chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Ultrasound scan, Visual impairment
Clinical narrative: CAN NOT WORK; TIRED; DON NOT HAVE ENERGY ANYMORE ANYWAY; COMMUNICATION VERY HARD NOW A DAYS; EYE ROLLED BACK IN HEAD AND WAS NOT THERE; FUNNY TASTE IN MOUTH; TEMPERATURE CHANGE/TEMPERATURE THE NEXT DAY AFTER VACCINATION; LETHARGIC TYPE STUFF; FELT LIKE HAD A FLU BUG/FLU-EYE TYPE STUFF; OUT OF CONTROL SPASMS AND THEY WERE CLENCHING THE JAW TO SHUT AND ARCHING BACK AND MAKING NOT ABLE TO MOVE ARMS AND LEGS WHEN THEY CALM DOWN; VISION ISSUES; BALANCE ISSUES; MUSCLE ACHES; COULD NOT TYPE ANYMORE AND BRAIN DOES NOT FUNCTION IN NUMBERS ANY MORE; LARYNGEAL SPASMS; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no allergic reactions to anything. The patient had no previous issues that would contribute. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 62 years old. No concomitant medications were reported. On 2021, the patient experienced could not type anymore and brain does not function in numbers any more, and laryngeal spasms. Laboratory data included: MRI not reported. On APR-2021, the patient experienced lethargic type stuff, felt like had a flu bug/flu-eye type stuff, out of control spasms and they were clenching the jaw to shut and arching back and making not able to move arms and legs when they calm down, vision issues, balance issues, and muscle aches. On 13-APR-2021, the patient experienced funny taste in mouth, and temperature change/temperature the next day after vaccination. Laboratory data included: Body temperature temperature change. On OCT-2021, the patient experienced eye rolled back in head and was not there. On 2022, the patient experienced communication very hard now a days, and don not have energy anymore anyway. Laboratory data included: Diagnostic ultrasound not reported. On an unspecified date, the patient experienced can not work, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from out of control spasms and they were clenching the jaw to shut and arching back and making not able to move arms and legs when they calm down, balance issues, communication very hard now a days, and laryngeal spasms, and the outcome of funny taste in mouth, lethargic type stuff, felt like had a flu bug/flu-eye type stuff, vision issues, muscle aches, could not type anymore and brain does not function in numbers any more, eye rolled back in head and was not there, don not have energy anymore anyway, tired, can not work and temperature change/temperature the next day after vaccination was not reported. This report was non-serious. This case, involving the same patient is linked to 20221248752.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. 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 and expiry were not reported) dose was not reported,1 total administered, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, 1 total administered on an unspecified date in JUL-2022 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 30-NOV-2022, the patient experienced covid-19 (Dose number in series 2) and it was reported as "Got my last booster in July. Got Covid 21 days ago. Lasted 21 days and I finally feel good. Would have been dead without the vaccines" (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 on 21-DEC-2022. This report was non-serious. This report was associated with a product quality complaint 90000264256.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Cough, Dehydration, Pain
Clinical narrative: COUGHING; DEHYDRATION; SORE; BURNING UP LIKE CRAZY; THIRSTY AND WAS DESPERATE FOR WATER; SHIVERING; FEVER; This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: nonsmoker, and alcohol user (not when patient got vaccinated. Patient does nowadays.), and other pre-existing medical conditions included: Patient did not have known allergies. No drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 24-MAY-2021 for covid-19 prophylaxis. Age at time of vaccination 19 years old. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAY-2021, the patient experienced coughing, dehydration, sore, burning up like crazy, thirsty and was desperate for water, shivering, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dehydration, and fever, had not recovered from coughing, and the outcome of sore, burning up like crazy, shivering and thirsty and was desperate for water was not reported. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Thirst
Clinical narrative: COUGHING; DEHYDRATION; SORE; BURNING UP LIKE CRAZY; THIRSTY AND WAS DESPERATE FOR WATER; SHIVERING; FEVER; This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: nonsmoker, and alcohol user (not when patient got vaccinated. Patient does nowadays.), and other pre-existing medical conditions included: Patient did not have known allergies. No drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 24-MAY-2021 for covid-19 prophylaxis. Age at time of vaccination 19 years old. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAY-2021, the patient experienced coughing, dehydration, sore, burning up like crazy, thirsty and was desperate for water, shivering, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dehydration, and fever, had not recovered from coughing, and the outcome of sore, burning up like crazy, shivering and thirsty and was desperate for water was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Off label use, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; OFF LABEL DOSING FREQUENCY; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnicity.   The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised. On an unspecified date, the patient previously received 2 doses of covid-19 vaccine (unspecified manufacturer)(dose number in series 1) (form of admin, route of admin, and batch number and expiry date were not reported), dose was not reported (dose number in series 1), for covid-19 prophylaxis. It was unknown whether patient had any adverse event following vaccination with 2 doses of covid-19 vaccine (unspecified manufacturer) (dose number in series 1). The patient previously received first booster with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2). The patient received second booster with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 3), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine and off label dosing frequency (Off label use) (Dose number in series 3). 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 suspected covid-19 infection twice (Dose number in series 3). First time patient had a bad cold and a fever, and second time with coughing and a headache.  It was reported as "I've had all my shots and two boosters and I've had COVID twice. And I'm immunocompromised. First time it was like a bad cold and I had a fever and I have it again now with coughing and a headache. I am so glad that I had those immunizations are I probably be sitting in a hospital bed". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of off label dosing frequency and revaccination with different covid-19 vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000264370.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) 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 (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.; serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.), POOR QUALITY PRODUCT ADMINISTERED (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.) 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. 057A22A, 018C22A, AS1412B, 043H22A) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.), POOR QUALITY PRODUCT ADMINISTERED (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.), POOR QUALITY PRODUCT ADMINISTERED (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication was provided by reporter.  HCP stated an unknown number of patients were vaccinated in a mobile unit after a serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022. Age group was from infant to adults. No AEs were reported.  No treatment medication was provided by reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: received the bivalent booster before the primary series of the Moderna vaccine; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (received the bivalent booster before the primary series of the Moderna vaccine) 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. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received the bivalent booster before the primary series of the Moderna vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received the bivalent booster before the primary series of the Moderna vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received the bivalent booster before the primary series of the Moderna vaccine).    Concomitant product use was not provided by the reporter.   Patient didn't received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Body temperature, Immunisation reaction, Pyrexia
Clinical narrative: She had a reaction to all 4 Moderna COVID-19 vaccines that she received.; The fever went very high 104F with the 4th shot (Bivalent Booster); This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (She had a reaction to all 4 Moderna COVID-19 vaccines that she received.) and PYREXIA (The fever went very high 104F with the 4th shot (Bivalent Booster)) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     There was no parental vaccine exposure.   On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (She had a reaction to all 4 Moderna COVID-19 vaccines that she received.) and PYREXIA (The fever went very high 104F with the 4th shot (Bivalent Booster)). At the time of the report, IMMUNISATION REACTION (She had a reaction to all 4 Moderna COVID-19 vaccines that she received.) outcome was unknown and PYREXIA (The fever went very high 104F with the 4th shot (Bivalent Booster)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104F.  For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.   On 20-Dec-2022, at 10:11 AM, the patient reported that she had a reaction to all 4 Moderna COVID-19 vaccines that she received. The fever went very high 104F with the 4th shot (Bivalent Booster) and she ended up in Emergency Room. She stated, she will never get another shot.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-690228 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-690228:Husband's case
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: company administered a 2nd Bivalent Booster 20DEC2022; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (company administered a 2nd Bivalent Booster 20DEC2022) and NO ADVERSE EVENT (No Adverse event) in an 83-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (company administered a 2nd Bivalent Booster 20DEC2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (company administered a 2nd Bivalent Booster 20DEC2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (company administered a 2nd Bivalent Booster 20DEC2022).    No concomitant medication details was reported. No other vaccines received in the 4 weeks prior to COVID-19 vaccine. No treatment medication details was reported.
Age: 62.0
Sex: U
Vaccine: COVID19-2
Symptoms: Pruritus, Urticaria
Clinical narrative: They were all itching; I got hives (15Dec2022). Some were big size 2-2.5 inches in length & 1.5 wide on my arm. I got them on my scalp, torso, upper back.; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (They were all itching) and URTICARIA ( I got hives (15Dec2022). Some were big size 2-2.5 inches in length & 1.5 wide on my arm. I got them on my scalp, torso, upper back.) in a 62-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No medical history information was reported.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 14-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Dec-2022, the patient experienced URTICARIA ( I got hives (15Dec2022). Some were big size 2-2.5 inches in length & 1.5 wide on my arm. I got them on my scalp, torso, upper back.). On an unknown date, the patient experienced PRURITUS (They were all itching). At the time of the report, PRURITUS (They were all itching) and URTICARIA ( I got hives (15Dec2022). Some were big size 2-2.5 inches in length & 1.5 wide on my arm. I got them on my scalp, torso, upper back.) was resolving.        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 drug details was reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: 113 Bivalent doses administered after the BUD to patients 12 and up.; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No Adverse event) in an adolescent 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    No Concomitant medication was reported. No treatment information was provided.  It was reported that Bivalent doses administered after the BUD to patients 12 and up. Breakdown of doses is as follows- 51 doses from Lot AS7140C, and 60 doses from Lot AS7148B.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 1 patient received a bivalent Moderna COVID19 vaccine as a primary series dose, first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (1 patient received a bivalent Moderna COVID19 vaccine as a primary series dose, first dose) and NO ADVERSE EVENT (No adverse event) in a 39-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015h22a) for COVID-19 prophylaxis.   No Medical History information was reported.    On 21-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 21-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 (1 patient received a bivalent Moderna COVID19 vaccine as a primary series dose, first 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 bivalent Moderna COVID19 vaccine as a primary series dose, first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (1 patient received a bivalent Moderna COVID19 vaccine as a primary series dose, first dose).    No concomitant medication information was provided.  It was unknown that patient was received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medication was provided.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Received a 0.5ml monovalent dose as a booster lot 057a22a on 21-Dec-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received a 0.5ml monovalent dose as a booster lot 057a22a on 21-Dec-2022) and NO ADVERSE EVENT (No adverse event) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057a22a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 21-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Received a 0.5ml monovalent dose as a booster lot 057a22a on 21-Dec-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received a 0.5ml monovalent dose as a booster lot 057a22a on 21-Dec-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received a 0.5ml monovalent dose as a booster lot 057a22a on 21-Dec-2022).    It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medications were provided. Patient received 4 doses of the Moderna COVID19 vaccine prior to this event. No treatment medication was provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; administered with a bivalent vaccine after more than 12 hours post puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with a bivalent vaccine after more than 12 hours post puncture) and NO ADVERSE EVENT (No Adverse event) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No known allergies, no parental vaccine exposure.  The patient's past medical history included Behavioural disorder. Concurrent medical conditions included Asthma. Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) from 19-Dec-2022 to an unknown date for an unknown indication.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 19-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with a bivalent vaccine after more than 12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with a bivalent vaccine after more than 12 hours post puncture) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered with a bivalent vaccine after more than 12 hours post puncture).    Patient received 1st dose of Moderna COVID-19 vaccine on 11-Apr-2021. Patient received 2nd dose of Moderna COVID-19 vaccine on 09-May-2021. Patient received 3rd dose (1st booster) of Moderna COVID-19 vaccine on 29-Dec-2021.  The vial was first punctured on 16-Dec-2022 and the patient got the vaccine on 19-Dec-2022. Treatment information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered after 12 hours post punctured; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered after 12 hours post punctured) and NO ADVERSE EVENT (No Adverse Event) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered after 12 hours post punctured) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered after 12 hours post punctured) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered after 12 hours post punctured).    Concomitant medication was not reported. Treatment drug was not reported.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills
Clinical narrative: chills after receiving the vaccine /chills lasted all night long and are still ongoing; feeling very anxious; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills after receiving the vaccine /chills lasted all night long and are still ongoing) and ANXIETY (feeling very anxious) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:History of cancer for which patient has received chemotherapy (Cancer was diagnosed many years ago, prior to receiving any COVID-19 vaccines);Question:Was there parental vaccine exposure?Answer:No.  The patient's past medical history included Cancer (patient has received chemotherapy (diagnosed many years ago, prior to receiving vaccines)) and Chemotherapy. 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 18-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Dec-2022, the patient experienced CHILLS (chills after receiving the vaccine /chills lasted all night long and are still ongoing) and ANXIETY (feeling very anxious). At the time of the report, CHILLS (chills after receiving the vaccine /chills lasted all night long and are still ongoing) and ANXIETY (feeling very anxious) 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 medication was provided by reporter.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient states that she has received 2 primary doses of the Moderna COVID-19 vaccine and 2 booster doses. She received the Moderna COVID-19 bivalent booster dose on 18DEC2022. She started experiencing chills after receiving the vaccine and they are still continuing today. She states that she received the bivalent booster shot at 6:10 PM on 18DEC2022 and the chills started at around 12 AM the same night. The chills lasted all night long and are still ongoing. She says that it has gone down in severity but she still has the chills. She is feeling very anxious about it as she didn't have any side effects from any of her previous Moderna doses.No treatment medication was provided by reporter.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: looking to receive her second dose of the monovalent vaccine in her primary series; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (looking to receive her second dose of the monovalent vaccine in her primary series) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 057M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (looking to receive her second dose of the monovalent vaccine in her primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (looking to receive her second dose of the monovalent vaccine in her primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Patient reported no disease state and no medication history .   No concomitant medications were reported. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The Patient does not report any other adverse reactions. It was reported that it was more than 35 days between the patients first and second dose of the Moderna Covid-19 primary vaccination series. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Laboratory test, Migraine, Visual impairment
Clinical narrative: visual problems/had visual changes like the color; migraines; severe headache; This spontaneous case was reported by an other health care professional and describes the occurrence of VISUAL IMPAIRMENT (visual problems/had visual changes like the color), MIGRAINE (migraines) and HEADACHE (severe headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, lot 010M21A ) on 03-Feb-2021, Moderna COVID-19 Vaccine (Dose 2, lot 013A21A ) on 03-Mar-2021, Moderna COVID-19 Vaccine (first booster and lot 033F21A ) on 10-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concomitant products included ELASOMERAN (MODERNA COVID-19 VACCINE) from 06-Oct-2022 to an unknown date for COVID-19 prophylaxis.    On 27-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2022, the patient experienced VISUAL IMPAIRMENT (visual problems/had visual changes like the color), MIGRAINE (migraines) and HEADACHE (severe headache). At the time of the report, VISUAL IMPAIRMENT (visual problems/had visual changes like the color), MIGRAINE (migraines) and HEADACHE (severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: She had tests done, but everything came back normal..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took second Moderna booster on 27May2022.  Moderna bivalent booster on 6Oct2022. Patient had some visual problems. She had the shot about 3 o'clock. That evening she had visual changes, like the color. She went to see the eye doctor. She wasn't sure if it was related to the vaccine because she also took the bivalent and she was fine. The patient also did not have any problems with any of her previous 3 Moderna shots.  Treatment drug was not reported.
Age: 2.0
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: somebody who is just lost somebody and is spoken with many many people onthe internet; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (somebody who is just lost somebody and is spoken with many many people onthe internet) in a 2-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Patient age was reported as 2.7 years. Treatment details were not reported by the reporter. Company comment-This spontaneous case concerns a 2-year-old child of an unknown gender, with no medical history reported, who experienced the unexpected, Fatal serious (medically significant) event of death after receiving an unspecified dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccine. Latency cannot be assessed since exact vaccination date and event onset date were not disclosed. Death occurred on an unknown date. The reported cause of death was unknown. It is unknown if an autopsy was performed. No further clinical information was available for review. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 2-year-old child of an unknown gender, with no medical history reported, who experienced the unexpected, Fatal serious (medically significant) event of death after receiving an unspecified dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccine. Latency cannot be assessed since exact vaccination date and event onset date were not disclosed. Death occurred on an unknown date. The reported cause of death was unknown. It is unknown if an autopsy was performed. No further clinical information was available for review. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Wrong product administered
Clinical narrative: Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (different dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (different dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (different dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (different dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant product use was not provided by the reporter. It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Wrong dose was given to adults mistakenly and were reported to VAERS, and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use. No treatment information was provided.  This case contains information for the  18 of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Wrong product administered
Clinical narrative: Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant Medication use information was not provided by reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  Treatment Medication use information was not provided by reporter.  This case contains information for the 23rd of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master Case
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine administered after beyond use date 07-Jul-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022).    No concomitant medication was reported.  Reportedly, the vaccine received date was 07-Jun-2022 and BUD date was 07-Jul-2022.  No treatment information was provided.