chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 28-APR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter.; Sender's Comments:  US-009507513-2106USA007355:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 12-MAY-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter. ; Sender's Comments:  US-009507513-2106USA007355:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 02-JUN-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter.; Sender's Comments:  US-009507513-2106USA007355:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 08-APR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter.; Sender's Comments:  US-009507513-2106USA007355:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE/PQC reported; temperature excursion on ROTATEQ/the product had been administered; This spontaneous report was received from an office manger and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 16-JUN-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1684151 has been verified to be a valid lot number, expiration date 23-JUN-2021 (formulation, strength, dose, frequency and route of administration were not reported) for prophylaxis. There was no adverse event reported.   On 16-JUN-2021, the temperature excursion was 47.8 degrees Fahrenheit for a 5 minutes. Data logger was involved. There were no previous excursions.; Sender's Comments:  US-009507513-2106USA007324:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; an expired dose of V AQT A was administered today; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/ allergies and concomitant medication were not reported.   On 29-JUN-2021 (reported as today), the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) (0.5 ml dose, lot# S037574, expiration date 10-APR-2021) intramuscularly for prophylaxis (Expired product administered). The dose was stored properly up through the time of administration. No additional adverse events reported. No product quality complaint. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S037574; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 1.92
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No reported adverse events or side effects; Expired vaccine used; This spontaneous report was received from a nurse concerning a 23 months old patient. No concurrent condition, medical history or concomitant therapy was reported.   On 29-JUN-2021, the nurse accidently administered an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot # T008698, expiration date 04-JUN-2021; at the dose of 0.5 milliliter, intramuscular) to patient for prophylaxis (expired product administered). The patient had had no reported adverse events or side effects. The nurse confirmed that administered vaccine had no previous temperature excursions.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: adverse reaction: none; pneumonia vaccine every year since 2015; Information has been received from a lawyer and an elderly female patient via a Plaintiff Fact Sheet referring to the patient. The patient was a non-smoker. Information regarding medical history, concurrent conditions and concomitant medications was not reported.  On unknown date in 2015, the patient received pneumonia vaccine (manufacturer unknown) (dose, route, lot number and expiration date were not provided) for prophylaxis. It was reported that the patient received the pneumonia vaccine (manufacturer unknown) every year since 2015 (inappropriate schedule of product administration). The patient did not experience any adverse reaction or side effects.  This is one of two cases for the same patient (link # 2012USA012896).; Sender's Comments:  US-009507513-2012USA012896:
Age: 67.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: had a flare up of his RA, his joints hurt more in his fingers and his feet; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer from (manufacturer control number US-AMGEN-USASL2021096112), license party for Manufacturer.  This serious solicited report (SL2021096112) was reported to Manufacturer on 21/JUN/2021 by a consumer from a commercial program (PSP00180) and involves a 67 years old male patient who experienced had a flare up of his ra, his joints hurt more in his fingers and his feet [rheumatoid arthritis] while receiving Enbrel. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided.The patient's co-suspect medication included Covid-19 Vaccine. The patient began Enbrel on an unknown date. On an unknown date, the patient received the COVID-19 (Coronavirus disease 2019) vaccine and had a flare up of his Rheumatoid Arthritis (RA). His joints hurt more in his fingers and his feet. No treatment information was received. The outcome of the event rheumatoid arthritis was reported as unknown. Action taken with Enbrel was reported as unknown for the event rheumatoid arthritis. The causal relationship between the event rheumatoid arthritis and Enbrel was not provided by the consumer. Follow up has been requested for lot number.  Manufacturer Comment: This individual case report does not change the safety profile of the product.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Manufacturer Causality Assessment: The event Rheumatoid arthritis flare up was unrelated to etanercept.  Pfizer is a marketing authorization holder of Covid-19 Vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Covid-19 Vaccine has submitted the same report to the regulatory authorities.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported event rheumatoid arthritis flare up and the vaccination with BNT162B2, based on the temporal association. The reported rheumatoid arthritis flare up is considered unrelated to the administration of suspect drug etanercept based on the available information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: VARZOS
Symptoms: Death, Dyspnoea, Product administered to patient of inappropriate age
Clinical narrative: He didn't wake up; short of breath; Inappropriate age at vaccine administration; This case was reported by a consumer via interactive digital media and described the occurrence of death nos in a 40-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced death nos (serious criteria death and GSK medically significant), shortness of breath and inappropriate age at vaccine administration. On an unknown date, the outcome of the death nos was fatal and the outcome of the shortness of breath and inappropriate age at vaccine administration were unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the death nos and shortness of breath to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient was 40 years old who received vaccine, which led to inappropriate age at vaccine administration. The reporter stated that, the patient became short of breath and went to bed instead of going to the hospital and did not wake up.; Reported Cause(s) of Death: Death NOS
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Tennis ball size redness / over the injection site; There is also a lump; There is also / sore / soreness at injection site; There is also / warm to the touch; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd June 2021, the patient received the 1st dose of Shingrix. In June 2021, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site lump, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site lump, injection site pain and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site lump, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient received the first dose of Shingrix 3 days ago and experienced redness about the size of a tennis ball over the injection site. There was also a lump that was sore and warm to the touch. The reactions had not recovered till the time of vaccination. The reporter would continue to watch site and contact physician if it doesn't clear up in a few more days.
Age: 14.0
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: i order for one and given for a 14 years old / administered an adult vaccine to a pediatric patient; administered an adult vaccine to a pediatric patient; This case was reported by a other health professional and described the occurrence of adult product administered to child in a 14-year-old patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional details were provided are as follows: Reporter reported that he had placed an order for the vaccine Havrix for pediatric. Havrix adult was accidentally given to 14 years old patient which led to adult product administered to child and overdose. No further details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: inching all over and i cant stop; This case was reported by a consumer and described the occurrence of generalized pruritus in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was not recovered/not resolved.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient. The patient had taken Shingrix vaccine and experiencing itching all over and patient cannot stop. The patient asked what should they do.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: shingrix was administered/after being out of range for 5 days; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the Shingrix vaccine was administered to an unspecified patient after being out of range for 5 days, which led to incorrect storage of drug. The reporter did not specify when Shingrix was administered. On 14th June 2021, the improperly stored Pneumovax 23 was administered to a patient. The reporter did call the other company manufacturer to make aware of the event. No additional adverse events was reported. N further information was provided. No product quality complaint.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: is nothing compared of the shingles/ Just got out of the shingles feel better; got the shot three days ago and have a big. Rash; still with the pain; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced shingles, rash and pain. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the rash was unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash and pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient. The age at vaccination was not reported. The patient had taken Shingles vaccine three days ago and had a big rashes but that is nothing compare of the shingles. The patient just got out of the shingles feel better still with pain and think could not went through that pain again
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Herpes zoster
Clinical narrative: two weeks later I got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Influenza vaccine Quadrivalent unspecified season. On an unknown date, 2 weeks after receiving Shingles vaccine and Influenza vaccine Quadrivalent unspecified season, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: This case was reported by patient. The age at vaccination was not reported. The patient had vaccination first came out to taken Flu shot and asked to patient had shingle shot or not. The patient had taken Shingles shot and two weeks later got the shingles.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Scar, Vaccination failure
Clinical narrative: suspected vaccination failure; got the shot. & they got shingles; He said it was very painful; left scar tissues were he got it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and scar. On an unknown date, the outcome of the vaccination failure, shingles, pain and scar were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and scar to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient got the shot and had shingles, it was very painful and it left scar tissues where he got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; still got shingles this week; This case was reported by a consumer and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In June 2021, less than 6 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's husband. The age at vaccination was not reported. The reporter stated that, the patient received Shingrix vaccine earlier this year and still got shingles at the reporting week. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I got the 1st vaccine in Nov 2019 and for got to get the 2nd one; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Therapeutic response unexpected
Clinical narrative: had a sore arm; since getting the vaccine/ has had no cold sores, but previously had them.; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores (In the 3 years since getting the vaccine the patient has had no cold sores, but previously had them).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix, the patient experienced pain in arm and unexpected therapeutic drug effect. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the unexpected therapeutic drug effect was unknown.   It was unknown if the reporter considered the pain in arm and unexpected therapeutic drug effect to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced sore arm. In the 3 years since getting the vaccine the patient has had no cold sores, but previously had them. The reporter Consented to follow up. This case had been linked to the case US2021140781, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021140781:same reporter and same patient
Age: 14.0
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 14 year old patient was given a Shingrix / errors in administration for the pediatric population; This case was reported by a other health professional via media and described the occurrence of inappropriate age at vaccine administration in a 14-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: Age at vaccination was reported. The reporter reported that a 14 year old patient was given a Shingrix shot, which led to inappropriate age at vaccine administration. The reporter was hoping to see if they have any information about errors in administration for the pediatric population.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; still have some outbreaks; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had chronic shingles).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had both doses of the shingrix after having chronic shingles. It had helped a lot, but the patient still had some outbreaks. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: was administrated  with the powder component of Menveo with sterile water; was administrated  with the powder component of Menveo with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that, the patient was administrated with the powder component of Menveo with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No other information was provided. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Incorrect dose administered, Product preparation issue
Clinical narrative: administered 2 vials of diluent; administered 2 vials of diluent.; administered 2 vials of diluent.; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 2LC3P, expiry date 15th November 2022) for prophylaxis.   On 25th June 2021, the patient received the 2nd dose of Shingrix. On 25th June 2021, unknown after receiving Shingrix, the patient experienced overdose, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the overdose, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The office manager reported that,  patient was supposed to receive his 2nd shot of Shingrix but instead they admiistered 2 vials of diluent, which led to overdose, inappropriate preparation of medication and inappropriate dose of vaccine administered. No more details reported. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 9-months female baby received HALF of Engerix-B adult dose; This case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 9-month-old female patient who received HBV (Engerix B adult) (batch number T254Z, expiry date 20th November 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (1st and 2nd dose received on an unknown date).   On 24th June 2021, the patient received the 3rd dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 24th June 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced adult product administered to child. On an unknown date, the outcome of the adult product administered to child was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows : The patient received half of dose of Engerix B adult, which led to adult product administered to child. No further information was reported. The reporter consented to follow-up by email please in order to check information with Nurse´s supervisor.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: slight dizziness; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd June 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 25th June 2021, 2 days after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was not recovered/not resolved.   The reporter considered the dizziness to be related to Shingrix.  Additional details were provided as follows:  The reporter was patient itself. The patient received Shingrix vaccine in right arm and experienced dizziness. Caller will call HCP if symptoms of dizziness gets worse. Caller does not give permission to contact health care professional. The reporter did not consent to follow up.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: received first dose f Menveo,/ 3 months later/ received a second dose of Menveo; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (received 1st dose on 24th march 2017).   On 7th June 2017, the patient received the 2nd dose of Menveo. On 7th June 2017, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: Nurse reported that patient had received first dose of Menveo. 3 months later the patient had received the second dose, which led to extra dose administered.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: swelling / at the injection site / has persisted, only decreasing slightly in size / area of swelling is about / size of a golf ball; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2021, the patient received the 1st dose of Shingrix. In April 2021, immediately after receiving Shingrix, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient. The patient received 1st dose of Shingrix in left upper arm, approximately 2 months ago from the day of reporting. The patient experienced swelling at the injection site, which began very shortly after vaccine was administered and had persisted, only decreasing slightly in size. The reporter stated that, the size of area of swelling was about he size of a golf ball and there was no pain associated with swelling, nor does it affected their arms functioning. The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was administrated with a frozen Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Herpes zoster (Shingrix) (batch number KB97C, expiry date 13th November 2022) for prophylaxis.   On 25th June 2021, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The patient was administrated with a frozen Shingrix vaccine, which led to incorrect storage of drug. The reporter stated that shingrix was frozen by mistake. No adverse event was reported. The reporter consented to follow up
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: Most people don't complain about flu like symptoms / that last more than 24 hours; Most people / referring to body aches; Most people / referring to / chills that kind of thing; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in an unspecified number patient's who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain and chills. On an unknown date, the outcome of the influenza-like symptoms, general body pain and chills were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, general body pain and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. Nurse reported that most people did not complain about flu like symptoms following Shingrix that lasted more than 24 hours. Most people got over with it in a day or so, about 24 hours.  The nurse referred to body aches, chills that kind of thing. The reporter consented to follow up.  No additional details are available. At the time they didn't even report it because we had told them what to watch out for. This case is linked with US2021AMR139399, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR139399:Same reporter. Case for: Maybe 15 people. US-GLAXOSMITHKLINE-US2021AMR139611:Same reporter. Invalid case for 1st dose.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received a 1st dose of Hiberix, Pediarix, and Rotarix on 02Jun2021 and received a 2nd dose of Hiberix, Pediarix, and Rotarix on24Jun2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 2-month-old female patient who received Hib (Hiberix) (batch number UJ437AB, expiry date 3rd May 2022) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number AZ472, expiry date 28th November 2022) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Rota (Rotarix lyophilized formulation) (batch number 5BC7N, expiry date 11th July 2022) for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   Concomitant products included Hib (Hiberix), DTPa-HBV-IPV (Pediarix) and Rota (Rotarix lyophilized formulation).   On 24th June 2021, the patient received the 2nd dose of Hiberix, the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device, the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 24th June 2021, unknown after receiving Hiberix, Pediarix, Pediarix Pre-Filled Syringe Device, Rotarix lyophilized formulation and Rotarix Oral Applicator Device and an unknown time after receiving Hiberix, Pediarix and Rotarix lyophilized formulation, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: A medical assistant had reported that a patient received a 1st dose of Hiberix, Pediarix, and Rotarix on 02 June 2021 and received a 2nd dose of Hiberix, Pediarix, and Rotarix earlier than the recomended interval, which led to drug administration interval too short. No symptoms were  reported. Reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received / first dose 2 years ago / never received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date, 2 years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist technician called to ask about Shingrix schedule if a patient received Shingrix first dose 2 years ago. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No information on the exact vaccination date of first dose was reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose was administered on 09Nov2019 / second has not been administered; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 93-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 9th November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose administered January 18, 2020 / wants to know how to proceed with the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th January 2020, about a year and half ago.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the patient wanted to proceed with 2nd dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The VAERS details were reported for 1st dose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose in May 2019/ had not yet received the second dose.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in May 2019 (a year and half before)).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The health care professional had no further information. No further events were reported. The reporter consented to follow up.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: patient received a dose of expired Pediarix.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number MG92G, expiry date 3rd May 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th June 2021, the patient received Pediarix (intramuscular) and Pediarix Pre-Filled Syringe Device. On 28th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the patient received a dose of expired Pediarix. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the 1st dose / in 2018 and is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No symptoms reported. The pharmacist did not have the exact date of vaccination for 1st dose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received dose 1 / Dec 12th 2016 / 2nd dose was not yet administered.; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th December 2016).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient called on the day of reporting to received 2nd dose. It was clarified that 2nd dose was not yet administered. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No Batch number or Expiration Date provided for 1st dose, as other health professional stated the 1st dose was administered at different facility. The VAERS details were reported for 1st dose. The reporter consented to follow up.