chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3rd dose given 4 weeks after 2nd; 1st dose 28Sept2022, 2nd dose 30Dec2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 5-month-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received 0.5 ml of 1st dose in an unknown thigh intramuscularly on 28th September 2022).   On 27th January 2023, the patient received the 3rd dose of Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 30th December 2022, the patient received the 2nd dose of Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 30th December 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On 27th January 2023, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too long and drug dose administration interval too short 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: 27-Jan-2023 Reporter's comment: The patient's mother stated that it was given at 4 weeks from the 2nd dose versus the 6 to 8 weeks as recommended in the prescribing information.   The reporter did not had any lot numbers for the vaccine. No follow-up with health care professional. The reporter did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Pediarix later than the recommended interval and 3rd dose of Pediarix earlier than the recommended interval, which led to lengthening of vaccine schedule and shortening of vaccine schedule. The 2nd dose was captured as suspect along with event drug dose administration interval too long based upon the vaccination dates.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Big red circle on arm,  below injection site; Big swollen circle on arm; Arm very sore to touch; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2023, the patient received the 1st dose of Shingrix. On 24th January 2023, less than a day after receiving Shingrix, the patient experienced erythema of extremities, swelling arm and pain in arm. On an unknown date, the outcome of the erythema of extremities, swelling arm and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comment: The case was self reported by the patient. The patient received first dose of Shingrix into unknown arm and afterwards developed a big red swollen circle on arm that was very sore to touch and it was about an inch below the injection site and it was still ongoing. The reporter did not have the lot number/expiration date of the dose. The patient reported that she was still experiencing these symptoms. Inadvertently did not collect if the affect arm was right of or left side. The reporter gave permission to save contact information. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Big red circle on arm,  below injection site; Big swollen circle on arm; Arm very sore to touch; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2023, the patient received the 1st dose of Shingrix. On 24th January 2023, less than a day after receiving Shingrix, the patient experienced erythema of extremities, swelling arm and pain in arm. On an unknown date, the outcome of the erythema of extremities, swelling arm and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comment: The case was self reported by the patient. The patient received first dose of Shingrix into unknown arm and afterwards developed a big red swollen circle on arm that was very sore to touch and it was about an inch below the injection site and it was still ongoing. The reporter did not have the lot number/expiration date of the dose. The patient reported that she was still experiencing these symptoms. Inadvertently did not collect if the affect arm was right of or left side. The reporter gave permission to save contact information. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Disease prodromal stage, Headache
Clinical narrative: Head ache; Premonitory symptoms, rash sensation; This case was reported by a physician via call center representative and described the occurrence of headache in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 9LG54, expiry date unknown) for prophylaxis.   On 7th August 2019, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and disease prodromal stage. On an unknown date, the outcome of the headache and disease prodromal stage were unknown.   It was unknown if the reporter considered the headache and disease prodromal stage to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comment: The reporter was the patient (health care professional) The physician called to inquire about the efficacy of Shingrix 3 years after the administration. The patient received their last dose on 7th August 2019, yet they attended a conference where it was stated that the efficacy diminished after a set amount of time.  The patient experienced adverse event as headache and premonitory symptoms. The premonitory symptoms they refer to the sensation in the area that a rash was going to appear. The reporter mentioned the symptoms but did not mention a specific time window.  The information about the vaccine and patient was recollected. The reporter reported that it was extremely difficult to make out what was said by the healthcare provider during the call.  The call was escalated to second line.  It was also difficult to understand as they went back and forth with the information provided. The reporter consent to follow up. Additional supportive information: The case had been linked with US2023AMR014478 reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR014478:Same reporter
Age: 0.33
Sex: U
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 4 Month old received Kinrix; Received Kinrix instead of Pediarix; Kinrix given as dose two of the DTaP series; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-Jan-2023 Reporter's comment: The nurse stated that  the medication error occurred at a different clinic and she did not had any additional details available so she did not consent to follow up from safety. Did not consent to follow-up.  Additional supportive information: The patient was inadvertently given Kinrix as dose two of the DTaP series instead of Pediarix at inappropriate age, which led to inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 12Oct2021, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 95-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Administered 1st dose of Shingrix on 12th October 2021, batch number:Z4427 and expiry date: 31-Jan-2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-FEB-2023 Reporter's Comment: The reporter and patient did not go back for 2nd dose of Shingrix.  The patient was now requesting the 2nd dose of Shingrix and 2nd dose had not yet been administered. Adverse event contained all reported information.  The reporter gave consent for safety team follow up. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak; This case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt date: 25-JAN-2023 Reporter comment: The GSK sales representative called the response center to report that a physician had informed her of an adverse event with Shingrix. The patient received 1st dose of shingrix and later developed Shingles. The reporter consented to follow up.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 23-year-old female patient who received HAV (Havrix 1440) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 1st February 2023, the patient received the 1st dose of Havrix 1440. On 1st February 2023, unknown after receiving Havrix 1440, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.    Additional Information: GSK Receipt date: 01-Feb-2023. Reporter's Comment: Pharmacy supervisor reported a nurse alerted her that a patient was administered a dose of Havrix which was already expired. Reporter believed this was patient's first dose in the series.  At the time of reporting, the dose has not been repeated. The reporter consented to follow-up. Additional Supportive Information: Patient received an expired Havrix vaccine, which led to expired vaccine used.
Age: 73.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: dose that expired was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 73-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st February 2023, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 1st February 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-FEB-2023 Reporter's Comment: The health care professional called to inform that a dose of Twinrix that expired and was administered to a patient.  The reporter consented to follow up. Additional Supportive Information: Expired Twinrix vaccine was administered to a patient, which led to expired vaccine used.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 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: 02-FEB-2023 Reporter's Comments: The reporter reported that the patient received an expired dose of Havrix. The vaccine expired on 30th January 2023. The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/1st dose on 01Mar2020, 2nd on 04Jun2020, had shingles 3x since then; Shingles 3x; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 4th June 2020, the patient received the 2nd dose of Shingrix. On 1st March 2020, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 2-Feb-2023 Reporter's comment: The patient stated he received his 2 doses of Shingrix and since then, the patient had experienced 3 recurrences of shingles.  Each time he was treated with Valacyclovir. The patient provided limited information.   The patient needed to end the call as he needed to leave for an appointment. Did not consent to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pruritus, Skin lesion
Clinical narrative: HORRIBLE ITCHING; SORES ALL OF BODY; This spontaneous report received from a patient via a company representative concerned a 7 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient did not had known drug allergies and drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 7 decade old. No concomitant medications were reported. On 2021, the patient experienced horrible itching, and sores all of body. Laboratory data (dates unspecified) included: Blood test could not find anything was allergic too. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from horrible itching, and sores all of body. This report was non-serious. This case is a duplicate of 20230207847.
Sex: U
Vaccine: COVID19
Symptoms: Radiculitis brachial
Clinical narrative: SEVERE BRACHIAL NEURITIS / LEFT HAND NUMB, LEFT THUMB USELESS / COULD NOT GRIP TOOLS SAFELY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced severe brachial neuritis / left hand numb, left thumb useless / could not grip tools safely. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe brachial neuritis / left hand numb, left thumb useless / could not grip tools safely. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site pain was not reported. This report was non-serious. This case, involving the same patient is linked.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 adults patients received doses after its beyond use date), PRODUCT STORAGE ERROR (Date vials were initially thawed: shipment received in liquid state on Oct 11 2022, vaccine was administered on 17-Nov-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061f22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 adults patients received doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date vials were initially thawed: shipment received in liquid state on Oct 11, 2022, vaccine was administered on 17-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 adults patients received doses after its beyond use date), PRODUCT STORAGE ERROR (Date vials were initially thawed: shipment received in liquid state on Oct 11, 2022, vaccine was administered on 17-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 adults patients received doses after its beyond use date) and PRODUCT STORAGE ERROR (Date vials were initially thawed: shipment received in liquid state on Oct 11, 2022, vaccine was administered on 17-Nov-2022).    Concomitant product use was not provided by the reporter.  Vials did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-706651 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-706651:Master case - 1st adult patient MODERNATX, INC.-MOD-2023-706901:2nd adult MODERNATX, INC.-MOD-2023-706942:Master case - 2nd adult patient
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).    This case contains information for the 3rd 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 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:Patient 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 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.  It was reported that the patient received a dose of Moderna vaccine post excursion.  Treatment information was not provided by the reporter.  This case contains information for 2nd of the 19 patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-706941 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-706941: Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Each patient received dose of Moderna vaccine post excursion; Each 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 (Each patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Each 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 POOR QUALITY PRODUCT ADMINISTERED (Each patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Each 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 (Each patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Each 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 (Each patient received dose of Moderna vaccine post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Each patient received dose of Moderna vaccine post excursion).    No concomitant medications were reported.  This case contains information for the 12th of 19 patients reported by the reporter.   No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:Pt 1 of 19 (master case)
Sex: U
Vaccine: COVID19-2
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 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.  It was reported that patient received the bivalent dose of Moderna vaccine post excursion.  Treatment information was not provided.  This case contains information for the 15th of 19 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:Patient 1 of 19
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patients got doses after the 30-day beyond use date; Vial was initially stored in refrigerator on 15NOV2022 and first dose was administered on 16DEC2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15NOV2022 and first dose was administered on 16DEC2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 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) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15NOV2022 and first dose was administered on 16DEC2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15NOV2022 and first dose was administered on 16DEC2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15NOV2022 and first dose was administered on 16DEC2022).    The case contains the information of 4th out of 14 patients who had received the vaccine as described by the reporter.  No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.   It was reported that the pharmacist had received the vaccine order on 15Nov2022 and accidently put the expiration date as 10 weeks instead of 30 days. 14 patients got the vaccine beyond use date and the reporter was enquiring the patients need to be re-vaccinated.  The size of the vial was reported as 2.5ml and vial was initially stored in refrigerator on 15Nov2022.  The doses were administered on 16Dec2022, 28Dec2022, 4Jan2023, 7Jan2023, 9Jan2023, 11Jan2023, 13Jan2023, and 18Jan2023. It was confirmed that the vial had not undergone any temperature excursion issue.  No treatment medication information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706920 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706920:MASTER  CASE
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patients got doses after the 30-day beyond use date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 16-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date) 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 EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date).    This case contains information for the 5th of 14 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  It was reported that there was no information about the previous COVID-19 vaccination doses.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The pharmacist received a Moderna order on 15 November 2022 but, accidentally put the expiration date as 10 weeks instead of 30 days. Some patients got doses after the 30-day beyond use date.   The vial size was reported as 2.5 ml.  The vial was initially stored in the refrigerator on 15 November 2022.  The vial did not undergo any temperature excursions.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706920 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706920:Master Case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: patients got doses after the 30-day beyond use date; Vial was initially stored in refrigerator on 15NOV2022 and first dose was administered on 16DEC2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15NOV2022 and first dose was administered on 16DEC2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 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) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15NOV2022 and first dose was administered on 16DEC2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15NOV2022 and first dose was administered on 16DEC2022) 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 EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15NOV2022 and first dose was administered on 16DEC2022).    This case contains information of 10th patient out of 14 patients as described by the reporter.  No concomitant medication was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.   It was reported that the pharmacist had received the vaccine order on 15-Nov-2022 and accidently put the expiration date as 10 weeks instead of 30 days. 14 patients got the vaccine beyond use date and the reporter was enquired the patients need to be re-vaccinated.   Reportedly, vial size included 2.5mL and date the vial was initially stored in the refrigerator on 15-Nov-2022 and the dates vaccine were administered on 16-Dec-2022, 28-Dec-2022, 4-Jan-2023, 7-Jan-2023, 9-Jan-2023, 11-Jan-2023, 13-Jan-2023, and 18-Jan-2023 and the vial did not undergone any temperature excursions.   Treatment medication was not provided by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-706920 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-706920: MASTER CASE
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: patients got doses after the 30-day beyond use date; patients got doses after the 30-day beyond use date; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (patients got doses after the 30-day beyond use date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender 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 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) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (patients got doses after the 30-day beyond use date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (patients got doses after the 30-day beyond use date) 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 EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date) and PRODUCT STORAGE ERROR (patients got doses after the 30-day beyond use date).    The case contains the information of 11th out of 14 patients who had received the vaccine as described by the reporter.  No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.   It was reported that the pharmacist had received the vaccine order on 15Nov2022 and accidently put the expiration date as 10 weeks instead of 30 days. 14 patients got the vaccine beyond use date and the reporter was enquiring the patients need to be re-vaccinated.  The size of the vial was reported as 2.5ml and vial was initially stored in refrigerator on 15Nov2022.  The doses were administered on 16Dec2022, 28Dec2022, 4Jan2023, 7Jan2023, 9Jan2023, 11Jan2023, 13Jan2023, and 18Jan2023. It was confirmed that the vial had not undergone any temperature excursion issue.  No treatment medication information was provided by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-706920 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-706920: MASTER CASE.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patients got doses after the 30-day beyond use date; Product storage error; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 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) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date) and PRODUCT STORAGE ERROR (Product storage error).    This case included information of patient 13th out of 14 patients.  No concomitant product reported by reporter.  Reporter had no information about previous COVID-19 vaccination doses. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The pharmacist received a Moderna order on 15Nov2022 but accidentally put the expiration date as 10 weeks instead of 30 days. Some patients got doses after the 30-day beyond use date. Vial size was 2.5 ml. Date the vial was initially stored in refrigerator was 15-Nov-2022 and administration dates were 16-Dec-2022, 28-Dec-2022, 04-Jan-2023, 07-Jan-2023, 09-Jan-2023, 11-Jan-2023, 13-Jan-2023 and 18-Jan-2023. Vial did not undergone any temperature excursion issue.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706920 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706920:MASTER  CASE
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: patients got doses after the 30-day beyond use date; Vial was initially stored in refrigerator on 15-Nov-2022 and first dose was administered on 16-Dec-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15-Nov-2022 and first dose was administered on 16-Dec-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 20221216) 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) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15-Nov-2022 and first dose was administered on 16-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15-Nov-2022 and first dose was administered on 16-Dec-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15-Nov-2022 and first dose was administered on 16-Dec-2022).    This case contains information of 14th patient out of 14 patients as described by the reporter.  No concomitant medication was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.   It was reported that the pharmacist had received the vaccine order on 15-Nov-2022 and accidently put the expiration date as 10 weeks instead of 30 days. 14 patients got the vaccine beyond use date and the reporter was enquired the patients need to be re-vaccinated.   Reportedly, vial size included was 2.5mL and date the vial was initially stored in the refrigerator on 15-Nov-2022 and the dates vaccine were administered on 16-Dec-2022, 28-Dec-2022, 4-Jan-2023, 7-Jan-2023, 9-Jan-2023, 11-Jan-2023, 13-Jan-2023, and 18-Jan-2023 and the vial did not undergo any temperature excursions.   Treatment medication was not provided by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-706920 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-706920: Master case