chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Gait inability, Impaired work ability, Oedema peripheral, Pain in extremity
Clinical narrative: SHORTNESS OF BREATH; NOT ABLE TO DO AS MUCH WORK/ CAN'T WORK AS HARD AT WORK, HARD TO GET UP; CANT EVEN WALK ON; THIGHS HURTS ON BOTH SIDES, BUT ESPECIALLY ON THE LEFT/LOT OF PAIN ON MY LEFT; THIGHS SWELL AND TURN RED/LEFT LEG FOULED UP EVERY NIGHT; This spontaneous report received from a patient via a company representative concerned a 38 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known medical history to contribute. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 38 years old. No concomitant medications were reported. On APR-2021, the patient experienced thighs swell and turn red/left leg fouled up every night. On an unspecified date, the patient experienced shortness of breath, not able to do as much work/ can't work as hard at work, hard to get up, cant even walk on, and thighs hurts on both sides, but especially on the left/lot of pain on my left. Treatment medications (dates unspecified) included: ibuprofen, and camphor/melaleuca leucadendra oil/mentha spp. oil/menthol/syzygium aromaticum oil. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from thighs swell and turn red/left leg fouled up every night, thighs hurts on both sides, but especially on the left/lot of pain on my left, and cant even walk on, and the outcome of shortness of breath and not able to do as much work/ can't work as hard at work, hard to get up was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pneumonia viral
Clinical narrative: VIRAL PNEUMONIA; This spontaneous report received from a patient via a company representative via media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced viral pneumonia. It was reported as "I got viral pneumonia after my J and J vaccine. I did not get anymore." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of viral pneumonia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20221228970-Viral pneumonia. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: REALLY SICK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient got really sick (dose number in series 2). It was reported that, "I got really sick from the shots, wish I never got them." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of really sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FELT HORRIBLE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced felt horrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt horrible was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 24-Oct-2022 and administered to patient on 29-Nov-2022, after the 30 day beyond use date; No Adverse event; administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 24-Oct-2022 and administered to patient on 29-Nov-2022, after the 30 day beyond use date) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 29-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 days beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 24-Oct-2022 and administered to patient on 29-Nov-2022, after the 30 day beyond use date) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 24-Oct-2022 and administered to patient on 29-Nov-2022, after the 30 day beyond use date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 24-Oct-2022 and administered to patient on 29-Nov-2022, after the 30 day beyond use date).    No concomitant medications were reported.  The vaccine coordinator reported that, they administered expired Bivalent booster Moderna COVID-19 vaccine after the 30-day beyond use date. It was individual vial with vial size of 2.5 mL. On 24-Oct-2022, the vial was initially stored in the refrigerator and vial did not undergo any temperature excursions.   No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Product storage error/freezer went to -10.5 C for 24 minutes; no adverse event; Doses were administered after the excursion happened on 15Nov2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses were administered after the excursion happened on 15Nov2022), PRODUCT STORAGE ERROR (Product storage error/freezer went to -10.5 C for 24 minutes) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses were administered after the excursion happened on 15Nov2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error/freezer went to -10.5 C for 24 minutes) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses were administered after the excursion happened on 15Nov2022), PRODUCT STORAGE ERROR (Product storage error/freezer went to -10.5 C for 24 minutes) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Doses were administered after the excursion happened on 15Nov2022) and PRODUCT STORAGE ERROR (Product storage error/freezer went to -10.5 C for 24 minutes).    No concomitant medication was reported. It was reported that for the Moderna monovalent vaccine, Max temp: -10.5 C (no breakdown available) was reached. It took 24 minutes to get back down to normal range. The medical assistant has data logs. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-685555 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-685555:same reporter
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 1 patient received a 0.5ml bivalent booster that was given as a primary series dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (1 patient received a 0.5ml bivalent booster that was given as a primary series dose) and NO ADVERSE EVENT (No adverse event) in a 37-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062f22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 08-Dec-2022,  after starting , the patient experienced WRONG PRODUCT ADMINISTERED (1 patient received a 0.5ml bivalent booster that was given as a primary series dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (1 patient received a 0.5ml bivalent booster that was given as a primary series dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (1 patient received a 0.5ml bivalent booster that was given as a primary series dose).    No concomitant medication was provided by reporter. It was reported that HCP wanted to know which the guidance or steps was to take after the following administration error 1 patient received a 0.5ml bivalent booster that was given as a primary series dose lot #062f22a as a first dose Date of administration 8Dec 2022. No treatment medication was provided by reporter.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Wrong product administered
Clinical narrative: arm soreness 12 hours after vaccination; inadvertently administered with Moderna COVID-19 Vaccine Bivalent instead of the 1st dose of the primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (arm soreness 12 hours after vaccination) and WRONG PRODUCT ADMINISTERED (inadvertently administered with Moderna COVID-19 Vaccine Bivalent instead of the 1st dose of the primary series) in a 20-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     Patient's relevant medical history/conditions, allergy, concomitant medications and risk factor was unknown.     On 09-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 5 milliliter. On 09-Dec-2022, the patient experienced VACCINATION SITE PAIN (arm soreness 12 hours after vaccination) and WRONG PRODUCT ADMINISTERED (inadvertently administered with Moderna COVID-19 Vaccine Bivalent instead of the 1st dose of the primary series). At the time of the report, VACCINATION SITE PAIN (arm soreness 12 hours after vaccination) and WRONG PRODUCT ADMINISTERED (inadvertently administered with Moderna COVID-19 Vaccine Bivalent instead of the 1st dose of the primary series) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: administered with the monovalent vaccine on 01Dec2022 which was past the manufacturer's expiration date; administered with the monovalent vaccine on 01Dec2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the monovalent vaccine on 01Dec2022 which was past the manufacturer's expiration date), WRONG PRODUCT ADMINISTERED (administered with the monovalent vaccine on 01Dec2022) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the monovalent vaccine on 01Dec2022 which was past the manufacturer's expiration date), WRONG PRODUCT ADMINISTERED (administered with the monovalent vaccine on 01Dec2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the monovalent vaccine on 01Dec2022 which was past the manufacturer's expiration date), WRONG PRODUCT ADMINISTERED (administered with the monovalent vaccine on 01Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered with the monovalent vaccine on 01Dec2022 which was past the manufacturer's expiration date) and WRONG PRODUCT ADMINISTERED (administered with the monovalent vaccine on 01Dec2022).    No concomitant medication information was reported. No treatment medication information was reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient received a bivalent Moderna covid-19 vaccine at a dose of 0.25mL instead of 0.5mL.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a bivalent Moderna covid-19 vaccine at a dose of 0.25mL instead of 0.5mL.) and NO ADVERSE EVENT (No adverse event) in a 51-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71673) for COVID-19 prophylaxis.     The patient's past medical history included Smoker (PMHx of smoking). Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine and Spikevax. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Spikevax.    On 09-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 09-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced ACCIDENTAL UNDERDOSE (Patient received a bivalent Moderna covid-19 vaccine at a dose of 0.25mL instead of 0.5mL.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a bivalent Moderna covid-19 vaccine at a dose of 0.25mL instead of 0.5mL.) had not resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received a bivalent Moderna covid-19 vaccine at a dose of 0.25mL instead of 0.5mL.).    No concomitant medication was reported. No treatment medication was reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, No adverse event
Clinical narrative: Patient sharing that they received a full dose instead of the half dose for both of their Moderna Monovalent booster doses.1st booster: unknown date2nd booster; no adverse event; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL OVERDOSE (Patient sharing that they received a full dose instead of the half dose for both of their Moderna Monovalent booster doses.1st booster: unknown date2nd booster) and NO ADVERSE EVENT (no adverse event) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (Johnson & Johnson one shot). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN.   On 09-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 ACCIDENTAL OVERDOSE (Patient sharing that they received a full dose instead of the half dose for both of their Moderna Monovalent booster doses.1st booster: unknown date2nd booster) and NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Patient sharing that they received a full dose instead of the half dose for both of their Moderna Monovalent booster doses.1st booster: unknown date2nd booster) and NO ADVERSE EVENT (no adverse event) outcome was unknown.            No concomitant product use was reported.  The patient said they did a little bit of reading about a months ago, the information they learned was that the Moderna booster was a half dose. When they went to the pharmacy, they asked them to give them a full dose and the pharmacy did that for them for both boosters. Also reported that they are due for another booster, and they know there was a new booster we have. Patient asked the pharmacy if they would provide them with a full dose booster when they come in and they said they would but it's already a full dose.  No treatment information was provided.   Reporter did not allow further contact
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; expired dose was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose was administered) and NO ADVERSE EVENT (No Adverse event) in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 054B22A and 054B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Dec-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 09-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose was administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose was administered) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired dose was administered).    Concomitant medication was not reported. The patient didn't report any side effects. Treatment drug was not reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: 3 adults received booster doses from the monovalent pediatric primary series; doses were administered beyond 30-day use by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (3 adults received booster doses from the monovalent pediatric primary series), EXPIRED PRODUCT ADMINISTERED (doses were administered beyond 30-day use by date) and NO ADVERSE EVENT (no adverse event) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 01-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (3 adults received booster doses from the monovalent pediatric primary series), EXPIRED PRODUCT ADMINISTERED (doses were administered beyond 30-day use by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (3 adults received booster doses from the monovalent pediatric primary series), EXPIRED PRODUCT ADMINISTERED (doses were administered beyond 30-day use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (3 adults received booster doses from the monovalent pediatric primary series) and EXPIRED PRODUCT ADMINISTERED (doses were administered beyond 30-day use by date).    No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patient received a bivalent Moderna covid-19 vaccine at a dose of 0.25mL instead of 0.5mL; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a bivalent Moderna covid-19 vaccine at a dose of 0.25mL instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71673) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient received a bivalent Moderna covid-19 vaccine at a dose of 0.25mL instead of 0.5mL) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a bivalent Moderna covid-19 vaccine at a 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 ACCIDENTAL UNDERDOSE (Patient received a bivalent Moderna covid-19 vaccine at a dose of 0.25mL instead of 0.5mL).    No concomitant medication was reported. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient has received a primary series and one previous booster of the Moderna COVID-19 vaccines. No treatment medication was reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, SARS-CoV-2 test, Wrong product administered
Clinical narrative: No adverse event; The patient received a Moderna Covid-19 vaccine bivalent booster dose for her one and only Covid-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient received a Moderna Covid-19 vaccine bivalent booster dose for her one and only Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     There was no parental vaccine exposure.  The patient's past medical history included COVID-19 (Patient had a Covid-19 infection and Patient lost her taste for 2 weeks.) in January 2021.    On 12-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (The patient received a Moderna Covid-19 vaccine bivalent booster dose for her one and only Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The patient received a Moderna Covid-19 vaccine bivalent booster dose for her one and only Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (The patient received a Moderna Covid-19 vaccine bivalent booster dose for her one and only Covid-19 vaccine).    No concomitant medication was provided.  Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: Felt lousy; covid 19/ tiredness and low grade fever; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19/ tiredness and low grade fever) and FEELING ABNORMAL (Felt lousy) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045B21A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1 Lot number: 002A21A) on 26-Feb-2021 and Moderna COVID-19 Vaccine (Dose 2 Lot number: 047A21A) on 25-Mar-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 06-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 01-Jan-2021, the patient experienced COVID-19 (covid 19/ tiredness and low grade fever). On an unknown date, the patient experienced FEELING ABNORMAL (Felt lousy). On 03-Jan-2021, COVID-19 (covid 19/ tiredness and low grade fever) had resolved. At the time of the report, FEELING ABNORMAL (Felt lousy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Hangover, Headache
Clinical narrative: comes on like a hangover; started having a headache / pain/ like it burns off a little bit, however it becomes better or worse; This spontaneous case was reported by a consumer and describes the occurrence of HANGOVER (comes on like a hangover) and HEADACHE (started having a headache / pain/ like it burns off a little bit, however it becomes better or worse) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in November 2021 and Headache (Had a headache with his covid for 11-12 days).    On 18-Nov-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Nov-2022, the patient experienced HANGOVER (comes on like a hangover) and HEADACHE (started having a headache / pain/ like it burns off a little bit, however it becomes better or worse). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HANGOVER (comes on like a hangover) and HEADACHE (started having a headache / pain/ like it burns off a little bit, however it becomes better or worse) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by the reporter. On 09-Mar-2021, the patient received first dose of MODERNA COVID-19 VACCINE, with the batch no 013A21A and on 06-Apr-2021, received second dose of MODERNA COVID-19 VACCINE, with the batch no 047A21A. It was reported that sometimes felt like it burns off a little bit, however it became better or worse at seemingly random times. This pain was rated at a 3 to a 5 currently, but he had considered going to the ER at times. He never had a reaction with the previous 2 shots. Had tried Advil, Tylenol, and migraine medications.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, COVID-19, Cerebral disorder
Clinical narrative: Caller then caught covid in July; first two covid 19 vaccines they started to have symptoms from the brain disorder; Caller got the first booster dose the following September and got twice the amount; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caller then caught covid in July), CEREBRAL DISORDER (first two covid 19 vaccines they started to have symptoms from the brain disorder) and ACCIDENTAL OVERDOSE (Caller got the first booster dose the following September and got twice the amount) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   In February 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2020, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Caller then caught covid in July), CEREBRAL DISORDER (first two covid 19 vaccines they started to have symptoms from the brain disorder) and ACCIDENTAL OVERDOSE (Caller got the first booster dose the following September and got twice the amount). At the time of the report, COVID-19 (Caller then caught covid in July), CEREBRAL DISORDER (first two covid 19 vaccines they started to have symptoms from the brain disorder) and ACCIDENTAL OVERDOSE (Caller got the first booster dose the following September and got twice the amount) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Reportedly, reporter had heard in people his age of being 30 that there was a risk of myocarditis and wondering if there was a potential of an increased risk of getting that with the Moderna Bivalent. It was reported that patient was getting surgery for his condition in January for his brain disorder that has already before patient had the vaccine.  Treatment details were not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: Revaccination with different COVID-19 vaccine; Interchange of vaccine products; No Adverse Event; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No Adverse Event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Pfizer vaccine as a first dose). Past adverse reactions to the above products included Vaccination adverse reaction with PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products).    No concomitant medications were reported. The reporter stated that she was at high risk because of her weight. No treatment medications were reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event; doses were administered beyond 30-day use by date; received booster doses from the monovalent pediatric primary series; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered beyond 30-day use by date), WRONG PRODUCT ADMINISTERED (received booster doses from the monovalent pediatric primary series) and NO ADVERSE EVENT (No adverse event) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered beyond 30-day use by date) and WRONG PRODUCT ADMINISTERED (received booster doses from the monovalent pediatric primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were administered beyond 30-day use by date), WRONG PRODUCT ADMINISTERED (received booster doses from the monovalent pediatric primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (doses were administered beyond 30-day use by date) and WRONG PRODUCT ADMINISTERED (received booster doses from the monovalent pediatric primary series).    Concomitant medications details were not reported by the reporter.  Reportedly, three adults were received booster doses from the monovalent pediatric primary series.  Treatment details were not reported by the reporter.
Sex: U
Vaccine: COVID19, UNK
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Some vials were used and returned to the freezer; experienced excursion, from 13SEP2022 until end of NOV2022. Max 11.2 F & Min 20.3 F; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Some vials were used and returned to the freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (experienced excursion, from 13SEP2022 until end of NOV2022. Max 11.2 F & Min 20.3 F) 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) .5 milliliter. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some vials were used and returned to the freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (experienced excursion, from 13SEP2022 until end of NOV2022. Max 11.2 F & Min 20.3 F) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT STORAGE ERROR (Some vials were used and returned to the freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (experienced excursion, from 13SEP2022 until end of NOV2022. Max 11.2 F & Min 20.3 F) 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 PRODUCT STORAGE ERROR (Some vials were used and returned to the freezer) and PRODUCT TEMPERATURE EXCURSION ISSUE (experienced excursion, from 13SEP2022 until end of NOV2022. Max 11.2 F & Min 20.3 F).    No concomitant medication reported.  Storage condition at the time of the excursion was frozen storage. Vial size was reported as both 2.5 mL or 5.5 mL. Bivalent batch numbers were AS7146B MFG Exp. Date: 27-MAY-2023, Lot# 019H22A MFG Exp. Date: 30-MAY-2023. Temperature was on & off out of range from 13-SEP-2022 until end of NOV-2022. Max: 11.2 F & Min: 20.3 F. Excursion duration was 1 month.  It was unknown when vial moved from freezer to refrigerator. Returned to the freezer and some vials were used. At the time of excursion there was no inspections done.  No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-686130 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-686130:
Sex: U
Vaccine: COVID19, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Some vials were used and returned to the freezer; experienced excursion, from 13SEP2022 until end of NOV2022. Max 11.2 F & Min 20.3 F; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Some vials were used and returned to the freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (experienced excursion, from 13SEP2022 until end of NOV2022. Max 11.2 F & Min 20.3 F) 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) .5 milliliter. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some vials were used and returned to the freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (experienced excursion, from 13SEP2022 until end of NOV2022. Max 11.2 F & Min 20.3 F) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT STORAGE ERROR (Some vials were used and returned to the freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (experienced excursion, from 13SEP2022 until end of NOV2022. Max 11.2 F & Min 20.3 F) 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 PRODUCT STORAGE ERROR (Some vials were used and returned to the freezer) and PRODUCT TEMPERATURE EXCURSION ISSUE (experienced excursion, from 13SEP2022 until end of NOV2022. Max 11.2 F & Min 20.3 F).    No concomitant medication reported.  Storage condition at the time of the excursion was frozen storage. Vial size was reported as both 2.5 mL or 5.5 mL. Bivalent batch numbers were AS7146B MFG Exp. Date: 27-MAY-2023, Lot# 019H22A MFG Exp. Date: 30-MAY-2023. Temperature was on & off out of range from 13-SEP-2022 until end of NOV-2022. Max: 11.2 F & Min: 20.3 F. Excursion duration was 1 month.  It was unknown when vial moved from freezer to refrigerator. Returned to the freezer and some vials were used. At the time of excursion there was no inspections done.  No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-686130 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-686130:
Sex: U
Vaccine: COVID19, UNK
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: No Adverse Event; Product Storage Error; experienced excursion, from 13SEP2022 until end of NOV2022. Temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Product Storage Error), PRODUCT TEMPERATURE EXCURSION ISSUE (experienced excursion, from 13SEP2022 until end of NOV2022. Temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     Concomitant products included mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    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) .5 mL/min. On 12-Sep-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (experienced excursion, from 13SEP2022 until end of NOV2022. Temperature excursion). On 12-Dec-2022, the patient experienced PRODUCT STORAGE ERROR (Product Storage Error). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). In November 2022, PRODUCT TEMPERATURE EXCURSION ISSUE (experienced excursion, from 13SEP2022 until end of NOV2022. Temperature excursion) outcome was unknown. At the time of the report, PRODUCT STORAGE ERROR (Product Storage Error) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      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 PRODUCT STORAGE ERROR (Product Storage Error) and PRODUCT TEMPERATURE EXCURSION ISSUE (experienced excursion, from 13SEP2022 until end of NOV2022. Temperature excursion).    Moderna is authorized to communicate with the vaccine recipient's primary healthcare professional regarding this notification. Storage condition at the time of the excursion was Frozen storage They are stored and returned to the freezer and some vials were used.  No Treatment Medication was provided by reporter.