chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Muscular weakness, Myalgia, Vomiting
Clinical narrative: mild muscle weakness; muscle arm soreness; vomiting; chills / chills on and off; extreme weakness all over; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (extreme weakness all over), MUSCULAR WEAKNESS (mild muscle weakness), CHILLS (chills / chills on and off), MYALGIA (muscle arm soreness) and VOMITING (vomiting) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced ASTHENIA (extreme weakness all over) and CHILLS (chills / chills on and off). On an unknown date, the patient experienced MUSCULAR WEAKNESS (mild muscle weakness), MYALGIA (muscle arm soreness) and VOMITING (vomiting). On 14-May-2021, ASTHENIA (extreme weakness all over) outcome was unknown. At the time of the report, MUSCULAR WEAKNESS (mild muscle weakness), CHILLS (chills / chills on and off), MYALGIA (muscle arm soreness) and VOMITING (vomiting) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-194112 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; 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 RASH (Rash) 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 RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: Nausea/ Extreme nausea; Vomiting; Extreme Fatigue; This spontaneous case was reported by a physician and describes the occurrence of NAUSEA (Nausea/ Extreme nausea), VOMITING (Vomiting) and FATIGUE (Extreme Fatigue) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, Anxiety and Depression. Concomitant products included THYROID (ARMOUR THYROID), PROBIOTICS NOS, DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) and ALUMINIUM HYDROXIDE, MAGNESIUM TRISILICATE, SODIUM ALGINATE (PEPCID [ALUMINIUM HYDROXIDE;MAGNESIUM TRISILICATE;SODIUM ALGINATE]) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced NAUSEA (Nausea/ Extreme nausea), VOMITING (Vomiting) and FATIGUE (Extreme Fatigue). At the time of the report, NAUSEA (Nausea/ Extreme nausea), VOMITING (Vomiting) and FATIGUE (Extreme Fatigue) 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.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: AE contact information,patient details added
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Little side effects; 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 VACCINATION COMPLICATION (Little side effects) 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 01-Jun-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 VACCINATION COMPLICATION (Little side effects). At the time of the report, VACCINATION COMPLICATION (Little side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not provided   Reporter did not allow further contact
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Myalgia, Pain, Tinnitus
Clinical narrative: Increased frequency and pitch of ringing in the ears; pain is pressure points; Headache; Whole body is hurting; Pain in glands underneath neck; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Increased frequency and pitch of ringing in the ears), PAIN (pain is pressure points), HEADACHE (Headache), MYALGIA (Whole body is hurting) and LYMPHADENOPATHY (Pain in glands underneath neck) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0041CA) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALPRAZOLAM (XANAX), BISOPROLOL FUMARATE (ZEBETA), CELECOXIB (CELEXA [CELECOXIB]), HYDRALAZINE, FUROSEMIDE SODIUM (LASIX LIQUIDUM), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), EVOLOCUMAB (REPATHA), ROSUVASTATIN CALCIUM (CRESTOR), ZOLPIDEM TARTRATE (AMBIEN) and GLYCERYL TRINITRATE (NITROGLYCERINE) for an unknown indication.   On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced TINNITUS (Increased frequency and pitch of ringing in the ears), PAIN (pain is pressure points), HEADACHE (Headache), MYALGIA (Whole body is hurting) and LYMPHADENOPATHY (Pain in glands underneath neck). At the time of the report, TINNITUS (Increased frequency and pitch of ringing in the ears), PAIN (pain is pressure points), HEADACHE (Headache), MYALGIA (Whole body is hurting) and LYMPHADENOPATHY (Pain in glands underneath neck) outcome was unknown.            No treatment medications was provided  Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste after the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Metallic taste after the 2nd dose). At the time of the report, DYSGEUSIA (Metallic taste after the 2nd dose) outcome was unknown.            Concomitant product use was not provider by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: Lump on my colon bone; 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 SKIN MASS (Lump on my colon bone) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (Lump on my colon bone). At the time of the report, SKIN MASS (Lump on my colon bone) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Bedridden
Clinical narrative: Could not get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Could not get out of bed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (Could not get out of bed). At the time of the report, BEDRIDDEN (Could not get out of bed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment information was provided.   This case was linked to MOD-2021-194149 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Trichorrhexis
Clinical narrative: Hair began to fall out; Hair began break off; 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 ALOPECIA (Hair began to fall out) and TRICHORRHEXIS (Hair began break off) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Hair began to fall out) and TRICHORRHEXIS (Hair began break off). At the time of the report, ALOPECIA (Hair began to fall out) and TRICHORRHEXIS (Hair began break off) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea  5-7hs after the shot; vomiting 5-7hs after the shot; 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 NAUSEA (Nausea  5-7hs after the shot) and VOMITING (vomiting 5-7hs after the shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea  5-7hs after the shot) and VOMITING (vomiting 5-7hs after the shot). At the time of the report, NAUSEA (Nausea  5-7hs after the shot) and VOMITING (vomiting 5-7hs after the shot) 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.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Erythema, Myalgia, Pyrexia
Clinical narrative: Experienced swelling of eyelids; Red and swollen ears, they were hot; Rash on the whole body; Fever all day (38.5-39°C); Joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (Experienced swelling of eyelids), ERYTHEMA (Red and swollen ears, they were hot), RASH (Rash on the whole body), PYREXIA (Fever all day (38.5-39°C)) and ARTHRALGIA (Joint pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lung embolism in 2019. Concomitant products included FLUOXETINE for an unknown indication.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced PYREXIA (Fever all day (38.5-39°C)), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). On 31-May-2021, the patient experienced SWELLING OF EYELID (Experienced swelling of eyelids), ERYTHEMA (Red and swollen ears, they were hot) and RASH (Rash on the whole body). The patient was treated with PARACETAMOL (TYLENOL) on 29-May-2021 for Fever, at a dose of 1 dosage form; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing from 31-May-2021 for Rash generalised, at a dose of 1 dosage form and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) on 01-Jun-2021 for Rash generalised, at a dose of 1 dosage form. On 30-May-2021, PYREXIA (Fever all day (38.5-39°C)), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) had resolved. At the time of the report, SWELLING OF EYELID (Experienced swelling of eyelids) and ERYTHEMA (Red and swollen ears, they were hot) outcome was unknown and RASH (Rash on the whole body) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2021, Body temperature: 38.5-39°c (High) 38.5-39°C.         Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Significant follow up received on 30 Jun 2021 - Updated Causal Relationship of Vaccine to Lung Embolism as No.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling of eyelid
Clinical narrative: Experienced swelling of eyelids; Red and swollen ears, they were hot; Rash on the whole body; Fever all day (38.5-39°C); Joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (Experienced swelling of eyelids), ERYTHEMA (Red and swollen ears, they were hot), RASH (Rash on the whole body), PYREXIA (Fever all day (38.5-39°C)) and ARTHRALGIA (Joint pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lung embolism in 2019. Concomitant products included FLUOXETINE for an unknown indication.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced PYREXIA (Fever all day (38.5-39°C)), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). On 31-May-2021, the patient experienced SWELLING OF EYELID (Experienced swelling of eyelids), ERYTHEMA (Red and swollen ears, they were hot) and RASH (Rash on the whole body). The patient was treated with PARACETAMOL (TYLENOL) on 29-May-2021 for Fever, at a dose of 1 dosage form; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing from 31-May-2021 for Rash generalised, at a dose of 1 dosage form and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) on 01-Jun-2021 for Rash generalised, at a dose of 1 dosage form. On 30-May-2021, PYREXIA (Fever all day (38.5-39°C)), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) had resolved. At the time of the report, SWELLING OF EYELID (Experienced swelling of eyelids) and ERYTHEMA (Red and swollen ears, they were hot) outcome was unknown and RASH (Rash on the whole body) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2021, Body temperature: 38.5-39°c (High) 38.5-39°C.         Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Significant follow up received on 30 Jun 2021 - Updated Causal Relationship of Vaccine to Lung Embolism as No.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps) and DIARRHEA (diarrhea) 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 26-May-2021 at 1:00 PM, 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 27-May-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps) and DIARRHEA (diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps) and DIARRHEA (diarrhea) had not resolved. No concomitant medication was provided. No treatment medications was provided. Action taken with mRNA1273 Moderna vaccine was Not Applicable
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: patient is two months late for her second Moderna Covid-19 injection/pateint received her first dose of Moderna Covid-19 injection on 01Apr2021; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient is two months late for her second Moderna Covid-19 injection/pateint received her first dose of Moderna Covid-19 injection on 01Apr2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient is two months late for her second Moderna Covid-19 injection/pateint received her first dose of Moderna Covid-19 injection on 01Apr2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient is two months late for her second Moderna Covid-19 injection/pateint received her first dose of Moderna Covid-19 injection on 01Apr2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Pain; severe muscle stiffness in my left hip leg; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Pain) and MUSCULOSKELETAL STIFFNESS (severe muscle stiffness in my left hip leg) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Pain) and MUSCULOSKELETAL STIFFNESS (severe muscle stiffness in my left hip leg). At the time of the report, PAIN (Pain) and MUSCULOSKELETAL STIFFNESS (severe muscle stiffness in my left hip leg) outcome was unknown.            Concomitant products used by the patient included Adelaide Foncha Treatment information was not provided
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, SARS-CoV-2 test positive
Clinical narrative: Felt Hot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Felt Hot) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history was provided by reporter.     On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced FEELING HOT (Felt Hot). On 24-Apr-2021, FEELING HOT (Felt Hot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, SARS-CoV-2 test positive: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: menstrual like cramps; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (menstrual like cramps) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (menstrual like cramps). At the time of the report, MUSCLE SPASMS (menstrual like cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: is there any long term affects reported like joint pain; 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 ARTHRALGIA (is there any long term affects reported like joint pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 ARTHRALGIA (is there any long term affects reported like joint pain). At the time of the report, ARTHRALGIA (is there any long term affects reported like joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and Treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: foot swollen; foot painful; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (foot swollen) and PAIN IN EXTREMITY (foot painful) 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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PERIPHERAL SWELLING (foot swollen) and PAIN IN EXTREMITY (foot painful). At the time of the report, PERIPHERAL SWELLING (foot swollen) and PAIN IN EXTREMITY (foot painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.   This case was linked to MOD-2021-194324 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Antibody test negative
Clinical narrative: tested for antibodies and had no antibodies; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (tested for antibodies and had no antibodies) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (tested for antibodies and had no antibodies). At the time of the report, ANTIBODY TEST NEGATIVE (tested for antibodies and had no antibodies) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Antibody test: had no antibodies (Negative) had no antibodies.         No concomitant medication was reported. The treatment information was unknown. Action taken with mRNA-1273 in response to the events were not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Lip discolouration
Clinical narrative: Lips are turning black after first dose; 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 DISCOLOURATION (Lips are turning black after first dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP DISCOLOURATION (Lips are turning black after first dose). At the time of the report, LIP DISCOLOURATION (Lips are turning black after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  No treatment information provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Vaccination site reaction, Vaginal haemorrhage
Clinical narrative: Localized reaction of right arm at injection site; Spotting and patient states she is not due for menstrual period for another 2 weeks; Fatigue; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Localized reaction of right arm at injection site), VAGINAL HAEMORRHAGE (Spotting and patient states she is not due for menstrual period for another 2 weeks), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 024C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced VACCINATION SITE REACTION (Localized reaction of right arm at injection site), VAGINAL HAEMORRHAGE (Spotting and patient states she is not due for menstrual period for another 2 weeks), FATIGUE (Fatigue) and PYREXIA (Fever). On an unknown date, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 25-May-2021, VACCINATION SITE REACTION (Localized reaction of right arm at injection site), FATIGUE (Fatigue) and PYREXIA (Fever) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (Spotting and patient states she is not due for menstrual period for another 2 weeks) and CHILLS (Chills) had resolved.            Birth control pills were reported as concomitant medication.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Outcome of events provided.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Rhinorrhoea
Clinical narrative: Runny nose after his second dose of the Moderna vaccine; Wasn't feeling well after his second dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose after his second dose of the Moderna vaccine) and MALAISE (Wasn't feeling well after his second dose of the Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose after his second dose of the Moderna vaccine) and MALAISE (Wasn't feeling well after his second dose of the Moderna vaccine). At the time of the report, RHINORRHOEA (Runny nose after his second dose of the Moderna vaccine) and MALAISE (Wasn't feeling well after his second dose of the Moderna vaccine) outcome was unknown.            No concomitant medication was reported.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: No new information was added
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site haemorrhage, Vaccination site rash, Vaccination site warmth
Clinical narrative: heat at the injection site; redness at the injection site; fever; red spot at the injection site; bleeding at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (heat at the injection site), VACCINATION SITE HAEMORRHAGE (bleeding at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), PYREXIA (fever) and VACCINATION SITE RASH (red spot at the injection site) 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) (Intramuscular) 1 dosage form. On 31-May-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (bleeding at the injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (heat at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), PYREXIA (fever) and VACCINATION SITE RASH (red spot at the injection site). At the time of the report, VACCINATION SITE WARMTH (heat at the injection site), VACCINATION SITE HAEMORRHAGE (bleeding at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), PYREXIA (fever) and VACCINATION SITE RASH (red spot at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Myalgia
Clinical narrative: inflammation; muscle pain; joints pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation), MYALGIA (muscle pain) and ARTHRALGIA (joints pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (inflammation), MYALGIA (muscle pain) and ARTHRALGIA (joints pain). At the time of the report, INFLAMMATION (inflammation), MYALGIA (muscle pain) and ARTHRALGIA (joints pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient  proceed with second dose tomorrow or wait until side effects of the first dose are completely gone?   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Cardiac discomfort, Discomfort, Palpitations, Paraesthesia
Clinical narrative: I had a scary thing happen with my heart; subsequently the rest of my body; My heart suddenly started pounding and racing; face was tingling and  hands were tingling; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISCOMFORT (I had a scary thing happen with my heart), DISCOMFORT (subsequently the rest of my body), PALPITATIONS (My heart suddenly started pounding and racing) and PARAESTHESIA (face was tingling and  hands were tingling) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced CARDIAC DISCOMFORT (I had a scary thing happen with my heart), DISCOMFORT (subsequently the rest of my body), PALPITATIONS (My heart suddenly started pounding and racing) and PARAESTHESIA (face was tingling and  hands were tingling). At the time of the report, CARDIAC DISCOMFORT (I had a scary thing happen with my heart), DISCOMFORT (subsequently the rest of my body), PALPITATIONS (My heart suddenly started pounding and racing) and PARAESTHESIA (face was tingling and  hands were tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  No treatment medication was provided
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Headache, Inflammation, Vertigo
Clinical narrative: Inflammation; Dizziness; Vertigo; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation), DIZZINESS (Dizziness), VERTIGO (Vertigo) and HEADACHE (Severe headache) 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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-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 VERTIGO (Vertigo) and HEADACHE (Severe headache). On an unknown date, the patient experienced INFLAMMATION (Inflammation) and DIZZINESS (Dizziness). At the time of the report, INFLAMMATION (Inflammation), DIZZINESS (Dizziness), VERTIGO (Vertigo) and HEADACHE (Severe headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Test performed for gout and everything was normal.         Action taken with mRNA-1273 in response to the events was not applicable.  No treatment medications were provided.  No concomitant medications information was reported.   This case was linked to MOD-2021-194267 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: 4 patients administered vaccine from 2 vials past beyond use date; 4 patients involved in vaccine administration error/deviation./1 patient was administered vaccine today from the other vial used past 30 days in refrigeration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients administered vaccine from 2 vials past beyond use date) and PRODUCT ADMINISTRATION ERROR (4 patients involved in vaccine administration error/deviation./1 patient was administered vaccine today from the other vial used past 30 days in refrigeration) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients administered vaccine from 2 vials past beyond use date) and PRODUCT ADMINISTRATION ERROR (4 patients involved in vaccine administration error/deviation./1 patient was administered vaccine today from the other vial used past 30 days in refrigeration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients administered vaccine from 2 vials past beyond use date) and PRODUCT ADMINISTRATION ERROR (4 patients involved in vaccine administration error/deviation./1 patient was administered vaccine today from the other vial used past 30 days in refrigeration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No laboratory data was provided.   No concomitant medications and treatment information was provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Joint pain in both knees/ knees hurt; Pain in his right hand; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain in both knees/ knees hurt) and PAIN IN EXTREMITY (Pain in his right hand) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21D) 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, the patient experienced ARTHRALGIA (Joint pain in both knees/ knees hurt) and PAIN IN EXTREMITY (Pain in his right hand). At the time of the report, ARTHRALGIA (Joint pain in both knees/ knees hurt) and PAIN IN EXTREMITY (Pain in his right hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was provided by the reporter.  No Treatment medications was provided by the reporter.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Mass, Myalgia
Clinical narrative: My arm felt heavy - Tender arm; Body aches - Tender arm; A painful lump above the collar bone; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (My arm felt heavy - Tender arm), MASS (A painful lump above the collar bone) and MYALGIA (Body aches - Tender arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 18-May-2021, the patient experienced MASS (A painful lump above the collar bone). On an unknown date, the patient experienced LIMB DISCOMFORT (My arm felt heavy - Tender arm) and MYALGIA (Body aches - Tender arm). The patient was treated with IBUPROFEN (MOTRIN IB) for Pain, at a dose of 1 dosage form as necessary. At the time of the report, LIMB DISCOMFORT (My arm felt heavy - Tender arm), MASS (A painful lump above the collar bone) and MYALGIA (Body aches - Tender arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) was unknown.       No concomitant medications provided
Sex: F
Vaccine: COVID19, UNK
Symptoms: Feeding disorder, Vaccination complication
Clinical narrative: hasn't been feeling feel; haven't been able to eat much other than liquids and Jello; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (hasn't been feeling feel) and FEEDING DISORDER (haven't been able to eat much other than liquids and Jello) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TUCATINIB (TUKYSA) for Malignant neoplasm of lower-outer quadrant of female breast.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and TUCATINIB (TUKYSA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (hasn't been feeling feel) and FEEDING DISORDER (haven't been able to eat much other than liquids and Jello). At the time of the report, VACCINATION COMPLICATION (hasn't been feeling feel) and FEEDING DISORDER (haven't been able to eat much other than liquids and Jello) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided  Action taken with mRNA1273 Moderna vaccine was Not Applicable
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Vaccination site swelling
Clinical narrative: Bruised; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruised) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced CONTUSION (Bruised) and VACCINATION SITE SWELLING (Vaccination site swelling). On 02-May-2021, CONTUSION (Bruised) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment include hydrocortisone cream.   This case was linked to MOD-2021-194420 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Clotting factor transfusion, Contusion, Platelet count, White blood cell count
Clinical narrative: she is reluctant to get second dose as she is afraid that she might have bleeding or bruising after vaccination; bruising on the opposite arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising on the opposite arm of injection) and ANXIETY (she is reluctant to get second dose as she is afraid that she might have bleeding or bruising after vaccination) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic reaction (She has experienced a severe anaphylactic reaction in the past to ASA.). Concomitant products included MULTIVITAMINS [VITAMINS NOS] and CALCIUM CARBONATE (TUMS 500 CALCIUM) for an unknown indication.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced CONTUSION (bruising on the opposite arm of injection). On 17-Jun-2021, the patient experienced ANXIETY (she is reluctant to get second dose as she is afraid that she might have bleeding or bruising after vaccination). At the time of the report, CONTUSION (bruising on the opposite arm of injection) and ANXIETY (she is reluctant to get second dose as she is afraid that she might have bleeding or bruising after vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, White blood cell count: increase (High) WBC Increase. On an unknown date, Clotting factor transfusion: normal (normal) Normal. On an unknown date, Platelet count: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were used.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Added new lab tests clotting factors and platelet counts. Added new event anxiety.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Rash, Vaccination complication
Clinical narrative: Intermittent side effects/all side effects; Spells,Close to dizziness; Very uncomfortable/very unpleasant; Rash across back; Cold chills across chest; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Intermittent side effects/all side effects), DIZZINESS (Spells,Close to dizziness), FEELING ABNORMAL (Very uncomfortable/very unpleasant), RASH (Rash across back) and CHILLS (Cold chills across chest) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012l20a) for COVID-19 vaccination.     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. On an unknown date, the patient experienced VACCINATION COMPLICATION (Intermittent side effects/all side effects), DIZZINESS (Spells,Close to dizziness), FEELING ABNORMAL (Very uncomfortable/very unpleasant), RASH (Rash across back) and CHILLS (Cold chills across chest). At the time of the report, VACCINATION COMPLICATION (Intermittent side effects/all side effects), DIZZINESS (Spells,Close to dizziness), FEELING ABNORMAL (Very uncomfortable/very unpleasant), RASH (Rash across back) and CHILLS (Cold chills across chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Medical history was not provided. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown. Treatment medication information was not provided. Concomitant medication information was not provided. Reporter did not allow further contact.