chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Vaccination site erythema, Vaccination site joint warmth, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Lymph nodes were tender at left side of axilla; Pain at injection site; Swelling at injection site; Itching at the injection site; Increased redness/erythema at injection site; Warm to the touch injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE JOINT WARMTH (Warm to the touch injection site), LYMPH NODE PAIN (Lymph nodes were tender at left side of axilla), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Increased redness/erythema at injection site) and VACCINATION SITE PAIN (Pain at injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic sinusitis and Eczema. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT), ALBUTEROL [SALBUTAMOL], CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and VITAMIN D3 for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE JOINT WARMTH (Warm to the touch injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Increased redness/erythema at injection site). On an unknown date, the patient experienced LYMPH NODE PAIN (Lymph nodes were tender at left side of axilla), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, VACCINATION SITE JOINT WARMTH (Warm to the touch injection site), LYMPH NODE PAIN (Lymph nodes were tender at left side of axilla), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Increased redness/erythema at injection site), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included steroids.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19 APR 2021 contains significant information
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Lymph nodes were tender at left side of axilla; Pain at injection site; Swelling at injection site; Itching at the injection site; Increased redness/erythema at injection site; Warm to the touch injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE JOINT WARMTH (Warm to the touch injection site), LYMPH NODE PAIN (Lymph nodes were tender at left side of axilla), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Increased redness/erythema at injection site) and VACCINATION SITE PAIN (Pain at injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic sinusitis and Eczema. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT), ALBUTEROL [SALBUTAMOL], CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and VITAMIN D3 for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE JOINT WARMTH (Warm to the touch injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Increased redness/erythema at injection site). On an unknown date, the patient experienced LYMPH NODE PAIN (Lymph nodes were tender at left side of axilla), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, VACCINATION SITE JOINT WARMTH (Warm to the touch injection site), LYMPH NODE PAIN (Lymph nodes were tender at left side of axilla), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Increased redness/erythema at injection site), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included steroids.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19 APR 2021 contains significant information
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Urinary incontinence, Vomiting
Clinical narrative: sick; lost control of bladder; vomiting; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), URINARY INCONTINENCE (lost control of bladder), VOMITING (vomiting) and NAUSEA (nauseated) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 25-Jan-2021, the patient experienced ILLNESS (sick), URINARY INCONTINENCE (lost control of bladder), VOMITING (vomiting) and NAUSEA (nauseated). At the time of the report, ILLNESS (sick), URINARY INCONTINENCE (lost control of bladder), VOMITING (vomiting) and NAUSEA (nauseated) 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. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Adverse Reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse Reactions) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse Reactions). At the time of the report, VACCINATION COMPLICATION (Adverse Reactions) 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. No treatment information was provided.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Oropharyngeal pain, Vaccination site erythema, Vaccination site induration
Clinical narrative: Mild sore throat; General achiness all over; the injection site, Puffy, tight skin feeling; Mild headache; Really red; Hot to the touch; The injection site started itching; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Mild sore throat), MYALGIA (General achiness all over), VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE PRURITUS (The injection site started itching) and VACCINATION SITE INDURATION (the injection site, Puffy, tight skin feeling) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (The injection site started itching). On 25-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch) and VACCINATION SITE ERYTHEMA (Really red). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Mild sore throat), MYALGIA (General achiness all over), VACCINATION SITE INDURATION (the injection site, Puffy, tight skin feeling) and HEADACHE (Mild headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, OROPHARYNGEAL PAIN (Mild sore throat), MYALGIA (General achiness all over), VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE PRURITUS (The injection site started itching), VACCINATION SITE INDURATION (the injection site, Puffy, tight skin feeling), VACCINATION SITE ERYTHEMA (Really red) and HEADACHE (Mild headache) 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.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: NNI FU.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Mild sore throat; General achiness all over; the injection site, Puffy, tight skin feeling; Mild headache; Really red; Hot to the touch; The injection site started itching; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Mild sore throat), MYALGIA (General achiness all over), VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE PRURITUS (The injection site started itching) and VACCINATION SITE INDURATION (the injection site, Puffy, tight skin feeling) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (The injection site started itching). On 25-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch) and VACCINATION SITE ERYTHEMA (Really red). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Mild sore throat), MYALGIA (General achiness all over), VACCINATION SITE INDURATION (the injection site, Puffy, tight skin feeling) and HEADACHE (Mild headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, OROPHARYNGEAL PAIN (Mild sore throat), MYALGIA (General achiness all over), VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE PRURITUS (The injection site started itching), VACCINATION SITE INDURATION (the injection site, Puffy, tight skin feeling), VACCINATION SITE ERYTHEMA (Really red) and HEADACHE (Mild headache) 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.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: NNI FU.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Flushing, Heart rate increased, Muscular weakness
Clinical narrative: hot flushing feeling in body; fast heartbeat; blood pressure at 127; weakness in legs when standing; rash on chest/rash on right side of face; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (hot flushing feeling in body), HEART RATE INCREASED (fast heartbeat), BLOOD PRESSURE INCREASED (blood pressure at 127), MUSCULAR WEAKNESS (weakness in legs when standing) and RASH (rash on chest/rash on right side of face) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced FLUSHING (hot flushing feeling in body), HEART RATE INCREASED (fast heartbeat), BLOOD PRESSURE INCREASED (blood pressure at 127), MUSCULAR WEAKNESS (weakness in legs when standing) and RASH (rash on chest/rash on right side of face). At the time of the report, FLUSHING (hot flushing feeling in body), HEART RATE INCREASED (fast heartbeat), BLOOD PRESSURE INCREASED (blood pressure at 127), MUSCULAR WEAKNESS (weakness in legs when standing) and RASH (rash on chest/rash on right side of face) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Blood pressure measurement: 127 (High) 127.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Diabetic medication. Treatment details included 50 mil of Benadryl, 1 shot of Epinephrine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: hot flushing feeling in body; fast heartbeat; blood pressure at 127; weakness in legs when standing; rash on chest/rash on right side of face; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (hot flushing feeling in body), HEART RATE INCREASED (fast heartbeat), BLOOD PRESSURE INCREASED (blood pressure at 127), MUSCULAR WEAKNESS (weakness in legs when standing) and RASH (rash on chest/rash on right side of face) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced FLUSHING (hot flushing feeling in body), HEART RATE INCREASED (fast heartbeat), BLOOD PRESSURE INCREASED (blood pressure at 127), MUSCULAR WEAKNESS (weakness in legs when standing) and RASH (rash on chest/rash on right side of face). At the time of the report, FLUSHING (hot flushing feeling in body), HEART RATE INCREASED (fast heartbeat), BLOOD PRESSURE INCREASED (blood pressure at 127), MUSCULAR WEAKNESS (weakness in legs when standing) and RASH (rash on chest/rash on right side of face) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Blood pressure measurement: 127 (High) 127.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Diabetic medication. Treatment details included 50 mil of Benadryl, 1 shot of Epinephrine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Dizziness, Feeling abnormal, Headache, Heart rate increased
Clinical narrative: Had a really bad headache; Still felt horrible; Slept most of that day; Suffer from BTV (vertigo) and it got very bad after the vaccine; Woke up feeling very agitated; Very dizzy; Had flu-like symptoms; Was not feeling well at all; Achy all over; Heart rate was higher, like 10 beats per minute higher; Started to shake; This spontaneous case was reported by a pharmacist and describes the occurrence of HEART RATE INCREASED (Heart rate was higher, like 10 beats per minute higher), TREMOR (Started to shake), VERTIGO (Suffer from BTV (vertigo) and it got very bad after the vaccine), AGITATION (Woke up feeling very agitated) and DIZZINESS (Very dizzy) in a 59-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.     Concurrent medical conditions included Vertigo (BTV).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021 at 7:00 AM, the patient experienced HEART RATE INCREASED (Heart rate was higher, like 10 beats per minute higher) and TREMOR (Started to shake). On 24-Jan-2021, the patient experienced VERTIGO (Suffer from BTV (vertigo) and it got very bad after the vaccine), AGITATION (Woke up feeling very agitated), DIZZINESS (Very dizzy), INFLUENZA LIKE ILLNESS (Had flu-like symptoms), MALAISE (Was not feeling well at all), HYPERSOMNIA (Slept most of that day) and MYALGIA (Achy all over). On 25-Jan-2021, the patient experienced FEELING ABNORMAL (Still felt horrible). On 28-Jan-2021, the patient experienced HEADACHE (Had a really bad headache). At the time of the report, HEART RATE INCREASED (Heart rate was higher, like 10 beats per minute higher), TREMOR (Started to shake), VERTIGO (Suffer from BTV (vertigo) and it got very bad after the vaccine), AGITATION (Woke up feeling very agitated), DIZZINESS (Very dizzy), INFLUENZA LIKE ILLNESS (Had flu-like symptoms), MALAISE (Was not feeling well at all), FEELING ABNORMAL (Still felt horrible), HYPERSOMNIA (Slept most of that day), HEADACHE (Had a really bad headache) and MYALGIA (Achy all over) 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.   No relevant concomitant medications were provided. Treatment included Beta Blocker and Tylenol
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Influenza like illness, Malaise, Myalgia, Tremor
Clinical narrative: Had a really bad headache; Still felt horrible; Slept most of that day; Suffer from BTV (vertigo) and it got very bad after the vaccine; Woke up feeling very agitated; Very dizzy; Had flu-like symptoms; Was not feeling well at all; Achy all over; Heart rate was higher, like 10 beats per minute higher; Started to shake; This spontaneous case was reported by a pharmacist and describes the occurrence of HEART RATE INCREASED (Heart rate was higher, like 10 beats per minute higher), TREMOR (Started to shake), VERTIGO (Suffer from BTV (vertigo) and it got very bad after the vaccine), AGITATION (Woke up feeling very agitated) and DIZZINESS (Very dizzy) in a 59-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.     Concurrent medical conditions included Vertigo (BTV).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021 at 7:00 AM, the patient experienced HEART RATE INCREASED (Heart rate was higher, like 10 beats per minute higher) and TREMOR (Started to shake). On 24-Jan-2021, the patient experienced VERTIGO (Suffer from BTV (vertigo) and it got very bad after the vaccine), AGITATION (Woke up feeling very agitated), DIZZINESS (Very dizzy), INFLUENZA LIKE ILLNESS (Had flu-like symptoms), MALAISE (Was not feeling well at all), HYPERSOMNIA (Slept most of that day) and MYALGIA (Achy all over). On 25-Jan-2021, the patient experienced FEELING ABNORMAL (Still felt horrible). On 28-Jan-2021, the patient experienced HEADACHE (Had a really bad headache). At the time of the report, HEART RATE INCREASED (Heart rate was higher, like 10 beats per minute higher), TREMOR (Started to shake), VERTIGO (Suffer from BTV (vertigo) and it got very bad after the vaccine), AGITATION (Woke up feeling very agitated), DIZZINESS (Very dizzy), INFLUENZA LIKE ILLNESS (Had flu-like symptoms), MALAISE (Was not feeling well at all), FEELING ABNORMAL (Still felt horrible), HYPERSOMNIA (Slept most of that day), HEADACHE (Had a really bad headache) and MYALGIA (Achy all over) 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.   No relevant concomitant medications were provided. Treatment included Beta Blocker and Tylenol
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Had a really bad headache; Still felt horrible; Slept most of that day; Suffer from BTV (vertigo) and it got very bad after the vaccine; Woke up feeling very agitated; Very dizzy; Had flu-like symptoms; Was not feeling well at all; Achy all over; Heart rate was higher, like 10 beats per minute higher; Started to shake; This spontaneous case was reported by a pharmacist and describes the occurrence of HEART RATE INCREASED (Heart rate was higher, like 10 beats per minute higher), TREMOR (Started to shake), VERTIGO (Suffer from BTV (vertigo) and it got very bad after the vaccine), AGITATION (Woke up feeling very agitated) and DIZZINESS (Very dizzy) in a 59-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.     Concurrent medical conditions included Vertigo (BTV).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021 at 7:00 AM, the patient experienced HEART RATE INCREASED (Heart rate was higher, like 10 beats per minute higher) and TREMOR (Started to shake). On 24-Jan-2021, the patient experienced VERTIGO (Suffer from BTV (vertigo) and it got very bad after the vaccine), AGITATION (Woke up feeling very agitated), DIZZINESS (Very dizzy), INFLUENZA LIKE ILLNESS (Had flu-like symptoms), MALAISE (Was not feeling well at all), HYPERSOMNIA (Slept most of that day) and MYALGIA (Achy all over). On 25-Jan-2021, the patient experienced FEELING ABNORMAL (Still felt horrible). On 28-Jan-2021, the patient experienced HEADACHE (Had a really bad headache). At the time of the report, HEART RATE INCREASED (Heart rate was higher, like 10 beats per minute higher), TREMOR (Started to shake), VERTIGO (Suffer from BTV (vertigo) and it got very bad after the vaccine), AGITATION (Woke up feeling very agitated), DIZZINESS (Very dizzy), INFLUENZA LIKE ILLNESS (Had flu-like symptoms), MALAISE (Was not feeling well at all), FEELING ABNORMAL (Still felt horrible), HYPERSOMNIA (Slept most of that day), HEADACHE (Had a really bad headache) and MYALGIA (Achy all over) 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.   No relevant concomitant medications were provided. Treatment included Beta Blocker and Tylenol
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore and achy arm; A spontaneous report was received from a Healthcare Professional concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore and achy arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the event the patient received their second of two planned doses of mRNA-1273 (lot: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced sore and achy arm.   No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not applicable.   The outcome of event, sore and achy arm was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness around injection site; Swelling around injection site; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness around injection site), VACCINATION SITE SWELLING (Swelling around injection site), FATIGUE (Fatigue) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around injection site), VACCINATION SITE SWELLING (Swelling around injection site), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, VACCINATION SITE ERYTHEMA (Redness around injection site), VACCINATION SITE SWELLING (Swelling around injection site), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis
Clinical narrative: Inflamed lymph nodes in the axillary area; A spontaneous report was received from a consumer concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and had inflamed lymph nodes in the axillary area of the same side.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the event, the patient received their dose of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient had inflamed lymph nodes in the axillary area of the same side. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event inflamed lymph nodes in the axillary area of the same side was not recovered (still having inflamed lymph nodes in the axillary area of the same side).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arm was sore; It was warm; Baseball size red spot on the arm; Arm swollen; A spontaneous report was received from a Consumer concerning a 54-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events baseball size spot on the arm, swollen, warm, red, sore.  The patient's medical history was not provided. Concomitant medications reported were Cholesterol med, Lipitor, probably Anastrozole (patient did not know how to spell it) 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: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 24 Jan 2021, the patient experienced the events baseball size spot on the arm. swollen, warm, red. On an unknown date, the patient experienced the events sore.  Treatment details included Benadryl and Tylenol told by doctor.  Action taken with mRNA-1273 in response to the events was not reported.   On 28 Jan 2021 the outcome of events baseball size spot on the arm was resolved.  On 28 Jan 2021 the outcome of events swollen was resolved.  On 28 Jan 2021 the outcome of events warm was resolved.  On 28 Jan 2021 the outcome of events red was resolved.  On an unknown date the outcome of events, sore was not reported.; Reporter's Comments: This case concerns a 54-year-old female who had NS expected vaccination site erythema, vaccination site pain, vaccination site swelling and NS unexpected vaccination site warmth.  Event onset occurred 11 days after the first dose of mRNA-1273. Treated with Benadryl and Tylenol. Most events resolved, with pain outcome unknown. Based on 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Pain on the injected arm to which heat applied and it got itchy; Pain on the injected arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Pain on the injected arm to which heat applied and it got itchy) and VACCINATION SITE PAIN (Pain on the injected arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included LOVASTATIN, LEVOTHYROXINE, VITAMIN D NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Pain on the injected arm to which heat applied and it got itchy) and VACCINATION SITE PAIN (Pain on the injected arm). At the time of the report, VACCINATION SITE PRURITUS (Pain on the injected arm to which heat applied and it got itchy) and VACCINATION SITE PAIN (Pain on the injected arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Vaccination site pain
Clinical narrative: Weakness; Extreme soreness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) and VACCINATION SITE PAIN (Extreme soreness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 ASTHENIA (Weakness) and VACCINATION SITE PAIN (Extreme soreness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weakness) and VACCINATION SITE PAIN (Extreme soreness) outcome was unknown.            Concomitant medications were not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable, reporter didn't provide causality assessment.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up received on 24-06-2021 contains reporter's Email address.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swollen shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen shoulder) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, ATORVASTATIN and LOSARTAN for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen shoulder). At the time of the report, PERIPHERAL SWELLING (Swollen shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Non significant follow up received on 20-APR-2021, no new information
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site was a little swollen; injection site redness; injection site itching; Injection site was mildly indurated; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE INDURATION (Injection site was mildly indurated), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE SWELLING (Injection site was a little swollen) and VACCINATION SITE ERYTHEMA (injection site redness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 15m2A?) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Peanut oil), Drug allergy (Relafen), Atrophic vaginitis, Prediabetes, Herpes simplex, Seasonal affective disorder and Hair loss. Concomitant products included VITAMIN D3, ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL), BUPROPION HYDROCHLORIDE (BUPROPION HCL XL), METFORMIN and SPIRONOLACTONE (SPIRONOLACTONE A L) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Injection site was mildly indurated), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE SWELLING (Injection site was a little swollen) and VACCINATION SITE ERYTHEMA (injection site redness). On 28-Jan-2021, VACCINATION SITE INDURATION (Injection site was mildly indurated), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE SWELLING (Injection site was a little swollen) and VACCINATION SITE ERYTHEMA (injection site redness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not indicated.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Follow-up information updated medical history, concomitant medications, start date of the events, and outcome of the events. On 15-Apr-2021: Follow-up information received on 15-Apr-2021 included no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 103.3 Degrees Farenheight; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 103.3 Degrees Farenheight) in a 67-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 27-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 PYREXIA (Fever of 103.3 Degrees Farenheight). At the time of the report, PYREXIA (Fever of 103.3 Degrees Farenheight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Body temperature: 103.3 degrees fahrenheit (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient self-treated with ibuprofen 200mg.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: Arm was Swollen and Red (Injection Site); Shortness of breath; injection site really red; Fatigue; Rash (Injection Site ); This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), VACCINATION SITE RASH (Rash (Injection Site )), VACCINATION SITE SWELLING (Arm was Swollen and Red (Injection Site)), DYSPNOEA (Shortness of breath) and VACCINATION SITE ERYTHEMA (injection site really red) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE RASH (Rash (Injection Site )). On 16-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Arm was Swollen and Red (Injection Site)), DYSPNOEA (Shortness of breath) and VACCINATION SITE ERYTHEMA (injection site really red). At the time of the report, FATIGUE (Fatigue), VACCINATION SITE RASH (Rash (Injection Site )), VACCINATION SITE SWELLING (Arm was Swollen and Red (Injection Site)), DYSPNOEA (Shortness of breath) and VACCINATION SITE ERYTHEMA (injection site really red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not provided. Treatment details were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Administration site discolouration, Blister, Body temperature, Hypersensitivity, Pyrexia
Clinical narrative: Just a bit of discoloration; Little blister; injection arm it swelled up significantly; Arm red from below her injection site to her elbow; hot with a temperature; allergic reaction to the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ADMINISTRATION SITE DISCOLOURATION (Just a bit of discoloration), BLISTER (Little blister), VACCINATION SITE SWELLING (injection arm it swelled up significantly), VACCINATION SITE ERYTHEMA (Arm red from below her injection site to her elbow) and PYREXIA (hot with a temperature) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Sulfa and penicillin. Past adverse reactions to the above products included Rash with Sulfa and penicillin. Concomitant products included LEVOTHYROXINE for an unknown indication.    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 ADMINISTRATION SITE DISCOLOURATION (Just a bit of discoloration), BLISTER (Little blister), VACCINATION SITE SWELLING (injection arm it swelled up significantly), VACCINATION SITE ERYTHEMA (Arm red from below her injection site to her elbow) and PYREXIA (hot with a temperature). an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction to the vaccine). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL, SODIUM CITRATE (BENADRYL [AMMONIUM CHLORIDE;DIPHENHYDRAMINE HYDROCHLORIDE;MENTHOL;SODIUM CITRATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ADMINISTRATION SITE DISCOLOURATION (Just a bit of discoloration), BLISTER (Little blister), VACCINATION SITE ERYTHEMA (Arm red from below her injection site to her elbow), PYREXIA (hot with a temperature) and HYPERSENSITIVITY (allergic reaction to the vaccine) outcome was unknown and VACCINATION SITE SWELLING (injection arm it swelled up significantly) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5 (High) Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Just a bit of discoloration; Little blister; injection arm it swelled up significantly; Arm red from below her injection site to her elbow; hot with a temperature; allergic reaction to the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ADMINISTRATION SITE DISCOLOURATION (Just a bit of discoloration), BLISTER (Little blister), VACCINATION SITE SWELLING (injection arm it swelled up significantly), VACCINATION SITE ERYTHEMA (Arm red from below her injection site to her elbow) and PYREXIA (hot with a temperature) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Sulfa and penicillin. Past adverse reactions to the above products included Rash with Sulfa and penicillin. Concomitant products included LEVOTHYROXINE for an unknown indication.    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 ADMINISTRATION SITE DISCOLOURATION (Just a bit of discoloration), BLISTER (Little blister), VACCINATION SITE SWELLING (injection arm it swelled up significantly), VACCINATION SITE ERYTHEMA (Arm red from below her injection site to her elbow) and PYREXIA (hot with a temperature). an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction to the vaccine). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL, SODIUM CITRATE (BENADRYL [AMMONIUM CHLORIDE;DIPHENHYDRAMINE HYDROCHLORIDE;MENTHOL;SODIUM CITRATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ADMINISTRATION SITE DISCOLOURATION (Just a bit of discoloration), BLISTER (Little blister), VACCINATION SITE ERYTHEMA (Arm red from below her injection site to her elbow), PYREXIA (hot with a temperature) and HYPERSENSITIVITY (allergic reaction to the vaccine) outcome was unknown and VACCINATION SITE SWELLING (injection arm it swelled up significantly) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5 (High) Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Very Itchy Injection Site; Little redness on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Little redness on the Injection Site) and INJECTION SITE PRURITUS (Very Itchy Injection Site) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included CHOLESTEROL and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    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 ERYTHEMA (Little redness on the Injection Site). On an unknown date, the patient experienced INJECTION SITE PRURITUS (Very Itchy Injection Site). On 23-Jan-2021, INJECTION SITE ERYTHEMA (Little redness on the Injection Site) had resolved. At the time of the report, INJECTION SITE PRURITUS (Very Itchy Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: Dizzy; Not feeling great; Extreme fatigue; Bad headaches; Heart doesn't feel as bad; A spontaneous report, was received from a consumer (patient), a 48-years-old female patient of unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced dizziness, not feeling great, really tired and pretty bad headaches.  The patient's medical history included pericarditis secondary to coronavirus. No relevant concomitant medications were reported. The patient underwent COVID-19 test which was negative on an unknown date in 2020. The patient was not sure if the vaccine triggered her present symptoms.   On 21 Jan 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (lot number: 029L20A), intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date in Jan 2021, after administering the vaccine, the patient had dizziness, bad headaches, really tired, and not feeling great. The patient experienced similar symptoms last year when she was diagnosed with pericarditis which was caused by coronavirus. but her heart doesn't  feel bad now. The patient did not have any testing at that time; but she was negative 7 weeks later. No treatment details were provided.  Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of events, heart doesn't feel as bad, dizzy, not feeling great, really tired, and pretty bad headaches were not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.