chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: Skin is falling off; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of skin peeling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced skin peeling (Verbatim: Skin is falling off). The outcome of the skin peeling was not reported.   It was unknown if the reporter considered the skin peeling to be related to Shingles vaccine.     It was unknown if the company considered the skin peeling to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-JUN-2023 This case was reported by a patient via interactive digital media. Patient stated that the vac brought mine on so. Patient reported that she/he just had first dose and it was not fancy.  However patient kept on going and the skin was falling off and patient survived. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Pain
Clinical narrative: sick; aching; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick) and pain (Verbatim: aching). The outcome of the sickness and pain were not reported.   It was unknown if the reporter considered the sickness and pain to be related to Shingles vaccine.     It was unknown if the company considered the sickness and pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR087210   Additional Information: Additional Information: GSK Receipt Date: 17-JUN-2023 The patient self-reported this case. This case was reported by a patient via interactive digital media. The patient received the dose of Shingles vaccine however, it made the patient sick and aching. The patient was glad after having the dose. For tolerance of 2nd dose refer case US2023AMR087210.; Sender's Comments:  US-GSK-US2023AMR087210:first dose case US2023AMR086707, same patient
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: felt like crap; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16-JUN-2023, the patient received Shingles vaccine. On 17-JUN-2023, 1 days after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: felt like crap). The outcome of the feeling abnormal was not reported.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.     It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-JUN-2023 This case was reported by a patient via interactive digital media. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 20-JUN-2023 This case was reported by patient via interactive digital media. The patient got the Shingles shots and had nothing more than a sore arm. Follow up was not possible, as no contact details were available.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Accidental overdose
Clinical narrative: given both Infanrix doses by mistake; This non-serious case was reported by a physician via sales rep and described the occurrence of accidental overdose in a 18-month-old male patient who received DTPa (Infanrix) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (INFANRIX).   On an unknown date, the patient received the 4th dose of Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced accidental overdose (Verbatim: given both Infanrix doses by mistake). The outcome of the accidental overdose 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: 19-APR-2023 The reporter stated that Twins (18 months) had a visit and Infanrix and Havrix were on a tray 1 of each for each patient (baby).  An immunocompetant patient was given both Infanrix doses by mistaken because of an interruption in their protocol by the patient's father.  Provider called Poison Control and was given guidance.   The reporter agreed to follow up from GlaxoSmithKline (GSK). The patient received 2 doses of Infanrix mistakenly, which led to accidental overdose
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Pain, Vaccine positive rechallenge
Clinical narrative: sick; aching; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (On an unknown date, the patient received first dose and experienced pain, refer case US2023AMR086707).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick) and pain (Verbatim: aching). Rechallenge with Shingles vaccine was positive. The outcome of the sickness and pain were not reported.   It was unknown if the reporter considered the sickness and pain to be related to Shingles vaccine.     It was unknown if the company considered the sickness and pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR086707   Additional Information: GSK Receipt Date: 17-JUN-2023 The patient self-reported this case. This case was reported by a patient via interactive digital media. The patient received both the doses of Shingles vaccine, however they both made the patient sick and aching. The patient was glad after having both the doses.; Sender's Comments:  US-GSK-US2023AMR086707:same Reporter case for first dose
Sex: F
Vaccine: TDAP
Symptoms: Breast feeding, Extra dose administered
Clinical narrative: she is/was breastfeeding; Extra dose administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of breast feeding in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Tdap Vaccine (prior dose was received in September 2019). Concurrent medical conditions included bell's palsy.   On 18-JUN-2023, the patient received the 2nd dose of Boostrix. On 18-JUN-2023, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Extra dose administered). On an unknown date, the patient experienced breast feeding (Verbatim: she is/was breastfeeding). The outcome of the breast feeding and extra dose administered were unknown.   It was unknown if the reporter considered the breast feeding to be related to Boostrix.     It was unknown if the company considered the breast feeding to be related to Boostrix.   Additional Information: GSK Receipt Date: 17-JUN-2023 The patient self-reported this case. The reporter was consumer. The patient reported that she developed Bell's Palsy recently, it was developed about 2 days before she delivered her son. The patient did not believe that her prior shot with the Tdap vaccine in 2019 had anything to do with her developing Bell's Palsy, she attributed the Bell's Palsy to being pregnant. The patient also knew that the disease control recommended that pregnant women should be vaccinated during the third trimester of pregnancy with Tdap however, the patient did not receive the vaccine during pregnancy because no one told her to get it. The patient did get a dose of Boostrix. The patient was no longer pregnant on 18th JUN-2023 but she was breastfeeding.  The patient did not have the lot number available. The reporter stated that getting the Boostix shot did not negatively affect her Bells Palsy.  The patient said prior to getting the shot she was about 70 percent better from the Bells Palsy and now she was about 90 percent better.  The face and tongue and speech were a lot better.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: accidentally gave an expired dose of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26-MAY-2023) for prophylaxis.   On 14-JUN-2023, the patient received the 1st dose of Kinrix. On 14-JUN-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: accidentally gave an expired dose of Kinrix). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-JUN-2023 and 21-JUN-2023 The details of vaccines, patient and event were given.  The reporter consented to follow up. The Vaccine Administration Facility was the same as primary reporter. The reporter reported that a medical assistant accidentally gave an expired dose of Kinrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Accidental overdose, Chills
Clinical narrative: Two doses were then inadvertently administered on 13-JUN-2023.; experiencing chills; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of chills in a adolescent female patient who received Herpes zoster (Shingrix) (batch number 577BF, expiry date 30-SEP-2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 17th February2023).   On 13-JUN-2023, the patient received Shingrix (unknown arm) and Shingrix (unknown arm). On 13-JUN-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced accidental overdose (Verbatim: Two doses were then inadvertently administered on 13-JUN-2023.). In JUN-2023, the patient experienced chills (Verbatim: experiencing chills). The outcome of the chills was not reported and the outcome of the accidental overdose was unknown.   It was unknown if the reporter considered the chills to be related to Shingrix and Shingrix.     It was unknown if the company considered the chills to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 14-JUN-2023 The reporter stated that patient received first dose o Shingrix and then inadvertently administered the two doses of Shingrix in different arms. The patient reportedly started experiencing chills.  The reporter declined to provide the additional patient information. The reporter declined the consent to follow up. The patient received 2 dose of Shingrix on same day in different arms, which led to accidental overdose.; Sender's Comments:  US-GSK-US2023083877:Same reporter
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstituted a dose of Menveo with sterile water instead of the provided diluent; Reconstituted a dose of Menveo with sterile water instead of the provided diluent; This non-serious 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 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA936A, expiry date 31-MAY-2024) for prophylaxis.   On 14-JUN-2023, the patient received the 1st dose of Menveo. On 14-JUN-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted a dose of Menveo with sterile water instead of the provided diluent) and inappropriate dose of vaccine administered (Verbatim: Reconstituted a dose of Menveo with sterile water instead of the provided diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-JUN-2023 The reporter was a medical assistant. The reporter reported that the nurse accidentally reconstituted a dose of Menveo vaccine with sterile water instead of the provided diluent  The reporter wanted to know how to proceed. The vaccine administration facility was the same as primary reporter. Menveo reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did consent to follow up.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 51-year-old female patient who received HBV (Engerix B adult) (batch number FR334, expiry date 24-AUG-2024) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B ADULT).   On 16-JUN-2023, the patient received the 2nd dose of Engerix B adult (left deltoid). On 16-JUN-2023, an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate schedule of vaccine). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 16-JUN-2023 Registered nurse called to inquire was the dose valid or another dose needed. The reporter wanted to know how to proceed. RN reported an adult was administered Engerix too early. Did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose has not been administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received several years ago prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose has not been administered). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-JUN-2023 The reporter reported that several years ago the patient received first dose of Shingrix vaccine and did not received second dose. The reporter wanted to know if need to restart the series. The reporter did consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Received dose 1 of SHINGRIX on March 4, 2020. He does not received dose 2; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th March 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Received dose 1 of SHINGRIX on March 4, 2020. He does not received dose 2). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-JUN-2023 The patient does not think that he received second dose of Shingrix vaccine. The patient vaccination records and pharmacy did not had any records of second dose given. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Meralgia paraesthetica
Clinical narrative: MERALGIA PARASITIC; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: osteoporosis. 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. No concomitant medications were reported. On an unspecified date, the patient experienced meralgia parasitic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of meralgia parasitic was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site reaction
Clinical narrative: WHERE GOT THE SHOT IT HAS BEEN SUCH A LENGTHY PERIOD OF TIME BUT IT HAS GRADUALLY GOTTEN WORSE INSTEAD OF THE INJECTION SITE GETTING BETTER; This spontaneous report received from a patient 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced where got the shot it has been such a lengthy period of time but it has gradually gotten worse instead of the injection site getting better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from where got the shot it has been such a lengthy period of time but it has gradually gotten worse instead of the injection site getting better. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin disorder
Clinical narrative: Patient started to have issues wth the skin; Itch; Rash; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SKIN DISORDER (Patient started to have issues wth the skin), PRURITUS (Itch) and RASH (Rash) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN DISORDER (Patient started to have issues wth the skin), PRURITUS (Itch) and RASH (Rash). At the time of the report, SKIN DISORDER (Patient started to have issues wth the skin), PRURITUS (Itch) and RASH (Rash) had not resolved.            No concomitant medications were reported. The patient's wife reported that both she and patient received original doses of the Moderna vaccine and three boosters. About two months after patient received second initial vaccine and started to have issues with his skin. They have seen dermatologists, allergists, their regular primary physician, his gastroenterologist and now a rheumatologist. Patient had relief from time to time, but the rash and itch has never gone away completely. Currently the patient skin was in terrible condition, according to the inquirer. The reporter stated that they do not believe that patient ever had Covid.  No treatment medications were reported.
Sex: F
Vaccine: COVID19-2
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: got Covid/started not feeling well/temp of 100.5, cold symptoms, no appetite/ sick for 2 days and just tested positive; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (got Covid/started not feeling well/temp of 100.5, cold symptoms, no appetite/ sick for 2 days and just tested positive) 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.    In June 2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Jun-2023, the patient experienced COVID-19 (got Covid/started not feeling well/temp of 100.5, cold symptoms, no appetite/ sick for 2 days and just tested positive). At the time of the report, COVID-19 (got Covid/started not feeling well/temp of 100.5, cold symptoms, no appetite/ sick for 2 days and just tested positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2023, Body temperature: 100.5. On 16-Jun-2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The physician reported that patient received 6th shot of vaccine approximately 6 days ago and experienced Covid-19 approximately 2 days ago. Patient was at a bridge tournament all week and started not feeling well about 2 days ago and was exposed about a week ago. Patient had cold symptoms, no appetite and had been sick for 2 days and just tested positive. Physician queried if Paxlovid may be given to patient who just recently got a Moderna bivalent booster 6 days ago. No other additional information was reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE EVENT; Doses were administered after the 30 day BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) 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. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 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. In June 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (NO ADVERSE EVENT). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) 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 (Doses were administered after the 30 day BUD).    Concomitant product use was not provided by the reporter.  It was reported that Doses were administered after the 30-day BUD between 8 to 15-Jun-2023. 7 doses were administered, though the clinic was not open on the weekend, so no doses were administered during that weekend. All doses were given to adult patients. There were no reported symptoms or side effects.  Treatment information was not provided.  This case contains information about patient 2nd out of 7 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-729901.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729901:(Master case Patient no-1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Doses were administered after the 30 day BUD; NO ADVERSE EVENT; Doses were administered after the 30 day BUD between 8-15JUN2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD between 8-15JUN2023.), PRODUCT STORAGE ERROR (Doses were administered after the 30 day BUD) 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. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 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. In June 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD between 8-15JUN2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (NO ADVERSE EVENT). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD between 8-15JUN2023.), PRODUCT STORAGE ERROR (Doses were administered after the 30 day BUD) 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 (Doses were administered after the 30 day BUD between 8-15JUN2023.) and PRODUCT STORAGE ERROR (Doses were administered after the 30 day BUD).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information about patient 3rd out of 7   This case was linked to US-MODERNATX, INC.-MOD-2023-729901 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729901:(case Patient no-1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE EVENT; Doses were administered after the 30 day BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) 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. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.  In June 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. In June 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (NO ADVERSE EVENT). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) 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 (Doses were administered after the 30 day BUD).    Concomitant product use was not provided by the reporter.  Doses were administered after the 30 day BUD between 08-Jun-2023 to 15-Jun-2023.  Seven doses were administered. No doses were administered during that weekend.   No reported symptoms or side effects.  Treatment information was not provided.  This case contains information for the 6th patient out of 7 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-729901.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729901:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE EVENT; Doses were administered after the 30 day BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) 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. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 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. In June 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (NO ADVERSE EVENT). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) 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 (Doses were administered after the 30 day BUD).    No concomitant medication was reported.  Doses were administered after the 30 day BUD between 08-JUN-2023 -15-JUN-2023. No treatment information was reported. This case contains information for patient 7 out of 7.   This case was linked to US-MODERNATX, INC.-MOD-2023-729901.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729901:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE EVENT; Doses were administered after the 30 day BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) 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. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 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. In June 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (NO ADVERSE EVENT). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) 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 (Doses were administered after the 30 day BUD).    Concomitant product use was not provided by the reporter.  It was reported that Doses were administered after the 30-day BUD between 8 to 15-Jun-2023. 7 doses were administered, though the clinic is not open on the weekend, so no doses were administered during that weekend. All doses were given to adult patients. No reported symptoms or side effects.  Treatment information was not provided.  This case contains information about patient 4th out of 7 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-729901 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729901:(Master case Patient no-1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE EVENT; Doses were administered after the 30 day BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) 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. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 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. In June 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (NO ADVERSE EVENT). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) 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 (Doses were administered after the 30 day BUD).    Concomitant product use was not provided by the reporter.  It was reported that Doses were administered after the 30-day BUD between 8 to 15-Jun-2023. 7 doses were administered, though the clinic was not open on the weekend, so no doses were administered during that weekend. All doses were given to adult patients. There were no reported symptoms or side effects.  Treatment information was not provided.  This case contains information about patient 5th out of 7 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-729901.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729901:(Master case Patient no-1)
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No patients have reported any adverse reactions at this time; it expired 6/8/23 but was administered to a patient 6/17/23; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (it expired 6/8/23 but was administered to a patient 6/17/23) and NO ADVERSE EVENT (No patients have reported any adverse reactions at this time) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (it expired 6/8/23 but was administered to a patient 6/17/23). On an unknown date, the patient experienced NO ADVERSE EVENT (No patients have reported any adverse reactions at this time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (it expired 6/8/23 but was administered to a patient 6/17/23) and NO ADVERSE EVENT (No patients have reported any adverse reactions at this time) 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 patients have reported any adverse reactions at this time) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (it expired 6/8/23 but was administered to a patient 6/17/23).    No concomitant medication information was provided. It was reported that there was an instance where an expiration date was incorrectly documented for lot number 043h22a. it expired 8Jun23 but was administered to a patient 17Jun23 . Reporter was looking for guidance if the patient needs another dose or not. The vial size was reported as 2.5ml. It was unknown when the vial was initially stored in the refrigerator. It was confirmed that the vial had not undergone temperature excursion issue.  Patient had had reported any adverse event at the time of report. No treatment medication information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-729716, US-MODERNATX, INC.-MOD-2023-729696.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2023: Follow up received contains Nonsignificant information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729716:Same reporter US-MODERNATX, INC.-MOD-2023-729696:Same reporter
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine administered administered to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered administered to a patient) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered administered to a patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered administered to a patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered administered to a patient).    No concomitant medication information was provided. It was reported that there was an instance where an expiration date was incorrectly documented for lot number 043h22a. it expired 8Jun23 but was administered to a patient 17Jun23 . Reporter was looking for guidance if the patient needs another dose or not. The vial size was reported as 2.5ml. It was unknown when the vial was initially stored in the refrigerator. It was confirmed that the vial had not undergone temperature excursion issue.  Patient had had reported any adverse event at the time of report. No treatment medication information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-729650, US-MODERNATX, INC.-MOD-2023-729716 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2023: Follow up received contains Non-significant information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729650:Same reporter US-MODERNATX, INC.-MOD-2023-729716:Same reporter
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Doses were administered after the 30 day BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) 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. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 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. In June 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) 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 (Doses were administered after the 30 day BUD).    No concomitant medication was reported.  Doses were administered after the 30 day BUD between 08-JUN-2023 -15-JUN-2023. No treatment information was reported.  This case contains information for patient 1 out of 7.   This case was linked to US-MODERNATX, INC.-MOD-2023-729912, US-MODERNATX, INC.-MOD-2023-729921, US-MODERNATX, INC.-MOD-2023-729922, US-MODERNATX, INC.-MOD-2023-729923, US-MODERNATX, INC.-MOD-2023-729924, US-MODERNATX, INC.-MOD-2023-729909 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729912:(Patient no- 3 out of 7) US-MODERNATX, INC.-MOD-2023-729921:(Patient no- 6 out of 7) US-MODERNATX, INC.-MOD-2023-729923:(Patient no-  4out of 7) US-MODERNATX, INC.-MOD-2023-729922:(Patient no-  7 out of 7) US-MODERNATX, INC.-MOD-2023-729924:(Patient no-5  out of 7) US-MODERNATX, INC.-MOD-2023-729909:(Patient no- 2 out of 7)
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; they got one in Sep2022 when it came out and a second Feb2023/potential AE: patient received second Bivalent dose before authorized; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (they got one in Sep2022 when it came out and a second Feb2023/potential AE: patient received second Bivalent dose before authorized) and NO ADVERSE EVENT (No adverse event) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   In September 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 February 2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. In February 2023, the patient experienced EXTRA DOSE ADMINISTERED (they got one in Sep2022 when it came out and a second Feb2023/potential AE: patient received second Bivalent dose before authorized). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (they got one in Sep2022 when it came out and a second Feb2023/potential AE: patient received second Bivalent dose before authorized) 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 EXTRA DOSE ADMINISTERED (they got one in Sep2022 when it came out and a second Feb2023/potential AE: patient received second Bivalent dose before authorized).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown. Concomitant medication details not reported by the reporter. It was reported that patient got one in Sep2022 when it came out and a second Feb2023. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 45.0
Sex: F
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-JUN-2023 and administered on 19-Jun-2023; No adverse event; Nurse is calling to report that a 45 year old patient received an expired (beyond MFG expiration date); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that a 45 year old patient received an expired (beyond MFG expiration date)), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-JUN-2023 and administered on 19-Jun-2023) and NO ADVERSE EVENT (No adverse event) in a 45-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that a 45 year old patient received an expired (beyond MFG expiration date)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-JUN-2023 and administered on 19-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that a 45 year old patient received an expired (beyond MFG expiration date)), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-JUN-2023 and administered on 19-Jun-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that a 45 year old patient received an expired (beyond MFG expiration date)) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-JUN-2023 and administered on 19-Jun-2023).    No concomitant medication was reported. It was reported that the patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Bivalent BA.4-5 Blue Cap Dose was administered after Manufacturer Date of Expiry. Individual Vial size was 2.5 ml.  The vial was initially stored in the refrigerator on 12-JUN-2023. The vial did not undergo any temperature excursions. No treatment information was reported.