chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an expired dose of HAVRIX; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received HAV (Havrix) (batch number J95H7, expiry date May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th June 2022, the patient received Havrix (intramuscular) 1 ml and Havrix Pre-Filled Syringe Device. On 6th June 2022, unknown after receiving Havrix and Havrix 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 Information: GSK Receipt Date: 06-JUN-2022 Reporter's Comment: The reporter stated that the patient received an expired dose of Havrix . The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 30.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient was administered expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 30-year-old male patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 2nd June 2022, the patient received the 2nd dose of Havrix. On 2nd June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-Jun-2022 Reporter's Comments: The reporter was a medical assistant. The patient received an expired dose of Havrix vaccine. The reporter consented to follow up. Additional Supportive Information: The patient received expired Havrix, which led to expired vaccine used.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: administrated vaccine reconstituted with another diluent; administrated vaccine reconstituted with another diluent; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, 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 Information: GSK receipt date: 6-June-2022 Reporter's comment: The pharmacist reported that patient was administrated with Hiberix. The vaccine was reconstituted with another diluent. No adverse event was reported. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. No patient's identifiers provided. No LOT number and expiration date provided. No vaccination date provided. Additional Supportive Information: The patient was administrated with Hiberix. The vaccine was reconstituted with another diluent which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 70.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 70-year-old female patient who received HAV (Havrix) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   On 6th June 2022, the patient received the 1st dose of Havrix. On 6th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-Jun-2022 Reporter's Comments:  The patient received an expired dose of Havrix on the day of reporting. The reporter was consented to follow up. Additional Supportive Information: The patient received expired Havrix , which led to expired vaccine used.
Age: 0.75
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Administration of Kinrix to 9 month old instead of Pediarix; Administration of Kinrix to 9 month old instead of Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 9-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 06-June-2022 Reporter's comment: The health care professional reported the administration of Kinrix to 9 month old patient instead of Pediarix. The reporter consented to follow-up. Additional supportive information: The patient received dose of Kinrix instead of Pediarix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 26.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Pt received a dose without reconstitution with powder vial; Pt received a dose without reconstitution with powder vial; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 26-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA659A, expiry date 31st January 2023) for prophylaxis.   On 6th June 2022, the patient received Menveo. On 6th June 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 6-June-2022 Reporter's comment: Pharmacist reported that patient received a dose of the liquid vial of Menveo without reconstitution with powder vial. The reporter did not consent to follow-up. Additional Supportive Information: The patient received a dose of the liquid vial of Menveo without reconstitution with powder vial which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Administered a dose that was expired; Administered an adult dose to a 19 years old patient; Administered an adult dose to a 19 years old patient; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received HBV (Engerix B adult) (batch number D423N, expiry date 1st June 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th June 2022, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 6th June 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used, inappropriate age at vaccine administration and overdose. On an unknown date, the outcome of the expired vaccine used, inappropriate age at vaccine administration and overdose were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 6-June-2022 Reporter's comment: The pharmacist reported that they administered a dose of ENGERIX B adult that was expired to a patient. No other symptoms reported. The reporter consented to follow up. Additional Supportive Information: 19 Years old patient received a dose of ENGERIX B adult that was expired which led to expired vaccine used, inappropriate age at vaccine administration and overdose.
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 2 month old patient received Kinrix instead of Pediarix; 2 month old patient received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 2-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th June 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 6th June 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-JUN-2022 Reporter's Comments: Reporter was the registered nurse, who reported on behalf of patient.  The reporter reported that 2 month old patient received Kinrix instead of Pediarix. The reporter consented to follow up. Additional Supportive Information: The patient received dose of Kinrix instead of Pediarix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: U
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: has not yet received the fourth dose; Dose 1: 11/3/2021, Dose 2: 3/11/2022, Dose 3: 4/19/2022; Dose 1: 11/3/2021, Dose 2: 3/11/2022, Dose 3: 4/19/2022; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (1st dose received on 3rd November 2021). Concurrent medical conditions included peritoneal dialysis.   On 19th April 2022, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 11th March 2022, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 11th March 2022, not applicable after receiving Engerix B and Engerix B Pre-Filled Syringe Device and unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. In April 2022, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long, drug dose administration interval too long and incomplete course of vaccination were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-Jun-2022 Reporter's Comments: Nurse reported that a patient who was on peritoneal dialysis had an interruption in their Engerix-B dosing schedule.  The patient has not yet received the fourth dose.  Health care professional (HCP) declined follow-up from Safety.  No additional information was provided. Additional Supportive Information: The patient received 1st dose on 3rd November 2021, 2nd dose on 11th March 2022 and 3rd dose on 19th April 2022, later than the recommended standard schedule for both 2nd and 3rd dose, which led to lengthening of the vaccination schedule. Till the time of reporting, the patient did not receive 4th dose of Engerix B, which led to incomplete course of vaccination.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: received only half formulation of engerix; Engerix B pediatric to adult patient; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 24-year-old male patient who received HBV (Engerix B pediatric) (batch number 7574E, expiry date 29th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th June 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 6th June 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-Jun-2022 Reporter's Comments: Pharmacist reported a maladministration of engerix-b where a patient received only half formulation of Engerix-B The reporter consent to follow up. Additional Supportive Information: The adult patient received Engerix B pediatric, which led to underdose and adult use of a child product.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on 2/19/2018, second dose today; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 19th February 2018).   On 6th June 2022, the patient received the 2nd dose of Shingrix. On 6th June 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date:  06-JUN-2022 Reporter's Comments: The patient received the second dose of the Shingrix vaccine on the day of reporting. The reporter consented to follow-up Additional Supportive Information: The patient received 2nd dose of Shingrix later than recommended interval, which led to lengthening vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received dose #3; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 9Y92A, expiry date 30th June 2023) for prophylaxis.   On 2nd June 2022, the patient received the 3rd dose of Shingrix (intramuscular). On 2nd June 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 07-Jun-2022 Reporter's Comments: The reporter was a pharmacist calling on behalf of the patient.  She stated she received a call from the patient's health care professional (HCP) stating that the dose of Shingrix the patient received in left deltoid was her 3rd dose. No symptoms reported.  The pharmacist asked more specific questions on what to look for if a patient receives 3 doses of Shingrix. The reporter consented to follow up. Additional Supportive Information: The patient received 3rd dose of Shingrix, which led to extra dose administered.
Age: 2.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: received an expired dose of dtap; Inappropriate age at vaccination; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   On 31st May 2022, the patient received the 4th dose of Boostrix. On 31st May 2021, unknown after receiving Boostrix, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 07-Jun-2022 Reporter's Comments: Reported that the patient received an expired dose of dtap vaccine. The reporter consented to follow up. Additional Supportive Information: the 2 years old patient received 4th dose of Boostrix vaccine on 31st May 2022, which was already expired on 28th May 2022, which led to expired vaccine used and inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient got a third dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) (batch number 7M7E5, expiry date 26th May 2023) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 07-Jun-2022 Reporter's Comments: Pharmacist reported that a patient got a third dose of Shingrix. The vaccine administration facility was the same as primary reporter. The agent did not ask if follow up was ok. Additional Supportive Information: The patient received 3rd dose of Shingrix vaccine, which led to extra dose administered.
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: expired vaccine was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (batch number D24J7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th June 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 7th June 2022, unknown after receiving Kinrix and Kinrix 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 Information: GSK Receipt Date: 7-JUN-2022 Reporter's Comment: The reporter stated that the expired Kinrix vaccine was administered by error to a patient. The reporter did not consent to follow-up. Additional Supportive Information: The patient received a dose of Kinrix vaccine which was already expired, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received their 2nd dose 8 months later; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in 2021, 8 months before receiving 2nd dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 8-Jun-2022 Reporter's Comments:  HCP reported that patient came into pharmacy after their doctor told them that they might need to receive a 3rd dose of Shingrix because they received their 2nd dose 8 months later. No reactions reported. The reporter consented to follow up via email. Additional Supportive Information: The patient received 2nd dose of Shingrix, 8 months after receiving 1st dose, later than the recommended standard interval, which led to lengthening of the vaccination schedule.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Dose administered on 06Jun2022 but it had expired on 22May2022.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number A955S, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th June 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 6th June 2022, unknown after receiving Twinrix and Twinrix 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 Information: GSK Receipt Date: 8-Jun-2022 Reporter's Comments: Registered nurse (RN) reported a Twinrix was administered on 6th June 2022 but it had expired on 22nd May 2022. The Vaccine Administration Facility was the same as Primary Reporter. Health care professional (HCP) had no patient info at time of call. The reporter consented to follow up via email. Additional Supportive Information: The patient received dose of Twinrix which was already expired, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient receiving the 1st dose of Shingrix on 09-APR-2019 and the 2nd dose was not administered yet.; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 9th April 2019).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 8-Jun-2022 Reporter's Comments: Pharma intern reported the second dose was not administered at the time of reporting. Health care professional did not have more information. The reporter did not consent to follow up. Did not give permission to gather information for Medical information database. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper
Clinical narrative: stomachache; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd June 2022, the patient received the 1st dose of Shingrix. On 3rd June 2022, less than a day after receiving Shingrix, the patient experienced stomach pain. On an unknown date, the outcome of the stomach pain was not recovered/not resolved.   It was unknown if the reporter considered the stomach pain to be related to Shingrix.     Additional Information: GSK receipt date: 08-JUN-2022 Reporter's comment: Consumer wished to remain anonymous.  The patient experienced an on going stomachache. The reporter did not consent to follow-up.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: Bexsero administered to patient who previously had Trumenba.; This case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXC05AA, expiry date 31st March 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 8th June 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, the patient received TRUMENBA. On 8th June 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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 Information: GSK Receipt Date: 08-JUN-2022 Reporter's comment: The reporter stated that Bexsero was administered to a patient who previously had Trumenba. The reporter consented to follow up via postal. Additional Supportive Information: The patient was administered with Bexsero who previously had Trumenba which led to interchange of vaccine products.
Age: 59.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: vaccinated with an expired dose; patient  vaccinated with Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 59-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th June 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 7th June 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's Comments: The reporter called to report that the patient was vaccinated with an expired dose of Bexsero. The reporter consented to follow up. Additional Supportive Information: The patient received Bexsero at the age of 59 years which was not the recommended age, which led to inappropriate age at vaccine administration. The patient was vaccinated with an expired dose of Bexsero, which led to expired vaccine used.
Sex: U
Vaccine: HEP, HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received two pediatric doses instead of adult dose; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a adult patient who received HBV (Engerix B pediatric) (batch number HN5BE, expiry date unknown) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) (batch number HN5BE, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B pediatric, the patient experienced adult use of a child product. On an unknown date, the outcome of the adult use of a child product was unknown.   Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's comments: The Healthcare Professional was looking for an information on a patient who received two pediatric doses (lot number: HN5BE) with 18 hours of difference instead of an adult dose.  The reporter stated that this situation happened a year ago from the day of reporting. The reporter consented to follow up via email. Additional Supportive Information: The patient received 2 doses of Engerix B pediatric instead of Engerix B adult, which led to adult use of a child product.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: TEMPERATURE EXCURSION, MINIMUM TEMPERATURE WAS MINUS 0.41 DEGREES CELSIUS TO MINUS 1.46 DEGREES CELSIUS AND MAXIMUM TEMPERATURE WAS MINUS 1.99 DEGREES CELSIUS WHICH WAS BELOW MINUS 2 DEGREES CELSIUS; INCORRECT STORAGE OF VACCINE; This spontaneous report received from a consumer via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: 10-MAY-2022) dose was not reported, administered on 24-MAR-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported.  On an unspecified date, the patient experienced temperature excursion, minimum temperature was minus 0.41 degrees celsius to minus 1.46 degrees celsius and maximum temperature was minus 1.99 degrees celsius which was below minus 2 degrees celsius, and incorrect storage of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion, minimum temperature was minus 0.41 degrees celsius to minus 1.46 degrees celsius and maximum temperature was minus 1.99 degrees celsius which was below minus 2 degrees celsius and incorrect storage of vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer Inc) concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with the additional information received on 07-JUN-2022.  The patient's height, and weight were not reported. The patient's concurrent conditions included: hypercholesterolemia, and the patient had no known allergies. The patients received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date, the patient had suspected clinical vaccination failure (Dose number in series 1). The patient received second dose of non-company suspect vaccine included: Moderna covid-19 vaccine (Elasomeran) (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The patient additionally received third dose of non-company suspect vaccine included: Pfizer Biontech covid-19 vaccine (Tozinameran) (Dose number in series 3) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, administered on MAY-2022 for prophylactic vaccination. On MAY-2022, the patient experienced severe Covid symptoms (suspected covid-19 infection) (Dose number in series 3). The patient was prescribed with non-company drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered first dose on MAY-2022 and last dose on 11-MAY-2022 for treatment of COVID-19. The patient 48 hours after finishing paxlovid drug, the Covid symptoms returned and were much more severe than initial symptoms. Concomitant medications included simvastatin. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and tozinameran was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with a product quality complaint.; Sender's Comments: V0-20220606747-Covid-19 vaccine ad26.cov2.s-Suspected Clinical Vaccination Failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Arthritis, Skin exfoliation, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; SKIN PEELING; ARTHRITIS AGGRAVATED; This spontaneous report received from a patient concerned a 65 year old female of an unspecified race and ethnic origin. Initial information was processed along with additional information received on 03-JUN-2022 and 06-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. Patient did not report any relevant past medical history. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) 40 mg, 1 in every 14 days from 02-AUG-2021 to MAR-2022 for psoriatic arthritis. No concomitant medications were reported. On MAR-2022, the patient experienced skin peeling, and arthritis aggravated (Dose number in series: 1). On an unspecified date, the patient had no antibodies against covid-19 despite receiving vaccine (suspected immunological vaccination failure) (Dose number in series: 1). Laboratory data (dates unspecified) included: Antibody test Negative. On an unspecified date, patient additionally received 2 doses of elasomeran (Moderna) (Dose number in series: 2) (form of admin not reported, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with elasomeran (Moderna) (Dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s, and adalimumab was not applicable; and action taken with elasomeran was not reported. The outcome of the suspected immunological vaccination failure, skin peeling and arthritis aggravated was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint number. The suspected product quality complaint has been confirmed to be voided as the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the evaluation/investigation performed.; Sender's Comments: V0-20220607585-Covid-19 vaccine ad26.cov2.s-Suspected Immunological Vaccination Failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: metastatic breast cancer, and other pre-existing medical conditions included: Patient was non-pregnant at the time of vaccination. The patient previously experienced drug allergy when treated with rifaximine. The patient was previously treated with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: UNKNOWN) dose was not reported, 1 total, dose number 1, administered on 17-MAR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A expiry: UNKNOWN) dose was not reported, 1 total, dose number 2, administered on 21-NOV-2021 for prophylactic vaccination. Age at time of vaccination 52 years old. Concomitant medications included letrozole, and palbociclib. The patient received paxlovid (form of admin, route of admin were not reported, batch number: unknown and expiry: UNKNOWN) dose was not reported, administered from 01-MAY-2022 to 05-MAY-2022 for treatment of COVID-19. On an unspecified date in 2022, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection (dose number in series 2). Patient was getting better, including fainter and fainter positive rapid test, then had a flare up and strong positive rapid test 7 days after completing Paxlovid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000234202.; Sender's Comments: V0: 20220607763-covid-19 vaccine ad26.cov2.s-Suspected Clinical Vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a consumer via other company manufacturer (Pfizer) concerned a 49 year old female. Initial information was processed along with the additional information received from department on 06-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, migraines, and skin cancer. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: unknown) dose was not reported, 1 total administered on 03-JAN-2022 for prophylactic vaccination. Age at time of vaccination 48 years old. Concomitant medications included benzonatate, sumatriptan, and valsartan. On 20-MAY-2022, the patient started non-company suspect drug Paxlovid for treatment of COVID-19. Paxlovid was discontinued on 24-MAY-2022. On 28-MAY-2022, the patient returned to positive rapid test after four negative days. (dose number in series 2). Laboratory data included: COVID-19 rapid POC test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with Paxlovid was drug discontinued. The outcome of covid-19 was not reported. This report was non-serious. This report was associated with product quality complaint: 90000234203.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 51 year old female. Initial information was processed with the additional information received on 09-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: very low level hashimotos (not taking medication), drug allergy and other pre-existing medical conditions included: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 (corona virus disease) treatment. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 04-APR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 50 years old.  The patient received non company suspect Paxlovid (form of administration and route of administration were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered from 03-MAY-2022 to 08-MAY-2022 for treatment of COVID-19. No concomitant medications were reported.  On 13-MAY-2022 at 14:00 (Friday night), the patient had night onset of fever, runny nose, sneezing, exhaustion (after contacting virus) and experienced the events of suspected covid-19 infection and suspected clinical vaccination failure. The fever lasted for one night and all other symptoms lasted for a week.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with Paxlovid was not reported. The patient recovered from suspected covid-19 infection on 26-MAY-2022, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000234825; Sender's Comments: V0: 20220607940-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE; This spontaneous report received from a patient concerned a 42 year old male The patient's height, and weight were not reported. The patient's concurrent conditions included: IVP dye allergy (Intravenous pyelogram dye). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: Unknown) dose was not reported, 1 total administered in left arm on 08-APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series: 1). Age at time of vaccination 41 years old. The patient received non-company suspect vaccine elasomeran (Moderna Covid-19 Vaccine) (Dose number in series: 2) (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) dose was not reported, administered in left arm on 22-NOV-2021 for prophylactic vaccination. The patient received non-company suspect drug Pavloid (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) dose was not reported, administered on 05-MAY-2022 for Covid-19 treatment, therapy stopped on 07-MAY-2022. Concomitant medications included azelastine, beclometasone dipropionate, calcium carbonate, cetirizine, escitalopram, lisinopril, paracetamol and salbutamol for an unknown indication. On 24-MAY-2022, the patient tested positive (COVID-19 virus test) (Dose number in series: 2). Laboratory data included: COVID-19 virus test Positive. On an unspecified date, Laboratory data included: COVID-19 virus test Negative. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran (Moderna Covid-19 Vaccine) was not applicable and with Pavloid was discontinued. The patient was recovering from tested positive.  This report was non-serious. This report was associated with product quality complaint number: 90000234315.