chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MENB
Symptoms: Limb discomfort, Pain, Pain in extremity
Clinical narrative: feels heavier'.; pain and throbbing in her arm; pain and throbbing in her arm; This non-serious case was reported by a physician via sales rep and described the occurrence of throbbing pain in a adolescent female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced throbbing pain (Verbatim: pain and throbbing in her arm), pain in arm (Verbatim: pain and throbbing in her arm) and heaviness in arm (Verbatim: feels heavier'.). The outcome of the throbbing pain and pain in arm were resolved (duration 1 week) and the outcome of the heaviness in arm was not reported.   It was unknown if the reporter considered the throbbing pain, pain in arm and heaviness in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the throbbing pain, pain in arm and heaviness in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 24-MAY-2023 The reporter reported that she administered vaccine Bexsero and there was pain and throbbing in her arm for a week after administration of the vaccine.  She had stated that a month after vaccination the arm that she got the vaccine in felt heavier'.  That was all she could report and the Doctor could probably explain more details. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-MAY-2023, the patient received Shingrix. In MAY-2023, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was not reported.   The reporter considered the pain in arm to be possibly related to Shingrix.     The company considered the pain in arm to be possibly related to Shingrix.   Additional Information: GSK receipt date: 25-May-2023 This case was reported by a patient via interactive digital media. The patient received the shingles vaccine the day before the reporting. The patient reported that felt fine except for a slightly sore arm. The reporter said that of course it might be the follow up shot in a month that affects her/him. The reporter's senator apparently got shingles and would retire, so it was not joke. The follow up would not possible, as no contact, details were available.
Age: 48.0
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 48-year-old patient who received HAB (Twinrix) (batch number J477Y, expiry date 20-MAY-2023) for prophylaxis.   On 24-MAY-2023, the patient received Twinrix. On 24-MAY-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Expired vaccine was administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-MAY-2023 Nurse reported on 24th May 2023, an expired Twinrix vaccine which was already expired in  (20th May 2023) was administered to a patient inadvertently which led to expired vaccine used.  The health care professional did not answer consent to follow-up inquiry through chat. Note: The product start date and expiry date was not clear, hence clarification raised for its confirmation.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 1st dose 4 years ago/did not receive a second dose until 16May2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 22M3K, expiry date 04-AUG-2024) for prophylaxis.   Previously administered products included Shingrix (1st dose received about 4 years ago).   On 16-MAY-2023, the patient received the 2nd dose of Shingrix. On 16-MAY-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Received 1st dose 4 years ago/did not receive a second dose until 16May2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 25-MAY-2023 The pharmacist reported that the patient received first dose of Shingrix about 4 years ago and did not receive a second dose until 16 May 2023. The reporter does not have the exact date or lot number information for the first dose. The reporter consented to follow up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Vomiting
Clinical narrative: The patient experienced stinging; Burning burning at the time of the injection; felt tired; Threw up after receiving the vaccine; Pain at injection site/burning at the time of the injection; Unable to lift arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-MAY-2023, the patient received the 1st dose of Shingrix (right arm). In MAY-2023, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at injection site/burning at the time of the injection), injected limb mobility decreased (Verbatim: Unable to lift arm), tiredness (Verbatim: felt tired) and vomiting (Verbatim: Threw up after receiving the vaccine). On 18-MAY-2023, the patient experienced stinging (Verbatim: The patient experienced stinging) and burning sensation (Verbatim: Burning burning at the time of the injection). The outcome of the injection site pain and injected limb mobility decreased were not resolved and the outcome of the stinging, tiredness, vomiting and burning sensation were unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, stinging, tiredness, vomiting and burning sensation to be related to Shingrix.     It was unknown if the company considered the injection site pain, injected limb mobility decreased, stinging, tiredness, vomiting and burning sensation to be related to Shingrix.   Additional Information: GSK receipt date: 25-May-2023 This case was self reported by the patient.  The patient received the first dose of Shingrix last Thursday (the day before reporting).  The patient experienced stinging and burning at the time of the injection.  The patient experiences pain at the injection site on right arm and was unable to lift the arm.  The patient also reported that was felt tired and threw up after receiving the vaccine.  The adverse event filed consented to follow up. The patient gave consent to follow up with healthcare professional.  The patient did not have phone number or address of the clinic.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: child received pediarix on 25-May-2023 instead of dtap inadvertently; This non-serious case was reported by a other health professional 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 TS425, expiry date 21-OCT-2024) for prophylaxis.   On 25-MAY-2023, the patient received Pediarix (other). On 25-MAY-2023, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: child received pediarix on 25-May-2023 instead of dtap inadvertently). The action taken with Pediarix was unknown. 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:25-May-2023 The medical assistance reported a 15 month old child received Pediarix instead of dtap inadvertently, which led to wrong vaccine administered. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: took only first dose of shingrix and second dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient received first dose on 02-AUG-2021 with batch number 9ZJ25 and expiry date 23-JAN-2023).   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 incomplete course of vaccination (Verbatim: took only first dose of shingrix and second dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-MAY-2023 The pharmacist reported that the patient received the first dose of Shingrix and the second dose had not been received yet.  The reporter asked if the series should restart. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. VAERS details provided corresponding to the 1st dose and the case was an incomplete course of vaccination
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: forgot to mix the vaccine; only got the adjuvant injected; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26-MAY-2023, the patient received the 1st dose of Shingrix (intramuscular, right arm). On 26-MAY-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: forgot to mix the vaccine) and inappropriate dose of vaccine administered (Verbatim: only got the adjuvant injected). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 26-MAY-2023 The patient reported that he received his first Shingrix vaccine, in the right arm and about 5 minutes later the pharmacist called back to tell the patient  that he forgot to mix the vaccine and he only got the adjuvant injected. The patient said he went back to the pharmacy, per the pharmacist request, and received the complete Shingrix vaccine in the same arm, in the same spot, about 15 minutes later.  The patient asked was this vaccine going to be effective. The patient phoned his primary doctor after the pharmacist gave him the second shot and his doctor told him to call GSK. The reporter consented to follow up. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Got their second dose of shingrix just under 4 years after the 1st; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on an unknown date).   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 drug dose administration interval too long (Verbatim: Got their second dose of shingrix just under 4 years after the 1st). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 26-MAY-2023 The patient got their second dose of Shingrix just under 4 years after the 1st dose. The reporter asked were they done with their series. The patient received their first dose at a different pharmacy. Healthcare professional became disconnected from the chat so there were no additional details available regarding the patients or events. It was unknown if follow up was permissible. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.  The case is linked with US2023AMR076149, same reporter different patient.; Sender's Comments:  US-GSK-US2023AMR076149:Original Case : US2023075222
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: she received her first Shingrix vaccine in October 2022; 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 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 0.5 ml, Intramuscularly in an unknown arm).   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: she received her first Shingrix vaccine in October 2022). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-MAY-2023 The reporter stated now she would go to receive her second dose of Shingrix vaccine. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-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. On 25-May-2023, the patient experienced UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that patient had their monovalent and a previous booster dose of bivalent vaccine.  Treatment medications were not provided.  This case was reported for elderly patient 16 of 20.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Patient no 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; 20 patients who were over 65 years old. They were given today 25-May-2023 0.25ml instead of 0.5 ml; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (20 patients who were over 65 years old. They were given today 25-May-2023 0.25ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-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. On 25-May-2023, the patient experienced UNDERDOSE (20 patients who were over 65 years old. They were given today 25-May-2023 0.25ml instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (20 patients who were over 65 years old. They were given today 25-May-2023 0.25ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (20 patients who were over 65 years old. They were given today 25-May-2023 0.25ml instead of 0.5 ml).    No concomitant medication was reported.   No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Patient no 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-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. On 25-May-2023, the patient experienced UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported. It was reported that patient had their monovalent and a previous booster dose of bivalent vaccine. Treatment medications were not provided.   Treatment information was not provided.  This case contains information about patient 18th out of 20 elderly patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Patient no 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; 20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-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. On 25-May-2023, the patient experienced UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information about patient 2nd out of 20 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Elderly Patient - 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-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. On 25-May-2023, the patient experienced UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported. It was reported that patient had their monovalent and a previous booster dose of bivalent vaccine. Treatment medications were not provided.  This case was reported for elderly patient 3 of 20.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Elderly Patient - 1
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; 20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-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. On 25-May-2023, the patient experienced ACCIDENTAL UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml) 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 (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml).    Concomitant products were not reported.  It was reported that patient received the Moderna bivalent to 20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml. All of these patients had their monovalent and a previous booster dose of bivalent vaccine.   Treatment medications were not reported.  Case corresponds to patient number 5 of elderlypatient.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:(Elderly Patient no 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; 20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-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. On 25-May-2023, the patient experienced ACCIDENTAL UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml) 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 (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml).    Concomitant products were not reported.  It was reported that patient received the Moderna bivalent to 20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml. All of these patients had their monovalent and a previous booster dose of bivalent vaccine.   Treatment medications were not reported.  Case corresponds to patient number 6 of elderly patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:(Elderly Patient no 1)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; 20 patients who were over 65 years old. They were given today 25May2023 0.25; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-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. On 25-May-2023, the patient experienced UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25).    Concomitant product use was not provided by the reporter.  It was reported that on 25-May-2023, 20 patients who were over 65 years old was administered with 0.25 ml Moderna bivalent vaccine instead of 0.5 ml. All these patients had their monovalent and a previous booster dose of bivalent vaccine.  Treatment information was not provided.  This case contains information about patient 19th out of 20 elderly patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Patient no - 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Patient received 0.25 ml of vaccine instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient received 0.25 ml of vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-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. On 25-May-2023, the patient experienced UNDERDOSE (Patient received 0.25 ml of vaccine instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25 ml of vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25 ml of vaccine instead of 0.5 ml).    The patient had their monovalent and a previous booster dose of bivalent vaccine.  The patient was over 65 years old.  No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 20 of 20th elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Patient no - 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-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. On 25-May-2023, the patient experienced UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that patient had their monovalent and a previous booster dose of bivalent vaccine.  Treatment medications were not provided.  This case was reported for elderly patient 10 of 20.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; 20 patients who were over 65 years old. They were given today 25-May-2023 0.25 mL; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (20 patients who were over 65 years old. They were given today 25-May-2023 0.25 mL) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-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. On 25-May-2023, the patient experienced UNDERDOSE (20 patients who were over 65 years old. They were given today 25-May-2023 0.25 mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (20 patients who were over 65 years old. They were given today 25-May-2023 0.25 mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (20 patients who were over 65 years old. They were given today 25-May-2023 0.25 mL).    No concomitant medication was reported.  No treatment information was reported.  This case contains information for patient 12 out of 20.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Elderly Patient - 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, 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 25-May-2023, the patient experienced UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported. It was reported that patient had their monovalent and a previous booster dose of bivalent vaccine. Treatment medications were not provided.  This case contains information about patient 13th out of 20 elderly patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Elderly Patient - 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; 20 patients who were over 65 years old. They were given today 25May2023 0.25; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-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. On 25-May-2023, the patient experienced UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25).    Concomitant product use was not provided by the reporter.  It was reported that on 25-May-2023, 20 patients who were over 65 years old was administered with 0.25 ml Moderna bivalent vaccine instead of 0.5 ml. All these patients had their monovalent and a previous booster dose of bivalent vaccine.  Treatment information was not provided.  This case contains information about patient 14th out of 20 elderly patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Elderly Patient - 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Patient received 0.25 ml of vaccine instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient received 0.25 ml of vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-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. On 25-May-2023, the patient experienced UNDERDOSE (Patient received 0.25 ml of vaccine instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25 ml of vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25 ml of vaccine instead of 0.5 ml).    The patient had their monovalent and a previous booster dose of bivalent vaccine.  The patient was over 65 years old.  No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 15 of 20th elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Elderly Patient - 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: no adverse event; 20 patients who were over 65 years old. They were given today 25May2023 0.25; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-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. On 25-May-2023, the patient experienced UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25).    Concomitant product use was not provided by the reporter.  It was reported that on 25-May-2023, 20 patients who were over 65 years old was administered with 0.25 ml Moderna bivalent vaccine instead of 0.5 ml. All these patients had their monovalent and a previous booster dose of bivalent vaccine.  Treatment information was not provided.  This case contains information about patient 8th out of 20 elderly patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Master case  (Elderly Patient no 1)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-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. On 25-May-2023, the patient experienced UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml).    No concomitant medications were provided. It was reported that patient had their monovalent and a previous booster dose of bivalent vaccine. No treatment medication was provided. This case contains information for the 9th of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Master case  (Elderly Patient no 1)