chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Diarrhoea, Dyspnoea, Myalgia
Clinical narrative: Chest tightness; Shortness of breath; Diarrhea; Runny nose; Muscle ache; Fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (Chest tightness), DYSPNOEA (Shortness of breath), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose) and MYALGIA (Muscle ache) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included NAPROXEN SODIUM (ALEVE), ATORVASTATIN, METFORMIN, WARFARIN, METOPROLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ACETYLSALICYLIC ACID (EQUATE [ACETYLSALICYLIC ACID]), BIFIDOBACTERIUM INFANTIS (ALIGN) and LISINOPRIL for an unknown indication.    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (Chest tightness), DYSPNOEA (Shortness of breath), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose), MYALGIA (Muscle ache), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, CHEST DISCOMFORT (Chest tightness), DYSPNOEA (Shortness of breath), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose), MYALGIA (Muscle ache), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Treatment medications were not provided by reporter.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Chest tightness; Shortness of breath; Diarrhea; Runny nose; Muscle ache; Fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (Chest tightness), DYSPNOEA (Shortness of breath), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose) and MYALGIA (Muscle ache) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included NAPROXEN SODIUM (ALEVE), ATORVASTATIN, METFORMIN, WARFARIN, METOPROLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ACETYLSALICYLIC ACID (EQUATE [ACETYLSALICYLIC ACID]), BIFIDOBACTERIUM INFANTIS (ALIGN) and LISINOPRIL for an unknown indication.    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (Chest tightness), DYSPNOEA (Shortness of breath), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose), MYALGIA (Muscle ache), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, CHEST DISCOMFORT (Chest tightness), DYSPNOEA (Shortness of breath), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose), MYALGIA (Muscle ache), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Treatment medications were not provided by reporter.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Paraesthesia
Clinical narrative: Out of energy more often than he did before receiving the vaccine; Shortness of breath; Tickle in his chest and felt that he needed to laugh code; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), ASTHENIA (Out of energy more often than he did before receiving the vaccine) and PARAESTHESIA (Tickle in his chest and felt that he needed to laugh code) in a 70-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.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PARAESTHESIA (Tickle in his chest and felt that he needed to laugh code). On 13-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath). On 05-Feb-2021, the patient experienced ASTHENIA (Out of energy more often than he did before receiving the vaccine). At the time of the report, DYSPNOEA (Shortness of breath), ASTHENIA (Out of energy more often than he did before receiving the vaccine) and PARAESTHESIA (Tickle in his chest and felt that he needed to laugh code) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Nausea
Clinical narrative: Fever; headache; chills; Nausea; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE ( headache), CHILLS (chills), NAUSEA (Nausea) and MYALGIA (Body aches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 18-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 an unknown date, the patient experienced PYREXIA (Fever), HEADACHE ( headache), CHILLS (chills), NAUSEA (Nausea) and MYALGIA (Body aches). At the time of the report, PYREXIA (Fever), HEADACHE ( headache), CHILLS (chills), NAUSEA (Nausea) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-017626 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; headache; chills; Nausea; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE ( headache), CHILLS (chills), NAUSEA (Nausea) and MYALGIA (Body aches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 18-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 an unknown date, the patient experienced PYREXIA (Fever), HEADACHE ( headache), CHILLS (chills), NAUSEA (Nausea) and MYALGIA (Body aches). At the time of the report, PYREXIA (Fever), HEADACHE ( headache), CHILLS (chills), NAUSEA (Nausea) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-017626 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchy Arm (Injection Site); Redness from Injection Site Spreading; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy Arm (Injection Site)) and VACCINATION SITE ERYTHEMA (Redness from Injection Site Spreading) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Arm (Injection Site)) and VACCINATION SITE ERYTHEMA (Redness from Injection Site Spreading). At the time of the report, VACCINATION SITE PRURITUS (Itchy Arm (Injection Site)) and VACCINATION SITE ERYTHEMA (Redness from Injection Site Spreading) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Feeling abnormal, Headache, Malaise
Clinical narrative: left arm throbbing; feels like she had been hit by a train; left arn is burning; after my second shot my left arm is now hurting, left arm is sore,both arm hurts; feels crappy; back of her head, neck and back hurts; back of her head, neck and back hurts; bad headache; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (left arm throbbing), MALAISE (feels like she had been hit by a train), BURNING SENSATION (left arn is burning), PAIN IN EXTREMITY (after my second shot my left arm is now hurting, left arm is sore,both arm hurts) and FEELING ABNORMAL (feels crappy) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medication history reported).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-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 PAIN (left arm throbbing), MALAISE (feels like she had been hit by a train), BURNING SENSATION (left arn is burning), PAIN IN EXTREMITY (after my second shot my left arm is now hurting, left arm is sore,both arm hurts), FEELING ABNORMAL (feels crappy), NECK PAIN (back of her head, neck and back hurts), BACK PAIN (back of her head, neck and back hurts) and HEADACHE (bad headache). At the time of the report, PAIN (left arm throbbing), MALAISE (feels like she had been hit by a train), BURNING SENSATION (left arn is burning), PAIN IN EXTREMITY (after my second shot my left arm is now hurting, left arm is sore,both arm hurts), FEELING ABNORMAL (feels crappy), NECK PAIN (back of her head, neck and back hurts), BACK PAIN (back of her head, neck and back hurts) and HEADACHE (bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: no blood clots were observed in the vein..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2021: No specific follow-up information recorded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Ultrasound scan
Clinical narrative: left arm throbbing; feels like she had been hit by a train; left arn is burning; after my second shot my left arm is now hurting, left arm is sore,both arm hurts; feels crappy; back of her head, neck and back hurts; back of her head, neck and back hurts; bad headache; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (left arm throbbing), MALAISE (feels like she had been hit by a train), BURNING SENSATION (left arn is burning), PAIN IN EXTREMITY (after my second shot my left arm is now hurting, left arm is sore,both arm hurts) and FEELING ABNORMAL (feels crappy) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medication history reported).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-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 PAIN (left arm throbbing), MALAISE (feels like she had been hit by a train), BURNING SENSATION (left arn is burning), PAIN IN EXTREMITY (after my second shot my left arm is now hurting, left arm is sore,both arm hurts), FEELING ABNORMAL (feels crappy), NECK PAIN (back of her head, neck and back hurts), BACK PAIN (back of her head, neck and back hurts) and HEADACHE (bad headache). At the time of the report, PAIN (left arm throbbing), MALAISE (feels like she had been hit by a train), BURNING SENSATION (left arn is burning), PAIN IN EXTREMITY (after my second shot my left arm is now hurting, left arm is sore,both arm hurts), FEELING ABNORMAL (feels crappy), NECK PAIN (back of her head, neck and back hurts), BACK PAIN (back of her head, neck and back hurts) and HEADACHE (bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: no blood clots were observed in the vein..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2021: No specific follow-up information recorded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itching real bad at the injection site - left arm; redness at the injection site - left arm; swelling at the injection site - left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching real bad at the injection site - left arm), VACCINATION SITE ERYTHEMA (redness at the injection site - left arm) and VACCINATION SITE SWELLING (swelling at the injection site - left arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching real bad at the injection site - left arm), VACCINATION SITE ERYTHEMA (redness at the injection site - left arm) and VACCINATION SITE SWELLING (swelling at the injection site - left arm). At the time of the report, VACCINATION SITE PRURITUS (itching real bad at the injection site - left arm), VACCINATION SITE ERYTHEMA (redness at the injection site - left arm) and VACCINATION SITE SWELLING (swelling at the injection site - left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-025255 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-025255:Case for patient's husband
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood cholesterol, Chills, Decreased appetite, Headache
Clinical narrative: lost the appetite; the arm was hurting at the vaccination site; shivers; Back ache; head aches; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lost the appetite), VACCINATION SITE PAIN (the arm was hurting at the vaccination site), CHILLS (shivers) and HEADACHE (head aches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Cholesterol.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DECREASED APPETITE (lost the appetite), VACCINATION SITE PAIN (the arm was hurting at the vaccination site), CHILLS (shivers) and HEADACHE (head aches). At the time of the report, DECREASED APPETITE (lost the appetite), VACCINATION SITE PAIN (the arm was hurting at the vaccination site), CHILLS (shivers) and HEADACHE (head aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: abnormal (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications were reported included medications for diabetes and cholesterol   No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up was received Reporter mentioned patient is fine now, outcome updated. No further FU required.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: lost the appetite; the arm was hurting at the vaccination site; shivers; Back ache; head aches; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lost the appetite), VACCINATION SITE PAIN (the arm was hurting at the vaccination site), CHILLS (shivers) and HEADACHE (head aches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Cholesterol.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DECREASED APPETITE (lost the appetite), VACCINATION SITE PAIN (the arm was hurting at the vaccination site), CHILLS (shivers) and HEADACHE (head aches). At the time of the report, DECREASED APPETITE (lost the appetite), VACCINATION SITE PAIN (the arm was hurting at the vaccination site), CHILLS (shivers) and HEADACHE (head aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: abnormal (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications were reported included medications for diabetes and cholesterol   No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up was received Reporter mentioned patient is fine now, outcome updated. No further FU required.
Sex: M
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Potential Adverse Event because of the infection and the potential relation with the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Potential Adverse Event because of the infection and the potential relation with the Moderna COVID-19 vaccine) in a male 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.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INFECTION (Potential Adverse Event because of the infection and the potential relation with the Moderna COVID-19 vaccine). At the time of the report, INFECTION (Potential Adverse Event because of the infection and the potential relation with the Moderna COVID-19 vaccine) outcome was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Lethargy, Myalgia
Clinical narrative: lethargic; chills; fever (99-100); no appetite; body aches (big time); no energy; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), CHILLS (chills), PYREXIA (fever (99-100)), DECREASED APPETITE (no appetite) and MYALGIA (body aches (big time)) in a 69-year-old male 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.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced LETHARGY (lethargic), CHILLS (chills), PYREXIA (fever (99-100)), DECREASED APPETITE (no appetite), MYALGIA (body aches (big time)) and ASTHENIA (no energy). On 07-Feb-2021, LETHARGY (lethargic), CHILLS (chills), PYREXIA (fever (99-100)), DECREASED APPETITE (no appetite), MYALGIA (body aches (big time)) and ASTHENIA (no energy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: lethargic; chills; fever (99-100); no appetite; body aches (big time); no energy; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), CHILLS (chills), PYREXIA (fever (99-100)), DECREASED APPETITE (no appetite) and MYALGIA (body aches (big time)) in a 69-year-old male 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.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced LETHARGY (lethargic), CHILLS (chills), PYREXIA (fever (99-100)), DECREASED APPETITE (no appetite), MYALGIA (body aches (big time)) and ASTHENIA (no energy). On 07-Feb-2021, LETHARGY (lethargic), CHILLS (chills), PYREXIA (fever (99-100)), DECREASED APPETITE (no appetite), MYALGIA (body aches (big time)) and ASTHENIA (no energy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Eating disorder, Gastrooesophageal reflux disease, Headache
Clinical narrative: sick; Nauseated; Vomited a lot; Massive headache; acid reflux; Not eaten; very weak; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), NAUSEA (Nauseated), VOMITING (Vomited a lot), HEADACHE (Massive headache) and GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ILLNESS (sick), NAUSEA (Nauseated), VOMITING (Vomited a lot), HEADACHE (Massive headache), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), EATING DISORDER (Not eaten), ASTHENIA (very weak) and ARTHRALGIA (Joint pain). On 06-Feb-2021, VOMITING (Vomited a lot) had resolved. At the time of the report, ILLNESS (sick), NAUSEA (Nauseated), HEADACHE (Massive headache), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), EATING DISORDER (Not eaten), ASTHENIA (very weak) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Vomiting
Clinical narrative: sick; Nauseated; Vomited a lot; Massive headache; acid reflux; Not eaten; very weak; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), NAUSEA (Nauseated), VOMITING (Vomited a lot), HEADACHE (Massive headache) and GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ILLNESS (sick), NAUSEA (Nauseated), VOMITING (Vomited a lot), HEADACHE (Massive headache), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), EATING DISORDER (Not eaten), ASTHENIA (very weak) and ARTHRALGIA (Joint pain). On 06-Feb-2021, VOMITING (Vomited a lot) had resolved. At the time of the report, ILLNESS (sick), NAUSEA (Nauseated), HEADACHE (Massive headache), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), EATING DISORDER (Not eaten), ASTHENIA (very weak) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pruritus, Vaccination site induration, Vaccination site pain
Clinical narrative: Reaction at the injection site about 2 inches wide, a circle; Severe itching; Pain; Sore; Raised; Hard; Warm to touch; When she moves her arm it hurts; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (Reaction at the injection site about 2 inches wide, a circle), PRURITUS (Severe itching), PAIN (Pain), VACCINATION SITE PAIN (Sore) and VACCINATION SITE SWELLING (Raised) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE REACTION (Reaction at the injection site about 2 inches wide, a circle), PRURITUS (Severe itching), PAIN (Pain), VACCINATION SITE PAIN (Sore), VACCINATION SITE SWELLING (Raised), VACCINATION SITE INDURATION (Hard), VACCINATION SITE WARMTH (Warm to touch) and PAIN IN EXTREMITY (When she moves her arm it hurts). At the time of the report, VACCINATION SITE REACTION (Reaction at the injection site about 2 inches wide, a circle), PRURITUS (Severe itching), PAIN (Pain), VACCINATION SITE PAIN (Sore), VACCINATION SITE SWELLING (Raised), VACCINATION SITE INDURATION (Hard), VACCINATION SITE WARMTH (Warm to touch) and PAIN IN EXTREMITY (When she moves her arm it hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Reaction at the injection site about 2 inches wide, a circle; Severe itching; Pain; Sore; Raised; Hard; Warm to touch; When she moves her arm it hurts; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (Reaction at the injection site about 2 inches wide, a circle), PRURITUS (Severe itching), PAIN (Pain), VACCINATION SITE PAIN (Sore) and VACCINATION SITE SWELLING (Raised) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE REACTION (Reaction at the injection site about 2 inches wide, a circle), PRURITUS (Severe itching), PAIN (Pain), VACCINATION SITE PAIN (Sore), VACCINATION SITE SWELLING (Raised), VACCINATION SITE INDURATION (Hard), VACCINATION SITE WARMTH (Warm to touch) and PAIN IN EXTREMITY (When she moves her arm it hurts). At the time of the report, VACCINATION SITE REACTION (Reaction at the injection site about 2 inches wide, a circle), PRURITUS (Severe itching), PAIN (Pain), VACCINATION SITE PAIN (Sore), VACCINATION SITE SWELLING (Raised), VACCINATION SITE INDURATION (Hard), VACCINATION SITE WARMTH (Warm to touch) and PAIN IN EXTREMITY (When she moves her arm it hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain on the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain on the site of injection) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain on the site of injection). On 03-Feb-2021, VACCINATION SITE PAIN (Pain on the site of injection) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pyrexia
Clinical narrative: fever; Headache; Nausea; chills; shaking; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), VACCINATION SITE PAIN (Pain at the injection site), PYREXIA (fever), HEADACHE (Headache) and NAUSEA (Nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 23-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 23-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 24-Feb-2021, the patient experienced TREMOR (shaking), PYREXIA (fever), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TREMOR (shaking), VACCINATION SITE PAIN (Pain at the injection site), PYREXIA (fever), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.         Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vaccination site pain
Clinical narrative: fever; Headache; Nausea; chills; shaking; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), VACCINATION SITE PAIN (Pain at the injection site), PYREXIA (fever), HEADACHE (Headache) and NAUSEA (Nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 23-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 23-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 24-Feb-2021, the patient experienced TREMOR (shaking), PYREXIA (fever), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TREMOR (shaking), VACCINATION SITE PAIN (Pain at the injection site), PYREXIA (fever), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.         Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling at the injection site; redness at the injection site; pain at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (pain at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not reported).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Didn't feel good for 3 days; Soreness at the injection site; Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Didn't feel good for 3 days) and VACCINATION SITE PAIN (Soreness at the injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Allergy.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced ASTHENIA (Didn't feel good for 3 days) and VACCINATION SITE PAIN (Soreness at the injection site). On 11-Jan-2021, ASTHENIA (Didn't feel good for 3 days) and VACCINATION SITE PAIN (Soreness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication information was reported. .   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up received contains non-significant information.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Redness at site of injection; Swollen injection site; Soreness on arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on arm of injection), VACCINATION SITE ERYTHEMA (Redness at site of injection) and VACCINATION SITE SWELLING (Swollen injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 VACCINATION SITE PAIN (Soreness on arm of injection). On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at site of injection) and VACCINATION SITE SWELLING (Swollen injection site). At the time of the report, VACCINATION SITE PAIN (Soreness on arm of injection), VACCINATION SITE ERYTHEMA (Redness at site of injection) and VACCINATION SITE SWELLING (Swollen injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: dizzy; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) and NAUSEA (nauseous) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced DIZZINESS (dizzy) and NAUSEA (nauseous). The patient was treated with MECLIZINE HCL at a dose of 25 mg as required and DIAZEPAM ongoing since an unknown date at a dose of 5 mg as required. On 25-Feb-2021, DIZZINESS (dizzy) and NAUSEA (nauseous) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fall
Clinical narrative: falling injury; Lower back pain; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events patient fell 2 weeks after first shot, lower back pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the event(s) patient fell 2 weeks after first shot, lower back pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 17 Feb 2021 the outcome of event(s), patient fell 2 weeks after first shot was resolved. The outcome of event(s), lower back pain was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (Hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Itching at injection site; Redness at injection site; Warmth at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE WARMTH (Warmth at injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE WARMTH (Warmth at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE WARMTH (Warmth at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Lethargy, Pain
Clinical narrative: Lethargic; No energy; No appetite; Body aches (big time); Fever (99-100); Chills; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), ASTHENIA (No energy), DECREASED APPETITE (No appetite), PAIN (Body aches (big time)) and PYREXIA (Fever (99-100)) in a 72-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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced LETHARGY (Lethargic), ASTHENIA (No energy), DECREASED APPETITE (No appetite), PAIN (Body aches (big time)), PYREXIA (Fever (99-100)) and CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 07-Feb-2021, LETHARGY (Lethargic), ASTHENIA (No energy), DECREASED APPETITE (No appetite), PAIN (Body aches (big time)), PYREXIA (Fever (99-100)) and CHILLS (Chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up information received on 12 Jul 2021 contains non significant information
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Lethargic; No energy; No appetite; Body aches (big time); Fever (99-100); Chills; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), ASTHENIA (No energy), DECREASED APPETITE (No appetite), PAIN (Body aches (big time)) and PYREXIA (Fever (99-100)) in a 72-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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced LETHARGY (Lethargic), ASTHENIA (No energy), DECREASED APPETITE (No appetite), PAIN (Body aches (big time)), PYREXIA (Fever (99-100)) and CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 07-Feb-2021, LETHARGY (Lethargic), ASTHENIA (No energy), DECREASED APPETITE (No appetite), PAIN (Body aches (big time)), PYREXIA (Fever (99-100)) and CHILLS (Chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up information received on 12 Jul 2021 contains non significant information
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Achy; Feeling feverish with 101.2 fever. And this morning 99.4; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) and PYREXIA (Feeling feverish with 101.2 fever. And this morning 99.4) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013LZ0A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced PAIN (Achy) and PYREXIA (Feeling feverish with 101.2 fever. And this morning 99.4). At the time of the report, PAIN (Achy) and PYREXIA (Feeling feverish with 101.2 fever. And this morning 99.4) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Body temperature: 101.2 Fever. On 08-Feb-2021, Body temperature: 99.4 Fever.         Other concomitant medication included unspecified Ace Inhibitor and Inhaler.   Treatment medication included Tylenol.   This case was linked to MOD-2021-092480 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Reporter contact information and weight updated.
Age: 80.0
Sex: F
Vaccine: COVID19, UNK, UNK, UNK
Symptoms: Chills, Pyrexia, Urticaria
Clinical narrative: Welts in the torso and back; Fever; Chills; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (Welts in the torso and back), PYREXIA (Fever) and CHILLS (Chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04L20A) for COVID-19 vaccination.    Co-suspect products included non-company products ESTRADIOL for an unknown indication, Blood pressure medication for an unknown indication and Vitamin supplement for an unknown indication.    No medical history was provided by the reporter.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ESTRADIOL (unknown route) at an unspecified dose, Blood pressure medication (unknown route) at an unspecified dose and Vitamin supplement (unknown route) at an unspecified dose. On 02-Feb-2021, the patient experienced URTICARIA (Welts in the torso and back), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; SERTRALINE HYDROCHLORIDE (SERTAC) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (Welts in the torso and back), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.