chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Reporting administration error as per Agency. We contacted Pfizer for expiration dates. Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only incude manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from then.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration error
Clinical narrative: Reporting administration error as per Agency. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only incude manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.   No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction reported since given vaccine.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration error, Product expiration date issue
Clinical narrative: Reporting administration error as per Agency. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only incude manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from then.  No adverse reaction reported from the patient at the time of the vaccination and no adverse reaction Reported since given vaccine.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration error, Product expiration date issue
Clinical narrative: Reporting administration error as per Agency. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only incude manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patient at the time of the vaccination and no adverse reaction Reported since given vaccine.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration error, Product expiration date issue
Clinical narrative: Reporting administration error as per Agency. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only incude manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction Reported since given vaccine.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration error, Product expiration date issue
Clinical narrative: Reporting administration error as per Agency. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only incude manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction Reported since given vaccine.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration error, Product expiration date issue
Clinical narrative: Reporting administration error as per Agency. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only incude manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction Reported since given vaccine.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Reporting administration error as per Agency. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only incude manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.
Sex: U
Vaccine: HEP, RV5, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reporting a second dose of "not supported" RECOMBIVAX HB vaccine was administered to a patient. She states the "not supported" products were not removed immediately and the patient accidently received another dose; Second "not supported" dose administered: 7/6/2022; First "not supported" dose administered: 6/29/2022; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On an unspecified date, an hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot number W002452 has been verified to be a valid lot number for hepatitis b vaccine (recombinant) (RECOMBIVAX HB), expiration date reported and confirmed as 26-FEB-2024) suffered a temperature excursion of -0.8 Celsius degrees (C) for a time frame of 1 hour 10 minutes. The vaccine had not suffered previous temperature excursions.  On 29-JUN-2022, the patient was vaccinated with the first "not supported" dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 0.5 ml (lot number W002452, expiration date 26-FEB-2024) (route of administration and anatomical location were not provided) as prophylaxis (Product storage error). The reporter stated the "not supported" products were not removed immediately and on 06-JUL-2022, the patient accidently received the second "not supported" dose (also reported as "another dose") of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 0.5 ml (lot number W002452, expiration date 26-FEB-2024) (route of administration and anatomical location were not provided) as prophylaxis (Product storage error) (Extra dose administered).
Sex: U
Vaccine: HEP, RV5, HEP
Symptoms: Extra dose administered, Product storage error
Clinical narrative: Caller reporting a second dose of "not supported" RECOMBIVAX HB vaccine was administered to a patient. She states the "not supported" products were not removed immediately and the patient accidently received another dose; Second "not supported" dose administered: 7/6/2022; First "not supported" dose administered: 6/29/2022; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On an unspecified date, an hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot number W002452 has been verified to be a valid lot number for hepatitis b vaccine (recombinant) (RECOMBIVAX HB), expiration date reported and confirmed as 26-FEB-2024) suffered a temperature excursion of -0.8 Celsius degrees (C) for a time frame of 1 hour 10 minutes. The vaccine had not suffered previous temperature excursions.  On 29-JUN-2022, the patient was vaccinated with the first "not supported" dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 0.5 ml (lot number W002452, expiration date 26-FEB-2024) (route of administration and anatomical location were not provided) as prophylaxis (Product storage error). The reporter stated the "not supported" products were not removed immediately and on 06-JUL-2022, the patient accidently received the second "not supported" dose (also reported as "another dose") of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 0.5 ml (lot number W002452, expiration date 26-FEB-2024) (route of administration and anatomical location were not provided) as prophylaxis (Product storage error) (Extra dose administered).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, MMRV
Symptoms: Extra dose administered
Clinical narrative: No additional AE; Medical Assistant calling to report that a 4-year old female patient was accidentally administered an extra dose of PROQUAD on July 8, 2022. Patient had previously finished the vaccination series on January 11, 2022. No additional AE information prov; This spontaneous report has been received from a medical assistant, concerning a 4-year-old female patient. The patient's medical history, concurrent conditions, previous drug reactions, allergies, and concomitant therapies were not provided.   On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection, as prophylaxis (dose, route of administration, anatomical location, site of injection, lot number and expiration date were not provided). On 11-JAN-2022, she finished the vaccination series.   On 08-JUL-2022, the patient was accidentally administered an extra dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliters (ml), lot number U017137 had been verified to be a valid number, expiration date reported and validated as 28-NOV-2022 , and upon internal validation established as the same date (route of administration and anatomical site of injection were not provided) as prophylaxis (extra dose administered). No additional adverse events were reported in the patient.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; Medical Assistant calling to report that a 4-year old female patient was accidentally administered an extra dose of PROQUAD on July 8, 2022. Patient had previously finished the vaccination series on January 11, 2022. No additional AE information prov; This spontaneous report has been received from a medical assistant, concerning a 4-year-old female patient. The patient's medical history, concurrent conditions, previous drug reactions, allergies, and concomitant therapies were not provided.   On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection, as prophylaxis (dose, route of administration, anatomical location, site of injection, lot number and expiration date were not provided). On 11-JAN-2022, she finished the vaccination series.   On 08-JUL-2022, the patient was accidentally administered an extra dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliters (ml), lot number U017137 had been verified to be a valid number, expiration date reported and validated as 28-NOV-2022 , and upon internal validation established as the same date (route of administration and anatomical site of injection were not provided) as prophylaxis (extra dose administered). No additional adverse events were reported in the patient.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster given earlier than recommended date) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013B22A) for COVID-19 prophylaxis. Concurrent medical conditions included Liver function test increased and Hyperlipidemia. Concomitant products included FLUTICASONE, LISINOPRIL, ROSUVASTATIN and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication. On 15-Jul-2022 at 3:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2022 at 3:30 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster given earlier than recommended date). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster given earlier than recommended date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment details were provided. Patient had no known allergies. Patient had no other illness at the time of vaccination and up to one month prior. Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2022: Follow up received contains significant information. Reporter's information, patient demographics, medical history, suspect product details, concomitant medication and events details were added. On 18-Jul-2022: Follow up received included no new information.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood sodium decreased, Blood test normal, Chest X-ray normal, Cognitive disorder, Computerised tomogram normal
Clinical narrative: confusion/not able to think; arm swelled a little at the injection site; felt icky; food tasted salty; seizure; Cannot drive; This case was reported by a consumer via call center representative and described the occurrence of seizure in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included no history of seizure.   On 29th June 2022 10:00, the patient received the 1st dose of Shingrix (intramuscular). In June 2022, more than a day after receiving Shingrix, the patient experienced taste salty (serious criteria hospitalization). On 29th June 2022, the patient experienced injection site swelling (serious criteria hospitalization) and nausea (serious criteria hospitalization). On 30th June 2022, the patient experienced confusion (serious criteria hospitalization). In July 2022, the patient experienced seizure (serious criteria hospitalization and GSK medically significant) and impaired driving ability. On 30th June 2022, the outcome of the confusion was recovered/resolved. On an unknown date, the outcome of the seizure, injection site swelling, taste salty and nausea were recovered/resolved and the outcome of the impaired driving ability was unknown.   The reporter considered the seizure to be related to Shingrix. It was unknown if the reporter considered the injection site swelling, confusion, taste salty, nausea and impaired driving ability to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-July-2022 Reporter's comment: The patient self-reported this case. The patient received Shingrix vaccine in the left arm.   Less than a after vaccination the patient reported her arm swelled a little at the injection site and felt icky the first day. The next morning, 1 day after vaccination, the patient reported confusion/not able to think which resolved that night. On 30th June 2022 at dinner, her food tasted salty. On 1st July 2022 at 2 am, 40 hours after vaccination she experienced a seizure that lasted 20 minutes. Emergency room visit required. The emergency medical services (EMS) was called and the patient was admitted to the hospital and kept for 2 days until she could get an MRI, CAT scan, EKG and bloodwork. All tests came back normal. Her (HCP) healthcare professional wanted her to follow-up with a neurologist. In less than a week after vaccination, the patient was upset she could not drive for 6 months and attributed the seizure to the Shingrix vaccine. The patient wanted to know if other people had experienced a seizure after a Shingrix vaccine. The reported consented to follow up and gave permission to contact her HCP and access her reports from the hospital.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Confusional state, Dizziness, Dysgeusia, Electroencephalogram normal, Erythema
Clinical narrative: confusion/not able to think; arm swelled a little at the injection site; felt icky; food tasted salty; seizure; Cannot drive; This case was reported by a consumer via call center representative and described the occurrence of seizure in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included no history of seizure.   On 29th June 2022 10:00, the patient received the 1st dose of Shingrix (intramuscular). In June 2022, more than a day after receiving Shingrix, the patient experienced taste salty (serious criteria hospitalization). On 29th June 2022, the patient experienced injection site swelling (serious criteria hospitalization) and nausea (serious criteria hospitalization). On 30th June 2022, the patient experienced confusion (serious criteria hospitalization). In July 2022, the patient experienced seizure (serious criteria hospitalization and GSK medically significant) and impaired driving ability. On 30th June 2022, the outcome of the confusion was recovered/resolved. On an unknown date, the outcome of the seizure, injection site swelling, taste salty and nausea were recovered/resolved and the outcome of the impaired driving ability was unknown.   The reporter considered the seizure to be related to Shingrix. It was unknown if the reporter considered the injection site swelling, confusion, taste salty, nausea and impaired driving ability to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-July-2022 Reporter's comment: The patient self-reported this case. The patient received Shingrix vaccine in the left arm.   Less than a after vaccination the patient reported her arm swelled a little at the injection site and felt icky the first day. The next morning, 1 day after vaccination, the patient reported confusion/not able to think which resolved that night. On 30th June 2022 at dinner, her food tasted salty. On 1st July 2022 at 2 am, 40 hours after vaccination she experienced a seizure that lasted 20 minutes. Emergency room visit required. The emergency medical services (EMS) was called and the patient was admitted to the hospital and kept for 2 days until she could get an MRI, CAT scan, EKG and bloodwork. All tests came back normal. Her (HCP) healthcare professional wanted her to follow-up with a neurologist. In less than a week after vaccination, the patient was upset she could not drive for 6 months and attributed the seizure to the Shingrix vaccine. The patient wanted to know if other people had experienced a seizure after a Shingrix vaccine. The reported consented to follow up and gave permission to contact her HCP and access her reports from the hospital.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Magnetic resonance imaging normal, Malaise, Memory impairment, Peripheral swelling
Clinical narrative: confusion/not able to think; arm swelled a little at the injection site; felt icky; food tasted salty; seizure; Cannot drive; This case was reported by a consumer via call center representative and described the occurrence of seizure in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included no history of seizure.   On 29th June 2022 10:00, the patient received the 1st dose of Shingrix (intramuscular). In June 2022, more than a day after receiving Shingrix, the patient experienced taste salty (serious criteria hospitalization). On 29th June 2022, the patient experienced injection site swelling (serious criteria hospitalization) and nausea (serious criteria hospitalization). On 30th June 2022, the patient experienced confusion (serious criteria hospitalization). In July 2022, the patient experienced seizure (serious criteria hospitalization and GSK medically significant) and impaired driving ability. On 30th June 2022, the outcome of the confusion was recovered/resolved. On an unknown date, the outcome of the seizure, injection site swelling, taste salty and nausea were recovered/resolved and the outcome of the impaired driving ability was unknown.   The reporter considered the seizure to be related to Shingrix. It was unknown if the reporter considered the injection site swelling, confusion, taste salty, nausea and impaired driving ability to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-July-2022 Reporter's comment: The patient self-reported this case. The patient received Shingrix vaccine in the left arm.   Less than a after vaccination the patient reported her arm swelled a little at the injection site and felt icky the first day. The next morning, 1 day after vaccination, the patient reported confusion/not able to think which resolved that night. On 30th June 2022 at dinner, her food tasted salty. On 1st July 2022 at 2 am, 40 hours after vaccination she experienced a seizure that lasted 20 minutes. Emergency room visit required. The emergency medical services (EMS) was called and the patient was admitted to the hospital and kept for 2 days until she could get an MRI, CAT scan, EKG and bloodwork. All tests came back normal. Her (HCP) healthcare professional wanted her to follow-up with a neurologist. In less than a week after vaccination, the patient was upset she could not drive for 6 months and attributed the seizure to the Shingrix vaccine. The patient wanted to know if other people had experienced a seizure after a Shingrix vaccine. The reported consented to follow up and gave permission to contact her HCP and access her reports from the hospital.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Seizure, Somnolence, Thyroid function test normal, Unresponsive to stimuli, X-ray
Clinical narrative: confusion/not able to think; arm swelled a little at the injection site; felt icky; food tasted salty; seizure; Cannot drive; This case was reported by a consumer via call center representative and described the occurrence of seizure in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included no history of seizure.   On 29th June 2022 10:00, the patient received the 1st dose of Shingrix (intramuscular). In June 2022, more than a day after receiving Shingrix, the patient experienced taste salty (serious criteria hospitalization). On 29th June 2022, the patient experienced injection site swelling (serious criteria hospitalization) and nausea (serious criteria hospitalization). On 30th June 2022, the patient experienced confusion (serious criteria hospitalization). In July 2022, the patient experienced seizure (serious criteria hospitalization and GSK medically significant) and impaired driving ability. On 30th June 2022, the outcome of the confusion was recovered/resolved. On an unknown date, the outcome of the seizure, injection site swelling, taste salty and nausea were recovered/resolved and the outcome of the impaired driving ability was unknown.   The reporter considered the seizure to be related to Shingrix. It was unknown if the reporter considered the injection site swelling, confusion, taste salty, nausea and impaired driving ability to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-July-2022 Reporter's comment: The patient self-reported this case. The patient received Shingrix vaccine in the left arm.   Less than a after vaccination the patient reported her arm swelled a little at the injection site and felt icky the first day. The next morning, 1 day after vaccination, the patient reported confusion/not able to think which resolved that night. On 30th June 2022 at dinner, her food tasted salty. On 1st July 2022 at 2 am, 40 hours after vaccination she experienced a seizure that lasted 20 minutes. Emergency room visit required. The emergency medical services (EMS) was called and the patient was admitted to the hospital and kept for 2 days until she could get an MRI, CAT scan, EKG and bloodwork. All tests came back normal. Her (HCP) healthcare professional wanted her to follow-up with a neurologist. In less than a week after vaccination, the patient was upset she could not drive for 6 months and attributed the seizure to the Shingrix vaccine. The patient wanted to know if other people had experienced a seizure after a Shingrix vaccine. The reported consented to follow up and gave permission to contact her HCP and access her reports from the hospital.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Computerised tomogram normal, Confusional state, Dysgeusia, Electrocardiogram normal
Clinical narrative: confusion/not able to think; arm swelled a little at the injection site; felt icky; food tasted salty; seizure; Cannot drive; This case was reported by a consumer via call center representative and described the occurrence of seizure in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included no history of seizure.   On 29th June 2022 10:00, the patient received the 1st dose of Shingrix (intramuscular). In June 2022, more than a day after receiving Shingrix, the patient experienced taste salty (serious criteria hospitalization). On 29th June 2022, the patient experienced injection site swelling (serious criteria hospitalization) and nausea (serious criteria hospitalization). On 30th June 2022, the patient experienced confusion (serious criteria hospitalization). In July 2022, the patient experienced seizure (serious criteria hospitalization and GSK medically significant) and impaired driving ability. On 30th June 2022, the outcome of the confusion was recovered/resolved. On an unknown date, the outcome of the seizure, injection site swelling, taste salty and nausea were recovered/resolved and the outcome of the impaired driving ability was unknown.   The reporter considered the seizure to be related to Shingrix. It was unknown if the reporter considered the injection site swelling, confusion, taste salty, nausea and impaired driving ability to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-July-2022 Reporter's comment: The patient self-reported this case. The patient received Shingrix vaccine in the left arm.   Less than a after vaccination the patient reported her arm swelled a little at the injection site and felt icky the first day. The next morning, 1 day after vaccination, the patient reported confusion/not able to think which resolved that night. On 30th June 2022 at dinner, her food tasted salty. On 1st July 2022 at 2 am, 40 hours after vaccination she experienced a seizure that lasted 20 minutes. Emergency room visit required. The emergency medical services (EMS) was called and the patient was admitted to the hospital and kept for 2 days until she could get an MRI, CAT scan, EKG and bloodwork. All tests came back normal. Her (HCP) healthcare professional wanted her to follow-up with a neurologist. In less than a week after vaccination, the patient was upset she could not drive for 6 months and attributed the seizure to the Shingrix vaccine. The patient wanted to know if other people had experienced a seizure after a Shingrix vaccine. The reported consented to follow up and gave permission to contact her HCP and access her reports from the hospital.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Impaired driving ability, Injection site swelling, Magnetic resonance imaging normal, Malaise, Mental impairment
Clinical narrative: confusion/not able to think; arm swelled a little at the injection site; felt icky; food tasted salty; seizure; Cannot drive; This case was reported by a consumer via call center representative and described the occurrence of seizure in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included no history of seizure.   On 29th June 2022 10:00, the patient received the 1st dose of Shingrix (intramuscular). In June 2022, more than a day after receiving Shingrix, the patient experienced taste salty (serious criteria hospitalization). On 29th June 2022, the patient experienced injection site swelling (serious criteria hospitalization) and nausea (serious criteria hospitalization). On 30th June 2022, the patient experienced confusion (serious criteria hospitalization). In July 2022, the patient experienced seizure (serious criteria hospitalization and GSK medically significant) and impaired driving ability. On 30th June 2022, the outcome of the confusion was recovered/resolved. On an unknown date, the outcome of the seizure, injection site swelling, taste salty and nausea were recovered/resolved and the outcome of the impaired driving ability was unknown.   The reporter considered the seizure to be related to Shingrix. It was unknown if the reporter considered the injection site swelling, confusion, taste salty, nausea and impaired driving ability to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-July-2022 Reporter's comment: The patient self-reported this case. The patient received Shingrix vaccine in the left arm.   Less than a after vaccination the patient reported her arm swelled a little at the injection site and felt icky the first day. The next morning, 1 day after vaccination, the patient reported confusion/not able to think which resolved that night. On 30th June 2022 at dinner, her food tasted salty. On 1st July 2022 at 2 am, 40 hours after vaccination she experienced a seizure that lasted 20 minutes. Emergency room visit required. The emergency medical services (EMS) was called and the patient was admitted to the hospital and kept for 2 days until she could get an MRI, CAT scan, EKG and bloodwork. All tests came back normal. Her (HCP) healthcare professional wanted her to follow-up with a neurologist. In less than a week after vaccination, the patient was upset she could not drive for 6 months and attributed the seizure to the Shingrix vaccine. The patient wanted to know if other people had experienced a seizure after a Shingrix vaccine. The reported consented to follow up and gave permission to contact her HCP and access her reports from the hospital.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Seizure
Clinical narrative: confusion/not able to think; arm swelled a little at the injection site; felt icky; food tasted salty; seizure; Cannot drive; This case was reported by a consumer via call center representative and described the occurrence of seizure in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included no history of seizure.   On 29th June 2022 10:00, the patient received the 1st dose of Shingrix (intramuscular). In June 2022, more than a day after receiving Shingrix, the patient experienced taste salty (serious criteria hospitalization). On 29th June 2022, the patient experienced injection site swelling (serious criteria hospitalization) and nausea (serious criteria hospitalization). On 30th June 2022, the patient experienced confusion (serious criteria hospitalization). In July 2022, the patient experienced seizure (serious criteria hospitalization and GSK medically significant) and impaired driving ability. On 30th June 2022, the outcome of the confusion was recovered/resolved. On an unknown date, the outcome of the seizure, injection site swelling, taste salty and nausea were recovered/resolved and the outcome of the impaired driving ability was unknown.   The reporter considered the seizure to be related to Shingrix. It was unknown if the reporter considered the injection site swelling, confusion, taste salty, nausea and impaired driving ability to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-July-2022 Reporter's comment: The patient self-reported this case. The patient received Shingrix vaccine in the left arm.   Less than a after vaccination the patient reported her arm swelled a little at the injection site and felt icky the first day. The next morning, 1 day after vaccination, the patient reported confusion/not able to think which resolved that night. On 30th June 2022 at dinner, her food tasted salty. On 1st July 2022 at 2 am, 40 hours after vaccination she experienced a seizure that lasted 20 minutes. Emergency room visit required. The emergency medical services (EMS) was called and the patient was admitted to the hospital and kept for 2 days until she could get an MRI, CAT scan, EKG and bloodwork. All tests came back normal. Her (HCP) healthcare professional wanted her to follow-up with a neurologist. In less than a week after vaccination, the patient was upset she could not drive for 6 months and attributed the seizure to the Shingrix vaccine. The patient wanted to know if other people had experienced a seizure after a Shingrix vaccine. The reported consented to follow up and gave permission to contact her HCP and access her reports from the hospital.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blister, Discharge, Discomfort, Injected limb mobility decreased, Loss of personal independence in daily activities
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: sever blistering on left arm-Severe, Additional Details: pt presented with sever blistering on left arm, got a steroid shot from pcp, advised to take benadryl
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mobility decreased, Pain, Pain in extremity, Rash, Rash erythematous
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: sever blistering on left arm-Severe, Additional Details: pt presented with sever blistering on left arm, got a steroid shot from pcp, advised to take benadryl
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash papular
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: sever blistering on left arm-Severe, Additional Details: pt presented with sever blistering on left arm, got a steroid shot from pcp, advised to take benadryl
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Allergy to vaccine, Blister rupture, Burning sensation, Insomnia, Pain
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: sever blistering on left arm-Severe, Additional Details: pt presented with sever blistering on left arm, got a steroid shot from pcp, advised to take benadryl
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site discomfort, Vaccination site reaction, Vaccination site urticaria, Vaccination site vesicles
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: sever blistering on left arm-Severe, Additional Details: pt presented with sever blistering on left arm, got a steroid shot from pcp, advised to take benadryl
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blister, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: sever blistering on left arm-Severe, Additional Details: pt presented with sever blistering on left arm, got a steroid shot from pcp, advised to take benadryl
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site swelling, Rash
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: sever blistering on left arm-Severe, Additional Details: pt presented with sever blistering on left arm, got a steroid shot from pcp, advised to take benadryl
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Haematoma, Malaise, Nausea
Clinical narrative: The day after receiving the second booster, I felt sick in the evening and 18 hours after the booster, I had nausea and fainted and sustained hematomas on my scalp and posterior right shoulder and had continued coccydynia for several weeks. I felt very weak and lightheaded most of the day.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: The day after receiving the second booster, I felt sick in the evening and 18 hours after the booster, I had nausea and fainted and sustained hematomas on my scalp and posterior right shoulder and had continued coccydynia for several weeks. I felt very weak and lightheaded most of the day.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Cannot lift right arm- weakness in right upper arm- very painful and limited abduction of right upper arm Felt like she was Wandering last night after the vaccine   Motor: No weakness elsewhere except right upper arm.. Normal tone, power except for right upper arm unable to abduct, no shoulder deformity- tenderness present around injection site over the deltoid - no hematoma or swelling at injection site, can cross right arm across chest; cannot perform internal rotation of the right arm - using left arm to help abduct right upper arm.        Gait: Gait normal.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity
Clinical narrative: Sore arm (1 hour after and on; 1:00pm) Chills (10pm and on) Nausea Headache
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: swollen and some discomfort Left lymph nodes neck/above collar bone.  By day 2  evening, it had increased in size so it was very visible by others compared to the right side, which is why I am submitting report. Extended down neck to collarbone. Tender to touch and some discomfort turning neck.  Right side neck lymph nodes very slightly swollen, no discomfort. sore arm on 7/21 improving by 7/22. slightly sore to. touch on 7/23. Fatigue on 7/21
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Systemic: Unable to reach patient, patient reported event to the pharmacist who notified the provider.-Mild, Additional Details: Attempted to call patient x 3 with no success. Event reported by Pharmacist to the provider that patient needed to go to the ER for evaluation due to vaccine side effects.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination error
Clinical narrative: Error: Patient Accidentally Stuck by Needle-
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient became lightheaded and dizzy after vaccination, passed out briefly and came to within minutes.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: patient heart rate, blood pressure and oxygen level within normal range. Checked by clinic nurse.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Injection site pain, Pain
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Report initiated by District Leader. Patient reports bursitis following first in series of Moderna COVID 19 vaccine with ongoing pain in bursa. District Leader will follow up with patient.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid pain, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: 100 degree fever day 1 Body aches day 1-2 Extreme fatigue day 1-3 Sore throat day 2 Headache day 2-3 Painful swollen eyelids (more left eye) day 3 and 4 (today is day 4 and unresolved)
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: 100 degree fever day 1 Body aches day 1-2 Extreme fatigue day 1-3 Sore throat day 2 Headache day 2-3 Painful swollen eyelids (more left eye) day 3 and 4 (today is day 4 and unresolved)
Age: 39.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Bilirubin urine present, Blood glucose normal, Blood sodium normal, Condition aggravated, Full blood count
Clinical narrative: Nausea,  vertigo, continual vomiting
Age: 39.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Lymphocyte percentage decreased, Mean cell haemoglobin increased, Mean cell volume increased, Metabolic function test, Monocyte percentage increased
Clinical narrative: Nausea,  vertigo, continual vomiting
Age: 39.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Nausea, Neutrophil percentage increased, Protein urine present, Urinary casts present, Urine analysis
Clinical narrative: Nausea,  vertigo, continual vomiting
Age: 39.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Urine ketone body present, Vertigo, Vomiting, White blood cells urine positive
Clinical narrative: Nausea,  vertigo, continual vomiting
Age: 2.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, HEPA
Symptoms: Pain in extremity, Peripheral swelling, Sleep disorder
Clinical narrative: Night waking Swelling in hands, feet and ankles. Legs not weight baring without pain
Age: 2.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, HEPA
Symptoms: Gait disturbance, Irritability, Oedema peripheral, Pain, Skin oedema
Clinical narrative: Night waking Swelling in hands, feet and ankles. Legs not weight baring without pain
Age: 2.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, HEPA
Symptoms: Sleep disorder, Urticaria, Weight bearing difficulty
Clinical narrative: Night waking Swelling in hands, feet and ankles. Legs not weight baring without pain
Age: 2.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, HEPA
Symptoms: Pain in extremity, Peripheral swelling, Sleep disorder
Clinical narrative: Patient got his 2nd Covid vaccine and his 2nd Hep A vaccine around 4pm in afternoon 7/22. Parents gave motrin before bed. He woke up around midnight, wide awake, whiney and wanting to sleep with parents. He did the same thing after his 1st covid vaccine but not after other vaccinations. Morning of 7/23 woke up around 6 am and had edema of hands, feet - skin taught - didnt want to bear weight or walk and said that it hurt. Otherwise happy, ate normally, acting normally. Came into office at 9am with newly developed urticarial rash on body. Not itchy. No swelling of lips, tongue, face. No difficulty breathing, vomiting, fever, irritability. Swelling from hands and feet had gone down a little and he was walking, climbing per usual.
Age: 2.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, HEPA
Symptoms: Gait disturbance, Irritability, Oedema peripheral, Pain, Skin oedema
Clinical narrative: Patient got his 2nd Covid vaccine and his 2nd Hep A vaccine around 4pm in afternoon 7/22. Parents gave motrin before bed. He woke up around midnight, wide awake, whiney and wanting to sleep with parents. He did the same thing after his 1st covid vaccine but not after other vaccinations. Morning of 7/23 woke up around 6 am and had edema of hands, feet - skin taught - didnt want to bear weight or walk and said that it hurt. Otherwise happy, ate normally, acting normally. Came into office at 9am with newly developed urticarial rash on body. Not itchy. No swelling of lips, tongue, face. No difficulty breathing, vomiting, fever, irritability. Swelling from hands and feet had gone down a little and he was walking, climbing per usual.
Age: 2.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, HEPA
Symptoms: Sleep disorder, Urticaria, Weight bearing difficulty
Clinical narrative: Patient got his 2nd Covid vaccine and his 2nd Hep A vaccine around 4pm in afternoon 7/22. Parents gave motrin before bed. He woke up around midnight, wide awake, whiney and wanting to sleep with parents. He did the same thing after his 1st covid vaccine but not after other vaccinations. Morning of 7/23 woke up around 6 am and had edema of hands, feet - skin taught - didnt want to bear weight or walk and said that it hurt. Otherwise happy, ate normally, acting normally. Came into office at 9am with newly developed urticarial rash on body. Not itchy. No swelling of lips, tongue, face. No difficulty breathing, vomiting, fever, irritability. Swelling from hands and feet had gone down a little and he was walking, climbing per usual.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune haemolytic anaemia, Haemoglobin decreased
Clinical narrative: About two weeks after receiving my 2nd booster, I started showing systems of Autoimmune Hemolytic Anemia; however, was not tried for this disease until July 14, 2022.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Pulmonary embolism, Pulmonary thrombosis
Clinical narrative: Pulmonary Embolism diagnosed after a CT of the heart showed clots in the lungs on 7/18/2022
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Amenorrhoea, Diarrhoea, Vaginal discharge
Clinical narrative: After the second dose in the initial series, I experienced amenorrhea for the subsequent menstrual cycle, which is extremely unusual. Instead of a normal bleeding, there was no blood and only strange gray discharge. I also experienced a strange acne-like rash on my face for months after both doses of the vaccine, which eventually faded. I also had loose stools starting after the first moderna dose that worsened after the second dose and went on for months until I started taking a probiotic. The menstrual cycle went back to normal the next month (March) and has remained normal. I have yet to get my booster. I do not take any form of birth control and never have.  I really wish that women could be given the expectation that there may be menstrual (and other) disruption as a result of these vaccines, even if temporary. This experience has made me lose confidence in these vaccines and their safety. If women could at least be told that the vax may cause hormonal/menstrual disruption, then they could at least be saved the worry and stress brought on by then wondering whether they could have a gynecological condition or be pregnant. It truly is like the vaccine makers don't care about people who menstruate or have fluctuating hormones and how they may be affected, despite the fact that this is a large segment of the population.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue
Clinical narrative: Severe chest pain and tiredness.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain, Pyrexia
Clinical narrative: Fever (around 101), chills and body aches, no energy
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood testosterone decreased, Headache, Libido decreased, Nervousness
Clinical narrative: At firs did not feel anything. But slowly my left side throat start coughing lots of thick saliva and than cough come out now and than.  Than body pain not much. I took rest and had healty diet But back of my head when i try to cough hurts.  On 22nd i felt little ok but head pain did not go way. Today morning i went for grocery i fealt little shaky and feaveris. On top i feel so so weak till now. Most impotently my libido or testosterone level went down very noticeabley which is no joke.   But day i went to get vaccine i was super healty and strong.