chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pruritus
Clinical narrative: Headaches; Nausea; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), HEADACHE (Headaches) and NAUSEA (Nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching), HEADACHE (Headaches) and NAUSEA (Nausea). At the time of the report, PRURITUS (Itching), HEADACHE (Headaches) and NAUSEA (Nausea) had resolved.            concomitant products were not provided treatment information were not provided   This case was linked to MOD-2021-163877 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Pain in my hole body; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain in my hole body) and PYREXIA (Fever) 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 31-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain in my hole body) and PYREXIA (Fever). At the time of the report, PAIN (Pain in my hole body) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medication was  reported.   A nurse advised patient to take paracetamol in case of fever and pain. It was unknown if the patient took the medication.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired driving ability, Vertigo
Clinical narrative: he could not drive; Since 12Apr2021, he had been stuck in vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Since 12Apr2021, he had been stuck in vertigo) and IMPAIRED DRIVING ABILITY (he could not drive) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seizure, Headache and Asthma. Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for Asthma, PARACETAMOL (TYLENOL) for Headache, LEVETIRACETAM for Seizure, DOCUSATE SODIUM (STOOL SOFTENER), MACROGOL 3350 (POLYETHYLENE GLYCOL 3350), MULTIVITAMIN [VITAMINS NOS], PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLE SODIUM), SIMVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), PHENYTOIN (DILANTIN [PHENYTOIN]) and QUETIAPINE FUMARATE (SEROQUEL XR) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced VERTIGO (Since 12Apr2021, he had been stuck in vertigo). On an unknown date, the patient experienced IMPAIRED DRIVING ABILITY (he could not drive). The patient was treated with DIMENHYDRINATE (DRAMAMINE) for Adverse event, at a dose of 1 dosage form and MECLIZINE [MECLOZINE] for Adverse event, at a dose of 1 dosage form. At the time of the report, VERTIGO (Since 12Apr2021, he had been stuck in vertigo) and IMPAIRED DRIVING ABILITY (he could not drive) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-272286 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine had been in the refrigerator > 30days and was expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided  No treatment medications provided.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a vaccine from a vial that was exposed to room temperature for 19 hours; This case was received via a Regulatory Authority (Reference number: US-irms-MOD21-125183) on 30-Jul-2021 and was forwarded to Moderna on 30-Jul-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine from a vial that was exposed to room temperature for 19 hours) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine from a vial that was exposed to room temperature for 19 hours). On 29-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine from a vial that was exposed to room temperature for 19 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   No treatment medication was reported.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Product administered to patient of inappropriate age
Clinical narrative: administered a dose of the vaccine to a 17 year; interchange of vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered a dose of the vaccine to a 17 year) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EW0175) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered a dose of the vaccine to a 17 year) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered a dose of the vaccine to a 17 year) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. Patient stated that nurse was called to administration of Moderna vaccine but Pfizer was given. Treatment medications was not provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling very tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling very tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was given.     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 FATIGUE (feeling very tired). At the time of the report, FATIGUE (feeling very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was received by the patient  No Treatment was received by the patient.   This case was linked to MOD-2021-124118 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Illness, Muscle spasms, Tension, Vertigo
Clinical narrative: his chests hurt all the time; He got really sick after the 2nd shot and was sick for 3 weeks; Sometimes he's cramped up; feeling a little tense; They plan to do an EEG on his brain on 11Aug2021. His vertigo is not consistent like he had it yesterday, but he's not having it currently on the phone; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (They plan to do an EEG on his brain on 11Aug2021. His vertigo is not consistent like he had it yesterday, but he's not having it currently on the phone), CHEST PAIN (his chests hurt all the time), ILLNESS (He got really sick after the 2nd shot and was sick for 3 weeks), MUSCLE SPASMS (Sometimes he's cramped up) and TENSION (feeling a little tense) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, PARACETAMOL (TYLENOL) for Headache, LEVETIRACETAM for Seizure, MACROGOL 3350 (POLYETHYLENE GLYCOL 3350), PANTOPRAZOLE SODIUM, SIMVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), QUETIAPINE FUMARATE (SEROQUEL XR), MULTIVITAMIN [VITAMINS NOS] and PHENYTOIN (DILANTIN [PHENYTOIN]) for an unknown indication.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced VERTIGO (They plan to do an EEG on his brain on 11Aug2021. His vertigo is not consistent like he had it yesterday, but he's not having it currently on the phone). On an unknown date, the patient experienced CHEST PAIN (his chests hurt all the time), ILLNESS (He got really sick after the 2nd shot and was sick for 3 weeks), MUSCLE SPASMS (Sometimes he's cramped up) and TENSION (feeling a little tense). The patient was treated with DIMENHYDRINATE (DRAMAMINE) at a dose of UNK dosage form and MECLIZINE HCL at a dose of UNK dosage form. At the time of the report, VERTIGO (They plan to do an EEG on his brain on 11Aug2021. His vertigo is not consistent like he had it yesterday, but he's not having it currently on the phone), CHEST PAIN (his chests hurt all the time), ILLNESS (He got really sick after the 2nd shot and was sick for 3 weeks), MUSCLE SPASMS (Sometimes he's cramped up) and TENSION (feeling a little tense) outcome was unknown.            Relevant concomitant medications also includes Stool softner 100mg, 2 capsules in the morning and 2 capsules in the afternoon, Allergy pill One in the morning. Laboratory exam was performed as EEG on 11-AUG-2021 and the result was not provided. Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-272260 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Insomnia, Myalgia, Vaccination complication, Vaccination site erythema
Clinical narrative: incapacitated and couldn't  get out of bed; Couldn't sleep; Chills; body aches; large red spot at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (incapacitated and couldn't  get out of bed), INSOMNIA (Couldn't sleep), CHILLS (Chills), MYALGIA (body aches) and VACCINATION SITE ERYTHEMA (large red spot at the injection site) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (incapacitated and couldn't  get out of bed), INSOMNIA (Couldn't sleep), CHILLS (Chills), MYALGIA (body aches) and VACCINATION SITE ERYTHEMA (large red spot at the injection site). At the time of the report, VACCINATION COMPLICATION (incapacitated and couldn't  get out of bed), INSOMNIA (Couldn't sleep), CHILLS (Chills), MYALGIA (body aches) and VACCINATION SITE ERYTHEMA (large red spot at the injection site) outcome was unknown.            No relevant concomitant medications were not reported It was reported that the patient received 1st dose on 12Feb2021 at 2:00 PM and after 12 hours he woke up and every part of his body hurt like he had been beaten with a bat. He took OTC medication Tylenol and within 20 minutes the pain feeling disappeared.  Treatment information was not provided by reporter
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache after the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of HEADACHE (headache after the second dose) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced HEADACHE (headache after the second dose). At the time of the report, HEADACHE (headache after the second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details provided.  No Treatment medication details provided.   This case was linked to MOD-2021-162301 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Feet swelling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Feet swelling) 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 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 PERIPHERAL SWELLING (Feet swelling). At the time of the report, PERIPHERAL SWELLING (Feet swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment Information was not reported.  Concomitant product information was not reported.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: Four inch red circle on injection site , swollen; red 4 inch circular rash on the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE SWELLING (Four inch red circle on injection site , swollen) and VACCINATION SITE RASH (red 4 inch circular rash on the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] and CALCIUM for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Four inch red circle on injection site , swollen) and VACCINATION SITE RASH (red 4 inch circular rash on the injection site). On 01-Feb-2021, VACCINATION SITE SWELLING (Four inch red circle on injection site , swollen) and VACCINATION SITE RASH (red 4 inch circular rash on the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   . No treatment medications are reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fall, Feeling abnormal, Tremor
Clinical narrative: feeling funny /not normal self; weakness; couldn't control his body and fell on the floor an hour ago; feeling shaking; hurt his wrist; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling funny /not normal self), ASTHENIA (weakness), FALL (couldn't control his body and fell on the floor an hour ago), TREMOR (feeling shaking) and ARTHRALGIA (hurt his wrist) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Knee surgery NOS. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), AMLODIPINE, LOSARTAN, ATORVASTATIN and HYDROCODONE for an unknown indication.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced FEELING ABNORMAL (feeling funny /not normal self), ASTHENIA (weakness), FALL (couldn't control his body and fell on the floor an hour ago), TREMOR (feeling shaking) and ARTHRALGIA (hurt his wrist). At the time of the report, FEELING ABNORMAL (feeling funny /not normal self), ASTHENIA (weakness), FALL (couldn't control his body and fell on the floor an hour ago), TREMOR (feeling shaking) and ARTHRALGIA (hurt his wrist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Patient was reported that he is taking other medications including pain medications for his past knee and ankle surgery.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site pain
Clinical narrative: My right arm is swollen and it hurts bad; My right arm is swollen and it hurts bad; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (My right arm is swollen and it hurts bad) and VACCINATION SITE PAIN (My right arm is swollen and it hurts bad) 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 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 PERIPHERAL SWELLING (My right arm is swollen and it hurts bad) and VACCINATION SITE PAIN (My right arm is swollen and it hurts bad). At the time of the report, PERIPHERAL SWELLING (My right arm is swollen and it hurts bad) and VACCINATION SITE PAIN (My right arm is swollen and it hurts bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site warmth
Clinical narrative: The site of the injection was hot; Achiness everywhere; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (The site of the injection was hot), MYALGIA (Achiness everywhere) and FATIGUE (Fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     The patient's past medical history included Neck surgery. Concomitant products included CYCLOBENZAPRINE, BENAZEPRIL and METOPROLOL for an unknown indication.    On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced VACCINATION SITE WARMTH (The site of the injection was hot), MYALGIA (Achiness everywhere) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (The site of the injection was hot), MYALGIA (Achiness everywhere) and FATIGUE (Fatigue) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-272689.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Induration, Pain in extremity
Clinical narrative: arm was sore; Arm was red; Arm had fever; Arm was raised and hard; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), ERYTHEMA (Arm was red), FEELING HOT (Arm had fever) and INDURATION (Arm was raised and hard) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Bone disorder. Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HYDROCHLOORTHIAZIDE), IRON and VITAMIN D NOS for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), ERYTHEMA (Arm was red), FEELING HOT (Arm had fever) and INDURATION (Arm was raised and hard). At the time of the report, PAIN IN EXTREMITY (arm was sore), ERYTHEMA (Arm was red), FEELING HOT (Arm had fever) and INDURATION (Arm was raised and hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was also given Pneumonia vaccine along with Moderna shot.   Treatment included application of rubbing alcohol on affected area.
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breast feeding) in a male infant of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 032L20A) , while the mother received the product for COVID-19 vaccination. MEDICAL HISTORY (Parent): The mother's past medical history included Seasonal allergy (Hay fever). Concurrent medical conditions included Polycystic ovarian syndrome since May 2006 and Nickel sensitivity (Skin rash from nickel). MEDICAL HISTORY (Patient): No medical history was reported.  Concomitant product exposures included FOLIC ACID from 04-Aug-2020 to an unknown date and PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID; RETINOL; TOCOPHEROL; VITAMIN B NOS;VITAMIN D NOS] from 14-Sep-2020 to an unknown date for Prenatal care, ASCORBIC ACID (VIT C) and LINUM USITATISSIMUM SEED OIL (FLAX OIL) for Vitamin supplementation. On 15-Jan-2021, the mother 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. The mother's last menstrual period was on 07-Aug-2020 and the estimated date of delivery was 28-May-2021. On 15-Jan-2021, the infant was diagnosed with EXPOSURE VIA BREAST MILK (Breast feeding). The mother had a vaginal delivery which occurred on an unknown date, which was reported as Full-term. For neonate 1, the birth weight was 1338 grams (2lbs 15oz) with an APGAR score of 9 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. 102.4 fever during delivery. On 15-Jan-2021, EXPOSURE VIA BREAST MILK (Breast feeding) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary), the reporter did not provide any causality assessments. Treatment medications were unknown. Concomitant medication includes prenatal gummy. This case was linked to MOD-2021-009555 (Parent-Child Link). See case MOD-2021-009555 for details regarding the Parent case.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: his second vaccine was scheduled for 27MAR2021,Patient did get the second vaccine on 06APRIL2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (his second vaccine was scheduled for 27MAR2021,Patient did get the second vaccine on 06APRIL2021) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 012A21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, LISINOPRIL, HYDROCHLOROTHIAZIDE and SIMVASTATIN for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (his second vaccine was scheduled for 27MAR2021,Patient did get the second vaccine on 06APRIL2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (his second vaccine was scheduled for 27MAR2021,Patient did get the second vaccine on 06APRIL2021) outcome was unknown.            The day patient  second vaccine was scheduled for, 27-Mar-2021, however that was when he had a TIA ,a mini stroke, (on that day27-Mar-2021), he was not sure if it was tied to the vaccine but he felt . This occurred on the way to getting his second vaccine and that was when he got the TIA.  Treatment medication details were not reported   This case was linked to MOD-2021-272321 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Illness, Pyrexia
Clinical narrative: diarreah; Very sick; fever; chillks; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarreah), ILLNESS (Very sick), PYREXIA (fever) and CHILLS (chillks) 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 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarreah), ILLNESS (Very sick), PYREXIA (fever) and CHILLS (chillks). At the time of the report, DIARRHOEA (diarreah), ILLNESS (Very sick), PYREXIA (fever) and CHILLS (chillks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment were reported No Concomitant use was reporeted
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste on the mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste on the mouth) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced DYSGEUSIA (Metallic taste on the mouth). At the time of the report, DYSGEUSIA (Metallic taste on the mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was unknown.   Reporter did not allow further contact
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Feeding disorder, Laryngitis, Pharyngitis, Taste disorder
Clinical narrative: Inability to eat; Everything tastes like crap (first bite is fine, then 2nd bite tastes bad and she cannot eat anymore); throat infection; Laryegitis; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Inability to eat), TASTE DISORDER (Everything tastes like crap (first bite is fine, then 2nd bite tastes bad and she cannot eat anymore)), PHARYNGITIS (throat infection) and LARYNGITIS (Laryegitis) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 003B21A) for COVID-19 vaccination.     The patient's past medical history included Asthma, Arrhythmia cardiac (NOS) (doesn't take heart medications) and Hysterectomy. Concomitant products included ALBUTEROL [SALBUTAMOL], SALBUTAMOL (VENTOLIN [SALBUTAMOL]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and LEVOTHYROXINE for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEEDING DISORDER (Inability to eat), TASTE DISORDER (Everything tastes like crap (first bite is fine, then 2nd bite tastes bad and she cannot eat anymore)), PHARYNGITIS (throat infection) and LARYNGITIS (Laryegitis). The patient was treated with AMOXICILLIN ongoing since an unknown date at a dose of unknown. At the time of the report, FEEDING DISORDER (Inability to eat), PHARYNGITIS (throat infection) and LARYNGITIS (Laryegitis) had resolved and TASTE DISORDER (Everything tastes like crap (first bite is fine, then 2nd bite tastes bad and she cannot eat anymore)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: throat infection and laryegitis.. On an unknown date, Weight decreased: Lost 30 lbs (from 150 lbs to 120lbs).         Patient reports she has no thyroid. Treatment information includes steroids.   Most recent FOLLOW-UP information incorporated above includes: On 07-Aug-2021: follow-up information received included treatment medication, newevent and event outcome updated.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Inability to eat; Everything tastes like crap (first bite is fine, then 2nd bite tastes bad and she cannot eat anymore); throat infection; Laryegitis; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Inability to eat), TASTE DISORDER (Everything tastes like crap (first bite is fine, then 2nd bite tastes bad and she cannot eat anymore)), PHARYNGITIS (throat infection) and LARYNGITIS (Laryegitis) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 003B21A) for COVID-19 vaccination.     The patient's past medical history included Asthma, Arrhythmia cardiac (NOS) (doesn't take heart medications) and Hysterectomy. Concomitant products included ALBUTEROL [SALBUTAMOL], SALBUTAMOL (VENTOLIN [SALBUTAMOL]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and LEVOTHYROXINE for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEEDING DISORDER (Inability to eat), TASTE DISORDER (Everything tastes like crap (first bite is fine, then 2nd bite tastes bad and she cannot eat anymore)), PHARYNGITIS (throat infection) and LARYNGITIS (Laryegitis). The patient was treated with AMOXICILLIN ongoing since an unknown date at a dose of unknown. At the time of the report, FEEDING DISORDER (Inability to eat), PHARYNGITIS (throat infection) and LARYNGITIS (Laryegitis) had resolved and TASTE DISORDER (Everything tastes like crap (first bite is fine, then 2nd bite tastes bad and she cannot eat anymore)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: throat infection and laryegitis.. On an unknown date, Weight decreased: Lost 30 lbs (from 150 lbs to 120lbs).         Patient reports she has no thyroid. Treatment information includes steroids.   Most recent FOLLOW-UP information incorporated above includes: On 07-Aug-2021: follow-up information received included treatment medication, newevent and event outcome updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna was administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna was administered) 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 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 EXPIRED PRODUCT ADMINISTERED (Expired Moderna was administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna was administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment information was not Provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Insomnia, Pruritus
Clinical narrative: itching in her body; very very itchy and keeps getting worse; She wakes up 28 times in the night, scratching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching in her body), CONDITION AGGRAVATED (very very itchy and keeps getting worse) and INSOMNIA (She wakes up 28 times in the night, scratching) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching in her body), CONDITION AGGRAVATED (very very itchy and keeps getting worse) and INSOMNIA (She wakes up 28 times in the night, scratching). At the time of the report, PRURITUS (itching in her body), CONDITION AGGRAVATED (very very itchy and keeps getting worse) and INSOMNIA (She wakes up 28 times in the night, scratching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: The second of the 2 doses of the Moderna vaccine was administered on the 38th day; vaccine was administered 8 days beyond its expiration date; headache; Fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The second of the 2 doses of the Moderna vaccine was administered on the 38th day), EXPIRED PRODUCT ADMINISTERED (vaccine was administered 8 days beyond its expiration date), HEADACHE (headache) and FATIGUE (Fatigue) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 019B21A) for COVID-19 vaccination.     No medical history was provided by reporter.  The patient's past medical history included Hypercholesterolemia on 01-Feb-2021. Concurrent medical conditions included Hyperlipidemia, Acid reflux (esophageal) and Constipation. Concomitant products included CALCIUM CARBONATE from 17-May-2021 to an unknown date for Acid reflux (esophageal), DOCUSATE from 01-Jun-2021 to an unknown date for Constipation, GEMFIBROZIL from 24-Feb-2021 to an unknown date for Hyperlipidemia.   On 08-Apr-2021 at 11:12 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021 at 9:52 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The second of the 2 doses of the Moderna vaccine was administered on the 38th day), EXPIRED PRODUCT ADMINISTERED (vaccine was administered 8 days beyond its expiration date), HEADACHE (headache) and FATIGUE (Fatigue). On 10-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The second of the 2 doses of the Moderna vaccine was administered on the 38th day) and EXPIRED PRODUCT ADMINISTERED (vaccine was administered 8 days beyond its expiration date) had resolved. At the time of the report, HEADACHE (headache) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up information received and updated patient demographics, medical history, product information. Added concomitant (Gemfibrozil). Updated start date of all events and added new events (headache and fatigue).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Rash, Swelling
Clinical narrative: Allergy on face and neck; She has allergy on face and neck./swollen and with rashes.; She has allergy on face and neck./swollen and with rashes.; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergy on face and neck), SWELLING (She has allergy on face and neck./swollen and with rashes.) and RASH (She has allergy on face and neck./swollen and with rashes.) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03AB21A and 021Z21A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included GLUCOSAMINE for an unknown indication.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced ALLERGY TO VACCINE (Allergy on face and neck), SWELLING (She has allergy on face and neck./swollen and with rashes.) and RASH (She has allergy on face and neck./swollen and with rashes.). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, ALLERGY TO VACCINE (Allergy on face and neck), SWELLING (She has allergy on face and neck./swollen and with rashes.) and RASH (She has allergy on face and neck./swollen and with rashes.) outcome was unknown.            Concomitant medications includes Vitamins   This case was linked to MOD-2021-272433 (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Product storage error
Clinical narrative: Fatigued; Headache; Vaccine administered to patients after 32 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator), FATIGUE (Fatigued) and HEADACHE (Headache) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 024C21A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol since 01-Feb-2021. Concomitant products included GEMFIBROZIL from 24-Feb-2021 to an unknown date for Hyperlipidemia.   On 08-Apr-2021 at 11:12 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021 at 9:52 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator). On 10-Jun-2021, the patient experienced FATIGUE (Fatigued) and HEADACHE (Headache). On 09-Jun-2021, PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator) had resolved. At the time of the report, FATIGUE (Fatigued) and HEADACHE (Headache) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The second of the 2 doses of the Moderna vaccine was administered on the 38th day after it has been stored in the refrigerator, i.e. 8 days beyond its expiration date.   Most recent FOLLOW-UP information incorporated above includes: On 14-Aug-2021: RA
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered to patients after 32 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021 at 8:34 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medications were reported. no treatment medications were reported.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Moderna vaccine was administered on the 38th day; Moderna vaccine was administered 8 days beyond its expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna vaccine was administered on the 38th day) and EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered 8 days beyond its expiration) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 024C21A) for COVID-19 vaccination.     The patient's medical history was not provided. The patient had no known allergies.    On 09-Jun-2021 at 8:31 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021 at 11:19 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna vaccine was administered on the 38th day) and EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered 8 days beyond its expiration). On 07-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna vaccine was administered on the 38th day) and EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered 8 days beyond its expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up document received  contains no new information.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered to patients after 32 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medicines were reported. No treatment information were reported.