chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 4 month old received Kinrix; Supposed to be 2nd dose of DTap; 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 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 24T2N) for prophylaxis.   On 13-MAR-2023, the patient received Kinrix. On 13-MAR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 4 month old received Kinrix) and inappropriate schedule of vaccine administered (Verbatim: Supposed to be 2nd dose of DTap). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 13-Mar-2023 On 13th March 2023 a Medical Assistant informed that a 4-month old patient had received a dose of Kinrix that was supposed to be the 2nd dose of the DTap series. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.  The 4-month-old patient received Kinrix as 2nd dose of DTap, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the adjuvant was administered; only the adjuvant was 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 52-year-old male patient who received Herpes zoster (Shingrix) (batch number 354DD, expiry date 06-OCT-2024) for prophylaxis.   On 13-MAR-2023, the patient received the 1st dose of Shingrix. On 13-MAR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: only the adjuvant was administered) and inappropriate dose of vaccine administered (Verbatim: only the adjuvant was administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 13-MAR-2023 The nurse called to report only the adjuvant portion of Shingrix was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via phone call.
Sex: U
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody, Therapy non-responder
Clinical narrative: low tittes, less than 10mIU/ml; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 26-year-old patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder (Verbatim: low tittes, less than 10mIU/ml). The outcome of the therapy non-responder was unknown.   Additional Information: GSK Receipt Date: 13-MAR-2023 Reporter's Comments:  Pharmacist reported that patient completed the series of hepB vaccines but had low tittes, less than 10mIU/ml. No additional information provided. Pharmacist was in a hurry and did not provide patient's data, facility information where vaccination took place, when the doses where given. It was not asked if follow up was ok.  Did not mention that previous HepB vaccines were Engerix B but did want to verify if administer Engerix B as a booster dose.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in 2018, 2nd on 10Aug2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On 10-AUG-2022, the patient received the 2nd dose of Shingrix. On 10-AUG-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose in 2018, 2nd on 10Aug2022). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 13-MAR-2023 Reporter's Comments:  Pharmacist reported that a immunocompetent patient over 50 year old received Shingrix. HCP declined to have an account on medical information database.  Consented to follow up by email.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph node on throat; Painful lymph node; Headache; Tired; Swollen arm; Redness; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of swollen lymph nodes in a adult female patient who received Herpes zoster (Shingrix) (batch number D734X, expiry date 28-MAY-2024) for prophylaxis.   Previously administered products included Shingrix (The patient received 1st dose on unknown date and did not develop anything).   On 06-MAR-2023, the patient received the 2nd dose of Shingrix. In MAR-2023, 3 days after receiving Shingrix, the patient experienced swollen lymph nodes (Verbatim: Swollen lymph node on throat), lymph node pain (Verbatim: Painful lymph node), headache (Verbatim: Headache), tiredness (Verbatim: Tired), swelling arm (Verbatim: Swollen arm) and erythema (Verbatim: Redness). The outcome of the swollen lymph nodes and lymph node pain were not recovered/not resolved and the outcome of the headache and tiredness were unknown and the outcome of the swelling arm was recovering/resolving and the outcome of the erythema was recovered/resolved.   It was unknown if the reporter considered the swollen lymph nodes, lymph node pain, headache, tiredness, swelling arm and erythema to be related to Shingrix.     It was unknown if the company considered the swollen lymph nodes, lymph node pain, headache, tiredness, swelling arm and erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-MAR-2023  The reporter reported that a patient 50 years and above (not sure exact age) received 2nd dose of Shingrix and developed painful, swollen lymph node on the throat, headache, tired.  The whole arm of the patient was swollen but then looked ok and redness was gone.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Swollen lymph node on throat; Painful lymph node; Headache; Tired; Swollen arm; Redness; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of swollen lymph nodes in a adult female patient who received Herpes zoster (Shingrix) (batch number D734X, expiry date 28-MAY-2024) for prophylaxis.   Previously administered products included Shingrix (The patient received 1st dose on unknown date and did not develop anything).   On 06-MAR-2023, the patient received the 2nd dose of Shingrix. In MAR-2023, 3 days after receiving Shingrix, the patient experienced swollen lymph nodes (Verbatim: Swollen lymph node on throat), lymph node pain (Verbatim: Painful lymph node), headache (Verbatim: Headache), tiredness (Verbatim: Tired), swelling arm (Verbatim: Swollen arm) and erythema (Verbatim: Redness). The outcome of the swollen lymph nodes and lymph node pain were not recovered/not resolved and the outcome of the headache and tiredness were unknown and the outcome of the swelling arm was recovering/resolving and the outcome of the erythema was recovered/resolved.   It was unknown if the reporter considered the swollen lymph nodes, lymph node pain, headache, tiredness, swelling arm and erythema to be related to Shingrix.     It was unknown if the company considered the swollen lymph nodes, lymph node pain, headache, tiredness, swelling arm and erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-MAR-2023  The reporter reported that a patient 50 years and above (not sure exact age) received 2nd dose of Shingrix and developed painful, swollen lymph node on the throat, headache, tired.  The whole arm of the patient was swollen but then looked ok and redness was gone.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 52.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in 2019, 2nd on 09Mar2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 52-year-old male patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   Previously administered products included Twinrix (1st dose received in 2019).   On 09-MAR-2023, the patient received the 2nd dose of Twinrix. On 09-MAR-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose in 2019, 2nd on 09Mar2023). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-MAR-2023 A pharmacist reported that a patient received the 1st dose of Twinrix in 2019 and a late 2nd dose on 09 March 2023. The reporter consented to follow up via email. On 09-MAR-2023, the patient received the 2nd dose of Twinrix, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 17Jan2022, 2nd not received; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 17th January 2022).   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: 1st dose on 17Jan2022, 2nd not received). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13-MAR-2023 Reporter was the patient, who stated that she and her husband received their first dose of Shingrix on 17th January 2022. She states that she and her husband never received their second dose.  Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up. This case has been linked to the case US2023039148 reported by the same reporter.; Sender's Comments:  US-GSK-US2023039148:Same reporter - husband case
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 17Jan2022, 2nd not received; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 17th January 2022).   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: 1st dose on 17Jan2022, 2nd not received). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13-MAR-2023 The reporter was the wife of the patient who states that she and her husband received their first dose of Shingrix on 17th January 2022. She states that she and her husband never received their second dose.  Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up. This case has been linked to the case US2023039146 reported by the same reporter.; Sender's Comments:  US-GSK-US2023039146:Same reporter - wife case
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 years ago, 2nd not received; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago from reporting).   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: 1st dose 2 years ago, 2nd not received). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 13-MAR-2023 The reporter asked if she could administer the second dose or if the patient had to start over with the vaccination. Consent for follow up was not requested. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; 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 19-year-old male patient who received Men B NVS (Bexsero) (batch number A2X3Y, expiry date 28-FEB-2023) for prophylaxis.   On 13-MAR-2023, the patient received Bexsero. On 13-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered). 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: 13-MAR-2023 The reporter consented to follow up. The patient received an expired dose of Bexsero, which led to expired vaccine used.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix-B expired dose; This non-serious case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a 26-year-old female patient who received HBV (Engerix B) (batch number 74EM4, expiry date 20-DEC-2022) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B expired dose). 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: 13-MAR-2023 Sales representative received information from office manager that an expired dose of Engerix-B was administered to the patient. The reporter consented to followup via email. Vaccination date and patient initials were asked but declined. The patient received expired dose of engerix b which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 21Aug2022, 2nd not yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in her left arm on 21-AUG-2022).   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: 1st dose 21Aug2022, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 13-MAR-2023 The patient self-reported this case. The reporter did not consent to follow-up. Till the time of reporting, the patient did not complete the vaccination series, which led to incomplete course of vaccination.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered a vaccine that expired; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (expiry date 30-SEP-2022) for prophylaxis.   On 13-MAR-2023, the patient received Havrix. On 13-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: administered a vaccine that expired). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 13 Mar 2023 The medical assistant administered a Hepatitis A (Havrix) vaccine to a patient on the day of reporting that expired on 30th September 2022.  The patient had already been notified. The reporter wanted to know what to do. No patient demographics provided. The permission for Safety follow-up not given.  The patient received expired Havrix vaccine which led to expired vaccine used.
Age: 16.0
Sex: F
Vaccine: DTAP, TD
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: 16 year old received Infanrix/ received Adacel a month before; got Tenivac on the same day; 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 16-year-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date 03-MAR-2024) for prophylaxis.   Co-suspect products included DIPHTHERIA VACCINE TOXOID + TETANUS VACCINE TOXOID (TENIVAC) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS TOXOID + TETANUS VACCINE TOXOID (ADACEL).   On 03-MAR-2023, the patient received Infanrix and TENIVAC. On 03-MAR-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 16 year old received Infanrix/ received Adacel a month before) and accidental overdose (Verbatim: got Tenivac on the same day). The outcome of the inappropriate age at vaccine administration and accidental overdose 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: 13-Mar-2023 Medical assistant stated that a 16-year-old patient received the Infanrix vaccine and a dose of Tenivac on the same day which means that they got an extra dose of tetanus and diphtheria.  The patient had no vaccine records as they had just come from out of the country. The reporter consented to follow up. The patient received dose of Infanrix vaccine and Tenivac, which led to accidental overdose and inappropriate age at vaccine administration.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Infanrix given instead of Boostrix; Infarix given to a 37-year-old; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 37-year-old female patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 15-MAR-2064) for prophylaxis.   On 06-FEB-2023, the patient received Infanrix. On 06-FEB-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Infanrix given instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: Infarix given to a 37-year-old). 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: 13-Mar-2023 A nurse practitioner called in to report that a dose of Infanrix was given instead of Boostrix. The information for the adverse event was collected and the reporter accepted to be transferred to second line. The reporter consented to follow up. The patient received dose of infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 37.0
Sex: F
Vaccine: HEPA
Symptoms: Arthropod bite, Infertility, Lyme disease, Metal poisoning
Clinical narrative: Mercury poisoning; Lyme Disease; Bitten by a tick; Fertility issue; This serious case was reported by a nurse via call center representative and described the occurrence of mercury poisoning in a adult female patient who received HAV (Havrix) (batch number D94mk) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number Mf9ea) for prophylaxis.   In APR-2019, the patient received Havrix and Boostrix. On an unknown date, an unknown time after receiving Havrix and Boostrix, the patient experienced mercury poisoning (Verbatim: Mercury poisoning) (serious criteria GSK medically significant), lyme disease (Verbatim: Lyme Disease) (serious criteria GSK medically significant), tick bite (Verbatim: Bitten by a tick) and fertility decreased (Verbatim: Fertility issue). The outcome of the mercury poisoning, lyme disease and fertility decreased were unknown and the outcome of the tick bite was not reported.   The reporter considered the mercury poisoning, lyme disease and fertility decreased to be possibly related to Havrix and Boostrix. It was unknown if the reporter considered the tick bite to be related to Havrix and Boostrix.     The company considered the mercury poisoning, lyme disease and fertility decreased to be possibly related to Havrix and Boostrix. It was unknown if the company considered the tick bite to be related to Havrix and Boostrix.   Additional Information: GSK receipt date: 20-MAR-2023 The nurse stated a patient blamed Havrix and Boostrix for giving her mercury poisoning, lyme disease, and causing a fertility issue. The patient was also bitten by a tick after which she contracted Lyme Disease. No further details provided. The consent granted for safety to follow up.  Upon internal review the case was updated on: 20-MAR-2023 Summary of changes: age and age at administration updated.
Age: 54.0
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 14-Jan-2023/Vaccine administered on 27-Feb-2023; No adverse event; patients had Moderna beyond the 30-day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients had Moderna beyond the 30-day BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 14-Jan-2023/Vaccine administered on 27-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 27-Feb-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 27-Feb-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 (patients had Moderna beyond the 30-day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 14-Jan-2023/Vaccine administered on 27-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients had Moderna beyond the 30-day BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 14-Jan-2023/Vaccine administered on 27-Feb-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 (patients had Moderna beyond the 30-day BUD) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 14-Jan-2023/Vaccine administered on 27-Feb-2023).    No concomitant medications were reported.  It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Vial size was 2.5 ml The vial was initially stored in the refrigerator 14-Jan-2023.  The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 3 of 3 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716944, US-MODERNATX, INC.-MOD-2023-716921, US-MODERNATX, INC.-MOD-2023-716921 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716944:Patient 2
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored on 17-Feb-2023 and administered on 21-Mar-23; No adverse event; HCP stated they accidentally administered 2 doses after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 2 doses after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was initially stored on 17-Feb-2023 and administered on 21-Mar-23) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     The patient had no known conditions for relevant medical history, allergy, concomitant diseases and risk factors. The patient did not receive other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 21-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 2 doses after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored on 17-Feb-2023 and administered on 21-Mar-23) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 2 doses after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was initially stored on 17-Feb-2023 and administered on 21-Mar-23) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 2 doses after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored on 17-Feb-2023 and administered on 21-Mar-23).    No concomitant medication details was reported. No treatment medication details was reported.   This case contains information for the 1st adult patient out of 2 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716780:Patient 2-Adult
Sex: U
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Bivalent vaccine administered outside vaccination window; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent vaccine administered outside vaccination window) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent vaccine administered outside vaccination window) and NO ADVERSE EVENT (no adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent vaccine administered outside vaccination window) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent vaccine administered outside vaccination window).    No concomitant medications was provided. No treatment medications was provided.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired bivalent first booster dose of Moderna COVID-19 vaccine beyond 30 days in the refrigerator), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 01-FEB-2023 and dose was administered on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis. No Medical History information was reported. On 14-Mar-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 14-Mar-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 (Patient received expired bivalent first booster dose of Moderna COVID-19 vaccine beyond 30 days in the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 01-FEB-2023 and dose was administered on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired bivalent first booster dose of Moderna COVID-19 vaccine beyond 30 days in the refrigerator), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 01-FEB-2023 and dose was administered on 14-MAR-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 (Patient received expired bivalent first booster dose of Moderna COVID-19 vaccine beyond 30 days in the refrigerator) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 01-FEB-2023 and dose was administered on 14-MAR-2023). No concomitant medications were reported. Vial size was 0.4 mL. Vial did not undergo any temperature excursions. No treatment information was provided.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; monovalent Moderna COVID-19 vaccine was administered after the published expiration date on 6MAR2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (monovalent Moderna COVID-19 vaccine was administered after the published expiration date on 6MAR2023.) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN on 10-Apr-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN.    On 06-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 06-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (monovalent Moderna COVID-19 vaccine was administered after the published expiration date on 6MAR2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (monovalent Moderna COVID-19 vaccine was administered after the published expiration date on 6MAR2023.) had not resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (monovalent Moderna COVID-19 vaccine was administered after the published expiration date on 6MAR2023.).    No concomitant medications were reported. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient did not reported any symptoms. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: All health issues related after receiving vaccine, damage of body, life; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (All health issues related after receiving vaccine, damage of body, life) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (All health issues related after receiving vaccine, damage of body, life). At the time of the report, IMMUNISATION REACTION (All health issues related after receiving vaccine, damage of body, life) 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 considered IMMUNISATION REACTION (All health issues related after receiving vaccine, damage of body, life) to be related.    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that patient had medical issues after vaccination.  It was also reported that involved.  Treatment medications were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2023: Live follow up received include no new information.
Age: 4.0
Sex: M
Vaccine: COVID19
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 a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1414B and AS1414B) for COVID-19 prophylaxis.     Patient had no allergy or no diseases. Patient receive other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Influenza, Dtap-ipv and MMRV vaccine. Past adverse reactions to the above products included No adverse event with Influenza, Dtap-ipv and MMRV vaccine.   On 19-Jan-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2023, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 20-Feb-2023, 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 (Moderna COVID-19 Vaccine) (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 medication details was reported. No treatment medication details was reported.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) 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)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First Dose, Lot:EL9810) on 05-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (Third Dose, Lot: FF2588), PFIZER BIONTECH COVID-19 VACCINE (Second dose and Lot:EN6205); for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Fourth Dose and  Lot: 005M21A). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 22-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.        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.   Concomitant medication details not reported by the reporter. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. On 15-APR-2022, patient received Moderna monovalent vaccine as additional booster dose with batch number 061F22A for COVID-19 prophylaxis indication. The patient explained that it may have been around 15-April-2022, because they caught COVID 10 days after booster dose.  Treatment details was not reported by the reporter.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Insomnia, SARS-CoV-2 test
Clinical narrative: Not sleeping well; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) and INSOMNIA (Not sleeping well) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016F22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Lot ER1742) on 03-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Lot EW0221) on 05-Jun-2021, PFIZER BIONTECH COVID-19 VACCINE (lot FD0810) on 20-Nov-2021 and PFIZER BIONTECH COVID-19 VACCINE (FM7380) on 20-Apr-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 05-Oct-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 14-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INSOMNIA (Not sleeping well). At the time of the report, COVID-19 (COVID-19) had not resolved and INSOMNIA (Not sleeping well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2023, SARS-CoV-2 test: Positive.     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 additional booster. It was reported that patient had a low grade fever, a touch of a headache and a bit of runny nose and fatigue and also patient checked chest and there was nothing in the lungs and sinuses. No treatment information was provided.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; Patient took 1st dose on 18-may-2021 and second dose on 15-jul-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 1st dose on 18-may-2021 and second dose on 15-jul-2021) and NO ADVERSE EVENT (no adverse event) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007131A and 007B21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza vaccine; for Drug use for unknown indication: Zoster. Past adverse reactions to the above products included No adverse event with Influenza vaccine and Zoster.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 1st dose on 18-may-2021 and second dose on 15-jul-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 1st dose on 18-may-2021 and second dose on 15-jul-2021) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 1st dose on 18-may-2021 and second dose on 15-jul-2021).    No concomitant medications was reported. It was reported that patient took 1st booster on 25-jan-2022 with lot number 084J21A and second booster on 25-jul-2022 with lot number 038A22A. No treatment drug details was reported.   This case was linked to MOD-2023-716927 (Patient Link).
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator 21MAR2023 and administration of vaccine 21MAR2023; No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 21MAR2023 and administration of vaccine 21MAR2023) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1420B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2023, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 21MAR2023 and administration of vaccine 21MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 21MAR2023 and administration of vaccine 21MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 21MAR2023 and administration of vaccine 21MAR2023).    No concomitant medication were reported.  It was reported that one stored correctly said 21-FEB-2023, remained frozen until removed from freezer on 21-MAR-2023 and administered to patient. Sticker from their pharmacy said 21-APR-2023 on the box, charted then found it wasn't in inventory. Checked expiry on website and it showed that vaccine expired 21-FEB-2023. The patient (3-years & 5 Months-old) received expired First Primary dose, Monovalent Moderna COVID-19 vaccine Blue Cap, Magenta label. Dose administered after manufacturer date of expiry Monovalent vaccine in intact cartons with vial size of 10 dose vial. The vial was initially stored in the refrigerator on 21-MAR-2023. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: 2 weeks ago she had a mild case of Covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (2 weeks ago she had a mild case of 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.     No Medical History information was reported.    On 19-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced COVID-19 (2 weeks ago she had a mild case of Covid 19). At the time of the report, COVID-19 (2 weeks ago she had a mild case of 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 medication were reported.  Patient received Moderna Covid 19 last booster and 2 weeks ago patient had a mild case of Covid 19  No treatment information was provided by the reporter.