chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Reconstituted with unapproved diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number KK3JM, expiry date 25th September 2023) for prophylaxis.   On 11th November 2022, the patient received the 1st dose of Shingrix. On 11th November 2022, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 16-nov-2022 Reporter's comments:  Registered nurse reported on 16th November 2022 that, the patient was vaccinated with shingrix 1st dose on 11th November 2022 but they used an unapproved diluent. The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. Additional supportive information: unproved diluent used to prepare shingrix vaccine and administered to patient, which led to wrong solution used in drug reconstitution.
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: BEXSERO given instead of MENVEO; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number 943S5, expiry date 31st March 2024) 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 5th November 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 5th November 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-NOV-2022 Reporter's comments:  Medical assistant called in to notify that a patient was wrongfully given a dose of bexsero instead of a dose on menveo on 5th November 2022 at a different location than the one from which they were calling and wished to know how to proceed. Call had to be escalated to second line but because of no availability, the healthcare professional accepted to be contacted via e-mail. Additional supportive information: The patient received Bexsero vaccine instead of Menveo, which led to wrong vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: swelling at the injection site; heat at the injection site; pain at the injection site; redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2022, the patient received the 1st dose of Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site warmth, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site pain and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site pain and injection site erythema to be related to Shingrix.     Additional Information: GSK receipt date: 17-Nov-2022 Reporter's comment: This case was self reported by the patient. The patient received the first dose of Shingrix. The patient was experiencing redness, heat, swelling and pain at the injection site. The adverse events was filed.  The reporter did not consent to follow up.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Pediarix given instead of flu shot; Administered a possible 4th dose; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 6-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date 25th March 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included DTAP + HEP B + IPV VACCINE (3rd dose received on 15th August 2016), DTAP + HEP B + IPV VACCINE (2nd dose received on 14th June 2016) and DTAP + HEP B + IPV VACCINE (1st dose received on 15th April 2016).   On 16th November 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 16th November 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-Nov-2022 Reporter's Comments  Nurse reported that a 6 years old patient was administered a possible 4th dose of Pediarix on 16th Nov 2022 instead of a flu shot.  Patient previously received 3 doses of DTAP/IPV/HEP-B vaccine with unknown manufacturer. The reporter did not want the information stored in our database but agreed to follow up via email. Additional Supportive Information: the patient received pediarix vaccine instead of flu vaccine, which led to wrong vaccine administered, and extra dose administered. Extra dose administered conservatively since patient received 3 doses of Dtap/ IPV/ Hep B vaccines (possible pediarix)
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 2 year-old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 16th November 2022, unknown after receiving Kinrix and Kinrix 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: 17-Nov-2022. Reporter's Comment: The medical assistant stated that Kinrix was administered to a 2 year-old patient.  The reporter asked for further instructions for patient's vaccination. Additional supportive Information: Two year old patient received Kinrix which led to inappropriate age at vaccine administration. The reporter gave consent to follow up.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive dose 3 yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received on an unknown date) and Engerix B (2nd dose received in June 2021).   On an unknown date, the patient did not receive the 3rd 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-NOV-2022 Reporter's comment: Pharmacist stated that the patient received dose one, then dose two in June 2021, but due to being displaced by a hurricane did not receive dose 3 yet.  No further information was available on call. The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive the 3rd dose of Engerix B, which led to Incomplete course of vaccination.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received Engerix that was expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number unknown, expiry date 8th November 2022) for prophylaxis.   On 15th November 2022, the patient received Engerix B. On 15th November 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-NOV-2022 Reporter's comment: The reporter stated that the patient received Engerix B 2 days ago on 15th November 2022 and the expiration date was 8th November 2022.  The reporter declined to provide any additional information on call. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Engerix B which was already expired, which led to expired vaccine used.
Age: 1.0
Sex: F
Vaccine: MMR, UNK
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered, Injection site discharge, Product administered at inappropriate site
Clinical narrative: Vaccine leaked from the injection site; 2 vaccines on the same leg flu and MMR; Vaccine leaked from the injection site; Vaccine leaked from the injection site; 14 month old patient received two booster doses of infanrix hexa(in JUNE and JULY 2022).; This case was reported by a nurse via call center representative and described the occurrence of injection site leaking in a 1-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number J39G3, expiry date unknown) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and MMR (MMR vaccine) for prophylaxis.   On 17th November 2022, the patient received Fluarix Quadrivalent 2022-2023 season, Fluarix Tetra Pre-Filled Syringe Device and MMR vaccine. On 17th November 2022, immediately after receiving Fluarix Quadrivalent 2022-2023 season, Fluarix Tetra Pre-Filled Syringe Device and MMR vaccine, the patient experienced injection site leaking, vaccine administered at inappropriate site, exposure via skin contact, inadvertent exposure to vaccine and incomplete dose administered. On an unknown date, the outcome of the injection site leaking, vaccine administered at inappropriate site, exposure via skin contact, inadvertent exposure to vaccine and incomplete dose administered were unknown.   It was unknown if the reporter considered the injection site leaking to be related to Fluarix Quadrivalent 2022-2023 season, Fluarix Tetra Pre-Filled Syringe Device and MMR vaccine.   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-Nov-2022 Reporter's Comments  Nurse called to report that on 17th November a 1-year-old female patient received 2 vaccines on the same leg flu and MMR and one of them leaked 4-5 drops but did not know which vaccine it was. The consented to follow up. HCP did not have information on the patient or vaccine, did not know if it was a prefilled syringe or vial. Follow up accepted via email. Additional Supportive Information: 1 year old patient received flu vaccine and MMR vaccine on same leg and one of then was leaked 4-5 drops, which led to injection site leaking, vaccine administered at inappropriate site, exposure via skin contact and inadvertent exposure to vaccine and incomplete dose administered.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: received an expired Shingrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 44-year-old female patient who received Herpes zoster (Shingrix) (batch number LN399, expiry date 9th October 2022) for prophylaxis.   On 16th November 2022, the patient received the 2nd dose of Shingrix. On 16th November 2022, unknown after receiving Shingrix, 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-Nov-2022. Reporter's Comment: The patient received an expired Shingrix second dose by error. The reporter did not consent to follow-up. Additional Supportive Information: The patient received an expired Shingrix second dose by error which leads to expire vaccine used.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered 2 liquid components of Menveo; Administered 2 liquid components of Menveo; This case was reported by a nurse via call center representative and described the occurrence of inappropriate reconstitution technique in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA762A, expiry date 30th November 2023) for prophylaxis.   On 14th November 2022, the patient received Menveo. On 14th November 2022, unknown after receiving Menveo, the patient experienced inappropriate reconstitution technique and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-Nov-2022 Reporter's Comments  Nurse reports that a staff member inadvertently administered 2 liquid components of Menveo vaccine instead of 1 liquid reconstituted with 1 powder vial.   At the time of reporting, the dose had not been repeated. Additional Supportive Information: the patient inadvertently administered 2 liquid components of mennveo vaccine instead of 1 liquid reconstituted with 1 powder vial, which led inappropriate preparation of medication and inappropriate dose of vaccine.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 07Jan2020, 2nd on 17Nov2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 81-year-old male patient who received Herpes zoster (Shingrix) (batch number 9254S, expiry date 18th September 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 7th January 2020).   On 17th November 2022, the patient received the 2nd dose of Shingrix. On 17th November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 17 NOV 2022 Reporter's comment: The patient did not receive the second dose until 17th November 2022. The first dose was given at a different location and the reporter did not have the lot number/expiration date information.  Additional supportive information: The patient received the second dose later than the recommended schedule, which led to lengthening of vaccination interval. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: an expired dose was administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 53-year-old female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th November 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 16th November 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-NOV-2022 Reporter's Comment: The reporter consented to follow up by email. Additional Supportive Information: The patient received a dose of Havrix which was already expired on 30th September 2022, led to expired vaccine used.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LC3P, expiry date 15th November 2022) for prophylaxis.   On 17th November 2022, the patient received Shingrix. On 17th November 2022, unknown after receiving Shingrix, 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-NOV-2022 Reporter's comment: The pharmacist reported that the patient was administered with a dose of Shingrix on 17th November 2022 which had expiry date of 15th November 2022. Additional; supportive information: The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Neck pain, Pain in extremity
Clinical narrative: NECK PAIN; FLU; THUMB PAIN; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: upadacitinib (tablet, oral, batch number: 1169051 expiry: UNKNOWN) 15 mg, 1 time every 1 day, from 2022 for rheumatoid arthritis. Concomitant medications included ascorbic acid/calcium/minerals nos/retinol/tocopheryl acetate/vitamin b nos/vitamins nos/zinc, ergocalciferol, famotidine, gabapentin, methotrexate, omeprazole, prednisone, retinol, sertraline hydrochloride, and tizanidine hydrochloride. On 2022, the patient experienced thumb pain. On FEB-2022, the patient experienced flu. On an unspecified date, the patient experienced neck pain. The action taken with covid-19 vaccine ad26.cov2.s, and upadacitinib was not applicable. The patient had not recovered from thumb pain, and neck pain, and the outcome of flu was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: PERICARDITIS; This spontaneous report received from a consumer via media via a company representative concerned a female of an unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced pericarditis. It was reported that, "My wife got pericarditis after the j and j jab". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pericarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20221149386-Pericarditis. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: doses administered after excursion; No adverse event; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 22-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Oct-2022, 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 19-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after 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 (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    Concomitant products were not provided. Vaccines which underwent a temperature excursion in the freezer were viable, temperature excursion occurred several days ago in the Freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer. Patient did not report any adverse reaction. Treatment medication were not reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received the bivalent vaccine instead of the monovalent vaccine for second dose of the primary series; This spontaneous case was reported by a medical assistant and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the bivalent vaccine instead of the monovalent vaccine for second dose of the primary series) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Nov-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the bivalent vaccine instead of the monovalent vaccine for second dose of the primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the bivalent vaccine instead of the monovalent vaccine for second dose of the primary series) 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 WRONG PRODUCT ADMINISTERED (Patient received the bivalent vaccine instead of the monovalent vaccine for second dose of the primary series).    No concomitant information was reported. The patient received the first dose of the Moderna Covid-19 vaccine on 21-OCT-2022 and lot number 063B22A. It was reported that patient had no other adverse reactions. No treatment information was provided.   This case was linked to MOD-2022-676514 (Patient Link).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: doses administered after excursion; No adverse event; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 47-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Oct-2022, 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 19-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after 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 (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    Concomitant products were not provided. Temperature excursion occurred several days ago in the Freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer. Patient did not report any adverse reaction. Treatment medication were not reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: doses administered after excursion; doses administered after excursion; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion), PRODUCT STORAGE ERROR (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, 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 (doses administered after excursion), PRODUCT STORAGE ERROR (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion), PRODUCT STORAGE ERROR (doses administered after 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 (doses administered after excursion) and PRODUCT STORAGE ERROR (doses administered after excursion).    No concomitant information was reported. Reporter called to discuss a temperature excursion that occurred several days ago in the Freezer. Patient received vaccine from vaccine that underwent a temperature excursion in the Freezer. It was found out about the excursion in an audit. No adverse event reported. No treatment information was reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine; No adverse event; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, 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 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine).    No concomitant information was reported. Reporter called to discuss a temperature excursion that occurred several days ago in the Freezer. Patient received vaccine from vaccine that underwent a temperature excursion in the Freezer. It was found out about the excursion in an audit. No adverse event reported. No treatment information was reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question; No adverse event; Doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, 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 18-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) 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 (Doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question).    No concomitant medication was reported.  Reportedly, temperature excursion occurred several days ago in the Freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer. Patient did not report any adverse reaction.  No treatment information was reported.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question; No adverse event; Doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) and NO ADVERSE EVENT (No adverse event) in a 36-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2022, 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 20-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) 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 (Doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question).    No concomitant medication was reported.  Reportedly, temperature excursion occurred several days ago in the Freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer. Patient did not report any adverse reaction.  No treatment information was provided.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product name confusion, Wrong product administered
Clinical narrative: No adverse effects were reported; The HCP reported that she picked up PROQUAD instead of MMR II/ the caller said PROQUAD and VARIVAX was then administered to a 12 month old patient instead of VARIVAX and MMR II.; The HCP said she read MMR V and thought it was MMR II; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and allergies were not reported. The patient's concomitant medications included sterile diluent (manufacturer unknown) and an unspecified flu vaccine (manufacturer unknown).  On 11-NOV-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) subcutaneous injection at dose 5 milliter (ml) once (lot number W024972 was verified to be a valid number, expiration reported and established as 05-FEB-2024) (strength, anatomical injection site, route of administration and vaccination scheme were not provided), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (dose, strength, anatomical injection site, route of administration, lot number, expiration date and vaccination scheme were not provided) (wrong product administered). The HCP said she read MMR V and thought it was MMR II (product name confusion). On the same date, the patient also was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection at dose 5 ml once (strength, anatomical injection site, route of administration, lot number, expiration date and vaccination scheme were not provided). Both vaccines were administered for prophylaxis. No additional adverse events were reported.
Sex: U
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: feel like i had strong autoimmune response; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (feel like i had strong autoimmune response) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (feel like i had strong autoimmune response) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (feel like i had strong autoimmune response) outcome was unknown.            No concomitant medications details were reported.  Patient received first 3 doses of Moderna to which patient had zero reaction, however patient felt like patient had strong autoimmune response to dose number 3, so patient avoided dose number 4 until updated booster.   On 12-Sep-2022, patient received Pfizer bivalent vaccine booster, 10 months after dose 3.   No treatment medications details were reported.  Company comment. This spontaneous case concerns a patient (unknown age and gender), with no medical history reported, who received three doses of mRNA  1273 vaccine and experienced the unexpected, serious (medically significant) event of autoimmune disorder. The patient received 10 months after third dose of mRNA  1273 vaccine a dose of Pfizer COVID  19 vaccines. Latency cannot be properly assessed since exact onset date and vaccination date was not provided. The report stated that the patient experienced a strong autoimmune response to dose 3. No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient (unknown age and gender), with no medical history reported, who received three doses of mRNA  1273 vaccine and experienced the unexpected, serious (medically significant) event of autoimmune disorder. The patient received 10 months after third dose of mRNA  1273 vaccine a dose of Pfizer COVID  19 vaccines. Latency cannot be properly assessed since exact onset date and vaccination date was not provided. The report stated that the patient experienced a strong autoimmune response to dose 3. No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise
Clinical narrative: Felt sick but had no fever or anything after shots; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Felt sick but had no fever or anything after shots) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053F21A, 031421A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Injury (on the left side of the body).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced MALAISE (Felt sick but had no fever or anything after shots). At the time of the report, MALAISE (Felt sick but had no fever or anything after shots) had resolved.            No concomitant medications were reported.  The event onset date after the 1st dose was reported as 13-Feb-2021 and stop date was 15-Feb-2021, event onset date after the 2nd dose was reported as 13-Mar-2021 and stop date was 15-Mar-2021 and event onset date after the 3rd dose was reported as 18-Aug-2021 and event stop date was reported as 20-Aug-2021.   No treatment medications were reported.   This case was linked to MOD-2022-677266 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Arthritis, Gait inability, Inflammation
Clinical narrative: Felt sick but had no fever or anything after shots; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Felt sick but had no fever or anything after shots) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053F21A, 031421A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Injury (on the left side of the body).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced MALAISE (Felt sick but had no fever or anything after shots). At the time of the report, MALAISE (Felt sick but had no fever or anything after shots) had resolved.            No concomitant medications were reported.  The event onset date after the 1st dose was reported as 13-Feb-2021 and stop date was 15-Feb-2021, event onset date after the 2nd dose was reported as 13-Mar-2021 and stop date was 15-Mar-2021 and event onset date after the 3rd dose was reported as 18-Aug-2021 and event stop date was reported as 20-Aug-2021.   No treatment medications were reported.   This case was linked to MOD-2022-677266 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Pain
Clinical narrative: A little Achy After the first Monovalent booster; First Monovalent booster dose was given on 23DEC2021 and 2nd dose was given on 05MAY2021; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (A little Achy After the first Monovalent booster) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Monovalent booster dose was given on 23DEC2021 and 2nd dose was given on 05MAY2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 027C21A and 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease (Crohn's Disease for the past 2 years.) and Immunocompromised.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced PAIN (A little Achy After the first Monovalent booster) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Monovalent booster dose was given on 23DEC2021 and 2nd dose was given on 05MAY2021). At the time of the report, PAIN (A little Achy After the first Monovalent booster) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Monovalent booster dose was given on 23DEC2021 and 2nd dose was given on 05MAY2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had Crohn's Disease, It was under control prior to receiving the Moderna COVID-19 Vaccine. No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-677400, MOD-2022-677451 (Patient Link).