chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Palpitations; Runny nose; Fatigue; Body aches/ whole body hurt; Nauseous; Fever; Fever of 101 F; Has to take a deep breath; Could not move her arm; Feeling really sick; Hurt, even her hair; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling really sick), PAIN (Hurt, even her hair), PALPITATIONS (Palpitations), DYSPNOEA (Has to take a deep breath) and LIMB DISCOMFORT (Could not move her arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014m20a and 012m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE for an unknown indication.   On 26-Feb-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 27-Feb-2021, the patient experienced MALAISE (Feeling really sick), PAIN (Hurt, even her hair), DYSPNOEA (Has to take a deep breath) and LIMB DISCOMFORT (Could not move her arm). 27-Feb-2021, the patient experienced PYREXIA (Fever of 101 F). On 28-Feb-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced PALPITATIONS (Palpitations), RHINORRHOEA (Runny nose), FATIGUE (Fatigue), MYALGIA (Body aches/ whole body hurt) and NAUSEA (Nauseous). At the time of the report, MALAISE (Feeling really sick) and PAIN (Hurt, even her hair) outcome was unknown, PALPITATIONS (Palpitations), DYSPNOEA (Has to take a deep breath), LIMB DISCOMFORT (Could not move her arm) and PYREXIA (Fever) was resolving, RHINORRHOEA (Runny nose), FATIGUE (Fatigue) and NAUSEA (Nauseous) had not resolved and MYALGIA (Body aches/ whole body hurt) and PYREXIA (Fever of 101 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 101 (High) Fever of 101 after 2nd dose.         No treatment medication was reported
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Dizziness, Headache, Maternal exposure during pregnancy, Pain
Clinical narrative: throbbing in joints; dizziness; body aches; headache; maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy), ARTHRITIS (throbbing in joints), DIZZINESS (dizziness), PAIN (body aches) and HEADACHE (headache) in a 33-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 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). On 11-Mar-2021, the patient experienced ARTHRITIS (throbbing in joints), DIZZINESS (dizziness), PAIN (body aches) and HEADACHE (headache). On 11-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved. At the time of the report, ARTHRITIS (throbbing in joints), DIZZINESS (dizziness), PAIN (body aches) and HEADACHE (headache) outcome was unknown. Not Provided          Concomitant medications were not reported. Treatment information  was not provided.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Muscular weakness, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Muscle weakness; Difficulty walking; runny nose; aches; pains; Fever 101; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakness), GAIT DISTURBANCE (Difficulty walking), RHINORRHOEA (runny nose), PAIN (aches) and PAIN (pains) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Previously administered products included for an unreported indication: MONOCLONAL ANTIBODIES (Received Bamlanibimab neutralizing antibody treatment.) on 28-Dec-2020.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (Muscle weakness), GAIT DISTURBANCE (Difficulty walking), RHINORRHOEA (runny nose), PAIN (aches), PAIN (pains) and PYREXIA (Fever 101). At the time of the report, MUSCULAR WEAKNESS (Muscle weakness), GAIT DISTURBANCE (Difficulty walking), RHINORRHOEA (runny nose), PAIN (aches), PAIN (pains) and PYREXIA (Fever 101) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Taking antibiotic between doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (Taking antibiotic between doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NO ADVERSE EVENT (Taking antibiotic between doses). At the time of the report, NO ADVERSE EVENT (Taking antibiotic between doses) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment information were not provided.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: patient received three doses of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EXTRA DOSE ADMINISTERED (patient received three doses of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, received third 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 10-Mar-2021, the patient experienced EXTRA DOSE ADMINISTERED (patient received three doses of the vaccine). On 10-Mar-2021, EXTRA DOSE ADMINISTERED (patient received three doses of the vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication reported. No treatment information was provided.  This report refers to a case of Extra dose administered for mRNA-1273 (Lot number: Unknown) with no associated AEs.; Sender's Comments: This report refers to a case of Extra dose administered for mRNA-1273 (Lot number: Unknown) with no associated AEs
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Facial pain, Headache
Clinical narrative: Pain in face; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (Pain in face) and HEADACHE (Headache) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced FACIAL PAIN (Pain in face) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, FACIAL PAIN (Pain in face) and HEADACHE (Headache) outcome was unknown.            No concomitant medication were provided. Action taken for Moderna COVID-19 Vaccine was not applicable.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot to touch; Red rash around injection site; Swelling at the injection site; Itch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE RASH (Red rash around injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PRURITUS (Itch at injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE RASH (Red rash around injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PRURITUS (Itch at injection site). At the time of the report, VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE RASH (Red rash around injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PRURITUS (Itch at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash itches very much; Small rash size of a quarter, gotten much bigger,oval size about 6 inches; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash itches very much) and RASH (Small rash size of a quarter, gotten much bigger,oval size about 6 inches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced RASH (Small rash size of a quarter, gotten much bigger,oval size about 6 inches). On 10-Mar-2021, the patient experienced RASH PRURITIC (Rash itches very much). At the time of the report, RASH PRURITIC (Rash itches very much) and RASH (Small rash size of a quarter, gotten much bigger,oval size about 6 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information included itch cream on the rash.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Injection site itching; Injection site redness; Nausea; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE ERYTHEMA (Injection site redness) and NAUSEA (Nausea) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (Soreness) and NAUSEA (Nausea). On 05-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE ERYTHEMA (Injection site redness). At the time of the report, PAIN (Soreness) and NAUSEA (Nausea) had resolved and VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Fatigue, Illness, Vaccination site pain
Clinical narrative: became sick after second dose; could not get out of bed; Little sore arm; could not get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (became sick after second dose), BEDRIDDEN (could not get out of bed), VACCINATION SITE PAIN (Little sore arm) and FATIGUE (could not get out of bed) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart failure, Hypertension, COPD, Kidney failure and Overweight.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced ILLNESS (became sick after second dose), BEDRIDDEN (could not get out of bed), VACCINATION SITE PAIN (Little sore arm) and FATIGUE (could not get out of bed). At the time of the report, ILLNESS (became sick after second dose), BEDRIDDEN (could not get out of bed), VACCINATION SITE PAIN (Little sore arm) and FATIGUE (could not get out of bed) outcome was unknown.            No Treatment information was provided. The patient's passed medical history was not provided. Concomitant medications was not provided.   This case was linked to MOD21-074459 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow-up received on 13-04-2021:Added events like became sick after second dose, could not get out of bed.; Sender's Comments:  MOD21-074459:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Heart rate, Palpitations
Clinical narrative: Dizziness; Palpitation; Shortness of breath; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PALPITATIONS (Palpitation), DYSPNOEA (Shortness of breath) and FATIGUE (Fatigue) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-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 DIZZINESS (Dizziness), PALPITATIONS (Palpitation), DYSPNOEA (Shortness of breath) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Dizziness), PALPITATIONS (Palpitation), DYSPNOEA (Shortness of breath) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Heart rate: 120-130 breaths per minute (Inconclusive) 120-130 beats per minutes. On an unknown date, Heart rate: 170 breaths per minute (High) 170 when climbing steers..         No concomitant medications were provided.  On 05-Mar-2021 and 09-Mar-2021 the patient sought medical attention at the Emergency Room (ER) where she was placed under observation for 7 hours and 4 hours, respectively. On both occasions, the Physician thought her symptoms were due to the vaccine.  No treatment was reported for the events.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Malaise
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE and BLOOD PRESSURE INCREASED in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 011J20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included METOPROLOL TARTRATE, LISINOPRIL, SIMVASTATIN, CLOPIDOGREL, CALCIUM CARBONATE, VITAMIN D, ZINC, and DOXYCYCLINE MONOHYDRATE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced MALAISE and BLOOD PRESSURE INCREASED. At the time of the report, MALAISE and BLOOD PRESSURE INCREASED outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood pressure measurement: 161/102 (High) (his normal range was 160/72). On 11-Mar-2021, Heart rate: 67 (Inconclusive) bpm.         Concomitant medications included clear lungs extra strength two a day. No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain and soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain and soreness at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported).    On 05-Mar-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021 at 11:00 PM, the patient experienced VACCINATION SITE PAIN (Pain and soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain and soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment details was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: Pain in top of arm; Pain going up to neck; Pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in top of arm), NECK PAIN (Pain going up to neck) and ARTHRALGIA (Pain in shoulder) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m20a) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), LEVOTHYROXINE SODIUM (SYNTHROID) and METOPROLOL TARTRATE (METOPROLOL - 1 A PHARMA) for an unknown indication.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in top of arm), NECK PAIN (Pain going up to neck) and ARTHRALGIA (Pain in shoulder). At the time of the report, PAIN IN EXTREMITY (Pain in top of arm), NECK PAIN (Pain going up to neck) and ARTHRALGIA (Pain in shoulder) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up received on 05-05-2021: Resolved all the events.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Dizziness, Dyspnoea, Gastrooesophageal reflux disease
Clinical narrative: GERD; Dizziness soon; Armpit glands swollen; Shortness of breath; Severe chest pain; Severe headache; Nauseous; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (GERD), DIZZINESS (Dizziness soon), AXILLARY PAIN (Armpit glands swollen), DYSPNOEA (Shortness of breath) and CHEST PAIN (Severe chest pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included RISPERIDONE (RISPERDAL), SIMVASTATIN, TAMSULOSIN, FINASTERIDE and PANTOPRAZOLE for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (GERD), DIZZINESS (Dizziness soon), AXILLARY PAIN (Armpit glands swollen), DYSPNOEA (Shortness of breath), CHEST PAIN (Severe chest pain), HEADACHE (Severe headache), NAUSEA (Nauseous) and VOMITING (Throwing up). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Mar-2021, GASTROOESOPHAGEAL REFLUX DISEASE (GERD) outcome was unknown and DIZZINESS (Dizziness soon), AXILLARY PAIN (Armpit glands swollen), DYSPNOEA (Shortness of breath), CHEST PAIN (Severe chest pain), HEADACHE (Severe headache), NAUSEA (Nauseous) and VOMITING (Throwing up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: GERD; Dizziness soon; Armpit glands swollen; Shortness of breath; Severe chest pain; Severe headache; Nauseous; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (GERD), DIZZINESS (Dizziness soon), AXILLARY PAIN (Armpit glands swollen), DYSPNOEA (Shortness of breath) and CHEST PAIN (Severe chest pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included RISPERIDONE (RISPERDAL), SIMVASTATIN, TAMSULOSIN, FINASTERIDE and PANTOPRAZOLE for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (GERD), DIZZINESS (Dizziness soon), AXILLARY PAIN (Armpit glands swollen), DYSPNOEA (Shortness of breath), CHEST PAIN (Severe chest pain), HEADACHE (Severe headache), NAUSEA (Nauseous) and VOMITING (Throwing up). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Mar-2021, GASTROOESOPHAGEAL REFLUX DISEASE (GERD) outcome was unknown and DIZZINESS (Dizziness soon), AXILLARY PAIN (Armpit glands swollen), DYSPNOEA (Shortness of breath), CHEST PAIN (Severe chest pain), HEADACHE (Severe headache), NAUSEA (Nauseous) and VOMITING (Throwing up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain, Pain in extremity, Vaccination site discolouration
Clinical narrative: Pink; Arm hurting the three days after the shot; A lot more body aches; it was warm; deep severe itch; arm was in pain and she could see the injection site; It was swollen; I t was red; Very sore arm; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Pink), PAIN IN EXTREMITY (Arm hurting the three days after the shot), PAIN (A lot more body aches), VACCINATION SITE WARMTH (it was warm) and VACCINATION SITE PRURITUS (deep severe itch) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis, Osteoporosis, Fibromyalgia, Hypertension, Hyperthyroidism since 1981, Osteoarthritis (Experienced much more pain than usual.) since 2019, Reactive airways disease and Drug allergy (Amoxicillin). Concomitant products included VITAMINS NOS for Vitamin supplementation, LEVOTHYROXINE, PRAVASTATIN from 12-Feb-2021 to an unknown date, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) and METOPROLOL for an unknown indication.   On 26-Feb-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021 at 3:25 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Pink), PAIN IN EXTREMITY (Arm hurting the three days after the shot), PAIN (A lot more body aches), VACCINATION SITE WARMTH (it was warm), VACCINATION SITE PRURITUS (deep severe itch), VACCINATION SITE PAIN (arm was in pain and she could see the injection site), VACCINATION SITE SWELLING (It was swollen), VACCINATION SITE ERYTHEMA (I t was red), MYALGIA (Very sore arm) and HEADACHE (Slight headache). At the time of the report, VACCINATION SITE DISCOLOURATION (Pink), PAIN IN EXTREMITY (Arm hurting the three days after the shot), PAIN (A lot more body aches), VACCINATION SITE WARMTH (it was warm), VACCINATION SITE PRURITUS (deep severe itch), VACCINATION SITE PAIN (arm was in pain and she could see the injection site), VACCINATION SITE SWELLING (It was swollen), VACCINATION SITE ERYTHEMA (I t was red), MYALGIA (Very sore arm) and HEADACHE (Slight headache) had resolved.            Treatment Used anti-itch cream on arm and went to sleep. Took nothing for the pain   This case was linked to MOD-2021-186809 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: Follow-up document was received with Initial receipt date retained as 11-MAR-2021 and safety received date on 26-MAY-2021. Patient's information including height, weight, race, ethnicity,dosage details, medical history, concomitant medications, additional event and event outcome were updated. It contains significant information.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pink; Arm hurting the three days after the shot; A lot more body aches; it was warm; deep severe itch; arm was in pain and she could see the injection site; It was swollen; I t was red; Very sore arm; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Pink), PAIN IN EXTREMITY (Arm hurting the three days after the shot), PAIN (A lot more body aches), VACCINATION SITE WARMTH (it was warm) and VACCINATION SITE PRURITUS (deep severe itch) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis, Osteoporosis, Fibromyalgia, Hypertension, Hyperthyroidism since 1981, Osteoarthritis (Experienced much more pain than usual.) since 2019, Reactive airways disease and Drug allergy (Amoxicillin). Concomitant products included VITAMINS NOS for Vitamin supplementation, LEVOTHYROXINE, PRAVASTATIN from 12-Feb-2021 to an unknown date, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) and METOPROLOL for an unknown indication.   On 26-Feb-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021 at 3:25 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Pink), PAIN IN EXTREMITY (Arm hurting the three days after the shot), PAIN (A lot more body aches), VACCINATION SITE WARMTH (it was warm), VACCINATION SITE PRURITUS (deep severe itch), VACCINATION SITE PAIN (arm was in pain and she could see the injection site), VACCINATION SITE SWELLING (It was swollen), VACCINATION SITE ERYTHEMA (I t was red), MYALGIA (Very sore arm) and HEADACHE (Slight headache). At the time of the report, VACCINATION SITE DISCOLOURATION (Pink), PAIN IN EXTREMITY (Arm hurting the three days after the shot), PAIN (A lot more body aches), VACCINATION SITE WARMTH (it was warm), VACCINATION SITE PRURITUS (deep severe itch), VACCINATION SITE PAIN (arm was in pain and she could see the injection site), VACCINATION SITE SWELLING (It was swollen), VACCINATION SITE ERYTHEMA (I t was red), MYALGIA (Very sore arm) and HEADACHE (Slight headache) had resolved.            Treatment Used anti-itch cream on arm and went to sleep. Took nothing for the pain   This case was linked to MOD-2021-186809 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: Follow-up document was received with Initial receipt date retained as 11-MAR-2021 and safety received date on 26-MAY-2021. Patient's information including height, weight, race, ethnicity,dosage details, medical history, concomitant medications, additional event and event outcome were updated. It contains significant information.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA (paresthesia on their left side (arms)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 008B21A) for COVID-19 vaccination. Concurrent medical conditions included Osteoarthritis since 02-Jan-2007, Hyperlipemia since 02-Jan-2000 and Actinic keratosis since 02-Jan-1995. Concomitant products included SIMVASTATIN from 02-Jan-2010 to an unknown date for Hyperlipidemia, ACETAMINOPHEN from 02-Jan-2007 to an unknown date, CURCUMA LONGA (TURMERIC CURCUMIN [CURCUMA LONGA]) from 11-Jan-2020 to an unknown date, CALCIUM CARBONATE from 02-Jan-2000 to an unknown date and COLECALCIFEROL (VIT D3) from 05-Jan-2009 to an unknown date for Osteoarthritis, PARACETAMOL (ACETAMINOPHEN EXTRA STRENGTH), MAGNESIUM, FAMOTIDINE and VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) for an unknown indication. On 16-Jan-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jan-2021 at 2:00 PM, the patient experienced PARAESTHESIA (paresthesias on their left side (arms)). On 22-Jan-2021, PARAESTHESIA (paresthesias on their left side (arms)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Reportedly, the patient stated experiencing patches of parasthesias 5 to 10 cm in diameter on the skin of her upper arms and legs. These parasthesias gradually subsided after about 5 days. The patient never sought medical attention other than asking her husband, who is a retired family physician. The patient took the second dose on schedule four weeks later, and had no recurrence of the parathesias. Treatment information was not provided by reporter. Action taken with mRNA-1273 was not applicable. This case was linked to MOD-2021-040841. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up received on 04-MAY-2021. Reporter details was reported. Patient details was reported. Suspect vaccine was updated. Event and outcome was reported. Concomitant medication was reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills; Fever (100,2°F); Little Headache; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills), PYREXIA (Fever (100,2°F)) and HEADACHE (Little Headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21H) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever (100,2°F)) and HEADACHE (Little Headache). At the time of the report, CHILLS (Chills), PYREXIA (Fever (100,2°F)) and HEADACHE (Little Headache) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable No concomitant medication was provided.  No treatment information provided.   This case was linked to MOD-2021-031782 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Dyspnoea, Headache, Myalgia
Clinical narrative: severe Diarrhoea; leg felt like pins and needles; cough; patient keeps running out of breath; headache; fever; could not sleep 3 nights; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe Diarrhoea), PAIN IN EXTREMITY (leg felt like pins and needles), COUGH (cough), DYSPNOEA (patient keeps running out of breath) and MYALGIA (sore arm) in a 62-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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced MYALGIA (sore arm). On 07-Mar-2021, the patient experienced DIARRHOEA (severe Diarrhoea), PAIN IN EXTREMITY (leg felt like pins and needles), COUGH (cough), DYSPNOEA (patient keeps running out of breath), HEADACHE (headache), PYREXIA (fever) and SLEEP DISORDER (could not sleep 3 nights). On 09-Mar-2021, SLEEP DISORDER (could not sleep 3 nights) had resolved. At the time of the report, DIARRHOEA (severe Diarrhoea) had not resolved and PAIN IN EXTREMITY (leg felt like pins and needles), COUGH (cough), DYSPNOEA (patient keeps running out of breath), MYALGIA (sore arm), HEADACHE (headache) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patients treatment information included Tylenol & Pregablin.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: severe Diarrhoea; leg felt like pins and needles; cough; patient keeps running out of breath; headache; fever; could not sleep 3 nights; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe Diarrhoea), PAIN IN EXTREMITY (leg felt like pins and needles), COUGH (cough), DYSPNOEA (patient keeps running out of breath) and MYALGIA (sore arm) in a 62-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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced MYALGIA (sore arm). On 07-Mar-2021, the patient experienced DIARRHOEA (severe Diarrhoea), PAIN IN EXTREMITY (leg felt like pins and needles), COUGH (cough), DYSPNOEA (patient keeps running out of breath), HEADACHE (headache), PYREXIA (fever) and SLEEP DISORDER (could not sleep 3 nights). On 09-Mar-2021, SLEEP DISORDER (could not sleep 3 nights) had resolved. At the time of the report, DIARRHOEA (severe Diarrhoea) had not resolved and PAIN IN EXTREMITY (leg felt like pins and needles), COUGH (cough), DYSPNOEA (patient keeps running out of breath), MYALGIA (sore arm), HEADACHE (headache) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patients treatment information included Tylenol & Pregablin.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test negative, SARS-CoV-2 antibody test
Clinical narrative: Took 2 doses of Moderna COVID-19 vaccine and IGG antibodies test 1 month later came nonreactive; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANTIBODY TEST NEGATIVE (Took 2 doses of Moderna COVID-19 vaccine and IGG antibodies test 1 month later came nonreactive) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Kidney polycystic in 1978 and Kidney transplant (Kidney transplant in November 2006.) in November 2006. Concurrent medical conditions included Allergy to antibiotic (Amoxycillin), Allergy to antibiotic (Doxycycline), Drug allergy (Percocet), Drug allergy (Allipurinol) and Drug allergy (Zestril). Concomitant products included EZETIMIBE, SIMVASTATIN (VYTORIN) for Cholesterol, MYCOPHENOLATE MOFETIL (MYCOPHENOLATE), SIROLIMUS and PREDNISONE for Kidney transplant, SITAGLIPTIN PHOSPHATE (JANUVIA) for Sugar blood increased, ACETYLSALICYLIC ACID (BABY ASPIRIN), COLCHICINE (COLCRYS), DOCUSATE, FAMOTIDINE, TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), METOPROLOL and NICOTINAMIDE for an unknown indication.   On 12-Jan-2021 at 10:29 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021 at 11:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021 at 4:14 PM, the patient experienced ANTIBODY TEST NEGATIVE (Took 2 doses of Moderna COVID-19 vaccine and IGG antibodies test 1 month later came nonreactive). At the time of the report, ANTIBODY TEST NEGATIVE (Took 2 doses of Moderna COVID-19 vaccine and IGG antibodies test 1 month later came nonreactive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, SARS-CoV-2 antibody test: negative (Negative) Negative and unreactive.         No treatment medication was provided.  Description: The patient's doctor told him that these results mean he had not developed immunity to the COVID-19 virus.  Company Comment  Some immunosuppressants drug have been found to reduce the effectiveness of COVID vaccines as such causal relationship cannot be excluded   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up received updated patient demographics, medical history, concomitant medications.; Sender's Comments: Some immunosuppressants drug have been found to reduce the effectiveness of COVID vaccines as such causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: rash non injection site arm; bumps non injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (bumps non injection site arm) and RASH (rash non injection site arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for an unknown indication.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced LYMPHADENOPATHY (bumps non injection site arm). On 05-Mar-2021, the patient experienced RASH (rash non injection site arm). At the time of the report, LYMPHADENOPATHY (bumps non injection site arm) and RASH (rash non injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE LYMPHADENOPATHY (bumps non injection site arm) and RASH (rash non injection site arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for an unknown indication.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 04-Mar-2021, the patient experienced INJECTION SITE LYMPHADENOPATHY (bumps non injection site arm). On 05-Mar-2021, the patient experienced RASH (rash non injection site arm). At the time of the report, INJECTION SITE LYMPHADENOPATHY (bumps non injection site arm) and RASH (rash non injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Consumer denied for further follow-up, she is doing good.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: BRCA2 gene mutation assay, Cardiac stress test, Feeding disorder, Headache, Muscle tightness
Clinical narrative: Little bit of a sore arm; Jaw felt like it was locked; Tightness in the jaw; Jaw started to ache, she thought that it was probably joint pain; Difficulty eating; Intense nausea; Head felt kuke she was hit with a bat / a little bit headachy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little bit of a sore arm), TRISMUS (Jaw felt like it was locked), MUSCLE TIGHTNESS (Tightness in the jaw), TEMPOROMANDIBULAR JOINT SYNDROME (Jaw started to ache, she thought that it was probably joint pain) and FEEDING DISORDER (Difficulty eating) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lymphoedema (Left arm) in 2002 and BRCA2 gene mutation in 2009. Concomitant products included MULTIVITAMIN [VITAMINS NOS], CURCUMA LONGA ROOT (TURMERIC [CURCUMA LONGA ROOT]), ZINC and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Little bit of a sore arm), TRISMUS (Jaw felt like it was locked), MUSCLE TIGHTNESS (Tightness in the jaw), TEMPOROMANDIBULAR JOINT SYNDROME (Jaw started to ache, she thought that it was probably joint pain), FEEDING DISORDER (Difficulty eating), NAUSEA (Intense nausea) and HEADACHE (Head felt kuke she was hit with a bat / a little bit headachy). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Little bit of a sore arm), TRISMUS (Jaw felt like it was locked), MUSCLE TIGHTNESS (Tightness in the jaw), TEMPOROMANDIBULAR JOINT SYNDROME (Jaw started to ache, she thought that it was probably joint pain), FEEDING DISORDER (Difficulty eating), NAUSEA (Intense nausea) and HEADACHE (Head felt kuke she was hit with a bat / a little bit headachy) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2009, BRCA2 gene mutation assay: positive (Positive) Positive. On an unknown date, Cardiac stress test: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-276557 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: updated reporter details, patient demographics, New event and lab data added
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Temporomandibular joint syndrome, Trismus
Clinical narrative: Little bit of a sore arm; Jaw felt like it was locked; Tightness in the jaw; Jaw started to ache, she thought that it was probably joint pain; Difficulty eating; Intense nausea; Head felt kuke she was hit with a bat / a little bit headachy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little bit of a sore arm), TRISMUS (Jaw felt like it was locked), MUSCLE TIGHTNESS (Tightness in the jaw), TEMPOROMANDIBULAR JOINT SYNDROME (Jaw started to ache, she thought that it was probably joint pain) and FEEDING DISORDER (Difficulty eating) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lymphoedema (Left arm) in 2002 and BRCA2 gene mutation in 2009. Concomitant products included MULTIVITAMIN [VITAMINS NOS], CURCUMA LONGA ROOT (TURMERIC [CURCUMA LONGA ROOT]), ZINC and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Little bit of a sore arm), TRISMUS (Jaw felt like it was locked), MUSCLE TIGHTNESS (Tightness in the jaw), TEMPOROMANDIBULAR JOINT SYNDROME (Jaw started to ache, she thought that it was probably joint pain), FEEDING DISORDER (Difficulty eating), NAUSEA (Intense nausea) and HEADACHE (Head felt kuke she was hit with a bat / a little bit headachy). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Little bit of a sore arm), TRISMUS (Jaw felt like it was locked), MUSCLE TIGHTNESS (Tightness in the jaw), TEMPOROMANDIBULAR JOINT SYNDROME (Jaw started to ache, she thought that it was probably joint pain), FEEDING DISORDER (Difficulty eating), NAUSEA (Intense nausea) and HEADACHE (Head felt kuke she was hit with a bat / a little bit headachy) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2009, BRCA2 gene mutation assay: positive (Positive) Positive. On an unknown date, Cardiac stress test: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-276557 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: updated reporter details, patient demographics, New event and lab data added
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pyrexia
Clinical narrative: Weakness; Fever; A spontaneous report was received from a consumer concerning a 84-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever and weakness.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on an unknown date. On 03 Mar 2021, at around 11:30 am, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 013M00A) Intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events fever and weakness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, fever and weakness was unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Company assessed the events to be unlikely related to company product.