chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: lupus, ehlers danlos syndrome, and pots (postural orthostatic tachycardia syndrome). The patient experienced drug allergy when treated with Suprax (cefotaxime sodium) for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (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 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.It was unknown if patient experienced any adverse event after vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 01-NOV-2021 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2). No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 infection (dose number in series 2). The patient received non company suspect Paxlovid (form of admin and route were not reported, batch number unknown and expiry: unknown) dose was not reported, administered from 05-SEP-2022 to 10-SEP-2022 for covid-19 treatment.  On 15-SEP-2022 (5 days after finishing Paxlovid), the patient experienced covid-19 rebound with symptoms (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and with Paxlovid was treatment discontinued. The patient had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious. Sender's Comments: V0- Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SLIGHTLY SORE ARM; This spontaneous report received from a patient concerned an adult female. The patient's weight was 265 pounds, and height was 66 inches.  The patient's past medical history included: infection, and hospitalization (History of hospitalization just 1 time), and concurrent conditions included: polyethylene glycol allergy (The patient had a very severe allergy to polyethylene glycol, the patient found out the allergy to polyethylene glycol accidentally, because the patient was given a samples of Blink eyedrop from doctor, after use patient eyes started swelling up, eyelids swell up like pillows and turned red and closed to the point could not see through them. The ingredient of Blink eyedrops is polyethylene glycol.), chronic asthma (respiratory issues), sleep apnea (respiratory issues), lung scarring, non-smoker (exposed to a lot of second-hand smoke.), obese, autoimmune issues (get sick easily), bipap user, vitamin d3 deficiency (now corrected, but keep taking Vitamin D3, weekly high dose), fatty liver (but they were not concerned liver functions normally.), drug allergy (Albuterol, thimerasol and potassium chromate), latex allergy, sulfa allergy, no alcohol use, nodules on lungs, kidney cyst (they were not concerned kidney functions normally), menopause, degenerative disk disease, arthritis type symptoms (makes it hard to move), gluten allergy, dairy allergy, allergic to potatoes, food allergy (Allergic to green beans), allergic to shrimp, and weight gain (gained weight after menopause), and other pre-existing medical conditions included: The patient had no any symptoms of positive COVID-19 disease prior to vaccination, had no pre-existing acute illness 30 days prior to vaccination. The patient was not a pregnant. The patient had family history of lot of heart issues (on mother's side, and most of mother's side died before 70 due to heart problem) and bad/gasping snoring. The patient experienced fatigue, more reactions, muscle aches and pain in arm when treated with varicella zoster vaccine for prophylactic vaccination, and more reactions when treated with influenza vaccine for prophylactic vaccination.  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 28-APR-2021 for covid-19 prophylaxis.  The batch number was not reported and has been requested. Age at time of vaccination 59 years old.  Concomitant medications included levosalbutamol hydrochloride for chronic asthma, montelukast sodium for chronic asthma, ibuprofen for pain, and colecalciferol for vitamin d3 severe deficiency.  On 2021, the patient experienced slightly sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slightly sore arm was not reported. This report was non-serious.  This case, involving the same patient is linked to 20220943780 and 20220956151.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INAPPROPRIATE PRODUCT STORAGE (FIVE VIALS STORED AT 35.05 DEGREES FAHRENHEIT FOR 4 HOURS AT THE TIME THEY WERE UNPUNCTURED); INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned multiple patients. 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 SEP-2022, the patient experienced inappropriate product storage (five vials stored at 35.05 degrees fahrenheit for 4 hours at the time they were unpunctured). On SEP-2022, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate product storage (five vials stored at 35.05 degrees fahrenheit for 4 hours at the time they were unpunctured) and incorrect product storage was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Lethargy, Paraesthesia, Pyrexia
Clinical narrative: VERY LETHARGIC; SLEEPLESSNESS; FEVER; SEVERE HEADACHES; TINGLING EXTREMITIES; This spontaneous report received from a patient 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 not reported, batch number: 1855190 expiry: UNKNOW) dose, start therapy date were not reported for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced very lethargic, sleeplessness, fever, severe headaches, and tingling extremities. Treatment medications (dates unspecified) included: serotonin, and melatonin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very lethargic, fever, severe headaches, and tingling extremities, and had not recovered from sleeplessness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Meconium in amniotic fluid
Clinical narrative: Small amount of meconium in amniotic fluid, NICU team removed a negligible amount from the infant's lungs immediately after birth; This spontaneous case was reported by a consumer and describes the occurrence of MECONIUM IN AMNIOTIC FLUID (Small amount of meconium in amniotic fluid, NICU team removed a negligible amount from the infant's lungs immediately after birth) in a 15-day-old female neonate exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Alcohol use (Prior use) on 17-Oct-2020.    MEDICAL HISTORY (Patient): The patient's past medical history included No adverse event.  On an unknown date, the mother received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The mother's last menstrual period was on 15-Sep-2020 and the estimated date of delivery was 13-Jun-2021. On an unknown date, the neonate was diagnosed with MECONIUM IN AMNIOTIC FLUID (Small amount of meconium in amniotic fluid, NICU team removed a negligible amount from the infant's lungs immediately after birth) (seriousness criterion medically significant). The Neonate was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The vaginal delivery occurred, which was reported as Full-term. For neonate 1, with an APGAR score of 8 and 9 at (1, 5 minutes). At the time of the report, MECONIUM IN AMNIOTIC FLUID (Small amount of meconium in amniotic fluid, NICU team removed a negligible amount from the infant's lungs immediately after birth) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown.  No concomitant medication listed.  No treatment details reported.  Company Comment: This is a case of product exposure during pregnancy with Associated AE for this 32-year-old female..Patient will continue to be contacted for further monitoring of AEs   This case was linked to MOD-2021-058822 (Parent-Child Link).   See case MOD-2021-058822 for details regarding the Parent case.  Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Upon internal review on 16-Sep-2022, non-significant correction was performed to update case received from field.; Sender's Comments: This is a case of product exposure during pregnancy with Associated AE for this 32-year-old female..Patient will continue to be contacted for further monitoring of AEs
Sex: F
Vaccine: COVID19
Symptoms: Fallot's tetralogy, Foetal growth restriction, Trisomy 22
Clinical narrative: sever IUGR; Tetralogy of fallot; trisomy 22; This spontaneous case was reported by a consumer and describes the occurrence of FOETAL GROWTH RESTRICTION (sever IUGR), FALLOT'S TETRALOGY (Tetralogy of fallot) and TRISOMY 22 (trisomy 22) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Allergy Pertussis Vaccine Historical Condition- DNC on 4- NOV-2020 Concomitant - Samrti Prenatals Start date : 5- FEB-2021 to  01-JUN-2021. Lab Test- Pregnancy Test On 05-FEB-2021 with Positive Result. Amniocentesis on 01-JUN-2021 For Trisomy 22.  The mother's past medical history included Maternal exposure during pregnancy since an unknown date.    No Medical History information was reported.    On 02-Mar-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) 1 dosage form. On 01-Jun-2021, the patient experienced TRISOMY 22 (trisomy 22) (seriousness criteria medically significant and congenital anomaly). On an unknown date, the patient experienced FOETAL GROWTH RESTRICTION (sever IUGR) (seriousness criterion medically significant) and FALLOT'S TETRALOGY (Tetralogy of fallot) (seriousness criteria medically significant and congenital anomaly). At the time of the report, FOETAL GROWTH RESTRICTION (sever IUGR), FALLOT'S TETRALOGY (Tetralogy of fallot) and TRISOMY 22 (trisomy 22) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) was unknown.       No Concomitant Medication Reported   No Treatment Medication Reported.  This is a spontaneous case concerning a female fetus with mother´s medical history of exposure during pregnancy, who experienced the serious (congenital and medically significant)  unexpected events Fallot´s tetralogy and Trisomy 22. Mother´s subject  received the first dose of vaccine at 4 weeks of gestation. Pregnancy outcome was elective termination at 24 weeks of gestation (reason for termination: Trisomy 22). The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-042859 (Parent-Child Link).   See case MOD-2021-042859 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Upon internal review on 16-Sep-2022 non-significant corrections performed to update case received from field; Sender's Comments: This is a spontaneous case concerning a female fetus with mother´s medical history of exposure during pregnancy, who experienced the serious (congenital and medically significant)  unexpected events Fallot´s tetralogy and Trisomy 22 . Mother´s subject  received the first dose of vaccine at 4 weeks of gestation. Pregnancy outcome was elective termination at 24 weeks of gestation (reason for termination: Trisomy 22). The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No reaction at all; First dose was given on 25-FEB-2021 11:30 and Second dose was given on 02-APR-2021 13:30; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 25-FEB-2021 11:30 and Second dose was given on 02-APR-2021 13:30) and NO ADVERSE EVENT (No reaction at all) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031M20A) for COVID-19 prophylaxis.     The patient's past medical history included Gout flare (Moderate) from 20-Feb-2021 to 13-Mar-2021. Concurrent medical conditions included Wood dust allergy, Grass allergy, Pollen allergy, Allergy to animal dander (Cat dander), Dust allergy, Gout (greatly exacerbated gout flare) since 2010, Asthma since 1980, Psoriasis since 1950, Kidney function abnormal (Reduced kidney function) since 1970, Osteo arthritis knees (increased left knee pain) since 2000 and Inflammation. Concomitant products included APIUM GRAVEOLENS SEED, BROMELAINS, CURCUMA LONGA ROOT, POTASSIUM CITRATE, PRUNUS SEROTINA FRUIT (GO OUT PLEX) for Gout flare, ZYFLAMEND for Inflammation, BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) for Probiotic therapy, VITAMIN B COMPLEX for Vitamin B complex supplementation, VITAMIN D3 for Vitamin D supplementation.   On 25-Feb-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021 at 1:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 25-FEB-2021 11:30 and Second dose was given on 02-APR-2021 13:30). On an unknown date, the patient experienced NO ADVERSE EVENT (No reaction at all). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 25-FEB-2021 11:30 and Second dose was given on 02-APR-2021 13:30) and NO ADVERSE EVENT (No reaction at all) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No reaction at all) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 25-FEB-2021 11:30 and Second dose was given on 02-APR-2021 13:30).    The patient received both doses in left upper arm.  The patient never diagnosed with/tested positive for COVID-19.  No treatment information was provided.   This case was linked to MOD-2021-032238 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Live follow up received. Updated event verbatim for no adverse event as no reaction at all.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: No reaction at all; First dose was given on 25-FEB-2021 11:30 and Second dose was given on 02-APR-2021 13:30; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 25-FEB-2021 11:30 and Second dose was given on 02-APR-2021 13:30) and NO ADVERSE EVENT (No reaction at all) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031M20A) for COVID-19 prophylaxis.     The patient's past medical history included Gout flare (Moderate) from 20-Feb-2021 to 13-Mar-2021. Concurrent medical conditions included Wood dust allergy, Grass allergy, Pollen allergy, Allergy to animal dander (Cat dander), Dust allergy, Gout (greatly exacerbated gout flare) since 2010, Asthma since 1980, Psoriasis since 1950, Kidney function abnormal (Reduced kidney function) since 1970, Osteo arthritis knees (increased left knee pain) since 2000 and Inflammation. Concomitant products included APIUM GRAVEOLENS SEED, BROMELAINS, CURCUMA LONGA ROOT, POTASSIUM CITRATE, PRUNUS SEROTINA FRUIT (GO OUT PLEX) for Gout flare, ZYFLAMEND for Inflammation, BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) for Probiotic therapy, VITAMIN B COMPLEX for Vitamin B complex supplementation, VITAMIN D3 for Vitamin D supplementation.   On 25-Feb-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021 at 1:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 25-FEB-2021 11:30 and Second dose was given on 02-APR-2021 13:30). On an unknown date, the patient experienced NO ADVERSE EVENT (No reaction at all). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 25-FEB-2021 11:30 and Second dose was given on 02-APR-2021 13:30) and NO ADVERSE EVENT (No reaction at all) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No reaction at all) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 25-FEB-2021 11:30 and Second dose was given on 02-APR-2021 13:30).    The patient received both doses in left upper arm.  The patient never diagnosed with/tested positive for COVID-19.  No treatment information was provided.   This case was linked to MOD-2021-032238 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Live follow up received. Updated event verbatim for no adverse event as no reaction at all.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Perfectly balanced reaction/minor reaction/textbook reaction; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Perfectly balanced reaction/minor reaction/textbook reaction) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient reported of not having any medical conditions or being on any medication prior to receiving the vaccine.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, 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 (Perfectly balanced reaction/minor reaction/textbook reaction). At the time of the report, IMMUNISATION REACTION (Perfectly balanced reaction/minor reaction/textbook reaction) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-651506, MOD-2021-032238 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: Perfectly balanced reaction/minor reaction/textbook reaction; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Perfectly balanced reaction/minor reaction/textbook reaction) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient reported of not having any medical conditions or being on any medication prior to receiving the vaccine.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, 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 (Perfectly balanced reaction/minor reaction/textbook reaction). At the time of the report, IMMUNISATION REACTION (Perfectly balanced reaction/minor reaction/textbook reaction) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-651506, MOD-2021-032238 (Patient Link).
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine was expired on 15-Sep-2022 and was administered to the patient on 23-Sep-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 15-Sep-2022 and was administered to the patient on 23-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     Patient had no allergies to medications, food and other products were reported.  Concurrent medical conditions included Tuberculosis (Current active infection). Concomitant products included ISONIAZID and RIFAMPIN for an unknown indication.    On 23-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 23-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 15-Sep-2022 and was administered to the patient on 23-Sep-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 15-Sep-2022 and was administered to the patient on 23-Sep-2022) 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 (Vaccine was expired on 15-Sep-2022 and was administered to the patient on 23-Sep-2022).    Patient was not diagnosed or tested positive for COVID-19. Patient had not received other vaccines within 1 month prior to Moderna COVID-19 vaccine. It was reported vial was in open carton in the freezer and vial size was 5.5 mL and vial had not undergone any temperature excursions. It was reported that the vaccine was administered to the patient on 23-Sep-2022 around 5pm. The adverse event had not caused patient to seek medical care (office visit, Urgent care, ER or hospitalized). It was reported that the reporter had not seen the vaccine expiration warning and later noted the expiry date.  It was reported that 2 primary full doses were administered to 2 patients.  Reporter stated that the reporters colleague checked in with the patients to see how they were feeling and they had no complaints. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Live significant follow up received contains patient details and I narrative were updated.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; expired vaccine administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to patient) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     Patient doesn't have any allergies (medications, food and other products) and patient never tested COVID-19 positive test or diagnosis. Patient received no other vaccines within one month prior to Moderna COVID-19 vaccine. No history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.     On 23-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 23-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to patient).    Patients year of birth was reported.  No concomitant medication.  It was reported vial was in open carton in the freezer and vial size was 5.5 mL and vial had not undergone any temperature excursions. It was also on 23-SEP-2022 around 5pm the dose was administered to patient and adverse event had not caused patient to seek medical care (office visit, Urgent care, ER, hospitalized). It was reported that the reporter had not seen the vaccine expiration warning and later noted the expiry date. 2 primary full doses were administered to 2 patients. Reporter stated that the reporters colleague checked in with the patients to see how they were feeling and they had no complaints.     Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Live follow up received: updated reporter state, updated narrative.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: flu-like reaction; temperature; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like reaction) and PYREXIA (temperature) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2022, 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 INFLUENZA LIKE ILLNESS (flu-like reaction) and PYREXIA (temperature). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like reaction) and PYREXIA (temperature) had resolved.            Concomitant medications were not reported.  On 29-Feb-2021, the patient received 1st dose of Moderna.  It was reported that after each of Moderna doses patient had a flu-like reaction with a temperature in the evening. This went away after 48-72 hours.   This case was linked to MOD-2022-650917 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Gait disturbance
Clinical narrative: Was really bad; Could hardly walk; Very dizzy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Was really bad), GAIT DISTURBANCE (Could hardly walk) and DIZZINESS (Very dizzy) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In September 2022, the patient experienced FEELING ABNORMAL (Was really bad), GAIT DISTURBANCE (Could hardly walk) and DIZZINESS (Very dizzy). At the time of the report, FEELING ABNORMAL (Was really bad), GAIT DISTURBANCE (Could hardly walk) and DIZZINESS (Very dizzy) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  The patient had no problems with any previous Covid doses.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-650982 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-650982:Male case
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: arm is hot; arm is swollen; arm is hard; red patch / red patch is traveling down to the elbow/patch from side of arm all the way around; rash a little bit below injection site; scratching/itching area is larger; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (scratching/itching area is larger), VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE ERYTHEMA (red patch / red patch is traveling down to the elbow/patch from side of arm all the way around), VACCINATION SITE RASH (rash a little bit below injection site) and VACCINATION SITE SWELLING (arm is swollen) 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. AS7163(0orG)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), LAMOTRIGINE (LAMICTAL) and BUSPIRONE for an unknown indication.    On 24-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 25-Sep-2022, the patient experienced VACCINATION SITE PRURITUS (scratching/itching area is larger), VACCINATION SITE ERYTHEMA (red patch / red patch is traveling down to the elbow/patch from side of arm all the way around) and VACCINATION SITE RASH (rash a little bit below injection site). On 26-Sep-2022, the patient experienced VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE SWELLING (arm is swollen) and VACCINATION SITE INDURATION (arm is hard). The patient was treated with HYDROCORTISONE on 25-Sep-2022 for Scratch, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (scratching/itching area is larger), VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE RASH (rash a little bit below injection site), VACCINATION SITE SWELLING (arm is swollen) and VACCINATION SITE INDURATION (arm is hard) outcome was unknown and VACCINATION SITE ERYTHEMA (red patch / red patch is traveling down to the elbow/patch from side of arm all the way around) had not resolved.            It was reported that patient was advised to take Benadryl by the pharmacist.  The patient took first dose on March-2021, second dose on 12-April-2021, first booster on Oct-2021 and second booster on 25-Apr-2022.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vaccination site warmth
Clinical narrative: arm is hot; arm is swollen; arm is hard; red patch / red patch is traveling down to the elbow/patch from side of arm all the way around; rash a little bit below injection site; scratching/itching area is larger; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (scratching/itching area is larger), VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE ERYTHEMA (red patch / red patch is traveling down to the elbow/patch from side of arm all the way around), VACCINATION SITE RASH (rash a little bit below injection site) and VACCINATION SITE SWELLING (arm is swollen) 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. AS7163(0orG)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), LAMOTRIGINE (LAMICTAL) and BUSPIRONE for an unknown indication.    On 24-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 25-Sep-2022, the patient experienced VACCINATION SITE PRURITUS (scratching/itching area is larger), VACCINATION SITE ERYTHEMA (red patch / red patch is traveling down to the elbow/patch from side of arm all the way around) and VACCINATION SITE RASH (rash a little bit below injection site). On 26-Sep-2022, the patient experienced VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE SWELLING (arm is swollen) and VACCINATION SITE INDURATION (arm is hard). The patient was treated with HYDROCORTISONE on 25-Sep-2022 for Scratch, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (scratching/itching area is larger), VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE RASH (rash a little bit below injection site), VACCINATION SITE SWELLING (arm is swollen) and VACCINATION SITE INDURATION (arm is hard) outcome was unknown and VACCINATION SITE ERYTHEMA (red patch / red patch is traveling down to the elbow/patch from side of arm all the way around) had not resolved.            It was reported that patient was advised to take Benadryl by the pharmacist.  The patient took first dose on March-2021, second dose on 12-April-2021, first booster on Oct-2021 and second booster on 25-Apr-2022.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: it was hurting so bad she can hardly move it; big swollen node in her left arm (injection site); it was hurting so bad she can hardly move it; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (it was hurting so bad she can hardly move it), VACCINATION SITE LYMPHADENOPATHY (big swollen node in her left arm (injection site)) and VACCINATION SITE PAIN (it was hurting so bad she can hardly move it) in an 80-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.     No Medical History information was reported.    On 26-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 26-Sep-2022, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (it was hurting so bad she can hardly move it), VACCINATION SITE LYMPHADENOPATHY (big swollen node in her left arm (injection site)) and VACCINATION SITE PAIN (it was hurting so bad she can hardly move it). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (it was hurting so bad she can hardly move it), VACCINATION SITE LYMPHADENOPATHY (big swollen node in her left arm (injection site)) and VACCINATION SITE PAIN (it was hurting so bad she can hardly move it) had not resolved.            Concomitant medications included blood pressure medications. Patient had no allergies to medications, food and other products. Patient never had COVID positive test or diagnosis. Patient had no history relating to adverse event and had no acute and chronic illnesses at the time of vaccination. Patient received first two doses on an unknown date (lot number and expiration date- unknown). Patient did not seek any medical care. Patient stated she did not experience any side effects with previous doses of the vaccine. No treatment was given.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Malaise, Pyrexia
Clinical narrative: a low grade with temperatures below 100°F; feeling tired about having fever; not feeling well; not feeling normal; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (not feeling well), FEELING ABNORMAL (not feeling normal), PYREXIA (a low grade with temperatures below 100°F) and FATIGUE (feeling tired about having fever) 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 no. AS7140C) for COVID-19 vaccination.     The patient's past medical history included Renal and pancreas transplant. Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, events only lasted for 48 hours.) on 22-Jan-2021, Pfizer (Dose 2, events only lasted for 48 hours.) on 13-Feb-2021, Pfizer (Dose 3, 1st booster dose, events only lasted for 48 hours.) on 16-Aug-2021, Pfizer (Dose 4, 2nd booster dose, events only lasted for 48 hours.) on 29-Mar-2022 and prevnar 20 pneumonia vaccination (received 48 hours before receiving the bivalent booster) on 07-Sep-2022. Past adverse reactions to the above products included No adverse event with prevnar 20 pneumonia vaccination; and Vaccination adverse reaction with Pfizer, Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Sulfonamide allergy (sulfa), Drug allergy (morphine) and Allergy to antibiotic (cipro antibiotics.).    On 09-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 10-Sep-2022, the patient experienced PYREXIA (a low grade with temperatures below 100°F). In September 2022, the patient experienced MALAISE (not feeling well), FEELING ABNORMAL (not feeling normal) and FATIGUE (feeling tired about having fever). At the time of the report, MALAISE (not feeling well), FEELING ABNORMAL (not feeling normal), PYREXIA (a low grade with temperatures below 100°F) and FATIGUE (feeling tired about having fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2022, Body temperature: below 100°F..         It was reported that patient took concomitant medication but were not specified.  It was reported that patient was going to call her doctor that morning, already reported to the agency. she had never experienced a similar event in the past.  Patient had never diagnosed with COVID nor had COVID positive test .  No treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; minor fever; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (minor fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (minor fever). At the time of the report, PAIN IN EXTREMITY (sore arm) and PYREXIA (minor fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that the patient was a volunteer in their original phase 3 Vaccine trial, the patient received the placebo, after that he received the vaccine and experienced minor fever and sore arm.  It was reported that the patient was also a volunteer for the Phase 2 clinical Trial of the Omicron and received the regular booster not the omicron. The patient stated they wanted him to go on October for a blood draw but he was offered by his Health plan the Omicron booster now, so "he asked them if he could receive the Omicron now and they said NO. The patient stated they should offer the vaccine after "they allowed the blood draw. The patient stated it was "unethical not allowing them to give them the booster after they come in for the blood draw. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Follow up received.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nasal congestion, Vaccination site pain
Clinical narrative: some mild congestion; chills; pain at the injection site.; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (some mild congestion), CHILLS (chills) and VACCINATION SITE PAIN (pain at the injection site.) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 20-Apr-2020.  On 23-Sep-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 25-Sep-2022, the patient experienced NASAL CONGESTION (some mild congestion), CHILLS (chills) and VACCINATION SITE PAIN (pain at the injection site.). At the time of the report, NASAL CONGESTION (some mild congestion), CHILLS (chills) and VACCINATION SITE PAIN (pain at the injection site.) outcome was unknown.     It was reported that, patient was less than 50 years old. No concomitant information provided Patient received 1st dose: 10Apr2021 with Lot: 037B21A Patient received 2nd dose: 09May2021 with Lot: 048B21A Patient received 1st booster: 21Nov2021 with Lot: 067F21A No treatment information provided   This case was linked to MOD-2022-650968, MOD-2022-651006 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Dyspnoea, Fatigue, Post-acute COVID-19 syndrome, SARS-CoV-2 antibody test
Clinical narrative: Long covid; Short of breath; Slightly anemic; Tired; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (Long covid), DYSPNOEA (Short of breath), ANAEMIA (Slightly anemic) and FATIGUE (Tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21P, 053E21A, 024M20A and 030L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (Long covid), DYSPNOEA (Short of breath), ANAEMIA (Slightly anemic) and FATIGUE (Tired). At the time of the report, POST-ACUTE COVID-19 SYNDROME (Long covid) and ANAEMIA (Slightly anemic) outcome was unknown and DYSPNOEA (Short of breath) and FATIGUE (Tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: (Negative) Negative. On an unknown date, SARS-CoV-2 antibody test: (Positive) Positive.         The concomitant medication was not reported by reporter. In Jan-2022 patient got tested and was negative. Patient did not quarantine with her husband, but did not experience any symptoms at the time. A few months later patient started getting short of breath. Patient went to a doctor who gave her an antibody test, which patient was positive for. Later, patient was also found to be slightly anemic. Patient had continued to feel short of breath and tired up until today. Patient had not taken any medications or treatments for her symptoms. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-650992 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-650992:same reporter
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Long covid; Short of breath; Slightly anemic; Tired; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (Long covid), DYSPNOEA (Short of breath), ANAEMIA (Slightly anemic) and FATIGUE (Tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21P, 053E21A, 024M20A and 030L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (Long covid), DYSPNOEA (Short of breath), ANAEMIA (Slightly anemic) and FATIGUE (Tired). At the time of the report, POST-ACUTE COVID-19 SYNDROME (Long covid) and ANAEMIA (Slightly anemic) outcome was unknown and DYSPNOEA (Short of breath) and FATIGUE (Tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: (Negative) Negative. On an unknown date, SARS-CoV-2 antibody test: (Positive) Positive.         The concomitant medication was not reported by reporter. In Jan-2022 patient got tested and was negative. Patient did not quarantine with her husband, but did not experience any symptoms at the time. A few months later patient started getting short of breath. Patient went to a doctor who gave her an antibody test, which patient was positive for. Later, patient was also found to be slightly anemic. Patient had continued to feel short of breath and tired up until today. Patient had not taken any medications or treatments for her symptoms. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-650992 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-650992:same reporter