chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: liquid adjuvant only used; administered liquid adjuvant only; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2022, the patient received Shingrix. On 11th November 2022, unknown after receiving Shingrix, 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: 14 NOV 2022 Reporter's comment: Pharmacist called to inquire how to proceed. Should the patient be revaccinated. Reported they inadvertently administered the Shingrix liquid adjuvant component only without the lyophilized powder to a patient. The pharmacist confirmed vaccine was administered in their facility.  Additional supportive information: Reported they inadvertently administered the Shingrix liquid adjuvant component only without the lyophilized powder to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose until 06Aug2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received first dose of Shingrix series on 15th October 2018).   On 6th August 2022, the patient received the 2nd dose of Shingrix. On 6th August 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: 14-Nov-2022. Reporter's Comment: The reporter stated patient did not get second dose until 6th August 2022.   The reporter did not have the lot number /expiration date information for either dose. Consented to follow up. Reporter gave permission for follow-up. Additional supportive Information: The patient did not get second dose until 6th August 2022, which led to drug dose administration interval too long.
Age: 67.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Apr2022, 2nd 14nov2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) 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 1st dose in April 2022).   On 14th November 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 14th November 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, 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.   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: 14 NOV 2022 Reporter's comment:  A pharmacist reported that the patient received late 2nd dose. The reporter consented to follow up. Additional supportive information: The patient received 2nd dose later than the recommended interval, which led to drug dose administration interval too long.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Sep2021, 2nd never; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2021 batch number 75BA4 and expiry date 5th February 2023).   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: 14 NOV 2022 Reporter's comment: The reporter stated that the patient had the first dose of Shingrix in September 2021, but never received the second dose of Shingrix. The patient stated that plans to get the second dose at the beginning of the new year. Additional supportive information. Till the time of reporting the patient did not received the second dose of Shingrix which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Oct2019, 2nd 14Nov2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In October 2019, received 1st dose). Concomitant products included INFLUENZA VACCINE.   On 14th November 2022, the patient received the 2nd dose of Shingrix. On 14th November 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: 14 NOV 2022 Reporter's comment: The patient had received the second dose of the Shingrix on the day of reporting. The patient also got flu shot that day in the opposite arm.  No other information was reported to the agent by the patient. The reporter did not consent to follow-up. Additional supportive information: The patient did not receive 2 doses of Shingrix within the recommended interval which led to lengthening of vaccination schedule. The Flu shot was administered on the same day as Shingrix, however it was not captured as co-suspect and was captured as agency since the case was reported for medication error for Shingrix only. No follow up attempts possible as no contact information available. The case US2022168165 was identified as duplicate of US2022AMR169180. The case US2022AMR169180 would be voided, and all the future correspondence would be added in this case US2022168165 which stands as a case of record for this patient.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: 2 adjuvant alone was mixed; adjuvant only administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 83-year-old female patient who received Herpes zoster (Shingrix) (batch number B2C9F, expiry date 11th February 2024) for prophylaxis.   On 14th November 2022, the patient received Shingrix. On 14th November 2022, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 14 NOV 2022 Reporter's comment: The reporter stated that the patient received 2 Shingrix adjuvant alone was mixed and administered to the one patient. The vaccine administration facility was the same as primary reporter. Reporter consented to follow up. Additional supportive information: As the patient received 2 Shingrix adjuvant alone, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2021, has not received dose 2; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th July 2021).   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: 14-Nov-2022 Reporter's comment: The patient has not yet received dose 2 of Shingrix. No birth date or age available at time of call and no further details were provided.  The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete curse of vaccination.
Age: 0.75
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 9 month old received Kinrix; Kinrix administered instead of Pediarix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old male patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 14th November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 14-Nov-2022. Reporter's Comment:  The reporter stated that a patient was inadvertently administered a Kinrix dose today in their facility 20 minutes ago on the day of reporting in the right thigh.  The reporter also mentioned they meant to grab Pediarix but instead grabbed the Kinrix. Consented to follow up was granted. Additional Supportive Information: A 9 year old patient received Kinrix, which led to inappropriate age at vaccine administration. HCP stated they meant to grab Pediarix but instead grabbed the Kinrix, which led to wrong vaccine administered.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered
Clinical narrative: Did not receive the full dose; Vaccine dripped on patient's arm; Vaccine dripped on patient's arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 38-year-old female patient who received Flu Seasonal QIV(FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th November 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 14th November 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine 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: 14-Nov-2022 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: During administration of Flulaval, vaccine dripped on patient's arm and the patient did not receive the full dose of vaccine, which led to incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine.
Age: 71.0
Sex: F
Vaccine: HEPA
Symptoms: Back pain, Expired product administered, Pain
Clinical narrative: Back and flint pain; flint pain; Patient received a dose of expired Havrix; This case was reported by a nurse via call center representative and described the occurrence of back pain in a female patient who received HAV (Havrix) (batch number 3F349, expiry date 9th August 2022) for prophylaxis.   On 22nd September 2022, the patient received the 1st dose of Havrix. In September 2022, 3 days after receiving Havrix, the patient experienced back pain, general body pain and expired vaccine used. On an unknown date, the outcome of the back pain, general body pain and expired vaccine used were unknown.   It was unknown if the reporter considered the back pain and general body pain to be related to Havrix.     Linked case(s) involving the same patient:  US2022169287   Additional Information: GSK Receipt Date: 14-NOV-2022 Reporter's comments: A nurse had reported that a female patient had received a dose of expired Havrix which was expired on 09 August 2022. The nurse had called back to report that the patient had to visit the emergency room 3 days after receiving expired Havrix as she had developed back and flint pain and believes it was from the vaccine. The reporter had consent to follow up.  Additional supportive information: The patient had received an expired dose of Havrix, which had led to expired vaccine used. This case was linked with US2022169287 which was reported by same reporter.; Sender's Comments:  US-GSK-US2022168179:Same reporter. US-GSK-US2022169287:Same reporter
Age: 52.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received a NOT reconstituted vaccine/ Without the Lyophilized Antigen Component; Got a NOT reconstituted vx. Repeat dose given 47 mins later; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 52-year-old patient who received Herpes zoster (Shingrix) (batch number PY3BT, expiry date 25th September 2023) for prophylaxis.   On 11th November 2022, the patient received the 1st dose of Shingrix. On 11th November 2022, unknown after receiving Shingrix, 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: 14-NOV-2022 Reporter's comments: The nurse had reported that, a patient with unknown gender had received a Shingrix vaccine which was not reconstituted with the lyophilized antigen component and 47 minutes later the patient was vaccinated with a reconstituted Shingrix vaccine.  It was the same lot number an expiration date administered. The reporter had consent to follow up by email. Additional supportive information: The patient had received a Shingrix vaccine which was not reconstituted with the lyophilized antigen component, which had led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Received Boostrix instead of Flu vaccine; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9ZK5T, expiry date 7th October 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th November 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 8th November 2022, unknown after receiving Boostrix and Boostrix 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: 14-NOV-2022 Reporters comment: The medical assistant reported that a colleague received a dose of Boostrix instead of an unnamed flu vaccine, and wished to know how to proceed, initials, and gender were given for the patient, but specific age was withheld.  The vaccine administration facility was the same as primary reporter The reporter consent to follow-up. Additional Supportive information:The patient received Boostrix instead of an unnamed flu vaccine, which led to wrong vaccine administered. This case has been linked to the cases US2022168196 and US2022168201 reported by the same reporter.; Sender's Comments:  US-GSK-US2022168201:Same reporter US-GSK-US2022168196:Same reporter
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: was administered only the diluent; was administered only the diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a child female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30th April 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: 14-NOV-2022 Reporters comment: The health care professional reported that after vaccination of 5 patients they became aware one of them was administered only the diluent of menveo without the lyophilized part but did not know which patient was. The reporter consent to follow-up by email. This case was for 2 of 5 linked patients, reported by same reporter. Additional Supportive information: The patient received the menveo vaccine before reconstitution with only the diluent portion which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022168204:same reporter US-GSK-US2022168209:same reporter US-GSK-US2022168210:same reporter US-GSK-US2022168199:same reporter
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only liquid portion was administered.; Only liquid portion was administered.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30th April 2023) for prophylaxis.   On 10th August 2022, the patient received Menveo. On 10th 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: 14-NOV-2022 Reporters comment: The health care professional reported that after vaccination of 5 patients they became aware one of them was administered only the diluent of menveo without the lyophilized part but did not know which patient was. The reporter consent to follow-up by email. This case was for 3 of 5 linked patients, reported by same reporter. Additional Supportive information: The patient received the menveo vaccine before reconstitution with only the diluent portion which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022168203:same reporter US-GSK-US2022168199:same reporter US-GSK-US2022168210:same reporter US-GSK-US2022168209:same reporter
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered
Clinical narrative: Only liquid portion was administered.; Only liquid portion was administered.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30th April 2023) for prophylaxis.   On 16th August 2022, the patient received Menveo. On 16th 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: 14-NOV-2022 Reporters comment: The health care professional reported that after vaccination of 5 patients they became aware one of them was administered only the diluent of menveo without the lyophilized part but did not know which patient was. The reporter consent to follow-up by email. This case was for 4 of 5 linked patients, reported by same reporter. Additional Supportive information: The patient received the menveo vaccine before reconstitution with only the diluent portion which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022168203:same reporter US-GSK-US2022168204:same reporter US-GSK-US2022168210:same reporter US-GSK-US2022168199:same reporter
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only liquid portion was administered.; Only liquid portion was administered.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30th April 2023) for prophylaxis.   On 24th August 2022, the patient received Menveo. On 24th 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: 14-NOV-2022 Reporters comment: The health care professional reported that after vaccination of 5 patients they became aware one of them was administered only the diluent of menveo without the lyophilized part but did not know which patient was. The reporter consent to follow-up by email. This case was for 5 of 5 linked patients, reported by same reporter. Additional Supportive information: The patient received the menveo vaccine before reconstitution with only the diluent portion which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022168209:same reporter US-GSK-US2022168203:same reporter US-GSK-US2022168204:same reporter US-GSK-US2022168199:same reporter
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: received Boostrix instead of Flu vaccine; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9ZK5T, expiry date 7th October 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th November 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 14th November 2022, unknown after receiving Boostrix and Boostrix 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: 14-NOV-2022 Reporters comment: The medical assistant reported that a colleague received a dose of Boostrix instead of an unnamed flu vaccine, and wished to know how to proceed, initials, and gender were given for the patient, but specific age was withheld.  The vaccine administration facility was the same as primary reporter The reporter consent to follow-up. Additional Supportive information:The patient received Boostrix instead of an unnamed flu vaccine, which led to wrong vaccine administered. This case has been linked to the cases US2022168196 and US2022168197reported by the same reporter .; Sender's Comments:  US-GSK-US2022168196:same reporter US-GSK-US2022168197:same reporter
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient received the Rotarix diluent only; patient received the Rotarix diluent only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 789CH, expiry date 8th July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 14th November 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 14th November 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, 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.   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: 14-NOV-2022 Reporters comment: The nurse reported that infant received the Rotarix diluent only.  The lot number and expiry were for the diluent that was administered. The reporter consent to follow-up. Additional Supportive information: The patient received the Rotarix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: received 2 doses, one month apart; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 32-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number X4G4C, expiry date 30th November 2024) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 14th November 2022, the patient received the 2nd dose of Boostrix. On 14th November 2022, unknown after receiving Boostrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 14-Nov-2022 Reporter's comment: No symptoms was reported. The reporter consented to follow-up. Additional supportive information: The patient accidentally received 2nd dose of Boostrix, which led to extra dose administered.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number ZY9MJ, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th November 2022, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On 14th November 2022, unknown after receiving FluLaval Tetra 2020-2021 season and Flulaval 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: 14-Nov-2022 Reporter's comment: The reporter asked if the patient had to be re-vaccinated. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Flulaval, which led to expired vaccine used. Suspect was coded as Flulaval tetra 2020-2021 season as both Flualval tetra and Flulaval quadrivalent both are same in terms of active ingredient and also considering the expiration date.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: pediatric dose was given to an adult; pediatric dose was given to an adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 46-year-old female patient who received HBV (Engerix B pediatric) (batch number 97KT7, expiry date 15th March 2024) for prophylaxis.   On 15th November 2022, the patient received Engerix B pediatric. On 15th November 2022, unknown after receiving Engerix B pediatric, 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.   Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comment: health care professional (HCP) called and stated that a pediatric dose was given to an adult patient.  Adverse event (AE) filed. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: the adult patient received Engerix B pediatric dose, which led to underdose and adult use of a child product.
Sex: M
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: Bexsero 1st dose, then as 2nd Trumemba; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products 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 and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   In October 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 14th November 2022, the patient received TRUMENBA. On 14th November 2022, an unknown time 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.   It was unknown if the reporter considered the interchange of vaccine products to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 15-Nov-2022 Reporter's Comment: Nurse Practitioner reported a male patient received first dose of Bexsero a month ago and came in 14th November 2022 for second dose but was administered Trumenba instead.  At the time of reporting the electronic medical record was not available for the Nurse Practitioner, so the reporter did not have the patient's age and date of birth.  However, she stated the patient was at least 16 years of age.  Reporter did not have the vaccine lot number or expiration date information. Additional Supportive Information: the patient received Trumenba vaccine instead of Bexsero, which led to Interchange of vaccine products.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: Unsure  if patient got full dose, Needle broke and some dose leaked; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number YA29D, expiry date 6th October 2023) for prophylaxis.   On 15th November 2022, the patient received the 2nd dose of Shingrix. On 15th November 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Linked case(s) involving the same patient:  US2022169285   Additional Information: GSK Receipt Date: 15-Nov-2022 Reporter's Comment: The patient had received the second dose of the shingrix vaccine, but during the application, the needle broke off and some of the dose leaked.  They relayed information that referred to the vaccine and basic patient information for report, but while medical information was being disclosed, she asked if help was actually going to be given before hanging up.  Consented to follow up. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: the patient received Shingrix vaccine and some of dose leaked, which led to incomplete dose administered.; Sender's Comments:  US-GSK-US2022169285:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 23-Oct-2019, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 23rd October 2019) and Zostavax (dose received on an unknown date).   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: 17-NOV-2022 Reporter's Comment: The reporter was the patient.   Reporter did not want to give her date of birth however she did indicate that she was over the age of 65. She received Shingrix 1st shot.  She had no record of receiving Shingrix 2nd shot. Did not consent to follow-up. 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: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Vaccine administered without reconstitution; Vaccine administered without reconstitution; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2022, the patient received Shingrix. In November 2022, unknown after receiving Shingrix, 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: 18-NOV-2022 Reporter's comment: The nurse reported that they had a staff member only gave the patient this part of the vaccine without reconstituting it. The nurse stated he/she need the lot number to figure out which patient it happened to. Sometime between 7th November 2022 and 11th November 2022. No additional data was available. The reporter consented to follow-up. Additional Supportive Information: The patient received dose Shingrix vaccine without reconstituting it, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ALL THESE ISSUES THAT I HAVE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 all these issues that i have. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of all these issues that i have was not reported. This report was non-serious. This case, from the same reporter is linked to 20221147999.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: THUMPING IN LEFT EAR; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced thumping in left ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from thumping in left ear. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death, Thrombosis
Clinical narrative: DIED; BLOOD CLOT; This spontaneous report received from a consumer via a company representative via social media (J&J corporate) concerned a male 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 was not reported, and batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date 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, after vaccination, the patient got a blood clot and died the next day. The date of death and cause of death was not reported. It was unknown if an autopsy was performed or not. It was reported that "Patient, my family Dr. got a blood clot after getting the shot. He died the next day". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20221148772-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable. 20221148772- Blood clot. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the RA Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 86.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SLIGHTLY SORE ARM BY THE INJECTION SITE; This spontaneous report received from a patient via a company representative via social media. concerned a 9 decade old of unspecified sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. On an unspecified date, the patient was previously vaccinated with of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, for covid-19 prophylaxis. Age at time of vaccination 85 years old. The patient did not have a problem with covid-19 vaccine ad26.cov2.s (Dose number in series 1). Ten months later the patient additionally 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, 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 86 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced slightly sore arm by the injection site (Dose number in series 2).  As per the reporter, "I had my Covid shot and did not have a problem. I was going on a cruise and opted to have a 2nd J&J Covid shot as a booster 10 months later. The only reaction I had was a slightly sore arm by the injection site. I was 85 the first shot and 86 for the second shot. The reason I opted for J&J was because I worked for them when they were working on a cure for AIDS and I had first hand knowledge of how they researched and tested for a safe answer." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slightly sore arm by the injection site was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Developed Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Developed Covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2022, the patient experienced COVID-19 (Developed Covid). At the time of the report, COVID-19 (Developed Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. It was reported that patient already had original shots and two boosters. The patient developed Covid back in July of 2022 and still going through some symptoms. The patient still could not taste. No treatment medication were provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: in a wheel chair due to Guillian Barre syndrome; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (in a wheel chair due to Guillian Barre syndrome) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (in a wheel chair due to Guillian Barre syndrome) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (in a wheel chair due to Guillian Barre syndrome) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant drug was reported. Reporter mentioned having acquaintances who had the beginning shots of Moderna vaccine that experienced neurologic consequences to that. Reporter further mentioned that patient was her neighbor, who was now in a wheel chair due to Guillian Barre. No treatment drug was reported.  Company comment: This is a spontaneous case concerning a adult female patient with no reported medical and vaccination history. The patient experienced the unexpected serious (medically significant) AESI event of Guillain-Barre Syndrome. The event's exact occurrence was unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. Allegedly the event was described as, the patient is on the wheelchair due to Guillian Barre syndrome. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-675058 (Linked Report).; Sender's Comments: This is a spontaneous case concerning a adult female patient with no reported medical and vaccination history. The patient experienced the unexpected serious (medically significant) AESI event of Guillain-Barre Syndrome. The event's exact occurrence was unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. Allegedly the event was described as, the patient is on the wheelchair due to Guillian Barre syndrome. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-675058:Patient 2
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Electrocardiogram T wave amplitude increased
Clinical narrative: increased T waves; This spontaneous case was reported by a patient and describes the occurrence of ELECTROCARDIOGRAM T WAVE AMPLITUDE INCREASED (increased T waves) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Jan-2022, the patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ELECTROCARDIOGRAM T WAVE AMPLITUDE INCREASED (increased T waves). At the time of the report, ELECTROCARDIOGRAM T WAVE AMPLITUDE INCREASED (increased T waves) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, Electrocardiogram: increased T wave. Concomitant product use was not provided by the reporter.  Approximately 2 weeks after receiving last dose patient had an increased T wave notification on smart watch which prompted patient to go and see cardiologist. The cardiologist also took an EKG which showed increased T waves, however they were not peaking. The cardiologist stated that was nothing to worry about. Patient had not taken any medication or treatments.