chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: 2 doses of Bexsero given in the same day; Intended to administer MCV-4 (MenQuadfi) but grabbed the Bexsero accidentally instead; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included MENINGOCOCCAL B VACCINE (BEXSERO).   On 22nd February 2023, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 22nd February 2023, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device and BEXSERO, the patient experienced overdose and wrong vaccine administered. On an unknown date, the outcome of the overdose and wrong 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: 24-FEB-2023 Reporter's Comment: The reporter reported that a patient was administered two doses of Bexsero on the same day in each arm. The reporter mentioned they meant to administer an MCV-4 (MenQuadfi) but grabbed the Bexsero accidentally instead. The reporter unable to provide any vaccine lot and expiration details. The reporter did not consent to follow-up. Additional supportive information: The patient was administered two doses of Bexsero on same day instead of MCV-4 (MenQuadfi) which led to overdose and wrong vaccine administered.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain around injection site; Redness around injection site; Swelling around injection site/ still swollen; Cellulitis at the injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to antibiotic (had allergy to neomycin) and allergy to chemicals (had allergy to formaldehyde).   On 21st February 2023, the patient received the 1st dose of Shingrix. In February 2023, less than a week after receiving Shingrix, the patient experienced injection site cellulitis. On 21st February 2023, the patient experienced injection site pain, injection site erythema and injection site swelling. The patient was treated with cefalexin (Keflex). On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and injection site cellulitis were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix. The reporter considered the injection site cellulitis to be unrelated to Shingrix.     Additional Information: GSK Receipt Date- 24-FEB-2023 and 27-Feb-2023 Reporter's Comments- The patient received a dose of Shingrix  in left arm and minutes after injection given she experienced pain, redness and swelling around injection site.  The patient stated that arm was becoming more swollen and her symptoms did not resolve. The patient mentioned that she was allergic to formaldehyde and neomycin and asks if Shingrix contains any of those ingredients.  On 27th February 2023, the health care professional reported that the patient visited her primary care provider and received a diagnosis of cellulitis at the injection site. The patient had completed a round of Keflex for treatment.  The patient was advised by her primary care provider that it was not a reaction to the vaccination and to continue the Shingrix series. Medical disclaimer and medical information phone number and transfer provided.  Spoken as per content, offered package insert and website. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Injection site soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd February 2023, the patient received the 1st dose of Shingrix (intramuscular). On 23rd February 2023, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-FEB-2023 Reporter's Comments: The reporter was the patient's wife.  The reporter mentioned her husband received his first Shingrix dose one day before reporting and experienced injection site soreness. Nothing else was reported. The reporter did not consent to follow-up.
Age: 0.25
Sex: F
Vaccine: FLU4
Symptoms: Crying, Diarrhoea, Irritability, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Fussiness; out of nowhere crying; Diarrhea; Temperature 99.9F; 3 month old received Flulaval; This case was reported by a physician via call center representative and described the occurrence of irritability in a 3-month-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number 93CP5, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th February 2023, the patient received FluLaval Quadrivalent 2022-2023 season (intramuscular) and Flulaval Tetra Pre-Filled Syringe Device. On 10th February 2023, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On 21st February 2023, the patient experienced irritability, crying, diarrhea and fever. On an unknown date, the outcome of the irritability, crying, diarrhea, fever and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the irritability, crying, diarrhea and fever to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Physician reports 3-month-old female patient was administered a dose of FluLaval QIV vaccine on 10th February 2023.  The physician states patient developed symptoms a few days ago on Tuesday, 21st February 2023 including fussiness, out of nowhere crying, diarrhea, temperature 99.9F. The physician unsure at this point if symptoms had resolved or not. Physician was unsure if the symptoms are related to the vaccine or not. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: a repeat dose in this scenario should be administered 4 weeks after the improperly reconstituted dose; Only adjuvant portion given; Only adjuvant portion given; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 7KG39, expiry date 17th February 2024) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 7KG39, expiry date 17th February 2024) for prophylaxis.   On 21st February 2023, the patient received the 2nd dose of Shingrix. On 20th February 2023, the patient received the 2nd dose of Shingrix. On 20th February 2023, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 21st February 2023, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-FEB-2023 Reporter's Comments: The reporter reported that CMA administered only the adjuvant portion of the Shingrix and received the repeat dose on next day with batch number 7KG39 and   As per the Disease Control recommendations, a repeat dose in this scenario should be administer 4 weeks after the improperly reconstituted dose (dose of adjuvant only).  That was coded for a vaccine as well for 21st February 2023. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient received the repeat dose of Shingrix next day instead of 4 weeks, which led to inappropriate schedule of vaccine administered.
Age: 8.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 8YO received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa-IPV (Kinrix) (batch number C472T, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included DTaP vaccine (receive 4 doses of DTaP vaccines and 4th dose was administered at 18 months) and IPV vaccine (receive 3 doses of IPV vaccine).   On 14th February 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 14th February 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-Feb-2023 Reporter's Comments: Medical Assistant reports 8 year old female patient was behind on DTaP and IPV vaccines came in to the office on 14th Feb 2023.   The patient had had four prior DTaP vaccines, with the fourth dose being at 18 months of age.   In an attempt to get the patient caught up, they administered a dose of Kinrix on 14th Feb 2023.  The dose of Kinrix given was the patient's fourth dose of IPV. Additional Supportive Information: The patient was administered with Kinrix vaccine, which was at age of 8 years, which led to Inappropriate age at vaccine administration
Age: 34.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, Laboratory test
Clinical narrative: 1st dose 2018, 2nd 23 feb2023; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 34-year-old male patient who received HAV (Havrix 1440 adult) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix 1440 (received a 1st dose of Havrix back in 2018 when patient was 29 years old).   On 23rd February 2023, the patient received the 2nd dose of Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 23rd February 2023, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   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: 24-FEB-2023 Reporter's Comment: The reporter called to inquire how to proceed with Havrix series Or would patient be considered complete. The reporter reported a patient.  The patient received a second dose of Havrix the day before reporting. The reporter mentioned that the reason they administered the second dose was due to the patient's lab work done on 9th August 2023 showed non-reactive. The reporter was unable to provide vaccine details of Lot and Expiration. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose of Havrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Vx mixed with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA675A, expiry date 31st March 2023) for prophylaxis.   On 23rd February 2023, the patient received Menveo. On 23rd February 2023, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 24-Feb-2022 Reporter's Comments:  Medical assistant reporting inappropriate reconstitution technique for Menveo.  Menveo mixed with sterile water and administered on 23rd February 2023. The reporter consented to follow up. AE contains all reported information. Additional Supportive Information: The patient received Menveo which was reconstituted with sterile water, which led to Wrong solution used in drug reconstitution.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-month-old female patient who received HAV (Havrix) (batch number LY35X, expiry date 16th February 2023) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-Feb-2023 Reporter's Comments: A medical assistant called in to report the administration of an expired Havrix dose to a 19-month-old female patient.  The reporter asked if the patient had to be re vaccinated. Additional Supportive Information: The patient was administered with Havrix vaccine, which was already expired, which led to expired vaccine used.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Adult dose given to a 18-month-old; Adult dose given to a 18-month-old; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 18-month-old female patient who received HAV (Havrix adult) (batch number 95DB2, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th February 2023, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 28th February 2023, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's Comment: A reporter called to inform that earlier that day an adult dose of Havrix was administered to an 18-month-old patient.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: A reporter called to inform that earlier that day an adult dose of Havrix was administered to an 18-month-old patient, which led to overdose and inappropriate age at vaccine administration.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Diluent administration only; Diluent administration only; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 377A4, expiry date 17th February 2024) for prophylaxis.   On 28th February 2023, the patient received Shingrix. On 28th February 2023, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's Comment: A reporter called in to report the administration of the diluent of Shingrix to a patient without reconstitution of lyophilized component. The Shingrix maladministration of the AS01B adjuvant only. The reporter asked how to proceed with the patient. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Information Tab: A reporter called to report the administration of the diluent of Shingrix to a patient without reconstitution of lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Brain neoplasm, Swelling
Clinical narrative: Brain tumor; Head swelling; This case was reported by a consumer via call center representative and described the occurrence of brain neoplasm in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included surgery. Concurrent medical conditions included deafness.   On 28th July 2022, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced brain neoplasm (serious criteria GSK medically significant) and swelling. On an unknown date, the outcome of the brain neoplasm and swelling were unknown.   It was unknown if the reporter considered the brain neoplasm and swelling to be related to Shingrix.     Additional Information: GSK Receipt date: 28-Feb-2023 Reporter's Comment: Patient was deaf, and caller was using an interpreter to communicate during call. The reporter stated that before returning for his second dose developed head swelling and was diagnosed with a brain tumor. The patient stated he had surgery in September of 2022 and as a result missed the recommended time frame for getting his second dose of Shingrix.  The patient did not indicate whether or not he intended to get his second dose of the vaccine. The reporter did not consent to follow up.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, UNK
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient through other manufacturer (Pfizer Inc.) concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergies, and other pre-existing medical conditions included: The patient stated he was not taking any other medication or products within 2 weeks of starting covid-19 treatment (Paxlovid). The patient received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: unknown) dose was not reported, 1 total was administered on 09-APR-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 51 years old. No concomitant medications were reported.  It was unknown whether patient had any adverse events following covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient also received second dose of non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin and route of admin were not reported, batch number: 011F21A, expiry: unknown) dose was not reported, administered on 23-OCT-2021 to left arm for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following Moderna covid-19 vaccine (elasomeran) (Dose number in series 2). The patient also received third dose of non-company suspect vaccine Pfizer biontech covid-19 vaccine (tozinameran) (Dose number in series 3) (form of admin and route of admin were not reported, batch number: GH9694, expiry: unknown) dose was not reported, administered on 10-SEP-2022 13:00 to left arm for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 3). On an unspecified date, patient experienced covid-19 infection (suspected covid-19 infection) (Dose number in series 3). The patient started taking treatment with non-company suspect drug Paxlovid, (nirmatrelvir/ritonavir) (form of admin and route of admin were not reported, batch number: GF9998 expiry: unknown) dose and frequency were not reported from 10-FEB-2023 to 15-FEB-2023 for treatment of covid-19.  On 21-FEB-2023 at 17.00, six days after non company suspect drug paxlovid treatment, the patient experienced covid-19 rebound infection.  The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and tozinameran was not applicable, and action taken with nirmatrelvir/ritonavir was not reported. The patient was recovering from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SOME WEIRD ABNORMAL SIDE EFFECTS FROM COVID SHOT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced some weird abnormal side effects from covid shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from some weird abnormal side effects from covid shot. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: DID NOT FEEL GOOD; This spontaneous report received from a consumer concerned a 32 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 4 decade old. No concomitant medications were reported. On an unspecified date, the patient experienced did not feel good. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from did not feel good. This report was non-serious. This case, from the same reporter is linked to 20221230410.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: two times patient experienced fever and chills with the vaccine; two times patient experienced fever and chills with the vaccine; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (two times patient experienced fever and chills with the vaccine) and CHILLS (two times patient experienced fever and chills with the vaccine) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Relapsing multiple sclerosis and Seasonal allergy. Concomitant products included OCRELIZUMAB (OCREVUS), COVID-19 VACCINE and NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (two times patient experienced fever and chills with the vaccine) and CHILLS (two times patient experienced fever and chills with the vaccine). At the time of the report, PYREXIA (two times patient experienced fever and chills with the vaccine) and CHILLS (two times patient experienced fever and chills with the vaccine) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Reportedly, on 10-Apr-2021, 28-Oct-2021 and 28-Sep-2022 patient received other doses of the vaccine.  It was reported that patient did not have assessment of her immune response to the  vaccine but tolerated the shots well. Additionally patient also reported that out of the four vaccinations patient had two times experienced fever and chills with the vaccine which resolved overnight and not further clarified by patient on which two dates the vaccination gave her fever and chills.  Treatment details were not reported by the reporter.
Sex: F
Vaccine: COVID19-2
Symptoms: Thrombosis
Clinical narrative: blot clot in her head; This spontaneous case was reported by a non-health professional and describes the occurrence of THROMBOSIS (blot clot in her head) 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 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 THROMBOSIS (blot clot in her head) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blot clot in her head) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713516 (E2B Linked Report).; Reporter's Comments: This is a regulatory case concerning an unknown years- old-female-patient with no medical history reported who experienced the seriousness criterion medically significant unexpected event of thrombosis (AESI) unknown days after a  dose of RNA- 1273 bivalent vaccine.  The benefit-risk relationship of mRNA-1273 bivalent vaccine is not affected by this report.  Event´s seriousness assessed as reporting; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713516:Coworkers sisters case
Sex: F
Vaccine: COVID19-2
Symptoms: Thrombosis
Clinical narrative: Cause of blood clot in leg of this coworker's sister's leg.; This spontaneous case was reported by a non-health professional and describes the occurrence of THROMBOSIS (Cause of blood clot in leg of this coworker's sister's leg.) 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 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 THROMBOSIS (Cause of blood clot in leg of this coworker's sister's leg.) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Cause of blood clot in leg of this coworker's sister's leg.) outcome was unknown.            Concomitant Medication use information was not provided by reporter.  Treatment Medication use information was not provided by reporter.  Company comment: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the serious (medically significant) unexpected AESI of Thrombosis (Cause of blood clot in leg of this coworker's sister's leg) which occurred unknown days after receiving a dose of mRNA-1273.222 bivalent vaccine. No other information regarding clinical course, investigations, treatment, outcome was reported. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-713514 (E2B Linked Report). Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713514: Coworkers case.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 12-Jan-2023, Dose were administered after 11-Feb-2023; No adverse event; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-Jan-2023, Dose were administered after 11-Feb-2023) 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. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Feb-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 14-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-Jan-2023, Dose were administered after 11-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-Jan-2023, Dose were administered after 11-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)) (Intramuscular), 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 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-Jan-2023, Dose were administered after 11-Feb-2023).    It was unknown patient had receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.   Date the vial was initially stored in the refrigerator on 12-Jan-2023.The vial did not undergo any temperature excursions. Vial size were unknown.  No treatment information was reported.   This case contains information of patient number 2 out of 8.   This case was linked to US-MODERNATX, INC.-MOD-2023-713727, US-MODERNATX, INC.-MOD-2023-713733, US-MODERNATX, INC.-MOD-2023-713731 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713727:Master case (Patient 1 of 8) US-MODERNATX, INC.-MOD-2023-713731:3 of patient 8 US-MODERNATX, INC.-MOD-2023-713733:5 of Patient 8 US-MODERNATX, INC.-MOD-2023-713736:8 of patient 8 US-MODERNATX, INC.-MOD-2023-713735:7 of patient 8 US-MODERNATX, INC.-MOD-2023-713734:6 of patient 8
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion started on 21-Feb-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent Vaccine underwent temperature excursion started on 21Feb2023) and NO ADVERSE EVENT (No adverse event) in a child 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. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent Vaccine underwent temperature excursion started on 21-Feb-2023 and were to be used within 24 hours but administered to 17 patients on unknown dates), PRODUCT TEMPERATURE EXCURSION ISSUE (Nurse manager reporting that Bivalent Vaccine underwent temperature excursion started on 21-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a child 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. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Nurse manager reporting that Bivalent Vaccine underwent temperature excursion started on 21-Feb-2023), POOR QUALITY PRODUCT ADMINISTERED (Bivalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023, They were to be used within 24 hours but administered to 17 patients on unknown dates.) and NO ADVERSE EVENT (No adverse event) in a child 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. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent Vaccine underwent temperature excursion started on 21Feb2023), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion started on 21-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a child 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. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: ; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023, They were to be used within 24 hours but administered to 17 patients on unknown dates.), PRODUCT TEMPERATURE EXCURSION ISSUE (Nurse manager reporting that Bivalent Vaccine underwent temperature excursion started on 21-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a child 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. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Having lupus effect extra side effects; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Having lupus effect extra side effects) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Having lupus effect extra side effects). At the time of the report, IMMUNISATION REACTION (Having lupus effect extra side effects) 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 product was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Feb-2023: Follow-up received included no new information.
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient got 1st dose of primary series of Moderna covid-19 vaccine on Jul-2022 from a competitor. His 2nd dose from competitor was given Pfizer Covid-19 Bivalent in Dec-2022.), COVID-19 IMMUNISATION (Patient got 1st dose of primary series of Moderna covid-19 vaccine on Jul-2022 from a competitor. His 2nd dose from competitor was given Pfizer Covid-19 Bivalent in Dec-2022.) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.
Age: 17.0
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 (expired vaccine used), PRODUCT STORAGE ERROR (Given after 30 day expiration from freezer to fridge) and NO ADVERSE EVENT (No adverse event) in a 17-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine.      Total 3 patients were administered with the Moderna Bivalent booster dose. No concomitant medications were reported. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Death, Loss of consciousness
Clinical narrative: Deceased; collapsed; This spontaneous case was reported by an other health care professional and describes the occurrence of DEATH (Deceased) and LOSS OF CONSCIOUSNESS (collapsed) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (Deceased) (seriousness criteria death and medically significant) and LOSS OF CONSCIOUSNESS (collapsed) (seriousness criterion medically significant). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, LOSS OF CONSCIOUSNESS (collapsed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.  Patient also reports that her Daughter In-law received the Moderna Covid-19 vaccine booster dose in 2021 and then passed away 10 days later. Patient collapsed and went to the hospital and was deceased. Her Daughter in laws husband, the callers son told his Mother the caller that the doctor who pronounced his wife deceased verbally told him that his wife died from the Moderna Covid-19 vaccine.  Company Comment: This spontaneous case concerns an adult female patient of unknown age, with no medical history reported, who experienced a serious (medically Significant) unexpected event of collapse and Serious (Death, Medically significant) unexpected event of death around 10 days after receiving a dose of mRNA-1273 vaccine. Patient collapsed and went to the hospital and was deceased. There was no information provided about the patient's age, underlying medical conditions, concomitant medications, onset date and clinical course of the events, associated symptoms, final diagnosis, diagnostic and treatment details autopsy details and cause of death. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   Reporter did not allow further contact; Reported Cause(s) of Death: Deceased
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Headache, Illness, Lethargy, Myalgia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of NIGHT SWEATS (night sweat), SOMNOLENCE (sleepy), LETHARGY (lethargic), ILLNESS (started getting sick) and DIZZINESS (dizzy) 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. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Foot surgery (on Friday prior to Bivalent vaccination and had to keep feet up). Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First Primary monovalent dose) on 06-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (2nd Primary monovalent dose) on 27-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (Shot 3 and First Pfizer Monovalent Booster overdose (4 doses in one shot)) on 08-Oct-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, P
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Night sweats, SARS-CoV-2 test, Somnolence
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of NIGHT SWEATS (night sweat), SOMNOLENCE (sleepy), LETHARGY (lethargic), ILLNESS (started getting sick) and DIZZINESS (dizzy) 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. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Foot surgery (on Friday prior to Bivalent vaccination and had to keep feet up). Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First Primary monovalent dose) on 06-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (2nd Primary monovalent dose) on 27-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (Shot 3 and First Pfizer Monovalent Booster overdose (4 doses in one shot)) on 08-Oct-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, P
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: ; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 Patient received one dose of the Moderna COVID19 vaccine bivalent after its BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-Jan-2023, and administered on 2-MAR-2023) 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)) (batch no. 045h22a) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE in August 2022 and COVID-19 VACCINE (Dose 1). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and COVID-19 VACCINE.
Age: 29.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient mistakenly received Moderna Covid-19 vaccine, bivalent for 1st dose of primary series.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient mistakenly received Moderna Covid-19 vaccine, bivalent for 1st dose of primary series.) and NO ADVERSE EVENT (No adverse event) in a 29-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. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jan-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 18-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient mistakenly received Moderna Covid-19 vaccine, bivalent for 1st dose of primary series.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient mistakenly received Moderna Covid-19 vaccine, bivalent for 1st dose of primary series.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient mistakenly received Moderna Covid-19 vaccine, bivalent for 1st dose of primary series.).    The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Two doses of bivalent Moderna COVID19 vaccine given today, but they expired last night at 9:30 PM.) 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)) for COVID-19 prophylaxis.     It was unknown that patient receive other vaccines in the 4 weeks prior to COVID-19 vaccine.      This case contains information for the 1st patient out of 2 adult patients.