chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness
Clinical narrative: a little dizziness; feeling confused; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (a little dizziness) and CONFUSIONAL STATE (feeling confused) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included Liver transplant. Concurrent medical conditions included Dizziness. Concomitant products included MECLOZINE HYDROCHLORIDE (ANTIVERT [MECLOZINE HYDROCHLORIDE]) for Dizziness, TACROLIMUS for Liver transplant, ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D3, ZOLPIDEM, LEVOTHYROXINE SODIUM (SYNTHROID), ESCITALOPRAM, MAGNESIUM OXIDE, TAMSULOSIN and VALGANCICLOVIR 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 an unknown date, the patient experienced DIZZINESS (a little dizziness) and CONFUSIONAL STATE (feeling confused). At the time of the report, DIZZINESS (a little dizziness) and CONFUSIONAL STATE (feeling confused) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication details was provided.   This case was linked to MOD-2021-122615 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: No new  information was received.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Patient received dose of a vaccine from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Patient received dose of a vaccine from an expired vial) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 11-May-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Patient received dose of a vaccine from an expired vial). On 11-May-2021, PRODUCT ADMINISTRATION ERROR (Patient received dose of a vaccine from an expired vial) 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.   Pharmacist and Physician called to report ten patients receiving doses of Moderna COVID-19 vaccine from an expired vial. The vial was stored at the facility on 07Apr2021 and kept in their fridge past the expiration date of 07May2021. The doses were received on 11May2021   This case was linked to, INC.-MOD-2021-122517, INC.-MOD-2021-122422, US-MODERNATX, INC.-MOD-2021-122588 (E2B Linked Report).; Sender's Comments: INC.-MOD-2021-122422: INC.-MOD-2021-122588:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: Shortness of Breath; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath) and PYREXIA (Fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) 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) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced DYSPNOEA (Shortness of Breath) and PYREXIA (Fever). On 19-Apr-2021, DYSPNOEA (Shortness of Breath) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not reported by the reportere.  Concomitant product use was not provided by the reporter.   This case was linked to MOD21-089504, US-MODERNATX, INC.-MOD-2021-123376 (E2B Linked Report).; Sender's Comments:  MOD21-089504:crosslinked US-MODERNATX, INC.-MOD-2021-123376:Husband case
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Dizziness
Clinical narrative: Experiencing watery stools 6-12x a day; Dizzy at time; Achy chest pains; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Experiencing watery stools 6-12x a day), DIZZINESS (Dizzy at time) and CHEST PAIN (Achy chest pains) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included Colitis. Concomitant products included TOPIRAMATE (TOPAMAX), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), GABAPENTIN, BUSPIRONE HYDROCHLORIDE (BUSPAR), DULOXETINE, LORAZEPAM (ATIVAN), LEVOTHYROXINE, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]), PRAZOSIN, DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]), ESTRADIOL and IBUPROFEN for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced DIARRHOEA (Experiencing watery stools 6-12x a day), DIZZINESS (Dizzy at time) and CHEST PAIN (Achy chest pains). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Loose stools, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (Experiencing watery stools 6-12x a day) had not resolved and DIZZINESS (Dizzy at time) and CHEST PAIN (Achy chest pains) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The Patient went to see her gynecologist around the time of her first dose. She also visited her neurologist and lost noticed she's almost 10 lbs. She has tried eating blend foods, no foods, and it just won't stop and the complaints persisted for one month. Action taken with mRNA-1273 in response to the event was no change.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Asthenia, Bedridden, Cough, Dysphagia
Clinical narrative: 8 days in bed; phlegm; runny nose; Fever; Ganglia got swelled up; Lost my voice/Lost my voice again; I am with cough. At night I cough, cough, cough; My throat hurts when I swallow/sore throat; Feel decay, without strength; Cant swallow; Feel lumps below my arm; Very sore arm after second shot; This spontaneous case was reported by a consumer and describes the occurrence of SYNOVIAL CYST (Ganglia got swelled up), APHONIA (Lost my voice/Lost my voice again), COUGH (I am with cough. At night I cough, cough, cough), OROPHARYNGEAL PAIN (My throat hurts when I swallow/sore throat) and ASTHENIA (Feel decay, without strength) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 021B221A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Sulfa). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Very sore arm after second shot). On 30-Apr-2021, the patient experienced SYNOVIAL CYST (Ganglia got swelled up), APHONIA (Lost my voice/Lost my voice again), COUGH (I am with cough. At night I cough, cough, cough), OROPHARYNGEAL PAIN (My throat hurts when I swallow/sore throat), ASTHENIA (Feel decay, without strength), DYSPHAGIA (Cant swallow) and MASS (Feel lumps below my arm). On an unknown date, the patient experienced BEDRIDDEN (8 days in bed), PRODUCTIVE COUGH (phlegm), RHINORRHOEA (runny nose) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at a dose of 1 dosage form; AZITHROMYCIN at a dose of 1 dosage form and DEXTROMETHORPHAN HYDROBROMIDE, ETHANOL, GUAIFENESIN (ROBITUSSIN [DEXTROMETHORPHAN HYDROBROMIDE;ETHANOL;GUAIFENESIN]) for Cough, at a dose of 1 dosage form. On 11-May-2021, APHONIA (Lost my voice/Lost my voice again) outcome was unknown. At the time of the report, SYNOVIAL CYST (Ganglia got swelled up), COUGH (I am with cough. At night I cough, cough, cough), OROPHARYNGEAL PAIN (My throat hurts when I swallow/sore throat), ASTHENIA (Feel decay, without strength), DYSPHAGIA (Cant swallow), MASS (Feel lumps below my arm), BEDRIDDEN (8 days in bed), PRODUCTIVE COUGH (phlegm), RHINORRHOEA (runny nose), PAIN IN EXTREMITY (Very sore arm after second shot) and PYREXIA (Fever) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Translated Follow-up document received on 14-JUL-2021 contains significant information. The treatment products were added. New events were added.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Oropharyngeal pain, Pain in extremity, Productive cough, Pyrexia
Clinical narrative: 8 days in bed; phlegm; runny nose; Fever; Ganglia got swelled up; Lost my voice/Lost my voice again; I am with cough. At night I cough, cough, cough; My throat hurts when I swallow/sore throat; Feel decay, without strength; Cant swallow; Feel lumps below my arm; Very sore arm after second shot; This spontaneous case was reported by a consumer and describes the occurrence of SYNOVIAL CYST (Ganglia got swelled up), APHONIA (Lost my voice/Lost my voice again), COUGH (I am with cough. At night I cough, cough, cough), OROPHARYNGEAL PAIN (My throat hurts when I swallow/sore throat) and ASTHENIA (Feel decay, without strength) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 021B221A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Sulfa). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Very sore arm after second shot). On 30-Apr-2021, the patient experienced SYNOVIAL CYST (Ganglia got swelled up), APHONIA (Lost my voice/Lost my voice again), COUGH (I am with cough. At night I cough, cough, cough), OROPHARYNGEAL PAIN (My throat hurts when I swallow/sore throat), ASTHENIA (Feel decay, without strength), DYSPHAGIA (Cant swallow) and MASS (Feel lumps below my arm). On an unknown date, the patient experienced BEDRIDDEN (8 days in bed), PRODUCTIVE COUGH (phlegm), RHINORRHOEA (runny nose) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at a dose of 1 dosage form; AZITHROMYCIN at a dose of 1 dosage form and DEXTROMETHORPHAN HYDROBROMIDE, ETHANOL, GUAIFENESIN (ROBITUSSIN [DEXTROMETHORPHAN HYDROBROMIDE;ETHANOL;GUAIFENESIN]) for Cough, at a dose of 1 dosage form. On 11-May-2021, APHONIA (Lost my voice/Lost my voice again) outcome was unknown. At the time of the report, SYNOVIAL CYST (Ganglia got swelled up), COUGH (I am with cough. At night I cough, cough, cough), OROPHARYNGEAL PAIN (My throat hurts when I swallow/sore throat), ASTHENIA (Feel decay, without strength), DYSPHAGIA (Cant swallow), MASS (Feel lumps below my arm), BEDRIDDEN (8 days in bed), PRODUCTIVE COUGH (phlegm), RHINORRHOEA (runny nose), PAIN IN EXTREMITY (Very sore arm after second shot) and PYREXIA (Fever) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Translated Follow-up document received on 14-JUL-2021 contains significant information. The treatment products were added. New events were added.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Synovial cyst
Clinical narrative: 8 days in bed; phlegm; runny nose; Fever; Ganglia got swelled up; Lost my voice/Lost my voice again; I am with cough. At night I cough, cough, cough; My throat hurts when I swallow/sore throat; Feel decay, without strength; Cant swallow; Feel lumps below my arm; Very sore arm after second shot; This spontaneous case was reported by a consumer and describes the occurrence of SYNOVIAL CYST (Ganglia got swelled up), APHONIA (Lost my voice/Lost my voice again), COUGH (I am with cough. At night I cough, cough, cough), OROPHARYNGEAL PAIN (My throat hurts when I swallow/sore throat) and ASTHENIA (Feel decay, without strength) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 021B221A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Sulfa). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Very sore arm after second shot). On 30-Apr-2021, the patient experienced SYNOVIAL CYST (Ganglia got swelled up), APHONIA (Lost my voice/Lost my voice again), COUGH (I am with cough. At night I cough, cough, cough), OROPHARYNGEAL PAIN (My throat hurts when I swallow/sore throat), ASTHENIA (Feel decay, without strength), DYSPHAGIA (Cant swallow) and MASS (Feel lumps below my arm). On an unknown date, the patient experienced BEDRIDDEN (8 days in bed), PRODUCTIVE COUGH (phlegm), RHINORRHOEA (runny nose) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at a dose of 1 dosage form; AZITHROMYCIN at a dose of 1 dosage form and DEXTROMETHORPHAN HYDROBROMIDE, ETHANOL, GUAIFENESIN (ROBITUSSIN [DEXTROMETHORPHAN HYDROBROMIDE;ETHANOL;GUAIFENESIN]) for Cough, at a dose of 1 dosage form. On 11-May-2021, APHONIA (Lost my voice/Lost my voice again) outcome was unknown. At the time of the report, SYNOVIAL CYST (Ganglia got swelled up), COUGH (I am with cough. At night I cough, cough, cough), OROPHARYNGEAL PAIN (My throat hurts when I swallow/sore throat), ASTHENIA (Feel decay, without strength), DYSPHAGIA (Cant swallow), MASS (Feel lumps below my arm), BEDRIDDEN (8 days in bed), PRODUCTIVE COUGH (phlegm), RHINORRHOEA (runny nose), PAIN IN EXTREMITY (Very sore arm after second shot) and PYREXIA (Fever) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Translated Follow-up document received on 14-JUL-2021 contains significant information. The treatment products were added. New events were added.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Laid out; 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 MALAISE (Laid out) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced MALAISE (Laid out). At the time of the report, MALAISE (Laid out) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-072598 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072598:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Headache, Vaccination site pain
Clinical narrative: Sore arm; headache; Minor nose bleeding from left nostril; This spontaneous case was reported by a patient and describes the occurrence of EPISTAXIS (Minor nose bleeding from left nostril), VACCINATION SITE PAIN (Sore arm) and HEADACHE (headache) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 025C21A) for COVID-19 vaccination.     Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced EPISTAXIS (Minor nose bleeding from left nostril). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EPISTAXIS (Minor nose bleeding from left nostril), VACCINATION SITE PAIN (Sore arm) and HEADACHE (headache) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Nervousness, Vaccination site pain
Clinical narrative: Arm pain; Nervousness; felt pressure in body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain), NERVOUSNESS (Nervousness) and DISCOMFORT (felt pressure in body) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Allergy.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm pain), NERVOUSNESS (Nervousness) and DISCOMFORT (felt pressure in body). On 21-Apr-2021, VACCINATION SITE PAIN (Arm pain), NERVOUSNESS (Nervousness) and DISCOMFORT (felt pressure in body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took Natural Herbal Supplements  as concomitant medication. No treatment medication were reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: itching,felt itchy,itching like crazy; has hives; down towards her elbow, it has been Hurting Ever since; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching,felt itchy,itching like crazy), VACCINATION SITE URTICARIA (has hives) and ARTHRALGIA (down towards her elbow, it has been Hurting Ever since) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 VACCINATION SITE PRURITUS (itching,felt itchy,itching like crazy), VACCINATION SITE URTICARIA (has hives) and ARTHRALGIA (down towards her elbow, it has been Hurting Ever since). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itching,felt itchy,itching like crazy), VACCINATION SITE URTICARIA (has hives) and ARTHRALGIA (down towards her elbow, it has been Hurting Ever since) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient is outside of 42 day window for second dose administration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient is outside of 42 day window for second dose administration) 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 an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient is outside of 42 day window for second dose administration). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient is outside of 42 day window for second dose administration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Reporter did not allow further contact
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Shoulder pain is no longer there/don't feel the pain anymore/haven't touched the Tylenol since the shot/ pain has substantially decreased, and some movement has improved; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Shoulder pain is no longer there/don't feel the pain anymore/haven't touched the Tylenol since the shot/ pain has substantially decreased, and some movement has improved) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 047A21A) for COVID-19 vaccination.     The patient's past medical history included Shoulder replacement in 2020. Concurrent medical conditions included Penicillin allergy, Blood pressure high, Arthritis (Related to shoulder) and Arthritis (Related to Knee). Concomitant products included AMLODIPINE for Blood pressure, LISINOPRIL for Blood pressure high, ATORVASTATIN for Cholesterol, METFORMIN for Diabetes, ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN C [ASCORBIC ACID], MULTIVITAMIN [VITAMINS NOS], MAGNESIUM and TAMSULOSIN for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Shoulder pain is no longer there/don't feel the pain anymore/haven't touched the Tylenol since the shot/ pain has substantially decreased, and some movement has improved). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, qd and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Shoulder pain is no longer there/don't feel the pain anymore/haven't touched the Tylenol since the shot/ pain has substantially decreased, and some movement has improved) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up SD received on 13-MAY-2021 updated the Additional information about treatment drug and patient information On 12-Jun-2021: Follow-up SD received on 12-MAY-2021 updated the about additional information.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick; This spontaneous case was reported by an other and describes the occurrence of ILLNESS (got sick) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick). At the time of the report, ILLNESS (got sick) outcome was unknown.            No concomitant and treatment medications were provided   This case was linked to MOD-2021-034296 (Patient Link).
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received dose of a vaccine from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) 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 medication were reported No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-122422, US-MODERNATX, INC.-MOD-2021-122517, US-MODERNATX, INC.-MOD-2021-122557 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-122422: US-MODERNATX, INC.-MOD-2021-122557:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Dizziness, Weight decreased
Clinical narrative: lost noticed she's almost 10 lbs; experiencing achy chest pains; gets dizzy at times; experiencing watery stools 6-12x a day; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (experiencing watery stools 6-12x a day), WEIGHT DECREASED (lost noticed she's almost 10 lbs), CHEST PAIN (experiencing achy chest pains) and DIZZINESS (gets dizzy at times) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 046B21A) for COVID-19 vaccination.     The patient's past medical history included Colitis. Concomitant products included TOPIRAMATE (TOPAMAX), VITAMIN D NOS, GABAPENTIN, BUSPIRONE HYDROCHLORIDE (BUSPAR), DULOXETINE, LORAZEPAM (ATIVAN), LEVOTHYROXINE, CEFIXIME (FLEXERIL [CEFIXIME]), PRAZOSIN, VALSARTAN (VALTARAN), ESTRADIOL and IBUPROFEN for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced DIARRHOEA (experiencing watery stools 6-12x a day). On an unknown date, the patient experienced WEIGHT DECREASED (lost noticed she's almost 10 lbs), CHEST PAIN (experiencing achy chest pains) and DIZZINESS (gets dizzy at times). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (experiencing watery stools 6-12x a day) had not resolved and WEIGHT DECREASED (lost noticed she's almost 10 lbs), CHEST PAIN (experiencing achy chest pains) and DIZZINESS (gets dizzy at times) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.
Sex: U
Vaccine: COVID19
Symptoms: Underdose, Wrong technique in product usage process
Clinical narrative: Vaccine was running down her arm; Vaccine was running down her 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 UNDERDOSE (Vaccine was running down her arm) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine was running down her 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 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced UNDERDOSE (Vaccine was running down her arm) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine was running down her arm). On 11-May-2021, UNDERDOSE (Vaccine was running down her arm) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine was running down her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment medication were reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Soreness at the injection site; Itching under the skin where the injection was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching under the skin where the injection was given) and VACCINATION SITE PAIN (Soreness at the injection site) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). In May 2021, the patient experienced VACCINATION SITE PRURITUS (Itching under the skin where the injection was given). In May 2021, VACCINATION SITE PAIN (Soreness at the injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itching under the skin where the injection was given) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were reported.  No treatment medication were reported.  Patient had soreness at the injection site, but this disappeared on an unspecified date. He now reports that he has itching under the skin where the injection was given, and this has persisted for over a week now. The patient also reported that the events had no negative impact on him.    Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Action taken, vaccination site pruritus outcome and listedness sections were updated.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: second dose is past 36 day mark; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second dose is past 36 day mark) 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 26-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 is past 36 day mark). At the time of the report, PRODUCT DOSE OMISSION ISSUE (second dose is past 36 day mark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Vaccination site reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE REACTION (Vaccination site reaction) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Vaccination site reaction). At the time of the report, VACCINATION SITE REACTION (Vaccination site reaction) 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.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered from a vial that was punctured 24 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered from a vial that was punctured 24 hours ago) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered from a vial that was punctured 24 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered from a vial that was punctured 24 hours ago) 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.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Erythema, Feeling hot, Limb discomfort, Myalgia
Clinical narrative: red arm day after that faded days later; itching arm; hot arm; swelling arm; looks like a bullseye on my right arm; described it as a Covid Arm; sore arm; red arm day after that faded days later; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red arm day after that faded days later), SKIN DISCOLOURATION (red arm day after that faded days later), PRURITUS (itching arm), FEELING HOT (hot arm) and PERIPHERAL SWELLING (swelling arm) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-May-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 ERYTHEMA (red arm day after that faded days later). On 11-May-2021, the patient experienced SKIN DISCOLOURATION (red arm day after that faded days later), PRURITUS (itching arm), FEELING HOT (hot arm), PERIPHERAL SWELLING (swelling arm), LIMB DISCOMFORT (looks like a bullseye on my right arm), COVID-19 (described it as a Covid Arm) and MYALGIA (sore arm). At the time of the report, ERYTHEMA (red arm day after that faded days later), SKIN DISCOLOURATION (red arm day after that faded days later), PRURITUS (itching arm), FEELING HOT (hot arm), PERIPHERAL SWELLING (swelling arm), LIMB DISCOMFORT (looks like a bullseye on my right arm), COVID-19 (described it as a Covid Arm) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Skin discolouration
Clinical narrative: red arm day after that faded days later; itching arm; hot arm; swelling arm; looks like a bullseye on my right arm; described it as a Covid Arm; sore arm; red arm day after that faded days later; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red arm day after that faded days later), SKIN DISCOLOURATION (red arm day after that faded days later), PRURITUS (itching arm), FEELING HOT (hot arm) and PERIPHERAL SWELLING (swelling arm) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-May-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 ERYTHEMA (red arm day after that faded days later). On 11-May-2021, the patient experienced SKIN DISCOLOURATION (red arm day after that faded days later), PRURITUS (itching arm), FEELING HOT (hot arm), PERIPHERAL SWELLING (swelling arm), LIMB DISCOMFORT (looks like a bullseye on my right arm), COVID-19 (described it as a Covid Arm) and MYALGIA (sore arm). At the time of the report, ERYTHEMA (red arm day after that faded days later), SKIN DISCOLOURATION (red arm day after that faded days later), PRURITUS (itching arm), FEELING HOT (hot arm), PERIPHERAL SWELLING (swelling arm), LIMB DISCOMFORT (looks like a bullseye on my right arm), COVID-19 (described it as a Covid Arm) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Dizziness, Erythema, Fatigue
Clinical narrative: red patch down to elbow; sweating profusely at night/ dripping with sweat to the point of water running down arm and needing to put a towel and change clothes; headache; sore arm, aching arm; wiped out for about 18 hours, extremely tired; nauseated; vomited 3 times; diarrhea; dizziness; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm, aching arm), ERYTHEMA (red patch down to elbow), DIZZINESS (dizziness), HYPERHIDROSIS (sweating profusely at night/ dripping with sweat to the point of water running down arm and needing to put a towel and change clothes) and DIARRHOEA (diarrhea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021 and Pneumonia. Concurrent medical conditions included Drug allergy (Fosamax). Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced DIARRHOEA (diarrhea), FATIGUE (wiped out for about 18 hours, extremely tired), NAUSEA (nauseated) and VOMITING (vomited 3 times). On 10-Apr-2021 at 10:00 AM, the patient experienced PAIN IN EXTREMITY (sore arm, aching arm). On 11-Apr-2021, the patient experienced HYPERHIDROSIS (sweating profusely at night/ dripping with sweat to the point of water running down arm and needing to put a towel and change clothes) and HEADACHE (headache). In April 2021, the patient experienced DIZZINESS (dizziness). On an unknown date, the patient experienced ERYTHEMA (red patch down to elbow). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE, PHENYLTOLOXAMINE CITRATE (SINUTABS) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm, aching arm), ERYTHEMA (red patch down to elbow), DIZZINESS (dizziness), HYPERHIDROSIS (sweating profusely at night/ dripping with sweat to the point of water running down arm and needing to put a towel and change clothes), DIARRHOEA (diarrhea), HEADACHE (headache), FATIGUE (wiped out for about 18 hours, extremely tired), NAUSEA (nauseated) and VOMITING (vomited 3 times) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.4 f - 103 f (High) 102.4 F - 103 F for about 4-5 days.     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.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Nausea, Pain in extremity, Vomiting
Clinical narrative: red patch down to elbow; sweating profusely at night/ dripping with sweat to the point of water running down arm and needing to put a towel and change clothes; headache; sore arm, aching arm; wiped out for about 18 hours, extremely tired; nauseated; vomited 3 times; diarrhea; dizziness; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm, aching arm), ERYTHEMA (red patch down to elbow), DIZZINESS (dizziness), HYPERHIDROSIS (sweating profusely at night/ dripping with sweat to the point of water running down arm and needing to put a towel and change clothes) and DIARRHOEA (diarrhea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021 and Pneumonia. Concurrent medical conditions included Drug allergy (Fosamax). Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced DIARRHOEA (diarrhea), FATIGUE (wiped out for about 18 hours, extremely tired), NAUSEA (nauseated) and VOMITING (vomited 3 times). On 10-Apr-2021 at 10:00 AM, the patient experienced PAIN IN EXTREMITY (sore arm, aching arm). On 11-Apr-2021, the patient experienced HYPERHIDROSIS (sweating profusely at night/ dripping with sweat to the point of water running down arm and needing to put a towel and change clothes) and HEADACHE (headache). In April 2021, the patient experienced DIZZINESS (dizziness). On an unknown date, the patient experienced ERYTHEMA (red patch down to elbow). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE, PHENYLTOLOXAMINE CITRATE (SINUTABS) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm, aching arm), ERYTHEMA (red patch down to elbow), DIZZINESS (dizziness), HYPERHIDROSIS (sweating profusely at night/ dripping with sweat to the point of water running down arm and needing to put a towel and change clothes), DIARRHOEA (diarrhea), HEADACHE (headache), FATIGUE (wiped out for about 18 hours, extremely tired), NAUSEA (nauseated) and VOMITING (vomited 3 times) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.4 f - 103 f (High) 102.4 F - 103 F for about 4-5 days.     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.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received dose of a vaccine from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical history reported.     On 11-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) 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 considered EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) to be not applicable.    Treatment information not provided. Concomitant medications were not provided. Symptom text in narrative included Pharmacist and Physician called to report ten patients receiving doses of Moderna COVID-19 vaccine from an expired vial. The vial was stored at the facility on 07Apr2021 and kept in their fridge past the expiration date of 07May2021. The doses were received on 11May2021.   This case was linked to MOD21-089564, MOD21-089636, MOD21-089642, MOD21-089644, MOD21-089646, MOD21-089650, MOD21-089658, MOD21-089660, MOD21-089655, US-MODERNATX, INC.-MOD-2021-122781, US-MODERNATX, INC.-MOD-2021-123137 (E2B Linked Report).; Sender's Comments:  MOD21-089564:Same reporter MOD21-089636:Same reporter MOD21-089642:Same reporter MOD21-089644:Same reporter MOD21-089646:Same reporter MOD21-089650:Same reporter MOD21-089658:Same reporter MOD21-089660:Same reporter MOD21-089655:Same reporter US-MODERNATX, INC.-MOD-2021-122781: US-MODERNATX, INC.-MOD-2021-123137:crosslinked
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: ongoing diarrhea for 7 days after Moderna COVID19 Vaccine Administration; Ongoing nausea for 7 days after Moderna Covid vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (ongoing diarrhea for 7 days after Moderna COVID19 Vaccine Administration) and NAUSEA (Ongoing nausea for 7 days after Moderna Covid vaccine administration) in a 95-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 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced DIARRHOEA (ongoing diarrhea for 7 days after Moderna COVID19 Vaccine Administration) and NAUSEA (Ongoing nausea for 7 days after Moderna Covid vaccine administration). At the time of the report, DIARRHOEA (ongoing diarrhea for 7 days after Moderna COVID19 Vaccine Administration) and NAUSEA (Ongoing nausea for 7 days after Moderna Covid vaccine administration) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.