chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: 10 minutes after received GARDAIL 9 a headache came on; This spontaneous report was received from a medical assistant and refers to a 11 year old female patient. No information was given reagarding the patietn's concomitant medications, concurrent conditions or medical history.  On 24-JUN-2019 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R009614, intramuscular for prophylaxis. 10 minutes after patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) a headache came on. Acetaminophen (TYLENOL) was given for treatment, however it was unknown how long the headache lasted for.  No lab diagnostics were performed, no medical attention sought or hospitalization.  The outcome of headache and the causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported in the patient; A patient received a dose of ROTATEQ on 6/25/2019 after its labeled expiration date; This spontaneous report was received from a physician concerning a male patient of an unknown age. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were not reported.   On 25-JUN-2019, the patient was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) per oral administration, lot number N030176, expiration date 17-JUN-2019 (strength, dose and frequency were not reported) for prophylaxis. The vaccine was administered after it's labeled expiration date (expired product administered).  No adverse effects were reported (no adverse event).
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Multiple patients were administered improperly stored PROQUAD. Temperature -3 C; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions/allergies, concurrent conditions and concomitant medication were not reported.      On 06-JUN-2019, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R030805, expiration date: 22-APR-2020, albumin status: rha) (dose number, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot #, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA008695: US-009507513-1906USA010324: US-009507513-1906USA010325: US-009507513-1906USA010331: US-009507513-1906USA010326: US-009507513-1906USA010327: US-009507513-1906USA010328: US-009507513-1906USA010329: US-009507513-1906USA010330: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662:
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Multiple patients were administered improperly stored PROQUAD. Temperature -3 C; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions/allergies, concurrent conditions and concomitant medication were not reported.      On 10-JUN-2019, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R030805, expiration date: 22-APR-2020, albumin status: rha) (dose number, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot #, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA010323: US-009507513-1906USA008695: US-009507513-1906USA010325: US-009507513-1906USA010326: US-009507513-1906USA010327: US-009507513-1906USA010328: US-009507513-1906USA010329: US-009507513-1906USA010330: US-009507513-1906USA010331: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662:
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Multiple patients were administered improperly stored PROQUAD. Temperature -3 C; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions/allergies, concurrent conditions and concomitant medication were not reported.      On 06-JUN-2019, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R030805, expiration date: 22-APR-2020, albumin status: rha) (dose number, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot #, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA010324: US-009507513-1906USA010323: US-009507513-1906USA008695: US-009507513-1906USA010326: US-009507513-1906USA010327: US-009507513-1906USA010328: US-009507513-1906USA010329: US-009507513-1906USA010330: US-009507513-1906USA010331: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662:
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Multiple patients were administered improperly stored PROQUAD. Temperature -3 C; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions/allergies, concurrent conditions and concomitant medication were not reported.      On 06-JUN-2019, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R030805, expiration date: 22-APR-2020, albumin status: rha) (dose number, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot #, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA010325: US-009507513-1906USA010324: US-009507513-1906USA010323: US-009507513-1906USA008695: US-009507513-1906USA010327: US-009507513-1906USA010328: US-009507513-1906USA010329: US-009507513-1906USA010331: US-009507513-1906USA010330: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662:
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Multiple patients were administered improperly stored PROQUAD. Temperature -3 C; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions/allergies, concurrent conditions and concomitant medication were not reported.      On 07-JUN-2019, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R030805, expiration date: 22-APR-2020, albumin status: rha) (dose number, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot #, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA010324: US-009507513-1906USA010325: US-009507513-1906USA010323: US-009507513-1906USA008695: US-009507513-1906USA010326: US-009507513-1906USA010328: US-009507513-1906USA010329: US-009507513-1906USA010330: US-009507513-1906USA010331: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662:
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Multiple patients were administered improperly stored PROQUAD. Temperature -3 C; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions/allergies, concurrent conditions and concomitant medication were not reported.      On 06-JUN-2019, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R030805, expiration date: 22-APR-2020, albumin status: rha) (dose number, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot #, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA010323: US-009507513-1906USA010324: US-009507513-1906USA010325: US-009507513-1906USA010327: US-009507513-1906USA008695: US-009507513-1906USA010326: US-009507513-1906USA010329: US-009507513-1906USA010330: US-009507513-1906USA010331: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Multiple patients were administered improperly stored PROQUAD. Temperature -3 C; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions/allergies, concurrent conditions and concomitant medication were not reported.      On 12-JUN-2019, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R030805, expiration date: 22-APR-2020, albumin status: rha) (dose number, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot #, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA010323: US-009507513-1906USA010324: US-009507513-1906USA010325: US-009507513-1906USA010328: US-009507513-1906USA010327: US-009507513-1906USA008695: US-009507513-1906USA010326: US-009507513-1906USA010330: US-009507513-1906USA010331: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662:
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Multiple patients were administered improperly stored PROQUAD. Temperature -3 C; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions/allergies, concurrent conditions and concomitant medication were not reported.      On 12-JUN-2019, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R030805, expiration date: 22-APR-2020, albumin status: rha) (dose number, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot #, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA010323: US-009507513-1906USA010324: US-009507513-1906USA010325: US-009507513-1906USA010328: US-009507513-1906USA010329: US-009507513-1906USA010327: US-009507513-1906USA008695: US-009507513-1906USA010326: US-009507513-1906USA010331: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662:
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Multiple patients were administered improperly stored PROQUAD. Temperature -3 C; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions/allergies, concurrent conditions and concomitant medication were not reported.      On 10-JUN-2019, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R030805, expiration date: 22-APR-2020, albumin status: rha) (dose number, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot #, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA010323: US-009507513-1906USA010324: US-009507513-1906USA010325: US-009507513-1906USA010330: US-009507513-1906USA010328: US-009507513-1906USA010329: US-009507513-1906USA010327: US-009507513-1906USA008695: US-009507513-1906USA010326: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Injection site reaction; Injection site swelling; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's age group was not reported but captured as adult as per vaccine indication. The patient experienced these injection site reaction having severity grade 3. The events were ongoing.
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Intensive care, Pertussis
Clinical narrative: whooping cough; This case was reported by a consumer via interactive digital media and described the occurrence of whooping cough in a female patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, immediately after receiving DTPa vaccine, the patient experienced whooping cough (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the whooping cough was unknown.   It was unknown if the reporter considered the whooping cough to be related to DTPa vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient expereinced whooping cough right after receiving infanrix. The patient was in intensive care unit for days.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The pharmacist stated that the patient complained of fever after receiving the first dose of the vaccine. It was reported that in spite of having a fever, the patient came back and got the 2nd dose.  The pharmacist recommended Tylenol immediately before receiving the 2nd dose. No patient demographics were provided. This case has been linked with the case US2019109631, reported by same reporter.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Rash, Rash pruritic
Clinical narrative: itchy rash on face; felt cold; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th June 2019, the patient received Shingrix (intramuscular). On 11th June 2019, 1 days after receiving Shingrix, the patient experienced feeling cold. On 15th June 2019, the patient experienced itchy rash. On an unknown date, the outcome of the feeling cold was recovered/resolved and the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the feeling cold and itchy rash to be related to Shingrix.  Additional details were provided as follows: The next day of vaccination, the patient felt very cold even though it was a warm day. Five days after receiving Shingrix, the patient developed an itchy rash on her face. The reporter consented to follow up
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. No patient demographics were provided. The pharmacist stated that the patient complained of fever after receiving the dose of the Shingrix vaccine. It was reported that in spite of having a fever, the patient came back and got the 2nd dose.  The pharmacist recommended Tylenol immediately before receiving the 2nd dose. This case has been linked with the case US2019AMR113675, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: injection site swelling; injection site redness; flu-like symptoms; This case was reported by a other health professional via sales rep and described the occurrence of extensive swelling of vaccinated limb in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema and influenza like illness. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and influenza like illness were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and influenza like illness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix and experienced redness, swelling around the injection sites which was 4 to 5 inches. The patient also had flu like symptoms. The reporter did not have the patient identifiers or batch number and expiry date of Shingrix.
Age: 67.0
Sex: F
Vaccine: MENB
Symptoms: Aggression, Dizziness, Expired product administered, Gait inability, Hyperhidrosis
Clinical narrative: Incorrect storage of drug; dizzy; sweaty; couldnt walk; violent reaction; expired vaccine administered; This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 67-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA32AA, expiry date unknown) for prophylaxis.   On 17th June 2019, the patient received Bexsero. On 17th June 2019, unknown after receiving Bexsero, the patient experienced expired vaccine used. On 18th June 2019, the patient experienced dizziness, sweating, unable to walk and violent behavior. On an unknown date, the patient experienced incorrect storage of drug. On 19th June 2019, the outcome of the dizziness, sweating, unable to walk and violent behavior were recovered/resolved. On an unknown date, the outcome of the expired vaccine used and incorrect storage of drug were unknown.   It was unknown if the reporter considered the dizziness, sweating, unable to walk and violent behavior to be related to Bexsero.  Additional details were provided as follows: The pharmacist stated that a patient picked up Bexsero from the pharmacy, and stored the Bexsero at room temperature at home. The patient received the Bexsero at a doctor's office, and this was after the Bexsero was out of range for 72 hours, which led to incorrect storage of drug. One day after vaccination, the patient experienced significant dizziness while standing, and couldn't walk due to this. The patient also felt sweaty and violent reaction. This was early in the morning the day after receiving the vaccine, and the patient felt better by the next day. The reporter did not consent to follow-up. Follow-up was declined.
Age: 67.0
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Incorrect storage of drug; dizzy; sweaty; couldnt walk; violent reaction; expired vaccine administered; This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 67-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA32AA, expiry date unknown) for prophylaxis.   On 17th June 2019, the patient received Bexsero. On 17th June 2019, unknown after receiving Bexsero, the patient experienced expired vaccine used. On 18th June 2019, the patient experienced dizziness, sweating, unable to walk and violent behavior. On an unknown date, the patient experienced incorrect storage of drug. On 19th June 2019, the outcome of the dizziness, sweating, unable to walk and violent behavior were recovered/resolved. On an unknown date, the outcome of the expired vaccine used and incorrect storage of drug were unknown.   It was unknown if the reporter considered the dizziness, sweating, unable to walk and violent behavior to be related to Bexsero.  Additional details were provided as follows: The pharmacist stated that a patient picked up Bexsero from the pharmacy, and stored the Bexsero at room temperature at home. The patient received the Bexsero at a doctor's office, and this was after the Bexsero was out of range for 72 hours, which led to incorrect storage of drug. One day after vaccination, the patient experienced significant dizziness while standing, and couldn't walk due to this. The patient also felt sweaty and violent reaction. This was early in the morning the day after receiving the vaccine, and the patient felt better by the next day. The reporter did not consent to follow-up. Follow-up was declined.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: tenderness at injection site; redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number CA374, expiry date 28th June 2021) for prophylaxis.   On 17th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 17th June 2019, several hours after receiving Shingrix, the patient experienced injection site tenderness and injection site erythema. On an unknown date, the outcome of the injection site tenderness and injection site erythema were unknown.   It was unknown if the reporter considered the injection site tenderness and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in the left arm. Several unspecified hours later receiving the 2nd dose of Shingrix, the patient experienced tenderness and redness emanating from the injection site. The size of the redness was described as 4 inches by 2 inches wide. The reporter did not wish to provide greater detail for patient number as she was busy and in a hurry. The reporter consented to follow up. The information was reported as per the pharmacist's words with no elaboration. This case has been linked to case US2019111404, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Lethargy
Clinical narrative: Lethargic; This case was reported by a pharmacist via call center representative and described the occurrence of lethargy in an unspecified number of adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced lethargy. On an unknown date, the outcome of the lethargy was recovered/resolved.   It was unknown if the reporter considered the lethargy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient's age group was not reported but captured as adult as per vaccine indication. The reporter mentioned that, there were many patients who received Shingrix and reported feeling lethargic for over 48 hours. Then on the third day, the patient's felt fine like nothing had happened. No additional details were provided.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: expired dose of Adacel vaccine administered inadvertently; Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked with 2019SA172512 (same reporter).  This case involves a male patient of an unknown age, who received an expired 0.5 ml dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [Adacel] lot number, expiry date: 02-May-2019,  not reported route unknown in the left deltoid on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   It was an actual medication error case due to expired vaccine used.  It was not reported whether the patient had any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: expired dose of Adacel vaccine administered inadvertently; Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA172505 (same reporter).  This case involves a female patient of unknown age who was vaccinated inadvertently with a 0.5ml expired dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Exp. Date 02-MAY-2019) lot number not reported via unknown route in the left deltoid on an unknown date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: administering the ActHIB twice to the patient that received the correct diluent; received the incorrect diluent; Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2019SA172523.  This case involves a 6 months old female patient received the incorrect diluent of third dose of HIB (PRP/T) VACCINE [ACT-HIB] on 21-Jun-2019 intramuscularly in right thigh (LOT: UI973AA, exp: 04-April-2020,)and administering the ACTHIB twice as first dose an second dose both intramuscularly in right thigh on 31-Jan-2019  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (Pediarix) for Immunisation; pneumococcal vaccine conj 7v (crm197) (Prevnar) for Immunisation; and rotavirus vaccine live reassort oral 5v (Rotateq) for Immunisation.  It was an actual medication error due to Wrong solution used in drug reconstitution and overdose.  It was unknown whether patient experienced any adverse reaction after the injection.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.; Sender's Comments: It is not possible to state which of these entered medication error scenarios belong to each of these patients. A physician reporting having 2-patients received the ActHIB injection on the same day and one received the correct diluent and one-patient that received the incorrect diluent. The physician does not know which patient was given the correct or incorrect diluent. The physician only reported that the staff uses diluents that are stocked separately in the clinic with the ActHIB and as per the inventory, the wrong number of diluents are missing if a dose was to have been given correctly.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patients were accidentally given the Daptacel and Ipol liquid portions only and not given the ActHIB powder portions of the Pentacel injection/No AE; Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA172656 same reporter.  This case involves 4 years male patient who received only liquid portions of the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ082AA, expiry date-13-Oct-2020 via intramuscular route in the left deltoid on 30-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and AESCULUS HIPPOCASTANUM (VARIVAX [AESCULUS HIPPOCASTANUM]) for Immunisation.  It was a case of actual medication error due to inappropriate reconstitution technique. Nurse reported that patients were accidentally given the Daptacel and Ipol liquid portions only and not given the ActHIB powder portions of the Pentacel injection.  No AE reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: receiving Daptacel with short expiration dates (4 months out upon receipt); Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked with AER# 2019SA172658 and 2019SA172657  This case involves unknown age and gender of patient who received expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Daptacel] lot C5190AA (expiration dates (4 months out upon receipt) in an unknown route on 25-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  It was an actual medication error case due to expired vaccine used.  It was not reported whether the patient had any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was accidentally given the Daptacel and Ipol liquid portions only and not given the ActHIB powder portions of the Pentacel injection/ no AE; Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA172647 (same reporter).  This case involves a 8 weeks old female patient who experienced patient was accidentally given the DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and IPV (VERO) [IPOL] liquid portions only and not given the ACTHIB powder portions of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine (lot UJ082AA, expiry date 13-Oct-2020) via intramuscular route in the right thigh on 28-May-2019.  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.   It was an actual medication error due to inappropriate reconstitution technique.  It was reported that patient was accidentally given the Daptacel and Ipol liquid portions only and not given the ActHIB powder portions of the Pentacel injection.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Physician receiving Daptacel with short expiration dates (4 months out upon receipt), patient had received expired Daptacel because of this; Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.  This case linked with AER# 2019SA172651 and 2019SA172658 (same reporter).  This case involves a patient of an unknown age and gender who received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Daptacel] lot C5190AA (expiration dates (4 months out upon receipt) in an unknown route on 14-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  It was an actual medication error case due to expired vaccine used. Physician stated that he had been receiving Daptacel with short expiration dates (4 months out upon receipt). He stated that this was unacceptable. He added that 3 separate patients have received expired Daptacel because of this.  It was not reported whether the patient had any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Daptacel with short expiration dates (4 months out upon receipt)/no AE; Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2019SA172657 and 2019SA172651.  This case involves a patient of unknown demography who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and reported that Daptacel with short expiration dates (4 months out upon receipt)/no AE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 17-Jun-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5190AA and expiry date: 24-Apr-2019 via unknown route in unknown administration site.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: male received a booster dose of Menactra  SC instead of IM in the Right arm, no advesre event; Initial information received on 24-Jun-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 22 years old male patient who was vaccinated with a 0.5 ml dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] )(lot U6016AA and Exp. Date 19-OCT-2019) via subcutaneous route instead of intramuscular route in the right arm on 24-Jun-2019.  The patient's medical history was not reported and concomitant medications included HPV VACCINE VLP RL1 9V (YEAST) (HPV VACCINE VLP RL1 9V (YEAST)) in the Left Deltoid for Immunisation.  It was an actual medication error case due to inappropriate route of vaccination.  No initial side effects reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema, Pruritus, Skin warm
Clinical narrative: Erythema, itch, edema, warmth
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Urticaria
Clinical narrative: Painful and red when she got home so she applied ice off and on and then at about 6/7pm she broke out she then was extremely itchy and came up with hives that were painful she then took an antihistamine which helped but as soon as it wore off it would come back as well as Cortizone Cream, Ibuprofen and Bengay for relief it finally seemed to go away as of today 6/24/2019.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Blood creatine phosphokinase, Chest X-ray, Chest discomfort, Electrocardiogram, Eyelid sensory disorder
Clinical narrative: Redness and swelling at injection site, noticed next morning. Patient described tingling and numbness down her arm and up neck. She was taken to local ED just over 24 hours after vaccination due to feeling of chest tightness and some wheezing, also had low grade fever of 100.4-100.6 F. Also, c/o sensitive feeling to eyelids.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Full blood count, Human chorionic gonadotropin, Hypoaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site, noticed next morning. Patient described tingling and numbness down her arm and up neck. She was taken to local ED just over 24 hours after vaccination due to feeling of chest tightness and some wheezing, also had low grade fever of 100.4-100.6 F. Also, c/o sensitive feeling to eyelids.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Metabolic function test, Paraesthesia, Pyrexia, Troponin I, Wheezing
Clinical narrative: Redness and swelling at injection site, noticed next morning. Patient described tingling and numbness down her arm and up neck. She was taken to local ED just over 24 hours after vaccination due to feeling of chest tightness and some wheezing, also had low grade fever of 100.4-100.6 F. Also, c/o sensitive feeling to eyelids.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Induration, Rash erythematous
Clinical narrative: Per parent report: round, red erythematous rash, appearing indurated, about 7-8 cm in diameter appearing 24-48 hrs post injection.  Resolved once seen in our office on 06/03/2019.