chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: A little 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 RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   In AUG-2023, the patient received RSV vaccine. In AUG-2023, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: A little sore arm).  In AUG-2023, the outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: Receipt date: 19-AUG-2023 This case was reported by a patient via interactive digital media. The patient stated that check with your local pharmacy, the vaccine was available. The patient took RSV vaccine this week and had a little sore arm but he/she was good. The follow-up could not be possible as no contact details were available.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Scar, Skin discolouration, Skin lesion
Clinical narrative: Shingles on both my arms, my legs and my elbows; Left purple scars; Lesions; Purple scars; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included shingles vaccine with an associated reaction of herpes zoster (received roughly 20 years ago from reporting).   On an unknown date, the patient received the 1st dose of Shingrix (left arm). In AUG-2023, 1 week after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles on both my arms, my legs and my elbows), scar (Verbatim: Left purple scars) and skin discoloration (Verbatim: Purple scars). On an unknown date, the patient experienced skin lesion (Verbatim: Lesions).  In AUG-2023, the outcome of the shingles, scar and skin discoloration were resolved. The outcome of the skin lesion was resolved.   It was unknown if the reporter considered the shingles, scar, skin lesion and skin discoloration to be related to Shingrix.     It was unknown if the company considered the shingles, scar, skin lesion and skin discoloration to be related to Shingrix.   Additional Information: Receipt date: 21-AUG-2023 and 22-AUG-2023 The patient reported that he had a 1 shingle for 33 years. It comes and goes due to stress. Like the butterball thermometer in a turkey.  When the first shingle shot vaccine came out, he got one and never had any effect on his butterball thermometer.  Now the patient received Shingrix about 3 weeks ago from reporting and approximately 7 days later he got shingles on both arms, legs and elbows. Left purple scars where they popped up.  The lesions had cleared up and the consumer did not go to his doctor.  The patient stated that this was the result of shingles.  Now the patient questioning if the second shot is worth it, did use a live virsus, would he get it worse with the second shot. The patient states that his dermatology appointment on 17th October 2023. The reporter consented to follow up. Consent to follow up with dermatologist was obtained.
Sex: M
Vaccine: VARZOS
Symptoms: Electrocardiogram normal, Heart rate increased, Injection site erythema, Injection site pain, Tachycardia
Clinical narrative: noticed slight redness below the injection site; Tachycardia; arm was painful at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included atrial fibrillation and vestibular disorder. Concurrent medical conditions included anxiety. Concomitant products included fexofenadine hydrochloride (Allegra) and lorazepam.   On 16-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown arm). On 16-AUG-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: arm was painful at the injection site). On 17-AUG-2023, the patient experienced injection site erythema (Verbatim: noticed slight redness below the injection site) and tachycardia (Verbatim: Tachycardia).  The outcome of the injection site pain, injection site erythema and tachycardia were resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and tachycardia to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site erythema and tachycardia to be related to Shingrix.   Additional Information: Receipt Date: 21-AUG-2023 The reporter was the patient. The patient received 1st Shingrix dose and his arm was painful at the injection site. The next morning the patient noticed slight redness below the injection site. Late afternoon on 17th August 2023 his heart rate was 126 so the patient went to the emergency room. The emergency room doctor said the tachycardia might be due to anxiety or a reaction to the vaccine. The patient was not admitted. The patient's normal resting heart rate was upper 70s to low 80s. The patient experienced one more episode of increased heart rate (120s) on 19th August 2023, he relaxed and his heart rate returned to normal. Nothing else was reported. The reporter did not consent to follow-up. Emergency room Visit Required. The patient declined to provide last name, address or date of birth.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: pharmacist did not reconstitute the Aexvy vaccine/administration of vaccine adjuvant without active component; pharmacist did not reconstitute the Aexvy vaccine/administration of vaccine adjuvant without active component; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9B2Y4, expiry date 20-OCT-2024) for prophylaxis.   On 19-AUG-2023, the patient received the 1st dose of Arexvy (intramuscular, right arm). On 19-AUG-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: pharmacist did not reconstitute the Aexvy vaccine/administration of vaccine adjuvant without active component) and inappropriate dose of vaccine administered (Verbatim: pharmacist did not reconstitute the Aexvy vaccine/administration of vaccine adjuvant without active component).The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-AUG-2023 The reporter reported that a pharmacist did not reconstitute the Arexvy vaccine and the administration of vaccine adjuvant without active component was given in right arm, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. They had not been able to reach the patient to inform her. The caller was also transferred back to VSC asking for replacement of adjuvant vial. The reporter did not consent to follow-up.
Sex: M
Vaccine: COVID19, PPV, VARZOS
Symptoms: Feeling abnormal
Clinical narrative: feeling pretty bad; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis and COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis.   The patient's past medical history included smoker (quit smoking about 2 years ago.). Concurrent medical conditions included chronic obstructive pulmonary disease (diagnosed with COPD about 8 years ago.).   On an unknown date, the patient received the 1st dose of Shingrix, the 1st dose of PNEUMONIA VACCINE and COVID-19 BOOSTER. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling bad (Verbatim: feeling pretty bad).  The outcome of the feeling bad was resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.     It was unknown if the company considered the feeling bad to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR114355   Additional Information: GSK Receipt date: 21-AUG-2023 The patient reported that he received the 1st dose of Shingrix at the same time as a Covid booster and a pneumonia shot (unknown products) from his pharmacy, and was out of it for 2 to 3 days feeling pretty bad. The patient also reports that he was diagnosed with COPD about 8 years ago (pre existing Shingrix) and quit smoking about 2 years ago.  It was unknown if the reporter considered the feeling bad to be related to Covid booster and pneumonia vaccine. For tolerance of 2nd dose refer case US2023AMR114355  The reporter consent to follow up.; Sender's Comments:  US-GSK-US2023AMR114355:same patient
Sex: M
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Havrix: adult dose given to pediatric patient; 2 pediatric patient (siblings) receive an adult dose of Havrix yesterday on 8/21/2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 9-year-old male patient who received HAV (Havrix) (batch number 9SDB2, expiry date 13-DEC-2024) for prophylaxis.   On 21-AUG-2023, the patient received the 1st dose of Havrix. On 21-AUG-2023, an unknown time after receiving Havrix, the patient experienced overdose (Verbatim: Havrix: adult dose given to pediatric patient) and adult product administered to child (Verbatim: 2 pediatric patient (siblings) receive an adult dose of Havrix yesterday on 8/21/2023).  The outcome of the overdose and adult product administered to child were unknown.   Additional Information: Receipt Date: 22-AUG-2023 Nurse had a pediatric patient received an adult dose of Havrix, which led to overdose and adult product administered to child. The reporter asked what the next step. The reporter consented to follow up. This case had been linked with US2023114115, reported by same reporter.; Sender's Comments:  US-GSK-US2023114115:2 patient (siblings)
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: she broke out in hives from her left shoulder to her left wrist; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. On 12-AUG-2023, 2 days after receiving Shingrix, the patient experienced hives (Verbatim: she broke out in hives from her left shoulder to her left wrist).  On 14-AUG-2023, the outcome of the hives was resolved (duration 2 days).   It was unknown if the reporter considered the hives to be related to Shingrix.     It was unknown if the company considered the hives to be related to Shingrix.   Additional Information: GSK Receipt date: 22-AUG-2023 The patient reported that she received the Shingrix vaccine about 1 and ½ weeks ago in her left arm.  The patient states that 2 days later she broke out in hives from her left shoulder to her left wrist and the hives cleared up in 2 days.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: about 2 years ago and has not yet received her second Shingrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received by intramuscularly at unknown arm about 2 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: about 2 years ago and has not yet received her second Shingrix vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-AUG-2023 The reporter reported that no other information was known. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023114896:Same reporter
Age: 14.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: 14 year old male was given an injection of Bexsero, however, he should have received Menveo; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 14-year-old male patient who received Men B NVS (Bexsero) (batch number 25db5, expiry date 31-JUL-2025) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: 14 year old male was given an injection of Bexsero, however, he should have received Menveo).  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: 23-AUG-2023 The patient was given an injection of Bexsero; however, he should had received Menveo, which led to wrong vaccine administered. The reporter consented to follow up. No further information was known.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered adjuvant portion only without reconstituting with the lyophilized portion; Administered adjuvant portion only without reconstituting with the lyophilized portion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 9AT7A, expiry date 06-AUG-2024) for prophylaxis.   On 23-AUG-2023, the patient received the 2nd dose of Shingrix. On 23-AUG-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Administered adjuvant portion only without reconstituting with the lyophilized portion) and inappropriate dose of vaccine administered (Verbatim: Administered adjuvant portion only without reconstituting with the lyophilized portion).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-AUG-2023 The reporter reported that she realized that this morning she administered a dose of the Shingrix adjuvant portion only without reconstituting with lyophilized portion. The reporter reported that this was their second dose in the series. The reporter stated that at the time of reporting the repeat dose had not been administered. The vaccine administration facility was the same as primary reporter. Only adjuvant of shingrix administered to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received a second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   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: never received a second dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: Receipt date: 23-Aug-2023 Education provided per content regarding vaccine schedule and disease control recommendation. The reporter was the patient who stated she received first dose of Shingrix in 2018 but never received a second dose, which led to incomplete course of vaccination The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only the adjuvant was administered; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Only the adjuvant was administered) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date:24-AUG-2023 Pharmacist calling to report that a Shingrix vaccination was given without the antigen.  Only the adjuvant was administered which led to inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   The event has been reported to VAERS by the pharmacy.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received a dose of Engerix-B approximately 8 years ago. Partial; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (patient received a dose of Engerix-B approximately 8 years ago.).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: patient received a dose of Engerix-B approximately 8 years ago. Partial).  The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 24-Aug-2023 The vaccine administration facility was the same as primary reporter, Partial information was provided for the adverse event, vaccine and patient. The provider requested to no be contacted. The patient received a dose of Engerix-B approximately 8 years ago, which led to incomplete course of vaccination.  The reporter did not consented to follow up.; Sender's Comments: GSK receipt date: 24-Aug-2023 The vaccine administration facility was the same as primary reporter, Partial information was provided for the adverse event, vaccine and patient. The provider requested to no be contacted. The patient received a dose of Engerix-B approximately 8 years ago, which led to incomplete course of vaccination.  The reporter did not consented to follow up.
Sex: F
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: patient inquired, could they go ahead and get the Twinrix vaccine because it contains both the Hep A and Hep B components to count as the Havrix portion and to start the Hep B series.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received HAV (Havrix adult) for prophylaxis.   Previously administered products included Havrix adult (1st dose received in 2015).   On an unknown date, the patient did not receive the 2nd dose of Havrix adult. On an unknown date, an unknown time after receiving Havrix adult, the patient experienced incomplete course of vaccination (Verbatim: patient inquired, could they go ahead and get the Twinrix vaccine because it contains both the Hep A and Hep B components to count as the Havrix portion and to start the Hep B series.). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:24-AUG-2023 Pharmacist called to inquire the how to proceed. Do we need to restart the whole series of Havrix Or can the patient get the Twinrix vaccine to have the combo Hep A and Hep B. RPH stated the Adult patient received the first dose of Havrix back in 2015 and came back to complete the Havrix series. But the patient inquired, could they go ahead and get the Twinrix vaccine because it contains both the Hep A and Hep B components to count as the Havrix portion and to start the Hep B series. At the time of call, Havrix and Twinrix has not been administered, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: She administered the liquid component of the 2 vials alone without mixing the 2 vials together; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 3A3TC, expiry date 05-AUG-2024) for prophylaxis.   On 05-AUG-2023, the patient received the 2nd dose of Shingrix. On 05-AUG-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: She administered the liquid component of the 2 vials alone without mixing the 2 vials together).  The outcome of the inappropriate preparation of medication was unknown.   Additional Information: GSK receipt date 24 August 2023: The long term care pharmacy that sent the Shingrix vaccine out to a nursing facility for a nurse to administer. She administered the liquid component of the 2 vials alone without mixing the 2 vials together, which led to inappropriate preparation of medication. The safety follow-up was not asked.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: patient got the first dose of Shingrix on 2019 and the second dose was administered on 2021; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: patient got the first dose of Shingrix on 2019 and the second dose was administered on 2021).  The outcome of the social problem was unknown.   Additional Information: GSK Receipt Date:24-AUG-2023 Pharmacist reported on August 24th 2023 that patient got the first dose of Shingrix on 2019 and the second dose was administered on 2021 (Late dose due to pandemic). Asked Should restart the series. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. The health care professional did not have vaccine or patient's identifiers available.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received the first dose of Havrix in 2015 and a booster dose in 8-21-23; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 9-year-old male patient who received HAV (Havrix) (batch number Y3ME2, expiry date 23-FEB-2025) for prophylaxis.   Previously administered products included Havrix (1st dose received in 2015).   On 21-AUG-2023, the patient received the 2nd dose of Havrix. On 21-AUG-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too long (Verbatim: patient received the first dose of Havrix in 2015 and a booster dose in 8-21-23).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: Receipt Date:24-AUG-2023 Medical assistant calls to report a patient received the first dose of Havrix in 2015 and a booster dose in 21st August 2023 which led to lengthening of vaccination schedule. The reporter consented to follow up via email.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: it was administered subcutaneously; she will soon get her second dose of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of intramuscular formulation administered by other route in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: it was administered subcutaneously) and incomplete course of vaccination (Verbatim: she will soon get her second dose of Shingrix).  The outcome of the intramuscular formulation administered by other route and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt date: 25-AUG-2023 A reporter reported for herself approximately 5 years ago she had her first injection of Shingrix and it was administered subcutaneously which led to Intramuscular formulation administered by other route. The reporter states that she will soon get her second dose of Shingrix. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia areata
Clinical narrative: ALOPECIA AREATA; This spontaneous report received from a physician 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. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced alopecia areata. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of alopecia areata was not reported. This report was non-serious.
Age: 25.0
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 25-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, 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. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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 (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  They accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage. No adverse event was reported for any of the patients.  Treatment medications were not reported.  This case contains information for patient 2 out of 25.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2023: Live significant follow-up received contains patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:Patient 1 (Master Case)
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, 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. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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 (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  They accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage. No adverse event was reported for any of the patients.  Treatment medications were not reported.  This case contains information for patient 3 out of 25.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2023: Live significant follow-up received contains Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:Patient 1 (Master Case)
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, 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. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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 (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  They accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage. No adverse event was reported for any of the patients.  Treatment medications were not reported.  This case contains information for patient 16 out of 25.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2023: Live significant follow-up received contains Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:patient 16
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, 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. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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 (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    This case contains information for patient 04 out of 25. No concomitant medication information was reported. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No adverse events were reported for any of the patients. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live significant follow-up received which included Patient age, initials, gender and new references were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:Patient 1 (Master Case)
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, 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. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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 (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  They accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage. No adverse event was reported for any of the patients.  Treatment medications were not reported.  This case contains information for patient 17 out of 25.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2023: Live significant follow-up received contains Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:master case
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26-AUG-2023 and 27-AUG-2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26-AUG-2023 and 27-AUG-2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 58-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, 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. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26-AUG-2023 and 27-AUG-2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26-AUG-2023 and 27-AUG-2023 to adult patients, instead of the usual 0.5 mL dosage) 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 (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26-AUG-2023 and 27-AUG-2023 to adult patients, instead of the usual 0.5 mL dosage).    No concomitant medications were reported.  No adverse event was reported for patient.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live significant follow-up received contain: Patient age, initials, gender updated and new reference numbers added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:Patient 1 (Master Case)
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, 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. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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 (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  No adverse event was reported for patient.  Treatment medications were not reported. This case contains information for patient 06 out of 25 described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live significant follow-up received: Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:Patient 1 (Master Case)