chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vaccination complication
Clinical narrative: Vaccine reaction; Slight dizziness/light headedness; Blood Pressure High; Little Nauseous; Strong heart beating on chest; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood Pressure High), VACCINATION COMPLICATION (Vaccine reaction), NAUSEA (Little Nauseous), HEART RATE IRREGULAR (Strong heart beating on chest) and DIZZINESS (Slight dizziness/light headedness) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 041C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Aspirin). Concomitant products included COLCHICINE for Gout, ASCORBIC ACID (VIT C) and FISH OIL for an unknown indication.   On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-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 HYPERTENSION (Blood Pressure High), NAUSEA (Little Nauseous) and HEART RATE IRREGULAR (Strong heart beating on chest). On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccine reaction) and DIZZINESS (Slight dizziness/light headedness). At the time of the report, HYPERTENSION (Blood Pressure High) had not resolved and VACCINATION COMPLICATION (Vaccine reaction), NAUSEA (Little Nauseous), HEART RATE IRREGULAR (Strong heart beating on chest) and DIZZINESS (Slight dizziness/light headedness) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Blood pressure measurement (120-80): 157/101 (High) blood pressure at 10:25AM 157/101, 157/93 (High) at 10:50AM 157/93 and 165/103 (High) at 12:13PM 165/103, 70. On 05-May-2021, Heart rate: 61 (Low) 10:25AM, 63 (Low) at 10:50 AM and 70 (normal) at 12:13 PM.     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.   No treatment medications were provided by reporter.   This case was linked to MOD-2021-213383 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Non significant follow up received on 08-JUN-2021, patient demo graphics updated, events updated
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dry mouth, Nasal congestion, Oral discomfort
Clinical narrative: still congested for a little bit; dry mouth, which is ongoing; Fast heartbeat made me feel kind of faint; almost passed out in the gas station; It felt like my heart was racing; couldn't see; legs were going out from under me, like a wet noodle; burning tongue, mouth, and throat; burning tongue, mouth, and throat; burning tongue, mouth, and throat; mouth was raw; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), NASAL CONGESTION (still congested for a little bit), TONGUE DISCOMFORT (burning tongue, mouth, and throat), ORAL DISCOMFORT (burning tongue, mouth, and throat) and OROPHARYNGEAL DISCOMFORT (burning tongue, mouth, and throat) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoporosis and Paroxysmal supraventricular tachycardia. Concomitant products included DENOSUMAB (PROLIA) for Osteoporosis, METOPROLOL SUCCINATE for Paroxysmal supraventricular tachycardia, VITAMIN D NOS for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced RHINORRHOEA (Runny nose), TONGUE DISCOMFORT (burning tongue, mouth, and throat), ORAL DISCOMFORT (burning tongue, mouth, and throat), OROPHARYNGEAL DISCOMFORT (burning tongue, mouth, and throat) and STOMATITIS (mouth was raw). On 09-Apr-2021, the patient experienced PRESYNCOPE (almost passed out in the gas station), PALPITATIONS (It felt like my heart was racing), VISUAL IMPAIRMENT (couldn't see) and ASTHENIA (legs were going out from under me, like a wet noodle). On 11-Apr-2021, the patient experienced DIZZINESS (Fast heartbeat made me feel kind of faint). On an unknown date, the patient experienced NASAL CONGESTION (still congested for a little bit) and DRY MOUTH (dry mouth, which is ongoing). On 09-Apr-2021, PRESYNCOPE (almost passed out in the gas station), PALPITATIONS (It felt like my heart was racing), VISUAL IMPAIRMENT (couldn't see) and ASTHENIA (legs were going out from under me, like a wet noodle) had resolved. At the time of the report, RHINORRHOEA (Runny nose), NASAL CONGESTION (still congested for a little bit), TONGUE DISCOMFORT (burning tongue, mouth, and throat), ORAL DISCOMFORT (burning tongue, mouth, and throat), OROPHARYNGEAL DISCOMFORT (burning tongue, mouth, and throat) and STOMATITIS (mouth was raw) had resolved, DIZZINESS (Fast heartbeat made me feel kind of faint) outcome was unknown and DRY MOUTH (dry mouth, which is ongoing) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Allergy pill for runny nose(over-the counter).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Palpitations, Presyncope, Rhinorrhoea, Stomatitis
Clinical narrative: still congested for a little bit; dry mouth, which is ongoing; Fast heartbeat made me feel kind of faint; almost passed out in the gas station; It felt like my heart was racing; couldn't see; legs were going out from under me, like a wet noodle; burning tongue, mouth, and throat; burning tongue, mouth, and throat; burning tongue, mouth, and throat; mouth was raw; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), NASAL CONGESTION (still congested for a little bit), TONGUE DISCOMFORT (burning tongue, mouth, and throat), ORAL DISCOMFORT (burning tongue, mouth, and throat) and OROPHARYNGEAL DISCOMFORT (burning tongue, mouth, and throat) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoporosis and Paroxysmal supraventricular tachycardia. Concomitant products included DENOSUMAB (PROLIA) for Osteoporosis, METOPROLOL SUCCINATE for Paroxysmal supraventricular tachycardia, VITAMIN D NOS for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced RHINORRHOEA (Runny nose), TONGUE DISCOMFORT (burning tongue, mouth, and throat), ORAL DISCOMFORT (burning tongue, mouth, and throat), OROPHARYNGEAL DISCOMFORT (burning tongue, mouth, and throat) and STOMATITIS (mouth was raw). On 09-Apr-2021, the patient experienced PRESYNCOPE (almost passed out in the gas station), PALPITATIONS (It felt like my heart was racing), VISUAL IMPAIRMENT (couldn't see) and ASTHENIA (legs were going out from under me, like a wet noodle). On 11-Apr-2021, the patient experienced DIZZINESS (Fast heartbeat made me feel kind of faint). On an unknown date, the patient experienced NASAL CONGESTION (still congested for a little bit) and DRY MOUTH (dry mouth, which is ongoing). On 09-Apr-2021, PRESYNCOPE (almost passed out in the gas station), PALPITATIONS (It felt like my heart was racing), VISUAL IMPAIRMENT (couldn't see) and ASTHENIA (legs were going out from under me, like a wet noodle) had resolved. At the time of the report, RHINORRHOEA (Runny nose), NASAL CONGESTION (still congested for a little bit), TONGUE DISCOMFORT (burning tongue, mouth, and throat), ORAL DISCOMFORT (burning tongue, mouth, and throat), OROPHARYNGEAL DISCOMFORT (burning tongue, mouth, and throat) and STOMATITIS (mouth was raw) had resolved, DIZZINESS (Fast heartbeat made me feel kind of faint) outcome was unknown and DRY MOUTH (dry mouth, which is ongoing) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Allergy pill for runny nose(over-the counter).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort, Visual impairment
Clinical narrative: still congested for a little bit; dry mouth, which is ongoing; Fast heartbeat made me feel kind of faint; almost passed out in the gas station; It felt like my heart was racing; couldn't see; legs were going out from under me, like a wet noodle; burning tongue, mouth, and throat; burning tongue, mouth, and throat; burning tongue, mouth, and throat; mouth was raw; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), NASAL CONGESTION (still congested for a little bit), TONGUE DISCOMFORT (burning tongue, mouth, and throat), ORAL DISCOMFORT (burning tongue, mouth, and throat) and OROPHARYNGEAL DISCOMFORT (burning tongue, mouth, and throat) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoporosis and Paroxysmal supraventricular tachycardia. Concomitant products included DENOSUMAB (PROLIA) for Osteoporosis, METOPROLOL SUCCINATE for Paroxysmal supraventricular tachycardia, VITAMIN D NOS for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced RHINORRHOEA (Runny nose), TONGUE DISCOMFORT (burning tongue, mouth, and throat), ORAL DISCOMFORT (burning tongue, mouth, and throat), OROPHARYNGEAL DISCOMFORT (burning tongue, mouth, and throat) and STOMATITIS (mouth was raw). On 09-Apr-2021, the patient experienced PRESYNCOPE (almost passed out in the gas station), PALPITATIONS (It felt like my heart was racing), VISUAL IMPAIRMENT (couldn't see) and ASTHENIA (legs were going out from under me, like a wet noodle). On 11-Apr-2021, the patient experienced DIZZINESS (Fast heartbeat made me feel kind of faint). On an unknown date, the patient experienced NASAL CONGESTION (still congested for a little bit) and DRY MOUTH (dry mouth, which is ongoing). On 09-Apr-2021, PRESYNCOPE (almost passed out in the gas station), PALPITATIONS (It felt like my heart was racing), VISUAL IMPAIRMENT (couldn't see) and ASTHENIA (legs were going out from under me, like a wet noodle) had resolved. At the time of the report, RHINORRHOEA (Runny nose), NASAL CONGESTION (still congested for a little bit), TONGUE DISCOMFORT (burning tongue, mouth, and throat), ORAL DISCOMFORT (burning tongue, mouth, and throat), OROPHARYNGEAL DISCOMFORT (burning tongue, mouth, and throat) and STOMATITIS (mouth was raw) had resolved, DIZZINESS (Fast heartbeat made me feel kind of faint) outcome was unknown and DRY MOUTH (dry mouth, which is ongoing) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Allergy pill for runny nose(over-the counter).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Rash macular, Vaccination site erythema
Clinical narrative: red spots and little bumps below the injection site; red spots and little bumps below the injection site; red spots and little bumps below the injection site; a lot of pain; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red spots and little bumps below the injection site), PAIN (a lot of pain), VACCINATION SITE MASS (red spots and little bumps below the injection site), VACCINATION SITE ERYTHEMA (red spots and little bumps below the injection site) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-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 03-May-2021, the patient experienced PAIN (a lot of pain), PYREXIA (fever) and CHILLS (chills). On 05-May-2021, the patient experienced RASH MACULAR (red spots and little bumps below the injection site), VACCINATION SITE MASS (red spots and little bumps below the injection site) and VACCINATION SITE ERYTHEMA (red spots and little bumps below the injection site). At the time of the report, RASH MACULAR (red spots and little bumps below the injection site), PAIN (a lot of pain), PYREXIA (fever) and CHILLS (chills) outcome was unknown and VACCINATION SITE MASS (red spots and little bumps below the injection site) and VACCINATION SITE ERYTHEMA (red spots and little bumps below the injection site) had not resolved.            No concomitant medications were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Follow-up received on 05-JUN-2021, no new information was updated.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: red spots and little bumps below the injection site; red spots and little bumps below the injection site; red spots and little bumps below the injection site; a lot of pain; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red spots and little bumps below the injection site), PAIN (a lot of pain), VACCINATION SITE MASS (red spots and little bumps below the injection site), VACCINATION SITE ERYTHEMA (red spots and little bumps below the injection site) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-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 03-May-2021, the patient experienced PAIN (a lot of pain), PYREXIA (fever) and CHILLS (chills). On 05-May-2021, the patient experienced RASH MACULAR (red spots and little bumps below the injection site), VACCINATION SITE MASS (red spots and little bumps below the injection site) and VACCINATION SITE ERYTHEMA (red spots and little bumps below the injection site). At the time of the report, RASH MACULAR (red spots and little bumps below the injection site), PAIN (a lot of pain), PYREXIA (fever) and CHILLS (chills) outcome was unknown and VACCINATION SITE MASS (red spots and little bumps below the injection site) and VACCINATION SITE ERYTHEMA (red spots and little bumps below the injection site) had not resolved.            No concomitant medications were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Follow-up received on 05-JUN-2021, no new information was updated.
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Product storage error
Clinical narrative: Dose Administration Error (Invalid Dose); 4 doses were administered; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Dose Administration Error (Invalid Dose)) and PRODUCT ADMINISTRATION ERROR (4 doses were administered) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced PRODUCT STORAGE ERROR (Dose Administration Error (Invalid Dose)) and PRODUCT ADMINISTRATION ERROR (4 doses were administered). At the time of the report, PRODUCT STORAGE ERROR (Dose Administration Error (Invalid Dose)) and PRODUCT ADMINISTRATION ERROR (4 doses were administered) 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 provided. No treatment drugs were reported.     This case was linked to (E2B Linked Report).;crosslinked crosslinked
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden
Clinical narrative: laid up for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (laid up for 3 days) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer and Aneurysm.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced BEDRIDDEN (laid up for 3 days). At the time of the report, BEDRIDDEN (laid up for 3 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up information received on 07-JUN-2021 contains non-significant information- Contact information updated
Sex: F
Vaccine: COVID19
Symptoms: Antibody test negative
Clinical narrative: Tested negative; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (Tested negative) 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 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (Tested negative). At the time of the report, ANTIBODY TEST NEGATIVE (Tested negative) outcome was unknown. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-106737 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106737:Case for husband
Sex: U
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: most everything smells like garbage and taste like it too; most everything smells like garbage and taste like it too; This spontaneous case was reported by a physician and describes the occurrence of TASTE DISORDER (most everything smells like garbage and taste like it too) and PAROSMIA (most everything smells like garbage and taste like it too) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 28-Feb-2021.   On 16-Apr-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 an unknown date, the patient experienced TASTE DISORDER (most everything smells like garbage and taste like it too) and PAROSMIA (most everything smells like garbage and taste like it too). At the time of the report, TASTE DISORDER (most everything smells like garbage and taste like it too) and PAROSMIA (most everything smells like garbage and taste like it too) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment information was reported
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Product dose omission issue, Vertigo, Vomiting
Clinical narrative: afraid from getting the second shot even her health Care provider advised; vomiting; vertigo; confusion; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), CONFUSIONAL STATE (confusion), PRODUCT DOSE OMISSION ISSUE (afraid from getting the second shot even her health Care provider advised) and VOMITING (vomiting) in a 76-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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced VERTIGO (vertigo), CONFUSIONAL STATE (confusion) and VOMITING (vomiting). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (afraid from getting the second shot even her health Care provider advised). At the time of the report, VERTIGO (vertigo), CONFUSIONAL STATE (confusion) and VOMITING (vomiting) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (afraid from getting the second shot even her health Care provider advised) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Inappropriate schedule of product administration, Somnolence
Clinical narrative: still feeling a little groggy but not bad; second dose given a week before his original second dose appointment; he felt like was getting sick; weird feeling; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (he felt like was getting sick), FEELING ABNORMAL (weird feeling), SOMNOLENCE (still feeling a little groggy but not bad) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given a week before his original second dose appointment) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced ILLNESS (he felt like was getting sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given a week before his original second dose appointment). 04-May-2021, the patient experienced FEELING ABNORMAL (weird feeling). On 05-May-2021, the patient experienced SOMNOLENCE (still feeling a little groggy but not bad). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (he felt like was getting sick), FEELING ABNORMAL (weird feeling), SOMNOLENCE (still feeling a little groggy but not bad) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given a week before his original second dose appointment) outcome was unknown.            Relevant concomitant medications included ADHD medications and HIV medications.     This case was linked to MOD-2021-106709 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rhinorrhoea
Clinical narrative: runny nose; allergy symptoms; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) and HYPERSENSITIVITY (allergy symptoms) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00A2L1A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced RHINORRHOEA (runny nose) and HYPERSENSITIVITY (allergy symptoms). At the time of the report, RHINORRHOEA (runny nose) and HYPERSENSITIVITY (allergy symptoms) had not resolved. Not Provided      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.   Patient was reported to be taking using Zyrtec for her allergies before receiving the vaccine but stopped using Zyrtec as soon as she got the vaccine. No treatment medications were reported
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine) in a 55-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine) outcome was unknown. Not Provided      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.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Ear discomfort, Hot flush, Skin warm
Clinical narrative: ears were burning; heavy stomach cramps that made her double over; really bad hot flashes that were on and off during the day; Ears were really hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (heavy stomach cramps that made her double over), HOT FLUSH (really bad hot flashes that were on and off during the day), SKIN WARM (Ears were really hot to the touch) and EAR DISCOMFORT (ears were burning) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Allergic reaction (to the flue Vaccine). Concomitant products included MELOXICAM for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (heavy stomach cramps that made her double over), HOT FLUSH (really bad hot flashes that were on and off during the day) and SKIN WARM (Ears were really hot to the touch). On an unknown date, the patient experienced EAR DISCOMFORT (ears were burning). At the time of the report, ABDOMINAL PAIN UPPER (heavy stomach cramps that made her double over), HOT FLUSH (really bad hot flashes that were on and off during the day), SKIN WARM (Ears were really hot to the touch) and EAR DISCOMFORT (ears were burning) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO treatment medication details were provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Pain, Pyrexia
Clinical narrative: Tested positive for COVID-19; Chills; Aches; lingering cough; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PAIN (Aches), COUGH (lingering cough), PYREXIA (fever) and COVID-19 (Tested positive for COVID-19) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced CHILLS (Chills), PAIN (Aches), COUGH (lingering cough) and PYREXIA (fever). On 16-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID-19). The patient was treated with BENZONATATE at a dose of 1 dosage form. At the time of the report, CHILLS (Chills), PAIN (Aches), COUGH (lingering cough), PYREXIA (fever) and COVID-19 (Tested positive for COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included Blood pressure medications. Treatment medication also included cough syrup at night to help sleep and inhaler.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Chills; Aches; lingering cough; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PAIN (Aches), COUGH (lingering cough), PYREXIA (fever) and COVID-19 (Tested positive for COVID-19) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced CHILLS (Chills), PAIN (Aches), COUGH (lingering cough) and PYREXIA (fever). On 16-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID-19). The patient was treated with BENZONATATE at a dose of 1 dosage form. At the time of the report, CHILLS (Chills), PAIN (Aches), COUGH (lingering cough), PYREXIA (fever) and COVID-19 (Tested positive for COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included Blood pressure medications. Treatment medication also included cough syrup at night to help sleep and inhaler.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: many people who have received the vaccine had pain in the arm¨; 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 MYALGIA (many people who have received the vaccine had pain in the arm¨) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (many people who have received the vaccine had pain in the arm¨). At the time of the report, MYALGIA (many people who have received the vaccine had pain in the arm¨) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-106915, US-MODERNATX, INC.-MOD-2021-106499 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106915:case for patient US-MODERNATX, INC.-MOD-2021-106499:Case for patient nephew
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose was scheduled on 30Apr2021. Patient could not get it and it is possible that patient does not get second dose until 22May2021; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose was scheduled on 30Apr2021. Patient could not get it and it is possible that patient does not get second dose until 22May2021) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-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 PRODUCT DOSE OMISSION ISSUE (Second dose was scheduled on 30Apr2021. Patient could not get it and it is possible that patient does not get second dose until 22May2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose was scheduled on 30Apr2021. Patient could not get it and it is possible that patient does not get second dose until 22May2021) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Dose Administration Error (Invalid Dose); This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Dose Administration Error (Invalid Dose)) 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 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Dose Administration Error (Invalid Dose)). At the time of the report, INCORRECT DOSE ADMINISTERED (Dose Administration Error (Invalid Dose)) outcome was unknown. Not Provided      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. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-106726, US-MODERNATX, INC.-MOD-2021-106777, US-MODERNATX, INC.-MOD-2021-106851 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106726:crosslinked US-MODERNATX, INC.-MOD-2021-106777:crosslinked US-MODERNATX, INC.-MOD-2021-106851:crosslinked
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Administration of second dose of vaccine past the 36 day window; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Administration of second dose of vaccine past the 36 day window) 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 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Administration of second dose of vaccine past the 36 day window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Administration of second dose of vaccine past the 36 day window) had resolved. Not Provided      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.   No concomitant medications were reported No treatment drugs were reported
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Myalgia
Clinical narrative: difficulty sleeping, or staying asleep; little arm pain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (difficulty sleeping, or staying asleep) and MYALGIA (little arm pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D3, ACETYLSALICYLIC ACID (ASPIRIN LOW), MULTIVITAMINS [VITAMINS NOS], BACLOFEN, FOLIC ACID, GABAPENTIN, CLONAZEPAM, IBUPROFEN, VORTIOXETINE HYDROBROMIDE (TRINTELLIX) and OMEPRAZOLE for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced INSOMNIA (difficulty sleeping, or staying asleep) and MYALGIA (little arm pain). At the time of the report, INSOMNIA (difficulty sleeping, or staying asleep) and MYALGIA (little arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment information provided by the reporter   This case was linked to MOD-2021-106855 (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 event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: administered from the punctured Moderna vial that had been stored at room temperature > 24 hours.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (administered from the punctured Moderna vial that had been stored at room temperature > 24 hours.) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced PRODUCT STORAGE ERROR (administered from the punctured Moderna vial that had been stored at room temperature > 24 hours.). At the time of the report, PRODUCT STORAGE ERROR (administered from the punctured Moderna vial that had been stored at room temperature > 24 hours.) outcome was unknown. Not Provided      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. Treatment information was unknown.   This case was linked to US-MODERNATX, INC.-MOD-2021-106726, US-MODERNATX, INC.-MOD-2021-106777, US-MODERNATX, INC.-MOD-2021-106844, US-MODERNATX, INC.-MOD-2021-106726, US-MODERNATX, INC.-MOD-2021-106777 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106726:crosslinked US-MODERNATX, INC.-MOD-2021-106777:crosslinked US-MODERNATX, INC.-MOD-2021-106844:crosslinked US-MODERNATX, INC.-MOD-2021-106777:crosslinked US-MODERNATX, INC.-MOD-2021-106726:crosslinked
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eyelid pain, Eyelid ptosis, Fatigue, Headache
Clinical narrative: droopy and swollen eyelid; droopy and swollen eyelid/swollen rt eyelid; painful; chills; achy body; really bad headache; body aches/pain/tiredness; This spontaneous case was reported by a consumer and describes the occurrence of EYELID PTOSIS (droopy and swollen eyelid), SWELLING OF EYELID (droopy and swollen eyelid/swollen rt eyelid), EYELID PAIN (painful), CHILLS (chills) and MYALGIA (achy body) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included HCTZ from March 2015 to an unknown date and CARVEDILOL from May 2017 to an unknown date for an unknown indication.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced CHILLS (chills), MYALGIA (achy body), HEADACHE (really bad headache) and FATIGUE (body aches/pain/tiredness). On 04-May-2021, the patient experienced EYELID PTOSIS (droopy and swollen eyelid), SWELLING OF EYELID (droopy and swollen eyelid/swollen rt eyelid) and EYELID PAIN (painful). The patient was treated with MONTELUKAST SODIUM (SINGULAIR) at an unspecified dose and frequency and LORATADINE (CLARITINE) at a dose of 2 Doses. On 05-May-2021, SWELLING OF EYELID (droopy and swollen eyelid/swollen rt eyelid) had resolved. At the time of the report, EYELID PTOSIS (droopy and swollen eyelid), EYELID PAIN (painful), CHILLS (chills), MYALGIA (achy body), HEADACHE (really bad headache) and FATIGUE (body aches/pain/tiredness) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Treatment details included Eye drops every 4 hours and heat applied on face,as provided by the patient.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up information received on 09-Jun-2021, Added patient demographics, medical history, start date and route of concomitant drug and new Event (fatigue). Updated outcome of event (swollen eyelid) to recovered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Swelling of eyelid
Clinical narrative: droopy and swollen eyelid; droopy and swollen eyelid/swollen rt eyelid; painful; chills; achy body; really bad headache; body aches/pain/tiredness; This spontaneous case was reported by a consumer and describes the occurrence of EYELID PTOSIS (droopy and swollen eyelid), SWELLING OF EYELID (droopy and swollen eyelid/swollen rt eyelid), EYELID PAIN (painful), CHILLS (chills) and MYALGIA (achy body) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included HCTZ from March 2015 to an unknown date and CARVEDILOL from May 2017 to an unknown date for an unknown indication.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced CHILLS (chills), MYALGIA (achy body), HEADACHE (really bad headache) and FATIGUE (body aches/pain/tiredness). On 04-May-2021, the patient experienced EYELID PTOSIS (droopy and swollen eyelid), SWELLING OF EYELID (droopy and swollen eyelid/swollen rt eyelid) and EYELID PAIN (painful). The patient was treated with MONTELUKAST SODIUM (SINGULAIR) at an unspecified dose and frequency and LORATADINE (CLARITINE) at a dose of 2 Doses. On 05-May-2021, SWELLING OF EYELID (droopy and swollen eyelid/swollen rt eyelid) had resolved. At the time of the report, EYELID PTOSIS (droopy and swollen eyelid), EYELID PAIN (painful), CHILLS (chills), MYALGIA (achy body), HEADACHE (really bad headache) and FATIGUE (body aches/pain/tiredness) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Treatment details included Eye drops every 4 hours and heat applied on face,as provided by the patient.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up information received on 09-Jun-2021, Added patient demographics, medical history, start date and route of concomitant drug and new Event (fatigue). Updated outcome of event (swollen eyelid) to recovered.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: headache; achiness; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (achiness) and FATIGUE (tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 30-Mar-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 31-Mar-2021, the patient experienced HEADACHE (headache), MYALGIA (achiness) and FATIGUE (tiredness). At the time of the report, HEADACHE (headache), MYALGIA (achiness) and FATIGUE (tiredness) outcome was unknown. Not Provided          No concomitant medications reported. No treatment reported.    This case was linked to MOD-2021-042992 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hyperhidrosis
Clinical narrative: burning sensation all over inside the body; diaphoretic; This spontaneous case was reported by a nurse and describes the occurrence of BURNING SENSATION (burning sensation all over inside the body) and HYPERHIDROSIS (diaphoretic) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seafood allergy (Febreze.). No concomitant medication was reported  On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced BURNING SENSATION (burning sensation all over inside the body) and HYPERHIDROSIS (diaphoretic). At the time of the report, BURNING SENSATION (burning sensation all over inside the body) and HYPERHIDROSIS (diaphoretic) 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.