chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Second dose vaccine was expired; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Second dose vaccine was expired) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) 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 13-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Second dose vaccine was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Second dose vaccine was expired) outcome was unknown.            No Concomitant medications were reported. No Treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-132195 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132195:Boyfriend's case
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) and PYREXIA (Fever) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced VOMITING (Vomiting) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, VOMITING (Vomiting) and PYREXIA (Fever) outcome was unknown.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Mobility decreased, Pyrexia
Clinical narrative: Cannot get out of bed; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Cannot get out of bed), HEADACHE (Headache) and PYREXIA (Fever) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No reported medical history.     On 15-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, the patient experienced MOBILITY DECREASED (Cannot get out of bed), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, MOBILITY DECREASED (Cannot get out of bed), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.            Concomitant product use was not provided. There were no treatment medications. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to MOD-2021-132680 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed the second dose by more than 42 days interval.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the second dose by more than 42 days interval.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the second dose by more than 42 days interval.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the second dose by more than 42 days interval.) 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 relevant concomitant medications were reported.   Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Throat irritation
Clinical narrative: Feeling poorly; Scratchy throat; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling poorly), THROAT IRRITATION (Scratchy throat) and COUGH (Coughing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-May-2021 at 2:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced FEELING ABNORMAL (Feeling poorly) and THROAT IRRITATION (Scratchy throat). May 2021, the patient experienced COUGH (Coughing). At the time of the report, FEELING ABNORMAL (Feeling poorly), THROAT IRRITATION (Scratchy throat) and COUGH (Coughing) outcome was unknown.            No relevant concomitant medications were reported.   No treatment information was provided.       Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Reporter contact details updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Irritability, Myalgia, Pain, Peripheral swelling
Clinical narrative: pain; barely had sleep; restless last night; left arm is swollen; I feel irritated; body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), INSOMNIA (barely had sleep), RESTLESSNESS (restless last night), PERIPHERAL SWELLING (left arm is swollen) and IRRITABILITY (I feel irritated) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardiac valve prosthesis user (artificial valve for the heart). Concomitant products included METOPROLOL for Heart disorder.   On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced PAIN (pain), INSOMNIA (barely had sleep), RESTLESSNESS (restless last night), PERIPHERAL SWELLING (left arm is swollen), IRRITABILITY (I feel irritated) and MYALGIA (body ache). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form and TRAMADOL for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (pain), INSOMNIA (barely had sleep), RESTLESSNESS (restless last night), PERIPHERAL SWELLING (left arm is swollen), IRRITABILITY (I feel irritated) and MYALGIA (body ache) had not resolved.            Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: NNI
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Restlessness
Clinical narrative: pain; barely had sleep; restless last night; left arm is swollen; I feel irritated; body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), INSOMNIA (barely had sleep), RESTLESSNESS (restless last night), PERIPHERAL SWELLING (left arm is swollen) and IRRITABILITY (I feel irritated) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardiac valve prosthesis user (artificial valve for the heart). Concomitant products included METOPROLOL for Heart disorder.   On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced PAIN (pain), INSOMNIA (barely had sleep), RESTLESSNESS (restless last night), PERIPHERAL SWELLING (left arm is swollen), IRRITABILITY (I feel irritated) and MYALGIA (body ache). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form and TRAMADOL for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (pain), INSOMNIA (barely had sleep), RESTLESSNESS (restless last night), PERIPHERAL SWELLING (left arm is swollen), IRRITABILITY (I feel irritated) and MYALGIA (body ache) had not resolved.            Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: NNI
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: A sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A sore arm at injection site) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), SOTALOL, PARACETAMOL (TYLENOL), ALBUTEROL [SALBUTAMOL], EMPAGLIFLOZIN (JARDIANCE), FINASTERIDE (PROSCAR), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), FUROSEMIDE (LASIX [FUROSEMIDE]), GABAPENTIN, MAGNESIUM OXIDE, METFORMIN, MONTELUKAST SODIUM (SINGULAIR MINI), TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), VITAMIN B6 and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (A sore arm at injection site). At the time of the report, VACCINATION SITE PAIN (A sore arm at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test: negative (Negative) negative. On 18-Jan-2021, SARS-CoV-2 test: negative (Negative) negative test for his CoV-2 antibodies Nucleocapsid Protein IgG Antibody Test. On 22-Feb-2021, SARS-CoV-2 test: negative (Negative) negative. On 21-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Myalgia
Clinical narrative: Very flushed, face is red like had alcohol; Very sore today, body aching; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Very flushed, face is red like had alcohol) and MYALGIA (Very sore today, body aching) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 15-May-2021, the patient experienced FLUSHING (Very flushed, face is red like had alcohol) and MYALGIA (Very sore today, body aching). At the time of the report, FLUSHING (Very flushed, face is red like had alcohol) and MYALGIA (Very sore today, body aching) outcome was unknown.            Treatment medication was not provided Action taken with mRNA-1273 in response to the event was not applicable.     Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up information received on 21-jun-2021 contains no significant information.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included IBUPROFEN (ADVIL 12 HOUR) for Headache.    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 ARTHRALGIA (Sore shoulder). At the time of the report, ARTHRALGIA (Sore shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications was reported. Ibuprofen was taken 2 hours prior to vaccination.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Feeling abnormal, Myalgia
Clinical narrative: contracted covid after receiving second dose of vaccine; chills; aches; felt blah; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt blah), COVID-19 (contracted covid after receiving second dose of vaccine), CHILLS (chills) and MYALGIA (aches) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0131020A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (felt blah), CHILLS (chills) and MYALGIA (aches). On 14-May-2021, the patient experienced COVID-19 (contracted covid after receiving second dose of vaccine). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt blah), COVID-19 (contracted covid after receiving second dose of vaccine), CHILLS (chills) and MYALGIA (aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-132184 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Erythema, Heart rate increased, Swelling face
Clinical narrative: confusion; facial swelling; elevated heart rate; entire face turned red; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (confusion), SWELLING FACE (facial swelling), HEART RATE INCREASED (elevated heart rate) and ERYTHEMA (entire face turned red) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced CONFUSIONAL STATE (confusion), SWELLING FACE (facial swelling), HEART RATE INCREASED (elevated heart rate) and ERYTHEMA (entire face turned red). The patient was treated with ACRIVASTINE (BENADRYL ALLERGY RELIEF) for Adverse event, at an unspecified dose and frequency. On 07-May-2021, CONFUSIONAL STATE (confusion), SWELLING FACE (facial swelling), HEART RATE INCREASED (elevated heart rate) and ERYTHEMA (entire face turned red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications on use included  "HRT" and did not disclose specific name. Treatment included Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Non significant follow up appended
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder soreness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder soreness) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced ARTHRALGIA (Shoulder soreness). On 15-Apr-2021, ARTHRALGIA (Shoulder soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that after first dose he experienced shoulder soreness the day after the injection.   No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-132260 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: NNI, reporter confirms that information was already given via phone call
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache, Speech disorder, Thinking abnormal
Clinical narrative: Not thinking clearly; she couldn't speak; Headache; This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (Not thinking clearly), SPEECH DISORDER (she couldn't speak) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 10-May-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 10-May-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced THINKING ABNORMAL (Not thinking clearly) and SPEECH DISORDER (she couldn't speak). At the time of the report, THINKING ABNORMAL (Not thinking clearly), SPEECH DISORDER (she couldn't speak) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: (Inconclusive) inconclusive.         No concomitant medication details was reported. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site bruising, Vaccination site erythema, Vaccination site haemorrhage, Vaccination site mass
Clinical narrative: right arm bruise where she got vaccine; line beneath the bruise where she got vaccine; red blotch beneath where she got vaccine and it bled a lot; red ball protruding; hot to the touch at vaccination site; red blotch beneath where she got vaccine; It does not hurt as much as yesterday; red blotch beneath where she got vaccine,the ball had gone down but it is red still; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (right arm bruise where she got vaccine), VACCINATION SITE REACTION (line beneath the bruise where she got vaccine), VACCINATION SITE HAEMORRHAGE (red blotch beneath where she got vaccine and it bled a lot), VACCINATION SITE MASS (red ball protruding) and VACCINATION SITE WARMTH (hot to the touch at vaccination site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, VITAMIN C [ASCORBIC ACID], CALCIUM, MAGNESIUM, ZINC (CALCIUM MAGNESIUM ZINC [CALCIUM;MAGNESIUM;ZINC]) and COLLAGEN for an unknown indication.   On 05-May-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. In May 2021, the patient experienced VACCINATION SITE REACTION (line beneath the bruise where she got vaccine), VACCINATION SITE HAEMORRHAGE (red blotch beneath where she got vaccine and it bled a lot), VACCINATION SITE MASS (red ball protruding), VACCINATION SITE WARMTH (hot to the touch at vaccination site), RASH MACULAR (red blotch beneath where she got vaccine), VACCINATION SITE PAIN (It does not hurt as much as yesterday) and VACCINATION SITE ERYTHEMA (red blotch beneath where she got vaccine,the ball had gone down but it is red still). On an unknown date, the patient experienced VACCINATION SITE BRUISING (right arm bruise where she got vaccine). At the time of the report, VACCINATION SITE BRUISING (right arm bruise where she got vaccine), VACCINATION SITE REACTION (line beneath the bruise where she got vaccine), VACCINATION SITE HAEMORRHAGE (red blotch beneath where she got vaccine and it bled a lot), VACCINATION SITE MASS (red ball protruding), VACCINATION SITE WARMTH (hot to the touch at vaccination site), RASH MACULAR (red blotch beneath where she got vaccine), VACCINATION SITE PAIN (It does not hurt as much as yesterday) and VACCINATION SITE ERYTHEMA (red blotch beneath where she got vaccine,the ball had gone down but it is red still) outcome was unknown.            Concomitant medications reported was Women's Complete Vitamins. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site reaction, Vaccination site warmth
Clinical narrative: right arm bruise where she got vaccine; line beneath the bruise where she got vaccine; red blotch beneath where she got vaccine and it bled a lot; red ball protruding; hot to the touch at vaccination site; red blotch beneath where she got vaccine; It does not hurt as much as yesterday; red blotch beneath where she got vaccine,the ball had gone down but it is red still; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (right arm bruise where she got vaccine), VACCINATION SITE REACTION (line beneath the bruise where she got vaccine), VACCINATION SITE HAEMORRHAGE (red blotch beneath where she got vaccine and it bled a lot), VACCINATION SITE MASS (red ball protruding) and VACCINATION SITE WARMTH (hot to the touch at vaccination site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, VITAMIN C [ASCORBIC ACID], CALCIUM, MAGNESIUM, ZINC (CALCIUM MAGNESIUM ZINC [CALCIUM;MAGNESIUM;ZINC]) and COLLAGEN for an unknown indication.   On 05-May-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. In May 2021, the patient experienced VACCINATION SITE REACTION (line beneath the bruise where she got vaccine), VACCINATION SITE HAEMORRHAGE (red blotch beneath where she got vaccine and it bled a lot), VACCINATION SITE MASS (red ball protruding), VACCINATION SITE WARMTH (hot to the touch at vaccination site), RASH MACULAR (red blotch beneath where she got vaccine), VACCINATION SITE PAIN (It does not hurt as much as yesterday) and VACCINATION SITE ERYTHEMA (red blotch beneath where she got vaccine,the ball had gone down but it is red still). On an unknown date, the patient experienced VACCINATION SITE BRUISING (right arm bruise where she got vaccine). At the time of the report, VACCINATION SITE BRUISING (right arm bruise where she got vaccine), VACCINATION SITE REACTION (line beneath the bruise where she got vaccine), VACCINATION SITE HAEMORRHAGE (red blotch beneath where she got vaccine and it bled a lot), VACCINATION SITE MASS (red ball protruding), VACCINATION SITE WARMTH (hot to the touch at vaccination site), RASH MACULAR (red blotch beneath where she got vaccine), VACCINATION SITE PAIN (It does not hurt as much as yesterday) and VACCINATION SITE ERYTHEMA (red blotch beneath where she got vaccine,the ball had gone down but it is red still) outcome was unknown.            Concomitant medications reported was Women's Complete Vitamins. No treatment details were reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Depressed mood, Feeling abnormal, Headache, Heavy menstrual bleeding
Clinical narrative: This spontaneous case reported by a consumer and describes the occurrence of feeling abnormal (got a little bit bad), pyrexia (fever), chills, headache and malaise (not feeling too well) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 014C21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On May 4, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced  feeling abnormal (got a little bit bad), pyrexia (fever), chills, headache, malaise (not feeling too well), depressed mood (feeling down) and heavy menstrual bleeding (one day before vaccination, started menstrual period; and more than a week after still on her period). The patient treated with acetaminophen at a dose of 1 dosage form. At the time of the report, feeling abnormal (got a little bit bad), pyrexia (fever), chills, headache, malaise (not feeling too well), depressed mood (feeling down) and heavy menstrual bleeding (one day before vaccination, started menstrual period; and more than a week after still on her period) outcome: unknown. Concomitant medication not reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer and describes the occurrence of feeling abnormal (got a little bit bad), pyrexia (fever), chills, headache and malaise (not feeling too well) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 014C21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On May 4, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced  feeling abnormal (got a little bit bad), pyrexia (fever), chills, headache, malaise (not feeling too well), depressed mood (feeling down) and heavy menstrual bleeding (one day before vaccination, started menstrual period; and more than a week after still on her period). The patient treated with acetaminophen at a dose of 1 dosage form. At the time of the report, feeling abnormal (got a little bit bad), pyrexia (fever), chills, headache, malaise (not feeling too well), depressed mood (feeling down) and heavy menstrual bleeding (one day before vaccination, started menstrual period; and more than a week after still on her period) outcome: unknown. Concomitant medication not reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash on both ankles and wrists; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on both ankles and wrists) and PRURITUS (Itchy) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 022C21A) for COVID-19 vaccination.     No medical history were reported.  Concomitant products included HYDROXYCHLOROQUINE for Rheumatoid arthritis.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-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 RASH (Rash on both ankles and wrists) and PRURITUS (Itchy). At the time of the report, RASH (Rash on both ankles and wrists) and PRURITUS (Itchy) outcome was unknown.            A few days after the first vaccination, the patient got a rash in a band like pattern about 2-3 inches wide on both ankles and wrists. It is itchy, but there were no other symptoms. The rash did not dissipate, and it continued even after she got her second vaccination.  Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not Applicable.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Malaise, Myalgia, Pain in extremity
Clinical narrative: arm hurts; couldn't sleep last night; felt pretty bad; body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts), INSOMNIA (couldn't sleep last night), MALAISE (felt pretty bad), MYALGIA (body aches) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced PAIN IN EXTREMITY (arm hurts), INSOMNIA (couldn't sleep last night), MALAISE (felt pretty bad), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (arm hurts), INSOMNIA (couldn't sleep last night), MALAISE (felt pretty bad), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication was provided.    This case was linked to MOD-2021-132284 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Vaccination site pain
Clinical narrative: Headache; A little bit dizzy; So tired / extremely tired; Started to get the chills; Little pain at the injection site with certain moves of the arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (A little bit dizzy), FATIGUE (So tired / extremely tired), CHILLS (Started to get the chills), VACCINATION SITE PAIN (Little pain at the injection site with certain moves of the arm) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A.) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (took Imodium for the therapy.).    On 15-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced VACCINATION SITE PAIN (Little pain at the injection site with certain moves of the arm). On 16-May-2021, the patient experienced DIZZINESS (A little bit dizzy). 16-May-2021, the patient experienced FATIGUE (So tired / extremely tired) and CHILLS (Started to get the chills). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, DIZZINESS (A little bit dizzy), FATIGUE (So tired / extremely tired), CHILLS (Started to get the chills), VACCINATION SITE PAIN (Little pain at the injection site with certain moves of the arm) and HEADACHE (Headache) outcome was unknown.            No treatment medications provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Additional info received on 17-MAY-2021: New events updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine administrator used the vaccine vial again. 2 patients were involved; 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 (The vaccine administrator used the vaccine vial again. 2 patients were involved) 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 13-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine administrator used the vaccine vial again. 2 patients were involved). On 13-May-2021, EXPIRED PRODUCT ADMINISTERED (The vaccine administrator used the vaccine vial again. 2 patients were involved) 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.   Reporter stated that on 07-MAY-2021, a vaccine administrator punctured one Modena covid-19 vials and they put it back in the refrigerator. On 13-MAY-2021, the vaccine administrator used the vaccine vial again and 2 patients were involved.  Reporter stated that she did not have any detailed information about the patients or the vial.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Body temperature decreased, Malaise, Pyrexia, Tremor
Clinical narrative: Worried about getting blood clot; Tremor; Low temperature; Unable to lift her arm; Not feeling well; Swollen left arm; High temperature (Fever); This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Worried about getting blood clot), TREMOR (Tremor), BODY TEMPERATURE DECREASED (Low temperature), VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift her arm) and MALAISE (Not feeling well) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced ANXIETY (Worried about getting blood clot), TREMOR (Tremor), BODY TEMPERATURE DECREASED (Low temperature), VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift her arm), MALAISE (Not feeling well), VACCINATION SITE SWELLING (Swollen left arm) and PYREXIA (High temperature (Fever)). At the time of the report, ANXIETY (Worried about getting blood clot), TREMOR (Tremor), BODY TEMPERATURE DECREASED (Low temperature), VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift her arm), MALAISE (Not feeling well), VACCINATION SITE SWELLING (Swollen left arm) and PYREXIA (High temperature (Fever)) outcome was unknown.            No concomitant medication details was reported. No treatment medication was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site swelling
Clinical narrative: Worried about getting blood clot; Tremor; Low temperature; Unable to lift her arm; Not feeling well; Swollen left arm; High temperature (Fever); This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Worried about getting blood clot), TREMOR (Tremor), BODY TEMPERATURE DECREASED (Low temperature), VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift her arm) and MALAISE (Not feeling well) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced ANXIETY (Worried about getting blood clot), TREMOR (Tremor), BODY TEMPERATURE DECREASED (Low temperature), VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift her arm), MALAISE (Not feeling well), VACCINATION SITE SWELLING (Swollen left arm) and PYREXIA (High temperature (Fever)). At the time of the report, ANXIETY (Worried about getting blood clot), TREMOR (Tremor), BODY TEMPERATURE DECREASED (Low temperature), VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift her arm), MALAISE (Not feeling well), VACCINATION SITE SWELLING (Swollen left arm) and PYREXIA (High temperature (Fever)) outcome was unknown.            No concomitant medication details was reported. No treatment medication was provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: Whelps on the injection site arm; Swelling on the injection site arm; Redness on the injection site arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE URTICARIA (Whelps on the injection site arm), VACCINATION SITE SWELLING (Swelling on the injection site arm) and VACCINATION SITE ERYTHEMA (Redness on the injection site arm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE for an unknown indication.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced VACCINATION SITE URTICARIA (Whelps on the injection site arm), VACCINATION SITE SWELLING (Swelling on the injection site arm) and VACCINATION SITE ERYTHEMA (Redness on the injection site arm). At the time of the report, VACCINATION SITE URTICARIA (Whelps on the injection site arm), VACCINATION SITE SWELLING (Swelling on the injection site arm) and VACCINATION SITE ERYTHEMA (Redness on the injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Nausea
Clinical narrative: dizzy; sick to his stomach; queasy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ABDOMINAL DISCOMFORT (sick to his stomach) and NAUSEA (queasy) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PANTOPRAZOLE for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced DIZZINESS (dizzy), ABDOMINAL DISCOMFORT (sick to his stomach) and NAUSEA (queasy). At the time of the report, DIZZINESS (dizzy), ABDOMINAL DISCOMFORT (sick to his stomach) and NAUSEA (queasy) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-132303 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  Patient was tested positive on the day he was scheduled to get his second dose.  No treatment information was provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vaccination site pain
Clinical narrative: pain and aches; nausea; soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (pain and aches), NAUSEA (nausea) and VACCINATION SITE PAIN (soreness at the injection site) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (pain and aches), NAUSEA (nausea) and VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, MYALGIA (pain and aches), NAUSEA (nausea) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.  No concomitant medications provided.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna covid 19 vaccine given to a 17 year old female; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna covid 19 vaccine given to a 17 year old female) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna covid 19 vaccine given to a 17 year old female). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna covid 19 vaccine given to a 17 year old female) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-132172 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132172:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspepsia, Fatigue, Myalgia
Clinical narrative: Digestive issues; Chills; Body aches; Exhaustion; This spontaneous case was reported by a patient and describes the occurrence of DYSPEPSIA (Digestive issues), CHILLS (Chills), MYALGIA (Body aches) and FATIGUE (Exhaustion) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 22-Apr-2021, the patient experienced DYSPEPSIA (Digestive issues), CHILLS (Chills), MYALGIA (Body aches) and FATIGUE (Exhaustion). At the time of the report, DYSPEPSIA (Digestive issues), CHILLS (Chills), MYALGIA (Body aches) and FATIGUE (Exhaustion) outcome was unknown.            Patient experienced digestive issues, chills, exhaustion, and body aches after the 2nd dose of vaccine which is 22Apr2021.  Action taken with mRNA1273 Moderna vaccine was Not Applicable
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate, Myalgia
Clinical narrative: headache; soreness all over body; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache) and MYALGIA (soreness all over body) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 12-May-2021, the patient experienced HEADACHE (headache) and MYALGIA (soreness all over body). At the time of the report, HEADACHE (headache) and MYALGIA (soreness all over body) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Heart rate: unknown (High) high heart rate.         No concomitant medications were reported.  No treatment medications were provided.  Action taken with mRNA-1273 in response to the events was  not applicable.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for Covid-19 a week later; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid-19 a week later) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced COVID-19 (Tested positive for Covid-19 a week later). At the time of the report, COVID-19 (Tested positive for Covid-19 a week later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.