chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional adverse events; Caller is medical assistant reporting administered doses of improperly stored vaccines; This spontaneous report has been received from a medical assistant concerning to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, a temperature excursion occurred for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), in which the vaccine was at the following temperatures: 8.8 degrees Celsius for 1 hour and 27 minutes, 8.5 degrees Celsius for 6 hours and 39 minutes, 8.8 degrees Celsius for 8 hours and 45 minutes, 10.7 degrees Celsius for 11 hours and 42 minutes, 9.83 degrees Celsius for 18 hours and 48 minutes, 9.5 degrees Celsius for 14 hours and 10 minutes and 9 degrees Celsius for 9 hours and 24 minutes. Also a temperature excursion occurred for varicella virus vaccine live (oka/merck) (VARIVAX), which was at a temperature of -13.1 degrees Celsius for 18 minutes and -11.9 degrees Celsius for 21 minutes (both temperatures were also reported as "-14 to -10 degrees Celsius"). No previous temperature excursions were reported for any of the vaccines.  On 30-JUN-2022, the patient was vaccinated with 1 dose of one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II)  lot # U006485, expiration date 26-FEB-2023 (dose, route of administration and anatomical location were not provided) for prophylaxis and 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX)  lot # U002400, expiration date 22-JAN-2023 (dose, route of administration and anatomical location were not provided) for prophylaxis (product error). No additional events were reported (no adverse event).  This is one of multiple reports from the same reporter.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; received VARIVAX/that experienced a temperature excursion; This spontaneous report was received from a registered nurse referring to unknown patients of unknown age and gender. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 11-JUL-2022, following vaccines were administered after temperature excursion to 10.8 degree Celsius for 2 hours 27 minutes (product storage error). Names of vaccines involved: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) (lot # U011995, expiration date: 15-APR-2023, lot # U009511 expiration date: 25-MAR-2023, lot# U014656 expiration date: 07-MAY-2023, lot # U022318, expiration date: 15-JUL-2023, lot # T025930, expiration date: 30-JUL-2022, lot # U029619, expiration date: 22-SEP-2023) for prophylaxis (strength, dose and route of administration were not provided), measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot #U029319, expiration date: 19-MAR-2023, lot# U024296 expiration date 21-SEP-2023, lot# U039723 expiration date: 15-DEC-2023, lot# U015679 expiration 18-AMY-2023), varicella virus vaccine live (oka/merck) (VARIVAX) (lot #U010396, expiration date: 01-APR-2023, lot# U039723 expiration date: 15-DEC-2023, lot# U015679 expiration date: 18-MAY-2023, U024296 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX) expiration date reported as 21-SEP-2023) for prophylaxis (all vaccines strength, dose, anatomical location and route of administration were not provided). The reported was unsure how many administrations occurred and did not have individual patient information. No additional adverse event was reported (no adverse event).  This case is non-valid due to the number of patients was unspecified and lack of patients' identifiers.  Follow-up information was received from a registered nurse on 09-AUG-2022. This case was previously considered non-valid but per follow-up it was determined to be valid (there were only 3 patients who receive the vaccines). This spontaneous report refers to a 12 month old male patient. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On 13-JUL-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # U026207, expiration date 24-AUG-2023, for prophylaxis (dose and route of administration was not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot # U009511, expiration date 25-MAR-2023 (dose and route of administration was not provided) for prophylaxis, both experienced a temperature excursion. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA005428: US-009507513-2208USA004875:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; received PROQUAD/that experienced a temperature excursion; This spontaneous report was received from a registered nurse referring to unknown patients of unknown age and gender. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 11-JUL-2022, following vaccines were administered after temperature excursion to 10.8 degree Celsius for 2 hours 27 minutes (product storage error). Names of vaccines involved: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) (lot # U011995, expiration date: 15-APR-2023, lot # U009511 expiration date: 25-MAR-2023, lot# U014656 expiration date: 07-MAY-2023, lot # U022318, expiration date: 15-JUL-2023, lot # T025930, expiration date: 30-JUL-2022, lot # U029619, expiration date: 22-SEP-2023) for prophylaxis (strength, dose and route of administration were not provided), measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot #U029319, expiration date: 19-MAR-2023, lot# U024296 expiration date 21-SEP-2023, lot# U039723 expiration date: 15-DEC-2023, lot# U015679 expiration 18-AMY-2023), varicella virus vaccine live (oka/merck) (VARIVAX) (lot #U010396, expiration date: 01-APR-2023, lot# U039723 expiration date: 15-DEC-2023, lot# U015679 expiration date: 18-MAY-2023, U024296 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX) expiration date reported as 21-SEP-2023) for prophylaxis (all vaccines strength, dose, anatomical location and route of administration were not provided). The reported was unsure how many administrations occurred and did not have individual patient information. No additional adverse event was reported (no adverse event).  This case is non-valid due to the number of patients was unspecified and lack of patients' identifiers.  Follow-up information was received from a registered nurse on 09-AUG-2022. This case was previously considered non-valid but per follow-up it was determined to be valid (there were only 3 patients who receive the vaccines). This spontaneous report refers to a 4 year old male patient. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On 14-JUL-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # W004027, expiration date 02-AUG-2023, for prophylaxis (dose and route of administration was not provided) that experienced a temperature excursion. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA005428: US-009507513-2208USA004874:
Age: 5.0
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 5 years of child was given Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a 5-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 Information: GSK Receipt Date: 05-Aug-2022. Reporter's Comments: This case was reported by the parent of the patient via  interactive digital media. The 5 years old patient received Shingrix in error. Additional Supportive Information: The 5 years old patient received Shingrix in error, which led to inappropriate age at vaccine administration. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: A little sore in the arm where the shot was; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In August 2022, the patient received the 1st dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 05-Aug-2022. Reporter's Comments: This case was reported by a patient via interactive digital media. The patient had his/her first vaccine 3 days prior to the reporting. The patient received Shingles vaccine on an unknown arm. The only reaction experienced by the patient was a little sore in the arm where the shot was given.  The patient had to return in 2 to 6 months for the second dose.  The patient was very glad, he/she got it to reduce the chances of catching shingles. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: One dose and got shingles; Not planning on getting the 2 dose shot; 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 Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and had not received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-Aug-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got one dose shot 5 years ago and got shingles.  Patient was not planning to get the 2 dose shot. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of shingles vaccine, which led to incomplete course of vaccination. The follow-up could not be possible as no contact detail were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Huge itchy rash at the injection sight; Huge itchy rash at the injection sight; Extremely painful; This case was reported by a consumer via interactive digital media and described the occurrence of injection site itching 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, unknown after receiving Shingles vaccine, the patient experienced injection site itching, injection site rash and pain. On an unknown date, the outcome of the injection site itching, injection site rash and pain were unknown.   It was unknown if the reporter considered the injection site itching, injection site rash and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 6-Aug-2022 Reporter's Comments: The case was received from the patient via interactive digital media. The patient was due for his/her second shingles shot next month. The first one was extremely painful and developed a huge itchy rash at the injection sight. He/she hope this was worth it. Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Swelling
Clinical narrative: sore and a bump on my arm; a bump on my arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and local swelling. On an unknown date, the outcome of the pain in arm and local swelling were recovered/resolved.   It was unknown if the reporter considered the pain in arm and local swelling to be related to Shingles vaccine.     Additional Information: GSK receipt date: 27-Jul-2022 Reporters comment: This case was reported by the patient via interactive digital media. The patient received 2 shingles shots. The second shot was sore and a bump on his/her arm. It went away and he/she was good now. Additional Supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Recurring shingles 6-8 months post dose 2/ Suspected vaccination failure; Recurring shingles; This case was reported by a pharmacist via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and unknown 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 and Shingrix.     Additional Information: GSK Receipt Date: 04-AUG-2022 Reporter's Comments: Sales Representative submitted medical information request including information regarding recurring shingles in a patient 6 to 8 months post dose 2.  No additional details provided. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles were unknown at the time of reporting.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: administrated with an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 28-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number bm9zy, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th July 2022, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 29th July 2022, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra 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: 05-AUG-2022 Reporter's Comments: The pharmacist reported that a female patient was administrated with an expired dose of Fluarix on 29th July 2022.  The vaccine expired on 30th Jun 2022. No adverse event was reported. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Fluarix, which led to expired vaccine used.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Paraesthesia
Clinical narrative: tingling on left side of her body, underarm, side and top of breast; muscle pain on left side of her body, underarm, side and top of breast; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included covid-19 (hospitalized with COVID-19 for 11 days back in February 2022).   On 6th May 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced tingling and muscle pain. On an unknown date, the outcome of the tingling and muscle pain were unknown.   It was unknown if the reporter considered the tingling and muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-AUG-2022 Reporter's comment: The case was self reported by the patient. The patient received her dose of Shingrix and experienced tingling and muscle pain on the left side of her body and described the tingling and muscle pain to be on her underarm, side and top of her breast. The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expired Bexsero administered; This case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 30th July 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 4th August 2022, the patient received the 1st dose of Bexsero (intramuscular) .5 ml and Bexsero Pre-Filled Syringe Device. On 4th August 2022, unknown after receiving Bexsero and Bexsero 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: 05-AUG-2022 Reporter's Comments: The reporter was the patient's mother stating that the patient got his first Bexsero vaccine which was 5 days expired. The patient received Bexsero in left arm. The reporter did not report any side effects from the patient getting the expired vaccine. The reporter consented follow up. Health care professional for follow up. Additional Supportive Information: The patient received 5 days expired vaccine, which led to expired vaccine used.
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: patient received expired Bexsero; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received Men B NVS (Bexsero) 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 an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero 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: 05-Aug-2022 Reporter's comment: The Pharmacist reported patient received Bexsero that expired 5 days prior to the administration date. The administration date was not available. The healthcare professional could not provide any adverse event details. The healthcare professional consented to follow up by safety team. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Sex: U
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: received kinrix instead of boostrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 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. On an unknown date, the outcome of the wrong vaccine administered 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-Aug-2022 Reporter's comment: A nurse reported that a patient received kinrix instead of boostrix inadvertently. The reporter consented to follow up. Additional Supportive Information: The patient inadvertently received kinrix instead of boostrix, which led to wrong vaccine administered.
Age: 3.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Boostrix instead of Infanrix; 3 YO received Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7H593, expiry date 7th April 2024) for prophylaxis.   On 22nd July 2022, the patient received Boostrix. On 22nd July 2022, unknown after receiving Boostrix, 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.   Additional Information: GSK Receipt Date: 08-Aug-2022 Reporter's comments: The healthcare professional (HCP) called and stated that a male patient received Boostrix instead of the intended Infanrix. Spoke per package insert and content. The phone number for GlaxoSmithKline Medical Information given for future reference and warm transfer provided. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The 3 years old patient received Boostrix instead of the intended Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only liquid component of Menveo; administered only liquid component of Menveo; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA659A, expiry date 31st January 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, 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: 8-Aug-2022 Reporter's comment: The physician reported that a medical assistant inadvertently administered only the liquid component of Menveo to two unknown patients out of a group of a possible six patients. It was unknown which two of the group of six patients received only the liquid component.  It was confirmed that no patients only had the powder component. The reporter declined follow-up from Safety.  Additional supportive information: The patient was administered only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case is for 1 of 6 linked patients reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR116728:Same reporter US-GSK-US2022AMR116730:Same reporter US-GSK-US2022AMR116731:Same reporter US-GSK-US2022AMR116737:Same reporter US-GSK-US2022AMR116736:Same reporter
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: received only one dose August 2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received HAB (Twinrix) 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.   Previously administered products included Twinrix (received first dose in August 2021).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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-Aug-2022 Reporter's comment: A pharmacist reported that a patient received only one dose of Twinrix on August 2021. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting the patient had not received the second dose of Twinrix yet, which led to incomplete course of vaccination. This case was linked with US2022116443,reported by same reporter.; Sender's Comments:  US-GSK-US2022116443:Same repoter
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: received expired dose of Bexsero; 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 Men B NVS (Bexsero) (batch number ABXB29BA, expiry date 30th June 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 an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero 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: 08-Aug-2022 Reporter's comment: The pharmacy intern reported that a patient inadvertently received an expired dose of Bexsero on an unknown date. The healthcare professional (HCP) opted out of follow-up. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered Boostrix that expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 229AN, expiry date 5th July 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th August 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 6th August 2022, unknown after receiving Boostrix and Boostrix 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: 09-AUG-2022 Reporter's Comments: The patient received expired vaccine. No reactions reported. The reporter consented to follow up via postal. Additional Supportive Information: The patient received Boostrix which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Bexsero expired and 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 Men B NVS (Bexsero) (batch number unknown, expiry date 31st July 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 2nd August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero 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: 09-AUG-2022 Reporter's Comment: The reporter reported that the patient was administered Bexsero vaccine which was expired on 31st July 2022. The reporter consented to follow up.  Additional supportive information: The patient received a Bexsero vaccine which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix B administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number B23EA, expiry date 15th May 2022) for prophylaxis.   On 9th August 2022, the patient received Engerix B. On 9th August 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 09-AUG-2022 Reporter's comment: The pharmacist reported that the patient received Engerix-B on 9th August 2022 that had expired on 15th May 2022. The reporter did not consent to follow up. Additional Supportive Information: The patient received an expired dose of Engerix-B vaccine, which led to expired vaccine used.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: liquid vial not reconstitutied with powder vial; only liquid vial administered; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA712A, expiry date 31st May 2023) for prophylaxis.   On 9th August 2022, the patient received Menveo. On 9th August 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: 9-Aug-2022 Reporter's comment: Medical doctor reported that a patient received only the liquid vial of Menveo without reconstitution with the powder vial. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of only the liquid vial of Menveo without reconstitution with the powder vial, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 7.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 7-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB39AB, expiry date 31st July 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 1st August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st August 2022, unknown after receiving Bexsero and Bexsero 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: 9-Aug-2022 Reporter's comment: The healthcare professional (HCP )reported that on 1st August 2022 a patient received a dose of Bexsero that expired on 31st July 2022. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Antibody test abnormal, COVID-19
Clinical narrative: COVID-19 THREE TIMES; B CELL LYMPHOCYTE ANTIBODY SOMEWHAT DEFICIENT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 three times, and b cell lymphocyte antibody somewhat deficient. Laboratory data (dates unspecified) included: Antibody test somewhat deficient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the b cell lymphocyte antibody somewhat deficient and covid-19 three times was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthritis reactive
Clinical narrative: REACTIVE ARTHRITIS; This spontaneous report received from a patient via other manufacturer (Abbvie) concerned an adult female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: ankylosing spondylitis. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  The patient received non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) citrate free, frequency, and therapy dates were not reported for ankylosing spondylitis. No concomitant medications were reported.  On an unspecified date, the patient experienced reactive arthritis, difficulty in walking (duration 1 week), and some pain after physical activities (dose number in series 1). The patient received booster dose of Pfizer BioNtech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin was not reported, intramuscular, batch number: unknown, expiry: unknown) dose and start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with Pfizer BioNtech covid-19 vaccine (tozinameran) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of reactive arthritis was not reported. This report was serious (Other Medically Important Condition)
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: mild arthritis, irritable bowel, lower back pain and drug allergy (unspecified). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805031 expiry: unknown) dose was not reported, 1 total, administered on 01-APR-2021 at right arm for covid-19 prophylaxis. No concomitant medications were reported.  The patient received two doses of non-company suspect vaccine (Pfizer biontech covid-19 vaccine) tozinameran (Dose number in series 2) (form of admin, route of admin were not reported, batch number: FF 2593 expiry: UNKNOWN) dose was not reported, administered on 24-OCT-2021 at right arm and (form of admin, route of admin were not reported, batch number: FJ 4989 expiry: UNKNOWN) dose was not reported, administered on 29-APR-2022 at right arm for covid-19 prophylaxis.  On 19-JUL-2022, covid symptoms started and tested positive for COVID-19 PCR test (coronavirus disease-19 polymerase chain reaction) which led to confirmed covid-19 infection (Dose number in series 2) and hence confirmed clinical vaccination failure (Dose number in series 1).  The patient received non-company suspect drug: (Paxlovid) Nirmatrelvir/ritonavir (form of admin, route of admin were not reported, batch number: unknown and expiry: UNKNOWN) dose was not reported, therapy started from 20-JUL-2022 till 24-JUL-2022 for covid-19 treatment.  Covid symptoms greatly improved after 48 hours. Patient finished full five day course.  On 25-JUL-2022, first negative rapid test. On 28-JUL-2022, patient felt fully recovered and rapid tested negative again. On 30-JUL-2022, patient started feeling sick again. Rapid test was positive. On 03-AUG-2022 (day of reporting), patient was still sick and testing positive. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran was not applicable and with paxlovid was not reported. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0:20220820818-COVID-19 VACCINE Ad26.COV2.S- confirmed 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dysphonia, Pain, Sinus disorder
Clinical narrative: COVID-19; AWFUL BODY ACHES/PAIN; SINUS ISSUE; HOARSE VOICE; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hashimotos disease, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-JAN-2021 13:00 for covid-19 prophylaxis. Age at time of vaccination 49 years old. The batch number was not reported and has been requested. Concomitant medications included levothyroxine, omeprazole, and pramipexole.  On 30-JUL-2022, the patient experienced awful body aches/pain, sinus issue, and hoarse voice. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from awful body aches/pain, sinus issue, and hoarse voice, and the outcome of covid-19 was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received via other company (Pfizer) from a patient concerned a 32 year old of an male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes and allergy (unspecified). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, dose 1, 1 in total administered in right arm for covid-19 prophylaxis. The batch number was not reported and has been requested.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series: 1). 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, start therapy date were not reported, dose 2 administered in right arm for covid-19 prophylaxis. No concomitant medications were reported.  On an unspecified date in 2022, the patient experienced suspected covid-19 infection (Dose number in series: 2).  On 07-JUL-2022, the patient received non-company co suspect drug Paxlovid (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) dose was not reported, administered for treatment of covid-19. Paxlovid last drug administration was 12-JUL-2022. On 24-JUL-2022 after 12 days of finishing Paxlovid, the patient again had COVID symptoms (covid-19 symptoms) (Dose number in series: 2).  The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran (Moderna Covid-19 vaccine) was not applicable and with paxlovid was withdrawn. The patient was recovering from suspected covid-19 infection. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: SWEATING ON FINGERPRINTS; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2. s (Unspecified manufacturer) (Dose number in series: 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following covid-19 vaccine ad26. cov2. s (Unspecified manufacturer) (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, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sweating on fingerprints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sweating on fingerprints was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dysgeusia, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; STOMACHACHE; METALLIC TASTE IN MOUTH; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, and sulfur allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of report. The patient was other health care professional. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-OCT-2021 for covid-19 prophylaxis. Age at time of vaccination 59 years old. The batch number was not reported and has been requested. Concomitant medications included metformin hydrochloride, and pioglitazone. On 29-JUL-2022, the patient experienced stomachache, and metallic taste in mouth. On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomachache, and metallic taste in mouth, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Myalgia, Skin plaque, Vaccination site pain
Clinical narrative: Patient experienced small pops of plaque on certain areas; Second booster made her arm hurt really bad; She felt horrible with muscle aches; Fatigue extreme; This spontaneous case was reported by a patient and describes the occurrence of SKIN PLAQUE (Patient experienced small pops of plaque on certain areas), VACCINATION SITE PAIN (Second booster made her arm hurt really bad), MYALGIA (She felt horrible with muscle aches) and FATIGUE (Fatigue extreme) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included APREMILAST (OTEZLA) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN PLAQUE (Patient experienced small pops of plaque on certain areas), VACCINATION SITE PAIN (Second booster made her arm hurt really bad), MYALGIA (She felt horrible with muscle aches) and FATIGUE (Fatigue extreme). At the time of the report, SKIN PLAQUE (Patient experienced small pops of plaque on certain areas) was resolving, VACCINATION SITE PAIN (Second booster made her arm hurt really bad) outcome was unknown and MYALGIA (She felt horrible with muscle aches) and FATIGUE (Fatigue extreme) had resolved.            Concomitant drugs were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of Small pops on plaque on certain areas was a reasonable possibility.   The reporter's causality for the events of Arm hurt really bad ,Felt horrible with muscle aches and Extreme fatigue was not provided.  To treat her skin plague patient used some topical cream .    Reporter did not allow further contact