chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Mobility decreased, Myalgia, Nausea, Pyrexia
Clinical narrative: mightily, described as being sick / deathly ill since receiving the series; Both arms are described to be essentially useless due to the symptom; shakes; sweats; migraine headache; diarrhea; chills; fever / modest fever of 99.5 degrees; nausea; his right arm started hurting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (mightily, described as being sick / deathly ill since receiving the series), MOBILITY DECREASED (Both arms are described to be essentially useless due to the symptom), TREMOR (shakes), HYPERHIDROSIS (sweats) and MIGRAINE (migraine headache) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine headache.   On 11-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 ILLNESS (mightily, described as being sick / deathly ill since receiving the series), MOBILITY DECREASED (Both arms are described to be essentially useless due to the symptom), TREMOR (shakes), HYPERHIDROSIS (sweats), MIGRAINE (migraine headache), DIARRHEA (diarrhea), CHILLS (chills), PYREXIA (fever / modest fever of 99.5 degrees), NAUSEA (nausea) and MYALGIA (his right arm started hurting). At the time of the report, ILLNESS (mightily, described as being sick / deathly ill since receiving the series), MOBILITY DECREASED (Both arms are described to be essentially useless due to the symptom), TREMOR (shakes), HYPERHIDROSIS (sweats), MIGRAINE (migraine headache), DIARRHEA (diarrhea), CHILLS (chills), PYREXIA (fever / modest fever of 99.5 degrees), NAUSEA (nausea) and MYALGIA (his right arm started hurting) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5 (normal) 99.5.         Treatment He applied ice to his hurting arm and took Motrin after the first dose. No concomitant medication details was reported. No treatment medication details was reported.  Action taken with mRNA-1273 in response to the events was not applicable.     This case was linked to US-MODERNATX, INC.-MOD-2021-073635 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073635:1st dose case
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: mightily, described as being sick / deathly ill since receiving the series; Both arms are described to be essentially useless due to the symptom; shakes; sweats; migraine headache; diarrhea; chills; fever / modest fever of 99.5 degrees; nausea; his right arm started hurting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (mightily, described as being sick / deathly ill since receiving the series), MOBILITY DECREASED (Both arms are described to be essentially useless due to the symptom), TREMOR (shakes), HYPERHIDROSIS (sweats) and MIGRAINE (migraine headache) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine headache.   On 11-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 ILLNESS (mightily, described as being sick / deathly ill since receiving the series), MOBILITY DECREASED (Both arms are described to be essentially useless due to the symptom), TREMOR (shakes), HYPERHIDROSIS (sweats), MIGRAINE (migraine headache), DIARRHEA (diarrhea), CHILLS (chills), PYREXIA (fever / modest fever of 99.5 degrees), NAUSEA (nausea) and MYALGIA (his right arm started hurting). At the time of the report, ILLNESS (mightily, described as being sick / deathly ill since receiving the series), MOBILITY DECREASED (Both arms are described to be essentially useless due to the symptom), TREMOR (shakes), HYPERHIDROSIS (sweats), MIGRAINE (migraine headache), DIARRHEA (diarrhea), CHILLS (chills), PYREXIA (fever / modest fever of 99.5 degrees), NAUSEA (nausea) and MYALGIA (his right arm started hurting) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5 (normal) 99.5.         Treatment He applied ice to his hurting arm and took Motrin after the first dose. No concomitant medication details was reported. No treatment medication details was reported.  Action taken with mRNA-1273 in response to the events was not applicable.     This case was linked to US-MODERNATX, INC.-MOD-2021-073635 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073635:1st dose case
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Hot flush, Nausea, Vaccination complication
Clinical narrative: feeling sick; diarrhea; hot flash; itchy arm; nausea; vomiting; chills; red arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feeling sick), DIARRHOEA (diarrhea), HOT FLUSH (hot flash), VACCINATION SITE PRURITUS (itchy arm) and NAUSEA (nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018BZ1A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included DILTIAZEM, METOPROLOL, METFORMIN, SIMVASTATIN, DIGOXIN, FUROSEMIDE (LASIX [FUROSEMIDE]), MAGNESIUM and SITAGLIPTIN (JANUVIA [SITAGLIPTIN]) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION COMPLICATION (feeling sick), DIARRHOEA (diarrhea), HOT FLUSH (hot flash), VACCINATION SITE PRURITUS (itchy arm), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and VACCINATION SITE ERYTHEMA (red arm). At the time of the report, VACCINATION COMPLICATION (feeling sick), DIARRHOEA (diarrhea), HOT FLUSH (hot flash), VACCINATION SITE PRURITUS (itchy arm), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and VACCINATION SITE ERYTHEMA (red arm) was resolving. Not Provided          Treatment medication included Tylenol. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to US-MODERNATX, INC.-MOD-2021-073639 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073639:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vomiting
Clinical narrative: feeling sick; diarrhea; hot flash; itchy arm; nausea; vomiting; chills; red arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feeling sick), DIARRHOEA (diarrhea), HOT FLUSH (hot flash), VACCINATION SITE PRURITUS (itchy arm) and NAUSEA (nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018BZ1A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included DILTIAZEM, METOPROLOL, METFORMIN, SIMVASTATIN, DIGOXIN, FUROSEMIDE (LASIX [FUROSEMIDE]), MAGNESIUM and SITAGLIPTIN (JANUVIA [SITAGLIPTIN]) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION COMPLICATION (feeling sick), DIARRHOEA (diarrhea), HOT FLUSH (hot flash), VACCINATION SITE PRURITUS (itchy arm), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and VACCINATION SITE ERYTHEMA (red arm). At the time of the report, VACCINATION COMPLICATION (feeling sick), DIARRHOEA (diarrhea), HOT FLUSH (hot flash), VACCINATION SITE PRURITUS (itchy arm), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and VACCINATION SITE ERYTHEMA (red arm) was resolving. Not Provided          Treatment medication included Tylenol. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to US-MODERNATX, INC.-MOD-2021-073639 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073639:
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) 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 04-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. 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) (Unknown) was unknown.       No concomitant medication details was reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-073689 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073689:Daughter case
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Nausea, Neuralgia, Pain
Clinical narrative: very painful area that follows the nerve line from the centerline of the back to the right, over the upper part of the shoulder blade and today it started going down the fore arm; feeling bad; pain is severe; feel pretty awful; chills; nausea; This spontaneous case was reported by a physician and describes the occurrence of NEURALGIA (very painful area that follows the nerve line from the centerline of the back to the right, over the upper part of the shoulder blade and today it started going down the fore arm), FEELING ABNORMAL (feeling bad), PAIN (pain is severe), FEELING ABNORMAL (feel pretty awful) and CHILLS (chills) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Myofascial pain syndrome.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced NEURALGIA (very painful area that follows the nerve line from the centerline of the back to the right, over the upper part of the shoulder blade and today it started going down the fore arm), FEELING ABNORMAL (feeling bad), PAIN (pain is severe), FEELING ABNORMAL (feel pretty awful), CHILLS (chills) and NAUSEA (nausea). At the time of the report, NEURALGIA (very painful area that follows the nerve line from the centerline of the back to the right, over the upper part of the shoulder blade and today it started going down the fore arm), FEELING ABNORMAL (feeling bad), PAIN (pain is severe), FEELING ABNORMAL (feel pretty awful), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Pain, Pyrexia
Clinical narrative: stomach cramping; Diarrhea; body aches throughout body but especially her back; nausea; Fever; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramping), DIARRHOEA (Diarrhea), PAIN (body aches throughout body but especially her back), NAUSEA (nausea) and PYREXIA (Fever) in a 23-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.     Concomitant products included BIOTIN, VITAMINS NOS (MULTIVITAMINUM) and ORAL CONTRACEPTIVE NOS for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021 at 3:00 AM, the patient experienced ABDOMINAL PAIN UPPER (stomach cramping), DIARRHOEA (Diarrhea), PAIN (body aches throughout body but especially her back), NAUSEA (nausea), PYREXIA (Fever) and VOMITING (Vomiting). On 12-Apr-2021, PYREXIA (Fever) and VOMITING (Vomiting) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomach cramping), DIARRHOEA (Diarrhea), PAIN (body aches throughout body but especially her back) and NAUSEA (nausea) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included unspecified topical face medicine. No treatment medication details was reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: stomach cramping; Diarrhea; body aches throughout body but especially her back; nausea; Fever; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramping), DIARRHOEA (Diarrhea), PAIN (body aches throughout body but especially her back), NAUSEA (nausea) and PYREXIA (Fever) in a 23-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.     Concomitant products included BIOTIN, VITAMINS NOS (MULTIVITAMINUM) and ORAL CONTRACEPTIVE NOS for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021 at 3:00 AM, the patient experienced ABDOMINAL PAIN UPPER (stomach cramping), DIARRHOEA (Diarrhea), PAIN (body aches throughout body but especially her back), NAUSEA (nausea), PYREXIA (Fever) and VOMITING (Vomiting). On 12-Apr-2021, PYREXIA (Fever) and VOMITING (Vomiting) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomach cramping), DIARRHOEA (Diarrhea), PAIN (body aches throughout body but especially her back) and NAUSEA (nausea) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included unspecified topical face medicine. No treatment medication details was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Fatigue, Illness
Clinical narrative: Sick; weak; burning sensation all over the body; tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), BURNING SENSATION (burning sensation all over the body), FATIGUE (tired) and ILLNESS (Sick) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced ASTHENIA (weak), BURNING SENSATION (burning sensation all over the body) and FATIGUE (tired). On an unknown date, the patient experienced ILLNESS (Sick). At the time of the report, ASTHENIA (weak), BURNING SENSATION (burning sensation all over the body), FATIGUE (tired) and ILLNESS (Sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: things started to smell and taste different; sour and bitter; things started to smell and taste different; sour and bitter; things that smell distinctively different have the same chemical smell; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (things started to smell and taste different; sour and bitter), PAROSMIA (things started to smell and taste different; sour and bitter) and PAROSMIA (things that smell distinctively different have the same chemical smell) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M2A and 026A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event and COVID-19. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Seasonal allergy, MELATONIN, NAPROXEN and MINOXIDIL (ROGAINE) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced TASTE DISORDER (things started to smell and taste different; sour and bitter), PAROSMIA (things started to smell and taste different; sour and bitter) and PAROSMIA (things that smell distinctively different have the same chemical smell). At the time of the report, TASTE DISORDER (things started to smell and taste different; sour and bitter), PAROSMIA (things started to smell and taste different; sour and bitter) and PAROSMIA (things that smell distinctively different have the same chemical smell) outcome was unknown.            Concomitant medications reported include allergy injections.  Treatment information was not provided.    This case was linked to MOD-2021-073644 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Horrible headaches; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Horrible headaches) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced HEADACHE (Horrible headaches) and CHILLS (Chills). At the time of the report, HEADACHE (Horrible headaches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment Acetaminophen 500 mg twice; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia, Tremor
Clinical narrative: violently shaking; fever; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (violently shaking), PYREXIA (fever) and PAIN IN EXTREMITY (arm was sore) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 021B21A) for COVID-19 vaccination.     The patient's past medical history included Carotid artery disease. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), RIVAROXABAN (XARELTO), LABETALOL, ALPRAZOLAM and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021 at 4:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 09-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (violently shaking) and PYREXIA (fever). At the time of the report, TREMOR (violently shaking), PYREXIA (fever) and PAIN IN EXTREMITY (arm was sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: degree Celsius (High) 38 38.05 38.1 38.6.         Patient was having anxiety medications as concomitant medication. He took four Tylenol for the treatment in 24 hours.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Headache, Oropharyngeal pain
Clinical narrative: sore throat; waist pain; fever up to 101.4F; fatigue; started feeling bad; headache; pain in the arm of the injection and under her arm: ¨it was hard to raise my hand¨; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (started feeling bad), OROPHARYNGEAL PAIN (sore throat), PAIN (waist pain), HEADACHE (headache) and VACCINATION SITE PAIN (pain in the arm of the injection and under her arm: ¨it was hard to raise my hand¨) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid cancer. Concurrent medical conditions included Breast cyst. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced FEELING ABNORMAL (started feeling bad), HEADACHE (headache) and VACCINATION SITE PAIN (pain in the arm of the injection and under her arm: ¨it was hard to raise my hand¨). On 10-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), PAIN (waist pain), PYREXIA (fever up to 101.4F) and FATIGUE (fatigue). At the time of the report, FEELING ABNORMAL (started feeling bad), OROPHARYNGEAL PAIN (sore throat), PAIN (waist pain), HEADACHE (headache), VACCINATION SITE PAIN (pain in the arm of the injection and under her arm: ¨it was hard to raise my hand¨), PYREXIA (fever up to 101.4F) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Body temperature: 101.4 (High) Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Tylenol from 12-Apr-2021. Second dose is scheduled for 30-Apr-2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: sore throat; waist pain; fever up to 101.4F; fatigue; started feeling bad; headache; pain in the arm of the injection and under her arm: ¨it was hard to raise my hand¨; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (started feeling bad), OROPHARYNGEAL PAIN (sore throat), PAIN (waist pain), HEADACHE (headache) and VACCINATION SITE PAIN (pain in the arm of the injection and under her arm: ¨it was hard to raise my hand¨) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid cancer. Concurrent medical conditions included Breast cyst. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced FEELING ABNORMAL (started feeling bad), HEADACHE (headache) and VACCINATION SITE PAIN (pain in the arm of the injection and under her arm: ¨it was hard to raise my hand¨). On 10-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), PAIN (waist pain), PYREXIA (fever up to 101.4F) and FATIGUE (fatigue). At the time of the report, FEELING ABNORMAL (started feeling bad), OROPHARYNGEAL PAIN (sore throat), PAIN (waist pain), HEADACHE (headache), VACCINATION SITE PAIN (pain in the arm of the injection and under her arm: ¨it was hard to raise my hand¨), PYREXIA (fever up to 101.4F) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Body temperature: 101.4 (High) Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Tylenol from 12-Apr-2021. Second dose is scheduled for 30-Apr-2021.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site mass, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Injection Site Hurts; Hard Injection Site; Big Knot Injection Site; Hot Injection Site; Red (Baseball size) Injection Site; Itchy Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection Site Hurts), INJECTION SITE INDURATION (Hard Injection Site), INJECTION SITE MASS (Big Knot Injection Site), VACCINATION SITE WARMTH (Hot Injection Site) and VACCINATION SITE ERYTHEMA (Red (Baseball size) Injection Site) in a 46-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.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE PAIN (Injection Site Hurts), INJECTION SITE INDURATION (Hard Injection Site), INJECTION SITE MASS (Big Knot Injection Site), VACCINATION SITE WARMTH (Hot Injection Site), VACCINATION SITE ERYTHEMA (Red (Baseball size) Injection Site) and VACCINATION SITE PRURITUS (Itchy Injection Site). On 12-Apr-2021, VACCINATION SITE PAIN (Injection Site Hurts), INJECTION SITE INDURATION (Hard Injection Site) and VACCINATION SITE WARMTH (Hot Injection Site) had resolved. At the time of the report, INJECTION SITE MASS (Big Knot Injection Site), VACCINATION SITE ERYTHEMA (Red (Baseball size) Injection Site) and VACCINATION SITE PRURITUS (Itchy Injection Site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Injection Site Hurts; Hard Injection Site; Big Knot Injection Site; Hot Injection Site; Red (Baseball size) Injection Site; Itchy Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection Site Hurts), INJECTION SITE INDURATION (Hard Injection Site), INJECTION SITE MASS (Big Knot Injection Site), VACCINATION SITE WARMTH (Hot Injection Site) and VACCINATION SITE ERYTHEMA (Red (Baseball size) Injection Site) in a 46-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.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE PAIN (Injection Site Hurts), INJECTION SITE INDURATION (Hard Injection Site), INJECTION SITE MASS (Big Knot Injection Site), VACCINATION SITE WARMTH (Hot Injection Site), VACCINATION SITE ERYTHEMA (Red (Baseball size) Injection Site) and VACCINATION SITE PRURITUS (Itchy Injection Site). On 12-Apr-2021, VACCINATION SITE PAIN (Injection Site Hurts), INJECTION SITE INDURATION (Hard Injection Site) and VACCINATION SITE WARMTH (Hot Injection Site) had resolved. At the time of the report, INJECTION SITE MASS (Big Knot Injection Site), VACCINATION SITE ERYTHEMA (Red (Baseball size) Injection Site) and VACCINATION SITE PRURITUS (Itchy Injection Site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: violently shaking; fever 100.4; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (violently shaking), PYREXIA (fever 100.4) and PAIN IN EXTREMITY (arm was sore) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), RIVAROXABAN (XARELTO), LABETALOL, ALPRAZOLAM and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 09-Apr-2021, the patient experienced TREMOR (violently shaking) and PYREXIA (fever 100.4). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, TREMOR (violently shaking), PYREXIA (fever 100.4) and PAIN IN EXTREMITY (arm was sore) outcome was unknown.            Current condition includes Carotid heart disease.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed 2nd dose on due date; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose on due date) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     no medical history was provided by the reporter.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose on due date). On 03-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose on due date) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient missed the 2nd dose which was scheduled on 03-04-2021   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up information received captured no new information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After the first dose, she just had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After the first dose, she just had a sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder and Clotting disorder.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, 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 experienced PAIN IN EXTREMITY (After the first dose, she just had a sore arm). At the time of the report, PAIN IN EXTREMITY (After the first dose, she just had a sore arm) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-073670 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: unable to get 2nd shot at schedule time; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (unable to get 2nd shot at schedule time) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (unable to get 2nd shot at schedule time). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (unable to get 2nd shot at schedule time) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The second dose was scheduled for 31March202, but they were unable to get the shot at that time.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Pain, Pain in extremity
Clinical narrative: Loose stools; Swelling in the arm; Soreness of the arm; Body aches; Fatigue; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Loose stools), PERIPHERAL SWELLING (Swelling in the arm), PAIN IN EXTREMITY (Soreness of the arm), PAIN (Body aches) and FATIGUE (Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction. Concomitant products included SIMVASTATIN, CLONAZEPAM, RALOXIFENE HYDROCHLORIDE (EVISTA), FINASTERIDE and LOTEPREDNOL ETABONATE (LOTREL [LOTEPREDNOL ETABONATE]) for an unknown indication.   On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling in the arm), PAIN IN EXTREMITY (Soreness of the arm), PAIN (Body aches), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Fever). On 05-Apr-2021, the patient experienced DIARRHOEA (Loose stools). On 30-Mar-2021, PERIPHERAL SWELLING (Swelling in the arm), PAIN IN EXTREMITY (Soreness of the arm), PAIN (Body aches), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, DIARRHOEA (Loose stools) outcome was unknown.            Treatment includes Ibuprofen, Lomotil The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was unknown For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route), the reporter did not provide any causality assessments.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Loose stools; Swelling in the arm; Soreness of the arm; Body aches; Fatigue; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Loose stools), PERIPHERAL SWELLING (Swelling in the arm), PAIN IN EXTREMITY (Soreness of the arm), PAIN (Body aches) and FATIGUE (Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction. Concomitant products included SIMVASTATIN, CLONAZEPAM, RALOXIFENE HYDROCHLORIDE (EVISTA), FINASTERIDE and LOTEPREDNOL ETABONATE (LOTREL [LOTEPREDNOL ETABONATE]) for an unknown indication.   On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling in the arm), PAIN IN EXTREMITY (Soreness of the arm), PAIN (Body aches), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Fever). On 05-Apr-2021, the patient experienced DIARRHOEA (Loose stools). On 30-Mar-2021, PERIPHERAL SWELLING (Swelling in the arm), PAIN IN EXTREMITY (Soreness of the arm), PAIN (Body aches), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, DIARRHOEA (Loose stools) outcome was unknown.            Treatment includes Ibuprofen, Lomotil The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was unknown For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash erythematous, Swelling, Vaccination site discolouration
Clinical narrative: sore arm; swelling; discoloration; red dots on legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), SWELLING (swelling), VACCINATION SITE DISCOLOURATION (discoloration) and RASH ERYTHEMATOUS (red dots on legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), SWELLING (swelling), VACCINATION SITE DISCOLOURATION (discoloration) and RASH ERYTHEMATOUS (red dots on legs). At the time of the report, PAIN IN EXTREMITY (sore arm), SWELLING (swelling), VACCINATION SITE DISCOLOURATION (discoloration) and RASH ERYTHEMATOUS (red dots on legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Fatigue, Malaise, Vomiting
Clinical narrative: coughing; felt crappy; tired; Last night started coughing a little bit, then started coughing hard and started throwing up; This spontaneous case was reported by a consumer and describes the occurrence of COUGH ( coughing), MALAISE (felt crappy), FATIGUE (tired) and VOMITING (Last night started coughing a little bit, then started coughing hard and started throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 029K20A) for an unknown indication.     The patient's past medical history included Heart disorder and Clotting disorder. Concomitant products included DABIGATRAN ETEXILATE MESILATE (PRADAXA) and METOPROLOL for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced COUGH ( coughing), MALAISE (felt crappy), FATIGUE (tired) and VOMITING (Last night started coughing a little bit, then started coughing hard and started throwing up). At the time of the report, COUGH ( coughing), MALAISE (felt crappy), FATIGUE (tired) and VOMITING (Last night started coughing a little bit, then started coughing hard and started throwing up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature (102-Unknown): 102 102.         This case was linked to MOD-2021-073665 (E2B Linked Report).; Sender's Comments:  MOD-2021-073665:Linked to 1st dose
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Hot flush, Pruritus, Swelling
Clinical narrative: feeling tired; swelling has gone down; red; hot to the touch; itchy; Covid Arm; swollen; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Covid Arm), SWELLING (swollen), ERYTHEMA (red), HOT FLUSH (hot to the touch) and PRURITUS (itchy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Covid Arm), SWELLING (swollen), HOT FLUSH (hot to the touch) and PRURITUS (itchy). On 10-Apr-2021, the patient experienced ERYTHEMA (red). On 12-Apr-2021, the patient experienced SWELLING (swelling has gone down). On an unknown date, the patient experienced FATIGUE (feeling tired). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Covid Arm), SWELLING (swollen), ERYTHEMA (red), HOT FLUSH (hot to the touch), PRURITUS (itchy), FATIGUE (feeling tired) and SWELLING (swelling has gone down) outcome was unknown. Not Provided          No relevant concomitant medication was reported.  Treatment details include, ice packs and oral antihistamine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Type IV hypersensitivity reaction
Clinical narrative: feeling tired; swelling has gone down; red; hot to the touch; itchy; Covid Arm; swollen; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Covid Arm), SWELLING (swollen), ERYTHEMA (red), HOT FLUSH (hot to the touch) and PRURITUS (itchy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Covid Arm), SWELLING (swollen), HOT FLUSH (hot to the touch) and PRURITUS (itchy). On 10-Apr-2021, the patient experienced ERYTHEMA (red). On 12-Apr-2021, the patient experienced SWELLING (swelling has gone down). On an unknown date, the patient experienced FATIGUE (feeling tired). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Covid Arm), SWELLING (swollen), ERYTHEMA (red), HOT FLUSH (hot to the touch), PRURITUS (itchy), FATIGUE (feeling tired) and SWELLING (swelling has gone down) outcome was unknown. Not Provided          No relevant concomitant medication was reported.  Treatment details include, ice packs and oral antihistamine.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PHARYNGEAL SWELLING (right sided throat swelling) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. Concurrent medical conditions included Reaction to food coloring. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PHARYNGEAL SWELLING (right sided throat swelling). At the time of the report, PHARYNGEAL SWELLING (right sided throat swelling) 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. This case was linked to MOD-2021-073668.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sorness in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sorness in arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Thyroid activity decreased (UNDERACTIVE THYROID). Previously administered products included for an unreported indication: ZOSTER (SHINGRIX) since an unknown date and INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE (FLU SHOT) since an unknown date. Concurrent medical conditions included High cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, LEVOTHYROXINE for Thyroid disorder, VITAMIN D3, MULTIVITAMIN ACTIVE WOMAN, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), TOCOPHEROL (VITAMIN E [TOCOPHEROL]), LACTOBACILLUS ACIDOPHILUS (PROBIOTIC ACIDOPHILUS [LACTOBACILLUS ACIDOPHILUS]), CALCIUM and CLARITHROMYCIN (BIAXIN) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (sorness in arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 325 mg. At the time of the report, VACCINATION SITE PAIN (sorness in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-073679 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: ADR Form received on 19-May-2021  and it mentioned patient height and weight also outcome of the events , patient contact information was updated, other relevant history was updated, concomitant medication was updated.; Sender's Comments:  MOD-2021-073679:second dose dose
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache in daily life; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache in daily life) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache in daily life). At the time of the report, HEADACHE (headache in daily life) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.