chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Accidentally received only the liquid portion; Accidentally received only the liquid portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA764A, expiry date 31st December 2023) for prophylaxis.   On 30th January 2023, the patient received the 2nd dose of Menveo. On 30th January 2023, 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: 31-JAN-2023 Reporter's Comments: The patient had accidentally received only the liquid portion of Menveo on 30th January 2023.  They gave the vaccine details, patient's details and requested information about how to proceed.  She accepted follow-up and provided her e-mail address so that the medical information could be sent. The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: The patient received only nly the Menveo diluent was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case had been linked with the case US2023015033, reported by the same reporter.; Sender's Comments:  US-GSK-US2023015033:Same reporter.
Age: 72.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Havrix administered 1 day after expiration; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 72-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 31st January 2023, the patient received Havrix. On 31st January 2023, 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: 31-JAN-2023 Reporter's Comments: Registered nurse reported Havrix was administered 1 day after expiration.  Havrix was administered on 31st January 2023 and expired on 30th January 2023. The reporter consented to follow up. Additional Supportive Information: The patient received Havrix, which was already expired.
Age: 54.0
Sex: M
Vaccine: HEP, HEPAB
Symptoms: Incomplete course of vaccination, Wrong product administered
Clinical narrative: Twinrix 1st dose, 2nd dose Engerix B only; Twinrix 1st dose, 2nd dose Engerix B only; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 54-year-old male patient who received HBV (Engerix B) (batch number 7xy23, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 27th January 2023, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 27th January 2023, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device and an unknown time after receiving TWINRIX, the patient experienced wrong vaccine administered. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the wrong vaccine administered and incomplete course of vaccination were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comments: Nurse reported that patient received Twinrix on 29th December 2022 as a first dose and on 27th January 2023 patient received just HepB (Engerix B).  The reporter asked how to proceed. The reporter consented to follow up.  The vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: the patient received 1st dose of Twinrix and then Engerix B, which led to wrong vaccine administered. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination for hepatitis A antigen.
Sex: U
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: Pt received a 3rd dose of Rotarix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered 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.   On 31st January 2023, the patient received the 3rd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 31st January 2023, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose 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: 31-JAN-2023 Reporter's Comments: A pharmacist reported that a patient accidentally received a 3rd dose of Rotarix.  No symptoms reported. HCP did not have patient info or lot/exp and the formulation was undetermined. HCP consented to follow up via email. Additional Supportive Information: The patient received 3rd dose of Rotarix, which led to extra dose administered.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on July2022, did not receive the 2nd; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included engerix B (received 1st dose in July 2022).   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: 31-JAN-2023 Reporter's Comments: The patient who received the first dose of Engerix-B in July 2022.  The patient did not receive the second dose.  The reporter asked if they could administer the Engerix-B second dose or if the patient had to start over with the vaccination. The reporter did not share either patient initials or information about the first Engerix-b 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 Engerix B, which led to incomplete course of vaccination.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Apr2022, 2nd 31Jan2023; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in April 2022).   On 31st January 2023, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 31st January 2023, 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: 31-JAN-2023 Reporter's Comments: The patient received their first dose of Twinrix vaccine in April 2022 and did not receive second dose until 31st January 2023.   Reporter declined to provide any patient information.  The reporter did not have the exact date of the first dose and did not have the lot number or expiration date of either dose. The consent to follow up was not obtained. Additional Supportive Information: The patient received 2nd dose of Twinrix on 31st January 2023, later than recommended schedule, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: SEVERE ABDOMINAL PAIN; 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, batch number and expiry date 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 severe abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe abdominal pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patient received dose of Moderna vaccine post excursion; patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender 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 PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion).    This case contains information for the 10th of 19 patients reported by the reporter. No concomitant medication were reported. No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:pt 1 of 19
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patient received dose of Moderna vaccine post excursion; patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender 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 POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:Patient 1 of 19
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patient received dose of Moderna vaccine post excursion; patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender 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 POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion).    Concomitant medication was not reported. Treatment drug was not reported. This case contains information for the 9th of 19 patients reported by the reporter   This case was linked to US-MODERNATX, INC.-MOD-2023-706941 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:Patient 1 of 19
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patient received dose of Moderna vaccine post excursion; patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion).    This case was for 16th patient out of 19 reported.  No concomitant medication was reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941, US-MODERNATX, INC.-MOD-2023-706966 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:Patient 1 of 19 US-MODERNATX, INC.-MOD-2023-706966:Patient 16 of 19
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Moderna Bivalent dose but he had only received 1 dose of monovalent vaccine; no adverse event; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Moderna Bivalent dose but he had only received 1 dose of monovalent vaccine) and NO ADVERSE EVENT (no adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Moderna Bivalent dose but he had only received 1 dose of monovalent vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Moderna Bivalent dose but he had only received 1 dose of monovalent vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Moderna Bivalent dose but he had only received 1 dose of monovalent vaccine).    Concomitant medication was not provided. Patient was given Moderna Bivalent dose but had only received 1 dose of monovalent vaccine. Treatment medication information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received dose of Moderna vaccine post excursion; Patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion).    No concomitant medications were reported.  No treatment medication were reported.  This case was for 5th patient out of 19 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941, US-MODERNATX, INC.-MOD-2023-706966 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:Patient 1 of 19 US-MODERNATX, INC.-MOD-2023-706966:Patient 5 of 19
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patient received dose of Moderna vaccine post excursion; patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender 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 PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion).    This case contains information for the 08th out of 19 patients described by the reporter  Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941, US-MODERNATX, INC.-MOD-2023-706966 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:Patient 1 of 19 (Master case) US-MODERNATX, INC.-MOD-2023-706966:Patient 8 of 19
Age: 0.5
Sex: M
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: 6-month-old patient was given a PENTACEL vaccine today (01Feb2023) but the vaccine expired yesterday; Initial information received on 01-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 month old male patient who had taken DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] on 01-feb-2023 but the vaccine expired yesterday.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine Live Reassort Oral 5v (Rotateq); Hepatitis B Vaccine (Hepatitis B Vaccine) and (Pneumococcal Vaccines).  On 01-Feb-2023, the patient received a dose 1 of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE for Suspension for injection (Frequency: Once, lot: UJ659AAA, expiry date: 31-Jan-2023) via unknown route in unknown administration site for immunization.  On 01-Feb-2023, (latency: same day) the patient was given a pentacel vaccine today but the vaccine expired yesterday (expired product administered).  No lab data available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: An expired dose of PENTACEL was administered with no reported adverse event; Initial information received  on 02-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 6-month-old female patient and it was reported that an expired dose of Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus vaccine live reassort oral 5V (ROTATEQ) for immunisation; and pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13) for immunisation.  On 01-Feb-2023, the patient received 0.5 ml (millilitre) (dose 3) (once) (strength: standard) of suspect Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (lot UJ640AAA, expiry date: 28-Feb-2023) via intramuscular route in the right thigh for immunization.  On 01-Feb-2023 the reporter reported that an expired dose of pentacel was administered with no reported adverse event (expired product administered) (latency: same day).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Skin fissures, Vaccination failure
Clinical narrative: had 2 shingles shots, this was on feet and hands, suspected vaccination failure; this was on my feet and hands; symptoms are blisters; crack skin; This case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and skin cracked. On an unknown date, the outcome of the vaccination failure, shingles, blister and skin cracked were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, blister and skin cracked to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 30-JAN-2023 Reporter's Comments: The patient self-reported this case. The patient was taken pictures of the bottom of his or her to show his or her symptoms  physically.  The patient had at least 2 shingles related shots and he or she thought that this was what this was on his or her feet and it was also a little bit on his or her hands but according to the symptoms were blisters and this was crack skin. The patient said he or she keep feet and he or she really good so did have any idea was this another form of she knows he or she did not think so but could help him or her with this. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The event shingles and vaccination failure were coded conservatively since the narrative stated that this was what appeared on their feet and hands'. Follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Malaise
Clinical narrative: Got ill; Red mark on arm; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unwell and erythema. On an unknown date, the outcome of the unwell and erythema were unknown.   It was unknown if the reporter considered the unwell and erythema to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 28-JAN-2023 Reporter comment: This case was reported by a patient via interactive digital media. The patient received shingrix got ill and have red mark on his/her arm. The follow-up could not be possible as no contact details were available. Note: outcome kept as unknown as not sure whether it was recovered or not recovered at the time of reporting for event red mark
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Conjunctivitis, Pain
Clinical narrative: body aches; chills; Pink eye; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2023, the patient received the 1st dose of Shingrix. In January 2023, 1 week after receiving Shingrix, the patient experienced general body pain, chills and pinkeye. On an unknown date, the outcome of the general body pain, chills and pinkeye were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, chills and pinkeye to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-JAN-2023 Reporter's Comment: The reporter called and stated that patient received first dose of Shingrix. The reporter reported that about a week later started to experience pink eye, chills, and body aches. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: Back pain; This case was reported by a consumer via call center representative and described the occurrence of back pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced back pain. On an unknown date, the outcome of the back pain was recovered/resolved.   It was unknown if the reporter considered the back pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-JAN-2023 Reporter's Comment: The reporter was the patient.  The reporter reported patient received dose of Shingrix approximately two months ago. The reporter reported that patient experiencing back pain for approximately one week, after dose of Shingrix. The reporter did not consent to follow up.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Engerix- adult was given to 19-year old; Engerix- adult was given to 19-year old; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B adult) (batch number NT9X3, expiry date 9th September 2024) for prophylaxis.   On 31st January 2023, the patient received Engerix B adult. On 31st January 2023, unknown after receiving Engerix B adult, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comment: The healthcare professional reported that the patient received a dose of Engerix B adult. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The 19 years old patient received an adult Engerix B dose, which led to overdose and inappropriate age at vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patient received dose of Moderna vaccine post excursion; patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender 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 PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion).    Concomitant medication was not reported. Treatment drug was not reported. This case contains information for the 4th of 19 patients reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941, US-MODERNATX, INC.-MOD-2023-706966 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:pt 1 of 19 US-MODERNATX, INC.-MOD-2023-706966:Patient 4 of 19
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patient received dose of Moderna vaccine post excursion; patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This case is for 17th patient out of total 19th patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941, US-MODERNATX, INC.-MOD-2023-706966 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:Patient 1 of 19 US-MODERNATX, INC.-MOD-2023-706966:Patient 17 of 19
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patient received dose of Moderna vaccine post excursion; patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender 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 POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion).    No concomitant products reported.  It was reported that patient received the dose of Moderna vaccine post excursion.  No treatment products reported.   This case contains information for the 7th of 19 patients reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:pt 1 of 19 (master case)
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received dose of Moderna vaccine post excursion; Patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion).    This case contains information for the 11th patient out of 19 patients as described by the reporter.  Concomitant medications were not reported.   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received dose of Moderna vaccine post excursion; Patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion).    No Concomitant products reported.  It was reported that patient received the dose of Moderna vaccine post excursion.  No treatment products reported.  This case contains information for the 14th of 19 patients reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941, US-MODERNATX, INC.-MOD-2023-706966 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941: US-MODERNATX, INC.-MOD-2023-706966: