chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Feeling abnormal, Headache, Lethargy
Clinical narrative: fever; headache; felt awful; was not hungry; lethargic; didn't feel very wel; achy,sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (didn't feel very wel), MYALGIA (achy,sore arm), PYREXIA (fever), LETHARGY (lethargic) and HEADACHE (headache) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Allergy to AMOX), Allergy to antibiotic (Allergy to Cephalosporins.), Food allergy (Food Allergy) and Allergy to antibiotic (Allergy to Sulfanate).    On 05-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 MALAISE (didn't feel very wel), MYALGIA (achy,sore arm), PYREXIA (fever), LETHARGY (lethargic), HEADACHE (headache), FEELING ABNORMAL (felt awful) and DECREASED APPETITE (was not hungry). At the time of the report, MALAISE (didn't feel very wel), MYALGIA (achy,sore arm), PYREXIA (fever), LETHARGY (lethargic), HEADACHE (headache), FEELING ABNORMAL (felt awful) and DECREASED APPETITE (was not hungry) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (normal) not more than 100.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Updated Patient Demographics, Medical History, Dose details,. Added new events Head ache, lethargy.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: fever; headache; felt awful; was not hungry; lethargic; didn't feel very wel; achy,sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (didn't feel very wel), MYALGIA (achy,sore arm), PYREXIA (fever), LETHARGY (lethargic) and HEADACHE (headache) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Allergy to AMOX), Allergy to antibiotic (Allergy to Cephalosporins.), Food allergy (Food Allergy) and Allergy to antibiotic (Allergy to Sulfanate).    On 05-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 MALAISE (didn't feel very wel), MYALGIA (achy,sore arm), PYREXIA (fever), LETHARGY (lethargic), HEADACHE (headache), FEELING ABNORMAL (felt awful) and DECREASED APPETITE (was not hungry). At the time of the report, MALAISE (didn't feel very wel), MYALGIA (achy,sore arm), PYREXIA (fever), LETHARGY (lethargic), HEADACHE (headache), FEELING ABNORMAL (felt awful) and DECREASED APPETITE (was not hungry) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (normal) not more than 100.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Updated Patient Demographics, Medical History, Dose details,. Added new events Head ache, lethargy.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypersomnia, Myalgia, Vaccination complication
Clinical narrative: Slept for 4 days; Threw up ( projectile threw up); Sitting in one spot and it just came out; Chills; Body ache; Severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept for 4 days), VOMITING PROJECTILE (Threw up ( projectile threw up)), VACCINATION COMPLICATION (Sitting in one spot and it just came out), CHILLS (Chills) and MYALGIA (Body ache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced HYPERSOMNIA (Slept for 4 days), VOMITING PROJECTILE (Threw up ( projectile threw up)), VACCINATION COMPLICATION (Sitting in one spot and it just came out), CHILLS (Chills), MYALGIA (Body ache) and HEADACHE (Severe headaches). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, HYPERSOMNIA (Slept for 4 days), VOMITING PROJECTILE (Threw up ( projectile threw up)), VACCINATION COMPLICATION (Sitting in one spot and it just came out), CHILLS (Chills), MYALGIA (Body ache) and HEADACHE (Severe headaches) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No concomitant drug information was reported.   This case was linked to MOD-2021-019027 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Patient is feeling fine now and does not wish to follow up further
Sex: F
Vaccine: COVID19
Symptoms: Vomiting projectile
Clinical narrative: Slept for 4 days; Threw up ( projectile threw up); Sitting in one spot and it just came out; Chills; Body ache; Severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept for 4 days), VOMITING PROJECTILE (Threw up ( projectile threw up)), VACCINATION COMPLICATION (Sitting in one spot and it just came out), CHILLS (Chills) and MYALGIA (Body ache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced HYPERSOMNIA (Slept for 4 days), VOMITING PROJECTILE (Threw up ( projectile threw up)), VACCINATION COMPLICATION (Sitting in one spot and it just came out), CHILLS (Chills), MYALGIA (Body ache) and HEADACHE (Severe headaches). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, HYPERSOMNIA (Slept for 4 days), VOMITING PROJECTILE (Threw up ( projectile threw up)), VACCINATION COMPLICATION (Sitting in one spot and it just came out), CHILLS (Chills), MYALGIA (Body ache) and HEADACHE (Severe headaches) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No concomitant drug information was reported.   This case was linked to MOD-2021-019027 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Patient is feeling fine now and does not wish to follow up further
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swelling in the left collar bone lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling in the left collar bone lymph nodes) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 LYMPHADENOPATHY (swelling in the left collar bone lymph nodes). At the time of the report, LYMPHADENOPATHY (swelling in the left collar bone lymph nodes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: first dose of Moderna vaccine at age of 17 years, 4 months; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose of Moderna vaccine at age of 17 years, 4 months) in a 17-year-old female patient 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) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose of Moderna vaccine at age of 17 years, 4 months). On 02-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose of Moderna vaccine at age of 17 years, 4 months) 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.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Migraine, Ocular hyperaemia, Pain
Clinical narrative: Eye blood vessel been shot/Red eye; tired; migraine; sharp pain; fever; stabbing pain on the left side of her skull; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (stabbing pain on the left side of her skull), FATIGUE (tired), MIGRAINE (migraine) and PAIN (sharp pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced PYREXIA (fever), HEADACHE (stabbing pain on the left side of her skull) and PAIN (sharp pain). On 01-Apr-2021, the patient experienced FATIGUE (tired) and MIGRAINE (migraine). On 25-Apr-2021, the patient experienced OCULAR HYPERAEMIA (Eye blood vessel been shot/Red eye). On 01-Apr-2021, PYREXIA (fever), HEADACHE (stabbing pain on the left side of her skull) and PAIN (sharp pain) had resolved. At the time of the report, FATIGUE (tired), MIGRAINE (migraine) and OCULAR HYPERAEMIA (Eye blood vessel been shot/Red eye) outcome was unknown.            Concomitant medication history not provided.Treatment information provided by reporter included Tylenol.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Eye blood vessel been shot/Red eye; tired; migraine; sharp pain; fever; stabbing pain on the left side of her skull; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (stabbing pain on the left side of her skull), FATIGUE (tired), MIGRAINE (migraine) and PAIN (sharp pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced PYREXIA (fever), HEADACHE (stabbing pain on the left side of her skull) and PAIN (sharp pain). On 01-Apr-2021, the patient experienced FATIGUE (tired) and MIGRAINE (migraine). On 25-Apr-2021, the patient experienced OCULAR HYPERAEMIA (Eye blood vessel been shot/Red eye). On 01-Apr-2021, PYREXIA (fever), HEADACHE (stabbing pain on the left side of her skull) and PAIN (sharp pain) had resolved. At the time of the report, FATIGUE (tired), MIGRAINE (migraine) and OCULAR HYPERAEMIA (Eye blood vessel been shot/Red eye) outcome was unknown.            Concomitant medication history not provided.Treatment information provided by reporter included Tylenol.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Coughing become worst again; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing become worst again) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypersensitivity and Hay fever. Previously administered products included for Product used for unknown indication: Erythromycin (Erythromycin- Hives) in 1976 and Zanaflex (Erythromycin- Hives) in February 2021. Past adverse reactions to the above products included Hives with Erythromycin; and Passed out with Zanaflex. Concurrent medical conditions included Drug allergy (ZANAFLEX and Erythromycin), Clot blood since 06-Dec-2006, Cardiovascular disorder since December 2006 and High cholesterol since 1991. Concomitant products included METOPROLOL, HYDROCHLOROTHIAZIDE and DOXAZOSIN for Blood pressure management, APIXABAN (ELIQUIS) for Clot blood, ATORVASTATIN for High cholesterol.   On 03-Mar-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021 at 9:00 AM, 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 COUGH (Coughing become worst again). The patient was treated with AZITHROMYCIN at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, COUGH (Coughing become worst again) had not resolved.            Treatment details included Cough medicine.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-091736 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Events out come updated, medical history updated and concomitant drugs reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chills, Headache, Malaise
Clinical narrative: chills; temperature of 99F; headache; stomach ache; left shoulder pain; not feeling well after the 1st dose of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (temperature of 99F), HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache) and ARTHRALGIA (left shoulder pain) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (allergic to Benadryl.).    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 CHILLS (chills), PYREXIA (temperature of 99F), HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache), ARTHRALGIA (left shoulder pain) and MALAISE (not feeling well after the 1st dose of Moderna vaccine). At the time of the report, CHILLS (chills), PYREXIA (temperature of 99F), HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache), ARTHRALGIA (left shoulder pain) and MALAISE (not feeling well after the 1st dose of Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: New event was updated  not feeling well after the 1st dose of Moderna vaccine.allergic to Benadryl
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; temperature of 99F; headache; stomach ache; left shoulder pain; not feeling well after the 1st dose of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (temperature of 99F), HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache) and ARTHRALGIA (left shoulder pain) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (allergic to Benadryl.).    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 CHILLS (chills), PYREXIA (temperature of 99F), HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache), ARTHRALGIA (left shoulder pain) and MALAISE (not feeling well after the 1st dose of Moderna vaccine). At the time of the report, CHILLS (chills), PYREXIA (temperature of 99F), HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache), ARTHRALGIA (left shoulder pain) and MALAISE (not feeling well after the 1st dose of Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: New event was updated  not feeling well after the 1st dose of Moderna vaccine.allergic to Benadryl
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Off label use
Clinical narrative: Off label use; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OFF LABEL USE (Off label use) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included CLL.   On 13-Jan-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced OFF LABEL USE (Off label use). On 08-Apr-2021, OFF LABEL USE (Off label use) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow up  received on 31 may 2021 included no new information On 20-Jul-2021: Follow-up information received on 20-Jul-2021 contains no new  information.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Illness, Lymphoedema, Pruritus
Clinical narrative: her arm is hard & swollen; experiencing severe itching; burning itch; feeling abnormal; couldn't cook food; had to lay down; at the injection site it was reddish-pinkish that is now moving down the arm; arm feels likes extremely hot like its feverish; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (her arm is hard & swollen), PRURITUS (experiencing severe itching), PRURITUS (burning itch), FEELING ABNORMAL (feeling abnormal) and ILLNESS (couldn't cook food) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042152A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced LYMPHOEDEMA (her arm is hard & swollen), PRURITUS (experiencing severe itching), PRURITUS (burning itch), FEELING ABNORMAL (feeling abnormal), ILLNESS (couldn't cook food), ASTHENIA (had to lay down), VACCINATION SITE ERYTHEMA (at the injection site it was reddish-pinkish that is now moving down the arm) and PYREXIA (arm feels likes extremely hot like its feverish). At the time of the report, LYMPHOEDEMA (her arm is hard & swollen), PRURITUS (experiencing severe itching), PRURITUS (burning itch), FEELING ABNORMAL (feeling abnormal), ILLNESS (couldn't cook food), ASTHENIA (had to lay down), VACCINATION SITE ERYTHEMA (at the injection site it was reddish-pinkish that is now moving down the arm) and PYREXIA (arm feels likes extremely hot like its feverish) outcome was unknown.            Concomitant product use include hydrocodeine for pain, blood pressure.   This case was linked to US-MODERNATX, INC.-MOD-2021-092231, US-MODERNATX, INC.-MOD-2021-092438 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092231:case for son US-MODERNATX, INC.-MOD-2021-092438:case for daughter
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema
Clinical narrative: her arm is hard & swollen; experiencing severe itching; burning itch; feeling abnormal; couldn't cook food; had to lay down; at the injection site it was reddish-pinkish that is now moving down the arm; arm feels likes extremely hot like its feverish; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (her arm is hard & swollen), PRURITUS (experiencing severe itching), PRURITUS (burning itch), FEELING ABNORMAL (feeling abnormal) and ILLNESS (couldn't cook food) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042152A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced LYMPHOEDEMA (her arm is hard & swollen), PRURITUS (experiencing severe itching), PRURITUS (burning itch), FEELING ABNORMAL (feeling abnormal), ILLNESS (couldn't cook food), ASTHENIA (had to lay down), VACCINATION SITE ERYTHEMA (at the injection site it was reddish-pinkish that is now moving down the arm) and PYREXIA (arm feels likes extremely hot like its feverish). At the time of the report, LYMPHOEDEMA (her arm is hard & swollen), PRURITUS (experiencing severe itching), PRURITUS (burning itch), FEELING ABNORMAL (feeling abnormal), ILLNESS (couldn't cook food), ASTHENIA (had to lay down), VACCINATION SITE ERYTHEMA (at the injection site it was reddish-pinkish that is now moving down the arm) and PYREXIA (arm feels likes extremely hot like its feverish) outcome was unknown.            Concomitant product use include hydrocodeine for pain, blood pressure.   This case was linked to US-MODERNATX, INC.-MOD-2021-092231, US-MODERNATX, INC.-MOD-2021-092438 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092231:case for son US-MODERNATX, INC.-MOD-2021-092438:case for daughter
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills for 2 days; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills for 2 days) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced CHILLS (chills for 2 days). On 28-Mar-2021, CHILLS (chills for 2 days) had resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable.  No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-091749 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vitreous floaters
Clinical narrative: "floater showers" on both eye ,could read the 1st 3 letters of the word but not the last 2 letters; mild headache; tiredness; low back pain; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS ("floater showers" on both eye ,could read the 1st 3 letters of the word but not the last 2 letters), FATIGUE (tiredness), MYALGIA (low back pain) and HEADACHE (mild headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 044B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 18-Apr-2021, the patient experienced FATIGUE (tiredness) and MYALGIA (low back pain). On 27-Apr-2021, the patient experienced VITREOUS FLOATERS ("floater showers" on both eye ,could read the 1st 3 letters of the word but not the last 2 letters) and HEADACHE (mild headache). On 20-Apr-2021, FATIGUE (tiredness) and MYALGIA (low back pain) outcome was unknown. On 27-Apr-2021, VITREOUS FLOATERS ("floater showers" on both eye ,could read the 1st 3 letters of the word but not the last 2 letters) outcome was unknown. At the time of the report, HEADACHE (mild headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Chest pain, Dizziness, Headache
Clinical narrative: Chest pain; Terrible halal headache; Nausea; Dizziness; Belly pain; Postural hypotension; Persistent malaise; Feels weak; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL PAIN (Belly pain), CHEST PAIN (Chest pain), ORTHOSTATIC HYPOTENSION (Postural hypotension) and MALAISE (Persistent malaise) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.  Concomitant products included BENAZEPRIL for Renal impairment.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced DIZZINESS (Dizziness), ABDOMINAL PAIN (Belly pain), ORTHOSTATIC HYPOTENSION (Postural hypotension), MALAISE (Persistent malaise), ASTHENIA (Feels weak) and NAUSEA (Nausea). On 09-Apr-2021, the patient experienced HEADACHE (Terrible halal headache). On 14-Apr-2021, the patient experienced CHEST PAIN (Chest pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), ABDOMINAL PAIN (Belly pain), CHEST PAIN (Chest pain), ORTHOSTATIC HYPOTENSION (Postural hypotension), MALAISE (Persistent malaise), ASTHENIA (Feels weak), HEADACHE (Terrible halal headache) and NAUSEA (Nausea) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: No specific follow-up information recorded. On 04-Jun-2021: No specific follow-up information recorded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Orthostatic hypotension
Clinical narrative: Chest pain; Terrible halal headache; Nausea; Dizziness; Belly pain; Postural hypotension; Persistent malaise; Feels weak; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL PAIN (Belly pain), CHEST PAIN (Chest pain), ORTHOSTATIC HYPOTENSION (Postural hypotension) and MALAISE (Persistent malaise) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.  Concomitant products included BENAZEPRIL for Renal impairment.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced DIZZINESS (Dizziness), ABDOMINAL PAIN (Belly pain), ORTHOSTATIC HYPOTENSION (Postural hypotension), MALAISE (Persistent malaise), ASTHENIA (Feels weak) and NAUSEA (Nausea). On 09-Apr-2021, the patient experienced HEADACHE (Terrible halal headache). On 14-Apr-2021, the patient experienced CHEST PAIN (Chest pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), ABDOMINAL PAIN (Belly pain), CHEST PAIN (Chest pain), ORTHOSTATIC HYPOTENSION (Postural hypotension), MALAISE (Persistent malaise), ASTHENIA (Feels weak), HEADACHE (Terrible halal headache) and NAUSEA (Nausea) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: No specific follow-up information recorded. On 04-Jun-2021: No specific follow-up information recorded.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17YR old got the 1st shot; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17YR old got the 1st shot) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17YR old got the 1st shot). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17YR old got the 1st shot) 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.   No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Big lump on his left arm that looks like it was bitten by a big mosquito; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Big lump on his left arm that looks like it was bitten by a big mosquito) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PERIPHERAL SWELLING (Big lump on his left arm that looks like it was bitten by a big mosquito). On 27-May-2021, PERIPHERAL SWELLING (Big lump on his left arm that looks like it was bitten by a big mosquito) 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.   Concomitant product use was not provided by the reporter.  No treatment medication was provided.  The patient states that will inform his physician on 28-APR-2021 morning.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: TCR form
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Renal pain, SARS-CoV-2 test negative
Clinical narrative: kidney pain which has worsened; cough; tested negative for COVID; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (kidney pain which has worsened), COUGH (cough) and SARS-COV-2 TEST NEGATIVE (tested negative for COVID) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Kidney pain (kidney pain which has worsened from past 2 weeks.).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced RENAL PAIN (kidney pain which has worsened), COUGH (cough) and SARS-COV-2 TEST NEGATIVE (tested negative for COVID). At the time of the report, RENAL PAIN (kidney pain which has worsened), COUGH (cough) and SARS-COV-2 TEST NEGATIVE (tested negative for COVID) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: TCR added.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: sore arm; muscle aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches) and FATIGUE (fatigue) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches) and FATIGUE (fatigue). On 02-Apr-2021, PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information were provided.   This case was linked to MOD-2021-091831 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Diarrhoea, Eating disorder symptom, Heart rate, Hot flush
Clinical narrative: diarrhea; heat flashes; 7-8 blisters on the inside of his lower lip; sweats; was not eating; real bad body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), HOT FLUSH (heat flashes), LIP BLISTER (7-8 blisters on the inside of his lower lip), HYPERHIDROSIS (sweats) and EATING DISORDER SYMPTOM (was not eating) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 08B21AHAN) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Congestive heart failure in January 2020.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced DIARRHOEA (diarrhea), HOT FLUSH (heat flashes), LIP BLISTER (7-8 blisters on the inside of his lower lip), HYPERHIDROSIS (sweats), EATING DISORDER SYMPTOM (was not eating) and MYALGIA (real bad body aches). At the time of the report, DIARRHOEA (diarrhea), HOT FLUSH (heat flashes), LIP BLISTER (7-8 blisters on the inside of his lower lip), HYPERHIDROSIS (sweats), EATING DISORDER SYMPTOM (was not eating) and MYALGIA (real bad body aches) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Blood pressure measurement: 160/128 mmHg (High) Blood Pressure increased. On 23-Apr-2021, Heart rate: 77 (normal) 77 per minute. On 23-Apr-2021, Oxygen saturation: 97 (normal) 97 Percent.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.  No relevant concomitant medications were reported.   Treatment medication include rinse his mouth with warm water and salt .   This case was linked to US-MODERNATX, INC.-MOD-2021-092048 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Outcome of the events was updated from Unknown to Recovered.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092048:Crosse linked
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lip blister, Myalgia, Oxygen saturation
Clinical narrative: diarrhea; heat flashes; 7-8 blisters on the inside of his lower lip; sweats; was not eating; real bad body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), HOT FLUSH (heat flashes), LIP BLISTER (7-8 blisters on the inside of his lower lip), HYPERHIDROSIS (sweats) and EATING DISORDER SYMPTOM (was not eating) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 08B21AHAN) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Congestive heart failure in January 2020.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced DIARRHOEA (diarrhea), HOT FLUSH (heat flashes), LIP BLISTER (7-8 blisters on the inside of his lower lip), HYPERHIDROSIS (sweats), EATING DISORDER SYMPTOM (was not eating) and MYALGIA (real bad body aches). At the time of the report, DIARRHOEA (diarrhea), HOT FLUSH (heat flashes), LIP BLISTER (7-8 blisters on the inside of his lower lip), HYPERHIDROSIS (sweats), EATING DISORDER SYMPTOM (was not eating) and MYALGIA (real bad body aches) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Blood pressure measurement: 160/128 mmHg (High) Blood Pressure increased. On 23-Apr-2021, Heart rate: 77 (normal) 77 per minute. On 23-Apr-2021, Oxygen saturation: 97 (normal) 97 Percent.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.  No relevant concomitant medications were reported.   Treatment medication include rinse his mouth with warm water and salt .   This case was linked to US-MODERNATX, INC.-MOD-2021-092048 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Outcome of the events was updated from Unknown to Recovered.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092048:Crosse linked
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Terrible sore arm for two weeks; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Terrible sore arm for two weeks) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Terrible sore arm for two weeks). At the time of the report, PAIN IN EXTREMITY (Terrible sore arm for two weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Headache, Illness, Influenza like illness
Clinical narrative: sickness; Covered in hive like a lobster, face, throat; face, throat, tongue swelling; face, throat, tongue swelling; face, throat, tongue swelling; vomiting and diarrhea.....; vomiting; 104 temp; felt like she had the flu; body aches; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had the flu), ILLNESS (sickness), URTICARIA (Covered in hive like a lobster, face, throat), SWELLING FACE (face, throat, tongue swelling) and PHARYNGEAL SWELLING (face, throat, tongue swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu), MYALGIA (body aches) and HEADACHE (HEADACHE). On an unknown date, the patient experienced ILLNESS (sickness), URTICARIA (Covered in hive like a lobster, face, throat), SWELLING FACE (face, throat, tongue swelling), PHARYNGEAL SWELLING (face, throat, tongue swelling), SWOLLEN TONGUE (face, throat, tongue swelling), DIARRHOEA (vomiting and diarrhea.....), VOMITING (vomiting) and PYREXIA (104 temp). On 20-Mar-2021, INFLUENZA LIKE ILLNESS (felt like she had the flu), MYALGIA (body aches) and HEADACHE (HEADACHE) had resolved. At the time of the report, ILLNESS (sickness), URTICARIA (Covered in hive like a lobster, face, throat), SWELLING FACE (face, throat, tongue swelling), PHARYNGEAL SWELLING (face, throat, tongue swelling), SWOLLEN TONGUE (face, throat, tongue swelling), DIARRHOEA (vomiting and diarrhea...), VOMITING (vomiting) and PYREXIA (104 temp) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104 temp.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-091854, MOD-2021-092133 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow up was received on 28-May-2021 included additional events were updated.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pharyngeal swelling, Pyrexia, Swelling face, Swollen tongue
Clinical narrative: sickness; Covered in hive like a lobster, face, throat; face, throat, tongue swelling; face, throat, tongue swelling; face, throat, tongue swelling; vomiting and diarrhea.....; vomiting; 104 temp; felt like she had the flu; body aches; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had the flu), ILLNESS (sickness), URTICARIA (Covered in hive like a lobster, face, throat), SWELLING FACE (face, throat, tongue swelling) and PHARYNGEAL SWELLING (face, throat, tongue swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu), MYALGIA (body aches) and HEADACHE (HEADACHE). On an unknown date, the patient experienced ILLNESS (sickness), URTICARIA (Covered in hive like a lobster, face, throat), SWELLING FACE (face, throat, tongue swelling), PHARYNGEAL SWELLING (face, throat, tongue swelling), SWOLLEN TONGUE (face, throat, tongue swelling), DIARRHOEA (vomiting and diarrhea.....), VOMITING (vomiting) and PYREXIA (104 temp). On 20-Mar-2021, INFLUENZA LIKE ILLNESS (felt like she had the flu), MYALGIA (body aches) and HEADACHE (HEADACHE) had resolved. At the time of the report, ILLNESS (sickness), URTICARIA (Covered in hive like a lobster, face, throat), SWELLING FACE (face, throat, tongue swelling), PHARYNGEAL SWELLING (face, throat, tongue swelling), SWOLLEN TONGUE (face, throat, tongue swelling), DIARRHOEA (vomiting and diarrhea...), VOMITING (vomiting) and PYREXIA (104 temp) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104 temp.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-091854, MOD-2021-092133 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow up was received on 28-May-2021 included additional events were updated.