chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient 1st dose when she was 5 years old never got the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 20-year-old female patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (1st dose received on an unknown date for batch no AHAVB1ZAA).   On an unknown date, the patient did not receive the 2nd dose of Havrix. On an unknown date, unknown after receiving Havrix, 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: 13-JUN-2022  Reporter's comment: Health care professional (HCP) reported patient got first dose when she was 5 years old never got the 2nd dose of Havrix.  Patient was now 20 years old, The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Havrix, which led to incomplete course of vaccination. Note: VARES details pertains to 1st dose of Havrix in product tab.
Age: 69.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong technique in product usage process
Clinical narrative: pediatric dose given to adult patient; Wrong technique in product usage process; pediatric dose given to adult patient, gave an additional pediatric dose; Wrong technique in product usage process; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 69-year-old male patient who received HBV (Engerix B pediatric) (batch number HN5BE, expiry date 16th September 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B pediatric) for prophylaxis.   On 10th June 2021, the patient received the 1st dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 11th June 2021, the patient received Engerix B pediatric. On 10th June 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device and not applicable after receiving Engerix B pediatric, the patient experienced adult use of a child product and wrong technique in product usage process. On 11th June 2021, the patient experienced adult use of a child product and wrong technique in product usage process. On an unknown date, the outcome of the adult use of a child product, adult use of a child product, wrong technique in product usage process and wrong technique in product usage process 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-JUN-2022 Reporter's Comments: The reporter stated that on 10th June 2021 where a pediatric dose of ENGERIX B was given to an adult patient.  The following day, 11th June 2021 HCP called the patient back in and gave an additional dose of ENGERIX B pediatric dose.  The reporter mentioned no prior adverse event. The reporter did not give consent to follow up. Additional supportive Information: The pediatric dose given to adult patient which leads to adult use of pediatric product and wrong technique in product usage process.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose / Child received expired Menveo; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA468A, expiry date 31st March 2022) for prophylaxis.   On 6th June 2022, the patient received Menveo. On 6th June 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-Jun-2022 Reporter's Comments: The reporter stated that the patient received Menveo that was expired. The reporter had nothing else to report. The reporter consented to follow up.  Additional Supportive Information: The patient received Menveo that was expired, which led to Expired vaccine administered.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th February 2022, the patient received the 1st dose of Shingrix. On 14th February 2022, 4 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments: The reporter was patient who called in to report side effect of Shingrix. The patient received dose of shingrix and developed a case of shingles (confirmed by HCP). The reporter consented to follow up and consented to contact HCP.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on May 11th 2022 planning to receive second on Jun 29th 2022; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, 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: 15-June-2022 Reporter's comment: The pharmacist asked how to proceed if the patient was late for Engerix-B second dose.  The first dose was on 11th May 2022 but due internal issues, they were planning to received Engerix-B second dose on 29th June 2022.  The reporter did not consent to follow-up.  Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination. This is one of 5 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR093987:Same reporter US-GLAXOSMITHKLINE-US2022AMR093988:Same reporter US-GLAXOSMITHKLINE-US2022AMR093989:Same reporter US-GLAXOSMITHKLINE-US2022AMR093990:Same reporter
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: administrated with a 3rd dose of an expired Twinrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a male patient who received HAB (Twinrix) (batch number 75c72, expiry date 13th June 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th June 2022, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 15th June 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:  15-JUN-2022 Reporter's Comments: The patient was administrated with a 3rd dose of an expired Twinrix No adverse event was reported .  The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. No patient's identifiers provided. Additional supportive information: The patient received Twinrix which was already expired which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort
Clinical narrative: Arm trouble; This case was reported by a consumer via call center representative and described the occurrence of arm discomfort in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th March 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced arm discomfort. On an unknown date, the outcome of the arm discomfort was unknown.   It was unknown if the reporter considered the arm discomfort to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments: Reporter was the patient, who stated that after receiving her Shingrix dose, she started to experience arm trouble. Call was disconnected before any demographic information could be collected.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st vaccine in 2018, has not received her 2nd; This case was reported by a consumer 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 (patient received 1st dose of Shingrix in 2018 in unknown arm via intramuscular route of administration).   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: 15-JUN-2022 Reporter's comment: The reporter reported that, her friend had not received her second Shingrix vaccine. No patient information or reporter information were provided. The reporter did not consent to follow-up. Additional Supportive Information: Till the time f reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 34.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered Infanrix to an adult patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 34-year-old male patient who received DTPa (Infanrix) (batch number XG942, expiry date 22nd August 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 14th June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 15-JUN-2022 Reporter's Comment: LPN (Licensed Practical Nurse) reported that they inadvertently administered Infanrix to an adult patient. Licensed practical nurse inquired how to proceed, any recommendations. The reporter did not consent to follow-up. Additional supportive information: The adult patient received dose of Infanrix vaccine, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 10-January-2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th January 2020).   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: 15-JUN-2022 Reporter's Comments: The pharmacist reported that the patient did not received the second dose of Shingrix. The reporter wanted to know if the patient had to restart the series. 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 course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in 2019, 2nd dose June 14, 2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient received 1st dose of Shingrix in 2019).   On 14th June 2022, the patient received the 2nd dose of Shingrix. On 14th June 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments: The reporter was patient's wife.   The reporter stated her husband received his first dose of Shingrix in 2019. Her husband received a second dose on 14th Jun 2022. The reporter did not wish to provide any other information. The reporter did not give consent to follow-up. Additional Supportive Information: The patient received 2nd dose later then recommended interval, which led to lengthening of vaccination schedule
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Administered Havrix after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received HAV (Havrix) (batch number 2K57N, expiry date 11th December 2022) for prophylaxis.   On 17th March 2022, the patient received the 2nd dose of Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Linked case(s) involving the same patient:  US2022093644   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's comment: The medical assistant reported a patient was administered the Havrix on left arm after a temperature excursion. The reporter consented to follow up. Additional supportive information: Havrix was administered after a temperature excursion, which led to incorrect storage of vaccine. This case is one of 12 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093597:Same reporter. US-GLAXOSMITHKLINE-US2022093643:Same reporter. US-GLAXOSMITHKLINE-US2022093602:Same reporter. US-GLAXOSMITHKLINE-US2022093637:Same reporter. US-GLAXOSMITHKLINE-US2022093638:Same reporter. US-GLAXOSMITHKLINE-US2022093640:Same reporter. US-GLAXOSMITHKLINE-US2022093642:Same reporter. US-GLAXOSMITHKLINE-US2022093644:Same reporter. US-GLAXOSMITHKLINE-US2022093645:Same reporter US-GLAXOSMITHKLINE-US2022093646:Same reporter US-GLAXOSMITHKLINE-US2022093647:Same reporter US-GLAXOSMITHKLINE-US2022093648:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Female patient received first dose of Shingrix 22Aug2020, and has not yet received second dose.; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose (lot number 7BC47, expiration date 29th June 2023) received on 22nd August 2020 prior before reporting.).   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: 15th June 2022 Reporters comment: The reporter was a Pharmacy Operations Manager. The VAERS details was reported for 1st dose.  The reporter consent for follow-up. Additional Supportive information: Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course vaccination. This case had been linked with US2022093603, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093603:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix in 2020; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (1st dose (batch number 3454N, expiry date 13th October 2020) received on 23rd August 2020).   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: 16-June-2022 Reporter's Comments: The nurse reported that the patient who received the first dose of Shingrix in 2020 and would they get the 2nd dose on the day of reporting or do they need to restart the series. The reporter consented to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: RV1, RV5
Symptoms: Interchange of vaccine products
Clinical narrative: Rotarix after receiving Rotatech; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and ROTAVIRUS VACCINE (ROTATEQ) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation, Rotarix Oral Applicator Device and ROTATEQ. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comment: The reporter reported that, the patient received a dose of Rotarix after receiving an initial dose of Rotateq. The reporter did not provide lot number, expiration date, patient demographics, or full mailing address. Additional Supportive Information: The patient received a dose of Rotarix after receiving an initial dose of Rotateq, which led to interchange of vaccine products.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain in jaw
Clinical narrative: Headache; Jaw pain; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of headache in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix, the patient experienced headache, jaw pain and fatigue. On an unknown date, the outcome of the headache, jaw pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the headache, jaw pain and fatigue to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR094718   Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The patient self-reported this case. She received Shingrix dose in an unknown arm. She had nothing else to report. The reporter consented to follow up. Additional supportive information: For tolerance of 2nd dose of Shingrix, refer case US2022AMR094718.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022094110:Same reporter US-GLAXOSMITHKLINE-US2022AMR094718:Same Reporter, Same Patient, 2nd dose
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Incorrect dose administered, Incorrect route of product administration, No adverse event, Product preparation error
Clinical narrative: ROTARIX was diluted with sterile water; ROTARIX was diluted with sterile water; Injected IM into the Right Vastus Lateralis; 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 2-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number YH345, expiry date 9th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 16th June 2022, the patient received Rotarix lyophilized formulation (intramuscular) .5 ml and Rotarix Oral Applicator Device. On 16th June 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate dose of vaccine administered, wrong solution used in drug reconstitution and wrong route of administration. On an unknown date, the outcome of the inappropriate dose of vaccine administered, wrong solution used in drug reconstitution and wrong route of administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-Jun-2022 Reporter's comment: The reporter was a Medical Assistant stating that Rotarix was diluted with sterile water, then injected into the right vastus lateralis of the patient. The amount injected was 0.5 ml, the entire dose of the vaccine was administered per the reporter. No other adverse events were noted at the time of the call.  The reporter consented to follow up. Additional Supportive Information: The patient received Rotarix diluted with sterile water via intramuscular route, which led to inappropriate dose of vaccine administered, wrong solution used in drug reconstitution and wrong route of administration.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient was administrated with only the diluent; Patient was administrated with only the diluent; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo (unknown). 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: 16-Jun-2022 Reporter's comment: The pharmacist reported that a patient was administrated with only the diluent of Menveo. No adverse event was reported. The reporter consented to follow up. The patient's identifiers, vaccination date, no lot number and expiration date were not provided. Vaccine was administrated on another facility. Additional Supportive information: The patient was administrated with only the diluent of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on July 2021, Jun 16th 2022 2nd dose has not been administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received in July 2021).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, 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-Jun-2022 Reporter's comments: The patient that received Engerix B first dose in July 2021, would like to receive the second dose but first of all pharmacist wanted to check with GlaxoSmithKline. Till the time of reporting, the second dose had not been administered. The consent to follow up was given. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Engerix B, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose approximately 7 months ago, not yet received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received approximately 7 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The patient reported case for himself. The patient not yet received the second dose. The reporter 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: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 3 years ago and did not receive second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 94-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years before the date of reporting).   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-Jun-2022 Reporter's comments: This case was reported by the patient. The patient received his first dose of Shingrix 3 years ago and did not receive second dose. The patient was planning to receive second dose as soon as possible. The consent to follow up was given. 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: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a male patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 17th June 2022, the patient received Havrix. On 17th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-Jun-2022 Reporter's comments: A medical assistant reported that the patient received an expired dose of Havrix. No symptoms were reported. The consent to follow up was given. The healthcare professional did not have the patient's date of birth at time of report. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: Use of Unapproved Diluent; Use of Unapproved Diluent; Use of Unapproved Diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number Amva642a, expiry date 1st November 2022) for prophylaxis.   On 8th June 2022, the patient received Menveo (intramuscular). On 8th June 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 17-Jun-2022 Reporter's comments: The patient received Menveo in left deltoid, which was reconstituted with unapproved diluent. The consent to follow up was given. Additional Supportive Information: The patient received Menveo that was reconstituted with unapproved diluent, which led to wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and inappropriate preparation of medication.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: Few leaks may have dropped out during administration; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number Z4G559, expiry date 7th July 2023) for prophylaxis.   On 16th June 2022, the patient received Shingrix. On 16th June 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 17-Jun-2022 Reporter's comments: The patient received a Shingrix in left deltoid that a few leaks might have dropped out during administration. Additional Supportive Information: While receiving Shingrix, few leaks might have dropped out, which led to incomplete dose administered.
Age: 16.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received a dose that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received HBV (Engerix B) (batch number unknown, expiry date 30th April 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th May 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 25th May 2022, unknown after receiving Engerix B and Engerix B 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: 17-Jun-2022 Reporter's comments: Medical assistant reported that the patient received Engerix-B that had expired. The consent to follow up was given. Additional Supportive Information: The patient received expired dose of Engerix B, which led to expired vaccine used.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: received a dose that had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received Men B NVS (Bexsero) (batch number ADXA87AZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th June 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 17th June 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: 17-Jun-2022 Reporter's comments: The patient received a dose of Bexsero which was expired. The consent to follow up was given. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient received expired dose of Bexsero, which led to expired vaccine used.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Product administered at inappropriate site
Clinical narrative: Bexsero and Menveo administered on same arm; This case was reported by a other health professional via call center representative and described the occurrence of vaccine administered at inappropriate site in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA660A, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number M7455, expiry date 31st December 2022) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th June 2022, the patient received Menveo, Bexsero and Bexsero Pre-Filled Syringe Device. On 17th June 2022, unknown after receiving Menveo, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site 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: 17-Jun-2022 Reporter's comments: The healthcare professional reported that Bexsero and Menveo was administered in the same arm to the patient. The consent to follow up was given. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient received Bexsero and Menveo in the same arm, which led to vaccine administered at inappropriate site.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: first dose on 06/17/2021, not received second; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17th June 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: 17-Jun-2022 Reporter's comments: Healthcare provider reported that the patient received Shingrix and had not received their second dose. The reporter did not consent to follow-up. The healthcare professional did not provide any adverse event details. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: FLUX
Symptoms: Oedema peripheral, Urine abnormality
Clinical narrative: foaming of the urine; severe edema of the legs; Minimal change disease; Chronic kidney disease (CKD stage 2); This case was reported in a literature article and described the occurrence of minimal change disease in a adult female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.  Concurrent medical conditions included hypertension.   On an unknown date, the patient received Influenza vaccine. In June 2018, 15 days after receiving Influenza vaccine, the patient experienced minimal change disease (serious criteria GSK medically significant) and chronic kidney disease (serious criteria GSK medically significant). On an unknown date, the patient experienced foamy urine and leg edema. The patient was treated with prednisone. On an unknown date, the outcome of the minimal change disease, chronic kidney disease, foamy urine and leg edema were recovering/resolving.   The reporter considered the minimal change disease, chronic kidney disease, foamy urine and leg edema to be probably related to Influenza vaccine.     Additional Information: GSK Receipt Date: 17-JUN-2022 Author Comment: The patient's age was 54 years at the time of reporting. The patient was had a medical history of hypertension. The patient provided informed verbal consent for her case to be presented. In 2018, the patient received Influenza vaccine. She was initially diagnosed with minimal change disease (MCD) in June 2018, approximately 15 days after receiving the influenza vaccine. The initial presenting symptoms included foaming of the urine and severe edema of the legs. The diagnosis was made following a kidney biopsy. After a course of prednisone therapy, she remained in remission for 4 months. However, she relapsed in October 2018 and was deemed to be in remission after being treated with prednisone the second time. She was tapered off the prednisone over the next 3 months, after a 6 months taper was originally planned. However, the patient experienced moon facies and blistering skin as adverse effects of taking steroids, so she requested a shorter taper period. She was diagnosed with chronic kidney disease (CKD stage 2) after the first episode of MCD. She remained in remission for over 3 years following treatment with steroids. She did not receive the influenza vaccine or any other vaccine during the time she was in remission because she was concerned about a relapse. She chose to receive the Pfizer vaccine against COVID-19 because she worked in healthcare and had reactivation of MCD after receiving the Pfizer vaccine.  The development of MCD has also been reported after influenza, hepatitis B, pneumococcal, measles, and tetanus-diphtheria-poliomyelitis vaccines. There have been various cases of reactivation of MCD after the administration of the influenza vaccine. The exact pathogenesis of MCD following influenza vaccination is not known; however, it is plausible for immune complexes to form or deposit in the subepithelial space because of the interaction between the influenza vaccine antigen and native antibodies, leading to this pathological process.
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling
Clinical narrative: SWOLLEN BREAST AFTER THE VACCINE; This spontaneous report received from a consumer concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced swollen breast after the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen breast after the vaccine. This report was non-serious. This case, from the same reporter is linked to 20220610772.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vials were moved from freezer to refrigerated conditions on 28-DEC-2021; Vaccine was expired on 29-Jan-2022 and administered on 08-Feb-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 29-Jan-2022 and administered on 08-Feb-2022) and PRODUCT STORAGE ERROR (The vials were moved from freezer to refrigerated conditions on 28-DEC-2021) in a 36-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 032F21A) for COVID-19 prophylaxis.     Concomitant products included CHLORPROMAZINE, DOLUTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY), PALIPERIDONE PALMITATE (INVEGA SUSTENNA) and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM DS) for an unknown indication.    On 08-Feb-2022 at 2:45 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 08-Feb-2022 at 2:45 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 29-Jan-2022 and administered on 08-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vials were moved from freezer to refrigerated conditions on 28-DEC-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 29-Jan-2022 and administered on 08-Feb-2022) and PRODUCT STORAGE ERROR (The vials were moved from freezer to refrigerated conditions on 28-DEC-2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patient had no known drug allergies and no known allergies. It was unknown whether the patient had been diagnosed with/ tested positive for COVID 19.  Acute illness at the time of vaccination and up to one month before was reported as unknown.  Chronic or long standing health conditions were reported as unknown.  The vial did not undergo any temperature excursions.  The vials were moved from freezer to refrigerated conditions on 28-DEC-2021.  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2022: Follow-up received contains Non significant information, Reporter information was added. On 20-Jun-2022: Follow up was received with significant information: Added reporter, patient details including their date of birth, age, gender, height and weight, concomitant medication and updated narrative.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Femur fracture
Clinical narrative: Broke her femur; Fell; This spontaneous case was reported by a consumer and describes the occurrence of FEMUR FRACTURE (Broke her femur) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Clot blood (prior to Moderna vaccinations). Previously administered products included for Clot blood: Enoxaparin (enoxaparin for 6 weeks as a blood clot preventative.). Past adverse reactions to the above products included No adverse event with Enoxaparin.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2022, the patient experienced FEMUR FRACTURE (Broke her femur) (seriousness criterion medically significant) and FALL (Fell). At the time of the report, FEMUR FRACTURE (Broke her femur) and FALL (Fell) outcome was unknown.            No concomitant medication information provided  The reporter stated that the patient had so far received three Moderna COVID-19 doses. The reporter also reported that the patient did not experienced any adverse events after the first three Moderna doses. The patient was scheduled to received the second Moderna booster dose on today 16Jun2022. The patient fell and broke the femur on 30Apr2022 and had to have surgery and rehab. The patient had a history of blood clots (prior to Moderna vaccinations), so the patient was placed on enoxaparin for 6 weeks as a blood clot preventative.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID positive) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (moderate to severe).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID positive). At the time of the report, COVID-19 (COVID positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medication of the patient was not reported.   Formulation of Humira (adalimumab) was reported as solution for injection in pre-filled pen.  Primary reporter did not have the lot number information of Humira (Adalimumab), because the packaging was discarded. It was unknown if the patient was enrolled in a COVID-19 vaccine trial.  Causality for Humira (adalimumab): The reporter's causality for the event of COVID positive with Humira (adalimumab) was no reasonable possibility.  No treatment information was provided by the reporter.  Company Comment: This is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine and the co-suspect, non-company product Adalimumab (Humira). No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine and the co-suspect, non-company product Adalimumab (Humira). No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.