chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Mood swings, Pharyngeal swelling
Clinical narrative: Not feeling well/not expecting to feel the way he feels; Tired; Confused (meaning he could not put thoughts together); Moody; Throat swelled up; Could not breath; Started to sweat; Eyes hurts; Joint hurts; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confused (meaning he could not put thoughts together)), MOOD SWINGS (Moody), PHARYNGEAL SWELLING (Throat swelled up), DYSPNOEA (Could not breath) and HYPERHIDROSIS (Started to sweat) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE, LOSARTAN and SPIRONOLACTONE for an unknown indication.    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient experienced PHARYNGEAL SWELLING (Throat swelled up), DYSPNOEA (Could not breath), HYPERHIDROSIS (Started to sweat), EYE PAIN (Eyes hurts) and ARTHRALGIA (Joint hurts). On 04-Oct-2021, the patient experienced CONFUSIONAL STATE (Confused (meaning he could not put thoughts together)), MOOD SWINGS (Moody) and FATIGUE (Tired). On an unknown date, the patient experienced MALAISE (Not feeling well/not expecting to feel the way he feels). At the time of the report, CONFUSIONAL STATE (Confused (meaning he could not put thoughts together)) and MOOD SWINGS (Moody) was resolving and PHARYNGEAL SWELLING (Throat swelled up), DYSPNOEA (Could not breath), HYPERHIDROSIS (Started to sweat), EYE PAIN (Eyes hurts), MALAISE (Not feeling well/not expecting to feel the way he feels), ARTHRALGIA (Joint hurts) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Three days after vaccination patient noted that his thyroid medication was not working.  No treatment information was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Heart rate
Clinical narrative: side effects; Sore throat; Ringing in the ears; Diarrhea; rash for 7 days; Tiredness; Headache; Muscle pain; Chills; Fever over a hundred; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects), OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea) and RASH (rash for 7 days) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (symptoms were headache, ringing in the ears and diarrhea one time).    On 08-Sep-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 COMPLICATION (side effects), OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea), RASH (rash for 7 days), FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever over a hundred) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION COMPLICATION (side effects), OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea), RASH (rash for 7 days), FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever over a hundred) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) Fast heart rate/fast heart rate which comes and goes.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported.   This case was linked to MOD-2021-348398 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: side effects; Sore throat; Ringing in the ears; Diarrhea; rash for 7 days; Tiredness; Headache; Muscle pain; Chills; Fever over a hundred; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects), OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea) and RASH (rash for 7 days) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (symptoms were headache, ringing in the ears and diarrhea one time).    On 08-Sep-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 COMPLICATION (side effects), OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea), RASH (rash for 7 days), FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever over a hundred) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION COMPLICATION (side effects), OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea), RASH (rash for 7 days), FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever over a hundred) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) Fast heart rate/fast heart rate which comes and goes.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported.   This case was linked to MOD-2021-348398 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination complication
Clinical narrative: side effects; Sore throat; Ringing in the ears; Diarrhea; rash for 7 days; Tiredness; Headache; Muscle pain; Chills; Fever over a hundred; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects), OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea) and RASH (rash for 7 days) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (symptoms were headache, ringing in the ears and diarrhea one time).    On 08-Sep-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 COMPLICATION (side effects), OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea), RASH (rash for 7 days), FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever over a hundred) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION COMPLICATION (side effects), OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea), RASH (rash for 7 days), FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever over a hundred) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) Fast heart rate/fast heart rate which comes and goes.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported.   This case was linked to MOD-2021-348398 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Histamine reaction/Itching from head to toe; Can not sleep at night; Injection site was warm; Itchy Injection site; Injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Histamine reaction/Itching from head to toe), INSOMNIA (Can not sleep at night), VACCINATION SITE WARMTH (Injection site was warm), VACCINATION SITE PRURITUS (Itchy Injection site) and VACCINATION SITE SWELLING (Injection site was swollen) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Allergic to Sulfa), Cancer and Diabetes.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced PRURITUS (Histamine reaction/Itching from head to toe), INSOMNIA (Can not sleep at night), VACCINATION SITE WARMTH (Injection site was warm), VACCINATION SITE PRURITUS (Itchy Injection site) and VACCINATION SITE SWELLING (Injection site was swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at a dose of 1 dosage form and PREDNISONE for Itching, at a dose of 1 dosage form. In August 2021, VACCINATION SITE WARMTH (Injection site was warm) and VACCINATION SITE SWELLING (Injection site was swollen) had resolved. At the time of the report, PRURITUS (Histamine reaction/Itching from head to toe) and VACCINATION SITE PRURITUS (Itchy Injection site) had not resolved and INSOMNIA (Can not sleep at night) outcome was unknown.            It was reported that as long as the patient takes Benadryl, the itching stopped but when the patient stopped taking Benadryl, the itching came back. Patient stated that her 70-year old brother and 55 year old sister having same reaction with third dose were all allergic to sulfa. Patient was not sure if the third dose was administered in the muscle.   No concomitant medications were reported   This case was linked to MOD-2021-046381 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore right arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunosuppression.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore right arm). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. On 04-Mar-2021, VACCINATION SITE PAIN (Sore right arm) had resolved.            It was reported that patient was taking immunosuppressive medications.   This case was linked to MOD-2021-348356 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Follow up received included batch number of suspect drug and reporter address and updated start date of second dose.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: both her shoulder blades down to her lower back, she had excruciating pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (both her shoulder blades down to her lower back, she had excruciating pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced ARTHRALGIA (both her shoulder blades down to her lower back, she had excruciating pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK, as necessary. On 20-Sep-2021, ARTHRALGIA (both her shoulder blades down to her lower back, she had excruciating pain) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-348431 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-348431:dose 2
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Sore throat; Ringing in the ears; Diarrhea; Fast heart rate; Rash for 7 days; Tiredness; Headache; Muscle pain; Chills; Fever over a hundred; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea), HEART RATE INCREASED (Fast heart rate) and RASH (Rash for 7 days) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (symptoms were headache, ringing in the ears and diarrhea one time).    On 06-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea), HEART RATE INCREASED (Fast heart rate), RASH (Rash for 7 days), FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever over a hundred) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea), RASH (Rash for 7 days), FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever over a hundred) and NAUSEA (Nausea) had resolved and HEART RATE INCREASED (Fast heart rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: over a hundred (High) over a hundred.         No concomitants drugs were provided. Future date (23-DEC-2021) was captured for the Historical Condition Covid -19 in the source document. Patient mentioned that EVENT Fast heart rate comes and goes.   This case was linked to MOD-2021-348365 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Myalgia, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat; Ringing in the ears; Diarrhea; Fast heart rate; Rash for 7 days; Tiredness; Headache; Muscle pain; Chills; Fever over a hundred; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea), HEART RATE INCREASED (Fast heart rate) and RASH (Rash for 7 days) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (symptoms were headache, ringing in the ears and diarrhea one time).    On 06-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea), HEART RATE INCREASED (Fast heart rate), RASH (Rash for 7 days), FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever over a hundred) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea), RASH (Rash for 7 days), FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever over a hundred) and NAUSEA (Nausea) had resolved and HEART RATE INCREASED (Fast heart rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: over a hundred (High) over a hundred.         No concomitants drugs were provided. Future date (23-DEC-2021) was captured for the Historical Condition Covid -19 in the source document. Patient mentioned that EVENT Fast heart rate comes and goes.   This case was linked to MOD-2021-348365 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Tinnitus
Clinical narrative: Sore throat; Ringing in the ears; Diarrhea; Fast heart rate; Rash for 7 days; Tiredness; Headache; Muscle pain; Chills; Fever over a hundred; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea), HEART RATE INCREASED (Fast heart rate) and RASH (Rash for 7 days) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (symptoms were headache, ringing in the ears and diarrhea one time).    On 06-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea), HEART RATE INCREASED (Fast heart rate), RASH (Rash for 7 days), FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever over a hundred) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea), RASH (Rash for 7 days), FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever over a hundred) and NAUSEA (Nausea) had resolved and HEART RATE INCREASED (Fast heart rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: over a hundred (High) over a hundred.         No concomitants drugs were provided. Future date (23-DEC-2021) was captured for the Historical Condition Covid -19 in the source document. Patient mentioned that EVENT Fast heart rate comes and goes.   This case was linked to MOD-2021-348365 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hypoaesthesia, Paraesthesia
Clinical narrative: tickling in her legs; numbness in her legs; was falling; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tickling in her legs), HYPOAESTHESIA (numbness in her legs) and FALL (was falling) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PARAESTHESIA (tickling in her legs), HYPOAESTHESIA (numbness in her legs) and FALL (was falling). At the time of the report, PARAESTHESIA (tickling in her legs), HYPOAESTHESIA (numbness in her legs) and FALL (was falling) outcome was unknown.            No concomitant medication was provided.        No treatment information was provided.   This case was linked to MOD-2021-348433 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Feeling hot, Hypoaesthesia, Tinnitus
Clinical narrative: bone aches/bone sensation/fore arm's bone aches; lower part of palm is numb; feels like someone is pouring warm water in the lower part of the leg, below the knee sensation of something warm spilled in the muscle towards the other leg; sore in the shoulder; constant tinnitus/constant ringing in my ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (constant tinnitus/constant ringing in my ears), BONE PAIN (bone aches/bone sensation/fore arm's bone aches), HYPOAESTHESIA (lower part of palm is numb), FEELING HOT (feels like someone is pouring warm water in the lower part of the leg, below the knee sensation of something warm spilled in the muscle towards the other leg) and ARTHRALGIA (sore in the shoulder) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     Concomitant products included METFORMIN HYDROCHLORIDE (MEFORMIN), HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN + HIDROCLOROTIAZIDA), ATORVASTATIN, COLECALCIFEROL (VITAMIN D3), GLUCOSAMINE and ASCORBIC ACID, RETINOL, TOCOPHEROL (OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL]) for an unknown indication.    On 25-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Sep-2021, the patient experienced TINNITUS (constant tinnitus/constant ringing in my ears). On an unknown date, the patient experienced BONE PAIN (bone aches/bone sensation/fore arm's bone aches), HYPOAESTHESIA (lower part of palm is numb), FEELING HOT (feels like someone is pouring warm water in the lower part of the leg, below the knee sensation of something warm spilled in the muscle towards the other leg) and ARTHRALGIA (sore in the shoulder). At the time of the report, TINNITUS (constant tinnitus/constant ringing in my ears), BONE PAIN (bone aches/bone sensation/fore arm's bone aches), HYPOAESTHESIA (lower part of palm is numb), FEELING HOT (feels like someone is pouring warm water in the lower part of the leg, below the knee sensation of something warm spilled in the muscle towards the other leg) and ARTHRALGIA (sore in the shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medication includes Vitamins for eyes,Low dose aspirin,Visual pills, fiber supplements. No treatment medications were reported.    This case was linked to MOD21-151515, MOD-2021-347991 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: very, very sore arm; somewhat fatigued; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (very, very sore arm) and FATIGUE (somewhat fatigued) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A, 016B21A and 048C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included PREDNISONE for Asthma.   On 20-Feb-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 21-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced MYALGIA (very, very sore arm) and FATIGUE (somewhat fatigued). On 22-Feb-2021, MYALGIA (very, very sore arm) and FATIGUE (somewhat fatigued) had resolved.            Patient was placed on a double dose or prednisone for asthma. Patient experienced the same side effects after getting the 1st, 2nd and 3rd doses.  Patient felt fatigue for 24 hours. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-348439, MOD-2021-348441 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Gait disturbance
Clinical narrative: problems with catching deep breaths; problems moving around easily; The pain radiates to the middle of her back down to her lower back; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (problems with catching deep breaths), GAIT DISTURBANCE (problems moving around easily) and BACK PAIN (The pain radiates to the middle of her back down to her lower back) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 050E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, the patient experienced DYSPNOEA (problems with catching deep breaths), GAIT DISTURBANCE (problems moving around easily) and BACK PAIN (The pain radiates to the middle of her back down to her lower back). At the time of the report, DYSPNOEA (problems with catching deep breaths), GAIT DISTURBANCE (problems moving around easily) and BACK PAIN (The pain radiates to the middle of her back down to her lower back) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No Treatments were reported.   This case was linked to MOD-2021-348389 (E2B Linked Report).; Sender's Comments:  -MOD-2021-348389:dose 1
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site erythema
Clinical narrative: arm  so heavy she could not lift her arm  for 14 days; arm  turned bright red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm  turned bright red) and LIMB DISCOMFORT (arm  so heavy she could not lift her arm  for 14 days) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm  turned bright red) and LIMB DISCOMFORT (arm  so heavy she could not lift her arm  for 14 days). On 16-Feb-2021, VACCINATION SITE ERYTHEMA (arm  turned bright red) outcome was unknown and LIMB DISCOMFORT (arm  so heavy she could not lift her arm  for 14 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided  No treatment medications were provided.   This case was linked to MOD-2021-348400 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a physician and describes the occurrence of RASH (Rash) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) had not resolved.        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.   Concomitant medication use was not provided.  Treatment information was not reported.   This case was linked to MOD-2021-348460 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hypersensitivity, Myalgia, Nausea
Clinical narrative: Hives all over body from the neck down; It started as a prickly rash that developed into hives overnight; Chills; Nausea; Muscle ache; Joint ache; Allergic reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (Hives all over body from the neck down), RASH (It started as a prickly rash that developed into hives overnight), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Muscle ache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021, the patient experienced URTICARIA (Hives all over body from the neck down), RASH (It started as a prickly rash that developed into hives overnight), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Muscle ache), ARTHRALGIA (Joint ache) and HYPERSENSITIVITY (Allergic reaction). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK dosage form. At the time of the report, URTICARIA (Hives all over body from the neck down), RASH (It started as a prickly rash that developed into hives overnight), CHILLS (Chills), MYALGIA (Muscle ache), ARTHRALGIA (Joint ache) and HYPERSENSITIVITY (Allergic reaction) had not resolved and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives all over body from the neck down; It started as a prickly rash that developed into hives overnight; Chills; Nausea; Muscle ache; Joint ache; Allergic reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (Hives all over body from the neck down), RASH (It started as a prickly rash that developed into hives overnight), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Muscle ache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021, the patient experienced URTICARIA (Hives all over body from the neck down), RASH (It started as a prickly rash that developed into hives overnight), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Muscle ache), ARTHRALGIA (Joint ache) and HYPERSENSITIVITY (Allergic reaction). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK dosage form. At the time of the report, URTICARIA (Hives all over body from the neck down), RASH (It started as a prickly rash that developed into hives overnight), CHILLS (Chills), MYALGIA (Muscle ache), ARTHRALGIA (Joint ache) and HYPERSENSITIVITY (Allergic reaction) had not resolved and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Somewhat fatigued; Very, very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Somewhat fatigued) and MYALGIA (Very, very sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 20-Feb-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 31-Mar-2021, the patient experienced FATIGUE (Somewhat fatigued) and MYALGIA (Very, very sore arm). The patient was treated with PREDNISONE for Asthma, at an unspecified dose and frequency. On 01-Apr-2021, FATIGUE (Somewhat fatigued) and MYALGIA (Very, very sore arm) had resolved.            No Concomitant medication was reported.   This case was linked to MOD-2021-348409, MOD-2021-348441 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: she had a headache at the back of the neck rather than the temple; very, very sore arm; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very, very sore arm), FATIGUE (fatigued) and HEADACHE (she had a headache at the back of the neck rather than the temple) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included PREDNISONE for an unknown indication.    On 21-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced PAIN IN EXTREMITY (very, very sore arm) and FATIGUE (fatigued). On 23-Sep-2021, the patient experienced HEADACHE (she had a headache at the back of the neck rather than the temple). On 23-Sep-2021, PAIN IN EXTREMITY (very, very sore arm) and FATIGUE (fatigued) had resolved. On 26-Sep-2021, HEADACHE (she had a headache at the back of the neck rather than the temple) had resolved.            It was reported that patient was placed on a double dose or prednisone.  Treatment information was not specified.   This case was linked to MOD-2021-348439, MOD-2021-348409 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: 3 days of languishing in bed/it laid her out; zapped the energy she may have had; Extreme tiredness; Muscles hurt; Joints hurt; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (3 days of languishing in bed/it laid her out), ASTHENIA (zapped the energy she may have had), FATIGUE (Extreme tiredness), MYALGIA (Muscles hurt) and ARTHRALGIA (Joints hurt) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Cancer (cancer 8 years ago and was on her left side.), Blood pressure high, Pancreatic insufficiency and COPD. Concomitant products included FLUTICASONE for Abnormal breathing, AMLODIPINE for Blood pressure management, OLODATEROL HYDROCHLORIDE, TIOTROPIUM BROMIDE MONOHYDRATE (STIOLTO RESPIMAT) for COPD, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) and EMPAGLIFLOZIN (JARDIANCE) for Diabetes, PANCREATIN (CREON) for Pancreatic disorder, GABAPENTIN, PRAVASTATIN, VENLAFAXINE, VALSARTAN and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced FEELING ABNORMAL (3 days of languishing in bed/it laid her out), ASTHENIA (zapped the energy she may have had), FATIGUE (Extreme tiredness), MYALGIA (Muscles hurt) and ARTHRALGIA (Joints hurt). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. In 2021, FEELING ABNORMAL (3 days of languishing in bed/it laid her out), ASTHENIA (zapped the energy she may have had), FATIGUE (Extreme tiredness), MYALGIA (Muscles hurt) and ARTHRALGIA (Joints hurt) had resolved.            This case was linked to MOD-2021-348554 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Original eruption that had no cleared got worse; This spontaneous case was reported by a physician and describes the occurrence of RASH (Original eruption that had no cleared got worse) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced RASH (Original eruption that had no cleared got worse). At the time of the report, RASH (Original eruption that had no cleared got worse) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-348436 (Patient Link).   Reporter did not allow further contact
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Somnolence
Clinical narrative: After the 1st dose, felt sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (After the 1st dose, felt sleepy) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     The patient's past medical history included Headache (serious headaches 30 days before the Moderna vaccine.).    On 11-Sep-2021 at 10:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced SOMNOLENCE (After the 1st dose, felt sleepy). In 2021, SOMNOLENCE (After the 1st dose, felt sleepy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative before the vaccine..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.  The patient got tested for COVID-19 infection and was negative before the vaccine.   This case was linked to MOD-2021-348348, MOD-2021-348438 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever after second dose; Chills after second dose; Whole body hurt after the second; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after second dose), CHILLS (Chills after second dose) and MYALGIA (Whole body hurt after the second) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever after second dose), CHILLS (Chills after second dose) and MYALGIA (Whole body hurt after the second). At the time of the report, PYREXIA (Fever after second dose), CHILLS (Chills after second dose) and MYALGIA (Whole body hurt after the second) outcome was unknown.            No Concomitants and Treatment medication were reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Pain in extremity, Product dose omission issue, Pruritus, Urticaria
Clinical narrative: More than 36 days after the first dose without receiving the second dose; Had an allergic reaction; All her body was filled with like weal, her face, her ears, all her body; Couldn't stop scratching herself; Her arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (All her body was filled with like weal, her face, her ears, all her body), PRURITUS (Couldn't stop scratching herself), PAIN IN EXTREMITY (Her arm hurt), PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose) and ALLERGY TO VACCINE (Had an allergic reaction) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus and Allergy. Concomitant products included METFORMIN for Diabetes.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (Her arm hurt). On 29-Mar-2021, the patient experienced URTICARIA (All her body was filled with like weal, her face, her ears, all her body), PRURITUS (Couldn't stop scratching herself) and ALLERGY TO VACCINE (Had an allergic reaction). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 28-Mar-2021, PAIN IN EXTREMITY (Her arm hurt) had resolved. On 30-Mar-2021, URTICARIA (All her body was filled with like weal, her face, her ears, all her body), PRURITUS (Couldn't stop scratching herself) and ALLERGY TO VACCINE (Had an allergic reaction) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was diabetic she couldn't get the vaccine, and also, that she could not  be given the second dose because it would be a stronger reaction.  Additional treatment information were steroids and another medication for allergies.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling abnormal, Headache, Illness
Clinical narrative: Having menstrual bleeding 5 days early; More than 35 days between 1st and 2nd dose; After 2nd dose-fuzzy brain; After 2nd dose-never been this sick in life; After 2nd dose-headaches; After 2nd dose-chills; After 2nd dose-12 hours of vomiting; Fever; After 2nd dose-no energy/couldn't get off bathroom floor; This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (Having menstrual bleeding 5 days early), ASTHENIA (After 2nd dose-no energy/couldn't get off bathroom floor), FEELING ABNORMAL (After 2nd dose-fuzzy brain), ILLNESS (After 2nd dose-never been this sick in life) and HEADACHE (After 2nd dose-headaches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026P21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced ASTHENIA (After 2nd dose-no energy/couldn't get off bathroom floor), ILLNESS (After 2nd dose-never been this sick in life), HEADACHE (After 2nd dose-headaches), CHILLS (After 2nd dose-chills), VOMITING (After 2nd dose-12 hours of vomiting) and PYREXIA (Fever). On 11-Oct-2021, the patient experienced FEELING ABNORMAL (After 2nd dose-fuzzy brain). On an unknown date, the patient experienced POLYMENORRHOEA (Having menstrual bleeding 5 days early) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between 1st and 2nd dose). On 10-Oct-2021, ILLNESS (After 2nd dose-never been this sick in life) and CHILLS (After 2nd dose-chills) had resolved. At the time of the report, POLYMENORRHOEA (Having menstrual bleeding 5 days early), ASTHENIA (After 2nd dose-no energy/couldn't get off bathroom floor), FEELING ABNORMAL (After 2nd dose-fuzzy brain) and HEADACHE (After 2nd dose-headaches) had not resolved and VOMITING (After 2nd dose-12 hours of vomiting), PYREXIA (Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between 1st and 2nd dose) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-348452 (Patient Link).