chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose was in June 2022 and 2nd dose in 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   In July 2022, the patient received the 2nd dose of Shingrix. In July 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 30-NOV-2022 Reporters comment: The pharmacist reported that the patient he/she received 2nd dose of shingrix less than the minimal interval.  The patient not immunocompromised, first dose was in June 2022 and 2nd dose in July 2022. No other information available The reporter consent to follow-up. Additional Supportive information: The patient received 2nd dose of shingrix less than the minimal interval, first dose was in June 2022 and 2nd dose in July 2022, which led to shortening of vaccinations schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received 3 shingrix vaccinations; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in June 2021) and Shingrix (2nd dose received in September 2021).   In November 2022, the patient received the 3rd dose of Shingrix. In November 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional Information: GSK Receipt Date: 30-NOV-2022 and 01-DEC-2022 Reporter's Comments: The patient had reported the case for himself/herself. The patient received 3 Shingrix vaccinations. No further information provided. The reporter consented to follow up. Additional Supportive Information: The patient received the 3rd dose of Shingrix, which led to extra dose administered.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 01Aug2018, 2nd on 14Aug2019; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 0.5 ml first dose on 1st August 2018 in an unknown arm intramuscularly).   On 14th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 14th August 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 1-Dec-2022 Reporter's comment: The caller did not gave permission to follow-up with her health care professional. The reporter did not consented to follow-up. Additional supportive information: The patient received second dose of Sihngrix in unknown arm later than the recommended interval, which led to lengthening of vaccine schedule.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Sep2021, 2nd 1dec2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in unknown arm intramuscularly in September 2021).   On 1st December 2022, the patient received the 2nd dose of Shingrix. On 1st December 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 1-Dec-2022 Reporter's comment: Nothing else was reported. The reporter consented to follow-up. Additional supportive information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: Pediarix intead of Dtap 4th dose; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number x9hs4, expiry date 25th March 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Dtap vaccine (received 1st dose 19th October 2021), Dtap vaccine (received 2nd dose on 23rd December 2021) and Dtap vaccine (received 3rd dose 24th February 2022).   On 28th November 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 28th November 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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: 01-DEC-2022 Reporter's comment: The reporter reported that 15 months old patient supposed to be receiving a Dtap 4th dose but Pediarix was administered instead.  The patent previously received 3 doses of Dtap vaccine. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The patient received Pediarix vaccine instead of Dtap vaccine, which led to Wrong vaccine administered.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Menveo Administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA641A, expiry date 31st October 2022) for prophylaxis.   On 22nd November 2022, the patient received Menveo. On 22nd November 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 1-Dec-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. Additional supportive information: The patient received an expired dose of Menveo, which led to expired vaccine used.
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: EYES TO START BLEEDING; This spontaneous report received from a consumer via a company representative via social media (J and J) concerned a female of an unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: eye disease (ocular histo) and other pre-existing medical conditions included: The patient worked for 2 years at a hospital. 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, 1 total, administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced eyes to start bleeding and she was unable to work since OCT-2021. It was reported that "My wife worked everyday for 2 years at a hospital where she was giving the order to take the shot or be fired at the end of 2 year pandemic. Her doctor told her not to take the shot because of her eye disease (ocular histo) she had a letter stating that which the hospital ignored. No doctors would say it was the shot (vaccine) that made her eyes to start bleeding and the medicine she has been receiving for 20 plus years no longer stopped the bleeding. She hasn't been able to return to work since October of 2021. Glad to see Johnson and Johnson doing so well, able to build a monument to the all mighty dollar they made from the botched COVID vaccine. What a wonderful country we have become. Ha. The hell of it is she is only 1 in probably millions with worst stories to tell". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from eyes to start bleeding. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221210901-eyes to start bleeding. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: VAX (VACCINE) DAMAGED THE ANTIBODIES; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced vax (vaccine) damaged the antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vax (vaccine) damaged the antibodies was not reported. This report was non-serious. This case, from the same reporter is linked to 20221214638.
Sex: U
Vaccine: COVID19
Symptoms: Cardiovascular disorder
Clinical narrative: CARDIOVASCULAR PROBLEMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced cardiovascular problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cardiovascular problems was not reported. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: flu like symptoms; pain all over the body; aches; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (pain all over the body), PAIN (aches), PYREXIA (fever) and FATIGUE (fatigue) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU, ASKU and ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Janssen (Similar side effects as Moderna COVID-19 vaccine and First Booster dose) in December 2021. Past adverse reactions to the above products included Flu-like symptoms with Janssen.   On 21-Apr-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2022, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (pain all over the body), PAIN (aches), PYREXIA (fever) and FATIGUE (fatigue). On 02-Aug-2022, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (pain all over the body), PAIN (aches), PYREXIA (fever) and FATIGUE (fatigue) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had stated that he will be 56 in 2 weeks.  Concomitant medications details were not reported by the reporter.  Reportedly, patient received dose 5 of Bivalent Booster (Moderna COVID-19 Bivalent) on 06-Dec-2022 (Lot number and Expiration Date was unknown). Patient was asking that should he expect the same symptoms with the Bivalent Booster. Patient did not have his vaccination card handy. Patient had symptoms lasted for 2-4 days.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-685156 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms; Fever; Fatigue; pain all over the body; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), FATIGUE (Fatigue) and PAIN (pain all over the body) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Jansen COVID-19 in December 2021. Past adverse reactions to the above products included No adverse event with Jansen COVID-19.   On 21-Apr-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), FATIGUE (Fatigue) and PAIN (pain all over the body). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), FATIGUE (Fatigue) and PAIN (pain all over the body) had resolved. Not Provided          Patient had stated that he will be 56 in 2 weeks. Concomitant medications details were not reported by the reporter. Reportedly, patient received dose 5 of Bivalent Booster (Moderna COVID-19 Bivalent) on 06-Dec-2022 (Lot number and Expiration Date was unknown). Patient was asking that should he expect the same symptoms with the Bivalent Booster. Patient did not have his vaccination card handy.  Treatment details were not reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; Patient was administered the Bivalent Moderna COVID-19 Vaccine. He requested a booster/Wrong vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was administered the Bivalent Moderna COVID-19 Vaccine. He requested a booster/Wrong vaccine administered) 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. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 06-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient was administered the Bivalent Moderna COVID-19 Vaccine. He requested a booster/Wrong vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was administered the Bivalent Moderna COVID-19 Vaccine. He requested a booster/Wrong vaccine administered) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient was administered the Bivalent Moderna COVID-19 Vaccine. He requested a booster/Wrong vaccine administered).    Concomitant medications were not reported. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Dec-2022: Significant Live Follow up received contains event start date and narrative updated.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Moderna Covid-19 vaccine, bivalent received; No Adverse event; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (Moderna Covid-19 vaccine, bivalent received) and NO ADVERSE EVENT (No Adverse event) in a 76-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 059S22A and AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Dec-2022, 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 .5 milliliter. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Moderna Covid-19 vaccine, bivalent received) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Moderna Covid-19 vaccine, bivalent received) was resolving 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 (Moderna Covid-19 vaccine, bivalent received).    No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Interval between First and second primary doses was too short.Patient: Received first primary dose on 03Jun2022 and the second dose on 22Jun2022/ 3rd primary dose on 03Aug2022; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between First and second primary doses was too short.Patient: Received first primary dose on 03Jun2022 and the second dose on 22Jun2022/ 3rd primary dose on 03Aug2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 22-Jun-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between First and second primary doses was too short.Patient: Received first primary dose on 03Jun2022 and the second dose on 22Jun2022/ 3rd primary dose on 03Aug2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between First and second primary doses was too short.Patient: Received first primary dose on 03Jun2022 and the second dose on 22Jun2022/ 3rd primary dose on 03Aug2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between First and second primary doses was too short.Patient: Received first primary dose on 03Jun2022 and the second dose on 22Jun2022/ 3rd primary dose on 03Aug2022).    No concomitant medications were reported. No treatment information was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation, Vaccination site pain, Vaccination site pruritus
Clinical narrative: red in the shot area; inflamed/It had spread a little bit, like five inches across and five inches down the injection site; sore/it hurts to the touch in the shot area; itchy to the touch in the shot area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red in the shot area), VACCINATION SITE INFLAMMATION (inflamed/It had spread a little bit, like five inches across and five inches down the injection site), VACCINATION SITE PAIN (sore/it hurts to the touch in the shot area) and VACCINATION SITE PRURITUS (itchy to the touch in the shot area) in a 62-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:None.  Previously administered products included for Product used for unknown indication: Flu vaccine (2 weeks ago). Past adverse reactions to the above products included No adverse event with Flu vaccine.    On 04-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Dec-2022, the patient experienced VACCINATION SITE ERYTHEMA (red in the shot area), VACCINATION SITE INFLAMMATION (inflamed/It had spread a little bit, like five inches across and five inches down the injection site), VACCINATION SITE PAIN (sore/it hurts to the touch in the shot area) and VACCINATION SITE PRURITUS (itchy to the touch in the shot area). At the time of the report, VACCINATION SITE ERYTHEMA (red in the shot area), VACCINATION SITE INFLAMMATION (inflamed/It had spread a little bit, like five inches across and five inches down the injection site), VACCINATION SITE PAIN (sore/it hurts to the touch in the shot area) and VACCINATION SITE PRURITUS (itchy to the touch in the shot area) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient received Moderna dose 1 and dose 2 (unknown lot numbers and administration dates). It had spread a little bit, like five inches across and five inches down the injection site. Now it seems to be stable but did not be 100 percent sure, patient was not sure if it was recovering or not. Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Date(s) of administration of vaccine:10/10/2210/18/2211/14/2211/15/2211/18/22 For lot number: AR5186CDate of first thaw (calendar date required):9/9Date(s) of administration of vaccine:10/10/2210/14/2211/8/22; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Date(s) of administration of vaccine:10/10/2210/18/2211/14/2211/15/2211/18/22 For lot number: AR5186CDate of first thaw (calendar date required):9/9Date(s) of administration of vaccine:10/10/2210/14/2211/8/22) and NO ADVERSE EVENT (no adverse event) in an infant patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B, AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Date(s) of administration of vaccine:10/10/2210/18/2211/14/2211/15/2211/18/22 For lot number: AR5186CDate of first thaw (calendar date required):9/9Date(s) of administration of vaccine:10/10/2210/14/2211/8/22) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Date(s) of administration of vaccine:10/10/2210/18/2211/14/2211/15/2211/18/22 For lot number: AR5186CDate of first thaw (calendar date required):9/9Date(s) of administration of vaccine:10/10/2210/14/2211/8/22) and NO ADVERSE EVENT (no adverse event) outcome 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 (Date(s) of administration of vaccine:10/10/2210/18/2211/14/2211/15/2211/18/22 For lot number: AR5186CDate of first thaw (calendar date required):9/9Date(s) of administration of vaccine:10/10/2210/14/2211/8/22).    No relevant concomitant medications were reported.  Date of first thaw was reported as 09-Sep-2022. No treatment information was provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient received a 0.25ml booster dose instead of 0.5ml dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a 0.25ml booster dose instead of 0.5ml dose) and NO ADVERSE EVENT (No adverse event) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 06-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced ACCIDENTAL UNDERDOSE (Patient received a 0.25ml booster dose instead of 0.5ml dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a 0.25ml booster dose instead of 0.5ml dose) 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 ACCIDENTAL UNDERDOSE (Patient received a 0.25ml booster dose instead of 0.5ml dose).    No concomitant medication was provided.  It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment medication was not provided by the reporter.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date.) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date.).    Concomitant medications were not reported.  They stated they administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date. No adverse events were reported. The case is for the 3rd patient. Treatment medications were not reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: HCP administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date; HCP administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date), PRODUCT STORAGE ERROR (HCP administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date), PRODUCT STORAGE ERROR (HCP administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date), PRODUCT STORAGE ERROR (HCP administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and PRODUCT STORAGE ERROR (HCP administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date).    No concomitant drug information was provided by the reporter. Dosage text was reported as Additional Booster, Frequency-After, Done number 13. No adverse events post vaccination were reported. No treatment drug information was provided by the reporter.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 44-year-old patient received Bivalent Moderna COVID-19 vaccine instead of Monovalent first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (44-year-old patient received Bivalent Moderna COVID-19 vaccine instead of Monovalent first dose) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (44-year-old patient received Bivalent Moderna COVID-19 vaccine instead of Monovalent first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (44-year-old patient received Bivalent Moderna COVID-19 vaccine instead of Monovalent first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (44-year-old patient received Bivalent Moderna COVID-19 vaccine instead of Monovalent first dose).    Relevant concomitant medications were not reported.  Patient received Bivalent Moderna COVID-19 vaccine instead of Monovalent first dose.  Treatment information was not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No adverse event) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date).    No concomitant medications were reported.  It was reported Patient identifiers for patient number 12 are documented in this case.  No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP stated they administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (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 stated they administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date).    No concomitant medications were reported. No treatment information was provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; patient received a monovalent Moderna COVID-19 Vaccine booster (0.5 mL) instead of the bivalent; 0.5 mL Monovalent booster administered; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a monovalent Moderna COVID-19 Vaccine booster (0.5 mL) instead of the bivalent), ACCIDENTAL OVERDOSE (0.5 mL Monovalent booster administered) and NO ADVERSE EVENT (No Adverse Event) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient received a monovalent Moderna COVID-19 Vaccine booster (0.5 mL) instead of the bivalent) and ACCIDENTAL OVERDOSE (0.5 mL Monovalent booster administered). 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 monovalent Moderna COVID-19 Vaccine booster (0.5 mL) instead of the bivalent) had resolved and ACCIDENTAL OVERDOSE (0.5 mL Monovalent booster administered) 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 WRONG PRODUCT ADMINISTERED (patient received a monovalent Moderna COVID-19 Vaccine booster (0.5 mL) instead of the bivalent) and ACCIDENTAL OVERDOSE (0.5 mL Monovalent booster administered).    No concomitant medications were reported. No adverse events were reported by the patient. No treatment medications were reported.
Age: 11.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired bivalent booster after MFG expiration date; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired bivalent booster after MFG expiration date) and NO ADVERSE EVENT (No Adverse Event) in an 11-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired bivalent booster after MFG expiration date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired bivalent booster after MFG expiration date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient received expired bivalent booster after MFG expiration date).    No concomitant information was reported. No treatment information was reported.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; had an administration error for a pediatric patient who was supposed to receive a Moderna bivalent booster dose but received the monovalent Moderna booster dose instead.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (had an administration error for a pediatric patient who was supposed to receive a Moderna bivalent booster dose but received the monovalent Moderna booster dose instead.) and NO ADVERSE EVENT (No Adverse event) in an 11-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     There was no parental vaccine exposure.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1), PFIZER BIONTECH COVID-19 VACCINE (Booster) and PFIZER BIONTECH COVID-19 VACCINE (Dose 2). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 03-Dec-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (had an administration error for a pediatric patient who was supposed to receive a Moderna bivalent booster dose but received the monovalent Moderna booster dose instead.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (had an administration error for a pediatric patient who was supposed to receive a Moderna bivalent booster dose but received the monovalent Moderna booster dose instead.) 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 (had an administration error for a pediatric patient who was supposed to receive a Moderna bivalent booster dose but received the monovalent Moderna booster dose instead.).    Concomitant product use was not provided by the reporter. Care Team HCP stated that they had an administration error for a pediatric patient who was supposed to receive a Moderna bivalent booster dose but received the monovalent Moderna booster dose instead. The incorrect product was administered on 3-DEC-2022 from Moderna monovalent (0.25 mL dose) lot # 018C22A, expiration date: 9JAN2023. The patient has previously received 2 primary doses and 1 booster dose of the Pfizer COVID-19 vaccine. No adverse reactions have been reported by the patient at this time. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of NO ADVERSE EVENT (no adverse event) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related.    No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 88.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; dose of Moderna Covid-19 Vaccine, Bivalent was given to a patient who didn't have the primary series.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (dose of Moderna Covid-19 Vaccine, Bivalent was given to a patient who didn't have the primary series.) and NO ADVERSE EVENT (No adverse event) in an 88-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 07-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (dose of Moderna Covid-19 Vaccine, Bivalent was given to a patient who didn't have the primary series.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (dose of Moderna Covid-19 Vaccine, Bivalent was given to a patient who didn't have the primary series.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (dose of Moderna Covid-19 Vaccine, Bivalent was given to a patient who didn't have the primary series.).    No concomitant medications were reported. No treatment medications were reported.