chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Physician reporting possible late 2nd dose and physician unsure of date of when he received 1st dose of Shingrix. He reports it as "6 months ago".; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 6 months ago).   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: Physician reporting possible late 2nd dose and physician unsure of date of when he received 1st dose of Shingrix. He reports it as "6 months ago".). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-JUL-2023 and 19-JUL-2023 The reporter was reporting possible late 2nd dose of Shingrix.  The reporter was unsure of date of when he received 1st dose of Shingrix and he reported that it was 6 months ago. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave consent for safety team follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Heart rate increased, Pyrexia
Clinical narrative: Physician reports he experienced erythema 1 foot long, chills, fevers, elevated HR- for 3 days.; Physician reports he experienced erythema 1 foot long, chills, fevers, elevated HR- for 3 days.; Physician reports he experienced erythema 1 foot long, chills, fevers, elevated HR- for 3 days.; Physician reports he experienced erythema 1 foot long, chills, fevers, elevated HR- for 3 days.; This non-serious case was reported by a physician via call center representative and described the occurrence of heart rate increased in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In JUL-2023, an unknown time after receiving Shingrix, the patient experienced heart rate increased (Verbatim: Physician reports he experienced erythema 1 foot long, chills, fevers, elevated HR- for 3 days.), erythema (Verbatim: Physician reports he experienced erythema 1 foot long, chills, fevers, elevated HR- for 3 days.), chills (Verbatim: Physician reports he experienced erythema 1 foot long, chills, fevers, elevated HR- for 3 days.) and fever (Verbatim: Physician reports he experienced erythema 1 foot long, chills, fevers, elevated HR- for 3 days.). On 18-JUL-2023, the outcome of the heart rate increased, erythema, chills and fever were resolved (duration 3 days).   It was unknown if the reporter considered the heart rate increased, erythema, chills and fever to be related to Shingrix.     It was unknown if the company considered the heart rate increased, erythema, chills and fever to be related to Shingrix.   Additional Information: GSK receipt date: 18-JUL-2023 Physician reported he experienced erythema 1 foot long, chills, fevers, elevated heart rate for 3 days. The Vaccine Administration Facility is the same as Primary Reporter. Consented to follow up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental underdose, Syringe issue, Underdose
Clinical narrative: Underdose/received a little more than half a first dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number 2BR9G, expiry date 09-JUL-2024) for prophylaxis.   On 18-JUL-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 18-JUL-2023, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: Underdose/received a little more than half a first dose of Shingrix). The outcome of the accidental underdose was unknown.   Additional Information: GSK receipt date: 18-JUL-2023 The reporter was the HCP (pharmacist). The patient received a little more than half a first dose of Shingrix. The syringe malfunctioned and the remainder of the dose leaked out. Nothing else was reported.  PQC was ruled out. The vaccine Administration Facility was the same as Primary Reporter. Consented to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema
Clinical narrative: feeling "very tired"; redness at the injection site; he had shivers last night; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-JUL-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm). In JUL-2023, less than a day after receiving Shingrix, the patient experienced tiredness (Verbatim: feeling "very tired"), injection site erythema (Verbatim: redness at the injection site) and shivering (Verbatim: he had shivers last night). The outcome of the tiredness was not resolved and the outcome of the injection site erythema and shivering were resolved.   It was unknown if the reporter considered the tiredness, injection site erythema and shivering to be related to Shingrix.     It was unknown if the company considered the tiredness, injection site erythema and shivering to be related to Shingrix.   Additional Information: GSK receipt date: 18-JUL-2023 The reporter was the patient.  Reporter stated he had shivers last night  Patient reported feeling very tired .  Patient also reported redness at the injection site. The reporter did not provide date of his first Shingrix dose. The reporter did not report adverse event with the first dose.  Not all information was available. Lot and expiry date was unknown. The reporter provided consent to follow up with HCP.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: red streaks down the arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: red streaks down the arm). The outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.     It was unknown if the company considered the erythema of extremities to be related to Shingrix.   Additional Information: GSK receipt date: 18- JUL-2023 Pharmacist stated that a patient reported to her that after receiving her dose of Shingrix she had red streaks down her arm. The Vaccine Administration Facility was the same as Primary Reporter. Did not consent to follow-up.
Age: 2.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix was administered to a 2 year old patient inadvertently on 17Jul2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number DR2GR, expiry date 29-NOV-2024) for prophylaxis.   On 17-JUL-2023, the patient received Boostrix. On 17-JUL-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix was administered to a 2 year old patient inadvertently on 17Jul2023). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 19-JUL-2023 The reporter was a medical assistant. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via mail. The reporter reported that a dose of Boostrix was administered to a 2 year old patient inadvertently, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administration of only the liquid component of Menveo; administration of only the liquid component of Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: administration of only the liquid component of Menveo) and inappropriate dose of vaccine administered (Verbatim: administration of only the liquid component of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-JUL-2023 The healthcare professional asked for guidance on this situation. The reporter did not provide patient information nor data about the dose of Menveo (lot number, expiry date). The reporter consented to follow up. The reporter called to report that the administration of only the liquid component of Menveo to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-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 (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    Concomitant product use was not provided by the reporter.  On 10-Jun-2023, the vial was initially thawed.  On 17-Jun-2023, the vial was administered with 2.  Treatment information was not provided.  This case contains information for the 15th patient out of 30 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report). This case was linked to MOD-2023-733204 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live follow-up information received included Suspect details and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:master case (Patient 1)
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Pollakiuria
Clinical narrative: couldn't stop urinating; lost of feeling; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (couldn't stop urinating) and FEELING ABNORMAL (lost of feeling) in an 84-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Breast cancer and Allergy (Allergic to suffer).    On 13-Sep-2022, the patient received fifth 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 POLLAKIURIA (couldn't stop urinating) and FEELING ABNORMAL (lost of feeling). At the time of the report, POLLAKIURIA (couldn't stop urinating) and FEELING ABNORMAL (lost of feeling) outcome was unknown.        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 drug information was provided. Patient had received monovalent dose 3 on 31-Aug-2021, lot number 045LZ1A and dose 4 on 17-Mar-2022.  No treatment drug information was provided.   This case was linked to MOD-2023-733251 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2023: Follow-up received, updated the events.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral venous thrombosis
Clinical narrative: Cerebral Venous Thrombosis; This literature-non-study case was reported in a literature article and describes the occurrence of CEREBRAL VENOUS THROMBOSIS (Cerebral Venous Thrombosis) in a 29-year-old female patient 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 CEREBRAL VENOUS THROMBOSIS (Cerebral Venous Thrombosis) (seriousness criterion medically significant). At the time of the report, CEREBRAL VENOUS THROMBOSIS (Cerebral Venous Thrombosis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment:  This is a Literature-Non-Study case concerning a 29-year-old, female patient with no relevant reported medical history, who experienced the unexpected serious (medically significant) event of Cerebral venous thrombosis which occurred after the administration of a dose of mRNA-1273 vaccine. Latency could not be assessed due to lack of information. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.) 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 13-Jul-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 13-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.) 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 (4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.).    Concomitant product use was not provided by the reporter.  4 doses were administered after 30-day Use by date or after Manufacturer Date of Expiry in a health center nearby. This happened at a different location, not at the facility were he works, so reporter states he did not had any additional information. Expiry date of suspect vaccine was reported as 12-Jul-2023. Dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 2nd out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733816 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733816:Master case (patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 4 doses were administered past the expiration date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-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 13-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration 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 (4 doses were administered past the expiration date).    No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided. This case is reported for patient 3 out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733816 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733816:master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.) 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 13-Jul-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 13-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.) 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 (4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.).    No concomitant information was reported. Suspect product dosage text was reported as unknown. The expiry date was reported as 12-Jul-2023.  No treatment information was provided. This case is reported for patient 4 out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733816 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733816:Master case (patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19, Dizziness
Clinical narrative: He got covid July 14th 2023/ he said his cough felt like metal scrapping; he's been dizzy; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (He got covid July 14th 2023/ he said his cough felt like metal scrapping) and DIZZINESS (he's been dizzy) 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. 010H22A) 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 14-Jul-2023, the patient experienced COVID-19 (He got covid July 14th 2023/ he said his cough felt like metal scrapping) and DIZZINESS (he's been dizzy). The patient was treated with BENZONATATE at an unspecified dose and frequency and NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (He got covid July 14th 2023/ he said his cough felt like metal scrapping) and DIZZINESS (he's been dizzy) 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. It was reported that patient was on paxlovid and had a horrible metal taste in his mouth ,vomitted and he finally ate the first time yesterday on 16-Jul-2023. Patient was very tired and was taking, over the counter medication 3 times a day and he said his cough felt like metal scrapping.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pruritus, Rash
Clinical narrative: sore; little tired; itches; He started to breakout on his back; This spontaneous case was reported by a patient and describes the occurrence of PAIN (sore), PRURITUS (itches), RASH (He started to breakout on his back) and FATIGUE (little tired) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 028L20A) for COVID-19 prophylaxis.     Patient did not describe Medical history or condition.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PRURITUS (itches) and RASH (He started to breakout on his back). On an unknown date, the patient experienced PAIN (sore) and FATIGUE (little tired). At the time of the report, PAIN (sore), PRURITUS (itches), RASH (He started to breakout on his back) and FATIGUE (little tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. It was reported that patient had no problem until last September beside of the general side effects of being a little tired and sore. Treatment details was not reported by the reporter.
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; A 7-month-old patient received Bivalent pink Cap as a first & Second dose instead of Bivalent Blue cap Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (A 7-month-old patient received Bivalent pink Cap as a first & Second dose instead of Bivalent Blue cap Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 7-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 214K22A and 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jul-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (A 7-month-old patient received Bivalent pink Cap as a first & Second dose instead of Bivalent Blue cap Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A 7-month-old patient received Bivalent pink Cap as a first & Second dose instead of Bivalent Blue cap Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A 7-month-old patient received Bivalent pink Cap as a first & Second dose instead of Bivalent Blue cap Moderna COVID-19 vaccine).    Concomitant product use was not provided by the reporter.  Patient received Bivalent pink Cap as a first & Second dose instead of Bivalent Blue cap Moderna COVID-19 vaccine on 9-June-2023 and 12-JUL-2023. The lot number was the same for both doses. Expiry date of suspect vaccine was 29-Aug-2023.  Treatment information was not provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired vaccine was dosed to 4 individuals; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine was dosed to 4 individuals) 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. 065H22A) 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. In July 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine was dosed to 4 individuals). 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 dosed to 4 individuals) 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 dosed to 4 individuals).    No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that expired vaccine was dosed to 4 individuals on 10-Jul-2023, 14-Jul-2023 and 17-Jul-2023. The  vial size was unknown. The vial was initially stored in the refrigerator on 10-Jul-2023. The vial didnot undergo any temperature excursions. No treatment medication was reported..   This case contains information about patient 1 out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733876, US-MODERNATX, INC.-MOD-2023-733877, US-MODERNATX, INC.-MOD-2023-733879 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733877:Patient 3 US-MODERNATX, INC.-MOD-2023-733876:Patient 2 US-MODERNATX, INC.-MOD-2023-733879:Patient 4
Age: 77.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered and Expired vaccine; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered and Expired vaccine) and NO ADVERSE EVENT (no adverse event) in a 77-year-old 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. 014h22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth 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 (Patient was administered and Expired vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered and Expired vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered and Expired vaccine).    No concomitant medication was reported.  No treatment information was reported. Date of expiration of the vaccine was reported as 23-MAY-2023.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date; No adverse event; HCP is calling to report that a 65-year-old patient received an expired 6th dose of Moderna COVID-19 vaccine (Lot# & Exp. Date: unknown) on 17JUL2023, beyond 30 days use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP is calling to report that a 65-year-old patient received an expired 6th dose of Moderna COVID-19 vaccine (Lot# & Exp. Date: unknown) on 17JUL2023, beyond 30 days use by date.), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient 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 17-Jul-2023, the patient received sixth 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-Jul-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 (HCP is calling to report that a 65-year-old patient received an expired 6th dose of Moderna COVID-19 vaccine (Lot# & Exp. Date: unknown) on 17JUL2023, beyond 30 days use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP is calling to report that a 65-year-old patient received an expired 6th dose of Moderna COVID-19 vaccine (Lot# & Exp. Date: unknown) on 17JUL2023, beyond 30 days use by date.), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By 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 (HCP is calling to report that a 65-year-old patient received an expired 6th dose of Moderna COVID-19 vaccine (Lot# &amp; Exp. Date: unknown) on 17JUL2023, beyond 30 days use by date.) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine were unknown. Concomitant medication details not reported by the reporter. Dosage text was reported as unknown. Vial was initially stored in the refrigerator on 16-JUN-2023. Size of the vial was reported as 2.5 ml. Vial did not undergo any temperature excursions. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was administered 30-day Use By Date or after Manufacturer Date of Expiry; No adverse event; 4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.), PRODUCT STORAGE ERROR (Vaccine was administered 30-day Use By Date or after Manufacturer Date of Expiry) 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 13-Jul-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 13-Jul-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 (4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was administered 30-day Use By Date or after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.), PRODUCT STORAGE ERROR (Vaccine was administered 30-day Use By Date or 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration date. Lot number unknown. Expiration date: 12Jul2023 Administration date: 13Jul2023.) and PRODUCT STORAGE ERROR (Vaccine was administered 30-day Use By Date or after Manufacturer Date of Expiry).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-733821, US-MODERNATX, INC.-MOD-2023-733824, US-MODERNATX, INC.-MOD-2023-733826 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733821: US-MODERNATX, INC.-MOD-2023-733824: US-MODERNATX, INC.-MOD-2023-733826:
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error, Wrong product administered
Clinical narrative: The date given was 24-Jun-2023 which is 30 days from the date the vaccine was received.; No adverse event; She stated the dose was administer past the beyond used by date.; Patient received expired Moderna Bivalent vaccine as first dose of primary series; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She stated the dose was administer past the beyond used by date.), WRONG PRODUCT ADMINISTERED (Patient received expired Moderna Bivalent vaccine as first dose of primary series), PRODUCT STORAGE ERROR (The date given was 24-Jun-2023 which is 30 days from the date the vaccine was received.) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7180B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 18-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She stated the dose was administer past the beyond used by date.) and WRONG PRODUCT ADMINISTERED (Patient received expired Moderna Bivalent vaccine as first dose of primary series). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The date given was 24-Jun-2023 which is 30 days from the date the vaccine was received.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She stated the dose was administer past the beyond used by date.), WRONG PRODUCT ADMINISTERED (Patient received expired Moderna Bivalent vaccine as first dose of primary series), PRODUCT STORAGE ERROR (The date given was 24-Jun-2023 which is 30 days from the date the vaccine was received.) 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 (She stated the dose was administer past the beyond used by date.), WRONG PRODUCT ADMINISTERED (Patient received expired Moderna Bivalent vaccine as first dose of primary series) and PRODUCT STORAGE ERROR (The date given was 24-Jun-2023 which is 30 days from the date the vaccine was received.).    No concomitant medication was reported.  The date given was 24-Jun-2023 which is 30 days from the date the vaccine was received. The vaccine was received thawed. No treatment information was reported.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (covid 19) 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.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     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 COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.        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.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 12-Jun-2023 and vaccine was administered on 13-Jul-2023.; no adverse event; 2 Moderna Bivalent vaccine doses were administered 1 day after the Beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 Moderna Bivalent vaccine doses were administered 1 day after the Beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 12-Jun-2023 and vaccine was administered on 13-Jul-2023.) and NO ADVERSE EVENT (no adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7643E) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 13-Jul-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 (2 Moderna Bivalent vaccine doses were administered 1 day after the Beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 12-Jun-2023 and vaccine was administered on 13-Jul-2023.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 Moderna Bivalent vaccine doses were administered 1 day after the Beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 12-Jun-2023 and vaccine was administered on 13-Jul-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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (2 Moderna Bivalent vaccine doses were administered 1 day after the Beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 12-Jun-2023 and vaccine was administered on 13-Jul-2023.).    Concomitant product use was not provided by the reporter.  Individual vial was 2.5 ml. Vial did not undergo any temperature excursions. Dose administered after 30-day use by date or after manufacturer date of expiry.  Treatment information was not provided.  This case contains information about patient 2nd out of 2 elderly patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733885 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733885:
Age: 25.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was administered 30-day Use By Date or after Manufacturer Date of Expiry; no adverse event; Customer called in to report that she gave an employee a dose of an expired vaccine, and that the vial expired on 6.23.2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Customer called in to report that she gave an employee a dose of an expired vaccine, and that the vial expired on 6.23.2023.), PRODUCT STORAGE ERROR (Vaccine was administered 30-day Use By Date or after Manufacturer Date of Expiry) and NO ADVERSE EVENT (no adverse event) in a 25-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57184B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-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) 1 dosage form. On 18-Jul-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 (Customer called in to report that she gave an employee a dose of an expired vaccine, and that the vial expired on 6.23.2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was administered 30-day Use By Date or after Manufacturer Date of Expiry) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Customer called in to report that she gave an employee a dose of an expired vaccine, and that the vial expired on 6.23.2023.), PRODUCT STORAGE ERROR (Vaccine was administered 30-day Use By Date or 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Customer called in to report that she gave an employee a dose of an expired vaccine, and that the vial expired on 6.23.2023.) and PRODUCT STORAGE ERROR (Vaccine was administered 30-day Use By Date or after Manufacturer Date of Expiry).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.