chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fall, Limb discomfort, Peripheral swelling
Clinical narrative: Arm swell up; Couldn't use her both arms; Fell on the floor; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swell up), LIMB DISCOMFORT (Couldn't use her both arms) and FALL (Fell on the floor) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm swell up), LIMB DISCOMFORT (Couldn't use her both arms) and FALL (Fell on the floor). At the time of the report, PERIPHERAL SWELLING (Arm swell up) had resolved and LIMB DISCOMFORT (Couldn't use her both arms) and FALL (Fell on the floor) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: TCR received on 14 JUL 2021 and added patient took 2nd does a month later after 1st dose without any adverse event. event outcome updated.; Sender's Comments: There is not enough information to assess the event of fall as patient state at the time of fall and reason for falling was not provided.  The event of couldn't use her both arms, and arm swell up is due to the fall, therefore assessed as unlike related to mRNA-1273 use.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Tachycardia
Clinical narrative: trouble breathing; heart rate went up to 150, 160; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble breathing) and TACHYCARDIA (heart rate went up to 150, 160) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 DYSPNOEA (trouble breathing) and TACHYCARDIA (heart rate went up to 150, 160). At the time of the report, DYSPNOEA (trouble breathing) outcome was unknown and TACHYCARDIA (heart rate went up to 150, 160) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  No concomitant medications were reported. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on arms and legs; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of RASH (Rash on arms and legs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 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 RASH (Rash on arms and legs). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (oral) ongoing since an unknown date at a dose of 10 mg. At the time of the report, RASH (Rash on arms and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included Zytec 10mg x1.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  Rash is consistent with the product known safety profile
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Developed a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Developed a cold) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced NASOPHARYNGITIS (Developed a cold). At the time of the report, NASOPHARYNGITIS (Developed a cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up information received on 23-JUN-2021 contains no significant information. Updated reporter details.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Chills, Cough, Headache
Clinical narrative: Out of balance when walking; High temperature of 101.9; Chills; Nauseated; Cough; In bed all day; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), ASTHENIA (In bed all day), BALANCE DISORDER (Out of balance when walking), CHILLS (Chills) and NAUSEA (Nauseated) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0421L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced HEADACHE (Headache). On 26-Jan-2021, the patient experienced COUGH (Cough), ASTHENIA (In bed all day), CHILLS (Chills) and NAUSEA (Nauseated). On 01-Feb-2021, the patient experienced BALANCE DISORDER (Out of balance when walking) and PYREXIA (High temperature of 101.9). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Fever, at an unspecified dose and frequency. At the time of the report, COUGH (Cough), ASTHENIA (In bed all day), CHILLS (Chills) and PYREXIA (High temperature of 101.9) was resolving and BALANCE DISORDER (Out of balance when walking), NAUSEA (Nauseated) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment details included Cough medicine for cough and prescription medication for the nausea.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  Chills, nausea, pyrexia and headache are consistent with the product known safety profile
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Out of balance when walking; High temperature of 101.9; Chills; Nauseated; Cough; In bed all day; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), ASTHENIA (In bed all day), BALANCE DISORDER (Out of balance when walking), CHILLS (Chills) and NAUSEA (Nauseated) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0421L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced HEADACHE (Headache). On 26-Jan-2021, the patient experienced COUGH (Cough), ASTHENIA (In bed all day), CHILLS (Chills) and NAUSEA (Nauseated). On 01-Feb-2021, the patient experienced BALANCE DISORDER (Out of balance when walking) and PYREXIA (High temperature of 101.9). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Fever, at an unspecified dose and frequency. At the time of the report, COUGH (Cough), ASTHENIA (In bed all day), CHILLS (Chills) and PYREXIA (High temperature of 101.9) was resolving and BALANCE DISORDER (Out of balance when walking), NAUSEA (Nauseated) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment details included Cough medicine for cough and prescription medication for the nausea.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  Chills, nausea, pyrexia and headache are consistent with the product known safety profile
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: Fatigue; Temperature was 101.2F; Arm was kind of sore; Didn't feel right; Had the shakes really really bad; Internal chills, like quivering; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm was kind of sore), FEELING ABNORMAL (Didn't feel right), TREMOR (Had the shakes really really bad), CHILLS (Internal chills, like quivering) and FATIGUE (Fatigue) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was kind of sore), FEELING ABNORMAL (Didn't feel right), TREMOR (Had the shakes really really bad), CHILLS (Internal chills, like quivering) and PYREXIA (Temperature was 101.2F). On 08-Feb-2021, the patient experienced FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Feb-2021, PYREXIA (Temperature was 101.2F) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was kind of sore), FEELING ABNORMAL (Didn't feel right), TREMOR (Had the shakes really really bad) and CHILLS (Internal chills, like quivering) outcome was unknown and FATIGUE (Fatigue) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 101.2 f (High) Fever of 101.2 F. On 05-Feb-2021, Body temperature: 101 f (High) Fever of 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow-up information received on 26-Apr-2021 contains non-significant information.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Fatigue; Temperature was 101.2F; Arm was kind of sore; Didn't feel right; Had the shakes really really bad; Internal chills, like quivering; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm was kind of sore), FEELING ABNORMAL (Didn't feel right), TREMOR (Had the shakes really really bad), CHILLS (Internal chills, like quivering) and FATIGUE (Fatigue) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was kind of sore), FEELING ABNORMAL (Didn't feel right), TREMOR (Had the shakes really really bad), CHILLS (Internal chills, like quivering) and PYREXIA (Temperature was 101.2F). On 08-Feb-2021, the patient experienced FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Feb-2021, PYREXIA (Temperature was 101.2F) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was kind of sore), FEELING ABNORMAL (Didn't feel right), TREMOR (Had the shakes really really bad) and CHILLS (Internal chills, like quivering) outcome was unknown and FATIGUE (Fatigue) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 101.2 f (High) Fever of 101.2 F. On 05-Feb-2021, Body temperature: 101 f (High) Fever of 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow-up information received on 26-Apr-2021 contains non-significant information.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site rash
Clinical narrative: Rash - Near Injection Site; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash - Near Injection Site) and NAUSEA (Nausea) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-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 - Near Injection Site) and NAUSEA (Nausea). At the time of the report, VACCINATION SITE RASH (Rash - Near Injection Site) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment.  No concomitant medications were reported.  Treatment information was not provided.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received vaccine under 18 years old; A spontaneous report was received from a pharmacist for a female patient under 18 years of age who received Moderna's COVID-19 vaccine (mRNA-1273). No adverse event was reported after the administration of the vaccine.  The patient's medical history was not provided. No concomitant product use was reported.  On 01 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  Treatment information was not applicable.  Action taken with mRNA-1273 was unknown.  The outcome of the event, received vaccine under 18 years old, was recovered.; Reporter's Comments: This case concerns a female patient under 18 year-old who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swelling around the injection site; Redness around the injection site that is about 4 inches across; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site that is about 4 inches across) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site that is about 4 inches across). At the time of the report, VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site that is about 4 inches across) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Event outcome is updated. ( Not recovered (Ongoing) to Resolved).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Myalgia, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen area around the injection site), VACCINATION SITE PAIN (mild pain around the injection site), ARTHRALGIA (mild pain on finger joints in the arm of injection), PYREXIA (Felt feverish) and FATIGUE (Fatigue) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Jan-2021 at 12:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swollen area around the injection site), VACCINATION SITE PAIN (mild pain around the injection site), ARTHRALGIA (mild pain on finger joints in the arm of injection), PYREXIA (Felt feverish), FATIGUE (Fatigue) and MYALGIA (body aching). On 01-Feb-2021, VACCINATION SITE SWELLING (Swollen area around the injection site), VACCINATION SITE PAIN (mild pain around the injection site) and ARTHRALGIA (mild pain on finger joints in the arm of injection) was resolving, PYREXIA (Felt feverish) and FATIGUE (Fatigue) had resolved. At the time of the report, MYALGIA (body aching) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, Body temperature: 100 degree f abnormal. Concomitant medications were not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen area around the injection site), VACCINATION SITE PAIN (mild pain around the injection site), ARTHRALGIA (mild pain on finger joints in the arm of injection), PYREXIA (Felt feverish) and FATIGUE (Fatigue) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Jan-2021 at 12:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swollen area around the injection site), VACCINATION SITE PAIN (mild pain around the injection site), ARTHRALGIA (mild pain on finger joints in the arm of injection), PYREXIA (Felt feverish), FATIGUE (Fatigue) and MYALGIA (body aching). On 01-Feb-2021, VACCINATION SITE SWELLING (Swollen area around the injection site), VACCINATION SITE PAIN (mild pain around the injection site) and ARTHRALGIA (mild pain on finger joints in the arm of injection) was resolving, PYREXIA (Felt feverish) and FATIGUE (Fatigue) had resolved. At the time of the report, MYALGIA (body aching) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, Body temperature: 100 degree f abnormal. Concomitant medications were not provided. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Gout, Vaccination site pain
Clinical narrative: gout inflammation; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (gout inflammation) and VACCINATION SITE PAIN (Pain at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Gout (Patient reported , even before the vaccination, he noticed(was feeling) that he would have a gout attack.).    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 01-Feb-2021, the patient experienced GOUT (gout inflammation). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 01-Feb-2021 for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, GOUT (gout inflammation) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Sore throat; drippy nose; mild headache that is not worth mentioning; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (drippy nose) and HEADACHE (mild headache that is not worth mentioning) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-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 OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (drippy nose) and HEADACHE (mild headache that is not worth mentioning). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (drippy nose) and HEADACHE (mild headache that is not worth mentioning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  No concomitant medications were reported. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt badly; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt badly) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (felt badly). At the time of the report, MALAISE (felt badly) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported using medications for Crohn's Disease concomitantly. She mentioned that she cut back on her medicine and started feeling better. She feels it was her other medication causing her to feel badly. No treatment information was provided.   Reporter did not allow further contact
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: a rash in both legs /a rash in lower back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a rash in both legs /a rash in lower back) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced RASH (a rash in both legs /a rash in lower back). At the time of the report, RASH (a rash in both legs /a rash in lower back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment. Concomitant product included cholesterol medication and high blood pressure medication.  Patient used cream Icy Hot (idiopathic patch) for the treatment.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow-up document was received. Email information and address of reporter was updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise
Clinical narrative: Didn't feel good; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Didn't feel good), CHILLS (Chills) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-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 24-Feb-2021, the patient experienced MALAISE (Didn't feel good), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, MALAISE (Didn't feel good), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported.    This case was linked (E2B Linked Report).; Sender's Comments:  same reporter, different patient and event same reporter, different patient and event
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Gingival discomfort, Hypersensitivity, Pain in jaw, Pyrexia, Swelling face
Clinical narrative: gums feel like jely; jaw pain; right side of face is swolen; allergic reaction; fever; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL DISCOMFORT (gums feel like jely), PAIN IN JAW (jaw pain), SWELLING FACE (right side of face is swolen), HYPERSENSITIVITY (allergic reaction) and PYREXIA (fever) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 7006320006 and 7006320003) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced GINGIVAL DISCOMFORT (gums feel like jely), PAIN IN JAW (jaw pain), SWELLING FACE (right side of face is swolen), HYPERSENSITIVITY (allergic reaction) and PYREXIA (fever). At the time of the report, GINGIVAL DISCOMFORT (gums feel like jely), PAIN IN JAW (jaw pain), SWELLING FACE (right side of face is swolen), HYPERSENSITIVITY (allergic reaction) and PYREXIA (fever) outcome was unknown.            No concomitant medication was reported. Action taken with mRNA-1273 in response to the event was not applicable. Patient went to the dentist for a root canal and doctor gave him Clindamycin 150mg for infection just in case. The patient stated that they were apart of the Phase 3 trial and was offered vaccines when it was unblinded.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Reporter information added.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Very strong shaking chills; lymph nodes was swollen and sore; lymph nodes was swollen and sore; Headache; arm was sore, Arm became more sore; body aches; Fatigue; Very strong shaking chills, fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PAIN IN EXTREMITY (arm was sore, Arm became more sore), MYALGIA (body aches), FATIGUE (Fatigue) and PYREXIA (Very strong shaking chills, fever of 101) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced HEADACHE (Headache), PAIN IN EXTREMITY (arm was sore, Arm became more sore), MYALGIA (body aches), FATIGUE (Fatigue) and PYREXIA (Very strong shaking chills, fever of 101). On 08-Feb-2021, the patient experienced LYMPHADENOPATHY (lymph nodes was swollen and sore) and LYMPH NODE PAIN (lymph nodes was swollen and sore). On an unknown date, the patient experienced CHILLS (Very strong shaking chills). On 07-Feb-2021, HEADACHE (Headache), MYALGIA (body aches) and PYREXIA (Very strong shaking chills, fever of 101) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore, Arm became more sore), FATIGUE (Fatigue), LYMPHADENOPATHY (lymph nodes was swollen and sore), LYMPH NODE PAIN (lymph nodes was swollen and sore) and CHILLS (Very strong shaking chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Ibuprofen and pain relievers
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Very strong shaking chills; lymph nodes was swollen and sore; lymph nodes was swollen and sore; Headache; arm was sore, Arm became more sore; body aches; Fatigue; Very strong shaking chills, fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PAIN IN EXTREMITY (arm was sore, Arm became more sore), MYALGIA (body aches), FATIGUE (Fatigue) and PYREXIA (Very strong shaking chills, fever of 101) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced HEADACHE (Headache), PAIN IN EXTREMITY (arm was sore, Arm became more sore), MYALGIA (body aches), FATIGUE (Fatigue) and PYREXIA (Very strong shaking chills, fever of 101). On 08-Feb-2021, the patient experienced LYMPHADENOPATHY (lymph nodes was swollen and sore) and LYMPH NODE PAIN (lymph nodes was swollen and sore). On an unknown date, the patient experienced CHILLS (Very strong shaking chills). On 07-Feb-2021, HEADACHE (Headache), MYALGIA (body aches) and PYREXIA (Very strong shaking chills, fever of 101) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore, Arm became more sore), FATIGUE (Fatigue), LYMPHADENOPATHY (lymph nodes was swollen and sore), LYMPH NODE PAIN (lymph nodes was swollen and sore) and CHILLS (Very strong shaking chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Ibuprofen and pain relievers
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ERYTHEMA (Red hot), FEELING HOT (Red hot) and SWELLING (Swollen like a bee sting). At the time of the report, ERYTHEMA (Red hot), FEELING HOT (Red hot) and SWELLING (Swollen like a bee sting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment.  Treatment information was not provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: headache; high fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of   in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00/A2/A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient was treated with IBUPROFEN on 25-Feb-2021 for Symptomatic treatment, at an unspecified dose and frequency.        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 assessment.  Concomitant product included blood pressure medication and diabetic medication.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: some of the vaccine leaked from the barrel of the plunger; some of the vaccine leaked from the barrel of the plunger; A spontaneous report was received from a pharmacist concerning a patient of an unspecified age and gender who received Moderna's COVID-19 vaccine (mRNA-1273). Some of the vaccine leaked from the barrel of the plunger while administration of the vaccine.  The patient's medical history was not provided. No concomitant product use was reported.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. It was reported that some of the vaccine leaked from the barrel of the plunger while administration of the vaccine leading to under dose of the vaccine.  Treatment information was not applicable.  Action taken with mRNA-1273 was not applicable.  The outcome of the event, some of the vaccine leaked from the barrel of the plunger,  was not applicable.; Reporter's Comments: This report refers to a case of syringe leaking issue for mRNA-1273, unknown lot with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: lots of dizziness; more like a brain fog, "she can do stuff but says it felts dizzy"; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lots of dizziness) and FEELING ABNORMAL (more like a brain fog, "she can do stuff but says it felts dizzy") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (lots of dizziness) and FEELING ABNORMAL (more like a brain fog, "she can do stuff but says it felts dizzy"). At the time of the report, DIZZINESS (lots of dizziness) and FEELING ABNORMAL (more like a brain fog, "she can do stuff but says it felts dizzy") outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  No concomitant medications were reported No treatment information was provided   This case was linked to MOD-2021-026107 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site rash
Clinical narrative: itching; half dollar size red rash appeared at the injection site on arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of PRURITUS (itching) and VACCINATION SITE RASH (half dollar size red rash appeared at the injection site on arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching) and VACCINATION SITE RASH (half dollar size red rash appeared at the injection site on arm). At the time of the report, PRURITUS (itching) and VACCINATION SITE RASH (half dollar size red rash appeared at the injection site on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment for the event includes 10mg of Zyrtec x1 dose.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Heart rate increased
Clinical narrative: Felt off like light headed; Heart was racing; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt off like light headed) and HEART RATE INCREASED (Heart was racing) in a 72-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 05-Feb-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Felt off like light headed) and HEART RATE INCREASED (Heart was racing). At the time of the report, DIZZINESS (Felt off like light headed) and HEART RATE INCREASED (Heart was racing) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure increased: Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Mild headache that is not worth mentioning; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Mild headache that is not worth mentioning) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 28-Jan-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 HEADACHE (Mild headache that is not worth mentioning). At the time of the report, HEADACHE (Mild headache that is not worth mentioning) outcome was unknown.        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.; 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 headache, a causal relationship cannot be excluded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm). At the time of the report, PAIN IN EXTREMITY (Soreness of arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot to the touch at injection site; sore arm at injection site; red at injection site; Swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch at injection site), VACCINATION SITE PAIN (sore arm at injection site), VACCINATION SITE ERYTHEMA (red at injection site) and VACCINATION SITE SWELLING (Swollen at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch at injection site), VACCINATION SITE PAIN (sore arm at injection site), VACCINATION SITE ERYTHEMA (red at injection site) and VACCINATION SITE SWELLING (Swollen at injection site). At the time of the report, VACCINATION SITE WARMTH (hot to the touch at injection site), VACCINATION SITE PAIN (sore arm at injection site), VACCINATION SITE ERYTHEMA (red at injection site) and VACCINATION SITE SWELLING (Swollen at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment.  No concomitant medications were reported.  Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hypersomnia, Myalgia, Pyrexia
Clinical narrative: Tiny red dots (right arm) between her wrist and elbow; Slept a lot; Feverish; Arm was sore(inj site); Felt tired; Had chills; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Tiny red dots (right arm) between her wrist and elbow), HYPERSOMNIA (Slept a lot), PYREXIA (Feverish), VACCINATION SITE PAIN (Arm was sore(inj site)) and FATIGUE (Felt tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) 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 04-Feb-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced HYPERSOMNIA (Slept a lot), PYREXIA (Feverish), VACCINATION SITE PAIN (Arm was sore(inj site)), FATIGUE (Felt tired), CHILLS (Had chills) and MYALGIA (Muscle aches). On 06-Feb-2021, the patient experienced RASH MACULAR (Tiny red dots (right arm) between her wrist and elbow). At the time of the report, RASH MACULAR (Tiny red dots (right arm) between her wrist and elbow), HYPERSOMNIA (Slept a lot), PYREXIA (Feverish), VACCINATION SITE PAIN (Arm was sore(inj site)), FATIGUE (Felt tired), CHILLS (Had chills) and MYALGIA (Muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site pain
Clinical narrative: Tiny red dots (right arm) between her wrist and elbow; Slept a lot; Feverish; Arm was sore(inj site); Felt tired; Had chills; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Tiny red dots (right arm) between her wrist and elbow), HYPERSOMNIA (Slept a lot), PYREXIA (Feverish), VACCINATION SITE PAIN (Arm was sore(inj site)) and FATIGUE (Felt tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) 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 04-Feb-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced HYPERSOMNIA (Slept a lot), PYREXIA (Feverish), VACCINATION SITE PAIN (Arm was sore(inj site)), FATIGUE (Felt tired), CHILLS (Had chills) and MYALGIA (Muscle aches). On 06-Feb-2021, the patient experienced RASH MACULAR (Tiny red dots (right arm) between her wrist and elbow). At the time of the report, RASH MACULAR (Tiny red dots (right arm) between her wrist and elbow), HYPERSOMNIA (Slept a lot), PYREXIA (Feverish), VACCINATION SITE PAIN (Arm was sore(inj site)), FATIGUE (Felt tired), CHILLS (Had chills) and MYALGIA (Muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided