chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: subcutaneous administration instead of intramuscular; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 30-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number B4C44, expiry date 10-NOV-2024) for prophylaxis.   On 23-FEB-2023, the patient received Boostrix (subcutaneous). On 23-FEB-2023, an unknown time after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: subcutaneous administration instead of intramuscular). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 06-MAR-2023 The reporter was a healthcare professional. The reporter reported that the patient administered Boostrix vaccine subcutaneously instead of intramuscular route. The reporter did consent to follow up. The patient received Boostrix vaccine was given subcutaneous instead of intramuscular, which led to intramuscular formulation administered by other route
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Shingles 3 to 4 months after 2nd dose / Suspected vaccination failure; Shingles (full blown case); Rash on forehead; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 3 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Shingles 3 to 4 months after 2nd dose / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles (full blown case)) and rash (Verbatim: Rash on forehead). The outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 09-MAR-2023 The physician stated in his office at the time of reporting that a patient (no identifying factors for patient) in their mid-80's, had a full blown case of shingles 3 to 4 months after the 2nd dose of Shingrix, with a rash located on the patient's forehead.  The GlaxoSmithKline field representative did not had any further information about this incident, no information about the vaccination facility other than the doctor stated the vaccination did not occur in the doctor's office and the doctor did not know where the patient received the vaccine, no information about the date it occurred and no information about the patient. The consent to follow up with the healthcare professional was obtained. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: Got 2 shots, developed shingles / Suspected vaccination failure; Two Shingles outbreaks; received second dose almost 1 year after the first dose because the pharmacy had ran out; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Got 2 shots, developed shingles / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Two Shingles outbreaks) and drug dose administration interval too long (Verbatim: received second dose almost 1 year after the first dose because the pharmacy had ran out). The outcome of the vaccination failure, shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 09-MAR-2023 The reporter was the patient. The patient received her first dose of Shingrix in 2020 and the second dose in 2021. The patient developed shingles around Christmas time 2021. She developed shingles again 15th February 2023. The patient received the vaccines at 2 different pharmacies. The patient did not have the exact dates of the vaccine nor she had the specific contact information for the pharmacies at the time of the call. The reporter/patient gave consent to follow up with her and healthcare professional (pharmacies). The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Seasonal allergy
Clinical narrative: HAY FEVER; This spontaneous report received from a patient concerned an 8 decade old male. The patient's weight was 165 pounds, and height was 71 inches. The patient's concurrent conditions included: hay fever, and allergy (wigs him out terribly). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for covid-19 prophylaxis. Age at time of vaccination 71 years old. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced hay fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hay fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 02-Mar-2023 and administered after manufacturer expery(11-Feb-2023); No adverse event; Patient received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 and administered after manufacturer expery(11-Feb-2023)) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 and administered after manufacturer expery(11-Feb-2023)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 and administered after manufacturer expery(11-Feb-2023)) 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 (Patient received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 and administered after manufacturer expery(11-Feb-2023)).    Concomitant medication was not provided.  Nurse reported that the vial was intact carton and size was unknown. The vial was initially stored in refrigerator on 02-Mar-2023 and was administered to patient on 02-Mar-2023. The vial did not undergo any temperature excursion. Treatment information was not provided. This case contains information for the 3rd patient out of 6 child patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-715544, US-MODERNATX, INC.-MOD-2023-715545, US-MODERNATX, INC.-MOD-2023-715548, US-MODERNATX, INC.-MOD-2023-715549, US-MODERNATX, INC.-MOD-2023-715551 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715544:Patient 1(Master case) US-MODERNATX, INC.-MOD-2023-715545:Patient 2 US-MODERNATX, INC.-MOD-2023-715548:Patient 6 US-MODERNATX, INC.-MOD-2023-715549:Patient 4 US-MODERNATX, INC.-MOD-2023-715551:Patient 5
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expired vial was stored in refrigerator; No adverse event; 6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (Expired vial was stored in refrigerator) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 09-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vial was stored in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (Expired vial was stored in refrigerator) 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 (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Expired vial was stored in refrigerator).    No concomitant medications were reported.  Vial size was unknown.  The vial was initially stored in the refrigerator 1 vial on 16-Feb-2023; 1 vial on 02-Mar-2023 and 1 vial on 09-Mar-2023.  The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 5th of 6th child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-715549, US-MODERNATX, INC.-MOD-2023-715550, US-MODERNATX, INC.-MOD-2023-715548, US-MODERNATX, INC.-MOD-2023-715545 (Linked Report). This case was linked to MOD-2023-715544 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715550:Patient 5 US-MODERNATX, INC.-MOD-2023-715549:Patient 6 US-MODERNATX, INC.-MOD-2023-715548:Patient 5 US-MODERNATX, INC.-MOD-2023-715545:Patient 5
Age: 0.75
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event, Wrong product administered
Clinical narrative: Patient was supposed to get a Moderna primary series 2nd dose and instead he was administered the Pfizer-BioNTech COVID-19 Vaccine, Omicron Bivalent maroon cap formula 6 month to 4 years for his 2nd primary dose; Revaccination with different COVID-19 vaccine; Interchange of vaccine products; No adverse reaction; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was supposed to get a Moderna primary series 2nd dose and instead he was administered the Pfizer-BioNTech COVID-19 Vaccine, Omicron Bivalent maroon cap formula 6 month to 4 years for his 2nd primary dose), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No adverse reaction) in a 9-month-old 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.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was supposed to get a Moderna primary series 2nd dose and instead he was administered the Pfizer-BioNTech COVID-19 Vaccine, Omicron Bivalent maroon cap formula 6 month to 4 years for his 2nd primary dose), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was supposed to get a Moderna primary series 2nd dose and instead he was administered the Pfizer-BioNTech COVID-19 Vaccine, Omicron Bivalent maroon cap formula 6 month to 4 years for his 2nd primary dose), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Patient was supposed to get a Moderna primary series 2nd dose and instead he was administered the Pfizer-BioNTech COVID-19 Vaccine, Omicron Bivalent maroon cap formula 6 month to 4 years for his 2nd primary dose), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products).    No concomitant medication was reported.  Treatment information was not provided by the reporter.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Death, Expired product administered, Product storage error
Clinical narrative: She states that 5 patients were given expired doses. One elderly patient passed away the next day 24Feb2023.; Moderna lot 015B22A that expired 2/12/23. If a dose was given 2/23/23, She states that 5 patients were given expired doses; The vial was expired on 12-Feb-2023 and initially stored in the refrigerator on 23-Feb-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of DEATH (She states that 5 patients were given expired doses. One elderly patient passed away the next day 24Feb2023.) in an elderly male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 23-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna lot 015B22A that expired 2/12/23. If a dose was given 2/23/23, She states that 5 patients were given expired doses) and PRODUCT STORAGE ERROR (The vial was expired on 12-Feb-2023 and initially stored in the refrigerator on 23-Feb-2023). The patient died on 24-Feb-2023. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, EXPIRED PRODUCT ADMINISTERED (Moderna lot 015B22A that expired 2/12/23. If a dose was given 2/23/23, She states that 5 patients were given expired doses) and PRODUCT STORAGE ERROR (The vial was expired on 12-Feb-2023 and initially stored in the refrigerator on 23-Feb-2023) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported.  The treatment medication was not reported.  No information provided about individual vials or unbroken cartons. The vial size was 2.5 ml but the information was unknown. The vial was initially stored on 23-Feb-2023. The vial had undergone no temperature excursions.  Company comment: This spontaneous case concerns an elderly male patient of unspecified age with no medical history reported, who experienced the fatal unexpected serious (medically significant) event of death that occurred one day after receiving a dose of mRNA-1273 vaccine in COVID-19 vaccination series. It was reported that, an expired product was administered which was initially stored in refrigerator.  Cause of death was unknown. It is unknown if an autopsy was performed. No further details on risk factors, circumstances leading to death, patient's past medical history and additional vaccination details were reported.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-715165 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715165:Same reporter (4 patient's case); Reported Cause(s) of Death: Unknown cause of death
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: I lost a healthy niece in May 22 and she was 41 yrs old and she just dropped dead her autopsy; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (I lost a healthy niece in May 22 and she was 41 yrs old and she just dropped dead her autopsy) in a 41-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on 01-May-2022 The patient died on 01-May-2022. The cause of death was not reported. An autopsy was performed, but no results were provided.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were reported. It was reported that the patient just dropped dead and her autopsy come back undetermined.  No treatment medicine were reported.  Company comment: This spontaneous case reported by a consumer, concerns a 41-year-old female patient with no reported medical history, who met with a fatal outcome (PT: Death). Death occurred unknown days after administration of second dose of mRNA-1273 vaccine. Other details are not available for medical review. An autopsy was performed, however exact cause of death was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    Most recent FOLLOW-UP information incorporated above includes: On 13-Mar-2023: Non-significant follow-up appended; Reported Cause(s) of Death: Undetermined
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 10-FEB-2023; No adverse event; Dose administered after 30-day Use By Date and 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 and after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023) and NO ADVERSE EVENT (No adverse event) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date and after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-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 and after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) had not resolved and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date and after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023).    No concomitant medication details was reported. It was reported that Intact carton inside refrigerator, but placed in a bag in the cooler to transport to the site and maintained at 2-8C the entire time. Vial size was 5.5ml red cap. The vial did not undergo any temperature excursions. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No adverse event; Dose administered after manufacturer date of expiry; Vaccine was expired on 11-Mar-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administration of vaccine on 14-Mar-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vaccine was expired on 11-Mar-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administration of vaccine on 14-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 074B22A) for COVID-19 prophylaxis.   No Medical History information was reported.    On 14-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vaccine was expired on 11-Mar-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administration of vaccine on 14-Mar-2023). 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), PRODUCT STORAGE ERROR (Vaccine was expired on 11-Mar-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administration of vaccine on 14-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vaccine was expired on 11-Mar-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administration of vaccine on 14-Mar-2023).    No concomitant medications were reported.  It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vial size was 5.5 mL. Vial did not undergo any temperature excursions.  No treatment information was provided.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Psoriasis, Skin disorder, Urticaria
Clinical narrative: weird skin; eczema; psoriasis; hives; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (eczema), PSORIASIS (psoriasis), URTICARIA (hives) and SKIN DISORDER (weird skin) in a 43-year-old male patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     The patient had no allergies or no disease. The patient received no other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Sep-2022, the patient experienced ECZEMA (eczema), PSORIASIS (psoriasis) and URTICARIA (hives). On an unknown date, the patient experienced SKIN DISORDER (weird skin). At the time of the report, ECZEMA (eczema), PSORIASIS (psoriasis), URTICARIA (hives) and SKIN DISORDER (weird skin) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported.  The treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: a woman who received 2 doses of the vaccine and got covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (a woman who received 2 doses of the vaccine and got covid) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Spikevax. Past adverse reactions to the above products included No adverse event with Spikevax.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (a woman who received 2 doses of the vaccine and got covid). At the time of the report, COVID-19 (a woman who received 2 doses of the vaccine and got covid) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  It was reported that, woman who received 2 doses of the vaccine and got covid and felt like shit after getting covid.  No treatment medications was reported.   Reporter did not allow further contact
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; HCP states they accidentally administered an expire dose of the Moderna Covid 19 Monovalent.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states they accidentally administered an expire dose of the Moderna Covid 19 Monovalent.) and NO ADVERSE EVENT (No Adverse Event) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states they accidentally administered an expire dose of the Moderna Covid 19 Monovalent.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states they accidentally administered an expire dose of the Moderna Covid 19 Monovalent.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states they accidentally administered an expire dose of the Moderna Covid 19 Monovalent.).    Concomitant products were not provided. Treatment medication were not reported.  The vial was taken out of the freezer and thawed in the refrigerator on 13 Mar 2023. Vials did not undergo any temperature excursion.   Most recent FOLLOW-UP information incorporated above includes: On 14-Mar-2023: Follow-up contains non-significant information. On 14-Mar-2023: Live follow-up contains updated information, vaccine information and  narrative updated
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was expired on 11-Feb-2023 and was initially stored in refrigerator on 16-FEB-2023; No adverse event; 6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was expired on 11-Feb-2023 and was initially stored in refrigerator on 16-FEB-2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was expired on 11-Feb-2023 and was initially stored in refrigerator on 16-FEB-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was expired on 11-Feb-2023 and was initially stored in refrigerator on 16-FEB-2023) 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 (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial was expired on 11-Feb-2023 and was initially stored in refrigerator on 16-FEB-2023).    No concomitant medication was reported.   Date the vial was initially stored in the refrigerator 1 vial on 16-FEB-.2023. The vial did not undergo any temperature excursions.The case involved combination of first dose and some 2nd primary doses. No treatment information was reported.    This case is reported for patient 1 of 6. .   This case was linked to US-MODERNATX, INC.-MOD-2023-715548, US-MODERNATX, INC.-MOD-2023-715551, US-MODERNATX, INC.-MOD-2023-715549, US-MODERNATX, INC.-MOD-2023-715550, US-MODERNATX, INC.-MOD-2023-715545 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715545:Patient 02 US-MODERNATX, INC.-MOD-2023-715550:patient 03 US-MODERNATX, INC.-MOD-2023-715549:patient 04 US-MODERNATX, INC.-MOD-2023-715551:patient 05 US-MODERNATX, INC.-MOD-2023-715548:Patient 06
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 30-JAN-2023, BUD date was 01-MAR-2023 and dose was adminstered on 02-MAR-2023; No Adverse Event; HCP administered doses of the bivalent vaccine after BUD 01-Mar-2023; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP administered doses of the bivalent vaccine after BUD 01-Mar-2023), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-JAN-2023, BUD date was 01-MAR-2023 and dose was adminstered on 02-MAR-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. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-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 02-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 (HCP administered doses of the bivalent vaccine after BUD 01-Mar-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-JAN-2023, BUD date was 01-MAR-2023 and dose was adminstered on 02-MAR-2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP administered doses of the bivalent vaccine after BUD 01-Mar-2023), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-JAN-2023, BUD date was 01-MAR-2023 and dose was adminstered on 02-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 (HCP administered doses of the bivalent vaccine after BUD 01-Mar-2023) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-JAN-2023, BUD date was 01-MAR-2023 and dose was adminstered on 02-MAR-2023).    No concomitant medications were reported. Vial was initially stored in the refrigerator on 30-JAN-2023. Beyond used by date was 01-MAR-2023. Vial did not undergo any temperature excursions No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-715478 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715478:Same reporter , Patient 1
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Caller stated that he is immunocompromised due to a renal transplant in 2015. His vaccine schedule included 2 primary dose and 3 booster dose as of September 2022; This spontaneous case was reported by a patient and describes the occurrence of UNDERDOSE (Caller stated that he is immunocompromised due to a renal transplant in 2015. His vaccine schedule included 2 primary dose and 3 booster dose as of September 2022) and NO ADVERSE EVENT (No adverse event) in an adult male 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 patient's past medical history included Renal transplant in 2015. Previously administered products included for COVID-19 prophylaxis: Spikevax and Spikevax. Past adverse reactions to the above products included No adverse event with Spikevax and Spikevax. Concurrent medical conditions included Immunocompromised.    In 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 2022, the patient experienced UNDERDOSE (Caller stated that he is immunocompromised due to a renal transplant in 2015. His vaccine schedule included 2 primary dose and 3 booster dose as of September 2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Caller stated that he is immunocompromised due to a renal transplant in 2015. His vaccine schedule included 2 primary dose and 3 booster dose as of September 2022) 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 UNDERDOSE (Caller stated that he is immunocompromised due to a renal transplant in 2015. His vaccine schedule included 2 primary dose and 3 booster dose as of September 2022).    Concomitant medications details were not reported by the reporter. Reporter stated that patient was immunocompromised due to a renal transplant in 2015. Patient's vaccine schedule included 2 primary dose and 3 booster dose as of September 2022. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient received a Moderna monovalent booster instead of bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a Moderna monovalent booster instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (patient received a Moderna monovalent booster instead of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received a Moderna monovalent booster instead of bivalent booster) 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 WRONG PRODUCT ADMINISTERED (patient received a Moderna monovalent booster instead of bivalent booster).    No concomitant medication were reported. No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
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 a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 011F21A, 007B21A and 023M20A) for COVID-19 prophylaxis.     The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included COVID-19 (Patient had 4 Covid episodes -one before getting any of the vaccines). Concurrent medical conditions included Hypertension, High cholesterol and Asthma (from time to time).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient had 3 COVID-19 episodes in between the 2nd doses and the other succeeding doses and its symptoms included feeling tired. Treatment information was not provided.   This case was linked to MOD-2023-715619 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 15-Feb-2023 and vaccine was administered on 14-Mar-2023; No adverse event; 1 Patient received the affected dose as a 1st dose of the monovalent Moderna COVID19 vaccine, 0.5ml lot # 071B22A? date of administration Mar 14, 2023/Expiration Date: Mar 12, 2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 Patient received the affected dose as a 1st dose of the monovalent Moderna COVID19 vaccine, 0.5ml lot # 071B22A? date of administration Mar 14, 2023/Expiration Date: Mar 12, 2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 15-Feb-2023 and vaccine was administered on 14-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 14-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (1 Patient received the affected dose as a 1st dose of the monovalent Moderna COVID19 vaccine, 0.5ml lot # 071B22A? date of administration Mar 14, 2023/Expiration Date: Mar 12, 2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 15-Feb-2023 and vaccine was administered on 14-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 Patient received the affected dose as a 1st dose of the monovalent Moderna COVID19 vaccine, 0.5ml lot # 071B22A? date of administration Mar 14, 2023/Expiration Date: Mar 12, 2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 15-Feb-2023 and vaccine was administered on 14-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (1 Patient received the affected dose as a 1st dose of the monovalent Moderna COVID19 vaccine, 0.5ml lot # 071B22A? date of administration Mar 14, 2023/Expiration Date: Mar 12, 2023) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 15-Feb-2023 and vaccine was administered on 14-Mar-2023).    No concomitant medications was reported.  The vial was initially stored in the refrigerator on 15-Feb-2023. The vial did not undergone any temperature excursions.  Patient was fine and did not present any adverse reactions.  No treatment medications was reported.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Swelling, Vaccination site pain
Clinical narrative: right armpit also hurts and it is inflamed; right armpit also hurts and it is inflamed; after vaccination his right arm injection site started to hurt really bad; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (right armpit also hurts and it is inflamed), VACCINATION SITE PAIN (after vaccination his right arm injection site started to hurt really bad) and AXILLARY PAIN (right armpit also hurts and it is inflamed) in a 21-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 047C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced VACCINATION SITE PAIN (after vaccination his right arm injection site started to hurt really bad). On an unknown date, the patient experienced SWELLING (right armpit also hurts and it is inflamed) and AXILLARY PAIN (right armpit also hurts and it is inflamed). At the time of the report, SWELLING (right armpit also hurts and it is inflamed) and AXILLARY PAIN (right armpit also hurts and it is inflamed) outcome was unknown and VACCINATION SITE PAIN (after vaccination his right arm injection site started to hurt really bad) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient has not taken any treatment medications.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Patient received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) 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. 015B22A) 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, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine).    No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715570 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715570:Adult Patient 2