chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate irregular, Nausea, Pyrexia, Suspected COVID-19
Clinical narrative: a slight headache; fever; slight nausea; felt like COVID; irregular heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (a slight headache), PYREXIA (fever), NAUSEA (slight nausea), SUSPECTED COVID-19 (felt like COVID) and HEART RATE IRREGULAR (irregular heartbeat) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020. Concomitant products included PRAVASTATIN for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced HEADACHE (a slight headache), PYREXIA (fever), NAUSEA (slight nausea), SUSPECTED COVID-19 (felt like Covid) and HEART RATE IRREGULAR (irregular heartbeat). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of UNK dosage form. On 30-Mar-2021, HEADACHE (a slight headache), PYREXIA (fever), NAUSEA (slight nausea), SUSPECTED COVID-19 (felt like Covid) and HEART RATE IRREGULAR (irregular heartbeat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site pruritus
Clinical narrative: red blotch itching arm; red blotch itching arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotch itching arm) and VACCINATION SITE PRURITUS (red blotch itching arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (red blotch itching arm) and VACCINATION SITE PRURITUS (red blotch itching arm). At the time of the report, RASH MACULAR (red blotch itching arm) and VACCINATION SITE PRURITUS (red blotch itching arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment details were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: rash on the inside of both arms and around her stomach and both side of rib cage; rash itched on her right wrist; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on the inside of both arms and around her stomach and both side of rib cage) and RASH PRURITIC (rash itched on her right wrist) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received 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 RASH (rash on the inside of both arms and around her stomach and both side of rib cage) and RASH PRURITIC (rash itched on her right wrist). At the time of the report, RASH (rash on the inside of both arms and around her stomach and both side of rib cage) and RASH PRURITIC (rash itched on her right wrist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported. No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest discomfort, Diarrhoea, Dizziness, Dysphagia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS, THROAT IRRITATION, PHARYNGEAL SWELLING, PERIORBITAL SWELLING, and ABDOMINAL PAIN UPPER in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016A21A or 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced EYE PRURITUS, THROAT IRRITATION, PHARYNGEAL SWELLING, PERIORBITAL SWELLING, ABDOMINAL PAIN UPPER, DIARRHOEA, DIZZINESS, HEADACHE, SWELLING FACE, LIP SWELLING, CHEST DISCOMFORT, DYSPHONIA, DYSPNOEA, and DYSPHAGIA. The patient was treated with BENADRYL (intravenous) for Adverse event, at a dose of UNK dosage form, one time dose; BENADRYL for Adverse event, at a dose of UNK dosage form; ZYRTEC for Adverse event, at a dose of UNK dosage form and TYLENOL for Adverse event, at a dose of UNK dosage form. At the time of the report, EYE PRURITUS, THROAT IRRITATION, PHARYNGEAL SWELLING, PERIORBITAL SWELLING, ABDOMINAL PAIN UPPER, DIARRHOEA, DIZZINESS, HEADACHE, SWELLING FACE, LIP SWELLING, CHEST DISCOMFORT, DYSPHONIA, DYSPNOEA, and DYSPHAGIA outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Other treatment included intravenous steroids in the emergency room. She was prescribed an oral steroid after her visit to the emergency room.
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Dyspnoea, Eye pruritus, Headache, Lip swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS, THROAT IRRITATION, PHARYNGEAL SWELLING, PERIORBITAL SWELLING, and ABDOMINAL PAIN UPPER in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016A21A or 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced EYE PRURITUS, THROAT IRRITATION, PHARYNGEAL SWELLING, PERIORBITAL SWELLING, ABDOMINAL PAIN UPPER, DIARRHOEA, DIZZINESS, HEADACHE, SWELLING FACE, LIP SWELLING, CHEST DISCOMFORT, DYSPHONIA, DYSPNOEA, and DYSPHAGIA. The patient was treated with BENADRYL (intravenous) for Adverse event, at a dose of UNK dosage form, one time dose; BENADRYL for Adverse event, at a dose of UNK dosage form; ZYRTEC for Adverse event, at a dose of UNK dosage form and TYLENOL for Adverse event, at a dose of UNK dosage form. At the time of the report, EYE PRURITUS, THROAT IRRITATION, PHARYNGEAL SWELLING, PERIORBITAL SWELLING, ABDOMINAL PAIN UPPER, DIARRHOEA, DIZZINESS, HEADACHE, SWELLING FACE, LIP SWELLING, CHEST DISCOMFORT, DYSPHONIA, DYSPNOEA, and DYSPHAGIA outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Other treatment included intravenous steroids in the emergency room. She was prescribed an oral steroid after her visit to the emergency room.
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling, Pharyngeal swelling, Swelling face, Throat irritation
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS, THROAT IRRITATION, PHARYNGEAL SWELLING, PERIORBITAL SWELLING, and ABDOMINAL PAIN UPPER in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016A21A or 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced EYE PRURITUS, THROAT IRRITATION, PHARYNGEAL SWELLING, PERIORBITAL SWELLING, ABDOMINAL PAIN UPPER, DIARRHOEA, DIZZINESS, HEADACHE, SWELLING FACE, LIP SWELLING, CHEST DISCOMFORT, DYSPHONIA, DYSPNOEA, and DYSPHAGIA. The patient was treated with BENADRYL (intravenous) for Adverse event, at a dose of UNK dosage form, one time dose; BENADRYL for Adverse event, at a dose of UNK dosage form; ZYRTEC for Adverse event, at a dose of UNK dosage form and TYLENOL for Adverse event, at a dose of UNK dosage form. At the time of the report, EYE PRURITUS, THROAT IRRITATION, PHARYNGEAL SWELLING, PERIORBITAL SWELLING, ABDOMINAL PAIN UPPER, DIARRHOEA, DIZZINESS, HEADACHE, SWELLING FACE, LIP SWELLING, CHEST DISCOMFORT, DYSPHONIA, DYSPNOEA, and DYSPHAGIA outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Other treatment included intravenous steroids in the emergency room. She was prescribed an oral steroid after her visit to the emergency room.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site pain
Clinical narrative: Itching for 1 day; Rash that has increased in size 4 inches in diameter; Injection site was painful; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching for 1 day), RASH (Rash that has increased in size 4 inches in diameter) and VACCINATION SITE PAIN (Injection site was painful) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), LANSOPRAZOLE, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and MONTELUKAST SODIUM (SINGULAIR BABY) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection site was painful). On 29-Mar-2021, the patient experienced RASH (Rash that has increased in size 4 inches in diameter). On an unknown date, the patient experienced PRURITUS (Itching for 1 day). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) ongoing since an unknown date for Rash, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, PRURITUS (Itching for 1 day), RASH (Rash that has increased in size 4 inches in diameter) and VACCINATION SITE PAIN (Injection site was painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site hypersensitivity, Vaccination site mass, Vaccination site pain
Clinical narrative: golf sized hard bump at the injection site; hot to touch at the injection site; which is sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (golf sized hard bump at the injection site), VACCINATION SITE HYPERSENSITIVITY (hot to touch at the injection site) and VACCINATION SITE PAIN (which is sore at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-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 30-Mar-2021, the patient experienced VACCINATION SITE MASS (golf sized hard bump at the injection site), VACCINATION SITE HYPERSENSITIVITY (hot to touch at the injection site) and VACCINATION SITE PAIN (which is sore at the injection site). At the time of the report, VACCINATION SITE MASS (golf sized hard bump at the injection site), VACCINATION SITE HYPERSENSITIVITY (hot to touch at the injection site) and VACCINATION SITE PAIN (which is sore at the injection site) outcome was unknown.            No concomitant medication were provided  Treatment medication was not provided.  Action taken with mRNA-1273 Moderna vaccine was Not applicable
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-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 01-Jul-2020 and the estimated date of delivery was 04-Apr-2021. On 09-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy.  On 09-Mar-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: blood pressure has been up; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure has been up) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included blood clot (Back in 2016, she had a blood clot and was put on Eliquis for 4 months). Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL (ZESTRIL) for Hypertension, ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced HYPERTENSION (blood pressure has been up). At the time of the report, HYPERTENSION (blood pressure has been up) 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 treatment details were reported.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Pain, Vaccination site erythema, Vaccination site pain
Clinical narrative: Sleeps a lot; Sore it's now on the entire body; Right arm injection site itchy; Injection site pain; Injection site pink; Injection site on R arm swollen; Tired more than usual; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Sleeps a lot), PAIN (Sore it's now on the entire body), VACCINATION SITE PRURITUS (Right arm injection site itchy), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE ERYTHEMA (Injection site pink) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included EZETIMIBE, ROSUVASTATIN, MEMANTINE, PANTOPRAZOLE, chlorotine and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 06-Feb-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 HYPERSOMNIA (Sleeps a lot), PAIN (Sore it's now on the entire body), VACCINATION SITE PRURITUS (Right arm injection site itchy), VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE ERYTHEMA (Injection site pink), VACCINATION SITE SWELLING (Injection site on R arm swollen) and FATIGUE (Tired more than usual). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, HYPERSOMNIA (Sleeps a lot), PAIN (Sore it's now on the entire body), VACCINATION SITE PRURITUS (Right arm injection site itchy), VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE ERYTHEMA (Injection site pink), VACCINATION SITE SWELLING (Injection site on R arm swollen) and FATIGUE (Tired more than usual) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment provided also included a topical cream.   This case was linked to MOD-2021-064152 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Sleeps a lot; Sore it's now on the entire body; Right arm injection site itchy; Injection site pain; Injection site pink; Injection site on R arm swollen; Tired more than usual; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Sleeps a lot), PAIN (Sore it's now on the entire body), VACCINATION SITE PRURITUS (Right arm injection site itchy), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE ERYTHEMA (Injection site pink) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included EZETIMIBE, ROSUVASTATIN, MEMANTINE, PANTOPRAZOLE, chlorotine and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 06-Feb-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 HYPERSOMNIA (Sleeps a lot), PAIN (Sore it's now on the entire body), VACCINATION SITE PRURITUS (Right arm injection site itchy), VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE ERYTHEMA (Injection site pink), VACCINATION SITE SWELLING (Injection site on R arm swollen) and FATIGUE (Tired more than usual). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, HYPERSOMNIA (Sleeps a lot), PAIN (Sore it's now on the entire body), VACCINATION SITE PRURITUS (Right arm injection site itchy), VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE ERYTHEMA (Injection site pink), VACCINATION SITE SWELLING (Injection site on R arm swollen) and FATIGUE (Tired more than usual) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment provided also included a topical cream.   This case was linked to MOD-2021-064152 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Neck mass, Pain in extremity, Pyrexia, Vaccination site mass
Clinical narrative: Lump in left arm where she got injection; Lump on the neck; Couldnt lift arm; Temperature of 100 degree; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of   in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (abnormal) 100 degree.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: No adverse event removed as relevant history. Laboratory test added.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Muscle strength abnormal, Myalgia, Neck pain, Pain in extremity
Clinical narrative: his right arm was hurting so badly; Neck pain; Lose of strength in arm; Collapsing of arm; can sometimes feel a pulse in his neck; very extreme and very bad left and right arm issues with pain involved/ his right arm was hurting so badly; pain from the injection site on the right arm up the shoulder blade and up to his neck; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (his right arm was hurting so badly), NECK PAIN (Neck pain), MUSCLE STRENGTH ABNORMAL (Lose of strength in arm), LIMB DISCOMFORT (Collapsing of arm) and PULSE ABNORMAL (can sometimes feel a pulse in his neck) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-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 (his right arm was hurting so badly), NECK PAIN (Neck pain), MUSCLE STRENGTH ABNORMAL (Lose of strength in arm), LIMB DISCOMFORT (Collapsing of arm), PULSE ABNORMAL (can sometimes feel a pulse in his neck), MYALGIA (very extreme and very bad left and right arm issues with pain involved/ his right arm was hurting so badly) and VACCINATION SITE PAIN (pain from the injection site on the right arm up the shoulder blade and up to his neck). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form once a day and IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form once a day. At the time of the report, PAIN IN EXTREMITY (his right arm was hurting so badly), NECK PAIN (Neck pain), MUSCLE STRENGTH ABNORMAL (Lose of strength in arm), LIMB DISCOMFORT (Collapsing of arm), MYALGIA (very extreme and very bad left and right arm issues with pain involved/ his right arm was hurting so badly) and VACCINATION SITE PAIN (pain from the injection site on the right arm up the shoulder blade and up to his neck) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medicines reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: On 21-May-2021, follow up document was received which contains information of both the doses. On 24-May-2021: On 24-may-2021, the reporter's HCP demographics was updated. Reporter demographics was added.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pulse abnormal, Vaccination site pain
Clinical narrative: his right arm was hurting so badly; Neck pain; Lose of strength in arm; Collapsing of arm; can sometimes feel a pulse in his neck; very extreme and very bad left and right arm issues with pain involved/ his right arm was hurting so badly; pain from the injection site on the right arm up the shoulder blade and up to his neck; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (his right arm was hurting so badly), NECK PAIN (Neck pain), MUSCLE STRENGTH ABNORMAL (Lose of strength in arm), LIMB DISCOMFORT (Collapsing of arm) and PULSE ABNORMAL (can sometimes feel a pulse in his neck) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-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 (his right arm was hurting so badly), NECK PAIN (Neck pain), MUSCLE STRENGTH ABNORMAL (Lose of strength in arm), LIMB DISCOMFORT (Collapsing of arm), PULSE ABNORMAL (can sometimes feel a pulse in his neck), MYALGIA (very extreme and very bad left and right arm issues with pain involved/ his right arm was hurting so badly) and VACCINATION SITE PAIN (pain from the injection site on the right arm up the shoulder blade and up to his neck). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form once a day and IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form once a day. At the time of the report, PAIN IN EXTREMITY (his right arm was hurting so badly), NECK PAIN (Neck pain), MUSCLE STRENGTH ABNORMAL (Lose of strength in arm), LIMB DISCOMFORT (Collapsing of arm), MYALGIA (very extreme and very bad left and right arm issues with pain involved/ his right arm was hurting so badly) and VACCINATION SITE PAIN (pain from the injection site on the right arm up the shoulder blade and up to his neck) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medicines reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: On 21-May-2021, follow up document was received which contains information of both the doses. On 24-May-2021: On 24-may-2021, the reporter's HCP demographics was updated. Reporter demographics was added.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle swelling, Rash
Clinical narrative: swelling in the muscle; rash; This spontaneous case was reported by a physician and describes the occurrence of MUSCLE SWELLING (swelling in the muscle) and RASH (rash) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced MUSCLE SWELLING (swelling in the muscle) and RASH (rash). At the time of the report, MUSCLE SWELLING (swelling in the muscle) and RASH (rash) 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.   Concomitant medications include a medicine for cholesterol, blood pressure, and anxiety, not otherwise specified. No treatment details were provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Headache, Lethargy, Pain
Clinical narrative: Horrible headache; Vomiting; Chills; Achy; Very lethargic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Horrible headache), VOMITING (Vomiting), CHILLS (Chills), PAIN (Achy) and LETHARGY (Very lethargic) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 0022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced HEADACHE (Horrible headache), VOMITING (Vomiting), CHILLS (Chills), PAIN (Achy) and LETHARGY (Very lethargic). At the time of the report, HEADACHE (Horrible headache), VOMITING (Vomiting), CHILLS (Chills), PAIN (Achy) and LETHARGY (Very lethargic) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) Negative Covid-19 test.         No concomitant medications provided. No treatment details were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Horrible headache; Vomiting; Chills; Achy; Very lethargic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Horrible headache), VOMITING (Vomiting), CHILLS (Chills), PAIN (Achy) and LETHARGY (Very lethargic) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 0022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced HEADACHE (Horrible headache), VOMITING (Vomiting), CHILLS (Chills), PAIN (Achy) and LETHARGY (Very lethargic). At the time of the report, HEADACHE (Horrible headache), VOMITING (Vomiting), CHILLS (Chills), PAIN (Achy) and LETHARGY (Very lethargic) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) Negative Covid-19 test.         No concomitant medications provided. No treatment details were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Insomnia, Musculoskeletal chest pain
Clinical narrative: Pain on right side of her chest between ribcage; Difficulty breathing; Didn't had enough sleep on that night due to the pain.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Pain on right side of her chest between ribcage), DYSPNOEA (Difficulty breathing) and INSOMNIA (Didn't had enough sleep on that night due to the pain.) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 03M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (Pain on right side of her chest between ribcage), DYSPNOEA (Difficulty breathing) and INSOMNIA (Didn't had enough sleep on that night due to the pain.). The patient was treated with CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEINE) for Chest wall pain, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL CHEST PAIN (Pain on right side of her chest between ribcage), DYSPNOEA (Difficulty breathing) and INSOMNIA (Didn't had enough sleep on that night due to the pain.) outcome was unknown. Not applicable          Concomitant product use was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain, Somnolence, Vaccination site erythema
Clinical narrative: soreness on the entire body; tired more than usual, sleeps a lot; R arm sore at the injection site; injection site pink; injection site on R arm swollen; R arm injection site itchy; tired more than usual, sleeps a lot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (soreness on the entire body), SOMNOLENCE (tired more than usual, sleeps a lot), INJECTION SITE PAIN (R arm sore at the injection site), VACCINATION SITE ERYTHEMA (injection site pink) and VACCINATION SITE SWELLING (injection site on R arm swollen) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included EZETIMIBE, ROSUVASTATIN, MEMANTINE, PANTOPRAZOLE, CHLORAMPHENICOL (CHLOROTIN) and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-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 (soreness on the entire body), SOMNOLENCE (tired more than usual, sleeps a lot), INJECTION SITE PAIN (R arm sore at the injection site), VACCINATION SITE ERYTHEMA (injection site pink), VACCINATION SITE SWELLING (injection site on R arm swollen), VACCINATION SITE PRURITUS (R arm injection site itchy) and FATIGUE (tired more than usual, sleeps a lot). At the time of the report, PAIN (soreness on the entire body), SOMNOLENCE (tired more than usual, sleeps a lot), INJECTION SITE PAIN (R arm sore at the injection site), VACCINATION SITE ERYTHEMA (injection site pink), VACCINATION SITE SWELLING (injection site on R arm swollen), VACCINATION SITE PRURITUS (R arm injection site itchy) and FATIGUE (tired more than usual, sleeps a lot) outcome was unknown.            treatment med:  tylenol or Ibuprofen  and a topic cream. conmed: cranberry tablet
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: soreness on the entire body; tired more than usual, sleeps a lot; R arm sore at the injection site; injection site pink; injection site on R arm swollen; R arm injection site itchy; tired more than usual, sleeps a lot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (soreness on the entire body), SOMNOLENCE (tired more than usual, sleeps a lot), INJECTION SITE PAIN (R arm sore at the injection site), VACCINATION SITE ERYTHEMA (injection site pink) and VACCINATION SITE SWELLING (injection site on R arm swollen) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included EZETIMIBE, ROSUVASTATIN, MEMANTINE, PANTOPRAZOLE, CHLORAMPHENICOL (CHLOROTIN) and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-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 (soreness on the entire body), SOMNOLENCE (tired more than usual, sleeps a lot), INJECTION SITE PAIN (R arm sore at the injection site), VACCINATION SITE ERYTHEMA (injection site pink), VACCINATION SITE SWELLING (injection site on R arm swollen), VACCINATION SITE PRURITUS (R arm injection site itchy) and FATIGUE (tired more than usual, sleeps a lot). At the time of the report, PAIN (soreness on the entire body), SOMNOLENCE (tired more than usual, sleeps a lot), INJECTION SITE PAIN (R arm sore at the injection site), VACCINATION SITE ERYTHEMA (injection site pink), VACCINATION SITE SWELLING (injection site on R arm swollen), VACCINATION SITE PRURITUS (R arm injection site itchy) and FATIGUE (tired more than usual, sleeps a lot) outcome was unknown.            treatment med:  tylenol or Ibuprofen  and a topic cream. conmed: cranberry tablet
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza, Lethargy, Lymphadenopathy, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (It feels like I have the flu), LETHARGY (Feeling lethargic), LYMPHADENOPATHY (Lymph nodes are swollen on the left arm) and PYREXIA (Had fever of 101 degrees Faherheit) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. Concurrent medical conditions included Atrial fibrillation. Concomitant products included OMEPRAZOLE, VITAMIN D [VITAMIN D NOS] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for Atrial fibrillation. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced INFLUENZA (It feels like I have the flu), LETHARGY (Feeling lethargic), LYMPHADENOPATHY (Lymph nodes are swollen on the left arm) and PYREXIA (Had fever of 101 degrees Faherheit). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA (It feels like I have the flu), LETHARGY (Feeling lethargic) and PYREXIA (Had fever of 101 degrees Faherheit) had resolved and LYMPHADENOPATHY (Lymph nodes are swollen on the left arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: 101 (Inconclusive) Fever at 101 degrees Faherheit. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Patient's medical history, Concomitant medication, Outcome of event and causality of event Pyrexia were added.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Electrocardiogram, Heart rate, Heart rate increased
Clinical narrative: Increased heart rate; Increased blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Increased heart rate) and BLOOD PRESSURE INCREASED (Increased blood pressure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 011A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced HEART RATE INCREASED (Increased heart rate) and BLOOD PRESSURE INCREASED (Increased blood pressure). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of 81 mg. At the time of the report, HEART RATE INCREASED (Increased heart rate) and BLOOD PRESSURE INCREASED (Increased blood pressure) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Blood pressure measurement: 130 (High) High and 135 (High) High. On 29-Mar-2021, Electrocardiogram: normal (normal) Normal. On 29-Mar-2021, Heart rate: 90 beats per minute (High) High.         Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received contains significant information including outcome of event and lab test.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00AB212A) 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. On 30-Mar-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment was provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Heart rate irregular
Clinical narrative: Warmness; Irregular beats; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Warmness), HEART RATE IRREGULAR (Irregular beats) and HEADACHE (Headaches) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced FEELING HOT (Warmness), HEART RATE IRREGULAR (Irregular beats) and HEADACHE (Headaches). On 19-Mar-2021, FEELING HOT (Warmness), HEART RATE IRREGULAR (Irregular beats) and HEADACHE (Headaches) had resolved.            Concomitant product use was not provided by the reporter.  Patient experienced symptoms two days after the second dose of vaccine and resolved after approximately 12 hours. She had no other issues since then.  No treatment information was provided.      Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Updated patient medical history, event start date, event stop date, events outcome.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Feels fatigued; arm pain; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), PYREXIA (fever), CHILLS (chills) and FATIGUE (Feels fatigued) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain), PYREXIA (fever) and CHILLS (chills). On 31-Mar-2021, the patient experienced FATIGUE (Feels fatigued). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 31-Mar-2021, PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, PAIN IN EXTREMITY (arm pain) and FATIGUE (Feels fatigued) outcome was unknown. Not Provided          No concomitant medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: information about second dose
Sex: U
Vaccine: COVID19
Symptoms: Pain, Product administered to patient of inappropriate age
Clinical narrative: Three patients age 17 years old received first dose of Moderna vaccine; Pain; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Three patients age 17 years old received first dose of Moderna vaccine) and PAIN (Pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Three patients age 17 years old received first dose of Moderna vaccine) and PAIN (Pain). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Three patients age 17 years old received first dose of Moderna vaccine) had resolved and PAIN (Pain) 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 concomitant medications provided. No treatment details reported.    Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up received on 08-JUN-2021.Added new event very painful.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Wrong technique in product usage process
Clinical narrative: Vaccinated through bandage; Soreness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccinated through bandage) and VACCINATION SITE PAIN (Soreness at the site of injection) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccinated through bandage) and VACCINATION SITE PAIN (Soreness at the site of injection). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccinated through bandage) had resolved and VACCINATION SITE PAIN (Soreness at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug information was provided by reporter.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jul-2021: Follow up received contain no significant information. On 21-Jul-2021: Follow up received contain no new information.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Pyrexia, Tremor
Clinical narrative: 101F fever; Hands shaking; Headache; Stomach pains; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (101F fever), TREMOR (Hands shaking), HEADACHE (Headache), ABDOMINAL PAIN UPPER (Stomach pains) and FATIGUE (fatigue) in a 61-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PYREXIA (101F fever), TREMOR (Hands shaking) and HEADACHE (Headache). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pains) and FATIGUE (fatigue). On 03-Mar-2021, PYREXIA (101F fever), TREMOR (Hands shaking) and HEADACHE (Headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.