chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: Can still feel a little pinch like a sensation if she pushes down on that area; not feeling like her self; completely drained; arm real sore for about 4 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm real sore for about 4 days), FEELING ABNORMAL (Can still feel a little pinch like a sensation if she pushes down on that area), FEELING ABNORMAL (not feeling like her self) and FATIGUE (completely drained) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included METFORMIN and SIMVASTATIN for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm real sore for about 4 days). On an unknown date, the patient experienced FEELING ABNORMAL (Can still feel a little pinch like a sensation if she pushes down on that area), FEELING ABNORMAL (not feeling like her self) and FATIGUE (completely drained). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm real sore for about 4 days), FEELING ABNORMAL (Can still feel a little pinch like a sensation if she pushes down on that area), FEELING ABNORMAL (not feeling like her self) and FATIGUE (completely drained) had resolved.            Concomitant product included blood pressure medications. Treatment information included Tylenol 3 or 4 times.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dermatitis, Emphysema, Fatigue, Pain in extremity
Clinical narrative: dermatitis; emphysema; Arm was sore; rash on left leg below knee; chills; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DERMATITIS (dermatitis), EMPHYSEMA (emphysema), PAIN IN EXTREMITY (Arm was sore), RASH (rash on left leg below knee) and CHILLS (chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029a21a) 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced DERMATITIS (dermatitis), EMPHYSEMA (emphysema), PAIN IN EXTREMITY (Arm was sore), RASH (rash on left leg below knee), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with BETAMETHASONE ongoing since an unknown date at an unspecified dose and frequency and Triamcinolne acetonide ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DERMATITIS (dermatitis), EMPHYSEMA (emphysema), PAIN IN EXTREMITY (Arm was sore), RASH (rash on left leg below knee), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. Treatment information included betamethasone and triamcinolne acetonide.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: dermatitis; emphysema; Arm was sore; rash on left leg below knee; chills; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DERMATITIS (dermatitis), EMPHYSEMA (emphysema), PAIN IN EXTREMITY (Arm was sore), RASH (rash on left leg below knee) and CHILLS (chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029a21a) 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced DERMATITIS (dermatitis), EMPHYSEMA (emphysema), PAIN IN EXTREMITY (Arm was sore), RASH (rash on left leg below knee), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with BETAMETHASONE ongoing since an unknown date at an unspecified dose and frequency and Triamcinolne acetonide ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DERMATITIS (dermatitis), EMPHYSEMA (emphysema), PAIN IN EXTREMITY (Arm was sore), RASH (rash on left leg below knee), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. Treatment information included betamethasone and triamcinolne acetonide.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Liquid leaked out; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Liquid leaked out) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced UNDERDOSE (Liquid leaked out). On 05-Apr-2021, UNDERDOSE (Liquid leaked out) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that during the administration the plunger was being pushed down and some liquid leaked out, caller stated the patient received close to half of the dose. Concomitant medications were not reported. Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up received on 24-May-2021 and does not contain any new information. On 22-Jul-2021: Follow up received on 22-Jul-2021 and contains no new information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Liquid product physical issue
Clinical narrative: Patient noticed that vaccine in syringe was cloudy; This spontaneous case was reported by a consumer and describes the occurrence of LIQUID PRODUCT PHYSICAL ISSUE (Patient noticed that vaccine in syringe was cloudy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced LIQUID PRODUCT PHYSICAL ISSUE (Patient noticed that vaccine in syringe was cloudy). At the time of the report, LIQUID PRODUCT PHYSICAL ISSUE (Patient noticed that vaccine in syringe was cloudy) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: TCR form received on 16-JUN-2021 contain no new information.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose was administered in less than 25 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was administered in less than 25 days after first dose) in a 78-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 27-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 07-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was administered in less than 25 days after first dose). On 07-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was administered in less than 25 days after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not provided and no medical history
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Tenderness at vaccine site; Extreme swelling at vaccine site; Redness the size of a quarter at vaccine site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tenderness at vaccine site), VACCINATION SITE SWELLING (Extreme swelling at vaccine site) and VACCINATION SITE ERYTHEMA (Redness the size of a quarter at vaccine site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), MONTELUKAST SODIUM (SINGULAIR), GABAPENTIN, CELECOXIB (CELEBREX), HYDROCHLOROTHIAZIDE, VITAMIN D3, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), LOSARTAN, ALBUTEROL [SALBUTAMOL], ZOLPIDEM TARTRATE (AMBIEN), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), BIOFLAVONOIDS NOS, VITAMINS NOS (LIPOFLAVONOID [BIOFLAVONOIDS NOS;VITAMINS NOS]), MAGNESIUM, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]), GUAIFENESIN (MUCINEX) and ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (Tenderness at vaccine site), VACCINATION SITE SWELLING (Extreme swelling at vaccine site) and VACCINATION SITE ERYTHEMA (Redness the size of a quarter at vaccine site). At the time of the report, VACCINATION SITE PAIN (Tenderness at vaccine site) outcome was unknown and VACCINATION SITE SWELLING (Extreme swelling at vaccine site) and VACCINATION SITE ERYTHEMA (Redness the size of a quarter at vaccine site) had resolved. Not Provided          No treatment information were reported.  Action taken with the drug in response to events was not applicable.   This case was linked to MOD-2021-069877 (Linked Report).; Sender's Comments:  MOD-2021-069877:2nd dose
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Rn administered 1ml instead of 0.5 ml of Moderna Vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Rn administered 1ml instead of 0.5 ml of Moderna Vaccine) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No medical history information reported.  Concomitant products included OXYCODONE, HYDROXYZINE (ATARAX [HYDROXYZINE]), MILK OF MAGNESIA, MELATONIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), AMLODIPINE, ATORVASTATIN CALCIUM (LIPITOR), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), GABAPENTIN (NEURONTIN), LISINOPRIL, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), COBAMAMIDE (VITAMIN B12 [COBAMAMIDE]), VITAMIN D3, PARACETAMOL (TYLENOL), SALBUTAMOL SULFATE (VENTOLIN HFA) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 06-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (Rn administered 1ml instead of 0.5 ml of Moderna Vaccine). On 06-Apr-2021, ACCIDENTAL OVERDOSE (Rn administered 1ml instead of 0.5 ml of Moderna Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Registered nurse administered 1 milliliter instead of the 0.5 milliliter of the Moderna COVID-19 vaccine.   Per reporter, the patient had not reported any adverse events.   Treatment information was not provided.  This report refers to a case of accidental overdose for mRNA-1273, lot # 044A21A with no associated AEs.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up received o 27-May-21. ADR form - non-significant; Sender's Comments: This report refers to a case of accidental overdose for mRNA-1273, lot # 044A21A with no associated AEs.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain, Pyrexia, Tachycardia
Clinical narrative: felt worse as the day has gone on; chills; high temperatures that went from 100.8 to 101 F; body aches; fever; racing heart rate; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (racing heart rate), PAIN (felt worse as the day has gone on), CHILLS (chills), PYREXIA (high temperatures that went from 100.8 to 101 F) and MYALGIA (body aches) in a 71-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 06-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) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced TACHYCARDIA (racing heart rate), CHILLS (chills), PYREXIA (high temperatures that went from 100.8 to 101 F), MYALGIA (body aches) and PYREXIA (fever). On an unknown date, the patient experienced PAIN (felt worse as the day has gone on). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, TACHYCARDIA (racing heart rate), PAIN (felt worse as the day has gone on), CHILLS (chills), PYREXIA (high temperatures that went from 100.8 to 101 F), MYALGIA (body aches) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100.8 (High) 100.8 to 101 F and 101 (High) 100.8 to 101 F.         Concomitant product use was not provided by the reporter. Treatment information included aspirin.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Vaccination site pain
Clinical narrative: took first dose while pregnant; Injection site pain,Muscle pain in the injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (took first dose while pregnant) and VACCINATION SITE PAIN (Injection site pain,Muscle pain in the injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: TDAP (injection and left deltoid) on 17-Mar-2021. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 19-Jul-2019 to an unknown date and FOLIC ACID, IRON (IRON & FOLIC ACID) from 17-Feb-2021 to an unknown date for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 30-Aug-2020 and the estimated date of delivery was 06-Jun-2021. On 02-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (took first dose while pregnant) and VACCINATION SITE PAIN (Injection site pain,Muscle pain in the injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 03-Apr-2021, VACCINATION SITE PAIN (Injection site pain,Muscle pain in the injection site) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (took first dose while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications provided by the reporter included :Prenatal vitamins with DHA (indication:Take it with breakfast) , Iron supplement(take it with orange juice)       Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: follow up were received on 03-JUN-2021 , patient details were updated, concomitant medication updated
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: very achy; have headaches today; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (very achy) and HEADACHE (have headaches today) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 025B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced MYALGIA (very achy) and HEADACHE (have headaches today). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, MYALGIA (very achy) and HEADACHE (have headaches today) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter. Treatment information included tylenol.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at touch in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at touch in the injection site) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at touch in the injection site). At the time of the report, VACCINATION SITE PAIN (pain at touch in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-070213 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy thyroid gland, Product dose omission issue, Thyroid neoplasm
Clinical narrative: received first dose in 02March2021, has not received second dose yet; Thyroid tumour; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received first dose in 02March2021, has not received second dose yet) and THYROID NEOPLASM (Thyroid tumour) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE on 02-Mar-2021. Concurrent medical conditions included Breast cancer (The patient states that she has a breast cancer and is scheduled for needle biopsy of thyroid, states she has two tumors). Concomitant products included LETROZOLE for an unknown indication.    On 02-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 PRODUCT DOSE OMISSION ISSUE (received first dose in 02March2021, has not received second dose yet) and THYROID NEOPLASM (Thyroid tumour). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received first dose in 02March2021, has not received second dose yet) had resolved and THYROID NEOPLASM (Thyroid tumour) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy thyroid gland: Needle biopsy of Thyroid stated that there is presence of two tumors..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Fatigue, Nausea, Oropharyngeal pain, Vaccination site discomfort
Clinical narrative: sore throat with a clear mucus, and nausea; sore throat with a clear mucus, and nausea; a pinch in the injection site; fatigue; worsening on her off balance; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (fatigue), BALANCE DISORDER (worsening on her off balance), VACCINATION SITE DISCOMFORT (a pinch in the injection site), OROPHARYNGEAL PAIN (sore throat with a clear mucus, and nausea) and NAUSEA (sore throat with a clear mucus, and nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included THYROID and CRATAEGUS LAEVIGATA, MAGNESIUM CITRATE, PLECTRANTHUS HADIENSIS, THEANINE, THEOBROMA CACAO (HIGH BLOOD PRESSURURE) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced BALANCE DISORDER (worsening on her off balance). On 31-Mar-2021, the patient experienced FATIGUE (fatigue). On 07-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat with a clear mucus, and nausea). In April 2021, the patient experienced VACCINATION SITE DISCOMFORT (a pinch in the injection site). On an unknown date, the patient experienced NAUSEA (sore throat with a clear mucus, and nausea). On 30-Mar-2021, BALANCE DISORDER (worsening on her off balance) outcome was unknown. In April 2021, VACCINATION SITE DISCOMFORT (a pinch in the injection site) outcome was unknown. At the time of the report, FATIGUE (fatigue), OROPHARYNGEAL PAIN (sore throat with a clear mucus, and nausea) and NAUSEA (sore throat with a clear mucus, and nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Holy water (on the injection site) that cured the pinch
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: Stomach felt funny; Nausea; Some chills; Threw up several times; A little bit tired; Headache; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach felt funny), NAUSEA (Nausea), CHILLS (Some chills), VOMITING (Threw up several times) and FATIGUE (A little bit tired) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach felt funny), NAUSEA (Nausea), CHILLS (Some chills), VOMITING (Threw up several times), FATIGUE (A little bit tired), HEADACHE (Headache) and ARTHRALGIA (Joint pain). At the time of the report, ABDOMINAL DISCOMFORT (Stomach felt funny), NAUSEA (Nausea), CHILLS (Some chills), VOMITING (Threw up several times), FATIGUE (A little bit tired), HEADACHE (Headache) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use not provided.  Treatment for the events included Tylenol and Pepto-Bismol.  Based on the current available information and temporal association between the use of the product and the start date of the events one day after vaccinatonn, a causal relationship cannot be excluded. Further information has been requested; 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 one day after vaccinatonn, a causal relationship cannot be excluded. Further information has been requested
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Stomach felt funny; Nausea; Some chills; Threw up several times; A little bit tired; Headache; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach felt funny), NAUSEA (Nausea), CHILLS (Some chills), VOMITING (Threw up several times) and FATIGUE (A little bit tired) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach felt funny), NAUSEA (Nausea), CHILLS (Some chills), VOMITING (Threw up several times), FATIGUE (A little bit tired), HEADACHE (Headache) and ARTHRALGIA (Joint pain). At the time of the report, ABDOMINAL DISCOMFORT (Stomach felt funny), NAUSEA (Nausea), CHILLS (Some chills), VOMITING (Threw up several times), FATIGUE (A little bit tired), HEADACHE (Headache) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use not provided.  Treatment for the events included Tylenol and Pepto-Bismol.  Based on the current available information and temporal association between the use of the product and the start date of the events one day after vaccinatonn, a causal relationship cannot be excluded. Further information has been requested; 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 one day after vaccinatonn, a causal relationship cannot be excluded. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness
Clinical narrative: stomach is hurting on the bottom left side; extremely dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extremely dizzy) and ABDOMINAL PAIN (stomach is hurting on the bottom left side) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 003B21A) for COVID-19 vaccination.     The patient's past medical history included Stomach pain.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 03-Apr-2021, the patient experienced DIZZINESS (extremely dizzy). On 07-Apr-2021, the patient experienced ABDOMINAL PAIN (stomach is hurting on the bottom left side). At the time of the report, DIZZINESS (extremely dizzy) and ABDOMINAL PAIN (stomach is hurting on the bottom left side) outcome was unknown. Not Provided
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in his arm.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in his arm.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in his arm.). At the time of the report, PAIN IN EXTREMITY (soreness in his arm.) outcome was unknown. Not Provided          No treatment information was provided   Reporter did not allow further contact
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Peripheral swelling, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Allergic reaction; Red rash all over her body; Itchy rash all over her body; Hot rash all over her body; Hands are swollen; Hives, almost sun burn appearance, on legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction), RASH ERYTHEMATOUS (Red rash all over her body), RASH PRURITIC (Itchy rash all over her body), SKIN WARM (Hot rash all over her body) and PERIPHERAL SWELLING (Hands are swollen) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), APIXABAN (ELIQUIS), LOSARTAN 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 1 dosage form. On 05-Apr-2021, the patient experienced ALLERGY TO VACCINE (Allergic reaction), RASH ERYTHEMATOUS (Red rash all over her body), RASH PRURITIC (Itchy rash all over her body), SKIN WARM (Hot rash all over her body), PERIPHERAL SWELLING (Hands are swollen) and URTICARIA (Hives, almost sun burn appearance, on legs). The patient was treated with CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, ALLERGY TO VACCINE (Allergic reaction), RASH ERYTHEMATOUS (Red rash all over her body), RASH PRURITIC (Itchy rash all over her body), SKIN WARM (Hot rash all over her body), PERIPHERAL SWELLING (Hands are swollen) and URTICARIA (Hives, almost sun burn appearance, on legs) was resolving.            Action taken with mRNA-1273 in response to the events was not applicable.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Allergic reaction; Red rash all over her body; Itchy rash all over her body; Hot rash all over her body; Hands are swollen; Hives, almost sun burn appearance, on legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction), RASH ERYTHEMATOUS (Red rash all over her body), RASH PRURITIC (Itchy rash all over her body), SKIN WARM (Hot rash all over her body) and PERIPHERAL SWELLING (Hands are swollen) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), APIXABAN (ELIQUIS), LOSARTAN 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 1 dosage form. On 05-Apr-2021, the patient experienced ALLERGY TO VACCINE (Allergic reaction), RASH ERYTHEMATOUS (Red rash all over her body), RASH PRURITIC (Itchy rash all over her body), SKIN WARM (Hot rash all over her body), PERIPHERAL SWELLING (Hands are swollen) and URTICARIA (Hives, almost sun burn appearance, on legs). The patient was treated with CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, ALLERGY TO VACCINE (Allergic reaction), RASH ERYTHEMATOUS (Red rash all over her body), RASH PRURITIC (Itchy rash all over her body), SKIN WARM (Hot rash all over her body), PERIPHERAL SWELLING (Hands are swollen) and URTICARIA (Hives, almost sun burn appearance, on legs) was resolving.            Action taken with mRNA-1273 in response to the events was not applicable.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Family history included COVID-19 in November 2020.    On 05-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) 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.  No Concomitant product use was reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (very sore arm). At the time of the report, PAIN IN EXTREMITY (very sore arm) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.   Treatment information was not provided.    This case was linked to MOD-2021-069878 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site discomfort
Clinical narrative: Discomfort at the injection site; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Discomfort at the injection site) and FATIGUE (Tiredness) 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 04-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 VACCINATION SITE DISCOMFORT (Discomfort at the injection site) and FATIGUE (Tiredness). At the time of the report, VACCINATION SITE DISCOMFORT (Discomfort at the injection site) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Discomfort, Influenza, Lipoma, Pain in extremity
Clinical narrative: Flu; Fever of 101.1°F; Itchy rashes; bumps on his armpit; lumps all over his arm; pain in the arm; discomfort; This spontaneous case was reported by a health care professional and describes the occurrence of INFLUENZA (Flu), PYREXIA (Fever of 101.1°F), RASH PRURITIC (Itchy rashes), AXILLARY MASS (bumps on his armpit) and LIPOMA (lumps all over his arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017D21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sinusitis since an unknown date.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced INFLUENZA (Flu), PYREXIA (Fever of 101.1°F), RASH PRURITIC (Itchy rashes), AXILLARY MASS (bumps on his armpit), LIPOMA (lumps all over his arm) and PAIN IN EXTREMITY (pain in the arm). 02-Apr-2021, the patient experienced DISCOMFORT (discomfort). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 4 tylenol. At the time of the report, INFLUENZA (Flu), PYREXIA (Fever of 101.1°F), RASH PRURITIC (Itchy rashes), AXILLARY MASS (bumps on his armpit), LIPOMA (lumps all over his arm), PAIN IN EXTREMITY (pain in the arm) and DISCOMFORT (discomfort) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 02- Apr 2021 patient had fever of 101.1 °F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Concomitant medications was not provided by the reporter.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: Flu; Fever of 101.1°F; Itchy rashes; bumps on his armpit; lumps all over his arm; pain in the arm; discomfort; This spontaneous case was reported by a health care professional and describes the occurrence of INFLUENZA (Flu), PYREXIA (Fever of 101.1°F), RASH PRURITIC (Itchy rashes), AXILLARY MASS (bumps on his armpit) and LIPOMA (lumps all over his arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017D21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sinusitis since an unknown date.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced INFLUENZA (Flu), PYREXIA (Fever of 101.1°F), RASH PRURITIC (Itchy rashes), AXILLARY MASS (bumps on his armpit), LIPOMA (lumps all over his arm) and PAIN IN EXTREMITY (pain in the arm). 02-Apr-2021, the patient experienced DISCOMFORT (discomfort). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 4 tylenol. At the time of the report, INFLUENZA (Flu), PYREXIA (Fever of 101.1°F), RASH PRURITIC (Itchy rashes), AXILLARY MASS (bumps on his armpit), LIPOMA (lumps all over his arm), PAIN IN EXTREMITY (pain in the arm) and DISCOMFORT (discomfort) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 02- Apr 2021 patient had fever of 101.1 °F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Concomitant medications was not provided by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: fever of 103; chills; headache; fatigue/extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 103), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue/extremely tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (fever of 103), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue/extremely tired). At the time of the report, PYREXIA (fever of 103), CHILLS (chills) and HEADACHE (headache) outcome was unknown and FATIGUE (fatigue/extremely tired) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was taken.No concomitant medication was taken.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very sore arm) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Very sore arm). At the time of the report, PAIN IN EXTREMITY (Very sore arm) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-069869 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cough, Dizziness, Headache
Clinical narrative: grogginess; chills; severe headache; having the flu; dizzy; tightness in the chest; body aches; slight cough; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (having the flu), DIZZINESS (dizzy), CHEST DISCOMFORT (tightness in the chest), PAIN (body aches) and COUGH (slight cough) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GLIMEPIRIDE and AMLODIPINE for an unknown indication.   On 19-Feb-2021, the patient received first 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) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced INFLUENZA (having the flu), DIZZINESS (dizzy), CHEST DISCOMFORT (tightness in the chest), PAIN (body aches), COUGH (slight cough), CHILLS (chills) and HEADACHE (severe headache). On 21-Mar-2021, the patient experienced SOMNOLENCE (grogginess). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 20-Mar-2021, INFLUENZA (having the flu), DIZZINESS (dizzy), CHEST DISCOMFORT (tightness in the chest), PAIN (body aches), COUGH (slight cough), CHILLS (chills) and HEADACHE (severe headache) had resolved. At the time of the report, SOMNOLENCE (grogginess) had resolved. Not Provided           Action taken with mRNA-1273 in response to events were not applicable.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Pain, Somnolence
Clinical narrative: grogginess; chills; severe headache; having the flu; dizzy; tightness in the chest; body aches; slight cough; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (having the flu), DIZZINESS (dizzy), CHEST DISCOMFORT (tightness in the chest), PAIN (body aches) and COUGH (slight cough) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GLIMEPIRIDE and AMLODIPINE for an unknown indication.   On 19-Feb-2021, the patient received first 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) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced INFLUENZA (having the flu), DIZZINESS (dizzy), CHEST DISCOMFORT (tightness in the chest), PAIN (body aches), COUGH (slight cough), CHILLS (chills) and HEADACHE (severe headache). On 21-Mar-2021, the patient experienced SOMNOLENCE (grogginess). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 20-Mar-2021, INFLUENZA (having the flu), DIZZINESS (dizzy), CHEST DISCOMFORT (tightness in the chest), PAIN (body aches), COUGH (slight cough), CHILLS (chills) and HEADACHE (severe headache) had resolved. At the time of the report, SOMNOLENCE (grogginess) had resolved. Not Provided           Action taken with mRNA-1273 in response to events were not applicable.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Headache; Nausea; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Headache) and NAUSEA (Nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) 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) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). In April 2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.            Concomitant product use was not provided by the reporter.  On 07 Apr 2021, nausea was worst.  The patient did not receive any treatment.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.