chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Diarrhoea
Clinical narrative: Bloating; Abdominal pain; Chronic diarrhea/ every time eats she gets diarrhea 45 min after; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL DISTENSION (Bloating), ABDOMINAL PAIN (Abdominal pain) and DIARRHOEA (Chronic diarrhea/ every time eats she gets diarrhea 45 min after) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISTENSION (Bloating), ABDOMINAL PAIN (Abdominal pain) and DIARRHOEA (Chronic diarrhea/ every time eats she gets diarrhea 45 min after). At the time of the report, ABDOMINAL DISTENSION (Bloating), ABDOMINAL PAIN (Abdominal pain) and DIARRHOEA (Chronic diarrhea/ every time eats she gets diarrhea 45 min after) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment details included pills to relax bowels.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Feeling abnormal, Gait disturbance, Influenza like illness
Clinical narrative: Difficult to walk; Every joint in body hurt/Knees and ankles hurt so bad; stop up and couldn't breathe; Felt really bad; Felt like you feel when you are getting the flu; Feels different; This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING ABNORMAL (Feels different), MALAISE (Felt really bad), INFLUENZA LIKE ILLNESS (Felt like you feel when you are getting the flu), GAIT DISTURBANCE (Difficult to walk) and DYSPNOEA (stop up and couldn't breathe) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Oct-2021, the patient experienced MALAISE (Felt really bad), INFLUENZA LIKE ILLNESS (Felt like you feel when you are getting the flu) and DYSPNOEA (stop up and couldn't breathe). On 11-Oct-2021, the patient experienced GAIT DISTURBANCE (Difficult to walk) and ARTHRALGIA (Every joint in body hurt/Knees and ankles hurt so bad). In October 2021, the patient experienced FEELING ABNORMAL (Feels different). At the time of the report, FEELING ABNORMAL (Feels different) had not resolved and MALAISE (Felt really bad), INFLUENZA LIKE ILLNESS (Felt like you feel when you are getting the flu), GAIT DISTURBANCE (Difficult to walk), DYSPNOEA (stop up and couldn't breathe) and ARTHRALGIA (Every joint in body hurt/Knees and ankles hurt so bad) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. Patient reported by Monday afternoon it was difficult to walk because the knees and ankles hurt so bad and began to feel better by Tuesday afternoon, but still feels different.   Reporter did not allow further contact
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Difficult to walk; Every joint in body hurt/Knees and ankles hurt so bad; stop up and couldn't breathe; Felt really bad; Felt like you feel when you are getting the flu; Feels different; This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING ABNORMAL (Feels different), MALAISE (Felt really bad), INFLUENZA LIKE ILLNESS (Felt like you feel when you are getting the flu), GAIT DISTURBANCE (Difficult to walk) and DYSPNOEA (stop up and couldn't breathe) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Oct-2021, the patient experienced MALAISE (Felt really bad), INFLUENZA LIKE ILLNESS (Felt like you feel when you are getting the flu) and DYSPNOEA (stop up and couldn't breathe). On 11-Oct-2021, the patient experienced GAIT DISTURBANCE (Difficult to walk) and ARTHRALGIA (Every joint in body hurt/Knees and ankles hurt so bad). In October 2021, the patient experienced FEELING ABNORMAL (Feels different). At the time of the report, FEELING ABNORMAL (Feels different) had not resolved and MALAISE (Felt really bad), INFLUENZA LIKE ILLNESS (Felt like you feel when you are getting the flu), GAIT DISTURBANCE (Difficult to walk), DYSPNOEA (stop up and couldn't breathe) and ARTHRALGIA (Every joint in body hurt/Knees and ankles hurt so bad) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. Patient reported by Monday afternoon it was difficult to walk because the knees and ankles hurt so bad and began to feel better by Tuesday afternoon, but still feels different.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Off label use  [but is not immunocompromised]; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Off label use  [but is not immunocompromised]) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced OFF LABEL USE (Off label use  [but is not immunocompromised]). In August 2021, OFF LABEL USE (Off label use  [but is not immunocompromised]) had resolved.            No concomitant medication was mentioned. No treatment medication was mentioned.  It was reported that patient is not immunocompromised and may be because patient is married to someone who is immunocompromised as he is a lot older and because of that she received the third dose.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Dysphagia, Fatigue
Clinical narrative: Got the 3rd dose without being immunocompromised; Loose bowels/diarrhea; Can't eat; Little to no appetite; Very weak; Nausea; Tired/extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Loose bowels/diarrhea), DYSPHAGIA (Can't eat), DECREASED APPETITE (Little to no appetite), ASTHENIA (Very weak) and NAUSEA (Nausea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included CELECOXIB (CELEBREX), CORTISONE, BIMATOPROST (LUMIGAN) and GABAPENTIN for an unknown indication.    On 12-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced OFF LABEL USE (Got the 3rd dose without being immunocompromised). In September 2021, the patient experienced DIARRHOEA (Loose bowels/diarrhea), DYSPHAGIA (Can't eat), DECREASED APPETITE (Little to no appetite), ASTHENIA (Very weak), NAUSEA (Nausea) and FATIGUE (Tired/extremely fatigued). The patient was treated with LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) for Diarrhea, at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency. On 12-Sep-2021, OFF LABEL USE (Got the 3rd dose without being immunocompromised) had resolved. At the time of the report, DIARRHOEA (Loose bowels/diarrhea), DYSPHAGIA (Can't eat), DECREASED APPETITE (Little to no appetite), ASTHENIA (Very weak), NAUSEA (Nausea) and FATIGUE (Tired/extremely fatigued) had not resolved.       Concomitant medication included Thyroid medications 75 mg once a day.  It was reported that patient was not immunocompromised and the pharmacists indicated to get the shot.  The patient discontinued the medication Gabapentin after Dose 3 because of nausea.  A week after, Patient started having loose bowels and nausea and  had to go to the ER.   This case was linked to MOD-2021-354559, MOD-2021-354564 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Off label use
Clinical narrative: Got the 3rd dose without being immunocompromised; Loose bowels/diarrhea; Can't eat; Little to no appetite; Very weak; Nausea; Tired/extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Loose bowels/diarrhea), DYSPHAGIA (Can't eat), DECREASED APPETITE (Little to no appetite), ASTHENIA (Very weak) and NAUSEA (Nausea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included CELECOXIB (CELEBREX), CORTISONE, BIMATOPROST (LUMIGAN) and GABAPENTIN for an unknown indication.    On 12-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced OFF LABEL USE (Got the 3rd dose without being immunocompromised). In September 2021, the patient experienced DIARRHOEA (Loose bowels/diarrhea), DYSPHAGIA (Can't eat), DECREASED APPETITE (Little to no appetite), ASTHENIA (Very weak), NAUSEA (Nausea) and FATIGUE (Tired/extremely fatigued). The patient was treated with LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) for Diarrhea, at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency. On 12-Sep-2021, OFF LABEL USE (Got the 3rd dose without being immunocompromised) had resolved. At the time of the report, DIARRHOEA (Loose bowels/diarrhea), DYSPHAGIA (Can't eat), DECREASED APPETITE (Little to no appetite), ASTHENIA (Very weak), NAUSEA (Nausea) and FATIGUE (Tired/extremely fatigued) had not resolved.       Concomitant medication included Thyroid medications 75 mg once a day.  It was reported that patient was not immunocompromised and the pharmacists indicated to get the shot.  The patient discontinued the medication Gabapentin after Dose 3 because of nausea.  A week after, Patient started having loose bowels and nausea and  had to go to the ER.   This case was linked to MOD-2021-354559, MOD-2021-354564 (Patient Link).
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered past the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-354306, MOD-2021-355109.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered from a vial that was greater then 12 hours post puncture at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered from a vial that was greater then 12 hours post puncture at room temperature) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered from a vial that was greater then 12 hours post puncture at room temperature). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (dose administered from a vial that was greater then 12 hours post puncture at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-354372, MOD-2021-354432, MOD-2021-354712 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Contusion, Injection site extravasation, Skin discolouration, Vaccination site mass
Clinical narrative: blood trailing; lump in the middle of the breast; tenderness/pain in the injection arm; lump in the injection arm; Contusion of breast; bruise in breast got very purple; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE EXTRAVASATION (blood trailing), CONTUSION (Contusion of breast), SKIN DISCOLOURATION (bruise in breast got very purple), BREAST MASS (lump in the middle of the breast) and VACCINATION SITE PAIN (tenderness/pain in the injection arm) in a 57-year-old female 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 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced SKIN DISCOLOURATION (bruise in breast got very purple). On 19-Sep-2021, the patient experienced CONTUSION (Contusion of breast). On an unknown date, the patient experienced INJECTION SITE EXTRAVASATION (blood trailing), BREAST MASS (lump in the middle of the breast), VACCINATION SITE PAIN (tenderness/pain in the injection arm) and VACCINATION SITE MASS (lump in the injection arm). At the time of the report, INJECTION SITE EXTRAVASATION (blood trailing), VACCINATION SITE PAIN (tenderness/pain in the injection arm) and VACCINATION SITE MASS (lump in the injection arm) outcome was unknown and CONTUSION (Contusion of breast), SKIN DISCOLOURATION (bruise in breast got very purple) and BREAST MASS (lump in the middle of the breast) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: blood trailing; lump in the middle of the breast; tenderness/pain in the injection arm; lump in the injection arm; Contusion of breast; bruise in breast got very purple; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE EXTRAVASATION (blood trailing), CONTUSION (Contusion of breast), SKIN DISCOLOURATION (bruise in breast got very purple), BREAST MASS (lump in the middle of the breast) and VACCINATION SITE PAIN (tenderness/pain in the injection arm) in a 57-year-old female 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 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced SKIN DISCOLOURATION (bruise in breast got very purple). On 19-Sep-2021, the patient experienced CONTUSION (Contusion of breast). On an unknown date, the patient experienced INJECTION SITE EXTRAVASATION (blood trailing), BREAST MASS (lump in the middle of the breast), VACCINATION SITE PAIN (tenderness/pain in the injection arm) and VACCINATION SITE MASS (lump in the injection arm). At the time of the report, INJECTION SITE EXTRAVASATION (blood trailing), VACCINATION SITE PAIN (tenderness/pain in the injection arm) and VACCINATION SITE MASS (lump in the injection arm) outcome was unknown and CONTUSION (Contusion of breast), SKIN DISCOLOURATION (bruise in breast got very purple) and BREAST MASS (lump in the middle of the breast) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Pain, SARS-CoV-2 test
Clinical narrative: Body aches; Dry cough; Fatigue; tested positive for covid after being fully vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), COUGH (Dry cough), FATIGUE (Fatigue) and COVID-19 (tested positive for covid after being fully vaccinated) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced PAIN (Body aches), COUGH (Dry cough), FATIGUE (Fatigue) and COVID-19 (tested positive for covid after being fully vaccinated). At the time of the report, PAIN (Body aches), COUGH (Dry cough), FATIGUE (Fatigue) and COVID-19 (tested positive for covid after being fully vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: positive (Positive) Positive.         No relevant concomitant medications were reported.  Treatment medications included Quetitin  for COVID.; Sender's Comments: This case concerns a female patient of an unknown age with no reported medical history, who experienced the unexpected event of Covid-19.  The event occurred following an unspecified time after the first and second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as dosing times and details were not disclosed. Causality for the reported event was not provided by the reporter. Based on biological implausible and etiology, the event is considered not applicable. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events assessed as non-serious per regulatory authority reporting.  However, Covid-19 is an adverse event of special interest
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Covid arm; injection was bright red/ injection site was like Hamburger meat; injection site was raised; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Covid arm), VACCINATION SITE ERYTHEMA (injection was bright red/ injection site was like Hamburger meat) and VACCINATION SITE SWELLING (injection site was raised) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 011A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (get the same reaction when patient receive flu shot each year.). Past adverse reactions to the above products included Vaccination site reaction with Flu shot.   On 07-Apr-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Covid arm), VACCINATION SITE ERYTHEMA (injection was bright red/ injection site was like Hamburger meat) and VACCINATION SITE SWELLING (injection site was raised). At the time of the report, RASH (Covid arm), VACCINATION SITE ERYTHEMA (injection was bright red/ injection site was like Hamburger meat) and VACCINATION SITE SWELLING (injection site was raised) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-053283 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine beyond MFG Exp. Date administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Palpitations, Tachycardia
Clinical narrative: Tachycardia; Palpitations; Dyspnea; Tightness in the chest; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia), PALPITATIONS (Palpitations), DYSPNOEA (Dyspnea) and CHEST DISCOMFORT (Tightness in the chest) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, the patient experienced TACHYCARDIA (Tachycardia), PALPITATIONS (Palpitations), DYSPNOEA (Dyspnea) and CHEST DISCOMFORT (Tightness in the chest). At the time of the report, TACHYCARDIA (Tachycardia), PALPITATIONS (Palpitations), DYSPNOEA (Dyspnea) and CHEST DISCOMFORT (Tightness in the chest) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Pain in extremity, Palpitations
Clinical narrative: both of my arms are in excruciating pain; severe pressure in my chest; My heart is racing; short of breath; high fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (both of my arms are in excruciating pain), CHEST DISCOMFORT (severe pressure in my chest), PALPITATIONS (My heart is racing), DYSPNOEA (short of breath) and PYREXIA (high fever) in a 26-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 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (both of my arms are in excruciating pain), CHEST DISCOMFORT (severe pressure in my chest), PALPITATIONS (My heart is racing), DYSPNOEA (short of breath), PYREXIA (high fever) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (both of my arms are in excruciating pain), CHEST DISCOMFORT (severe pressure in my chest), PALPITATIONS (My heart is racing), DYSPNOEA (short of breath), PYREXIA (high fever) and FATIGUE (fatigue) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: both of my arms are in excruciating pain; severe pressure in my chest; My heart is racing; short of breath; high fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (both of my arms are in excruciating pain), CHEST DISCOMFORT (severe pressure in my chest), PALPITATIONS (My heart is racing), DYSPNOEA (short of breath) and PYREXIA (high fever) in a 26-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 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (both of my arms are in excruciating pain), CHEST DISCOMFORT (severe pressure in my chest), PALPITATIONS (My heart is racing), DYSPNOEA (short of breath), PYREXIA (high fever) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (both of my arms are in excruciating pain), CHEST DISCOMFORT (severe pressure in my chest), PALPITATIONS (My heart is racing), DYSPNOEA (short of breath), PYREXIA (high fever) and FATIGUE (fatigue) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Sore arm; 17 year old patient received of Moderna covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received of Moderna covid-19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received of Moderna covid-19 vaccine). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). On 17-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received of Moderna covid-19 vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) 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.   No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2021-354561 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site reaction
Clinical narrative: local reaction; a little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (local reaction) and VACCINATION SITE PAIN (a little sore arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included CELECOXIB (CELEBREX), CORTISONE, BIMATOPROST (LUMIGAN) and GABAPENTIN for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE REACTION (local reaction) and VACCINATION SITE PAIN (a little sore arm). At the time of the report, VACCINATION SITE REACTION (local reaction) and VACCINATION SITE PAIN (a little sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication also include thyroid medication 75 mg once a day. No treatment drug details was reported.  Patient had no history of myocarditis/pericarditis and Previous COVID19 infection   This case was linked to MOD-2021-354510, MOD-2021-354564 (Patient Link).
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old patient received both doses of the Moderna covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received both doses of the Moderna covid-19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received both doses of the Moderna covid-19 vaccine). On 15-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received both doses of the Moderna covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.    This case was linked to MOD-2021-354555 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 1 dose was administered from a vial that was 30 days past the use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose was administered from a vial that was 30 days past the use by date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose was administered from a vial that was 30 days past the use by date). In September 2021, EXPIRED PRODUCT ADMINISTERED (1 dose was administered from a vial that was 30 days past the use by date) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported. Treatment information was not provided.  1st dose information was not provided,Number of doses/vials used 1 dose from  1 vial,Date the vial was initially stored in the refrigerator on 9-sep-2021.Vail was not undergone any temperature excursions.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site reaction
Clinical narrative: Same local reaction; A little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Same local reaction) and VACCINATION SITE PAIN (A little sore arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A, 039K20A and 058E21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included CELECOXIB (CELEBREX), CORTISONE, BIMATOPROST (LUMIGAN) and GABAPENTIN for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE REACTION (Same local reaction) and VACCINATION SITE PAIN (A little sore arm). The patient was treated with LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) for Diarrhea, at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Same local reaction) and VACCINATION SITE PAIN (A little sore arm) outcome was unknown.            It was reported that concomitant medication gabapentin was discontinued after third dose due to nausea.  Concomitant medications also included thyroid medication 75 mg once a day.   This case was linked to MOD-2021-354510, MOD-2021-354559, MOD-2021-354510.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, Nausea
Clinical narrative: brain fog; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog) and NAUSEA (nausea) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced FEELING ABNORMAL (brain fog) and NAUSEA (nausea). On 30-Jul-2021, NAUSEA (nausea) had resolved. In August 2021, FEELING ABNORMAL (brain fog) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jul-2021, Heart rate: increased (High) Heart rate went up a little but went back to normal after a couple of minutes.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided. Patient has not seen an HCP and has not taken any treatments.   This case was linked to MOD-2021-354597 (Patient Link).
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received second dose from expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received second dose from expired vial) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received second dose from expired vial). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received second dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment medications are provided. The vial was thawed on 24-Sep-2021 and  vial was initially stored in the refrigerator on 24-Sep-2021, vial has not undergone any temperature excursions.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered after freezer excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after freezer excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after freezer excursion). On 05-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered after freezer excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the minimum and maximum temperature reached in the excursion was -22 °C and  -13 °C respectively.  The duration of the excursion was 5 Days  No concomitant medications were provided.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Tremor
Clinical narrative: trembling; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (trembling), NAUSEA (nausea) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced TREMOR (trembling), NAUSEA (nausea) and HEADACHE (headache). On 02-Mar-2021, TREMOR (trembling), NAUSEA (nausea) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: abnormal (abnormal) sudden increase and decrease in temperature.         No concomitant medication was mentioned. No treatment medication was mentioned.  The patient had experienced no adverse event after receiving the first dose of the vaccine.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction, Sluggishness
Clinical narrative: 4-6 weeks after taking his 2nd dose, he reports that he became impotent; He also observed that he became very sluggish; This spontaneous case was reported by a consumer and describes the occurrence of ERECTILE DYSFUNCTION (4-6 weeks after taking his 2nd dose, he reports that he became impotent) and SLUGGISHNESS (He also observed that he became very sluggish) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERECTILE DYSFUNCTION (4-6 weeks after taking his 2nd dose, he reports that he became impotent) (seriousness criterion medically significant) and SLUGGISHNESS (He also observed that he became very sluggish) (seriousness criterion medically significant). At the time of the report, ERECTILE DYSFUNCTION (4-6 weeks after taking his 2nd dose, he reports that he became impotent) and SLUGGISHNESS (He also observed that he became very sluggish) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported. Company comment: This case concerns a  78 year-old, male  with no medical history reported, who experienced the unexpected serious events of erectile dysfunction and sluggishness. The events occurred approximately 4-6 weeks after the second dose of mRNA-1273. Rechallenge is not applicable as the events occurred after the second dose and no more doses will be received by the patient. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a  78 year-old, male  with no medical history reported, who experienced the unexpected serious events of erectile dysfunction and sluggishness. The events occurred approximately 4-6 weeks after the second dose of mRNA-1273. Rechallenge is not applicable as the events occurred after the second dose and no more doses will be received by the patient. The benefit-risk relationship of the vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received dose from vial past the 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from vial past the 30-day use by date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from vial past the 30-day use by date). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from vial past the 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was not reported.  On 13-Sep-2021, the vial was initially stored in the refrigerator.  The dose was administered after 30-day use by date or after manufacturer date of expiry. The vial did not undergo any temperature excursions.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dysuria, Insomnia
Clinical narrative: Chest tightness; Difficulty urinating; Sleeplessness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest tightness), DYSURIA (Difficulty urinating) and INSOMNIA (Sleeplessness) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced CHEST DISCOMFORT (Chest tightness), DYSURIA (Difficulty urinating) and INSOMNIA (Sleeplessness). At the time of the report, CHEST DISCOMFORT (Chest tightness), DYSURIA (Difficulty urinating) and INSOMNIA (Sleeplessness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The batch number of suspect drug was reported as 026C21A or 026L21A.  No concomitant medication was reported. No treatment information was reported.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Feeling hot, Head discomfort, Pyrexia
Clinical narrative: feels very bad; feels like the head was going to explode; feels very warm; fever; chills; pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels very bad), HEAD DISCOMFORT (feels like the head was going to explode), FEELING HOT (feels very warm), PYREXIA (fever) and CHILLS (chills) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21A and 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Oct-2021, the patient experienced FEELING ABNORMAL (feels very bad), HEAD DISCOMFORT (feels like the head was going to explode), FEELING HOT (feels very warm), PYREXIA (fever), CHILLS (chills) and VACCINATION SITE PAIN (pain in the left arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (feels very bad), HEAD DISCOMFORT (feels like the head was going to explode), FEELING HOT (feels very warm), PYREXIA (fever), CHILLS (chills) and VACCINATION SITE PAIN (pain in the left arm) had not resolved.            No concomitant medications were reported.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: feels very bad; feels like the head was going to explode; feels very warm; fever; chills; pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels very bad), HEAD DISCOMFORT (feels like the head was going to explode), FEELING HOT (feels very warm), PYREXIA (fever) and CHILLS (chills) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21A and 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Oct-2021, the patient experienced FEELING ABNORMAL (feels very bad), HEAD DISCOMFORT (feels like the head was going to explode), FEELING HOT (feels very warm), PYREXIA (fever), CHILLS (chills) and VACCINATION SITE PAIN (pain in the left arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (feels very bad), HEAD DISCOMFORT (feels like the head was going to explode), FEELING HOT (feels very warm), PYREXIA (fever), CHILLS (chills) and VACCINATION SITE PAIN (pain in the left arm) had not resolved.            No concomitant medications were reported.