chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain
Clinical narrative: Inappropriate schedule of vaccine; Soreness 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 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Flu unspecified (Flu vaccine) for prophylaxis.   On 09-MAR-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 24-AUG-2020, the patient received the 1st dose of Shingrix (intramuscular, unknown arm) and Flu vaccine (unknown arm). On 24-AUG-2020, not applicable after receiving Shingrix and less than a day after receiving Shingrix and Flu vaccine, the patient experienced injection site pain (Verbatim: Soreness at the injection site). On 09-MAR-2023, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine). The outcome of the injection site pain was resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix and Flu vaccine.     It was unknown if the company considered the injection site pain to be related to Shingrix and Flu vaccine.   Additional Information: GSK Receipt Date: 16-MAY-2023 The reporter stated the patient who received dose of Shingrix with some Flu vaccine (manufacturer not provided) in her right arm and experienced soreness at the injection site, no other information provided.  The patient received second dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of 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 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in October 2019 in left arm).   On an unknown date, the patient did nor receive the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-May-2023  The patient received the 1st dose of Shingrix at a pharmacy location at the end of October 2019. The patient reports she received the vaccine in her left arm.  Patient reports that she did not receive the 2nd dose of the vaccine.  Lot number and expiry date information were unknown at the moment of the call. Not all information was available.  Customer reports that covid pandemic started at the time and the 2nd dose was never received.  The reporter said she got the covid vaccines and the boosters but not the 2nd dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: started having tinnitus after the vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of tinnitus in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   In NOV-2022, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced tinnitus (Verbatim: started having tinnitus after the vaccine). The outcome of the tinnitus was unknown.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.     It was unknown if the company considered the tinnitus to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-MAY-2023 The case was self reported by the patient. The patient received dose of Shingrix and started having tinnitus after the vaccine. No additional information was provided. Not all information was available or collected or provided.
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Received an expired dose of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (expiry date 15-JAN-2022) for prophylaxis.   On 16-FEB-2022, the patient received Kinrix. On 16-FEB-2022, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Received an expired dose of Kinrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 04-MAY-2023 The reporter did consent to follow up. The patient received an expired dose of kinrix vaccine, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Possible late 2nd dose of Shingrix; This non-serious case was reported by a physician 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 (1st dose received 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: Possible late 2nd dose of Shingrix). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 16-MAY-2023 The reporter reported that the patient possibly late received second dose of Shingrix vaccine. The vaccine administration facility was the same as primary reporter. The reporter stated that additional adverse event details are not available. The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Patient was inadvertently given an expired dose of Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 11-MAY-2023, the patient received Kinrix. On 11-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Patient was inadvertently given an expired dose of Kinrix). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 16-May-2023 The reporter was a nurse. The reporter reported that the patient inadvertently received an expired dose of Kinrix. The vaccine administration facility was the same as primary reporter. No further details were provided.  The reporter did consent to follow up. The patient received a Kinrix which was already expired, which led to expired vaccine used
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 immunisation, Oxygen saturation, Suspected COVID-19
Clinical narrative: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via another pharmaceutical company (Pfizer Inc.) concerned a 35 year old. The patient's height, and weight were not reported. The patient's past medical history included: stroke (Stroke at 25 years old), and concurrent conditions included: unspecified drug allergy. The patient received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on unspecified date for covid-19 prophylaxis. The batch number was not reported and has been requested. Concomitant medications included valaciclovir for unknown indication. It was unknown whether patient had any adverse events following covid-19 vaccine ad26.cov2.s (Dose number in series 1).  The patient also received second dose of non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following Moderna covid-19 vaccine (elasomeran) (Dose number in series 2).  The patient also received third dose of non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 3) (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on unspecified date to right arm for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 3). On an unspecified date in 2023, patient experienced suspected covid-19 infection (Dose number in series 3). The patient started taking treatment with non-company suspect drug Paxlovid, nirmatrelvir/ritonavir (form of admin and route of admin were not reported, batch number: GE3016 expiry: unknown) dose and frequency were not reported from 02-MAY-2023 to 06-MAY-2023 for treatment of covid-19. On 10-MAY-2023, four days after non company suspect drug paxlovid treatment, the patient experienced minor head cold. On 11-MAY-2023, the patient experienced more severe head cold (congestion, sneezing), minor aches, tightness in lungs and oxygen levels were 93-95%. Laboratory data included: Oxygen saturation (93-95%). On 12-MAY-2023, six days after non company suspect drug paxlovid patient felt tightness in lungs and Laboratory data included: Oxygen saturation (94%).  The action taken with covid-19 vaccine ad26.cov2.s, elasomeran (Dose number in series 2), and elasomeran (Dose number in series 3) was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (Patient received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) 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 a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: 17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) 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 (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    No concomitant medications were provided. No treatment medication was provided. This case contains information for the 3rd out of 17 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (Patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) 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 (Patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    Concomitant drugs were not reported. Treatment medications were not provided. This case was reported for patient 7 out of 17.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (Patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) 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 may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    Dosage text for suspect product was reported as unknown. Concomitant drugs were not reported. Treatment medications were not provided. This case was reported for patient 8 out of 17.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (Patient received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) 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 a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  No treatment medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: 17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) 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 (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    No concomitant medications were provided. No treatment medication was provided. This case contains information for the 14th out of 17 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: 17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) 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 (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    No concomitant medications were provided. No treatment medication was provided. This case contains information for the 15th of 17 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (Patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) 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 may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    Dosage text for suspect product was reported as unknown. Concomitant drugs were not reported. Treatment medications were not provided. This case was reported for patient 17 out of 17.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient 1
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Dyspnoea
Clinical narrative: Fogginess; Trouble breathing; This spontaneous case was reported by a non-health professional and describes the occurrence of BRAIN FOG (Fogginess) and DYSPNOEA (Trouble breathing) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BRAIN FOG (Fogginess) and DYSPNOEA (Trouble breathing). At the time of the report, BRAIN FOG (Fogginess) and DYSPNOEA (Trouble breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided.  Treatment information was not provided.
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Pyrexia
Clinical narrative: Fever and weakness; Fever and weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Fever and weakness) and PYREXIA (Fever and weakness) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy. Concomitant products included LEVOTHYROXINE, LOSARTAN and METFORMIN for an unknown indication.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Oct-2022, the patient experienced ASTHENIA (Fever and weakness) and PYREXIA (Fever and weakness). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 01-May-2023 to 05-May-2023 for COVID-19 treatment, at an unspecified dose and frequency. On 29-Oct-2022, ASTHENIA (Fever and weakness) and PYREXIA (Fever and weakness) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient race was reported. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The Device date was reported as 13-May-2023.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: 17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) 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 (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    Concomitant medication not reported by the reporter. No information about previous COVID-19 vaccination doses. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment medication not reported by the reporter. This case contains information about patient 16th out of 17 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: 17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) 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 (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    No concomitant medications were provided. No treatment medication was provided. This case contains information for the 4th of 17 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient 1
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Migraine
Clinical narrative: Soon after receiving the first dose, patient started having frequent migraines.; Patient used to have normal headaches like most people, but then there was a significant-sudden change in the pattern and severity of his headaches.; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Soon after receiving the first dose, patient started having frequent migraines.) and HEADACHE (Patient used to have normal headaches like most people, but then there was a significant-sudden change in the pattern and severity of his headaches.) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.  Concomitant products included CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Headache.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Soon after receiving the first dose, patient started having frequent migraines.) and HEADACHE (Patient used to have normal headaches like most people, but then there was a significant-sudden change in the pattern and severity of his headaches.). The patient was treated with GABAPENTIN for Migraine, at a dose of Daily and RIZATRIPTAN for Headache, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Soon after receiving the first dose, patient started having frequent migraines.) and HEADACHE (Patient used to have normal headaches like most people, but then there was a significant-sudden change in the pattern and severity of his headaches.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. . Patient stated that they started trying different treatments. Patient spent a couple of years adjusting things with the neurologist. Caller stated something about the vaccine changed his typical headache pattern. Now he took daily prescription medicines to manage the migraines. At first he thought it was something temporal but now it looked like it´s going to be something permanent and he will have to take those medicines for the rest of his life. He was seeing the neurologist on an annual basis to monitor the situation. They were able to manage the migraines with the medication.  .   This case was linked to MOD-2023-724597 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Migraine
Clinical narrative: Soon after receiving the first dose, patient started having frequent migraines.; Patient used to have normal headaches like most people, but then there was a significant-sudden change in the pattern and severity of his headaches.; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Soon after receiving the first dose, patient started having frequent migraines.) and HEADACHE (Patient used to have normal headaches like most people, but then there was a significant-sudden change in the pattern and severity of his headaches.) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.  Concomitant products included CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Headache.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Soon after receiving the first dose, patient started having frequent migraines.) and HEADACHE (Patient used to have normal headaches like most people, but then there was a significant-sudden change in the pattern and severity of his headaches.). The patient was treated with GABAPENTIN for Migraine, at a dose of Daily and RIZATRIPTAN for Headache, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Soon after receiving the first dose, patient started having frequent migraines.) and HEADACHE (Patient used to have normal headaches like most people, but then there was a significant-sudden change in the pattern and severity of his headaches.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. . Patient stated that they started trying different treatments. Patient spent a couple of years adjusting things with the neurologist. Caller stated something about the vaccine changed his typical headache pattern. Now he took daily prescription medicines to manage the migraines. At first he thought it was something temporal but now it looked like it´s going to be something permanent and he will have to take those medicines for the rest of his life. He was seeing the neurologist on an annual basis to monitor the situation. They were able to manage the migraines with the medication.  .   This case was linked to MOD-2023-724597 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: 17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) 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 (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    Out of 17 patients this Case for patient 12. Concomitant medication not reported.  No information about previous COVID-19 vaccination doses. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient 1
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 06-APR-2023 and vaccine was administred to patient on 13-MAY-2023; no adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-APR-2023 and vaccine was administred to patient on 13-MAY-2023) and NO ADVERSE EVENT (no adverse event) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-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) 1 dosage form. On 13-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-APR-2023 and vaccine was administred to patient on 13-MAY-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-APR-2023 and vaccine was administred to patient on 13-MAY-2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-APR-2023 and vaccine was administred to patient on 13-MAY-2023).    No concomitant medication was reported.  Dosage text reported as unknown. No treatment information was reported.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose administered after 30-day Use by Date the vial was initially stored in the refrigerator 06 Apr 2023; No adverse event; Dose administered after 30-day Use by Date the vial was initially stored in the refrigerator 06 Apr 2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date the vial was initially stored in the refrigerator 06 Apr 2023), PRODUCT STORAGE ERROR (Dose administered after 30-day Use by Date the vial was initially stored in the refrigerator 06 Apr 2023) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-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) 1 dosage form. On 05-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date the vial was initially stored in the refrigerator 06 Apr 2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use by Date the vial was initially stored in the refrigerator 06 Apr 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date the vial was initially stored in the refrigerator 06 Apr 2023), PRODUCT STORAGE ERROR (Dose administered after 30-day Use by Date the vial was initially stored in the refrigerator 06 Apr 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date the vial was initially stored in the refrigerator 06 Apr 2023) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use by Date the vial was initially stored in the refrigerator 06 Apr 2023).    Concomitant medication not reported.  Treatment medication not reported.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: The patient did not report any AEs; Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during about 2 hours; Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during about 2 hours; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during about 2 hours), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during about 2 hours) and NO ADVERSE EVENT (The patient did not report any AEs) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    On 16-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 16-May-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during about 2 hours) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during about 2 hours). On an unknown date, the patient experienced NO ADVERSE EVENT (The patient did not report any AEs). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during about 2 hours), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during about 2 hours) and NO ADVERSE EVENT (The patient did not report any AEs) 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 (The patient did not report any AEs) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during about 2 hours) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during about 2 hours).    No concomitant medication details was reported. No treatment medication details was reported.