chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Oxygen consumption decreased, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: lost sense of smell; oxygen dropped; more than 36 days between first and second dose; tested positive for covid again; weakness; cough; tested positive for covid; headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), COVID-19 (tested positive for covid), COVID-19 (tested positive for covid again), ASTHENIA (weakness) and ANOSMIA (lost sense of smell) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced COUGH (cough), COVID-19 (tested positive for covid), ASTHENIA (weakness) and HEADACHE (headache). On 11-Apr-2021, the patient experienced COVID-19 (tested positive for covid again). On an unknown date, the patient experienced ANOSMIA (lost sense of smell), OXYGEN CONSUMPTION DECREASED (oxygen dropped) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days between first and second dose). The patient was treated with VITAMINS NOS at an unspecified dose and frequency. At the time of the report, COUGH (cough), COVID-19 (tested positive for covid), COVID-19 (tested positive for covid again), ASTHENIA (weakness), ANOSMIA (lost sense of smell), OXYGEN CONSUMPTION DECREASED (oxygen dropped), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days between first and second dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Oxygen saturation: 94 (abnormal) dropped to 94% and 96 (abnormal) but then improved around 96%. On 23-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive. On 11-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included high blood pressure medication and blood sugar medication.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Formication, Injection site induration, Lymphadenopathy
Clinical narrative: dizzy; feeling very fatigued; skin feels like things are crawling on it, both legs an arms; with the enduration around the injection site hot; bruising in the middle part; lymph nodes near the left ear are swollen; with the enduration around the injection site red; her arm where she received the injections is swollen; Left lymph node under armpit is "bubbled out"; induration around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), FATIGUE (feeling very fatigued), FORMICATION (skin feels like things are crawling on it, both legs an arms), VACCINATION SITE WARMTH (with the enduration around the injection site hot) and VACCINATION SITE BRUISING (bruising in the middle part) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced FATIGUE (feeling very fatigued), FORMICATION (skin feels like things are crawling on it, both legs an arms), VACCINATION SITE WARMTH (with the enduration around the injection site hot), VACCINATION SITE BRUISING (bruising in the middle part), LYMPHADENOPATHY (lymph nodes near the left ear are swollen), VACCINATION SITE ERYTHEMA (with the enduration around the injection site red), VACCINATION SITE SWELLING (her arm where she received the injections is swollen), LYMPHADENOPATHY (Left lymph node under armpit is "bubbled out") and INJECTION SITE INDURATION (induration around the injection site). On an unknown date, the patient experienced DIZZINESS (dizzy). At the time of the report, DIZZINESS (dizzy), FATIGUE (feeling very fatigued), FORMICATION (skin feels like things are crawling on it, both legs an arms), VACCINATION SITE WARMTH (with the enduration around the injection site hot), VACCINATION SITE BRUISING (bruising in the middle part), LYMPHADENOPATHY (lymph nodes near the left ear are swollen), VACCINATION SITE ERYTHEMA (with the enduration around the injection site red), VACCINATION SITE SWELLING (her arm where she received the injections is swollen), LYMPHADENOPATHY (Left lymph node under armpit is "bubbled out") and INJECTION SITE INDURATION (induration around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Caller was able to sleep last night by intermittantly applying cold compresses to her arm.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: dizzy; feeling very fatigued; skin feels like things are crawling on it, both legs an arms; with the enduration around the injection site hot; bruising in the middle part; lymph nodes near the left ear are swollen; with the enduration around the injection site red; her arm where she received the injections is swollen; Left lymph node under armpit is "bubbled out"; induration around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), FATIGUE (feeling very fatigued), FORMICATION (skin feels like things are crawling on it, both legs an arms), VACCINATION SITE WARMTH (with the enduration around the injection site hot) and VACCINATION SITE BRUISING (bruising in the middle part) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced FATIGUE (feeling very fatigued), FORMICATION (skin feels like things are crawling on it, both legs an arms), VACCINATION SITE WARMTH (with the enduration around the injection site hot), VACCINATION SITE BRUISING (bruising in the middle part), LYMPHADENOPATHY (lymph nodes near the left ear are swollen), VACCINATION SITE ERYTHEMA (with the enduration around the injection site red), VACCINATION SITE SWELLING (her arm where she received the injections is swollen), LYMPHADENOPATHY (Left lymph node under armpit is "bubbled out") and INJECTION SITE INDURATION (induration around the injection site). On an unknown date, the patient experienced DIZZINESS (dizzy). At the time of the report, DIZZINESS (dizzy), FATIGUE (feeling very fatigued), FORMICATION (skin feels like things are crawling on it, both legs an arms), VACCINATION SITE WARMTH (with the enduration around the injection site hot), VACCINATION SITE BRUISING (bruising in the middle part), LYMPHADENOPATHY (lymph nodes near the left ear are swollen), VACCINATION SITE ERYTHEMA (with the enduration around the injection site red), VACCINATION SITE SWELLING (her arm where she received the injections is swollen), LYMPHADENOPATHY (Left lymph node under armpit is "bubbled out") and INJECTION SITE INDURATION (induration around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Caller was able to sleep last night by intermittantly applying cold compresses to her arm.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling cold
Clinical narrative: feeling cold; feeling dizzy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold) and DIZZINESS (feeling dizzy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (feeling cold) and DIZZINESS (feeling dizzy). At the time of the report, FEELING COLD (feeling cold) and DIZZINESS (feeling dizzy) outcome was unknown. Not Provided          NO concomitant medication was reported. No treatment medications were reported.    Reporter did not allow further contact
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: fever; body aches; his arm became swollen and "huge."; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (body aches) and PERIPHERAL SWELLING (his arm became swollen and "huge.") in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (fever), MYALGIA (body aches) and PERIPHERAL SWELLING (his arm became swollen and "huge."). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), MYALGIA (body aches) and PERIPHERAL SWELLING (his arm became swollen and "huge.") outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Erythema, Fatigue, Peripheral swelling
Clinical narrative: fatigue; dizziness; swollen/red arm; swollen/red arm; covid like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), DIZZINESS (dizziness), PERIPHERAL SWELLING (swollen/red arm), ERYTHEMA (swollen/red arm) and COVID-19 (covid like symptoms) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced FATIGUE (fatigue), DIZZINESS (dizziness), PERIPHERAL SWELLING (swollen/red arm) and COVID-19 (covid like symptoms). On an unknown date, the patient experienced ERYTHEMA (swollen/red arm). On 13-Apr-2021, FATIGUE (fatigue), DIZZINESS (dizziness), PERIPHERAL SWELLING (swollen/red arm) and COVID-19 (covid like symptoms) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache, Hypoaesthesia, Lymphadenopathy, Pain in extremity
Clinical narrative: weird numbness feeling in my body/numbness all over body,numbness is from my shin down, including my thighs to all the way down to my foot,numbness in front torso,numbness in arms,numbness in neck; feel my lymph nodes are swollen in my neck; arm is sore but its normal; it is still not comfortable; right side of my lip and tongue started getting tingly which is about 4 hours after getting the shot; had a headache yesterday evening but it went away; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (weird numbness feeling in my body/numbness all over body,numbness is from my shin down, including my thighs to all the way down to my foot,numbness in front torso,numbness in arms,numbness in neck), LYMPHADENOPATHY (feel my lymph nodes are swollen in my neck), PAIN IN EXTREMITY (arm is sore but its normal), DISCOMFORT (it is still not comfortable) and PARAESTHESIA (right side of my lip and tongue started getting tingly which is about 4 hours after getting the shot) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (weird numbness feeling in my body/numbness all over body,numbness is from my shin down, including my thighs to all the way down to my foot,numbness in front torso,numbness in arms,numbness in neck), LYMPHADENOPATHY (feel my lymph nodes are swollen in my neck), PAIN IN EXTREMITY (arm is sore but its normal), DISCOMFORT (it is still not comfortable), PARAESTHESIA (right side of my lip and tongue started getting tingly which is about 4 hours after getting the shot) and HEADACHE (had a headache yesterday evening but it went away). At the time of the report, HYPOAESTHESIA (weird numbness feeling in my body/numbness all over body,numbness is from my shin down, including my thighs to all the way down to my foot,numbness in front torso,numbness in arms,numbness in neck), LYMPHADENOPATHY (feel my lymph nodes are swollen in my neck), PAIN IN EXTREMITY (arm is sore but its normal), DISCOMFORT (it is still not comfortable), PARAESTHESIA (right side of my lip and tongue started getting tingly which is about 4 hours after getting the shot) and HEADACHE (had a headache yesterday evening but it went away) outcome was unknown. Not Provided      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.   Concomitant medications were not provided. Treatment medications include Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up information received on 17-JUN-2021 contains non-significant information.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: weird numbness feeling in my body/numbness all over body,numbness is from my shin down, including my thighs to all the way down to my foot,numbness in front torso,numbness in arms,numbness in neck; feel my lymph nodes are swollen in my neck; arm is sore but its normal; it is still not comfortable; right side of my lip and tongue started getting tingly which is about 4 hours after getting the shot; had a headache yesterday evening but it went away; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (weird numbness feeling in my body/numbness all over body,numbness is from my shin down, including my thighs to all the way down to my foot,numbness in front torso,numbness in arms,numbness in neck), LYMPHADENOPATHY (feel my lymph nodes are swollen in my neck), PAIN IN EXTREMITY (arm is sore but its normal), DISCOMFORT (it is still not comfortable) and PARAESTHESIA (right side of my lip and tongue started getting tingly which is about 4 hours after getting the shot) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (weird numbness feeling in my body/numbness all over body,numbness is from my shin down, including my thighs to all the way down to my foot,numbness in front torso,numbness in arms,numbness in neck), LYMPHADENOPATHY (feel my lymph nodes are swollen in my neck), PAIN IN EXTREMITY (arm is sore but its normal), DISCOMFORT (it is still not comfortable), PARAESTHESIA (right side of my lip and tongue started getting tingly which is about 4 hours after getting the shot) and HEADACHE (had a headache yesterday evening but it went away). At the time of the report, HYPOAESTHESIA (weird numbness feeling in my body/numbness all over body,numbness is from my shin down, including my thighs to all the way down to my foot,numbness in front torso,numbness in arms,numbness in neck), LYMPHADENOPATHY (feel my lymph nodes are swollen in my neck), PAIN IN EXTREMITY (arm is sore but its normal), DISCOMFORT (it is still not comfortable), PARAESTHESIA (right side of my lip and tongue started getting tingly which is about 4 hours after getting the shot) and HEADACHE (had a headache yesterday evening but it went away) outcome was unknown. Not Provided      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.   Concomitant medications were not provided. Treatment medications include Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up information received on 17-JUN-2021 contains non-significant information.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling sensation; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021. The most recent information was received on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced PARAESTHESIA (Tingling sensation). At the time of the report, PARAESTHESIA (Tingling sensation) had resolved. Not Provided          No Concomitant medications were reported  No Treatment medications were reported   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Significant FU- AE outcome updated
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Headache, Neck pain, Pyrexia
Clinical narrative: Felt like COVID 19 again; Aches especially on neck; slight swelling at injection site; Trrible headache; Fever of about 101; Aches especially on shoulder; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Felt like COVID 19 again), NECK PAIN (Aches especially on neck), VACCINATION SITE SWELLING (slight swelling at injection site), HEADACHE (Trrible headache) and PYREXIA (Fever of about 101) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 14-Apr-2021, the patient experienced COVID-19 (Felt like COVID 19 again), NECK PAIN (Aches especially on neck), VACCINATION SITE SWELLING (slight swelling at injection site), HEADACHE (Trrible headache), PYREXIA (Fever of about 101) and ARTHRALGIA (Aches especially on shoulder). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of UNK dosage form and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, COVID-19 (Felt like COVID 19 again), NECK PAIN (Aches especially on neck), VACCINATION SITE SWELLING (slight swelling at injection site), HEADACHE (Trrible headache), PYREXIA (Fever of about 101) and ARTHRALGIA (Aches especially on shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up received on 20-APR-2021. Reporter details was reported. Patient age was reported. Events was reported. Treatment medication was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Felt like COVID 19 again; Aches especially on neck; slight swelling at injection site; Trrible headache; Fever of about 101; Aches especially on shoulder; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Felt like COVID 19 again), NECK PAIN (Aches especially on neck), VACCINATION SITE SWELLING (slight swelling at injection site), HEADACHE (Trrible headache) and PYREXIA (Fever of about 101) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 14-Apr-2021, the patient experienced COVID-19 (Felt like COVID 19 again), NECK PAIN (Aches especially on neck), VACCINATION SITE SWELLING (slight swelling at injection site), HEADACHE (Trrible headache), PYREXIA (Fever of about 101) and ARTHRALGIA (Aches especially on shoulder). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of UNK dosage form and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, COVID-19 (Felt like COVID 19 again), NECK PAIN (Aches especially on neck), VACCINATION SITE SWELLING (slight swelling at injection site), HEADACHE (Trrible headache), PYREXIA (Fever of about 101) and ARTHRALGIA (Aches especially on shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up received on 20-APR-2021. Reporter details was reported. Patient age was reported. Events was reported. Treatment medication was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site irritation, Vaccination site rash, Vaccination site warmth
Clinical narrative: Itchy at the injection site; Little warm at the injection site; Rash around 4 * 2 inches at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (Itchy at the injection site), VACCINATION SITE WARMTH (Little warm at the injection site) and VACCINATION SITE RASH (Rash around 4 * 2 inches at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE IRRITATION (Itchy at the injection site), VACCINATION SITE WARMTH (Little warm at the injection site) and VACCINATION SITE RASH (Rash around 4 * 2 inches at the injection site). At the time of the report, VACCINATION SITE IRRITATION (Itchy at the injection site), VACCINATION SITE WARMTH (Little warm at the injection site) and VACCINATION SITE RASH (Rash around 4 * 2 inches at the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported. No concomitant medication was reported.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia, Rash, Urticaria
Clinical narrative: Hives; Red and brown rash on chest; Fever; Nausea; Chils; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), RASH (Red and brown rash on chest), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chils) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No specified medical history has been reported.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced URTICARIA (Hives), RASH (Red and brown rash on chest), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chils). At the time of the report, URTICARIA (Hives), RASH (Red and brown rash on chest), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chils) outcome was unknown.            No concomitant medications provided. Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow-up received on 07-May-2021. Patient initials was updated as Y-T from J-T On 14-Apr-2021: Follow-up received on 20-JUN-2021 and contains no new information.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Injection site discomfort, Myalgia
Clinical narrative: discomfort at injection site; tired; headache; muscle aches; redness and swelling on the injection site; redness and swelling on the injection site; vomiting; nausea; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE DISCOMFORT (discomfort at injection site), NAUSEA (nausea), VACCINATION SITE SWELLING (redness and swelling on the injection site), VOMITING (vomiting) and VACCINATION SITE ERYTHEMA (redness and swelling on the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, High cholesterol, Latex allergy and Adhesive tape allergy. Concomitant products included ATORVASTATIN for High cholesterol, OMEPRAZOLE for Reflux gastritis.   On 12-Mar-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021 at 3:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced NAUSEA (nausea) and VOMITING (vomiting). On 12-Apr-2021, the patient experienced VACCINATION SITE SWELLING (redness and swelling on the injection site) and VACCINATION SITE ERYTHEMA (redness and swelling on the injection site). On an unknown date, the patient experienced INJECTION SITE DISCOMFORT (discomfort at injection site), FATIGUE (tired), HEADACHE (headache) and MYALGIA (muscle aches). On 10-Apr-2021, NAUSEA (nausea) and VOMITING (vomiting) had resolved. At the time of the report, INJECTION SITE DISCOMFORT (discomfort at injection site), VACCINATION SITE SWELLING (redness and swelling on the injection site), VACCINATION SITE ERYTHEMA (redness and swelling on the injection site), FATIGUE (tired), HEADACHE (headache) and MYALGIA (muscle aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: iincreased High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included Advil  Action taken with mRNA-1273 in response to the events was not Applicable   This case was linked to MOD-2021-074989 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Events ( discomfort at injection site, fatigue, headache, myalgia) added.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site erythema, Vaccination site swelling, Vomiting
Clinical narrative: discomfort at injection site; tired; headache; muscle aches; redness and swelling on the injection site; redness and swelling on the injection site; vomiting; nausea; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE DISCOMFORT (discomfort at injection site), NAUSEA (nausea), VACCINATION SITE SWELLING (redness and swelling on the injection site), VOMITING (vomiting) and VACCINATION SITE ERYTHEMA (redness and swelling on the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, High cholesterol, Latex allergy and Adhesive tape allergy. Concomitant products included ATORVASTATIN for High cholesterol, OMEPRAZOLE for Reflux gastritis.   On 12-Mar-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021 at 3:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced NAUSEA (nausea) and VOMITING (vomiting). On 12-Apr-2021, the patient experienced VACCINATION SITE SWELLING (redness and swelling on the injection site) and VACCINATION SITE ERYTHEMA (redness and swelling on the injection site). On an unknown date, the patient experienced INJECTION SITE DISCOMFORT (discomfort at injection site), FATIGUE (tired), HEADACHE (headache) and MYALGIA (muscle aches). On 10-Apr-2021, NAUSEA (nausea) and VOMITING (vomiting) had resolved. At the time of the report, INJECTION SITE DISCOMFORT (discomfort at injection site), VACCINATION SITE SWELLING (redness and swelling on the injection site), VACCINATION SITE ERYTHEMA (redness and swelling on the injection site), FATIGUE (tired), HEADACHE (headache) and MYALGIA (muscle aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: iincreased High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included Advil  Action taken with mRNA-1273 in response to the events was not Applicable   This case was linked to MOD-2021-074989 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Events ( discomfort at injection site, fatigue, headache, myalgia) added.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 006B21A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 08-Jul-2021. On 15-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). On 12-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant mediations were provided
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were reported.     On 03-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  Treatment information not provided
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Illness
Clinical narrative: she felt sick for a week; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she felt sick for a week) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included THYROID (ARMOUR THYROID) for Hashimoto's disease.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ILLNESS (she felt sick for a week). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 milligram and IBUPROFEN (MOTRIN [IBUPROFEN]) (intravascular) at an unspecified dose and frequency. At the time of the report, ILLNESS (she felt sick for a week) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Blood pressure measurement: 137 (High) BP was usually 105/110.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-076351 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076351:For Second dose
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: achy; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy) and HEADACHE (severe headache) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included ANTIHYPERTENSIVES for Blood pressure abnormal, THYROID THERAPY for Thyroid function abnormal.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PAIN (achy) and HEADACHE (severe headache). At the time of the report, PAIN (achy) and HEADACHE (severe headache) had not resolved. Not Provided
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pruritus, Pyrexia, Rash
Clinical narrative: slight headache; fever; chill; rash on right arm of the injection site; spreading and itching a lot; right arm with the rash 98.7; not relieving the itchiness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight headache), PYREXIA (fever), CHILLS (chill), VACCINATION SITE RASH (rash on right arm of the injection site) and PRURITUS (spreading and itching a lot) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced HEADACHE (slight headache), PYREXIA (fever), CHILLS (chill), VACCINATION SITE RASH (rash on right arm of the injection site), PRURITUS (spreading and itching a lot), RASH (right arm with the rash 98.7) and PRURITUS (not relieving the itchiness). At the time of the report, HEADACHE (slight headache), PYREXIA (fever), CHILLS (chill), VACCINATION SITE RASH (rash on right arm of the injection site), PRURITUS (spreading and itching a lot), RASH (right arm with the rash 98.7) and PRURITUS (not relieving the itchiness) outcome was unknown.            He undergoes immunosuppressant therapy for treatment of non Hopkins lymphoma and has also been diagnosed with renal cell carcinoma. His PCP approved the vaccine.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: slight headache; fever; chill; rash on right arm of the injection site; spreading and itching a lot; right arm with the rash 98.7; not relieving the itchiness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight headache), PYREXIA (fever), CHILLS (chill), VACCINATION SITE RASH (rash on right arm of the injection site) and PRURITUS (spreading and itching a lot) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced HEADACHE (slight headache), PYREXIA (fever), CHILLS (chill), VACCINATION SITE RASH (rash on right arm of the injection site), PRURITUS (spreading and itching a lot), RASH (right arm with the rash 98.7) and PRURITUS (not relieving the itchiness). At the time of the report, HEADACHE (slight headache), PYREXIA (fever), CHILLS (chill), VACCINATION SITE RASH (rash on right arm of the injection site), PRURITUS (spreading and itching a lot), RASH (right arm with the rash 98.7) and PRURITUS (not relieving the itchiness) outcome was unknown.            He undergoes immunosuppressant therapy for treatment of non Hopkins lymphoma and has also been diagnosed with renal cell carcinoma. His PCP approved the vaccine.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Malaise, Pyrexia, Somnolence
Clinical narrative: not feeling well; slept for 12 hours that day; 101 degree F temperature; tired,draggy; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), SOMNOLENCE (slept for 12 hours that day), PYREXIA (101 degree F temperature) and FATIGUE (tired,draggy) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in August 2020.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced MALAISE (not feeling well), SOMNOLENCE (slept for 12 hours that day), PYREXIA (101 degree F temperature) and FATIGUE (tired,draggy). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 30-Mar-2021, SOMNOLENCE (slept for 12 hours that day) and PYREXIA (101 degree F temperature) had resolved. On 01-Apr-2021, FATIGUE (tired,draggy) had resolved. At the time of the report, MALAISE (not feeling well) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: 101 (Inconclusive) 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  After the day of vaccination, patient had a 101 degree F temperature, slept for 12 hours that day, was very tired, draggy until Thursday and had continued episodes of not feeling well intermittently (3-4 times to date). Sometimes it lasted for an afternoon, sometimes for a day.  Treatment information included ibuprofen
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus disorder, Vertigo, Vertigo positional
Clinical narrative: Vertigo; thought it was a sinus infection; Only bothered him when he stood up; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), SINUS DISORDER (thought it was a sinus infection) and VERTIGO POSITIONAL (Only bothered him when he stood up) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A210) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced VERTIGO (Vertigo), SINUS DISORDER (thought it was a sinus infection) and VERTIGO POSITIONAL (Only bothered him when he stood up). At the time of the report, VERTIGO (Vertigo) and VERTIGO POSITIONAL (Only bothered him when he stood up) outcome was unknown and SINUS DISORDER (thought it was a sinus infection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-183487 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Significant-  event was updated,2nd dose date was added
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Not doing too good; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not doing too good) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Not doing too good) and HEADACHE (Headache). At the time of the report, MALAISE (Not doing too good) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were provided.  No treatment information was provided.   This case was linked to MOD-2021-108228 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional information received on 06-MAY-2021 and included information regarding second dose of the vaccine and additional event(headache).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Illness, Nausea, Night sweats
Clinical narrative: a little weak; Sleepy; nauseas; Fever; they had a miserable night; Sick whole day and night; Had a night sweat; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021. The most recent information was received on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (they had a miserable night), ILLNESS (Sick whole day and night), NIGHT SWEATS (Had a night sweat), SOMNOLENCE (Sleepy) and ASTHENIA (a little weak) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient was infected with Covid-19 on 06-Feb-2021, and started to have symptoms on 10-11-Feb-2021.) on 06-Feb-2021.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced FEELING ABNORMAL (they had a miserable night), ILLNESS (Sick whole day and night), NIGHT SWEATS (Had a night sweat), NAUSEA (nauseas) and PYREXIA (Fever). On 13-Apr-2021, the patient experienced SOMNOLENCE (Sleepy). On 14-Apr-2021, the patient experienced ASTHENIA (a little weak). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (they had a miserable night), ILLNESS (Sick whole day and night), NIGHT SWEATS (Had a night sweat), SOMNOLENCE (Sleepy), ASTHENIA (a little weak), NAUSEA (nauseas) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, SARS-CoV-2 test: positive (Positive) Infection with Covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.      Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up was received on 4-AUG-2021 and contains second dose information and updated email address. On 05-Aug-2021: Follow-up was received on 6-AUG-2021 and contains no new Information.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Somnolence
Clinical narrative: a little weak; Sleepy; nauseas; Fever; they had a miserable night; Sick whole day and night; Had a night sweat; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021. The most recent information was received on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (they had a miserable night), ILLNESS (Sick whole day and night), NIGHT SWEATS (Had a night sweat), SOMNOLENCE (Sleepy) and ASTHENIA (a little weak) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient was infected with Covid-19 on 06-Feb-2021, and started to have symptoms on 10-11-Feb-2021.) on 06-Feb-2021.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced FEELING ABNORMAL (they had a miserable night), ILLNESS (Sick whole day and night), NIGHT SWEATS (Had a night sweat), NAUSEA (nauseas) and PYREXIA (Fever). On 13-Apr-2021, the patient experienced SOMNOLENCE (Sleepy). On 14-Apr-2021, the patient experienced ASTHENIA (a little weak). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (they had a miserable night), ILLNESS (Sick whole day and night), NIGHT SWEATS (Had a night sweat), SOMNOLENCE (Sleepy), ASTHENIA (a little weak), NAUSEA (nauseas) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, SARS-CoV-2 test: positive (Positive) Infection with Covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.      Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up was received on 4-AUG-2021 and contains second dose information and updated email address. On 05-Aug-2021: Follow-up was received on 6-AUG-2021 and contains no new Information.