chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 antibody test, Vomiting
Clinical narrative: nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and VOMITING (vomiting) 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 an unknown date, the patient experienced NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: pending (Inconclusive) pending.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient  is taking medicine for cirrhosis. patient had covid19 test and other lab tests the results will come after 2 days Patients second dose vaccine appointment  on 2Apr2021.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: sore arm; couldn't sleep on that arm for a day or so; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and INSOMNIA (couldn't sleep on that arm for a day or so) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 032B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and INSOMNIA (couldn't sleep on that arm for a day or so). At the time of the report, PAIN IN EXTREMITY (sore arm) and INSOMNIA (couldn't sleep on that arm for a day or so) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-067813 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067813:2nd dose
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness at injection site; Swelling at injection site; Chills; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and FATIGUE (Fatigue) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-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 CHILLS (Chills) and PYREXIA (Fever). On 05-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). On an unknown date, the patient experienced FATIGUE (Fatigue). On 05-Apr-2021, PYREXIA (Fever) had resolved. On 06-Apr-2021, VACCINATION SITE SWELLING (Swelling at injection site) had resolved. At the time of the report, CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown and FATIGUE (Fatigue) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided Action taken with mRNA-1273 in response to the events was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Outcome of events and new event Fatigue were added.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17year old received the 1st dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old received the 1st dose of the Moderna Covid-19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old received the 1st dose of the Moderna Covid-19 vaccine). On 06-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old received the 1st dose of the Moderna Covid-19 vaccine) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warm to touch; a bit itchy; a lump, on the injection site, muscle of her right arm / 1 to 2 inches in size lump and tender when touched; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (a bit itchy) and VACCINATION SITE SWELLING (a lump, on the injection site, muscle of her right arm / 1 to 2 inches in size lump and tender when touched) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypothyroidism. Concomitant products included GLIPIZIDE and METFORMIN for Diabetes, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) and LISINOPRIL for Hypothyroidism.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (a bit itchy) and VACCINATION SITE SWELLING (a lump, on the injection site, muscle of her right arm / 1 to 2 inches in size lump and tender when touched). At the time of the report, VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (a bit itchy) and VACCINATION SITE SWELLING (a lump, on the injection site, muscle of her right arm / 1 to 2 inches in size lump and tender when touched) 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 treatment medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: event outcome updated
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Underdose, Vaccination site haemorrhage
Clinical narrative: He didn't feel anything; Bled a little after the injection; Worried that he didn't received the full dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (He didn't feel anything), VACCINATION SITE HAEMORRHAGE (Bled a little after the injection) and UNDERDOSE (Worried that he didn't received the full dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 011M20A) for an unknown indication.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced FEELING ABNORMAL (He didn't feel anything), VACCINATION SITE HAEMORRHAGE (Bled a little after the injection) and UNDERDOSE (Worried that he didn't received the full dose). At the time of the report, FEELING ABNORMAL (He didn't feel anything), VACCINATION SITE HAEMORRHAGE (Bled a little after the injection) and UNDERDOSE (Worried that he didn't received the full dose) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the 1st dose but not the 2nd dose yet; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 1st dose but not the 2nd dose yet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 1st dose but not the 2nd dose yet). On 17-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 1st dose but not the 2nd dose yet) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine with 34F temperature administered to patient; two doses has been given to two; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine with 34F temperature administered to patient) and EXPIRED PRODUCT ADMINISTERED (two doses has been given to two) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical information was reported.).    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine with 34F temperature administered to patient) and EXPIRED PRODUCT ADMINISTERED (two doses has been given to two). On 05-Apr-2021, PRODUCT STORAGE ERROR (Vaccine with 34F temperature administered to patient) and EXPIRED PRODUCT ADMINISTERED (two doses has been given to two) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  Treatment information was not provided.; Sender's Comments: This report refers to a case of Product storage error and Expired product administered, for mRNA-1273, lot # 027B21A, with no associated AEs.
Age: 49.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash, Vaccination site pain
Clinical narrative: pain during injection; skin breakout; This spontaneous case was reported by a physician and describes the occurrence of RASH (skin breakout) and VACCINATION SITE PAIN (pain during injection) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In February 2021, the patient experienced RASH (skin breakout). On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain during injection). On 09-Mar-2021, VACCINATION SITE PAIN (pain during injection) had resolved. At the time of the report, RASH (skin breakout) 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 and Treatment information were reported.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: still experiencing arm soreness; swollen; red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (still experiencing arm soreness), PERIPHERAL SWELLING (swollen) and ERYTHEMA (red) 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 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (still experiencing arm soreness), PERIPHERAL SWELLING (swollen) and ERYTHEMA (red). At the time of the report, PAIN IN EXTREMITY (still experiencing arm soreness), PERIPHERAL SWELLING (swollen) and ERYTHEMA (red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: feeling like she was about to break out in hives but she never did; itchy; feeling like she was about to break out in hives but she never did; itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (feeling like she was about to break out in hives but she never did; itchy) and PRURITUS (feeling like she was about to break out in hives but she never did; itchy) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced URTICARIA (feeling like she was about to break out in hives but she never did; itchy). On an unknown date, the patient experienced PRURITUS (feeling like she was about to break out in hives but she never did; itchy). On 16-Mar-2021, URTICARIA (feeling like she was about to break out in hives but she never did; itchy) outcome was unknown. At the time of the report, PRURITUS (feeling like she was about to break out in hives but she never did; itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus
Clinical narrative: mouth and face itching; face, body, finger and toes tingling; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS, ORAL PRURITUS, and PARAESTHESIA in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included MINERAL SUPPLEMENTS and MULTIVITAMIN for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PARAESTHESIA. On an unknown date, the patient experienced PRURITUS, and ORAL PRURITUS. At the time of the report, PRURITUS and PARAESTHESIA outcome was unknown. Not Provided.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown. Treatment details include Benadryl.
Age: 49.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site pain, Rash
Clinical narrative: injection site pain; Skin Breakout; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE PAIN (injection site pain) and RASH (Skin Breakout) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   In November 2008, the patient received dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. In February 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Skin Breakout). On 09-Mar-2021, the patient experienced INJECTION SITE PAIN (injection site pain). On 09-Mar-2021, INJECTION SITE PAIN (injection site pain) had resolved. At the time of the report, RASH (Skin Breakout) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up information was received and contain no new information.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Peripheral swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of myalgia (still experiencing arm soreness), peripheral swelling (swollen) and erythema (red) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse event. On Apr 2, 2021, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 2, 2021, patient experienced myalgia (still experiencing arm soreness), peripheral swelling (swollen) and erythema (red). At the time of the report, myalgia (still experiencing arm soreness), peripheral swelling (swollen) and erythema (red) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Soreness of arm; Sick; Sore throat was worst; Super fatigue; Dizziness; Diarrhea; Cough; Severe muscle pain; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm), ILLNESS (Sick), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and COUGH (Cough) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety and Acid reflux (esophageal). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), SERTRALINE for Anxiety.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), COUGH (Cough), MYALGIA (Severe muscle pain) and ASTHENIA (Weakness). On 04-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat was worst) and FATIGUE (Super fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness of arm) and ILLNESS (Sick). At the time of the report, PAIN IN EXTREMITY (Soreness of arm), ILLNESS (Sick), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), COUGH (Cough), ASTHENIA (Weakness), OROPHARYNGEAL PAIN (Sore throat was worst) and FATIGUE (Super fatigue) had not resolved and MYALGIA (Severe muscle pain) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-067712 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067712:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Myalgia, Oropharyngeal pain, Pain in extremity
Clinical narrative: Soreness of arm; Sick; Sore throat was worst; Super fatigue; Dizziness; Diarrhea; Cough; Severe muscle pain; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm), ILLNESS (Sick), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and COUGH (Cough) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety and Acid reflux (esophageal). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), SERTRALINE for Anxiety.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), COUGH (Cough), MYALGIA (Severe muscle pain) and ASTHENIA (Weakness). On 04-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat was worst) and FATIGUE (Super fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness of arm) and ILLNESS (Sick). At the time of the report, PAIN IN EXTREMITY (Soreness of arm), ILLNESS (Sick), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), COUGH (Cough), ASTHENIA (Weakness), OROPHARYNGEAL PAIN (Sore throat was worst) and FATIGUE (Super fatigue) had not resolved and MYALGIA (Severe muscle pain) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-067712 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067712:
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: ever since the 1st dose, he has had diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (ever since the 1st dose, he has had diarrhea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced DIARRHOEA (ever since the 1st dose, he has had diarrhea). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIARRHOEA (ever since the 1st dose, he has had diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: infection; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (infection) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient tested positive for COVID-19 in Oct2020).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFECTION (infection). The patient was treated with AMOXICILLIN TRIHYDRATE (AMOXIL 12 H) at an unspecified dose and frequency. At the time of the report, INFECTION (infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Body temperature, Chills, Fatigue
Clinical narrative: Has not received the second dose  (60 days after the First Shot); Episodes of Weakness  4 to 5 times daily after first vaccine; Low Blood Pressure  50/39 mmHg and 60/140 mmHg  4 to 5 times a day after the first vaccine; Chills; Headache; Fatigue; Fever of 99.9; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Episodes of Weakness  4 to 5 times daily after first vaccine), HYPOTENSION (Low Blood Pressure  50/39 mmHg and 60/140 mmHg  4 to 5 times a day after the first vaccine), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Learning disability. Concomitant products included GABAPENTIN, BROMAZEPAM (LECTOPAM) and BUSPIRONE 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 01-Apr-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever of 99.9) and NAUSEA (Nausea). On 02-Apr-2021, the patient experienced ASTHENIA (Episodes of Weakness  4 to 5 times daily after first vaccine) and HYPOTENSION (Low Blood Pressure  50/39 mmHg and 60/140 mmHg  4 to 5 times a day after the first vaccine). On 30-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the second dose  (60 days after the First Shot)). On 16-Jun-2021, ASTHENIA (Episodes of Weakness  4 to 5 times daily after last vaccine) had resolved. At the time of the report, HYPOTENSION (Low Blood Pressure  50/39 mmHg and 60/140 mmHg  4 to 5 times a day after the first vaccine) and PRODUCT DOSE OMISSION ISSUE (Has not received the second dose  (60 days after the First Shot)) had resolved and CHILLS (Chills), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever of 99.9) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 50/39 (Low) low and 60/140 (Low) low. On an unknown date, Body temperature: 99.9 (High) high.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Treatment details not reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Updated contact details, patient demographics,events and event outcome.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypotension, Nausea, Product dose omission issue, Pyrexia
Clinical narrative: Has not received the second dose  (60 days after the First Shot); Episodes of Weakness  4 to 5 times daily after first vaccine; Low Blood Pressure  50/39 mmHg and 60/140 mmHg  4 to 5 times a day after the first vaccine; Chills; Headache; Fatigue; Fever of 99.9; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Episodes of Weakness  4 to 5 times daily after first vaccine), HYPOTENSION (Low Blood Pressure  50/39 mmHg and 60/140 mmHg  4 to 5 times a day after the first vaccine), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Learning disability. Concomitant products included GABAPENTIN, BROMAZEPAM (LECTOPAM) and BUSPIRONE 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 01-Apr-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever of 99.9) and NAUSEA (Nausea). On 02-Apr-2021, the patient experienced ASTHENIA (Episodes of Weakness  4 to 5 times daily after first vaccine) and HYPOTENSION (Low Blood Pressure  50/39 mmHg and 60/140 mmHg  4 to 5 times a day after the first vaccine). On 30-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the second dose  (60 days after the First Shot)). On 16-Jun-2021, ASTHENIA (Episodes of Weakness  4 to 5 times daily after last vaccine) had resolved. At the time of the report, HYPOTENSION (Low Blood Pressure  50/39 mmHg and 60/140 mmHg  4 to 5 times a day after the first vaccine) and PRODUCT DOSE OMISSION ISSUE (Has not received the second dose  (60 days after the First Shot)) had resolved and CHILLS (Chills), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever of 99.9) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 50/39 (Low) low and 60/140 (Low) low. On an unknown date, Body temperature: 99.9 (High) high.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Treatment details not reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Updated contact details, patient demographics,events and event outcome.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: She experienced hives on both legs,,face,Lips,all over her body; Itchiness on both legs.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (She experienced hives on both legs,,face,Lips,all over her body) and PRURITUS (Itchiness on both legs.) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced URTICARIA (She experienced hives on both legs,,face,Lips,all over her body) and PRURITUS (Itchiness on both legs.). The patient was treated with PREDNISOLONE ongoing since an unknown date for Hives, at an unspecified dose and frequency; FAMOTIDINE (PEPCID AC) ongoing since an unknown date for Hives, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) ongoing since an unknown date for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (She experienced hives on both legs,,face,Lips,all over her body) and PRURITUS (Itchiness on both legs.) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment of the events included, prednisone, famotidine and diphenhydramine. On 01 Apr 2021, patient went to emergency room.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous retrospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 07-Mar-2021. On 07-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The delivery occurred, which was reported as Full-term. For neonate 1, The outcome was reported as Term Birth NOS. On 07-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.            Concomitant and treatment medications were not reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Eating disorder, Myalgia, Vomiting
Clinical narrative: she could not do anything, she could not eat anything; diarrhea; she got it at 1PM and 1AM she woke up aching from head to toe with all of her joints hurting/The joint pain was in her elbows, wrists, knees, ankles; vomiting; The joint pain was in her elbows, wrists, knees, ankles; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (she got it at 1PM and 1AM she woke up aching from head to toe with all of her joints hurting/The joint pain was in her elbows, wrists, knees, ankles), EATING DISORDER (she could not do anything, she could not eat anything), VOMITING (vomiting), DIARRHOEA (diarrhea) and ARTHRALGIA (The joint pain was in her elbows, wrists, knees, ankles) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 05-Mar-2021, the patient experienced MYALGIA (she got it at 1PM and 1AM she woke up aching from head to toe with all of her joints hurting/The joint pain was in her elbows, wrists, knees, ankles), EATING DISORDER (she could not do anything, she could not eat anything), VOMITING (vomiting), DIARRHOEA (diarrhea) and ARTHRALGIA (The joint pain was in her elbows, wrists, knees, ankles). At the time of the report, MYALGIA (she got it at 1PM and 1AM she woke up aching from head to toe with all of her joints hurting/The joint pain was in her elbows, wrists, knees, ankles), EATING DISORDER (she could not do anything, she could not eat anything), VOMITING (vomiting), DIARRHOEA (diarrhea) and ARTHRALGIA (The joint pain was in her elbows, wrists, knees, ankles) had not resolved.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Swelling, Vaccination site rash
Clinical narrative: Redness in his arm; swelling  in his arm; rash the size of a ball around the injection site/ rash was not raised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash the size of a ball around the injection site/ rash was not raised) and SWELLING (swelling and redness in his arm) in a 59-year-old male patient 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 03-Apr-2021, the patient experienced VACCINATION SITE RASH (rash the size of a ball around the injection site/ rash was not raised) and SWELLING (swelling and redness in his arm). At the time of the report, VACCINATION SITE RASH (rash the size of a ball around the injection site/ rash was not raised) and SWELLING (swelling and redness in his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in his arm), SWELLING (swelling  in his arm) and VACCINATION SITE RASH (rash the size of a ball around the injection site/ rash was not raised) in a 59-year-old male patient 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 03-Apr-2021, the patient experienced ERYTHEMA (Redness in his arm), SWELLING (swelling  in his arm) and VACCINATION SITE RASH (rash the size of a ball around the injection site/ rash was not raised). At the time of the report, ERYTHEMA (Redness in his arm), SWELLING (swelling  in his arm) and VACCINATION SITE RASH (rash the size of a ball around the injection site/ rash was not raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       concominant and treatment medication were not provided
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: injection site warm to touch; injection site itchy; injection site red; injection site sore to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site red), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE WARMTH (injection site warm to touch) and VACCINATION SITE PAIN (injection site sore to touch) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site red), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE WARMTH (injection site warm to touch) and VACCINATION SITE PAIN (injection site sore to touch). On 05-Apr-2021, VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE WARMTH (injection site warm to touch) and VACCINATION SITE PAIN (injection site sore to touch) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (injection site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The treatment information was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Off label use, Vaccination site pain
Clinical narrative: sore arm at injection site; headache; got the second vaccine 9 weeks later; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (got the second vaccine 9 weeks later), VACCINATION SITE PAIN (sore arm at injection site) and HEADACHE (headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028A21A) for an unknown indication.     Concurrent medical conditions included COVID-19 on 30-Jan-2021.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced OFF LABEL USE (got the second vaccine 9 weeks later). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm at injection site) and HEADACHE (headache). At the time of the report, OFF LABEL USE (got the second vaccine 9 weeks later) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, COVID-19 (positive-positive positive): positive Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   NO CONCOMITANT AND MEDICATION DRUGS WERE USED   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Sore arm, HA post second dose
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Muscle pain; Joint pain; Headache; Fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache) and FATIGUE (Fatigue) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included HIV disease (positive) since an unknown date. Concomitant products included TRIMETAZIDINE HYDROCHLORIDE (TRIMET [TRIMETAZIDINE HYDROCHLORIDE]), VALACYCLOVIR [VALACICLOVIR], HYOSCYAMINE and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue). On an unknown date, the patient experienced MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication taken for the reported events is Advil.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: mild pain at site of injection; intense headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (intense headache) and VACCINATION SITE PAIN (mild pain at site of injection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced HEADACHE (intense headache). On 04-Apr-2021, the patient experienced VACCINATION SITE PAIN (mild pain at site of injection). At the time of the report, HEADACHE (intense headache) and VACCINATION SITE PAIN (mild pain at site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever) and COVID-19 (Tested positive for COVID 19) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for an unknown indication.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID 19). On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) and COVID-19 (Tested positive for COVID 19) 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.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Vaccination site reaction
Clinical narrative: Ended up getting really sick like they had the flu; Bad ,Stronger reaction; 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 ILLNESS (Ended up getting really sick like they had the flu), VACCINATION SITE REACTION (Bad reaction) and INJECTION SITE REACTION (Stronger reaction) 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 No adverse event.    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 ILLNESS (Ended up getting really sick like they had the flu), VACCINATION SITE REACTION (Bad reaction) and INJECTION SITE REACTION (Stronger reaction). At the time of the report, ILLNESS (Ended up getting really sick like they had the flu), VACCINATION SITE REACTION (Bad reaction) and INJECTION SITE REACTION (Stronger reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Swelling
Clinical narrative: Severe pain in the arm; Swollen arm, shoulder and breastbone; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), SWELLING (Swollen arm, shoulder and breastbone) and PAIN IN EXTREMITY (Severe pain in the arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Lisinopril                                                     High blood pressure medication for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced MYALGIA (Muscle pain). On 22-Mar-2021, the patient experienced SWELLING (Swollen arm, shoulder and breastbone) and PAIN IN EXTREMITY (Severe pain in the arm). At the time of the report, MYALGIA (Muscle pain) and PAIN IN EXTREMITY (Severe pain in the arm) 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: flu like symptoms; body ache; nausea; fatigue; head ache; high fever of 103 to 104 Degrees Farenheight; This spontaneous case was reported by a physician and describes the occurrence of NAUSEA (nausea), INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (fatigue), PAIN (body ache) and HEADACHE (head ache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced NAUSEA (nausea), INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (fatigue), PAIN (body ache), HEADACHE (head ache) and PYREXIA (high fever of 103 to 104 Degrees Farenheight). On 20-Mar-2021, NAUSEA (nausea), INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (fatigue), PAIN (body ache), HEADACHE (head ache) and PYREXIA (high fever of 103 to 104 Degrees Farenheight) had 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.