chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: redness close to the injection site; swelling close to the injection site; pain close to injection site; bumps in the arm; itchiness close to the injection site; bump close to the vaccination place; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness close to the injection site), VACCINATION SITE SWELLING (swelling close to the injection site), VACCINATION SITE PAIN (pain close to injection site), NODULE (bumps in the arm) and VACCINATION SITE PRURITUS (itchiness close to the injection site) in a 46-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 (No medically reported history).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness close to the injection site), VACCINATION SITE SWELLING (swelling close to the injection site), VACCINATION SITE PAIN (pain close to injection site), NODULE (bumps in the arm), VACCINATION SITE PRURITUS (itchiness close to the injection site) and VACCINATION SITE MASS (bump close to the vaccination place). At the time of the report, VACCINATION SITE ERYTHEMA (redness close to the injection site), VACCINATION SITE SWELLING (swelling close to the injection site), VACCINATION SITE PAIN (pain close to injection site), VACCINATION SITE PRURITUS (itchiness close to the injection site) and VACCINATION SITE MASS (bump close to the vaccination place) outcome was unknown and NODULE (bumps in the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reports taking HYDROCHLORIDE STEROID (NOS) and an ANTIHISTAMINE pill (NOS) to treat symptoms.   Concomitant medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: redness close to the injection site; swelling close to the injection site; pain close to injection site; bumps in the arm; itchiness close to the injection site; bump close to the vaccination place; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness close to the injection site), VACCINATION SITE SWELLING (swelling close to the injection site), VACCINATION SITE PAIN (pain close to injection site), NODULE (bumps in the arm) and VACCINATION SITE PRURITUS (itchiness close to the injection site) in a 46-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 (No medically reported history).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness close to the injection site), VACCINATION SITE SWELLING (swelling close to the injection site), VACCINATION SITE PAIN (pain close to injection site), NODULE (bumps in the arm), VACCINATION SITE PRURITUS (itchiness close to the injection site) and VACCINATION SITE MASS (bump close to the vaccination place). At the time of the report, VACCINATION SITE ERYTHEMA (redness close to the injection site), VACCINATION SITE SWELLING (swelling close to the injection site), VACCINATION SITE PAIN (pain close to injection site), VACCINATION SITE PRURITUS (itchiness close to the injection site) and VACCINATION SITE MASS (bump close to the vaccination place) outcome was unknown and NODULE (bumps in the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reports taking HYDROCHLORIDE STEROID (NOS) and an ANTIHISTAMINE pill (NOS) to treat symptoms.   Concomitant medications were not reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Pain, Pyrexia, Vaccination site erythema
Clinical narrative: injection site got bigger; redder; more sore; soreness; mild coldness; Headache; very low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (mild coldness), HEADACHE (Headache), PYREXIA (very low grade fever), VACCINATION SITE SWELLING (injection site got bigger) and VACCINATION SITE ERYTHEMA (redder) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced FEELING COLD (mild coldness), HEADACHE (Headache), PYREXIA (very low grade fever) and PAIN (soreness). On 19-Mar-2021, the patient experienced VACCINATION SITE SWELLING (injection site got bigger), VACCINATION SITE ERYTHEMA (redder) and VACCINATION SITE PAIN (more sore). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, FEELING COLD (mild coldness), HEADACHE (Headache), PYREXIA (very low grade fever) and PAIN (soreness) had resolved and VACCINATION SITE SWELLING (injection site got bigger), VACCINATION SITE ERYTHEMA (redder) and VACCINATION SITE PAIN (more sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported..
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site got bigger; redder; more sore; soreness; mild coldness; Headache; very low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (mild coldness), HEADACHE (Headache), PYREXIA (very low grade fever), VACCINATION SITE SWELLING (injection site got bigger) and VACCINATION SITE ERYTHEMA (redder) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced FEELING COLD (mild coldness), HEADACHE (Headache), PYREXIA (very low grade fever) and PAIN (soreness). On 19-Mar-2021, the patient experienced VACCINATION SITE SWELLING (injection site got bigger), VACCINATION SITE ERYTHEMA (redder) and VACCINATION SITE PAIN (more sore). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, FEELING COLD (mild coldness), HEADACHE (Headache), PYREXIA (very low grade fever) and PAIN (soreness) had resolved and VACCINATION SITE SWELLING (injection site got bigger), VACCINATION SITE ERYTHEMA (redder) and VACCINATION SITE PAIN (more sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported..
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: swollen lips; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swollen lips) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (swollen lips). At the time of the report, LIP SWELLING (swollen lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Erythema, Headache, Myalgia
Clinical narrative: sleepiness; arm swelled; arm red; body aches; muscle and joint aches; fever -not confirmed but she had chills and shaking; headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepiness), PERIPHERAL SWELLING (arm swelled), ERYTHEMA (arm red), MYALGIA (body aches) and ARTHRALGIA (muscle and joint aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer and Cancer surgery (kidney cancer surgery). Concomitant products included OMEPRAZOLE, LOSARTAN, EZETIMIBE, MONTELUKAST, COLECALCIFEROL (VIT D [COLECALCIFEROL]), CALCIUM and UBIDECARENONE (COQ) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced SOMNOLENCE (sleepiness), PERIPHERAL SWELLING (arm swelled), ERYTHEMA (arm red), MYALGIA (body aches), ARTHRALGIA (muscle and joint aches), CHILLS (fever -not confirmed but she had chills and shaking) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 13-Mar-2021, MYALGIA (body aches), ARTHRALGIA (muscle and joint aches), CHILLS (fever -not confirmed but she had chills and shaking) and HEADACHE (headache) had resolved. On 14-Mar-2021, PERIPHERAL SWELLING (arm swelled) and ERYTHEMA (arm red) had resolved. On 16-Mar-2021, SOMNOLENCE (sleepiness) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-053303 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Somnolence
Clinical narrative: sleepiness; arm swelled; arm red; body aches; muscle and joint aches; fever -not confirmed but she had chills and shaking; headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepiness), PERIPHERAL SWELLING (arm swelled), ERYTHEMA (arm red), MYALGIA (body aches) and ARTHRALGIA (muscle and joint aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer and Cancer surgery (kidney cancer surgery). Concomitant products included OMEPRAZOLE, LOSARTAN, EZETIMIBE, MONTELUKAST, COLECALCIFEROL (VIT D [COLECALCIFEROL]), CALCIUM and UBIDECARENONE (COQ) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced SOMNOLENCE (sleepiness), PERIPHERAL SWELLING (arm swelled), ERYTHEMA (arm red), MYALGIA (body aches), ARTHRALGIA (muscle and joint aches), CHILLS (fever -not confirmed but she had chills and shaking) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 13-Mar-2021, MYALGIA (body aches), ARTHRALGIA (muscle and joint aches), CHILLS (fever -not confirmed but she had chills and shaking) and HEADACHE (headache) had resolved. On 14-Mar-2021, PERIPHERAL SWELLING (arm swelled) and ERYTHEMA (arm red) had resolved. On 16-Mar-2021, SOMNOLENCE (sleepiness) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-053303 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flank pain, Flushing, Headache, Irritability
Clinical narrative: her face got flushed; her face got warm; her lips started tingling; felt irritated; flank pain on her right side; headache; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (her face got flushed), FEELING HOT (her face got warm), PARAESTHESIA ORAL (her lips started tingling), IRRITABILITY (felt irritated) and FLANK PAIN (flank pain on her right side) in a 59-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.     Previously administered products included for an unreported indication: VITAMIN D COMPLEX and SYNTHROID.    On 11-Mar-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 FLUSHING (her face got flushed), FEELING HOT (her face got warm), PARAESTHESIA ORAL (her lips started tingling), IRRITABILITY (felt irritated), FLANK PAIN (flank pain on her right side) and HEADACHE (headache). The patient was treated with APRONAL, DIPHENHYDRAMINE SALICYLATE, DIPROPHYLLINE (SEASICK) at an unspecified dose and frequency and LORATADINE (CLARITINE) at an unspecified dose and frequency. At the time of the report, FLUSHING (her face got flushed), FEELING HOT (her face got warm), PARAESTHESIA ORAL (her lips started tingling) and IRRITABILITY (felt irritated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: her face got flushed; her face got warm; her lips started tingling; felt irritated; flank pain on her right side; headache; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (her face got flushed), FEELING HOT (her face got warm), PARAESTHESIA ORAL (her lips started tingling), IRRITABILITY (felt irritated) and FLANK PAIN (flank pain on her right side) in a 59-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.     Previously administered products included for an unreported indication: VITAMIN D COMPLEX and SYNTHROID.    On 11-Mar-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 FLUSHING (her face got flushed), FEELING HOT (her face got warm), PARAESTHESIA ORAL (her lips started tingling), IRRITABILITY (felt irritated), FLANK PAIN (flank pain on her right side) and HEADACHE (headache). The patient was treated with APRONAL, DIPHENHYDRAMINE SALICYLATE, DIPROPHYLLINE (SEASICK) at an unspecified dose and frequency and LORATADINE (CLARITINE) at an unspecified dose and frequency. At the time of the report, FLUSHING (her face got flushed), FEELING HOT (her face got warm), PARAESTHESIA ORAL (her lips started tingling) and IRRITABILITY (felt irritated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warm; red; swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen). At the time of the report, VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swollen tongue
Clinical narrative: swelling tongue & lips; swelling tongue & lips; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (swelling tongue & lips) and LIP SWELLING (swelling tongue & lips) 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 reported).    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (swelling tongue & lips) and LIP SWELLING (swelling tongue & lips). At the time of the report, SWOLLEN TONGUE (swelling tongue & lips) and LIP SWELLING (swelling tongue & lips) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Nausea, Oropharyngeal pain, Pain
Clinical narrative: sleeping longer; sore throat; body aches; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (sleeping longer), OROPHARYNGEAL PAIN (sore throat), PAIN (body aches), NAUSEA (nausea) and FATIGUE (fatigue) 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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced HYPERSOMNIA (sleeping longer), OROPHARYNGEAL PAIN (sore throat), PAIN (body aches), NAUSEA (nausea) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERSOMNIA (sleeping longer), OROPHARYNGEAL PAIN (sore throat), PAIN (body aches), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna Vaccine administered to underage patient/16 year old patient was administered Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Vaccine administered to underage patient/16 year old patient was administered Moderna Covid-19 vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Vaccine administered to underage patient/16 year old patient was administered Moderna Covid-19 vaccine). On 19-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Vaccine administered to underage patient/16 year old patient was administered Moderna Covid-19 vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Contains Vaccination facility information.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old femal) for mRNA-1273 (lot number 046A21A) with no associated AEs reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: terrible headache; it was itchy; rash on the arm of the injection; red blotches on the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (it was itchy), VACCINATION SITE RASH (rash on the arm of the injection), VACCINATION SITE ERYTHEMA (red blotches on the arm of the injection) and HEADACHE (terrible headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (it was itchy), VACCINATION SITE RASH (rash on the arm of the injection) and VACCINATION SITE ERYTHEMA (red blotches on the arm of the injection). On 22-Mar-2021, the patient experienced HEADACHE (terrible headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (it was itchy), VACCINATION SITE RASH (rash on the arm of the injection), VACCINATION SITE ERYTHEMA (red blotches on the arm of the injection) and HEADACHE (terrible headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hot flush
Clinical narrative: hot flashes; trouble in breathing; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes) and DYSPNOEA (trouble in breathing) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-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 HOT FLUSH (hot flashes) and DYSPNOEA (trouble in breathing). At the time of the report, HOT FLUSH (hot flashes) and DYSPNOEA (trouble in breathing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided Treatment for the events, were not provided   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Patients initials and contact information updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Erythema, Headache, Pain
Clinical narrative: slight soreness in the injection site; headache; fever -not confirmed but she had chills and shaking; muscle and joint aches; body aches; arm swelled; arm red; sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), PERIPHERAL SWELLING (arm swelled), ERYTHEMA (arm red), SOMNOLENCE (sleepiness) and VACCINATION SITE PAIN (slight soreness in the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (breast cancer 6/7 years ago) and Renal surgery (cancer surgery last September (seems fine now)). Concomitant products included OMEPRAZOLE, LOSARTAN, EZETIMIBE, MONTELUKAST, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), CALCIUM and UBIDECARENONE (COQ10 [UBIDECARENONE]) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (body aches), PERIPHERAL SWELLING (arm swelled), ERYTHEMA (arm red), SOMNOLENCE (sleepiness), HEADACHE (headache), CHILLS (fever -not confirmed but she had chills and shaking) and ARTHRALGIA (muscle and joint aches). On an unknown date, the patient experienced VACCINATION SITE PAIN (slight soreness in the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Mar-2021, PAIN (body aches), HEADACHE (headache), CHILLS (fever -not confirmed but she had chills and shaking) and ARTHRALGIA (muscle and joint aches) had resolved. On 14-Mar-2021, PERIPHERAL SWELLING (arm swelled) and ERYTHEMA (arm red) had resolved. On 16-Mar-2021, SOMNOLENCE (sleepiness) had resolved. At the time of the report, VACCINATION SITE PAIN (slight soreness in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Somnolence, Vaccination site pain
Clinical narrative: slight soreness in the injection site; headache; fever -not confirmed but she had chills and shaking; muscle and joint aches; body aches; arm swelled; arm red; sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), PERIPHERAL SWELLING (arm swelled), ERYTHEMA (arm red), SOMNOLENCE (sleepiness) and VACCINATION SITE PAIN (slight soreness in the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (breast cancer 6/7 years ago) and Renal surgery (cancer surgery last September (seems fine now)). Concomitant products included OMEPRAZOLE, LOSARTAN, EZETIMIBE, MONTELUKAST, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), CALCIUM and UBIDECARENONE (COQ10 [UBIDECARENONE]) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (body aches), PERIPHERAL SWELLING (arm swelled), ERYTHEMA (arm red), SOMNOLENCE (sleepiness), HEADACHE (headache), CHILLS (fever -not confirmed but she had chills and shaking) and ARTHRALGIA (muscle and joint aches). On an unknown date, the patient experienced VACCINATION SITE PAIN (slight soreness in the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Mar-2021, PAIN (body aches), HEADACHE (headache), CHILLS (fever -not confirmed but she had chills and shaking) and ARTHRALGIA (muscle and joint aches) had resolved. On 14-Mar-2021, PERIPHERAL SWELLING (arm swelled) and ERYTHEMA (arm red) had resolved. On 16-Mar-2021, SOMNOLENCE (sleepiness) had resolved. At the time of the report, VACCINATION SITE PAIN (slight soreness in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Swollen tongue; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swollen tongue) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced SWOLLEN TONGUE (Swollen tongue). At the time of the report, SWOLLEN TONGUE (Swollen tongue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not provided. Treatment information included Benadryl.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness
Clinical narrative: lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (lightheadedness). At the time of the report, DIZZINESS (lightheadedness) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Blood pressure measurement: decreased. (Low) Decreased..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information were not provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: I still feel some dizzy today; Dizziness, wasn´t able to stand on my feets/Lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness, wasn´t able to stand on my feets/Lightheaded) and DIZZINESS (I still feel some dizzy today) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced DIZZINESS (Dizziness, wasn´t able to stand on my feets/Lightheaded). On 22-Mar-2021, the patient experienced DIZZINESS (I still feel some dizzy today). At the time of the report, DIZZINESS (Dizziness, wasn´t able to stand on my feets/Lightheaded) and DIZZINESS (I still feel some dizzy today) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment information were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pruritus, Swelling
Clinical narrative: Itching; Swelling; Top of shoulder is pink/Pain from Shoulder to Elbow/Pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), SWELLING (Swelling) and ARTHRALGIA (Top of shoulder is pink/Pain from Shoulder to Elbow/Pain in shoulder) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PRURITUS (Itching), SWELLING (Swelling) and ARTHRALGIA (Top of shoulder is pink/Pain from Shoulder to Elbow/Pain in shoulder). At the time of the report, PRURITUS (Itching), SWELLING (Swelling) and ARTHRALGIA (Top of shoulder is pink/Pain from Shoulder to Elbow/Pain in shoulder) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Concomitant and treatment information were not provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Decreased appetite, Dizziness, Fall
Clinical narrative: collapsed fell down floor in bathroom; weak and couple not get up; did not eat or drink anything; pain in lower back; feel dizzy; This spontaneous case was reported by a consumer and describes the occurrence of FALL (collapsed fell down floor in bathroom), ASTHENIA (weak and couple not get up), DECREASED APPETITE (did not eat or drink anything), BACK PAIN (pain in lower back) and DIZZINESS (feel dizzy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 012M20A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included AMLODIPINE, VITAMIN D3, ZINC, ACETYLSALICYLIC ACID (BABY ASPIRIN) and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced FALL (collapsed fell down floor in bathroom), ASTHENIA (weak and couple not get up), DECREASED APPETITE (did not eat or drink anything), BACK PAIN (pain in lower back) and DIZZINESS (feel dizzy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FALL (collapsed fell down floor in bathroom), ASTHENIA (weak and couple not get up), DECREASED APPETITE (did not eat or drink anything), BACK PAIN (pain in lower back) and DIZZINESS (feel dizzy) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up information was received on 06-aug-2021and  included no new information
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site rash
Clinical narrative: Boke out in rash 1 inch below the injection site; Itched; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (Boke out in rash 1 inch below the injection site) and PRURITUS (Itched) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergy to Latex).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE RASH (Boke out in rash 1 inch below the injection site) and PRURITUS (Itched). At the time of the report, VACCINATION SITE RASH (Boke out in rash 1 inch below the injection site) and PRURITUS (Itched) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicines reported. Treatment information included Benadryl.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Chills, Headache, Pyrexia
Clinical narrative: She lost her voice; She experienced chills; She experienced headache; She experienced fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (She experienced chills), HEADACHE (She experienced headache), PYREXIA (She experienced fever) and APHONIA (She lost her voice) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, ATORVASTATIN, VENLAFAXINE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 12-Mar-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 12-Mar-2021, the patient experienced CHILLS (She experienced chills), HEADACHE (She experienced headache) and PYREXIA (She experienced fever). On 13-Mar-2021, the patient experienced APHONIA (She lost her voice). At the time of the report, CHILLS (She experienced chills), HEADACHE (She experienced headache), PYREXIA (She experienced fever) and APHONIA (She lost her voice) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.  Treatment medication were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity, Pruritus, Swelling
Clinical narrative: swelling underneath the left arm/hard lump; not able to rise left arm; tenderness at injection site; muscle underneath left arm hurts; fatigue; tiredness; little itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (little itching), SWELLING (swelling underneath the left arm/hard lump), PAIN IN EXTREMITY (not able to rise left arm), VACCINATION SITE PAIN (tenderness at injection site) and MYALGIA (muscle underneath left arm hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ?40233A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PRURITUS (little itching). On 19-Mar-2021, the patient experienced SWELLING (swelling underneath the left arm/hard lump), PAIN IN EXTREMITY (not able to rise left arm), VACCINATION SITE PAIN (tenderness at injection site), MYALGIA (muscle underneath left arm hurts), FATIGUE (fatigue) and FATIGUE (tiredness). At the time of the report, PRURITUS (little itching), SWELLING (swelling underneath the left arm/hard lump), PAIN IN EXTREMITY (not able to rise left arm), VACCINATION SITE PAIN (tenderness at injection site), MYALGIA (muscle underneath left arm hurts), FATIGUE (fatigue) and FATIGUE (tiredness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient takes high blood pressure medication.  Patient was treated with Tylenol every 4 hours.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: swelling underneath the left arm/hard lump; not able to rise left arm; tenderness at injection site; muscle underneath left arm hurts; fatigue; tiredness; little itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (little itching), SWELLING (swelling underneath the left arm/hard lump), PAIN IN EXTREMITY (not able to rise left arm), VACCINATION SITE PAIN (tenderness at injection site) and MYALGIA (muscle underneath left arm hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ?40233A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PRURITUS (little itching). On 19-Mar-2021, the patient experienced SWELLING (swelling underneath the left arm/hard lump), PAIN IN EXTREMITY (not able to rise left arm), VACCINATION SITE PAIN (tenderness at injection site), MYALGIA (muscle underneath left arm hurts), FATIGUE (fatigue) and FATIGUE (tiredness). At the time of the report, PRURITUS (little itching), SWELLING (swelling underneath the left arm/hard lump), PAIN IN EXTREMITY (not able to rise left arm), VACCINATION SITE PAIN (tenderness at injection site), MYALGIA (muscle underneath left arm hurts), FATIGUE (fatigue) and FATIGUE (tiredness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient takes high blood pressure medication.  Patient was treated with Tylenol every 4 hours.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Feeling abnormal, Palpitations
Clinical narrative: Weak; Heart pounding; Her body was feeling funny; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Weak), PALPITATIONS (Heart pounding) and FEELING ABNORMAL (Her body was feeling funny) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced ASTHENIA (Weak), PALPITATIONS (Heart pounding) and FEELING ABNORMAL (Her body was feeling funny). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 20-Mar-2021, ASTHENIA (Weak), PALPITATIONS (Heart pounding) and FEELING ABNORMAL (Her body was feeling funny) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, Blood pressure measurement: Blood pressure shot way up..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Exposure during pregnancy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 04-Oct-2020 and the estimated date of delivery was 19-Jul-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Exposure during pregnancy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information were not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Diarrhoea, Energy increased, Eye disorder
Clinical narrative: " bad reaction to the first injection of Moderna"; "left arm was swollen"; "Hot"; "I felt like the wind was taken out of me"; "Bedridden"; "Chills"; "Diarrhea"; "the most distressing part, my eyes is not what they were prior receiving the injection"; "I use glasses to read and another to watch tv.; "I had script, and never had to use"; "I didn't know vision could go."; "more energetic"; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (" bad reaction to the first injection of Moderna"), PERIPHERAL SWELLING ("left arm was swollen"), FEELING HOT ("Hot"), FEELING ABNORMAL ("I felt like the wind was taken out of me") and BEDRIDDEN ("Bedridden") in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A,031MZ0A,031MZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included SARS (Had SARS in 2003). Concomitant products included BROMAZEPAM (LECTOPAM) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (" bad reaction to the first injection of Moderna"), PERIPHERAL SWELLING ("left arm was swollen"), FEELING HOT ("Hot"), FEELING ABNORMAL ("I felt like the wind was taken out of me"), BEDRIDDEN ("Bedridden"), CHILLS ("Chills"), DIARRHOEA ("Diarrhea"), EYE DISORDER ("the most distressing part, my eyes is not what they were prior receiving the injection"), EYE DISORDER ("I use glasses to read and another to watch tv.), FEELING ABNORMAL ("I had script, and never had to use"), VISUAL IMPAIRMENT ("I didn't know vision could go.") and ENERGY INCREASED ("more energetic"). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 500 mg,daily for 1 week. At the time of the report, HYPERSENSITIVITY (" bad reaction to the first injection of Moderna"), PERIPHERAL SWELLING ("left arm was swollen"), FEELING HOT ("Hot"), FEELING ABNORMAL ("I felt like the wind was taken out of me"), BEDRIDDEN ("Bedridden"), CHILLS ("Chills"), DIARRHOEA ("Diarrhea"), EYE DISORDER ("the most distressing part, my eyes is not what they were prior receiving the injection"), EYE DISORDER ("I use glasses to read and another to watch tv.), FEELING ABNORMAL ("I had script, and never had to use"), VISUAL IMPAIRMENT ("I didn't know vision could go.") and ENERGY INCREASED ("more energetic") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Concomitant medication was Tylenol 500mg Included.