chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Feeling abnormal
Clinical narrative: STROKE/PARALYZED ON THE RIGHT SIDE; FEELING BAD; This spontaneous report received from a consumer via a company representative via social media (JNJ corporate) and concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient 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 administrated for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1). The patient 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 administrated 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, right away after vaccination, the patient felt bad, and within weeks she had a stroke. Then 5 months later, the patient was still paralyzed on the right side and was unable to speak (dose number in series 2).  The reporter stated that "My girl got the shots and started feeling bad right away and within weeks had a stroke and here it is 5 months later she is still paralyzed right side and cannot talk. Thanks to NO long term study and your rush to make a profit of our taxes given you plus all your write offs. Just act like nothing bad is happening. I see your commercials and turn it off that channel right away can't stand you". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke/paralyzed on the right side, and the outcome of feeling bad was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20221166495-stroke/paralyzed on the right side. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cerebral disorder, Depression, Dysphemia, Eating disorder
Clinical narrative: DEPRESSION; COULD NOT EAT; LOSS OF WEIGHT; BRAIN IMBALANCE; ANXIETY; TREMBLING; STUTTERING; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy as a horse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 23-JUL-2021 for covid-19 prophylaxis. No concomitant medications were reported. On JUL-2021, the patient experienced headache, and nausea. On an unspecified date, the patient experienced depression, could not eat, loss of weight, brain imbalance, anxiety, trembling, and stuttering. Laboratory data (dates unspecified) included: Lab test vaccine had triggered something in her brain and caused an imbalance in her brain. Treatment medications (dates unspecified) included: sertraline, mirtazapine, clozapine, and aripiprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from depression, anxiety, trembling, and stuttering, and the outcome of headache, nausea, could not eat, loss of weight and brain imbalance was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Laboratory test, Nausea, Tremor, Weight decreased
Clinical narrative: DEPRESSION; COULD NOT EAT; LOSS OF WEIGHT; BRAIN IMBALANCE; ANXIETY; TREMBLING; STUTTERING; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy as a horse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 23-JUL-2021 for covid-19 prophylaxis. No concomitant medications were reported. On JUL-2021, the patient experienced headache, and nausea. On an unspecified date, the patient experienced depression, could not eat, loss of weight, brain imbalance, anxiety, trembling, and stuttering. Laboratory data (dates unspecified) included: Lab test vaccine had triggered something in her brain and caused an imbalance in her brain. Treatment medications (dates unspecified) included: sertraline, mirtazapine, clozapine, and aripiprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from depression, anxiety, trembling, and stuttering, and the outcome of headache, nausea, could not eat, loss of weight and brain imbalance was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via company representative via social media concerned a patient of an unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. On an unspecified date, the patient was vaccinated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered for covid-19 prophylaxis.  It was unknown whether the patient experienced any adverse events following vaccination with first dose of covid-19 vaccine (unspecified manufacturer) (Dose number in series 1) On an unspecified date, the patient was vaccinated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered for covid-19 prophylaxis.  It was unknown whether the patient experienced any adverse events following vaccination with second dose of covid-19 vaccine (unspecified manufacturer) (Dose number in series 2) The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The product was associated with Off label use related to dosing frequency (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.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. As per the patient, "I got the J and J at the first opportunity, which made it so I could feel at ease attending my mother's funeral. I have had 3 boosters, and I did have a breakthrough infection exactly 11 days before our family reunion last July. I am so grateful for medical advances." The outcome of off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20221162023 (dose number in series 4).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Pyrexia
Clinical narrative: GOT VERY SICK; CHILLS; FEVER; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 69.85 kilograms, and height was 163 centimeters. No past medical history or concurrent conditions were 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced got very sick, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got very sick, fever and chills was not reported. This report was non-serious. This case, involving the same patient is linked to 20221201975.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: SHIVERING; This spontaneous report received from a parent concerned a female of unspecified age. 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced shivering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shivering was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: She had minimal side effects with the 2 previous Moderna (Monovalent) COVID-19 boosters; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (She had minimal side effects with the 2 previous Moderna (Monovalent) COVID-19 boosters) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: J&J COVID-19 vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with J&J COVID-19 vaccine.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (She had minimal side effects with the 2 previous Moderna (Monovalent) COVID-19 boosters). At the time of the report, IMMUNISATION REACTION (She had minimal side effects with the 2 previous Moderna (Monovalent) COVID-19 boosters) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: sleepy; felt a little bit tired; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (sleepy) and FATIGUE (felt a little bit tired) in a 71-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No allergies reported.  Patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Blood pressure high, Heartburn and Arrhythmia (Irregular heartbeat). Concomitant products included CLONIDINE for Blood pressure high, PROPAFENONE for Heartbeats irregular.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleepy) and FATIGUE (felt a little bit tired). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (sleepy) and FATIGUE (felt a little bit tired) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient received OTC medication as concomitant for heartburn.  It was reported that one time, either with the 1st or 2nd dose of the Moderna COVID-19 vaccine, felt a little bit tired and sleepy.   This case was linked to MOD-2022-678666.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Product administration interrupted
Clinical narrative: kind of tired/some tiredness; arm hurt/sore arm; little headache; I have not had the 2nd shot of Moderna since December of last year; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (kind of tired/some tiredness), PAIN IN EXTREMITY (arm hurt/sore arm), HEADACHE (little headache) and PRODUCT ADMINISTRATION INTERRUPTED (I have not had the 2nd shot of Moderna since December of last year) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (She had COVID 2 years ago, prior to receiving any Moderna shots.) and Clot blood (She had to be hospitalized due to COVID and it caused her to have a small blood clot. ). Previously administered products included for Clot blood: Eloquis. Past adverse reactions to the above products included No adverse event with Eloquis.    On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced FATIGUE (kind of tired/some tiredness), PAIN IN EXTREMITY (arm hurt/sore arm), HEADACHE (little headache) and PRODUCT ADMINISTRATION INTERRUPTED (I have not had the 2nd shot of Moderna since December of last year). On 03-Dec-2021, FATIGUE (kind of tired/some tiredness), PAIN IN EXTREMITY (arm hurt/sore arm) and HEADACHE (little headache) had resolved. At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (I have not had the 2nd shot of Moderna since December of last year) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. It was reported that she never received her 2nd dose due to work related issues. She mentioned that she had COVID 2 years ago, prior to receiving any Moderna shots. She had to be hospitalized due to COVID and it caused her to had a small blood clot. She stated that she had to take Eloquis for 6 months due to this. No treatment medication was reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose on 02-Feb-2021 and second dose on  20-Mar-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 02-Feb-2021 and second dose on  20-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Ulcerative colitis. Concomitant products included ADALIMUMAB (HUMIRA) for Ulcerative colitis.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 02-Feb-2021 and second dose on  20-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 02-Feb-2021 and second dose on  20-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. No treatment details were reported.   This case was linked to MOD-2022-679858.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 1 of our nurses administer a dose of Moderna Covid-19 Vaccine Monovalent that had expired.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 of our nurses administer a dose of Moderna Covid-19 Vaccine Monovalent that had expired.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 061B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 of our nurses administer a dose of Moderna Covid-19 Vaccine Monovalent that had expired.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 of our nurses administer a dose of Moderna Covid-19 Vaccine Monovalent that had expired.) 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 (1 of our nurses administer a dose of Moderna Covid-19 Vaccine Monovalent that had expired.).    No concomitant medications was provided. Vial size was  5.5 ml the vial was initially stored in the refrigerator on  09Nov2022 the vial did not undergo any temperature excursions.  No treatment medications was provided.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Visual impairment
Clinical narrative: have been having vision issues; heart issues; This spontaneous case was reported by a patient and describes the occurrence of VISUAL IMPAIRMENT (have been having vision issues) and CARDIAC DISORDER (heart issues) 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)) 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 VISUAL IMPAIRMENT (have been having vision issues) and CARDIAC DISORDER (heart issues). At the time of the report, VISUAL IMPAIRMENT (have been having vision issues) and CARDIAC DISORDER (heart issues) outcome was unknown.            Relevant concomitant medications were not reported.  Treatment information was not provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received two Moderna bivalent Covid-19 vaccines; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received two Moderna bivalent Covid-19 vaccines) and NO ADVERSE EVENT (No adverse event) in a 34-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 023H22A and AS7165B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Oct-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 29-Nov-2022, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received two Moderna bivalent Covid-19 vaccines). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received two Moderna bivalent Covid-19 vaccines) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received two Moderna bivalent Covid-19 vaccines).    Concomitant medication was not provided.  The patient had no adverse reactions after both bivalent booster dose.  The patient received first Moderna primary series on 30-Apr-2021 lot number 004C21A. Patient received in the left arm. Patient reported no adverse reactions.  The patient received second Moderna COVID-19 vaccine primary series on 28-MAY-2021. Lot number 033B21A expiration date was not known. Patient received the dose in the left arm. Patient reported no Adverse Reactions.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Received expired first primary dose after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first primary dose after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. 053B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first primary dose after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired first primary dose after manufacturer date of expiry) 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 (Received expired first primary dose after manufacturer date of expiry).    No concomitant medications were reported. Broken cartons was reported. Vial size: 5.5mL. The vial did not undergo any temperature excursions. No treatment medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Patient received expired Moderna COVID-19 vaccine for the second primary series dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 vaccine for the second primary series dose) and NO ADVERSE EVENT (No Adverse Event) in a 58-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 052B22A and 052B22A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: SHINGRIX on 27-Oct-2022, PREVNAR on 27-Oct-2022 and Flu Vaccine on 27-Oct-2022. Past adverse reactions to the above products included No adverse event with Flu Vaccine, PREVNAR and SHINGRIX.   On 27-Oct-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Nov-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 vaccine for the second primary series dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 vaccine for the second primary series dose) 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 (Patient received expired Moderna COVID-19 vaccine for the second primary series dose).    It was reported that Individual  vial of monovalent, size 5.5 ml was initially stored in the refrigerator on 01-Nov-2022. The vial did not undergo any temperature excursions. No other adverse reactions were reported with both doses.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Patient received the vaccine and was experiencing atrial fibrillation; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (Patient received the vaccine and was experiencing atrial fibrillation) 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)) 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 ATRIAL FIBRILLATION (Patient received the vaccine and was experiencing atrial fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (Patient received the vaccine and was experiencing atrial fibrillation) outcome was unknown.            No concomitant medication information was provided.  Patient states she had questions about the new bivalent vaccine.  No treatment medication was provided.  Company Comment: This spontaneous case concerns a female patient of unknown age ,with no medical history reported, who experienced a serious (Medically significant) unexpected AESI of Atrial Fibrillation unspecified days after receiving a dose of mRNA-1273 bivalent BA.4/BA.5. There is no information regarding the patient's age, underlying medical conditions, concomitant medications, diagnostics, clinical course and treatment details have been provided.  The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5  is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age ,with no medical history reported, who experienced a serious (Medically significant) unexpected AESI of Atrial Fibrillation unspecified days after receiving a dose of mRNA-1273 bivalent BA.4/BA.5. There is no information regarding the patient's age, underlying medical conditions, concomitant medications, diagnostics, clinical course and treatment details have been provided.  The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5  is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Received 2nd Bivalent booster, 54 days after first Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Received 2nd Bivalent booster, 54 days after first Bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 017H22A and AS71432) for COVID-19 vaccination.     Concurrent medical conditions included Dementia.   On 06-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Nov-2022, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (Received 2nd Bivalent booster, 54 days after first Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Received 2nd Bivalent booster, 54 days after first Bivalent booster) 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 (Received 2nd Bivalent booster, 54 days after first Bivalent booster).    The patient received the primary series of unknown brand of monovalent dose (dose 1 and dose 2) on an unknown date with unknown lot and expiration date. On 22-Dec-2021, the patient received the first monovalent booster dose of Moderna COVID-19 vaccine (Lot:045C21A and expiry date: 02-May-2022). On 07-Jun-2022, the patient received the second monovalent booster dose of  Moderna COVID-19 vaccine (Lot: 056M21A and expiry date: 12-Aug-2022).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (One patient received the Moderna Primary Series vaccinations greater than 35 days apart), EXPIRED PRODUCT ADMINISTERED (Pediatric patient received Moderna Covid-19 vaccine that was past the 30 day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Oct-2022 and was administered on 28-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) ) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pediatric patient received Moderna Covid-19 vaccine that was past the 30 day use by date). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (One patient received the Moderna Primary Series vaccinations greater than 35 days apart), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Oct-2022 and was administered on 28-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (One patient received the Moderna Primary Series vaccinations greater than 35 days apart), EXPIRED PRODUCT ADMINISTERED (Pediatric patient received Moderna Covid-19 vaccine that was past the 30 day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Oct-2022 and was administered on 28-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         4 Patients received the vaccine. Individual vials that came from an unbroken carton. The vial size was 2.5ml. The vial was initially stored in the refrigerator on 25-Oct-2022. The vial did not undergo any temperature excursions. No treatment medication was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications reported as Flu started on 07-Oct-2022.   Pfizer bivalent vaccine was administered on 25-OCT-2022 12:00 PM. On 11/21/22, patient had developed an acute onset of shingles and have never before and see that there have been several reported cases of shingles with this booster.  Treatment received included NSAID, calamine lotion, analgesics.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammatory marker test, Rheumatoid arthritis
Clinical narrative: Developed rheumatoid arthritis; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Developed rheumatoid arthritis) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced RHEUMATOID ARTHRITIS (Developed rheumatoid arthritis) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Developed rheumatoid arthritis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Inflammatory marker test: Elevated.         Concomitant product use was not provided by the reporter. Treatment information was not provided. Company comment: This is a spontaneous case concerning a 55-years-old male patient, with no medical history reported, who experienced the unexpected and serious (medically significant) event of rheumatoid arthritis (AESI) that occurred approximately 1-2 months after dose mRNA-1273 administration, which was 3rd dose in COVID-19 vaccination schedule. Patient has also informed that the event was accompanied by elevated inflammatory markers. No further clinical information clinical course of the event with exact onset date and outcome, diagnostic work up, family history, concurrent conditions and concomitant medications, differential diagnosis and treatment were provided for medical review. Based on the provided information it cannot be differentiated if this event represented an instance of reactive arthritis or rheumatoid arthritis itself. Outcome of rheumatoid arthritis was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact. Sender's Comments: This is a spontaneous case concerning a 55-years-old male patient, with no medical history reported, who experienced the unexpected and serious (medically significant) event of rheumatoid arthritis (AESI) that occurred approximately 1-2 months after dose mRNA-1273 administration, which was 3rd dose in COVID-19 vaccination schedule. Patient has also informed that the event was accompanied by elevated inflammatory markers. No further clinical information clinical course of the event with exact onset date and outcome, diagnostic work up, family history, concurrent conditions and concomitant medications, differential diagnosis and treatment were provided for medical review. Based on the provided information it cannot be differentiated if this event represented an instance of reactive arthritis or rheumatoid arthritis itself. Outcome of rheumatoid arthritis was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 84.0
Sex: F
Vaccine: COVID19-2, FLUX, UNK
Symptoms: Illness
Clinical narrative: sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (sick) in an 84-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Crohn's disease and Ulcerative colitis and INFLUENZA VACCINE (FLU VACCINE VII) for Flu vaccination.    Concurrent medical conditions included Crohn's disease and Ulcerative colitis.   On 30-Sep-2022, the patient received third 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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) at an unspecified dose. On 30-Sep-2022, the patient experienced ILLNESS (sick). At the time of the report, ILLNESS (sick) had not resolved.            No concomitant medications were reported. Patient received first and second dose of Moderna vaccine on 07-Mar-2021 and 07-Apr-2021 resp. via intramuscular route. No treatment information was provided. The reporter assessed the causality for the event sickness due to Humira as not related and the reporter did not provided the causality assessment for the event sickness due to Flu shot.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave Moderna Spikevax 6-11 vaccine to a 10-year-old girl 4 days past the expiration date) and NO ADVERSE EVENT (No adverse event) in a 10-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0622A22) for COVID-19 vaccination.     No Medical History information was reported.  On 28-Nov-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave Moderna Spikevax 6-11 vaccine to a 10-year-old girl 4 days past the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave Moderna Spikevax 6-11 vaccine to a 10-year-old girl 4 days past the expiration 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Gave Moderna Spikevax 6-11 vaccine to a 10-year-old girl 4 days past the expiration date).    Concomitant product use was not provided by the reporter.  On 28-Nov-2022 at 09:00 am, nurse administered expired moderna 6-11 years of age covid vaccine to a 10 year old.  Treatment information was not provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received doses after its beyond use date), PRODUCT STORAGE ERROR (Patient received doses after its 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. 061f22a) 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 EXPIRED PRODUCT ADMINISTERED (Patient received doses after its beyond use date), PRODUCT STORAGE ERROR (Patient received doses after its beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received doses after its beyond use date), PRODUCT STORAGE ERROR (Patient received doses after its beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse Event; Administration of an expired vaccine; Date administered: 30Nov2022 2nd dose/Date administered: 04Aug2022 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Date administered: 30Nov2022 2nd dose/Date administered: 04Aug2022 1st dose) and NO ADVERSE EVENT (No Adverse Event) in a 46-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 083B22A and 011B22A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Type 2 diabetes mellitus, Blood pressure high, High cholesterol and Obesity.   On 04-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 30-Nov-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED   It was reported that nurse gave a vaccine today that expired on 28-Nov-2022 to a patient. Dose administered after 30-day Use By Date or after manufacturer date of expiry.  Individual vials were given. Vial size was reported as 5.5 ml. Vial was removed from the freezer and thawed for administration. The vial did not undergo any temperature excursions.  No treatment information was reported.
Sex: M
Vaccine: COVID19-2
Symptoms: Atrioventricular block
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of ATRIOVENTRICULAR BLOCK (blockage in his heart) in a male patient of an unknown age 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) 1 dosage form. On an unknown date, the patient experienced ATRIOVENTRICULAR BLOCK (blockage in his heart). At the time of the report, ATRIOVENTRICULAR BLOCK (blockage in his heart) outcome was unknown.            Concomitant medications were not reported.                                       No treatment information was provided by the reporter.    The report stated that the patient experienced a blockage in his heart. The outcome of the event was unknown. No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated 27 clients with expired vaccine), PRODUCT STORAGE ERROR  refrigeration date  on 27-Jul-2022 and vaccine was adminstered on 29-Jul-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial went to temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 017B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated 27 clients with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The (BUD) refrigeration date  on 27-Jul-2022 and vaccine was adminstered on 29-Jul-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial went to temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated 27 clients with expired vaccine), PRODUCT STORAGE ERROR (The (BUD) refrigeration date  on 27-Jul-2022 and vaccine was adminstered on 29-Jul-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial went to temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2022: Follow up received: Updated patient demographics and case narrative.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  with expired vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-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) 1 dosage form. On 11-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  with expired vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  with expired vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.) 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 (erroneously vaccinated  with expired vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.).    No concomitant medications were reported.  It was reported that the patient was administered dose after 30 day use by date. The size of the vial was 2.5 ml. The vial was initially stored in the refrigerator on 03-Oct-2022 and was administered on 11-Nov-2022. Beyond use date was reported as 02-Nov-2022. The vial underwent temperature excursion. 9 days past expiry date the patient received the vaccine.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2022: Follow up received wherein patient demographics, event added and narrative updated.