chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Urine output
Clinical narrative: 99.9°F Fever; Aches , joint pain , headaches; tenderness to touch; started to urinate frequently; sore arm; chills; A spontaneous report was received from a  consumer concerning an  68 -year old,  male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and    experienced  sore arm/ pain in extremity, chills, fever/ pyrexia, Aches , joint pain , headaches/ Pain, tenderness to touch/ tenderness, started to urinate frequently/ urine output,  The patient's medical history, was not provided by the reporter, included no known allergies,  Concomitant medications was  not reported.   On  13 Feb  2021prior to the onset of the symptoms, the patient received their First of two planned doses of mRNA-1273 (Batch number 013L20A)  for prophylaxis of COVID-19 infection.  On Unknown date after vaccination patient reported , the events sore arm, chills, fever, Aches , joint pain , headaches, tenderness to touch   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events, was not provided.  The outcome of the events  sore arm, chills, fever, Aches , joint pain , headaches, tenderness to touch, started to urinate frequently Unknown
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pain, Pain in extremity
Clinical narrative: ache in my (both) sides; hip joint aches; ARM ACHE; MILD CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (ache in my (both) sides), ARTHRALGIA (hip joint aches), PAIN IN EXTREMITY (ARM ACHE) and CHILLS (MILD CHILLS) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (ache in my (both) sides), ARTHRALGIA (hip joint aches), PAIN IN EXTREMITY (ARM ACHE) and CHILLS (MILD CHILLS). At the time of the report, PAIN (ache in my (both) sides), ARTHRALGIA (hip joint aches), PAIN IN EXTREMITY (ARM ACHE) and CHILLS (MILD CHILLS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Injection site bruising, Injection site erythema, Injection site haemorrhage, Injection site pain
Clinical narrative: injection site swelling; itching at the injection site; a little rash on the injection site; induration at the injection site; looked bruised at the injection site; tenderness; pain at the injection site; tenderness at the injection site; redness at the injection site; more than usual bleeding at the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INJECTION SITE HAEMORRHAGE (more than usual bleeding at the injection site), INDURATION (induration at the injection site), INJECTION SITE BRUISING (looked bruised at the injection site), TENDERNESS (tenderness) and INJECTION SITE PRURITUS (itching at the injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE HAEMORRHAGE (more than usual bleeding at the injection site). On 23-Jan-2021, the patient experienced INDURATION (induration at the injection site), INJECTION SITE BRUISING (looked bruised at the injection site), TENDERNESS (tenderness), INJECTION SITE PAIN (pain at the injection site), INJECTION SITE PAIN (tenderness at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site). On 30-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE RASH (a little rash on the injection site). On 31-Jan-2021, the patient experienced INJECTION SITE SWELLING (injection site swelling). On 27-Jan-2021, INDURATION (induration at the injection site), INJECTION SITE BRUISING (looked bruised at the injection site), TENDERNESS (tenderness), INJECTION SITE PAIN (pain at the injection site), INJECTION SITE PAIN (tenderness at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) had resolved. At the time of the report, INJECTION SITE HAEMORRHAGE (more than usual bleeding at the injection site), INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE RASH (a little rash on the injection site) and INJECTION SITE SWELLING (injection site swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had the flu shot at the beginning of December (no specific date provided) and that her arm kind of hurt ever since. No Concomitant medications were provided by the reporter. No Treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: injection site swelling AE updated.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Tenderness
Clinical narrative: injection site swelling; itching at the injection site; a little rash on the injection site; induration at the injection site; looked bruised at the injection site; tenderness; pain at the injection site; tenderness at the injection site; redness at the injection site; more than usual bleeding at the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INJECTION SITE HAEMORRHAGE (more than usual bleeding at the injection site), INDURATION (induration at the injection site), INJECTION SITE BRUISING (looked bruised at the injection site), TENDERNESS (tenderness) and INJECTION SITE PRURITUS (itching at the injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE HAEMORRHAGE (more than usual bleeding at the injection site). On 23-Jan-2021, the patient experienced INDURATION (induration at the injection site), INJECTION SITE BRUISING (looked bruised at the injection site), TENDERNESS (tenderness), INJECTION SITE PAIN (pain at the injection site), INJECTION SITE PAIN (tenderness at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site). On 30-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE RASH (a little rash on the injection site). On 31-Jan-2021, the patient experienced INJECTION SITE SWELLING (injection site swelling). On 27-Jan-2021, INDURATION (induration at the injection site), INJECTION SITE BRUISING (looked bruised at the injection site), TENDERNESS (tenderness), INJECTION SITE PAIN (pain at the injection site), INJECTION SITE PAIN (tenderness at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) had resolved. At the time of the report, INJECTION SITE HAEMORRHAGE (more than usual bleeding at the injection site), INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE RASH (a little rash on the injection site) and INJECTION SITE SWELLING (injection site swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had the flu shot at the beginning of December (no specific date provided) and that her arm kind of hurt ever since. No Concomitant medications were provided by the reporter. No Treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: injection site swelling AE updated.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Miliaria, Rash, Vaccination site rash
Clinical narrative: Small rash spot on her abdomen; Rash on injection arm; Injection arm generating heat; A spontaneous report was received from a Consumer concerning a 81-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection arm generating heat, rash on injection arm, small rash spot on her abdomen.  The patient's medical history was not provided. Concomitant medications reported were Diuretic, Blood Pressure Medication for drug use for unknown indication.  On 14 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039T20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced the events injection arm generating heat. rash on injection arm, small rash spot on her abdomen.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, injection arm generating heat, On an unknown date the outcome of events, rash on injection arm, On an unknown date the outcome of events, small rash spot on her abdomen was not reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: fever; nausea; could not get out of bed; body aches; very sore arm; A spontaneous report was received from a consumer, concerning a male patient of 63 age, who received Moderna's COVID-19 vaccine and experienced many side effects a very sore arm, 48 hours of nausea, he had muscle and body aches, a fever of 102.3F, and could not get out of bed for 3 days.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an 21Jan21, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis. On an unspecified date, after second dose of vaccine, the patient experienced ongoing very sore arm, 48 hours of nausea, he had muscle and body aches, a fever of 102.3F, and could not get out of bed for 3 days. No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event was unknown..
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm and only sore to touch; A spontaneous report was received from a consumer concerning her husband, a male patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a little sore arm that was only sore to touch/vaccination site pain.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, post receiving the vaccine the patient experienced a little sore arm that was only sore to touch and lasted about a day. Treatment information was unknown.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, a little sore arm that was only sore to touch was resolved at the time of this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Neck pain, Pain
Clinical narrative: Pain the neck; Runny nose; Body aches; Headache; Chills; Pain at the Injection Site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain the neck), RHINORRHOEA (Runny nose), PAIN (Body aches), HEADACHE (Headache) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced NECK PAIN (Pain the neck), RHINORRHOEA (Runny nose), PAIN (Body aches), HEADACHE (Headache), CHILLS (Chills), VACCINATION SITE PAIN (Pain at the Injection Site) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency.   At the time of the report, RHINORRHOEA (Runny nose), PAIN (Body aches), HEADACHE (Headache), CHILLS (Chills), VACCINATION SITE PAIN (Pain at the Injection Site) and FATIGUE (Fatigue) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Vaccination site pain
Clinical narrative: Pain the neck; Runny nose; Body aches; Headache; Chills; Pain at the Injection Site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain the neck), RHINORRHOEA (Runny nose), PAIN (Body aches), HEADACHE (Headache) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced NECK PAIN (Pain the neck), RHINORRHOEA (Runny nose), PAIN (Body aches), HEADACHE (Headache), CHILLS (Chills), VACCINATION SITE PAIN (Pain at the Injection Site) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency.   At the time of the report, RHINORRHOEA (Runny nose), PAIN (Body aches), HEADACHE (Headache), CHILLS (Chills), VACCINATION SITE PAIN (Pain at the Injection Site) and FATIGUE (Fatigue) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Joint swelling, Muscle discomfort, Pruritus
Clinical narrative: very uncomfortable; The left arm where injection site was, around wrest is swollen.; Itching on both arms and both legs; Discomfort in the upper muscle where shot was administered; A little tired; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISCOMFORT (Discomfort in the upper muscle where shot was administered), FATIGUE (A little tired), PRURITUS (Itching on both arms and both legs), JOINT SWELLING (The left arm where injection site was, around wrest is swollen.) and DISCOMFORT (very uncomfortable) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A.) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 06-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced MUSCLE DISCOMFORT (Discomfort in the upper muscle where shot was administered) and FATIGUE (A little tired). On 07-Feb-2021, the patient experienced PRURITUS (Itching on both arms and both legs). On 08-Feb-2021, the patient experienced JOINT SWELLING (The left arm where injection site was, around wrest is swollen.). On an unknown date, the patient experienced DISCOMFORT (very uncomfortable). The patient was treated with ISOPROPYL ALCOHOL at an unspecified dose and frequency and CORTISONE ACETATE (CORTISON) at a dose of 10 mg. At the time of the report, FATIGUE (A little tired), PRURITUS (Itching on both arms and both legs), JOINT SWELLING (The left arm where injection site was, around wrest is swollen.) and DISCOMFORT (very uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Based on MSA comment, Pruritus change to Unlisted
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: swelling at  injection site; it has been warm to the touch, the area is still hot to the touch, on and off; can feel a fever on it, comes and goes; still has some redness; pain at injection site; A spontaneous report was received from a healthcare professional concerning a 77-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain at injection site, swelling, still has some redness, can feel a fever on it, comes and goes.  The patient's medical history was not provided. Concomitant medications reported were Blood pressure, Cholesterol, 2 Baby Aspirin, Prilosec for drug use for unknown indication.  On 21 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) Intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient experienced the event(s) pain at injection site, swelling, still has some redness, can feel a fever on it, comes and goes.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain at injection site, swelling, still has some redness, can feel a fever on it, comes and goes was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on skin/butt/thighs/hands/back; A spontaneous report was received from a nurse concerning a 76-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced skin rash, rash on butt, rash on thighs, rash on hands, rash on back.   The patient's medical history, as provided by the reporter was unknown. concomitant medications provided by reporter was unknown.  On 27-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 27-Jan-2021, the patient experienced skin rash, rash on butt, rash on thighs, rash on hands, rash on back.   Treatment for the events included topical steroid cream, oral steroid.  Action taken with mRNA-1273 in response to the events was not reported.   The events, skin  rash, rash on butt, rash on thighs, rash on hands, rash on back were unknown.  Based on MSA comment, Rash (change listedness to listed and unlisted for Canadian monograph and factsheet)
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: arm left pain; Body ache severe; Fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm left pain), PAIN (Body ache severe), FATIGUE (Fatigue) and HEADACHE (headache) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced PAIN IN EXTREMITY (arm left pain), PAIN (Body ache severe), FATIGUE (Fatigue) and HEADACHE (headache).   At the time of the report, PAIN IN EXTREMITY (arm left pain), PAIN (Body ache severe), FATIGUE (Fatigue) and HEADACHE (headache) outcome was unknown.      Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-064095 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate decreased, Heart rate increased
Clinical narrative: Decrease Heart Rate; Increase pulse; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE DECREASED (Decrease Heart Rate) and HEART RATE INCREASED (Increase pulse) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HEART RATE DECREASED (Decrease Heart Rate) and HEART RATE INCREASED (Increase pulse). On 30-Jan-2021, HEART RATE DECREASED (Decrease Heart Rate) and HEART RATE INCREASED (Increase pulse) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was not given.   No laboratory was not given.   No treatment information was not given.   This case was linked to MOD-2021-026680 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received no new significant information.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, SARS-CoV-2 test positive, Sinusitis
Clinical narrative: loss of taste; loss of smell; tested positive for COVID; sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste), ANOSMIA (loss of smell), COVID-19 (tested positive for COVID) and SINUSITIS (sinus infection) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported). Concomitant products included DOXYCYCLINE for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced AGEUSIA (loss of taste), ANOSMIA (loss of smell), COVID-19 (tested positive for COVID) and SINUSITIS (sinus infection). At the time of the report, AGEUSIA (loss of taste), ANOSMIA (loss of smell), COVID-19 (tested positive for COVID) and SINUSITIS (sinus infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test positive: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Pain, Pruritus, Vaccination site mass
Clinical narrative: Lump in arm; redness is the size of half dollar; a little itchy; Like a shooting pain up until her head; experiencing pain from the bottom of skull to the top of her head; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump in arm), ERYTHEMA (redness is the size of half dollar), PRURITUS (a little itchy), PAIN (Like a shooting pain up until her head) and HEADACHE (experiencing pain from the bottom of skull to the top of her head) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported). Concomitant products included RAMIPRIL, AMLODIPINE, EZETIMIBE and HYDROCHLOROTHIAZIDE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE MASS (Lump in arm), ERYTHEMA (redness is the size of half dollar), PRURITUS (a little itchy), PAIN (Like a shooting pain up until her head) and HEADACHE (experiencing pain from the bottom of skull to the top of her head). At the time of the report, VACCINATION SITE MASS (Lump in arm), ERYTHEMA (redness is the size of half dollar), PRURITUS (a little itchy), PAIN (Like a shooting pain up until her head) and HEADACHE (experiencing pain from the bottom of skull to the top of her head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypotension
Clinical narrative: lower blood pressure after dose 1/even lower blood pressure after dose 2; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (lower blood pressure after dose 1/even lower blood pressure after dose 2) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOTENSION (lower blood pressure after dose 1/even lower blood pressure after dose 2). At the time of the report, HYPOTENSION (lower blood pressure after dose 1/even lower blood pressure after dose 2) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 101/66 and 101/65 less than or around.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Heart rate
Clinical narrative: sat up from lying down and was very lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (sat up from lying down and was very lightheaded) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included Glaucoma, Venous bleeding (optic vein in right eye burst) and Surgery (quadruple ablation performed). Concurrent medical conditions included Flu vaccination and Pneumococcal immunization (Allergic to Prevnar-13 (Pneumococcal) vaccine). Concomitant products included APIXABAN (ELIQUIS), CARVEDILOL, PRAVASTATIN, EZETIMIBE (ZETIA), CALCITRIOL, AFLIBERCEPT (EYLEA) and LATANOPROST for an unknown indication.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced DIZZINESS (sat up from lying down and was very lightheaded). At the time of the report, DIZZINESS (sat up from lying down and was very lightheaded) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Blood pressure measurement: Blood pressure 113/73 reported. On 14-Feb-2021, Heart rate: Heart rate reported 73..         This case was linked.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: reaction in her knees, a lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (reaction in her knees, a lot of pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported). Concomitant products included HYALURONIC ACID for an unknown indication.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ARTHRALGIA (reaction in her knees, a lot of pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (reaction in her knees, a lot of pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Pyrexia
Clinical narrative: arm is hot to touch; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (arm is hot to touch), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced FEELING HOT (arm is hot to touch), PYREXIA (fever) and CHILLS (chills). At the time of the report, FEELING HOT (arm is hot to touch), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Adverse reaction). At the time of the report, ADVERSE REACTION (Adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: reporting "adverse effect" from the 1st shot of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (reporting "adverse effect" from the 1st shot of the Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (reporting "adverse effect" from the 1st shot of the Moderna vaccine). At the time of the report, ADVERSE EVENT (reporting "adverse effect" from the 1st shot of the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia, Vaccination site erythema
Clinical narrative: Fatigue; Body Aches; fever; redness in the IS; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), MYALGIA (Body Aches), PYREXIA (fever) and VACCINATION SITE ERYTHEMA (redness in the IS) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced FATIGUE (Fatigue), MYALGIA (Body Aches), PYREXIA (fever) and VACCINATION SITE ERYTHEMA (redness in the IS). On 15-Feb-2021, FATIGUE (Fatigue), MYALGIA (Body Aches) and PYREXIA (fever) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (redness in the IS) had not resolved.            No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Frequent bowel movements, Gastrointestinal disorder, Pain in extremity
Clinical narrative: Light case of intestinal disturbance; Have to make frequent passess; Chills in the afternoon and not in morning; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), GASTROINTESTINAL DISORDER (Light case of intestinal disturbance), FREQUENT BOWEL MOVEMENTS (Have to make frequent passess) and CHILLS (Chills in the afternoon and not in morning) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 14-Feb-2021, the patient experienced GASTROINTESTINAL DISORDER (Light case of intestinal disturbance), FREQUENT BOWEL MOVEMENTS (Have to make frequent passess) and CHILLS (Chills in the afternoon and not in morning). At the time of the report, PAIN IN EXTREMITY (Sore arm), GASTROINTESTINAL DISORDER (Light case of intestinal disturbance), FREQUENT BOWEL MOVEMENTS (Have to make frequent passess) and CHILLS (Chills in the afternoon and not in morning) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Muscular weakness
Clinical narrative: weakness in legs; Difficulty to walk; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in legs) and GAIT DISTURBANCE (Difficulty to walk) 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 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (weakness in legs) and GAIT DISTURBANCE (Difficulty to walk). At the time of the report, MUSCULAR WEAKNESS (weakness in legs) and GAIT DISTURBANCE (Difficulty to walk) outcome was unknown.            No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: arm was itchy; became more swollen; hardness; little bit of a sore arm; redness on the site of the injection; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (little bit of a sore arm), VACCINATION SITE ERYTHEMA (redness on the site of the injection), VACCINATION SITE PRURITUS (arm was itchy), VACCINATION SITE SWELLING (became more swollen) and VACCINATION SITE INDURATION (hardness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (little bit of a sore arm) and VACCINATION SITE ERYTHEMA (redness on the site of the injection). On 05-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (arm was itchy), VACCINATION SITE SWELLING (became more swollen) and VACCINATION SITE INDURATION (hardness). On 11-Feb-2021, VACCINATION SITE PRURITUS (arm was itchy), VACCINATION SITE SWELLING (became more swollen) and VACCINATION SITE INDURATION (hardness) had resolved. At the time of the report, PAIN IN EXTREMITY (little bit of a sore arm) and VACCINATION SITE ERYTHEMA (redness on the site of the injection) had not 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.   Thyroid medication and Hydrochlorothiazide 25mg used as a Concomitant medication  baking soda paste used as a Treatment medication.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pustule, Vaccination site warmth
Clinical narrative: hard knot; warm to the touch at the injection site; red; bump the size of a quarter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PUSTULE (bump the size of a quarter), VACCINATION SITE INDURATION (hard knot) and VACCINATION SITE WARMTH (warm to the touch at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LAMOTRIGINE, ROPINIROLE, METOPROLOL, ATORVASTATIN and PANTOPRAZOLE for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PUSTULE (bump the size of a quarter). On an unknown date, the patient experienced VACCINATION SITE INDURATION (hard knot) and VACCINATION SITE WARMTH (warm to the touch at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PUSTULE (bump the size of a quarter) had not resolved and VACCINATION SITE INDURATION (hard knot) and VACCINATION SITE WARMTH (warm to the touch at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   o No treatment medications provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Pains all over the body; Big headache; Really tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), MYALGIA (Pains all over the body), HEADACHE (Big headache) and FATIGUE (Really tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), MYALGIA (Pains all over the body), HEADACHE (Big headache) and FATIGUE (Really tired). At the time of the report, PYREXIA (Fever), CHILLS (Chills), MYALGIA (Pains all over the body), HEADACHE (Big headache) and FATIGUE (Really tired) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Discomfort, Dizziness, Feeling jittery, Pharyngeal swelling
Clinical narrative: jittery (local to upper body); fast heartbeat; tightness in chest; lightheaded; swelling of tongue; over all general discomfort; swelling of throat; A spontaneous report () was received from a consumer  concerning a 72 years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced jittery (local to upper body) (feeling jittery), fast heartbeat (tachycardia), light headed (dizziness), swelling tongue (swollen tongue), swelling throat (pharyngeal swelling), tightness in chest (chest discomfort) and overall discomfort (discomfort).   The patient's medical history include allergic to Compazine as she experienced similar reactions 40 years back with Compazine.. The relevant concomitant medications were also not provided.  On 09 Feb 2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:012M20A ) through intramuscular route of administration in the left arm for prophylaxis of COVID-19 infection.     On 09 Feb 2021, approximately at 6pm patient experienced jittery (local to the upper body) , fast heartbeat, tightness in chest, lightheaded, swelling of throat and sides of tongue, over all general discomfort. No laboratory data was provided.No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The events  jittery (local to the upper body) , fast heartbeat, tightness in chest, lightheaded, swelling of throat and sides of tongue, over all general discomfort were now subsided not completely by considerably(recovering).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Tachycardia
Clinical narrative: jittery (local to upper body); fast heartbeat; tightness in chest; lightheaded; swelling of tongue; over all general discomfort; swelling of throat; A spontaneous report () was received from a consumer  concerning a 72 years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced jittery (local to upper body) (feeling jittery), fast heartbeat (tachycardia), light headed (dizziness), swelling tongue (swollen tongue), swelling throat (pharyngeal swelling), tightness in chest (chest discomfort) and overall discomfort (discomfort).   The patient's medical history include allergic to Compazine as she experienced similar reactions 40 years back with Compazine.. The relevant concomitant medications were also not provided.  On 09 Feb 2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:012M20A ) through intramuscular route of administration in the left arm for prophylaxis of COVID-19 infection.     On 09 Feb 2021, approximately at 6pm patient experienced jittery (local to the upper body) , fast heartbeat, tightness in chest, lightheaded, swelling of throat and sides of tongue, over all general discomfort. No laboratory data was provided.No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The events  jittery (local to the upper body) , fast heartbeat, tightness in chest, lightheaded, swelling of throat and sides of tongue, over all general discomfort were now subsided not completely by considerably(recovering).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse affects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse affects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse affects). At the time of the report, VACCINATION COMPLICATION (adverse affects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Dyspepsia, Illness, Nausea
Clinical narrative: stomach very sensitive; loss of appetite; felt very very sick and wanted to throw up; nausea; 102.2°F fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), DYSPEPSIA (stomach very sensitive), DECREASED APPETITE (loss of appetite), ILLNESS (felt very very sick and wanted to throw up) and NAUSEA (nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN (body aches), DECREASED APPETITE (loss of appetite), ILLNESS (felt very very sick and wanted to throw up), NAUSEA (nausea) and PYREXIA (102.2°F fever). On 14-Feb-2021, the patient experienced DYSPEPSIA (stomach very sensitive). On 14-Feb-2021, NAUSEA (nausea) had resolved. On 16-Feb-2021, PAIN (body aches), DYSPEPSIA (stomach very sensitive), DECREASED APPETITE (loss of appetite), ILLNESS (felt very very sick and wanted to throw up) and PYREXIA (102.2°F fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.2 102.2°F.         No concomitant medications reported by investigator o No treatment medications provided by the reporter.