chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: received his 2nd dose of Shingrix, 30-DEC-2019 in his left arm as a subcutaneous injection; This non-serious case was reported by a consumer via call center representative and described the occurrence of intramuscular formulation administered by other route in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 28th September 2019 as a intramuscular injection in his left arm).   On 30-DEC-2019, the patient received the 2nd dose of Shingrix (subcutaneous, left arm). On 30-DEC-2019, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: received his 2nd dose of Shingrix, 30-DEC-2019 in his left arm as a subcutaneous injection). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 27-JUN-2023 The case was reported by patient's wife. The consent to follow up with healthcare professional was not asked as the patient was not on the phone. The reporter reported that the patient received his 2nd dose of Shingrix in his left arm as a subcutaneous injection rather than intramuscularly, which led to intramuscular formulation administered by other route. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023089237:Same reporter
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo non-approved diluent/sterile water was used to reconstitute Menveo; Menveo non-approved diluent/sterile water was used to reconstitute Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo non-approved diluent/sterile water was used to reconstitute Menveo) and inappropriate dose of vaccine administered (Verbatim: Menveo non-approved diluent/sterile water was used to reconstitute Menveo). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-JUN-2023 The healthcare professional declined providing any information about the patient and vaccine. No consent to follow up because healthcare professional declined information to be stored and requested to be anonymous. The reporter did not consent to follow-up. The reporter reported that sterile water was used to reconstitute Menveo and it was administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 56.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Infanrix- Dtap instead of Tdap; Infanrix- Dtap instead of Tdap; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 56-year-old male patient who received DTPa (Infanrix) (batch number Y4259, expiry date 03-MAR-2024) for prophylaxis.   On 23-MAY-2023, the patient received Infanrix. On 23-MAY-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Infanrix- Dtap instead of Tdap) and inappropriate age at vaccine administration (Verbatim: Infanrix- Dtap instead of Tdap). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-JUN-2023 The reporter asked how to proceed with this patient. The reporter consented to follow up. The reporter reported that the administration of Infanrix instead of Boostrix to a 56 year old patient, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Late 2nd dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years (in 2021) before reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Late 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-JUN-2023 Nurse Practitioner asked if a patient took the original dose of Shingrix and they had not taken second dose, would the patient need to start again. Follow up with the Sales Representative was granted via email. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired dose of Menveo was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA580A, expiry date 31-AUG-2022) for prophylaxis.   On 07-SEP-2022, the patient received Menveo. On 07-SEP-2022, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: expired dose of Menveo was administered to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 28-JUN-2023 The reporter was a Clinical Supervisor. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expired dose of Infanrix (booster) was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 23-JUN-2023, the patient received Infanrix. On 23-JUN-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: expired dose of Infanrix (booster) was administered to a patient). 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: 29-JUN-2023 A pharmacist reported about a patient who received expired dose of Infanrix (booster). The Vaccine Administration Facility was the same as primary reporter. The reporter was consented to follow up via postal.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Never came back for the remainder doses; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 42-year-old female patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included Twinrix adult (1st dose received on 22nd July 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced incomplete course of vaccination (Verbatim: Never came back for the remainder doses). The outcome of the incomplete course of vaccination 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: 29-JUN-2023 The reporter wanted to know how to proceed with the Twinrix vaccine series. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Twinrix adult vaccine, which led to incomplete course of vaccination.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Shingrix subcutaneously instead of IM; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 2KK72, expiry date 17-JUN-2024) for prophylaxis.   On 29-JUN-2023, the patient received Shingrix (subcutaneous). On 29-JUN-2023, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Shingrix subcutaneously instead of IM). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 29-Jun-2023 No reactions were reported. The reporter consented to follow-up via email. The patient received Shingrix subcutaneously instead of intramuscular, led to intramuscular formulation administered by other route.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Nurse administered a Menveo powder with sterile water; Nurse administered a Menveo powder with sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA933A, expiry date 30-JUN-2024) for prophylaxis.   On 29-JUN-2023, the patient received Menveo. On 29-JUN-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Nurse administered a Menveo powder with sterile water) and inappropriate dose of vaccine administered (Verbatim: Nurse administered a Menveo powder with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-JUN-2023 A nurse administered a Menveo powder with sterile water taken from the MMR vaccine and not with the diluent provided by GSK, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up via email.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix: only diluent administered; Shingrix: only diluent administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number Y7PP4, expiry date 07-MAY-2025) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix: only diluent administered) and inappropriate dose of vaccine administered (Verbatim: Shingrix: only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-JUN-2023 The healthcare professional narrowed it down to 10 patients but not sure which of the 2 received only the diluent. No other information available of patient was available. The reporter consented to follow up. The reporter believed that the patient received only the diluent portion of the Shingrix vaccine and not the powder as they found 2 vial of antigen left in the box, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR091600:same reporter
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: never received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included Twinrix adult (received 1st dose in December 2022 with batch number 2KE55 and expiry date 22nd September 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced incomplete course of vaccination (Verbatim: never received the second dose). The outcome of the incomplete course of vaccination 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: 30-JUN-2023 The pharmacist called to inquired how to proceed with the Twinrix series. Any guidance on remainder doses. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Twinrix adult, which led to incomplete course of vaccination.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Shingles; late 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 07-JUN-2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles) and incomplete course of vaccination (Verbatim: late 2nd dose). The outcome of the shingles was not reported and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-JUN-2023 The reporter was a medical assistant. The reporter stated that the patient had a history of shingles; it was unknown if the episode of shingles occurred before or after the 1st dose of Shingrix. The reporter reported that the patient received the 1st dose of Shingrix and was late for the 2nd dose. The healthcare professional consented to follow-up via email. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number TM449, expiry date 02-JUN-2023) for prophylaxis.   On 30-JUN-2023, the patient received the 1st dose of Shingrix. On 30-JUN-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: expired dose of Shingrix (1st dose) administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 30-JUN-2023 The reporter consented to follow up. The reporter reported that an expired dose of Shingrix administered, which led to expired vaccine used.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEPA, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: vaccines were exposed to a low temperature of 29F in April 2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, HAV (Havrix) for prophylaxis and DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Infanrix, Menveo, Boostrix, Pediarix, Havrix and Kinrix. On an unknown date, an unknown time after receiving Infanrix, Menveo, Boostrix, Pediarix, Havrix and Kinrix, the patient experienced incorrect storage of drug (Verbatim: vaccines were exposed to a low temperature of 29F in April 2023). The outcome of the incorrect storage of drug 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: 30-JUN-2023 The reporter was a medical assistant. The reporter reported that Kinrix, Havrix, Pediarix, Boostrix, Menveo (2 vial formulation) and Infanrix vaccines were exposed to a low temperature of 29 degree F in April 2023.  It was not noticed at the time and the vaccines were subsequently administered to patients.  At the time of reporting, she did not have any patient details, lot number/expiration date information, and she did not know how many vaccines were administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter reported that Kinrix, Havrix, Pediarix, Boostrix, Menveo (2 vial formulation) and Infanrix vaccines were exposed to a low temperature of 29 degree F and administered, which led to incorrect storage of drug.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 30-JUN-2023 The reporter was an office manager. The reporter asked if patient get Shingrix out of the 2-6 month window, what was the expected efficacy. The reporter would share the response with the providers. The reporter did not speak with the Health Care Provider and asked to follow up with the Sales Rep for more information.  The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received only one dose of shingrix on 2020; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received only one dose of shingrix on 2020). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-JUN-2023 The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: a patient received only the liquid portion of Menveo; a patient received only the liquid portion of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA955A, expiry date 31-JUL-2024) for prophylaxis.   On 29-JUN-2023, the patient received the 1st dose of Menveo. On 29-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: a patient received only the liquid portion of Menveo) and inappropriate dose of vaccine administered (Verbatim: a patient received only the liquid portion of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-JUN-2023 The reporter reported that a patient received only the liquid portion of Menveo and wished to receive information about how to proceed.  The information about the event, vaccine and patient was given. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter reported that a patient received only the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique/received a dose of just diluent; Inappropriate Reconstitution Technique/received a dose of just diluent; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique/received a dose of just diluent) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique/received a dose of just diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-JUN-2023 The reporter request sent by sales representative on behalf of the healthcare professional that Priorix customer got to the end of a box of Priorix, realized they had one vial of vaccine left.  The tracked down record of the 10 patients who received Priorix.  The 3 patients had been ruled out, one of the remaining 7 patients received a dose of just diluent of Priorix.  The customer was wondering how to proceed with remaining patients and if they need to re-administer. The Vaccine Administration Facility was the same as Primary Reporter. No additional information was available.  It was unknown if permissible to follow up The patient received a dose of just diluent of Priorix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: Appendicitis; This literature-non-study case was reported in a literature article and describes the occurrence of APPENDICITIS (Appendicitis) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE:  No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced APPENDICITIS (Appendicitis) (seriousness criterion medically significant). At the time of the report, APPENDICITIS (Appendicitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  This study described simultaneous vaccination (SV) with primary series COVID-19 vaccines and assess 23 pre-specified health outcomes following SV among persons aged =5 years.  This study utilized COVID-19 vaccine surveillance data from December 11, 2020-May 21, 2022. Analyses assessed frequency.   Rate ratios (RRs) were estimated by Poisson regression when the number of outcomes was =5 across both doses, comparing outcome rates between COVID-19 vaccinees receiving and COVID-19 vaccinees receiving no in the 1-21 days following COVID-19 vaccine dose 1 and 1-42 days following dose 2 by SV type received.  The most frequent simultaneous vaccines were influenza, HPV, Tdap, and meningococcal. Outcomes following with COVID-19 vaccines were rare (total of 56 outcomes observed after dose 1 and dose 2). Overall rate of outcomes among COVID-19 vaccinees who received SV was not statistically significantly different than the rate among those who did not receive.  The most frequent simultaneous vaccines were influenza, HPV, Tdap, and meningococcal. Outcomes following SV with COVID-19 vaccines were rare (total of 56 outcomes observed after dose 1 and dose 2). Overall rate of outcomes among COVID-19 vaccines who received SV was not statistically significantly different than the rate among those who did not receive.  This is a literature non-study case concerning a patient of unknown age and gender with no reported medical history, who experienced the serious (due to medically significant) unexpected, AESI appendicitis. The event occurred after a dose of mRNA-1273 vaccine. (no date provided so latency could not be calculated) No treatment nor diagnostic test provided. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-731248 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731248:Seizure patient
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date) 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)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2023, 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 22-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date).    No patient details were provided.  Concomitant product use was not provided by the reporter.  It was reported that dose was administered after 30-day Use by Date or after manufacturer Date of Expiry. Individual vial size was reported as 2.5 ml. Dates vial was initially stored was 19-Jun-2023, 22-Jun-2023, and 23-Jun-2023. Vial did not undergo any temperature excursions. Vials were administered on 19-Jun-2023 (1Patient), 22-Jun-2023 (2 patients), and 23-Jun-2023 (2 Patients). Reporter stated that he wanted to wait on the assessment as it was just 1 day after expiration date. Suspect product dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 4th out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730746 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730746:Mater case
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Muscle spasms, Throat cancer
Clinical narrative: The client has had throat cancer since getting the vaccine; She also has these cramps that she gets in her stomach; Arms and hand cramps; This spontaneous case was reported by a patient and describes the occurrence of THROAT CANCER (The client has had throat cancer since getting the vaccine) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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 THROAT CANCER (The client has had throat cancer since getting the vaccine) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (She also has these cramps that she gets in her stomach) and MUSCLE SPASMS (Arms and hand cramps). At the time of the report, THROAT CANCER (The client has had throat cancer since getting the vaccine), ABDOMINAL PAIN UPPER (She also has these cramps that she gets in her stomach) and MUSCLE SPASMS (Arms and hand cramps) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided. Company Comment: This is a spontaneous case concerning a female patient of an unknown age with no reported medical history, who experienced the serious (due to medically significant) unexpected, event of throat cancer, together with other non-serious events, which occurred on an unknown day after a dose of RNA-1273 Bivalent .222 (original and omicron BA.4/BA.5) vaccine (unknown COVID-19 vaccination schedule). The outcome of the event was reported as recovering. No further information was disclosed. The benefit-risk relationship of RNA-1273 Bivalent .222 (original and omicron BA.4/BA.5) vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Autoimmune disorder, Hypertension, Pain, Vision blurred
Clinical narrative: developed an Auto Immune Disease; still having blurred vision; hypertension; aches; joint pain; This spontaneous case was reported by an other health care professional and describes the occurrence of AUTOIMMUNE DISORDER (developed an Auto Immune Disease) and VISION BLURRED (still having blurred vision) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (developed an Auto Immune Disease) (seriousness criterion medically significant), VISION BLURRED (still having blurred vision) (seriousness criterion medically significant), HYPERTENSION (hypertension), PAIN (aches) and ARTHRALGIA (joint pain). At the time of the report, AUTOIMMUNE DISORDER (developed an Auto Immune Disease), HYPERTENSION (hypertension), PAIN (aches) and ARTHRALGIA (joint pain) outcome was unknown and VISION BLURRED (still having blurred vision) had not resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that patient looks like having to retire from  job. The COVID vaccines were not part of the Countermeasure Program where the patient reported adverse effect day one. It was unknown if the patient experienced any additional symptoms/events. No treatment medication were provided.  Company comment: This spontaneous case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected, serious (medically significant) events of autoimmune disorder and vision blurred an unknown time after a dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as unknown for autoimmune disorder and not resolved for vision blurred. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: woke up swollen, ears were very large, very itchy. He had urticaria/hives; woke up swollen, ears were very large, very itchy. He had urticaria/hives/he is still a bit itchy and red; woke up swollen, ears were very large, very itchy. He had urticaria/hives/he is still a bit itchy and red; woke up swollen, ears were very large, very itchy. He had urticaria/hives; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (woke up swollen, ears were very large, very itchy. He had urticaria/hives), PRURITUS (woke up swollen, ears were very large, very itchy. He had urticaria/hives/he is still a bit itchy and red), ERYTHEMA (woke up swollen, ears were very large, very itchy. He had urticaria/hives/he is still a bit itchy and red) and URTICARIA (woke up swollen, ears were very large, very itchy. He had urticaria/hives) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 021B21A and 003A21A) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included Pain (Constant pain). Concurrent medical conditions included Disability and Nervous system injury.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, 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 experienced SWELLING (woke up swollen, ears were very large, very itchy. He had urticaria/hives), PRURITUS (woke up swollen, ears were very large, very itchy. He had urticaria/hives/he is still a bit itchy and red), ERYTHEMA (woke up swollen, ears were very large, very itchy. He had urticaria/hives/he is still a bit itchy and red) and URTICARIA (woke up swollen, ears were very large, very itchy. He had urticaria/hives). The patient was treated with FAMOTIDINE for Swelling, Itching and Urticaria, at an unspecified dose and frequency. At the time of the report, SWELLING (woke up swollen, ears were very large, very itchy. He had urticaria/hives), PRURITUS (woke up swollen, ears were very large, very itchy. He had urticaria/hives/he is still a bit itchy and red), ERYTHEMA (woke up swollen, ears were very large, very itchy. He had urticaria/hives/he is still a bit itchy and red) and URTICARIA (woke up swollen, ears were very large, very itchy. He had urticaria/hives) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Patient was also taking allergy pills.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Headache
Clinical narrative: started to experience headaches and "piiiipiiii" on the head; patient started to experience headaches; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (started to experience headaches and "piiiipiiii" on the head) and HEADACHE (patient started to experience headaches) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 13334518 and 030a31a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced HEAD DISCOMFORT (started to experience headaches and "piiiipiiii" on the head) and HEADACHE (patient started to experience headaches). At the time of the report, HEAD DISCOMFORT (started to experience headaches and "piiiipiiii" on the head) outcome was unknown and HEADACHE (patient started to experience headaches) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking several medication.   Reporter did not allow further contact
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Administered expired vaccine on 28-JUN-2023 that expired 17-JUN-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine on 28-JUN-2023 that expired 17-JUN-2023) and NO ADVERSE EVENT (no adverse event) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jun-2023, 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 17-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine on 28-JUN-2023 that expired 17-JUN-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine on 28-JUN-2023 that expired 17-JUN-2023) 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 (Administered expired vaccine on 28-JUN-2023 that expired 17-JUN-2023).    No concomitant medication was reported.  No treatment information was reported.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after Manufacturer Date of Expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No adverse event) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     It was reported that Hcp did not report any medical History or condition for the patient. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (1st dose) on 18-Aug-2021; for COVID-19 vaccination: COVID-19 VACCINE (2nd dose). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and Moderna COVID-19 Vaccine.    On 21-Jun-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 21-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry) 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 (Dose administered after Manufacturer Date of Expiry).    No concomitant information was reported. It was reported that the vaccine been expired about 8 or more days. Patient was not aware that he received an expired dose. No treatment information was provided.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; expired vaccine was administered  to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered  to patient) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     Medical History or Condition for the patient was not reported. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (dose 1 and  lot number was 031H21A) on 26-Nov-2021; for COVID-19 vaccination: COVID-19 VACCINE (dose 2). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and MODERNA COVID-19 VACCINE.    On 13-Jun-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 13-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered  to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered  to patient) 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 (expired vaccine was administered  to patient).    No concomitant medication was reported. It was reported that 4 expired vaccines were administered to 4 different patients. It was reported that the vaccine been expired about 8 or more days. Patient was not aware that he received an expired dose. No treatment medication was reported.  This case contains information about patient 2nd out of 4 patients.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Attention deficit hyperactivity disorder, Poor quality product administered, Product administration error, Psychotic disorder
Clinical narrative: a patient received the Pfizer Bivalent COVID Vaccine for adults on Day 71 after being placed in the refrigerator; a patient received the Pfizer Bivalent COVID Vaccine for adults on Day 71 after being placed in the refrigerator; anxiety; psychotic; ADHD; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 38-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown" and all described as "a patient received the Pfizer Bivalent COVID Vaccine for adults on Day 71 after being placed in the refrigerator"; ANXIETY (non-serious), outcome "unknown"; PSYCHOTIC DISORDER (non-serious), outcome "unknown", described as "psychotic"; ATTENTION DEFICIT HYPERACTIVITY DISORDER (non-serious), outcome "unknown", described as "ADHD". Therapeutic measures were taken as a result of anxiety, psychotic disorder, attention deficit hyperactivity disorder.  Additional information: Caller wanted to get information after a patient received the Pfizer Bivalent COVID Vaccine for adults on Day 71 after being placed in the refrigerator. Caller confirmed that the vaccine did not have any excursions. Caller stated that her colleague had already called to report the AE. Caller did not have patient details. She is on anti anxiety, anti psychotic and ADHD medications.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.  Follow (29Jun2023): This is a spontaneous follow-up report received from a contactable Pharmacist. This Pharmacist reported in response to the Non-HCP letter via email follow up that included: Updated information: new events added  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Blindness, Dizziness, Headache, Loss of consciousness
Clinical narrative: After the vaccine, within minutes had dizziness, loss of vision, syncopal episode in hallway leaving the exam room.  Loss of consciousness for several seconds.  Headaches for 2 days.  Staring episodes, stiffness, non-reacting intermittently next few days.  Weakness and body aches.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Pain, Staring, Syncope
Clinical narrative: After the vaccine, within minutes had dizziness, loss of vision, syncopal episode in hallway leaving the exam room.  Loss of consciousness for several seconds.  Headaches for 2 days.  Staring episodes, stiffness, non-reacting intermittently next few days.  Weakness and body aches.