chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Hypotension, Myalgia
Clinical narrative: very sleepy/had to sleep the whole day; felt like someone with low pressure who can't breath; felt like when someone has low blood pressure; very tired/felt like body was down/felt body tired; muscle aches; a little bit of a headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Sep-2021 and was forwarded to Moderna on 02-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (very sleepy/had to sleep the whole day), DYSPNOEA (felt like someone with low pressure who can't breath), HYPOTENSION (felt like when someone has low blood pressure), FATIGUE (very tired/felt like body was down/felt body tired) and MYALGIA (muscle aches) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history were provided.  Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes, METFORMIN, FAMOTIDINE, LISINOPRIL, GABAPENTIN and MELOXICAM for an unknown indication.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (very sleepy/had to sleep the whole day), DYSPNOEA (felt like someone with low pressure who can't breath), HYPOTENSION (felt like when someone has low blood pressure), FATIGUE (very tired/felt like body was down/felt body tired), MYALGIA (muscle aches) and HEADACHE (a little bit of a headache). At the time of the report, SOMNOLENCE (very sleepy/had to sleep the whole day), DYSPNOEA (felt like someone with low pressure who can't breath), HYPOTENSION (felt like when someone has low blood pressure), FATIGUE (very tired/felt like body was down/felt body tired), MYALGIA (muscle aches) and HEADACHE (a little bit of a headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment Information were provided by the reporter
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: very sleepy/had to sleep the whole day; felt like someone with low pressure who can't breath; felt like when someone has low blood pressure; very tired/felt like body was down/felt body tired; muscle aches; a little bit of a headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Sep-2021 and was forwarded to Moderna on 02-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (very sleepy/had to sleep the whole day), DYSPNOEA (felt like someone with low pressure who can't breath), HYPOTENSION (felt like when someone has low blood pressure), FATIGUE (very tired/felt like body was down/felt body tired) and MYALGIA (muscle aches) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history were provided.  Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes, METFORMIN, FAMOTIDINE, LISINOPRIL, GABAPENTIN and MELOXICAM for an unknown indication.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (very sleepy/had to sleep the whole day), DYSPNOEA (felt like someone with low pressure who can't breath), HYPOTENSION (felt like when someone has low blood pressure), FATIGUE (very tired/felt like body was down/felt body tired), MYALGIA (muscle aches) and HEADACHE (a little bit of a headache). At the time of the report, SOMNOLENCE (very sleepy/had to sleep the whole day), DYSPNOEA (felt like someone with low pressure who can't breath), HYPOTENSION (felt like when someone has low blood pressure), FATIGUE (very tired/felt like body was down/felt body tired), MYALGIA (muscle aches) and HEADACHE (a little bit of a headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment Information were provided by the reporter
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; Body aches; Head ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Body aches) and HEADACHE (Head ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), MYALGIA (Body aches) and HEADACHE (Head ache). At the time of the report, PYREXIA (Fever), MYALGIA (Body aches) and HEADACHE (Head ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was reported. No treatment medications were provided.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: he felt a little sore; tired for the a day; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (he felt a little sore) and FATIGUE (tired for the a day) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from April 2020 to May 2020. Concurrent medical conditions included Sleep disorder, Herpes zoster and Memory impairment. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for Herpes zoster, MULTIVITAMINS [VITAMINS NOS] for Memory disturbance, GINKGO BILOBA (GINGKO BILOBA) for Memory impairment, CLONAZEPAM (KLONOPIN) for Sleep disorder.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (he felt a little sore) and FATIGUE (tired for the a day). At the time of the report, MYALGIA (he felt a little sore) and FATIGUE (tired for the a day) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The gender of the patient was non-binary. No treatment medication was provided. They had an organ transplant and is immunocompromised.   This case was linked to MOD-2021-306223, MOD-2021-306228 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Chills, Fatigue, Hair texture abnormal
Clinical narrative: Malaise; anxiety; sleeplessness; hair started coming in curly; Nasuea; chills; fatigue; myalgia in gluteus area / Myalgia in lower back / body aches; hip pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), ANXIETY (anxiety), INSOMNIA (sleeplessness), HAIR TEXTURE ABNORMAL (hair started coming in curly) and NAUSEA (Nasuea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise), ANXIETY (anxiety), INSOMNIA (sleeplessness), HAIR TEXTURE ABNORMAL (hair started coming in curly), NAUSEA (Nasuea), CHILLS (chills), FATIGUE (fatigue), MYALGIA (myalgia in gluteus area / Myalgia in lower back / body aches) and ARTHRALGIA (hip pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (Malaise), ANXIETY (anxiety), INSOMNIA (sleeplessness), NAUSEA (Nasuea), CHILLS (chills) and FATIGUE (fatigue) was resolving, HAIR TEXTURE ABNORMAL (hair started coming in curly) outcome was unknown and MYALGIA (myalgia in gluteus area / Myalgia in lower back / body aches) and ARTHRALGIA (hip pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab data included ct scan, bone scan and blood work.  No  Concomitant medications were provided. Consumer stated she may have taken Advil or Tylenol to help alleviate the possible adverse events and non-drug treatment physical therapy were reported.   This case was linked to MOD-2021-306447 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Malaise, Myalgia, Nausea
Clinical narrative: Malaise; anxiety; sleeplessness; hair started coming in curly; Nasuea; chills; fatigue; myalgia in gluteus area / Myalgia in lower back / body aches; hip pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), ANXIETY (anxiety), INSOMNIA (sleeplessness), HAIR TEXTURE ABNORMAL (hair started coming in curly) and NAUSEA (Nasuea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise), ANXIETY (anxiety), INSOMNIA (sleeplessness), HAIR TEXTURE ABNORMAL (hair started coming in curly), NAUSEA (Nasuea), CHILLS (chills), FATIGUE (fatigue), MYALGIA (myalgia in gluteus area / Myalgia in lower back / body aches) and ARTHRALGIA (hip pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (Malaise), ANXIETY (anxiety), INSOMNIA (sleeplessness), NAUSEA (Nasuea), CHILLS (chills) and FATIGUE (fatigue) was resolving, HAIR TEXTURE ABNORMAL (hair started coming in curly) outcome was unknown and MYALGIA (myalgia in gluteus area / Myalgia in lower back / body aches) and ARTHRALGIA (hip pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab data included ct scan, bone scan and blood work.  No  Concomitant medications were provided. Consumer stated she may have taken Advil or Tylenol to help alleviate the possible adverse events and non-drug treatment physical therapy were reported.   This case was linked to MOD-2021-306447 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: he got tested for COVID 19 and came up with covid; shortness of breath / shortness of breath with zero amount of exertion; tightness in chest; some short jabs occasionally in his chest; fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (he got tested for COVID 19 and came up with covid), DYSPNOEA (shortness of breath / shortness of breath with zero amount of exertion), CHEST DISCOMFORT (tightness in chest), CHEST PAIN (some short jabs occasionally in his chest) and PYREXIA (fever) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Underweight and Stent placement (He had 5 stents put in every 3 months periodically) since 22-Feb-2021. Concurrent medical conditions included Heart disease, unspecified. Concomitant products included PRASUGREL HYDROCHLORIDE (EFFIENT), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), LISINOPRIL, METOPROLOL TARTRATE (METOPROLOL XL), PANTOPRAZOLE, ROSUVASTATIN, COLCHICINE and RANOLAZINE (RANEXA) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced DYSPNOEA (shortness of breath / shortness of breath with zero amount of exertion), CHEST DISCOMFORT (tightness in chest), CHEST PAIN (some short jabs occasionally in his chest) and PYREXIA (fever). On 15-Mar-2021, the patient experienced COVID-19 (he got tested for COVID 19 and came up with covid). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (he got tested for COVID 19 and came up with covid) outcome was unknown and DYSPNOEA (shortness of breath / shortness of breath with zero amount of exertion), CHEST DISCOMFORT (tightness in chest), CHEST PAIN (some short jabs occasionally in his chest) and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive. On 31-Aug-2021, Electrocardiogram: negative (Negative) Negative.     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.   This case was linked to MOD-2021-306623 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: he got tested for COVID 19 and came up with covid; shortness of breath / shortness of breath with zero amount of exertion; tightness in chest; some short jabs occasionally in his chest; fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (he got tested for COVID 19 and came up with covid), DYSPNOEA (shortness of breath / shortness of breath with zero amount of exertion), CHEST DISCOMFORT (tightness in chest), CHEST PAIN (some short jabs occasionally in his chest) and PYREXIA (fever) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Underweight and Stent placement (He had 5 stents put in every 3 months periodically) since 22-Feb-2021. Concurrent medical conditions included Heart disease, unspecified. Concomitant products included PRASUGREL HYDROCHLORIDE (EFFIENT), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), LISINOPRIL, METOPROLOL TARTRATE (METOPROLOL XL), PANTOPRAZOLE, ROSUVASTATIN, COLCHICINE and RANOLAZINE (RANEXA) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced DYSPNOEA (shortness of breath / shortness of breath with zero amount of exertion), CHEST DISCOMFORT (tightness in chest), CHEST PAIN (some short jabs occasionally in his chest) and PYREXIA (fever). On 15-Mar-2021, the patient experienced COVID-19 (he got tested for COVID 19 and came up with covid). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (he got tested for COVID 19 and came up with covid) outcome was unknown and DYSPNOEA (shortness of breath / shortness of breath with zero amount of exertion), CHEST DISCOMFORT (tightness in chest), CHEST PAIN (some short jabs occasionally in his chest) and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive. On 31-Aug-2021, Electrocardiogram: negative (Negative) Negative.     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.   This case was linked to MOD-2021-306623 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: She's been having the chills real bad. It started last night in her sleep.; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (She's been having the chills real bad. It started last night in her sleep.) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (She's been having the chills real bad. It started last night in her sleep.). At the time of the report, CHILLS (She's been having the chills real bad. It started last night in her sleep.) outcome was unknown.            No Concomitant medication information was reported. No treatment medications were provided.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, Insomnia
Clinical narrative: Hallucinations; He started to have trouble sleeping; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant) and INSOMNIA (He started to have trouble sleeping). At the time of the report, HALLUCINATION (Hallucinations) and INSOMNIA (He started to have trouble sleeping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment medication was not provided.  The events trouble sleeping and hallucinations started approximately one week after the first shot.  Very limited information regarding these events has been provided at this time. Further information has been requested.   This case was linked to MOD-2021-308135 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site reaction
Clinical narrative: Bad reaction in their arm on the site if the injection; Bad reaction that went over their shoulder/bad reaction  that went to the side of the neck/bad reaction that went  into their jaw like a charley horse; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Bad reaction in their arm on the site if the injection) and VACCINATION COMPLICATION (Bad reaction that went over their shoulder/bad reaction  that went to the side of the neck/bad reaction that went  into their jaw like a charley horse) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052G21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced VACCINATION SITE REACTION (Bad reaction in their arm on the site if the injection) and VACCINATION COMPLICATION (Bad reaction that went over their shoulder/bad reaction  that went to the side of the neck/bad reaction that went  into their jaw like a charley horse). On 19-Aug-2021, VACCINATION SITE REACTION (Bad reaction in their arm on the site if the injection) and VACCINATION COMPLICATION (Bad reaction that went over their shoulder/bad reaction  that went to the side of the neck/bad reaction that went  into their jaw like a charley horse) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medicine were not provided by the reporter.  Treatment medicine were not provided by the reporter.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A young person was given their first dose of the moderna covid-19 vaccine 20 days before his 18th birthday; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A young person was given their first dose of the moderna covid-19 vaccine 20 days before his 18th birthday ) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A young person was given their first dose of the moderna covid-19 vaccine 20 days before his 18th birthday ). On 03-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A young person was given their first dose of the moderna covid-19 vaccine 20 days before his 18th birthday ) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient not experienced any known symptoms and not received any treatments.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up appended: Patient demographics added.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Myalgia
Clinical narrative: stomach cramps; Diarrhea; Nausea; chills; sore left arm; I felt tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (chills) and MYALGIA (sore left arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (chills), MYALGIA (sore left arm) and FATIGUE (I felt tired). On 08-Aug-2021, ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (chills), MYALGIA (sore left arm) and FATIGUE (I felt tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow up received on 13-09-2021 contains age height weight and batch number updated
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: stomach cramps; Diarrhea; Nausea; chills; sore left arm; I felt tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (chills) and MYALGIA (sore left arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (chills), MYALGIA (sore left arm) and FATIGUE (I felt tired). On 08-Aug-2021, ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (chills), MYALGIA (sore left arm) and FATIGUE (I felt tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow up received on 13-09-2021 contains age height weight and batch number updated
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Side effects of first dose. No concomitant medication was reported.  No treatment medication use was reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Feeding disorder, Gait disturbance
Clinical narrative: She has not been eating; Walking lop-sided; Down and out on Friday; Pain; Dizzy; chills; headache; Nauseous; Very sick; Legs are weak; Vomited x1; Fever - feverish - temperature of 103'; Aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick), MUSCULAR WEAKNESS (Legs are weak), FEEDING DISORDER (She has not been eating), GAIT DISTURBANCE (Walking lop-sided) and VACCINATION COMPLICATION (Down and out on Friday) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was given.  Concurrent medical conditions included Blood pressure high. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 02-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced ILLNESS (Very sick), MUSCULAR WEAKNESS (Legs are weak), VOMITING (Vomited x1), PYREXIA (Fever - feverish - temperature of 103') and MYALGIA (Aches and pain). On an unknown date, the patient experienced FEEDING DISORDER (She has not been eating), GAIT DISTURBANCE (Walking lop-sided), VACCINATION COMPLICATION (Down and out on Friday), PAIN (Pain), DIZZINESS (Dizzy), CHILLS (chills), HEADACHE (headache) and NAUSEA (Nauseous). The patient was treated with IBUPROFEN for Adverse event, at a dose of alternating dose; ACEBUTOLOL (oral) ongoing from 2018 for Blood pressure, at a dose of 800 milligram; VALSARTAN (VALSACOR) (oral) ongoing from 2018 for Blood pressure, at a dose of 320 milligram; HYDRALAZINE (oral) ongoing from 2018 for Blood pressure, at a dose of 400 milligram and GUANFACINE (oral) ongoing from 2018 for Blood pressure, at a dose of 3 milligram. On 05-Sep-2021, MYALGIA (Aches and pain) had resolved. At the time of the report, ILLNESS (Very sick), MUSCULAR WEAKNESS (Legs are weak), FEEDING DISORDER (She has not been eating), GAIT DISTURBANCE (Walking lop-sided), VACCINATION COMPLICATION (Down and out on Friday), PAIN (Pain), DIZZINESS (Dizzy), VOMITING (Vomited x1), CHILLS (chills), HEADACHE (headache) and NAUSEA (Nauseous) outcome was unknown and PYREXIA (Fever - feverish - temperature of 103') had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Sep-2021, Body temperature: 104 (High) 104 F.         Concomitant medications include blood pressure medications. Took alternating dose of Ibuprofen and Advil.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Significant follow-up appended
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Muscular weakness, Myalgia, Nausea
Clinical narrative: She has not been eating; Walking lop-sided; Down and out on Friday; Pain; Dizzy; chills; headache; Nauseous; Very sick; Legs are weak; Vomited x1; Fever - feverish - temperature of 103'; Aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick), MUSCULAR WEAKNESS (Legs are weak), FEEDING DISORDER (She has not been eating), GAIT DISTURBANCE (Walking lop-sided) and VACCINATION COMPLICATION (Down and out on Friday) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was given.  Concurrent medical conditions included Blood pressure high. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 02-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced ILLNESS (Very sick), MUSCULAR WEAKNESS (Legs are weak), VOMITING (Vomited x1), PYREXIA (Fever - feverish - temperature of 103') and MYALGIA (Aches and pain). On an unknown date, the patient experienced FEEDING DISORDER (She has not been eating), GAIT DISTURBANCE (Walking lop-sided), VACCINATION COMPLICATION (Down and out on Friday), PAIN (Pain), DIZZINESS (Dizzy), CHILLS (chills), HEADACHE (headache) and NAUSEA (Nauseous). The patient was treated with IBUPROFEN for Adverse event, at a dose of alternating dose; ACEBUTOLOL (oral) ongoing from 2018 for Blood pressure, at a dose of 800 milligram; VALSARTAN (VALSACOR) (oral) ongoing from 2018 for Blood pressure, at a dose of 320 milligram; HYDRALAZINE (oral) ongoing from 2018 for Blood pressure, at a dose of 400 milligram and GUANFACINE (oral) ongoing from 2018 for Blood pressure, at a dose of 3 milligram. On 05-Sep-2021, MYALGIA (Aches and pain) had resolved. At the time of the report, ILLNESS (Very sick), MUSCULAR WEAKNESS (Legs are weak), FEEDING DISORDER (She has not been eating), GAIT DISTURBANCE (Walking lop-sided), VACCINATION COMPLICATION (Down and out on Friday), PAIN (Pain), DIZZINESS (Dizzy), VOMITING (Vomited x1), CHILLS (chills), HEADACHE (headache) and NAUSEA (Nauseous) outcome was unknown and PYREXIA (Fever - feverish - temperature of 103') had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Sep-2021, Body temperature: 104 (High) 104 F.         Concomitant medications include blood pressure medications. Took alternating dose of Ibuprofen and Advil.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Significant follow-up appended
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination complication, Vomiting
Clinical narrative: She has not been eating; Walking lop-sided; Down and out on Friday; Pain; Dizzy; chills; headache; Nauseous; Very sick; Legs are weak; Vomited x1; Fever - feverish - temperature of 103'; Aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick), MUSCULAR WEAKNESS (Legs are weak), FEEDING DISORDER (She has not been eating), GAIT DISTURBANCE (Walking lop-sided) and VACCINATION COMPLICATION (Down and out on Friday) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was given.  Concurrent medical conditions included Blood pressure high. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 02-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced ILLNESS (Very sick), MUSCULAR WEAKNESS (Legs are weak), VOMITING (Vomited x1), PYREXIA (Fever - feverish - temperature of 103') and MYALGIA (Aches and pain). On an unknown date, the patient experienced FEEDING DISORDER (She has not been eating), GAIT DISTURBANCE (Walking lop-sided), VACCINATION COMPLICATION (Down and out on Friday), PAIN (Pain), DIZZINESS (Dizzy), CHILLS (chills), HEADACHE (headache) and NAUSEA (Nauseous). The patient was treated with IBUPROFEN for Adverse event, at a dose of alternating dose; ACEBUTOLOL (oral) ongoing from 2018 for Blood pressure, at a dose of 800 milligram; VALSARTAN (VALSACOR) (oral) ongoing from 2018 for Blood pressure, at a dose of 320 milligram; HYDRALAZINE (oral) ongoing from 2018 for Blood pressure, at a dose of 400 milligram and GUANFACINE (oral) ongoing from 2018 for Blood pressure, at a dose of 3 milligram. On 05-Sep-2021, MYALGIA (Aches and pain) had resolved. At the time of the report, ILLNESS (Very sick), MUSCULAR WEAKNESS (Legs are weak), FEEDING DISORDER (She has not been eating), GAIT DISTURBANCE (Walking lop-sided), VACCINATION COMPLICATION (Down and out on Friday), PAIN (Pain), DIZZINESS (Dizzy), VOMITING (Vomited x1), CHILLS (chills), HEADACHE (headache) and NAUSEA (Nauseous) outcome was unknown and PYREXIA (Fever - feverish - temperature of 103') had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Sep-2021, Body temperature: 104 (High) 104 F.         Concomitant medications include blood pressure medications. Took alternating dose of Ibuprofen and Advil.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Significant follow-up appended
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Extra dose administered, Influenza like illness, Lethargy
Clinical narrative: Lethargic; Weak; Flu-like symptom; He experienced after getting the third dose of Moderna vaccine and he also added that he's not an immunocompromised patient.; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), ASTHENIA (Weak), INFLUENZA LIKE ILLNESS (Flu-like symptom) and EXTRA DOSE ADMINISTERED (He experienced after getting the third dose of Moderna vaccine and he also added that he's not an immunocompromised patient.) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066D21A and 070A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN 81), ATORVASTATIN CALCIUM (LIPITOR), BUPROPION, TADALAFIL and ZOLPIDEM for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced LETHARGY (Lethargic), ASTHENIA (Weak), INFLUENZA LIKE ILLNESS (Flu-like symptom) and EXTRA DOSE ADMINISTERED (He experienced after getting the third dose of Moderna vaccine and he also added that he's not an immunocompromised patient.). On 16-Aug-2021, EXTRA DOSE ADMINISTERED (He experienced after getting the third dose of Moderna vaccine and he also added that he's not an immunocompromised patient.) had resolved. On 17-Aug-2021, LETHARGY (Lethargic), ASTHENIA (Weak) and INFLUENZA LIKE ILLNESS (Flu-like symptom) had resolved.            No Treatment information  were reported.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pain
Clinical narrative: It's sore; REDNESS; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (It's sore) and ERYTHEMA (REDNESS) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 PAIN (It's sore) and ERYTHEMA (REDNESS). At the time of the report, PAIN (It's sore) and ERYTHEMA (REDNESS) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Lymphadenopathy, Mammogram, Ultrasound scan
Clinical narrative: They worsened after my second dose; Swollen lymph node right axilla; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (They worsened after my second dose) and LYMPHADENOPATHY (Swollen lymph node right axilla) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Spider bite, Drug allergy (Uribel), Drug allergy (Ciprofloxacin), Drug allergy (Propofol), Tendonitis (Biceps Tendonitis) since June 2019, Impingement syndrome since June 2019, Blood pressure increased (elevated blood pressure) since 2003, Constipation (Occasional Constipation), Fibrocystic breast and Shoulder arthritis (Left shoulder issues) since June 2019. Concomitant products included LISINOPRIL for Blood pressure increased, MACROGOL 3350 (MIRALAX) and DOCUSATE SODIUM (COLACE) for Constipation, MULTIVITAMIN [VITAMINS NOS] for Vitamin supplementation.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-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 CONDITION AGGRAVATED (They worsened after my second dose) and LYMPHADENOPATHY (Swollen lymph node right axilla). At the time of the report, CONDITION AGGRAVATED (They worsened after my second dose) and LYMPHADENOPATHY (Swollen lymph node right axilla) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Ultrasound scan: two lymph nodes under my right axilla (abnormal) two lymph nodes under right axilla.. On 04-Jun-2021, Mammogram: one lmph node had gone away while one lymph node r (abnormal) one lmph node had gone away while one lymph node remained on ultrasound that had shrunk in size. On 04-Jun-2021, Ultrasound scan: one lymph node had gone away (abnormal) one lymph node had gone away while one lymph node remained on ultrasound that had shrunk in size when compared to ultrasound done on 3/4/21..         On June 04, 2021 Mammogram was done.  No treatment medications were provided.   This case was linked to MOD-2021-240549 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise
Clinical narrative: She got dizzy & didn't do well; DIdn't do well; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (She got dizzy & didn't do well) and MALAISE (DIdn't do well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced DIZZINESS (She got dizzy & didn't do well) and MALAISE (DIdn't do well). At the time of the report, DIZZINESS (She got dizzy & didn't do well) and MALAISE (DIdn't do well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided. Patient friend was not sure regarding the vaccine but thought it was Pfizer.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient recieved 2nd dose after 47 days of 1st dose of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved 2nd dose after 47 days of 1st dose of vaccination) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 037F21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved 2nd dose after 47 days of 1st dose of vaccination). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved 2nd dose after 47 days of 1st dose of vaccination) had resolved.            No concomitant medications were reported.  No treatment medications were reported   This case was linked to MOD-2021-307830 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     Concurrent medical conditions included Pain and Headache. Concomitant products included IBUPROFEN for Pain and Headache, MULTIVITAMINS [VITAMINS NOS] and CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]) for an unknown indication.    On 04-May-2021 at 10:27 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced FATIGUE (Extreme fatigue). At the time of the report, FATIGUE (Extreme fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information was reported.   This case was linked to MOD-2021-209131 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscles in her hands, arms, legs and feet (not all at the same time; it moved around) would start aching; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscles in her hands, arms, legs and feet (not all at the same time; it moved around) would start aching) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscles in her hands, arms, legs and feet (not all at the same time; it moved around) would start aching). At the time of the report, MYALGIA (muscles in her hands, arms, legs and feet (not all at the same time; it moved around) would start aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment information was provided   This case was linked to MOD-2021-308639 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Peripheral swelling
Clinical narrative: arm slightly swollen; soreness in the injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm slightly swollen), INJECTION SITE PAIN (soreness in the injection site) and FATIGUE (fatigue) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 063E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm slightly swollen), INJECTION SITE PAIN (soreness in the injection site) and FATIGUE (fatigue). At the time of the report, PERIPHERAL SWELLING (arm slightly swollen), INJECTION SITE PAIN (soreness in the injection site) and FATIGUE (fatigue) outcome was unknown.            Reportedly, Patient and his partner received the third dose. Patient thought he had pain because had moved a big piece of antique furniture a night before.  Concomitants included HIV medication, Blood thinner medication, Chronic pancreatitis medication and Blood pressure medication.  Patient gave affirmative consent to follow-up with Safety Team.  No treatment medication was reported.   This case was linked to MOD-2021-308689, MOD-2021-308626 (Patient Link).