chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Felt like the gush of the medicine "went into her arm, then it went around her arm"; Mobility is difficult; Arm was swollen to size of golf ball/Swelling seems to be expanding; Arm started to bother her; Warm to touch/It was hot; It is hard; Right arm has large amount of swelling at the site/Inflammed/Injection site area is bigger; Fever; Chills; Redness; Injection site was tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DYSAESTHESIA (Felt like the gush of the medicine "went into her arm, then it went around her arm"), VACCINATION SITE MOVEMENT IMPAIRMENT (Mobility is difficult), PERIPHERAL SWELLING (Arm was swollen to size of golf ball/Swelling seems to be expanding), LIMB DISCOMFORT (Arm started to bother her) and VACCINATION SITE WARMTH (Warm to touch/It was hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DYSAESTHESIA (Felt like the gush of the medicine "went into her arm, then it went around her arm"), VACCINATION SITE MOVEMENT IMPAIRMENT (Mobility is difficult), PERIPHERAL SWELLING (Arm was swollen to size of golf ball/Swelling seems to be expanding), LIMB DISCOMFORT (Arm started to bother her), VACCINATION SITE WARMTH (Warm to touch/It was hot), VACCINATION SITE INDURATION (It is hard), VACCINATION SITE SWELLING (Right arm has large amount of swelling at the site/Inflammed/Injection site area is bigger), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Injection site was tender). At the time of the report, VACCINATION SITE DYSAESTHESIA (Felt like the gush of the medicine "went into her arm, then it went around her arm"), VACCINATION SITE MOVEMENT IMPAIRMENT (Mobility is difficult), PERIPHERAL SWELLING (Arm was swollen to size of golf ball/Swelling seems to be expanding), LIMB DISCOMFORT (Arm started to bother her), VACCINATION SITE WARMTH (Warm to touch/It was hot), VACCINATION SITE INDURATION (It is hard), VACCINATION SITE SWELLING (Right arm has large amount of swelling at the site/Inflammed/Injection site area is bigger), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Injection site was tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Small red and hurting bump (swelling) of two to three inches below the injection site; Small red and hurting bump (swelling) of two to three inches below the injection site; Small red and hurting bump (swelling) of two to three inches below the injection site; A Spontaneous report was received from a consumer, concerning herself, a 66-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed small red and hurting bump (swelling) of two to three inches below the injection site.  The patient's medical history and concomitant medication were not reported.  On 11-Jan-2021 prior to the onset of the event, the patient received their first dose of mRNA-1273 (Lot number: not provided) via intramuscular route on the left arm for prophylaxis of COVID-19 infection.   On an unspecified date in Jan-2021, on Saturday, after the day she received the vaccine, she developed small red and hurting bump (swelling) of two to three inches below the injection site. Laboratory test was not provided. Treatment for the event included acetaminophen and ice pack.  Action taken with the mRNA-1273 in response to the event was not provided.   The outcome of event, small red and hurting bump (swelling) of two to three inches below the injection site was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Pink on the injection site; itching on the upper left arm./top down of the arm it was itchy; after receiving the vaccine the arm was hurting (when swiped on the left side and felt the pain); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (after receiving the vaccine the arm was hurting (when swiped on the left side and felt the pain)), VACCINATION SITE PRURITUS (itching on the upper left arm./top down of the arm it was itchy) and VACCINATION SITE ERYTHEMA (Pink on the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Finger injury. Concomitant products included IBUPROFEN (MOTRIN [IBUPROFEN]) for Finger injury.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (after receiving the vaccine the arm was hurting (when swiped on the left side and felt the pain)). On 20-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching on the upper left arm./top down of the arm it was itchy). On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Pink on the injection site). In January 2021, VACCINATION SITE ERYTHEMA (Pink on the injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (after receiving the vaccine the arm was hurting (when swiped on the left side and felt the pain)) and VACCINATION SITE PRURITUS (itching on the upper left arm./top down of the arm it was itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Information regarding patient initials, gender and address is updated
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Hyperhidrosis
Clinical narrative: Lightheadedness; sweating; Loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness), HYPERHIDROSIS (sweating) and DECREASED APPETITE (Loss of appetite) in an 83-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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced DIZZINESS (Lightheadedness), HYPERHIDROSIS (sweating) and DECREASED APPETITE (Loss of appetite). At the time of the report, DIZZINESS (Lightheadedness), HYPERHIDROSIS (sweating) and DECREASED APPETITE (Loss of appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: extreme pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (extreme pain at the injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE PAIN (extreme pain at the injection site). At the time of the report, VACCINATION SITE PAIN (extreme pain at the injection site) outcome was unknown. 2nd shot      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: dizzy; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy) and HEADACHE (headache). At the time of the report, DIZZINESS (dizzy) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Lymphadenopathy, Nausea, Rash
Clinical narrative: Rash; bad nausea; swollen lymph nodes; hard; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (hard), RASH (Rash), NAUSEA (bad nausea) and LYMPHADENOPATHY (swollen lymph nodes) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced INDURATION (hard), NAUSEA (bad nausea) and LYMPHADENOPATHY (swollen lymph nodes). On 20-Feb-2021, the patient experienced RASH (Rash). At the time of the report, INDURATION (hard), RASH (Rash), NAUSEA (bad nausea) and LYMPHADENOPATHY (swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Myalgia
Clinical narrative: temperature; aches and pains; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (temperature) and MYALGIA (aches and pains) 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 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (temperature) and MYALGIA (aches and pains). At the time of the report, BODY TEMPERATURE INCREASED (temperature) and MYALGIA (aches and pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Pruritus
Clinical narrative: lymph nodes, itchy joints, especially on wrists and fatigue; lymph nodes, itchy joints, especially on wrists and fatigue; big red circle; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (lymph nodes, itchy joints, especially on wrists and fatigue), FATIGUE (lymph nodes, itchy joints, especially on wrists and fatigue) and INJECTION SITE ERYTHEMA (big red circle) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031220A) for COVID-19 vaccination.     The patient's past medical history included Shingles in January 2021.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (lymph nodes, itchy joints, especially on wrists and fatigue), FATIGUE (lymph nodes, itchy joints, especially on wrists and fatigue) and INJECTION SITE ERYTHEMA (big red circle). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PRURITUS (lymph nodes, itchy joints, especially on wrists and fatigue), FATIGUE (lymph nodes, itchy joints, especially on wrists and fatigue) and INJECTION SITE ERYTHEMA (big red circle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: arm soreness; 100.6 F fever; slight headache; A spontaneous report was received from a consumer concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm soreness, 100.6 f fever, slight headache.  The patient's medical history was not provided. Concomitant medications reported were Losartan for hypertension, Triamterene-Hctz diuretic, Vitamin B Complex supplemental, Vitamin D supplemental, Zinc supplemental, Vitamin C supplemental for drug use for unknown indication.  On 19 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the event(s) arm soreness, 100.6 f fever, slight headache.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm soreness, 100, 6 f fever, slight headache was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase decreased, Alanine aminotransferase increased, Aspartate aminotransferase increased, Enzyme abnormality, Hepatic enzyme abnormal
Clinical narrative: PSA is 4.49 which should be 2.2; her liver enzymes were off the charts; AST which is 158 and it should be 28; ALT is 101 which should be 12.; A spontaneous report was received from a female patient, concerning herself unknown years of age, who received Moderna's COVID-19 vaccine and experienced Hepatic enzyme abnormal, Enzyme abnormality, Alanine aminotransferase decreased, Prostatic specific antigen decreased,  The patient's medical was not provided by the patient.  Concomitant product use was not provided by the patient.    On 12-Feb-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (unknown batch number) via unknown route for COVID-19 infection.  On 14-Feb-2021, the patient experienced Hepatic enzyme abnormal, Enzyme abnormality, Alanine aminotransferase decreased, Prostatic specific antigen decreased. The test result shows changes in his AST which is 158 and it should be 28and his PSA is 4.49 which should be 2.2 and his ALT is 101 which should be 12.   Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event was considered to be recovered/ resolved at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen decreased
Clinical narrative: PSA is 4.49 which should be 2.2; her liver enzymes were off the charts; AST which is 158 and it should be 28; ALT is 101 which should be 12.; A spontaneous report was received from a female patient, concerning herself unknown years of age, who received Moderna's COVID-19 vaccine and experienced Hepatic enzyme abnormal, Enzyme abnormality, Alanine aminotransferase decreased, Prostatic specific antigen decreased,  The patient's medical was not provided by the patient.  Concomitant product use was not provided by the patient.    On 12-Feb-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (unknown batch number) via unknown route for COVID-19 infection.  On 14-Feb-2021, the patient experienced Hepatic enzyme abnormal, Enzyme abnormality, Alanine aminotransferase decreased, Prostatic specific antigen decreased. The test result shows changes in his AST which is 158 and it should be 28and his PSA is 4.49 which should be 2.2 and his ALT is 101 which should be 12.   Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event was considered to be recovered/ resolved at the time of this report.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Headache, Nausea, Vaccination site pain
Clinical narrative: projectile vomiting; vomiting; nausea; waves of abdominal cramps; Sudden onset of fatigue; headache; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (waves of abdominal cramps), VOMITING PROJECTILE (projectile vomiting), NAUSEA (nausea), VOMITING (vomiting) and VACCINATION SITE PAIN (arm pain) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm pain) and HEADACHE (headache). On 18-Feb-2021 at 1:30 PM, the patient experienced FATIGUE (Sudden onset of fatigue). On 19-Feb-2021 at 2:00 AM, the patient experienced ABDOMINAL PAIN (waves of abdominal cramps) and NAUSEA (nausea). On 19-Feb-2021 at 2:30 AM, the patient experienced VOMITING (vomiting). On 19-Feb-2021 at 3:00 AM, the patient experienced VOMITING PROJECTILE (projectile vomiting). On 20-Feb-2021, ABDOMINAL PAIN (waves of abdominal cramps), VOMITING PROJECTILE (projectile vomiting), NAUSEA (nausea) and VOMITING (vomiting) had resolved. At the time of the report, VACCINATION SITE PAIN (arm pain), FATIGUE (Sudden onset of fatigue) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-018999 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vomiting, Vomiting projectile
Clinical narrative: projectile vomiting; vomiting; nausea; waves of abdominal cramps; Sudden onset of fatigue; headache; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (waves of abdominal cramps), VOMITING PROJECTILE (projectile vomiting), NAUSEA (nausea), VOMITING (vomiting) and VACCINATION SITE PAIN (arm pain) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm pain) and HEADACHE (headache). On 18-Feb-2021 at 1:30 PM, the patient experienced FATIGUE (Sudden onset of fatigue). On 19-Feb-2021 at 2:00 AM, the patient experienced ABDOMINAL PAIN (waves of abdominal cramps) and NAUSEA (nausea). On 19-Feb-2021 at 2:30 AM, the patient experienced VOMITING (vomiting). On 19-Feb-2021 at 3:00 AM, the patient experienced VOMITING PROJECTILE (projectile vomiting). On 20-Feb-2021, ABDOMINAL PAIN (waves of abdominal cramps), VOMITING PROJECTILE (projectile vomiting), NAUSEA (nausea) and VOMITING (vomiting) had resolved. At the time of the report, VACCINATION SITE PAIN (arm pain), FATIGUE (Sudden onset of fatigue) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-018999 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Discomfort, Injection site pain
Clinical narrative: DISCOMFORT; soreness in the armpit, lymph node area; pain in the injection site started from the top to bottom shoulder / muscle pain at the injection site; A spontaneous report was received from a male patient, concerning himself 68  years of age, who received Moderna's COVID-19 vaccine and Pyrexia, Nausea, Headache The patient's medical history includes Hypertension, cholesterol, Acid Reflux, sleep pattern.   Concomitant product use provided by the patient was Lisinopril, Simvastatin, Prilosec, Ambien.    On 10-Feb-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (024M20A batch number) via intramuscular route for COVID-19 infection prophylaxis and experienced Injection site pain, Axillary pain, Discomfort.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event was considered to be unknown at the time of this report.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Headache, Pyrexia
Clinical narrative: Couldn't get out of bed; Chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Couldn't get out of bed), CHILLS (Chills), PYREXIA (fever) and HEADACHE (headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced BEDRIDDEN (Couldn't get out of bed), CHILLS (Chills), PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Feb-2021, CHILLS (Chills) and PYREXIA (fever) had resolved. On 20-Feb-2021, BEDRIDDEN (Couldn't get out of bed) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: a rash on his arm near his wrist; arm is little bit sore; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a rash on his arm near his wrist) and PAIN IN EXTREMITY (arm is little bit sore) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced RASH (a rash on his arm near his wrist) and PAIN IN EXTREMITY (arm is little bit sore). At the time of the report, RASH (a rash on his arm near his wrist) and PAIN IN EXTREMITY (arm is little bit sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Illness, Influenza like illness, Neck pain
Clinical narrative: real achy all over; felt bad; felt like when he had COVID back in December 2020; pain in his neck and back; pain in his neck and back; fever got up to 101 but most of the time it was between 100-101 degrees; chills all night long; A spontaneous report was received from a consumer concerning a 66-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events real achy all over, felt bad, felt like when he had covid back in December 2020, pain in his neck and back, fever got up to 101 but most of the time it was between 100-101 degrees, chills all night long.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 004M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the event(s) real achy all over, felt bad, felt like when he had covid back in December 2020, pain in his neck and back, fever got up to 101 but most of the time it was between 100-101 degrees, chills all night long.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 20 Feb 2021 the outcome of event(s), chills all night long was resolved. The outcome of event(s), real achy all over, felt bad, felt like when he had covid back in December 2020, pain in his neck and back, fever got up to 101 but most of the time it was between 100-101 degrees was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: real achy all over; felt bad; felt like when he had COVID back in December 2020; pain in his neck and back; pain in his neck and back; fever got up to 101 but most of the time it was between 100-101 degrees; chills all night long; A spontaneous report was received from a consumer concerning a 66-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events real achy all over, felt bad, felt like when he had covid back in December 2020, pain in his neck and back, fever got up to 101 but most of the time it was between 100-101 degrees, chills all night long.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 004M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the event(s) real achy all over, felt bad, felt like when he had covid back in December 2020, pain in his neck and back, fever got up to 101 but most of the time it was between 100-101 degrees, chills all night long.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 20 Feb 2021 the outcome of event(s), chills all night long was resolved. The outcome of event(s), real achy all over, felt bad, felt like when he had covid back in December 2020, pain in his neck and back, fever got up to 101 but most of the time it was between 100-101 degrees was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash below the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash below the injection site). At the time of the report, VACCINATION SITE RASH (Rash below the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the 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 start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Gait disturbance, Headache
Clinical narrative: walking on it was difficult; lower leg felt like it was cold; like a cramp was going to set in, but it didn't; leftover nerve pain..really bad; Chills; generally feels run down; Hives; Headache; Lower back pain; Thumb, pointer, and middle finger on the right hand went extremely numb and painful; felt a tight headband on my head; A spontaneous case report sent by a Other on 25-JAN-2021 from, which refers to a Female aged 53 Years.  On an unknown date  the patient received Moderna COVID-19 Vaccine for the prophylaxis of COVID-19 vaccination. Some    later,  the patient developed walking on it was difficult, the patient also developed Lower back pain,felt a tight headband on my head,Thumb, pointer, and middle finger on the right hand went extremely numb and painful,Headache,Chills,lower leg felt like it was cold,Hives,generally feels run down,like a Charlie horse was going to set in, but it didn't,leftover nerve pain that was really bad on that day.  Relevant laboratory details were unknown.  Relevant concomitant medications were none.  The patient was treated for the event with IBUPROFEN,BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE],ZYRTEC ALLERGY  for hives. The oncologist did not declare any relatedness between walking on it was difficult and Moderna COVID-19 Vaccine..  The clinical outcome of  leftover nerve pain was Unknown,walking on it was difficult was Unknown,like a Charlie horse was going to set in, but it didn't was  Unknown,generally feels run down was Unknown, Hives was  Unknown,lower leg felt like it was cold was Unknown, Chills was Unknown, Headache was Unknown,Thumb, pointer, and middle finger on the right hand went extremely numb and painful , which lasted couple of hours was Recovered/Resolved,felt a tight headband on my head  was Recovered/Resolved,Lower back painIt was there for about an hour and then it was gone  and was Recovered/Resolved.   Causality was not provided between the suspect drug and the events.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Muscle spasms, Neuralgia, Urticaria
Clinical narrative: walking on it was difficult; lower leg felt like it was cold; like a cramp was going to set in, but it didn't; leftover nerve pain..really bad; Chills; generally feels run down; Hives; Headache; Lower back pain; Thumb, pointer, and middle finger on the right hand went extremely numb and painful; felt a tight headband on my head; A spontaneous case report sent by a Other on 25-JAN-2021 from, which refers to a Female aged 53 Years.  On an unknown date  the patient received Moderna COVID-19 Vaccine for the prophylaxis of COVID-19 vaccination. Some    later,  the patient developed walking on it was difficult, the patient also developed Lower back pain,felt a tight headband on my head,Thumb, pointer, and middle finger on the right hand went extremely numb and painful,Headache,Chills,lower leg felt like it was cold,Hives,generally feels run down,like a Charlie horse was going to set in, but it didn't,leftover nerve pain that was really bad on that day.  Relevant laboratory details were unknown.  Relevant concomitant medications were none.  The patient was treated for the event with IBUPROFEN,BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE],ZYRTEC ALLERGY  for hives. The oncologist did not declare any relatedness between walking on it was difficult and Moderna COVID-19 Vaccine..  The clinical outcome of  leftover nerve pain was Unknown,walking on it was difficult was Unknown,like a Charlie horse was going to set in, but it didn't was  Unknown,generally feels run down was Unknown, Hives was  Unknown,lower leg felt like it was cold was Unknown, Chills was Unknown, Headache was Unknown,Thumb, pointer, and middle finger on the right hand went extremely numb and painful , which lasted couple of hours was Recovered/Resolved,felt a tight headband on my head  was Recovered/Resolved,Lower back painIt was there for about an hour and then it was gone  and was Recovered/Resolved.   Causality was not provided between the suspect drug and the events.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: arm soreness; redness; itchiness; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (arm soreness), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE PRURITUS (itchiness) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Allergy. Concomitant products included LEVOTHYROXINE for Thyroid activity decreased.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced INJECTION SITE PAIN (arm soreness), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE PRURITUS (itchiness). At the time of the report, INJECTION SITE PAIN (arm soreness), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE PRURITUS (itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included anti-itch cream.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Daydreaming
Clinical narrative: confusion; absent minded; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (confusion) and DAYDREAMING (absent minded) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Insomnia, Hypertension and Acid reflux (esophageal). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), LISINOPRIL for Hypertension, TEMAZEPAM and HYDROXYZINE PAMOATE for Insomnia.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced CONFUSIONAL STATE (confusion) and DAYDREAMING (absent minded). At the time of the report, CONFUSIONAL STATE (confusion) and DAYDREAMING (absent minded) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported    Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Excruciating pain in my feet; My left foot and right hand, around the ankle is swelling; I can't barely walk; Both my hands and feet are swollen; Both my hands and feet are swollen; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PERIPHERAL SWELLING (Both my hands and feet are swollen), the second episode of PERIPHERAL SWELLING (Both my hands and feet are swollen), GAIT DISTURBANCE (I can't barely walk), JOINT SWELLING (My left foot and right hand, around the ankle is swelling) and PAIN IN EXTREMITY (Excruciating pain in my feet) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Kidney disorder. Concurrent medical conditions included Blood pressure high (no medical history reported) and Type 2 diabetes mellitus. Concomitant products included AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR), GLIMEPIRIDE, VITAMIN D3, ATORVASTATIN CALCIUM, NEPHRO-VITE [ASCORBIC ACID;BIOTIN;CYANOCOBALAMIN;FOLIC ACID;NICOTINAMIDE;PANTOTHENIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE] and FAMOTIDINE for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced the first episode of PERIPHERAL SWELLING (Both my hands and feet are swollen) and the second episode of PERIPHERAL SWELLING (Both my hands and feet are swollen). On 21-Feb-2021, the patient experienced GAIT DISTURBANCE (I can't barely walk). On 22-Feb-2021, the patient experienced JOINT SWELLING (My left foot and right hand, around the ankle is swelling). On an unknown date, the patient experienced PAIN IN EXTREMITY (Excruciating pain in my feet). At the time of the report, last episode of PERIPHERAL SWELLING (Both my hands and feet are swollen), GAIT DISTURBANCE (I can't barely walk), JOINT SWELLING (My left foot and right hand, around the ankle is swelling) and PAIN IN EXTREMITY (Excruciating pain in my feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Epsom salt with warm water.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: follow up (TCR) was obtained on 02-JUN-2021,Reporter's email id was obtained
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: sore arm; redness at the injection site; Itchy at the injection site; Hot to the touch at the injection site; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, redness at the injection site, itchy at the injection site, hot to the touch at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) sore arm, redness at the injection site, Itchy at the injection site, Hot to the touch at the injection site.  Treatment details included ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, redness at the injection site, itchy at the injection site, hot to the touch at the injection site was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Headache, Pain
Clinical narrative: Loss of taste; loss of smell; Body aches; Severe chill; headache; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Feb-2021. The most recent information was received on 27-May-2021 and was forwarded to Moderna on 27-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), CHILLS (Severe chill), HEADACHE (headache), AGEUSIA (Loss of taste) and ANOSMIA (loss of smell) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 26-Mar-2020, COVID-19 on 11-May-2020 and Pneumonia in May 2020. Concurrent medical conditions included Sarcoidosis. Concomitant products included VITAMINS NOS for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN (Body aches), CHILLS (Severe chill) and HEADACHE (headache). On an unknown date, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (loss of smell). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Body aches), CHILLS (Severe chill), HEADACHE (headache), AGEUSIA (Loss of taste) and ANOSMIA (loss of smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-091740 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Events added; Reporter's Comments: female who
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site vesicles, Vaccination site erythema
Clinical narrative: Blistering at the injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE VESICLES (Blistering at the injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004mdoA) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced INJECTION SITE VESICLES (Blistering at the injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, INJECTION SITE VESICLES (Blistering at the injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.            Treatment medications were not provided by the reporter. No concomitant medications were reported by reporter.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Disturbance in attention, Injection site pain, Nausea, Pain
Clinical narrative: felt nauseous and dizzy; sensitive to light; low grade fever about 99.9; no energy today; Her first dose injection site has turned red again; tingling in her neck, tingling went down to her hands; a taste in her mouth; SORE ARM FOR SEVERAL WEEKS WITH A BRUISE; very painful; a rash all over her arm; A spontaneous report was received from a consumer concerning a 55-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events a sore arm for several weeks with a bruise, a rash all over her arm, very painful, tingling in her neck, tingling went down to her hands, a taste in her mouth, felt nauseous and dizzy, she cannot move her arm as it hurts so bad, she is having a hard time concentrating, sensitive to light, low grade fever about 99.9, no energy today, her first dose injection site has turned red again and it looks like the rash is about to start.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 026L20A) via unknown route for prophylaxis of COVID-19 infection. On 19 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 011M20A) via unknown route for prophylaxis of COVID-19 infection.  On 31 Jan 2021, the patient experienced the event(s) a sore arm for several weeks with a bruise, a rash all over her arm, very painful. On 19 Feb 2021, the patient experienced the event(s) tingling in her neck, tingling went down to her hands, a taste in her mouth, felt nauseous and dizzy. On 20 Feb 2021, the patient experienced the event(s) she cannot move her arm as it hurts so bad, she is having a hard time concentrating, sensitive to light, low grade fever about 99.9, no energy today, her first dose injection site has turned red again and it looks like the rash is about to start.  Treatment details included She did take some ibuprofen (for her back and knee pain) but has not taking any Ibuprofen for, the second dose. She has taken Benadryl post vaccination of both doses.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), a sore arm for several weeks with a bruise, a rash all over her arm, very painful, tingling in her neck, tingling went down to her hands, a taste in her mouth, felt nauseous and dizzy, she cannot move her arm as it hurts so bad, she is having a hard time concentrating, sensitive to light, low grade fever about 99, 9, no energy today, her first dose injection site has turned red again and it looks like the rash is about to start was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Rash, Rash erythematous, Taste disorder
Clinical narrative: felt nauseous and dizzy; sensitive to light; low grade fever about 99.9; no energy today; Her first dose injection site has turned red again; tingling in her neck, tingling went down to her hands; a taste in her mouth; SORE ARM FOR SEVERAL WEEKS WITH A BRUISE; very painful; a rash all over her arm; A spontaneous report was received from a consumer concerning a 55-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events a sore arm for several weeks with a bruise, a rash all over her arm, very painful, tingling in her neck, tingling went down to her hands, a taste in her mouth, felt nauseous and dizzy, she cannot move her arm as it hurts so bad, she is having a hard time concentrating, sensitive to light, low grade fever about 99.9, no energy today, her first dose injection site has turned red again and it looks like the rash is about to start.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 026L20A) via unknown route for prophylaxis of COVID-19 infection. On 19 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 011M20A) via unknown route for prophylaxis of COVID-19 infection.  On 31 Jan 2021, the patient experienced the event(s) a sore arm for several weeks with a bruise, a rash all over her arm, very painful. On 19 Feb 2021, the patient experienced the event(s) tingling in her neck, tingling went down to her hands, a taste in her mouth, felt nauseous and dizzy. On 20 Feb 2021, the patient experienced the event(s) she cannot move her arm as it hurts so bad, she is having a hard time concentrating, sensitive to light, low grade fever about 99.9, no energy today, her first dose injection site has turned red again and it looks like the rash is about to start.  Treatment details included She did take some ibuprofen (for her back and knee pain) but has not taking any Ibuprofen for, the second dose. She has taken Benadryl post vaccination of both doses.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), a sore arm for several weeks with a bruise, a rash all over her arm, very painful, tingling in her neck, tingling went down to her hands, a taste in her mouth, felt nauseous and dizzy, she cannot move her arm as it hurts so bad, she is having a hard time concentrating, sensitive to light, low grade fever about 99, 9, no energy today, her first dose injection site has turned red again and it looks like the rash is about to start was unknown.