chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Limb discomfort, Vaccination site pain, Vaccination site swelling
Clinical narrative: she feels tight and heavy; Pain at the injection site; Swelling at the injection site; Patient reported that since receiving the injection she feels tight and heavy; Having hard time walking; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Patient reported that since receiving the injection she feels tight and heavy), GAIT DISTURBANCE (Having hard time walking), FEELING ABNORMAL (she feels tight and heavy), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-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 04-Mar-2021, the patient experienced LIMB DISCOMFORT (Patient reported that since receiving the injection she feels tight and heavy), GAIT DISTURBANCE (Having hard time walking), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site). On an unknown date, the patient experienced FEELING ABNORMAL (she feels tight and heavy). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, LIMB DISCOMFORT (Patient reported that since receiving the injection she feels tight and heavy), GAIT DISTURBANCE (Having hard time walking), FEELING ABNORMAL (she feels tight and heavy), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No treatment medications were reported
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Feeling abnormal, Nausea
Clinical narrative: feeling worse; Fever of 100.5F; Chills; Nausea; Dizzy; Achy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PAIN (Achy), FEELING ABNORMAL (feeling worse), CHILLS (Chills) and NAUSEA (Nausea) 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.     The patient's past medical history included covid-19 in September 2020. Concurrent medical conditions included Rheumatoid arthritis.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Dizzy), PAIN (Achy), CHILLS (Chills) and NAUSEA (Nausea). On 04-Mar-2021, the patient experienced FEELING ABNORMAL (feeling worse) and PYREXIA (Fever of 100.5F). At the time of the report, DIZZINESS (Dizzy), PAIN (Achy), FEELING ABNORMAL (feeling worse), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever of 100.5F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 100.5 (High) 100.5F.     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.   treatment include Tylenol and Advil No concomitant medication reported by the reporter
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: feeling worse; Fever of 100.5F; Chills; Nausea; Dizzy; Achy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PAIN (Achy), FEELING ABNORMAL (feeling worse), CHILLS (Chills) and NAUSEA (Nausea) 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.     The patient's past medical history included covid-19 in September 2020. Concurrent medical conditions included Rheumatoid arthritis.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Dizzy), PAIN (Achy), CHILLS (Chills) and NAUSEA (Nausea). On 04-Mar-2021, the patient experienced FEELING ABNORMAL (feeling worse) and PYREXIA (Fever of 100.5F). At the time of the report, DIZZINESS (Dizzy), PAIN (Achy), FEELING ABNORMAL (feeling worse), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever of 100.5F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 100.5 (High) 100.5F.     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.   treatment include Tylenol and Advil No concomitant medication reported by the reporter
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, SARS-CoV-2 test
Clinical narrative: COVID-19; Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) and COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028LL208) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced COUGH (Cough). On 03-Mar-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COUGH (Cough) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided. No concomitant medication were provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site / it was minimal; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site / it was minimal) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site / it was minimal). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site / it was minimal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Paraesthesia oral
Clinical narrative: Tingling around the mouth; Swollen around the injection site; A spontaneous report was received from a consumer concerning a 67-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tingling around the mouth, swollen around the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 014ML0A) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced the event(s) tingling around the mouth, swollen around the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), tingling around the mouth, swollen around the injection site was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is taking antenatal vitamin. No concomitant medications reported by reporter. Treatment medication not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Hypoaesthesia, Paraesthesia
Clinical narrative: fingers numb; heaviness in chest for 30 minutes; Tingling sensation in fingers; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (fingers numb), CHEST DISCOMFORT (heaviness in chest for 30 minutes) and PARAESTHESIA (Tingling sensation in fingers) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HYPOAESTHESIA (fingers numb), CHEST DISCOMFORT (heaviness in chest for 30 minutes) and PARAESTHESIA (Tingling sensation in fingers). On 04-Mar-2021, CHEST DISCOMFORT (heaviness in chest for 30 minutes) had resolved. At the time of the report, HYPOAESTHESIA (fingers numb) and PARAESTHESIA (Tingling sensation in fingers) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 160/101 mmHg (High) 160/101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Night sweats, Pain in extremity
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (arm pain), NIGHT SWEATS (night sweat), PYREXIA (Temperature of 103 for 2 days and then 101F), CHILLS (chills) and MYALGIA (severe muscle aches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 15-Feb-2021, the patient experienced NIGHT SWEATS (night sweat), PYREXIA (Temperature of 103 for 2 days and then 101F), CHILLS (chills) and MYALGIA (severe muscle aches). The patient was treated with IBUPROFEN for Pain in arm, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 14-Feb-2021, PAIN IN EXTREMITY (arm pain) had resolved. On 17-Feb-2021, PYREXIA (Temperature of 103 for 2 days and then 101F) had resolved. On 20-Feb-2021, NIGHT SWEATS (night sweat), CHILLS (chills) and MYALGIA (severe muscle aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: 103 (High) 103 F for 2 days.. On 17-Feb-2021, Body temperature: 101 (High) got it down to 101..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medication includes Tylenol and ibuprofen .
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (arm pain), NIGHT SWEATS (night sweat), PYREXIA (Temperature of 103 for 2 days and then 101F), CHILLS (chills) and MYALGIA (severe muscle aches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 15-Feb-2021, the patient experienced NIGHT SWEATS (night sweat), PYREXIA (Temperature of 103 for 2 days and then 101F), CHILLS (chills) and MYALGIA (severe muscle aches). The patient was treated with IBUPROFEN for Pain in arm, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 14-Feb-2021, PAIN IN EXTREMITY (arm pain) had resolved. On 17-Feb-2021, PYREXIA (Temperature of 103 for 2 days and then 101F) had resolved. On 20-Feb-2021, NIGHT SWEATS (night sweat), CHILLS (chills) and MYALGIA (severe muscle aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: 103 (High) 103 F for 2 days.. On 17-Feb-2021, Body temperature: 101 (High) got it down to 101..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medication includes Tylenol and ibuprofen .
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on upper back and lower leg; A spontaneous report was received from a consumer concerning a 57-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash on upper back and lower leg/rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) rash on upper back and lower leg.  Treatment details included Patient received high doses of antihistamines .  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash on upper back and lower leg was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site swelling, Injection site warmth
Clinical narrative: Warmth at injection site; Swelling at injection site; Discomfort at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOMFORT (Discomfort at injection site), INJECTION SITE WARMTH (Warmth at injection site) and INJECTION SITE SWELLING (Swelling at injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included METFORMIN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced INJECTION SITE DISCOMFORT (Discomfort at injection site) and INJECTION SITE SWELLING (Swelling at injection site). On 22-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warmth at injection site). At the time of the report, INJECTION SITE DISCOMFORT (Discomfort at injection site), INJECTION SITE WARMTH (Warmth at injection site) and INJECTION SITE SWELLING (Swelling at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Developed COVID several days after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Developed COVID several days after the first shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Developed COVID several days after the first shot). At the time of the report, SARS-COV-2 TEST POSITIVE (Developed COVID several days after the first shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: unk (Positive) Patient received first dose of the Moderna COVID-19 vaccine and tested positive for SARS-CoV-2 infection several days later..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. No treatment medication was reported.   Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First shot was on 14Jan2021,supposed to get second on 11Feb2021, still haven't received second shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First shot was on 14Jan2021,supposed to get second on 11Feb2021, still haven't received second shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First shot was on 14Jan2021,supposed to get second on 11Feb2021, still haven't received second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First shot was on 14Jan2021,supposed to get second on 11Feb2021, still haven't received second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.; Sender's Comments: This report refers to a case of a 70-year-old male patient who experienced Product Dose Omission Issue for mRNA-1273 with no associated AEs
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 67-year-old female patient 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 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 medications were reported. No treatment medication was reported.   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) had not resolved.            No concomitant medications were reported.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The patient experienced the event headache for three days and it subsided for a while. Three weeks later, she experienced headache daily. She never had headaches before vaccination.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph Knot (Under Armpit); This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph Knot (Under Armpit)) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced LYMPHADENOPATHY (Lymph Knot (Under Armpit)). At the time of the report, LYMPHADENOPATHY (Lymph Knot (Under Armpit)) outcome was unknown.            No concomitant medications were reported. No treatment medication was reported.  Patient gave his consent for safety to Follow-up.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DYSGEUSIA (Metallic taste). At the time of the report, DYSGEUSIA (Metallic taste) outcome was unknown.            No concomitant medications were reported. No treatment medication was reported.  Patient gave consent to be followed up by safety.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itching) 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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itching). At the time of the report, VACCINATION SITE PRURITUS (Injection site itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: patient can't get his second dose yet, received first dose 6 weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient can't get his second dose yet, received first dose 6 weeks ago) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for an unknown indication.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient can't get his second dose yet, received first dose 6 weeks ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient can't get his second dose yet, received first dose 6 weeks ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication was reported.  Patient gave his consent for safety to Follow-up
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Dyspnoea, Thinking abnormal
Clinical narrative: difficulty breathing for about 2 minutes; couldn't function; couldn´t think straight; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing for about 2 minutes), ABNORMAL BEHAVIOUR (couldn't function) and THINKING ABNORMAL (couldn´t think straight) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0BA21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DYSPNOEA (difficulty breathing for about 2 minutes), ABNORMAL BEHAVIOUR (couldn't function) and THINKING ABNORMAL (couldn´t think straight). At the time of the report, DYSPNOEA (difficulty breathing for about 2 minutes), ABNORMAL BEHAVIOUR (couldn't function) and THINKING ABNORMAL (couldn´t think straight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received contains non-significant information of reporter details.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Headache; Slight fever/ low grade fever; Nausea/ nauseated; Tiredness/ so tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Slight fever/ low grade fever), NAUSEA (Nausea/ nauseated) and FATIGUE (Tiredness/ so tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FAMOTIDINE, ESZOPICLONE (LUNESTA), IBUPROFEN and REPAGLINIDE (PRANDIN [REPAGLINIDE]) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HEADACHE (Headache), PYREXIA (Slight fever/ low grade fever), NAUSEA (Nausea/ nauseated) and FATIGUE (Tiredness/ so tired). At the time of the report, HEADACHE (Headache), PYREXIA (Slight fever/ low grade fever), NAUSEA (Nausea/ nauseated) and FATIGUE (Tiredness/ so tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow-up received on 30-APR-2021 included: Patient declined further follow-up.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Vaccine Start date updated.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: He got 1ml dose instead of 0.5ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (He got 1ml dose instead of 0.5ml) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LORAZEPAM (ATIVAN) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (He got 1ml dose instead of 0.5ml). At the time of the report, ACCIDENTAL OVERDOSE (He got 1ml dose instead of 0.5ml) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported.  Patient gave consent for safety to Follow-up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: Mild itchiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Mild itchiness at injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history 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, the patient experienced INJECTION SITE PRURITUS (Mild itchiness at injection site). At the time of the report, INJECTION SITE PRURITUS (Mild itchiness at injection site) outcome was unknown.            No concomitant medications were provided. No treatment medication was provided.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Myalgia, Pyrexia
Clinical narrative: felt weak; fever; muscle aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak), PYREXIA (fever), MYALGIA (muscle aches) and CHILLS (Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced ASTHENIA (felt weak), PYREXIA (fever), MYALGIA (muscle aches) and CHILLS (Chills). On 04-Mar-2021, ASTHENIA (felt weak), PYREXIA (fever), MYALGIA (muscle aches) and CHILLS (Chills) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.   This case was linked to MOD21-045015 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Pain in extremity
Clinical narrative: lightheaded/dizzy; has ache in the right arm; loss in appetite; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheaded/dizzy), PAIN IN EXTREMITY (has ache in the right arm) and DECREASED APPETITE (loss in appetite) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Vertigo.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (lightheaded/dizzy), PAIN IN EXTREMITY (has ache in the right arm) and DECREASED APPETITE (loss in appetite). At the time of the report, DIZZINESS (lightheaded/dizzy), PAIN IN EXTREMITY (has ache in the right arm) and DECREASED APPETITE (loss in appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: She doesn't have an email address. She stated she is fine now and had both shots.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye irritation, Fatigue, Nasopharyngitis, Ocular hyperaemia
Clinical narrative: Cold; Bloody shot eye; Burning sensation underneath her eyes; General body pain; Jaw ache; Chills; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), OCULAR HYPERAEMIA (Bloody shot eye), EYE IRRITATION (Burning sensation underneath her eyes), PAIN (General body pain) and PAIN IN JAW (Jaw ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-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 NASOPHARYNGITIS (Cold), OCULAR HYPERAEMIA (Bloody shot eye), EYE IRRITATION (Burning sensation underneath her eyes), PAIN (General body pain), PAIN IN JAW (Jaw ache), CHILLS (Chills) and FATIGUE (Exhausted). At the time of the report, NASOPHARYNGITIS (Cold), OCULAR HYPERAEMIA (Bloody shot eye), EYE IRRITATION (Burning sensation underneath her eyes), PAIN (General body pain), PAIN IN JAW (Jaw ache), CHILLS (Chills) and FATIGUE (Exhausted) outcome was unknown.            Treatment Medications and Concomitant Medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-JUNE-2021 and does not contain any new information
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in jaw
Clinical narrative: Cold; Bloody shot eye; Burning sensation underneath her eyes; General body pain; Jaw ache; Chills; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), OCULAR HYPERAEMIA (Bloody shot eye), EYE IRRITATION (Burning sensation underneath her eyes), PAIN (General body pain) and PAIN IN JAW (Jaw ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-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 NASOPHARYNGITIS (Cold), OCULAR HYPERAEMIA (Bloody shot eye), EYE IRRITATION (Burning sensation underneath her eyes), PAIN (General body pain), PAIN IN JAW (Jaw ache), CHILLS (Chills) and FATIGUE (Exhausted). At the time of the report, NASOPHARYNGITIS (Cold), OCULAR HYPERAEMIA (Bloody shot eye), EYE IRRITATION (Burning sensation underneath her eyes), PAIN (General body pain), PAIN IN JAW (Jaw ache), CHILLS (Chills) and FATIGUE (Exhausted) outcome was unknown.            Treatment Medications and Concomitant Medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-JUNE-2021 and does not contain any new information
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) in a 22-year-old female patient 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 PAIN IN EXTREMITY (pain in the arm). At the time of the report, PAIN IN EXTREMITY (pain in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported.  No treatment medications were provided
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site erythema, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: hive like apperance/circumference is 3 and a quarter inches; itchy; redness; swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE URTICARIA (hive like apperance/circumference is 3 and a quarter inches), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (redness) and SWELLING (swelling) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Aortic valve replacement in 2020. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), RAMIPRIL, GABAPENTIN, LEVOTHYROXINE, VITAMIN D NOS and BIFIDOBACTERIUM INFANTIS (ALIGN) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (hive like apperance/circumference is 3 and a quarter inches), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (redness) and SWELLING (swelling). At the time of the report, VACCINATION SITE URTICARIA (hive like apperance/circumference is 3 and a quarter inches), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (redness) and SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included unspecified allergy shots taken once a week.   Treatment included loratadine and topical diphenhydramine.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Headache, SARS-CoV-2 test
Clinical narrative: Headache; Loss Of Taste; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache) and AGEUSIA (Loss Of Taste) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced HEADACHE (Headache) and AGEUSIA (Loss Of Taste). At the time of the report, HEADACHE (Headache) and AGEUSIA (Loss Of Taste) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Headache, Pain in extremity
Clinical narrative: just a sore arm; headache; Was not bothered much; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (just a sore arm), HEADACHE (headache) and ADVERSE EVENT (Was not bothered much) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Headache.    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 PAIN IN EXTREMITY (just a sore arm), HEADACHE (headache) and ADVERSE EVENT (Was not bothered much). At the time of the report, PAIN IN EXTREMITY (just a sore arm), HEADACHE (headache) and ADVERSE EVENT (Was not bothered much) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: No specific follow-up information recorded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Ear pain, Myalgia, Pyrexia
Clinical narrative: ear pain above my ear on my head/ear pain; ear infection in both ears but left is worse; fever of 101.2; body aches; This spontaneous case was reported by a nurse and describes the occurrence of EAR PAIN (ear pain above my ear on my head/ear pain), EAR INFECTION (ear infection in both ears but left is worse), PYREXIA (fever of 101.2) and MYALGIA (body aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant concomitant medications reported No relevant medical history was reported.    On 04-Jan-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. On 05-Feb-2021, the patient experienced PYREXIA (fever of 101.2) and MYALGIA (body aches). On 07-Feb-2021, the patient experienced EAR PAIN (ear pain above my ear on my head/ear pain). 07-Feb-2021, the patient experienced EAR INFECTION (ear infection in both ears but left is worse). On 06-Feb-2021, PYREXIA (fever of 101.2) and MYALGIA (body aches) had resolved. At the time of the report, EAR PAIN (ear pain above my ear on my head/ear pain) and EAR INFECTION (ear infection in both ears but left is worse) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   She states that the infection is in both ears but the left ear is worse. She has had to go through 3 rounds of antibiotics which have not helped heal the infection so far. She is currently on the 3rd round of antibiotics. Her HCP has also referred her to an ENT for further guidance.  Treatment medication she took included Amoxicillin, Omnicef
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Erythema, Hyperkeratosis, Hypoaesthesia, Limb discomfort
Clinical narrative: Her right foot is still hard, it goes numb; Her right foot is still hard, it goes numb; Feels like it weights a hundred pounds; foot still hurts; Couldn't move the right Hip and below; Itchiness; Red patches; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERKERATOSIS (Her right foot is still hard, it goes numb), HYPOAESTHESIA (Her right foot is still hard, it goes numb), LIMB DISCOMFORT (Feels like it weights a hundred pounds), PAIN IN EXTREMITY (Arm pain) and PRURITUS (Itchiness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroiditis. Concomitant products included AMLODIPINE, ATORVASTATIN, VITAMINS NOS, OXYBUTYNIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and OMEPRAZOLE for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). On 16-Feb-2021, the patient experienced PRURITUS (Itchiness) and ERYTHEMA (Red patches). On 18-Feb-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Couldn't move the right Hip and below). In March 2021, the patient experienced HYPERKERATOSIS (Her right foot is still hard, it goes numb), HYPOAESTHESIA (Her right foot is still hard, it goes numb), LIMB DISCOMFORT (Feels like it weights a hundred pounds) and PAIN IN EXTREMITY (foot still hurts). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, HYPERKERATOSIS (Her right foot is still hard, it goes numb), HYPOAESTHESIA (Her right foot is still hard, it goes numb) and LIMB DISCOMFORT (Feels like it weights a hundred pounds) outcome was unknown, PAIN IN EXTREMITY (Arm pain), PRURITUS (Itchiness), ERYTHEMA (Red patches) and MUSCULOSKELETAL DISCOMFORT (Couldn't move the right Hip and below) was resolving and PAIN IN EXTREMITY (foot still hurts) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Computerised tomogram: (normal) Normal. In March 2021, Computerised tomogram: (normal) CT scan was clear..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included an unspecified thyroid medication. Treatment for the events included topical cream and unknown pills.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2021: New event right foot is still hard, it goes numb and feels like it weights a hundred pounds were reported. New lab test CT scan was reported. On 09-Jul-2021: Event added.