because the floor was dirty and there were no seats available. Then, her son was saying what if I did this as he laid back and she thought he was joking at first, but his eyes started rolling back and his body was twitching. He was unresponsive. Another person saw this and had the pharmacist call. There was a lovely retired nurse doing some grocery shopping and the retired nurse had checked his pulse and his breathing and everything was okay. The patient had a CT scan, EKG, and everything seems to be clear. They were admitted into the Emergency Room, but patient was never admitted into the hospital. She mentions they checked his blood sugar and that was it. Everything seemed to be fine. He was discharged from the ER. The event required also physician office visit. The reporter stated also that people were saying maybe he fainted seeing the needle, but she would think if he fainted it would have happened rather quickly after the injection and not 7 minutes afterwards. Plus, her son was not scared of needles. He said that the COVID shot didnt hurt as bad as the HPV shot he had back in August. The outcome of event was recovered on an unspecified date in Oct2021.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Dizziness, Magnetic resonance imaging
Clinical narrative: HUMAN PAPILLOMA VIRUS INFECTION; THROAT CANCER; MOUTH CANCER; SPLOTCHINESS OF SKIN ON BACK AND SHOULDERS; VESTIBULAR NEURITIS; This spontaneous report received from a patient concerned a 62 year old male. The patient's weight was 244 pounds, and height was 71 inches. The patient's concurrent conditions included: alcohol user, and non-smoker, and other pre-existing medical conditions included: Patient did not drug abuse or illicit drug usage. Patient did not have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: unknown) dose was not reported, 1 total administered to left arm on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. In JUN-2021, beginning the patient experienced dizziness and end of June, patient was diagnosed with vestibular neuritis and was treated with antivirals and steroids. Magnetic resonance imaging and computerised tomogram scan with contrast showed clear results. In JUL-2021, the patient experienced splotchiness of skin on back that spreads up to the shoulders which had been getting worse. In middle or end of SEP-2021, the patient was diagnosed with throat cancer (back of tongue and lymph nodes). The patient was currently undergoing chemotherapy and radiation and assumed to be cause by the human papilloma virus.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mouth cancer, throat cancer and splotchiness of skin on back and shoulders and the outcome of vestibular neuritis and human papilloma virus infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211058975-covid-19 vaccine ad26.cov2.s- mouth cancer, throat cancer . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Lip and/or oral cavity cancer, Magnetic resonance imaging, Papilloma viral infection, Rash macular
Clinical narrative: HUMAN PAPILLOMA VIRUS INFECTION; THROAT CANCER; MOUTH CANCER; SPLOTCHINESS OF SKIN ON BACK AND SHOULDERS; VESTIBULAR NEURITIS; This spontaneous report received from a patient concerned a 62 year old male. The patient's weight was 244 pounds, and height was 71 inches. The patient's concurrent conditions included: alcohol user, and non-smoker, and other pre-existing medical conditions included: Patient did not drug abuse or illicit drug usage. Patient did not have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: unknown) dose was not reported, 1 total administered to left arm on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. In JUN-2021, beginning the patient experienced dizziness and end of June, patient was diagnosed with vestibular neuritis and was treated with antivirals and steroids. Magnetic resonance imaging and computerised tomogram scan with contrast showed clear results. In JUL-2021, the patient experienced splotchiness of skin on back that spreads up to the shoulders which had been getting worse. In middle or end of SEP-2021, the patient was diagnosed with throat cancer (back of tongue and lymph nodes). The patient was currently undergoing chemotherapy and radiation and assumed to be cause by the human papilloma virus.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mouth cancer, throat cancer and splotchiness of skin on back and shoulders and the outcome of vestibular neuritis and human papilloma virus infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211058975-covid-19 vaccine ad26.cov2.s- mouth cancer, throat cancer . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Throat cancer, Vestibular neuronitis
Clinical narrative: HUMAN PAPILLOMA VIRUS INFECTION; THROAT CANCER; MOUTH CANCER; SPLOTCHINESS OF SKIN ON BACK AND SHOULDERS; VESTIBULAR NEURITIS; This spontaneous report received from a patient concerned a 62 year old male. The patient's weight was 244 pounds, and height was 71 inches. The patient's concurrent conditions included: alcohol user, and non-smoker, and other pre-existing medical conditions included: Patient did not drug abuse or illicit drug usage. Patient did not have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: unknown) dose was not reported, 1 total administered to left arm on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. In JUN-2021, beginning the patient experienced dizziness and end of June, patient was diagnosed with vestibular neuritis and was treated with antivirals and steroids. Magnetic resonance imaging and computerised tomogram scan with contrast showed clear results. In JUL-2021, the patient experienced splotchiness of skin on back that spreads up to the shoulders which had been getting worse. In middle or end of SEP-2021, the patient was diagnosed with throat cancer (back of tongue and lymph nodes). The patient was currently undergoing chemotherapy and radiation and assumed to be cause by the human papilloma virus.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mouth cancer, throat cancer and splotchiness of skin on back and shoulders and the outcome of vestibular neuritis and human papilloma virus infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211058975-covid-19 vaccine ad26.cov2.s- mouth cancer, throat cancer . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Ear swelling, Gait disturbance, Headache, Injection site pain
Clinical narrative: . Significant facial swelling, left and right side near ears; Body aches; lethargy; headache; pain at injection site; High fever; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 intramuscular, administered in Arm Left on 14Oct2021 09:30 (Batch/Lot Number: EN0217) (at the age of 49 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. There were no concomitant medications. There was no other vaccine in four weeks. There were no known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 23Feb2021 09:00 (Batch/Lot Number: EL3247) (at the age of 49 years), and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 16Mar2021 09:00 (Batch/Lot Number: EL3247) (at the age of 49 years), both for COVID-19 immunisation. The patient experienced high fever, dizziness, body aches, lethargy, headache, pain at injection site/ Significant pain at injection site, and radiating inwards to underarm, all on 15Oct2021 04:00, significant facial swelling, left and right side near ears on 16Oct2021. The outcome of event pain at injection site was recovered with sequel on 17Oct2021, while for other events was recovered with sequel on 16Oct2021. There was no treatment for events. No COVID prior vaccination. No COVID tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on 15Oct2021 (High fever (102F+)), for 2 days after injection.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Pain, Pyrexia, Swelling face
Clinical narrative: . Significant facial swelling, left and right side near ears; Body aches; lethargy; headache; pain at injection site; High fever; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 intramuscular, administered in Arm Left on 14Oct2021 09:30 (Batch/Lot Number: EN0217) (at the age of 49 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. There were no concomitant medications. There was no other vaccine in four weeks. There were no known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 23Feb2021 09:00 (Batch/Lot Number: EL3247) (at the age of 49 years), and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 16Mar2021 09:00 (Batch/Lot Number: EL3247) (at the age of 49 years), both for COVID-19 immunisation. The patient experienced high fever, dizziness, body aches, lethargy, headache, pain at injection site/ Significant pain at injection site, and radiating inwards to underarm, all on 15Oct2021 04:00, significant facial swelling, left and right side near ears on 16Oct2021. The outcome of event pain at injection site was recovered with sequel on 17Oct2021, while for other events was recovered with sequel on 16Oct2021. There was no treatment for events. No COVID prior vaccination. No COVID tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on 15Oct2021 (High fever (102F+)), for 2 days after injection.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Dizziness, Headache, Lethargy, Pain
Clinical narrative: . Significant facial swelling, left and right side near ears; Body aches; lethargy; headache; pain at injection site; High fever; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 intramuscular, administered in Arm Left on 14Oct2021 09:30 (Batch/Lot Number: EN0217) (at the age of 49 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. There were no concomitant medications. There was no other vaccine in four weeks. There were no known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 23Feb2021 09:00 (Batch/Lot Number: EL3247) (at the age of 49 years), and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 16Mar2021 09:00 (Batch/Lot Number: EL3247) (at the age of 49 years), both for COVID-19 immunisation. The patient experienced high fever, dizziness, body aches, lethargy, headache, pain at injection site/ Significant pain at injection site, and radiating inwards to underarm, all on 15Oct2021 04:00, significant facial swelling, left and right side near ears on 16Oct2021. The outcome of event pain at injection site was recovered with sequel on 17Oct2021, while for other events was recovered with sequel on 16Oct2021. There was no treatment for events. No COVID prior vaccination. No COVID tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on 15Oct2021 (High fever (102F+)), for 2 days after injection.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Swelling face, Vaccination site pain
Clinical narrative: . Significant facial swelling, left and right side near ears; Body aches; lethargy; headache; pain at injection site; High fever; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 intramuscular, administered in Arm Left on 14Oct2021 09:30 (Batch/Lot Number: EN0217) (at the age of 49 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. There were no concomitant medications. There was no other vaccine in four weeks. There were no known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 23Feb2021 09:00 (Batch/Lot Number: EL3247) (at the age of 49 years), and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 16Mar2021 09:00 (Batch/Lot Number: EL3247) (at the age of 49 years), both for COVID-19 immunisation. The patient experienced high fever, dizziness, body aches, lethargy, headache, pain at injection site/ Significant pain at injection site, and radiating inwards to underarm, all on 15Oct2021 04:00, significant facial swelling, left and right side near ears on 16Oct2021. The outcome of event pain at injection site was recovered with sequel on 17Oct2021, while for other events was recovered with sequel on 16Oct2021. There was no treatment for events. No COVID prior vaccination. No COVID tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on 15Oct2021 (High fever (102F+)), for 2 days after injection.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site cyst, Injection site induration, Injection site pain
Clinical narrative: she developed a painful "hard ball" under the skin about the size of a marble at the injection site; she developed a painful "hard ball" under the skin about the size of a marble at the injection site; This spontaneous report was received from a health care worker and refers to a 31 year old female patient. The patient's concurrent condition included anxiety. The patient's food allergies included shellfish and squid which gave her facial swelling. She did not have drug allergies.The patient's medical history included covid-19. Concomitant therapies included hydrocortisone acetate (+) pramocaine hydrochloride (HYDROXINE).  On 30-AUG-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) by intramuscular route in her left deltoid as Human Papilloma Virus (HPV) prevention (lot # 1687293 has been verified to be a valid lot number, expiration date reported as 30-APR-2022, but upon internal validation established as 30-APR-2023) (dose was not reported). It was reported that everything went well after administration at the office.   In 2021 (reported as one month later the patient called the reporter), the patient developed a painful "hard ball" under the skin about the size of a marble at the injection site (vaccination site pain and vaccination site cyst). The patient was treated with warm compresses to the site. Regarding the events, a Papanicolaou (PAP) smear and Covid antigen test were performed both with normal results.   The second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was hold off on until her symptoms improve, in addition, the reporter mentioned she had not missed the second dose (reported as withdrawn on 23-SEP-2021).  At the reporting time, the outcome of vaccination site pain and vaccination site cyst was unknown.   The causal assessment between the events and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Age: 31.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site induration, Injection site pain, SARS-CoV-2 test negative, Smear cervix normal, Vaccination site cyst
Clinical narrative: she developed a painful "hard ball" under the skin about the size of a marble at the injection site; she developed a painful "hard ball" under the skin about the size of a marble at the injection site; This spontaneous report was received from a health care worker and refers to a 31 year old female patient. The patient's concurrent condition included anxiety. The patient's food allergies included shellfish and squid which gave her facial swelling. She did not have drug allergies.The patient's medical history included covid-19. Concomitant therapies included hydrocortisone acetate (+) pramocaine hydrochloride (HYDROXINE).  On 30-AUG-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) by intramuscular route in her left deltoid as Human Papilloma Virus (HPV) prevention (lot # 1687293 has been verified to be a valid lot number, expiration date reported as 30-APR-2022, but upon internal validation established as 30-APR-2023) (dose was not reported). It was reported that everything went well after administration at the office.   In 2021 (reported as one month later the patient called the reporter), the patient developed a painful "hard ball" under the skin about the size of a marble at the injection site (vaccination site pain and vaccination site cyst). The patient was treated with warm compresses to the site. Regarding the events, a Papanicolaou (PAP) smear and Covid antigen test were performed both with normal results.   The second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was hold off on until her symptoms improve, in addition, the reporter mentioned she had not missed the second dose (reported as withdrawn on 23-SEP-2021).  At the reporting time, the outcome of vaccination site pain and vaccination site cyst was unknown.   The causal assessment between the events and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Coronavirus infection, Cough, Dyspnoea
Clinical narrative: fatigue; shortness of breath; loss of sense of taste and smell; loss of sense of taste and smell; Allergies; This is a spontaneous report. A contactable female consumer (patient) reported.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. Patient Medical History and Concomitant medications were not reported. Patient mentioned that after her first dose she had allergies, loss of sense of taste and smell, had short-ness of breath and fatigue. Caller would like to know when will those be removed. Outcome of events was Unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Hypersensitivity, Nasopharyngitis, Nausea, Rhinorrhoea
Clinical narrative: fatigue; shortness of breath; loss of sense of taste and smell; loss of sense of taste and smell; Allergies; This is a spontaneous report. A contactable female consumer (patient) reported.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. Patient Medical History and Concomitant medications were not reported. Patient mentioned that after her first dose she had allergies, loss of sense of taste and smell, had short-ness of breath and fatigue. Caller would like to know when will those be removed. Outcome of events was Unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Dyspnoea, Fatigue, Hypersensitivity
Clinical narrative: fatigue; shortness of breath; loss of sense of taste and smell; loss of sense of taste and smell; Allergies; This is a spontaneous report. A contactable female consumer (patient) reported.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. Patient Medical History and Concomitant medications were not reported. Patient mentioned that after her first dose she had allergies, loss of sense of taste and smell, had short-ness of breath and fatigue. Caller would like to know when will those be removed. Outcome of events was Unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, Weight
Clinical narrative: Got sick three different times every few days; Nausea; Fever; chills; Headache; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team.   A 20-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number, Expiry date: was not reported), via an unspecified route of administration on 05May2021 (Age at vaccination: 20 years old) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, patient reported that she got sick three different times every few days, reported reoccurring symptoms of nausea, fever, chills and headache and they come and go at the same time, also reported that she is getting tested for covid today. She wanted to know if it is normal to have reoccurring symptoms after the vaccine. She also wanted to know if she should get her second shot. Outcome of events was recovered with sequel.  No follow-up attempts are completed; information about batch/lot cannot be obtained.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Illness, Nausea, Pyrexia
Clinical narrative: Got sick three different times every few days; Nausea; Fever; chills; Headache; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team.   A 20-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number, Expiry date: was not reported), via an unspecified route of administration on 05May2021 (Age at vaccination: 20 years old) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, patient reported that she got sick three different times every few days, reported reoccurring symptoms of nausea, fever, chills and headache and they come and go at the same time, also reported that she is getting tested for covid today. She wanted to know if it is normal to have reoccurring symptoms after the vaccine. She also wanted to know if she should get her second shot. Outcome of events was recovered with sequel.  No follow-up attempts are completed; information about batch/lot cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Joint swelling, Paraesthesia oral, Peripheral swelling
Clinical narrative: Within 5 minutes of vaccination, PT began to complain about having a severe headache.  PT began to have swelling of her hands and extremities. PT's hands were cool and clammy to the touch.  Yet the forehead was warm to the touch. The pharmacist took the PT's blood pressure and it was 196/137 with a pulse of 108.  (NOTE: PT's watch showed PT's pulse to remain above 100 bpm for several days.)  PT complained about experiencing itching all over her body.  PT complained about feeling extremely cold.  PT felt faint and the Pharmacist and I laid the PT on the ground and elevated her feet.  The pharmacist provided PT with 20mL of Tylenol to help with the pain and 20mL of Benedryl to help with the severe itching that the PT was experiencing. We sought medical assistance from a doctor's office in the same building but then just opted to ambulate by private vehicle to the Emergency Room across the way.  ER provided less than the desired level of care.  ER doctor stated that due to apprehension and anxiety the PT experienced a fainting spell.  The PT was discharged from the ER with no further care or instruction.  NOTE at no time did the PT ever lose consciousness or become unaware of her surroundings.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Within 5 minutes of vaccination, PT began to complain about having a severe headache.  PT began to have swelling of her hands and extremities. PT's hands were cool and clammy to the touch.  Yet the forehead was warm to the touch. The pharmacist took the PT's blood pressure and it was 196/137 with a pulse of 108.  (NOTE: PT's watch showed PT's pulse to remain above 100 bpm for several days.)  PT complained about experiencing itching all over her body.  PT complained about feeling extremely cold.  PT felt faint and the Pharmacist and I laid the PT on the ground and elevated her feet.  The pharmacist provided PT with 20mL of Tylenol to help with the pain and 20mL of Benedryl to help with the severe itching that the PT was experiencing. We sought medical assistance from a doctor's office in the same building but then just opted to ambulate by private vehicle to the Emergency Room across the way.  ER provided less than the desired level of care.  ER doctor stated that due to apprehension and anxiety the PT experienced a fainting spell.  The PT was discharged from the ER with no further care or instruction.  NOTE at no time did the PT ever lose consciousness or become unaware of her surroundings.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Cold sweat, Dizziness, Feeling cold, Feeling hot
Clinical narrative: Within 5 minutes of vaccination, PT began to complain about having a severe headache.  PT began to have swelling of her hands and extremities. PT's hands were cool and clammy to the touch.  Yet the forehead was warm to the touch. The pharmacist took the PT's blood pressure and it was 196/137 with a pulse of 108.  (NOTE: PT's watch showed PT's pulse to remain above 100 bpm for several days.)  PT complained about experiencing itching all over her body.  PT complained about feeling extremely cold.  PT felt faint and the Pharmacist and I laid the PT on the ground and elevated her feet.  The pharmacist provided PT with 20mL of Tylenol to help with the pain and 20mL of Benedryl to help with the severe itching that the PT was experiencing. We sought medical assistance from a doctor's office in the same building but then just opted to ambulate by private vehicle to the Emergency Room across the way.  ER provided less than the desired level of care.  ER doctor stated that due to apprehension and anxiety the PT experienced a fainting spell.  The PT was discharged from the ER with no further care or instruction.  NOTE at no time did the PT ever lose consciousness or become unaware of her surroundings.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Peripheral coldness, Peripheral swelling, Pruritus
Clinical narrative: Within 5 minutes of vaccination, PT began to complain about having a severe headache.  PT began to have swelling of her hands and extremities. PT's hands were cool and clammy to the touch.  Yet the forehead was warm to the touch. The pharmacist took the PT's blood pressure and it was 196/137 with a pulse of 108.  (NOTE: PT's watch showed PT's pulse to remain above 100 bpm for several days.)  PT complained about experiencing itching all over her body.  PT complained about feeling extremely cold.  PT felt faint and the Pharmacist and I laid the PT on the ground and elevated her feet.  The pharmacist provided PT with 20mL of Tylenol to help with the pain and 20mL of Benedryl to help with the severe itching that the PT was experiencing. We sought medical assistance from a doctor's office in the same building but then just opted to ambulate by private vehicle to the Emergency Room across the way.  ER provided less than the desired level of care.  ER doctor stated that due to apprehension and anxiety the PT experienced a fainting spell.  The PT was discharged from the ER with no further care or instruction.  NOTE at no time did the PT ever lose consciousness or become unaware of her surroundings.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Cough, Fatigue, Feeling abnormal, Lethargy
Clinical narrative: had COVID; had COVID; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 13Sep2021 (Batch/Lot number: FC31W2) as dose 2, single, and dose 1 via an unspecified route of administration, administered in right arm on 23Aug2021 (Batch/Lot Number: EC31W1) as dose 1, single for COVID-19 immunisation.  Medical history included lymph node removed 10 years ago and breast cancer female, both from an unknown date.  The patient received unspecified concomitant medications. The patient experienced had COVID on an unspecified date in Sep2021.    The patient stated they tested her for COVID, she was negative; but she actually had COVID.  The patient questioned even if she got the vaccination on the 13Sep2021 and then was tested on the 17Sep2021 is that possible that because she had the vaccination, is there possibility of having a false negative for the COVID test. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 17Sep2021.  The clinical outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101358056 similar report from same reporter; different events;US-PFIZER INC-202101358145 similar report from same reporter; different events
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Pulmonary embolism, Pyrexia, SARS-CoV-2 test
Clinical narrative: had COVID; had COVID; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 13Sep2021 (Batch/Lot number: FC31W2) as dose 2, single, and dose 1 via an unspecified route of administration, administered in right arm on 23Aug2021 (Batch/Lot Number: EC31W1) as dose 1, single for COVID-19 immunisation.  Medical history included lymph node removed 10 years ago and breast cancer female, both from an unknown date.  The patient received unspecified concomitant medications. The patient experienced had COVID on an unspecified date in Sep2021.    The patient stated they tested her for COVID, she was negative; but she actually had COVID.  The patient questioned even if she got the vaccination on the 13Sep2021 and then was tested on the 17Sep2021 is that possible that because she had the vaccination, is there possibility of having a false negative for the COVID test. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 17Sep2021.  The clinical outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101358056 similar report from same reporter; different events;US-PFIZER INC-202101358145 similar report from same reporter; different events
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urinary tract infection, X-ray
Clinical narrative: had COVID; had COVID; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 13Sep2021 (Batch/Lot number: FC31W2) as dose 2, single, and dose 1 via an unspecified route of administration, administered in right arm on 23Aug2021 (Batch/Lot Number: EC31W1) as dose 1, single for COVID-19 immunisation.  Medical history included lymph node removed 10 years ago and breast cancer female, both from an unknown date.  The patient received unspecified concomitant medications. The patient experienced had COVID on an unspecified date in Sep2021.    The patient stated they tested her for COVID, she was negative; but she actually had COVID.  The patient questioned even if she got the vaccination on the 13Sep2021 and then was tested on the 17Sep2021 is that possible that because she had the vaccination, is there possibility of having a false negative for the COVID test. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 17Sep2021.  The clinical outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101358056 similar report from same reporter; different events;US-PFIZER INC-202101358145 similar report from same reporter; different events