chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Irritability, Nuchal rigidity, Skin warm
Clinical narrative: redness on both sides of her neck; not that itchy but irritating; when touched, it is warm; feels rigid,like rough area on her neck; scattered little red bumps on her chest; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness on both sides of her neck), IRRITABILITY (not that itchy but irritating), SKIN WARM (when touched, it is warm), NUCHAL RIGIDITY (feels rigid,like rough area on her neck) and BLISTER (scattered little red bumps on her chest) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included FORMOTEROL FUMARATE (FORADIL) for an unknown indication.    On 20-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 ERYTHEMA (redness on both sides of her neck), IRRITABILITY (not that itchy but irritating), SKIN WARM (when touched, it is warm), NUCHAL RIGIDITY (feels rigid,like rough area on her neck) and BLISTER (scattered little red bumps on her chest). At the time of the report, ERYTHEMA (redness on both sides of her neck), IRRITABILITY (not that itchy but irritating), SKIN WARM (when touched, it is warm), NUCHAL RIGIDITY (feels rigid,like rough area on her neck) and BLISTER (scattered little red bumps on her chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Nausea, Pruritus
Clinical narrative: Itching of his left arm; Hypersensitivity reaction; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (Itching of his left arm), HYPERSENSITIVITY (Hypersensitivity reaction) and NAUSEA (Nausea) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PRURITUS (Itching of his left arm), HYPERSENSITIVITY (Hypersensitivity reaction) and NAUSEA (Nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) on 12-Apr-2021 at a dose of 25 mg po. At the time of the report, PRURITUS (Itching of his left arm), HYPERSENSITIVITY (Hypersensitivity reaction) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medication received was reported as Diphenhydramine (Benadryl)   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Reporter information, treatment medication updated.  Vaccination facility information and  event added
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anxiety, Diarrhoea, Epistaxis, Fatigue
Clinical narrative: anxiety; is making her eat a lot more; leg-cramps; itching on her heals; stomach cramps; excessive sweating; diarrhea; nosebleed; headache; very tired; couldn't even walk because she felt like her skin was about to break; water retention; arm got swollen; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), DIARRHOEA (diarrhea), FATIGUE (very tired), PRURITUS (itching on her heals) and ABDOMINAL PAIN UPPER (stomach cramps) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm got swollen). On 18-Apr-2021, the patient experienced HEADACHE (headache), FATIGUE (very tired), MOBILITY DECREASED (couldn't even walk because she felt like her skin was about to break) and FLUID RETENTION (water retention). On 19-Apr-2021, the patient experienced DIARRHOEA (diarrhea) and EPISTAXIS (nosebleed). On 21-Apr-2021, the patient experienced PRURITUS (itching on her heals), ABDOMINAL PAIN UPPER (stomach cramps), PAIN IN EXTREMITY (leg-cramps) and HYPERHIDROSIS (excessive sweating). On 22-Apr-2021, the patient experienced ANXIETY (anxiety) and INCREASED APPETITE (is making her eat a lot more). On 18-Apr-2021, HEADACHE (headache) and MOBILITY DECREASED (couldn't even walk because she felt like her skin was about to break) had resolved. On 19-Apr-2021, DIARRHOEA (diarrhea) and EPISTAXIS (nosebleed) had resolved. On 21-Apr-2021, PRURITUS (itching on her heals), ABDOMINAL PAIN UPPER (stomach cramps) and PAIN IN EXTREMITY (leg-cramps) outcome was unknown, HYPERHIDROSIS (excessive sweating) had resolved. At the time of the report, FATIGUE (very tired), ANXIETY (anxiety), FLUID RETENTION (water retention), PERIPHERAL SWELLING (arm got swollen) and INCREASED APPETITE (is making her eat a lot more) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fluid retention, Headache, Hyperhidrosis, Increased appetite, Mobility decreased
Clinical narrative: anxiety; is making her eat a lot more; leg-cramps; itching on her heals; stomach cramps; excessive sweating; diarrhea; nosebleed; headache; very tired; couldn't even walk because she felt like her skin was about to break; water retention; arm got swollen; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), DIARRHOEA (diarrhea), FATIGUE (very tired), PRURITUS (itching on her heals) and ABDOMINAL PAIN UPPER (stomach cramps) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm got swollen). On 18-Apr-2021, the patient experienced HEADACHE (headache), FATIGUE (very tired), MOBILITY DECREASED (couldn't even walk because she felt like her skin was about to break) and FLUID RETENTION (water retention). On 19-Apr-2021, the patient experienced DIARRHOEA (diarrhea) and EPISTAXIS (nosebleed). On 21-Apr-2021, the patient experienced PRURITUS (itching on her heals), ABDOMINAL PAIN UPPER (stomach cramps), PAIN IN EXTREMITY (leg-cramps) and HYPERHIDROSIS (excessive sweating). On 22-Apr-2021, the patient experienced ANXIETY (anxiety) and INCREASED APPETITE (is making her eat a lot more). On 18-Apr-2021, HEADACHE (headache) and MOBILITY DECREASED (couldn't even walk because she felt like her skin was about to break) had resolved. On 19-Apr-2021, DIARRHOEA (diarrhea) and EPISTAXIS (nosebleed) had resolved. On 21-Apr-2021, PRURITUS (itching on her heals), ABDOMINAL PAIN UPPER (stomach cramps) and PAIN IN EXTREMITY (leg-cramps) outcome was unknown, HYPERHIDROSIS (excessive sweating) had resolved. At the time of the report, FATIGUE (very tired), ANXIETY (anxiety), FLUID RETENTION (water retention), PERIPHERAL SWELLING (arm got swollen) and INCREASED APPETITE (is making her eat a lot more) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: anxiety; is making her eat a lot more; leg-cramps; itching on her heals; stomach cramps; excessive sweating; diarrhea; nosebleed; headache; very tired; couldn't even walk because she felt like her skin was about to break; water retention; arm got swollen; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), DIARRHOEA (diarrhea), FATIGUE (very tired), PRURITUS (itching on her heals) and ABDOMINAL PAIN UPPER (stomach cramps) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm got swollen). On 18-Apr-2021, the patient experienced HEADACHE (headache), FATIGUE (very tired), MOBILITY DECREASED (couldn't even walk because she felt like her skin was about to break) and FLUID RETENTION (water retention). On 19-Apr-2021, the patient experienced DIARRHOEA (diarrhea) and EPISTAXIS (nosebleed). On 21-Apr-2021, the patient experienced PRURITUS (itching on her heals), ABDOMINAL PAIN UPPER (stomach cramps), PAIN IN EXTREMITY (leg-cramps) and HYPERHIDROSIS (excessive sweating). On 22-Apr-2021, the patient experienced ANXIETY (anxiety) and INCREASED APPETITE (is making her eat a lot more). On 18-Apr-2021, HEADACHE (headache) and MOBILITY DECREASED (couldn't even walk because she felt like her skin was about to break) had resolved. On 19-Apr-2021, DIARRHOEA (diarrhea) and EPISTAXIS (nosebleed) had resolved. On 21-Apr-2021, PRURITUS (itching on her heals), ABDOMINAL PAIN UPPER (stomach cramps) and PAIN IN EXTREMITY (leg-cramps) outcome was unknown, HYPERHIDROSIS (excessive sweating) had resolved. At the time of the report, FATIGUE (very tired), ANXIETY (anxiety), FLUID RETENTION (water retention), PERIPHERAL SWELLING (arm got swollen) and INCREASED APPETITE (is making her eat a lot more) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Flu like symptoms; Body ache; Fever; Fatigue; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body ache), PYREXIA (Fever) and FATIGUE (Fatigue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to codeine.), Insomnia and Herpes infection. Concomitant products included VALACICLOVIR for Herpes infection, TRAZODONE for Insomnia.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body ache), PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 04-Feb-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body ache), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable.      Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: no new information
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: broke out with rash on both arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (broke out with rash on both arms) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043821A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 22-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (broke out with rash on both arms). At the time of the report, RASH (broke out with rash on both arms) had resolved. According to TCR dated 24-May-2021, She (Patient) reports rash resolved after a few days. She feels fine now.          The patient also states that she was on thyroid medication and quite a bit of medicine which she did not disclose. The treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: TCR: attached -Outcome of event was updated
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes near collar bone; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes near collar bone) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025821A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes near collar bone). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes near collar bone) outcome was unknown. Not Provided          No concomitant Medications were reported.  No treatment details were provided.  Patient reported that lymph nodes were not painful.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, CARVEDILOL, FENOFIBRATE (ADIPEX [FENOFIBRATE]), SIMVASTATIN, TADALAFIL (CIALIS), FUROSEMIDE, SPIRONOLACTONE, ASPIRIN [ACETYLSALICYLIC ACID], CODEINE PHOSPHATE, DIPHENHYDRAMINE HYDROCHLORIDE, EPHEDRINE HYDROCHLORIDE, PARACETAMOL (OVER NITE) and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Actinic keratosis, Myalgia
Clinical narrative: Mild sore arm; Patient with Chronic Actinic Ketosis Receive 2nd dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ACTINIC KERATOSIS (Patient with Chronic Actinic Ketosis Receive 2nd dose of Moderna COVID-19 vaccine) and MYALGIA (Mild sore arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 025520-2A) for COVID-19 vaccination.     Concurrent medical conditions included Actinic keratosis (Chronic Actinic Ketosis).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced ACTINIC KERATOSIS (Patient with Chronic Actinic Ketosis Receive 2nd dose of Moderna COVID-19 vaccine). On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Mild sore arm). At the time of the report, ACTINIC KERATOSIS (Patient with Chronic Actinic Ketosis Receive 2nd dose of Moderna COVID-19 vaccine) had resolved and MYALGIA (Mild sore arm) outcome was unknown.            Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-086721 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Actinic Keritosis event outcome was updated from unknown to recovered/resolved
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Pain in extremity, Ultrasound abdomen
Clinical narrative: sore arm; This spontaneous prospective pregnancy case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Asthma on 14-Nov-1990 and Hepatitis A on 31-Jul-2007. Concomitant products included FAMOTIDINE from 01-Jan-2021 to an unknown date for Heartburn, PRENATAL + DHA from 10-Feb-2020 to an unknown date.   On 14-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021 at 7:30 AM, 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 15-Sep-2020 and the estimated date of delivery was 22-Jun-2021. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2020, Glucose tolerance test: 28-mar-2021 passed 1 hour test.. On 11-Nov-2020, Ultrasound abdomen: 1-fetus and 17-dec-2020 placenta previa follow up schedule for 23-apr-2021.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   treatment to the events not reported.   This case was linked to MOD-2021-009033 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Patient has developed shingles 3 weeks ago even after receiving receiving shingles shot; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Patient has developed shingles 3 weeks ago even after receiving receiving shingles shot) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012O42A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRAVASTATIN and ALLOPURINOL for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced HERPES ZOSTER (Patient has developed shingles 3 weeks ago even after receiving receiving shingles shot). The patient was treated with GABAPENTIN at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Patient has developed shingles 3 weeks ago even after receiving receiving shingles shot) outcome was unknown.            Concomitant medications included BP medication. Treatment medications included steroid. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Vaccination site pain
Clinical narrative: Dizzy; Arm soreness; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (Dizzy) and VACCINATION SITE PAIN (Arm soreness) in a 63-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 Crohn's disease.    No Medical History information was reported.   On 06-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In March 2021, the patient experienced DIZZINESS (Dizzy) and VACCINATION SITE PAIN (Arm soreness). In March 2021, VACCINATION SITE PAIN (Arm soreness) had resolved. At the time of the report, DIZZINESS (Dizzy) had not 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.   The patient experienced the event dizzy two weeks after and arm soreness for several days after Moderna vaccine. No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments:  MOD-2021-086818:Case  MOD-2021-086996:Case  MOD-2021-087217:Case  MOD-2021-087097:Case  MOD-2021-085006:Case
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Pain
Clinical narrative: Pain at the injection site/ soreness; Doesn't go out of the bed; Pain all over the body; Extremely chills; Extremely fatigue; Intense headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Doesn't go out of the bed), PAIN (Pain all over the body), CHILLS (Extremely chills), FATIGUE (Extremely fatigue) and HEADACHE (Intense headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced FEELING ABNORMAL (Doesn't go out of the bed), PAIN (Pain all over the body), CHILLS (Extremely chills), FATIGUE (Extremely fatigue) and HEADACHE (Intense headache). On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at the injection site/ soreness). At the time of the report, FEELING ABNORMAL (Doesn't go out of the bed), PAIN (Pain all over the body), CHILLS (Extremely chills), FATIGUE (Extremely fatigue), HEADACHE (Intense headache) and VACCINATION SITE PAIN (Pain at the injection site/ soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site/ soreness; Doesn't go out of the bed; Pain all over the body; Extremely chills; Extremely fatigue; Intense headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Doesn't go out of the bed), PAIN (Pain all over the body), CHILLS (Extremely chills), FATIGUE (Extremely fatigue) and HEADACHE (Intense headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced FEELING ABNORMAL (Doesn't go out of the bed), PAIN (Pain all over the body), CHILLS (Extremely chills), FATIGUE (Extremely fatigue) and HEADACHE (Intense headache). On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at the injection site/ soreness). At the time of the report, FEELING ABNORMAL (Doesn't go out of the bed), PAIN (Pain all over the body), CHILLS (Extremely chills), FATIGUE (Extremely fatigue), HEADACHE (Intense headache) and VACCINATION SITE PAIN (Pain at the injection site/ soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Malaise, Nausea
Clinical narrative: Malaise; headache; flu-like; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like), MALAISE (Malaise), HEADACHE (headache), FATIGUE (fatigue) and NAUSEA (nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder NOS since 1974, Rheumatoid arthritis since 1974, Allergy to antibiotic (Ampecelin), Allergy to antibiotic (Bactrim), Allergy to antibiotic (clendomycin), Drug allergy (Isoniazid) and Drug allergy (indocin). Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), SIMVASTATIN and AMLODIPINE for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced FATIGUE (fatigue). On 01-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like). 01-Mar-2021, the patient experienced HEADACHE (headache) and NAUSEA (nausea). On an unknown date, the patient experienced MALAISE (Malaise). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like), HEADACHE (headache), FATIGUE (fatigue) and NAUSEA (nausea) had resolved and MALAISE (Malaise) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-027301 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Therapeutic response unexpected
Clinical narrative: Chronic Actinic Ketosis condition gone without treatment after administration of Moderna COVID-; Mild sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (Chronic Actinic Ketosis condition gone without treatment after administration of Moderna COVID-) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 025520-2A) for COVID-19 vaccination.     The patient's past medical history included Actinic keratosis.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Mild sore arm). On 22-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Chronic Actinic Ketosis condition gone without treatment after administration of Moderna COVID-). On 22-Apr-2021, THERAPEUTIC RESPONSE UNEXPECTED (Chronic Actinic Ketosis condition gone without treatment after administration of Moderna COVID-) had resolved. At the time of the report, PAIN IN EXTREMITY (Mild sore arm) outcome was unknown. Not Provided          No concomitant information was provided. No treatment information was provided. Action taken with vaccine was not applicable. Consent to follow up with safety was given.   This case was linked to MOD-2021-086684 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Followup email received on 24-05-2021 included No new significant information available.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Rhinorrhoea
Clinical narrative: Drippy nose; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Drippy nose) and HEADACHE (mild headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (windy weather allergy was reported).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced HEADACHE (mild headache). On 25-Apr-2021, the patient experienced RHINORRHOEA (Drippy nose). On 15-Apr-2021, HEADACHE (mild headache) outcome was unknown. At the time of the report, RHINORRHOEA (Drippy nose) outcome was unknown.            action taken with mRNA-1273 (COVID 19 Vaccine Moderna)(unknown), was unknown  for mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment. treatment medications were not reported no concomitant medications were reported   This case was linked to MOD21-066290, US-MODERNATX, INC.-MOD-2021-064059, MOD21-080635, MOD21-086138, MOD21-086170, US-MODERNATX, INC.-MOD-2021-103970 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: on 04 may 2021: event added, dosage form added, historical condition like allergy added.; Sender's Comments:  MOD21-066290: US-MODERNATX, INC.-MOD-2021-064059:Same reporter, Wife case MOD21-080635: MOD21-086138: MOD21-086170: US-MODERNATX, INC.-MOD-2021-103970:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: extremely tired, more than usual; soreness of the body; very little soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extremely tired, more than usual), MYALGIA (soreness of the body) and VACCINATION SITE PAIN (very little soreness in the arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]), PARACETAMOL (TYLENOL), CELECOXIB (CELEBREX), ACETYLSALICYLIC ACID (ECOTRIN) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 14-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 FATIGUE (extremely tired, more than usual), MYALGIA (soreness of the body) and VACCINATION SITE PAIN (very little soreness in the arm). At the time of the report, FATIGUE (extremely tired, more than usual), MYALGIA (soreness of the body) and VACCINATION SITE PAIN (very little soreness in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also included High blood pressure medication and Two different eyedrops for glaucoma. Treatment medications were not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: A little blister; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (A little blister) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced BLISTER (A little blister). At the time of the report, BLISTER (A little blister) had not resolved.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Injected limb mobility decreased, Insomnia, Neck pain
Clinical narrative: pain is in top of neck; pain is in top of her forearm over the shoulder blade (more in back than front) to top of neck and chest; unable to ambulate; Yesterday her arm bad she can hardly lift her arm; did not sleep very well last night; pain is over the shoulder blade (more in back than front); arm started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain is in top of neck), PAIN (pain is in top of her forearm over the shoulder blade (more in back than front) to top of neck and chest), GAIT INABILITY (unable to ambulate), INJECTED LIMB MOBILITY DECREASED (Yesterday her arm bad she can hardly lift her arm) and INSOMNIA (did not sleep very well last night) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm started to hurt). On 21-Apr-2021, the patient experienced NECK PAIN (pain is in top of neck), PAIN (pain is in top of her forearm over the shoulder blade (more in back than front) to top of neck and chest), GAIT INABILITY (unable to ambulate), INJECTED LIMB MOBILITY DECREASED (Yesterday her arm bad she can hardly lift her arm), INSOMNIA (did not sleep very well last night) and ARTHRALGIA (pain is over the shoulder blade (more in back than front)). On 21-Apr-2021, INSOMNIA (did not sleep very well last night) had resolved. At the time of the report, NECK PAIN (pain is in top of neck), PAIN (pain is in top of her forearm over the shoulder blade (more in back than front) to top of neck and chest), GAIT INABILITY (unable to ambulate), INJECTED LIMB MOBILITY DECREASED (Yesterday her arm bad she can hardly lift her arm), PAIN IN EXTREMITY (arm started to hurt) and ARTHRALGIA (pain is over the shoulder blade (more in back than front)) outcome was unknown.            No concomitant medication were reported.  No treatment information was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: pain is in top of neck; pain is in top of her forearm over the shoulder blade (more in back than front) to top of neck and chest; unable to ambulate; Yesterday her arm bad she can hardly lift her arm; did not sleep very well last night; pain is over the shoulder blade (more in back than front); arm started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain is in top of neck), PAIN (pain is in top of her forearm over the shoulder blade (more in back than front) to top of neck and chest), GAIT INABILITY (unable to ambulate), INJECTED LIMB MOBILITY DECREASED (Yesterday her arm bad she can hardly lift her arm) and INSOMNIA (did not sleep very well last night) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm started to hurt). On 21-Apr-2021, the patient experienced NECK PAIN (pain is in top of neck), PAIN (pain is in top of her forearm over the shoulder blade (more in back than front) to top of neck and chest), GAIT INABILITY (unable to ambulate), INJECTED LIMB MOBILITY DECREASED (Yesterday her arm bad she can hardly lift her arm), INSOMNIA (did not sleep very well last night) and ARTHRALGIA (pain is over the shoulder blade (more in back than front)). On 21-Apr-2021, INSOMNIA (did not sleep very well last night) had resolved. At the time of the report, NECK PAIN (pain is in top of neck), PAIN (pain is in top of her forearm over the shoulder blade (more in back than front) to top of neck and chest), GAIT INABILITY (unable to ambulate), INJECTED LIMB MOBILITY DECREASED (Yesterday her arm bad she can hardly lift her arm), PAIN IN EXTREMITY (arm started to hurt) and ARTHRALGIA (pain is over the shoulder blade (more in back than front)) outcome was unknown.            No concomitant medication were reported.  No treatment information was provided.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Energy increased, Feeling abnormal, Psychomotor hyperactivity
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of ANXIETY, FEELING ABNORMAL (feels like tickling inside), ENERGY INCREASED and PSYCHOMOTOR HYPERACTIVITY in a 37-year-old male patient who received mRNA-1273 (MODERNA COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Wolff-Parkinson-White syndrome. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced ANXIETY (feels anxious), FEELING ABNORMAL (feels like tickling inside), ENERGY INCREASED (feels energetic) and PSYCHOMOTOR HYPERACTIVITY. At the time of the report, ANXIETY (feels anxious), FEELING ABNORMAL (feels like tickling inside), ENERGY INCREASED (feels energetic) and PSYCHOMOTOR HYPERACTIVITY (feels hyperactive) outcome was unknown. Not Related      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.   Patient  was on the waiting list for a heart transplant. No  concomitant medications provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 031620A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.   This case was linked to MOD-2021-030908 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Vaccination site bruising, Vaccination site erythema, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (tightness of the muscle), VACCINATION SITE BRUISING (bruising on arm of the injection), VACCINATION SITE ERYTHEMA (injections is light reddish pink) and VACCINATION SITE SWELLING (arm of the injections swelling) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TIGHTNESS (tightness of the muscle), VACCINATION SITE BRUISING (bruising on arm of the injection), VACCINATION SITE ERYTHEMA (injections is light reddish pink) and VACCINATION SITE SWELLING (arm of the injections swelling). At the time of the report, MUSCLE TIGHTNESS (tightness of the muscle), VACCINATION SITE BRUISING (bruising on arm of the injection), VACCINATION SITE ERYTHEMA (injections is light reddish pink) and VACCINATION SITE SWELLING (arm of the injections swelling) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 019B21A) for COVID-19 vaccination. The patient's past medical history included COVID-19. Concomitant products included LORAZEPAM for an unknown indication. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. On 20-MAR-2021, Patient stated that she had less fatigue and things were getting better at the time of the report. Treatment details were not reported by the reporter. This case was linked to MOD-2021-086827.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031620A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            No concomitant medications was reported. No laboratory information was given. No treatment information was given.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Chills, Pharyngitis, Pyrexia, Tonsillitis
Clinical narrative: intermittent side effects; feverish; chilly; strep. throat; tonsils were inflamed; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (intermittent side effects), PHARYNGITIS (strep. throat), TONSILLITIS (tonsils were inflamed), PYREXIA (feverish) and CHILLS (chilly) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced PHARYNGITIS (strep. throat) and TONSILLITIS (tonsils were inflamed). On an unknown date, the patient experienced ADVERSE EVENT (intermittent side effects), PYREXIA (feverish) and CHILLS (chilly). At the time of the report, ADVERSE EVENT (intermittent side effects), PHARYNGITIS (strep. throat), TONSILLITIS (tonsils were inflamed), PYREXIA (feverish) and CHILLS (chilly) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided Treatment medication include ibuprofen and colloidal silver vitamin .
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: vaccine exposure during pregnancy; soreness in arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) and PAIN IN EXTREMITY (soreness in arm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 13-Oct-2020 and the estimated date of delivery was 21-Jul-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) and PAIN IN EXTREMITY (soreness in arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-third week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved and PAIN IN EXTREMITY (soreness in arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants were reported. No treatment was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-086821 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up received on 22-Apr-2021 contains pregnancy registry form.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086821:Case for dose 2
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills, same and all that stuff; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills, same and all that stuff) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills, same and all that stuff). At the time of the report, CHILLS (Chills, same and all that stuff) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu type reaction; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu type reaction) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu type reaction). At the time of the report, INFLUENZA LIKE ILLNESS (Flu type reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.