chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Body temperature, Headache, Memory impairment, Pyrexia
Clinical narrative: Was feeling really bad; Was doing stuff and forget about what he was doing/Went to work and was gapping up; went to work and was gapping up; Localized pain where the shot was; Fever of 100°F; Headache and when walks around has a ponding feeling on the head; head ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Was feeling really bad), MEMORY IMPAIRMENT (Was doing stuff and forget about what he was doing/Went to work and was gapping up), ABNORMAL BEHAVIOUR (went to work and was gapping up), VACCINATION SITE PAIN (Localized pain where the shot was) and PYREXIA (Fever of 100°F) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Available) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Was feeling really bad), MEMORY IMPAIRMENT (Was doing stuff and forget about what he was doing/Went to work and was gapping up), ABNORMAL BEHAVIOUR (went to work and was gapping up), VACCINATION SITE PAIN (Localized pain where the shot was), PYREXIA (Fever of 100°F), HEADACHE (Headache and when walks around has a ponding feeling on the head) and HEADACHE (head ache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Was feeling really bad), MEMORY IMPAIRMENT (Was doing stuff and forget about what he was doing/Went to work and was gapping up), ABNORMAL BEHAVIOUR (went to work and was gapping up), VACCINATION SITE PAIN (Localized pain where the shot was), PYREXIA (Fever of 100°F), HEADACHE (Headache and when walks around has a ponding feeling on the head) and HEADACHE (head ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Body temperature: 100 (Inconclusive) 100 degree Fahrenheit.         No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pain
Clinical narrative: Was feeling really bad; Was doing stuff and forget about what he was doing/Went to work and was gapping up; went to work and was gapping up; Localized pain where the shot was; Fever of 100°F; Headache and when walks around has a ponding feeling on the head; head ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Was feeling really bad), MEMORY IMPAIRMENT (Was doing stuff and forget about what he was doing/Went to work and was gapping up), ABNORMAL BEHAVIOUR (went to work and was gapping up), VACCINATION SITE PAIN (Localized pain where the shot was) and PYREXIA (Fever of 100°F) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Available) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Was feeling really bad), MEMORY IMPAIRMENT (Was doing stuff and forget about what he was doing/Went to work and was gapping up), ABNORMAL BEHAVIOUR (went to work and was gapping up), VACCINATION SITE PAIN (Localized pain where the shot was), PYREXIA (Fever of 100°F), HEADACHE (Headache and when walks around has a ponding feeling on the head) and HEADACHE (head ache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Was feeling really bad), MEMORY IMPAIRMENT (Was doing stuff and forget about what he was doing/Went to work and was gapping up), ABNORMAL BEHAVIOUR (went to work and was gapping up), VACCINATION SITE PAIN (Localized pain where the shot was), PYREXIA (Fever of 100°F), HEADACHE (Headache and when walks around has a ponding feeling on the head) and HEADACHE (head ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Body temperature: 100 (Inconclusive) 100 degree Fahrenheit.         No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; 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 PYREXIA (Fever) 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 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.            No concomitant medication reported. No treatment information reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever of 100.2F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 100.2F) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     no medical history was reported.     On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PYREXIA (fever of 100.2F). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PYREXIA (fever of 100.2F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (Inconclusive) Unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication were reported
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (no appetite), FEELING ABNORMAL ("felt terrible like I been hit by a bus"), DIARRHEA (diarrhea.), FEELING ABNORMAL (feels loopy/off) and FATIGUE (extreme fatigue) in a 38-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. No medical history was provided by the reporter. Concomitant products included OMEPRAZOLE for an unknown indication. On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced DECREASED APPETITE (no appetite), DIARRHEA (diarrhea.), FATIGUE (extreme fatigue), PYREXIA (8 am temperature of 100), MYALGIA (ache all over head to toe), CHILLS (chills), VACCINATION SITE PAIN (left arm pain no longer excruciating but pain is still there) and HEADACHE (excruciating headache). On 21-May-2021, the patient experienced FEELING ABNORMAL (feels loopy/off). On an unknown date, the patient experienced FEELING ABNORMAL ("felt terrible like I been hit by a bus"). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 21-May-2021, DECREASED APPETITE (no appetite), DIARRHOEA (diarrhea.), FATIGUE (extreme fatigue), PYREXIA (8 am temperature of 100), MYALGIA (ache all over head to toe), CHILLS (chills), VACCINATION SITE PAIN (left arm pain no longer excruciating but pain is still there) and HEADACHE (excruciating headache) had resolved. At the time of the report, FEELING ABNORMAL ("felt terrible like I been hit by a bus") had resolved and FEELING ABNORMAL (feels loopy/off) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Other Concomitant medication include unspecified birth control and a store brand allergy pill. Other Treatment include fluids throughout the day and a store brand sleeping tablet at night.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (no appetite), FEELING ABNORMAL ("felt terrible like I been hit by a bus"), DIARRHEA (diarrhea.), FEELING ABNORMAL (feels loopy/off) and FATIGUE (extreme fatigue) in a 38-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. No medical history was provided by the reporter. Concomitant products included OMEPRAZOLE for an unknown indication. On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced DECREASED APPETITE (no appetite), DIARRHEA (diarrhea.), FATIGUE (extreme fatigue), PYREXIA (8 am temperature of 100), MYALGIA (ache all over head to toe), CHILLS (chills), VACCINATION SITE PAIN (left arm pain no longer excruciating but pain is still there) and HEADACHE (excruciating headache). On 21-May-2021, the patient experienced FEELING ABNORMAL (feels loopy/off). On an unknown date, the patient experienced FEELING ABNORMAL ("felt terrible like I been hit by a bus"). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 21-May-2021, DECREASED APPETITE (no appetite), DIARRHOEA (diarrhea.), FATIGUE (extreme fatigue), PYREXIA (8 am temperature of 100), MYALGIA (ache all over head to toe), CHILLS (chills), VACCINATION SITE PAIN (left arm pain no longer excruciating but pain is still there) and HEADACHE (excruciating headache) had resolved. At the time of the report, FEELING ABNORMAL ("felt terrible like I been hit by a bus") had resolved and FEELING ABNORMAL (feels loopy/off) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Other Concomitant medication include unspecified birth control and a store brand allergy pill. Other Treatment include fluids throughout the day and a store brand sleeping tablet at night.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Muscle spasms
Clinical narrative: Tightness in left leg after 2nd dose; Muscle spasms in both calves after 2nd dose/ Spasms mostly in left calf after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Tightness in left leg after 2nd dose) and MUSCLE SPASMS (Muscle spasms in both calves after 2nd dose/ Spasms mostly in left calf after 2nd dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022c21a and 036b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-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 LIMB DISCOMFORT (Tightness in left leg after 2nd dose) and MUSCLE SPASMS (Muscle spasms in both calves after 2nd dose/ Spasms mostly in left calf after 2nd dose). At the time of the report, LIMB DISCOMFORT (Tightness in left leg after 2nd dose) and MUSCLE SPASMS (Muscle spasms in both calves after 2nd dose/ Spasms mostly in left calf after 2nd dose) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Movement disorder, Vaccination site pain
Clinical narrative: i cant even lift that arm,hurt; i cant even lift that arm; 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 PAIN IN EXTREMITY (i cant even lift that arm,hurt) and MOVEMENT DISORDER (i cant even lift that arm) 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 PAIN IN EXTREMITY (i cant even lift that arm,hurt) and MOVEMENT DISORDER (i cant even lift that arm). At the time of the report, PAIN IN EXTREMITY (i cant even lift that arm,hurt) and MOVEMENT DISORDER (i cant even lift that arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications reported. No treatment medication reported.  Patient submitted AE and stated that he was told to come back in if his arm continued to hurt after 24 hours. He stated that it's almost that time, and he can't even lift that arm.   Reporter did not allow further contact
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: broke out into itchy welts from her neck to her stomach, They moved to her lower abdomen, eyes, legs, and a couple places in the back of her neck and arms; states her rash has lessened but certain areas will still pop up and itch profusely, rash has started to go away but has moved to different sides.; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (broke out into itchy welts from her neck to her stomach, They moved to her lower abdomen, eyes, legs, and a couple places in the back of her neck and arms) and RASH PRURITIC (states her rash has lessened but certain areas will still pop up and itch profusely, rash has started to go away but has moved to different sides.) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced URTICARIA (broke out into itchy welts from her neck to her stomach, They moved to her lower abdomen, eyes, legs, and a couple places in the back of her neck and arms) and RASH PRURITIC (states her rash has lessened but certain areas will still pop up and itch profusely, rash has started to go away but has moved to different sides.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (broke out into itchy welts from her neck to her stomach, They moved to her lower abdomen, eyes, legs, and a couple places in the back of her neck and arms) and RASH PRURITIC (states her rash has lessened but certain areas will still pop up and itch profusely, rash has started to go away but has moved to different sides.) 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.   Other Treatment includes Steroid shot and alcohol spray for an unknown indication. No relevant concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-161637, US-MODERNATX, INC.-MOD-2021-161637 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-161637: US-MODERNATX, INC.-MOD-2021-161637:
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: Terrible stomach problems after getting the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Terrible stomach problems after getting the Moderna Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced ABDOMINAL DISCOMFORT (Terrible stomach problems after getting the Moderna Covid-19 vaccine). At the time of the report, ABDOMINAL DISCOMFORT (Terrible stomach problems after getting the Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-012577 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-012577:Same reporter
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Feeling abnormal, Limb discomfort
Clinical narrative: Felt like burning my skin; Felt bad; Dry cough; Sore throat; I slept a lot; For about 30 years I didn't feel that bad; Body pain; Very tired; I still feel weird, one day I am ok other days feel down, and go bed; Tested positive for COVID; Fever; Arm pain; Arm was felling tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), LIMB DISCOMFORT (Arm was felling tired), SKIN BURNING SENSATION (Felt like burning my skin), FEELING ABNORMAL (Felt bad) and COUGH (Dry cough) in a 50-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.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and LIMB DISCOMFORT (Arm was felling tired). On 27-Apr-2021, the patient experienced PYREXIA (Fever). On 30-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID). On 21-May-2021, the patient experienced VACCINATION COMPLICATION (I still feel weird, one day I am ok other days feel down, and go bed). On an unknown date, the patient experienced SKIN BURNING SENSATION (Felt like burning my skin), FEELING ABNORMAL (Felt bad), COUGH (Dry cough), OROPHARYNGEAL PAIN (Sore throat), SOMNOLENCE (I slept a lot), FEELING ABNORMAL (For about 30 years I didn't feel that bad), MYALGIA (Body pain) and FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and KETOROLAC TROMETHAMINE (KETOROLAC ABC) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain), LIMB DISCOMFORT (Arm was felling tired), SKIN BURNING SENSATION (Felt like burning my skin), FEELING ABNORMAL (Felt bad), COUGH (Dry cough), OROPHARYNGEAL PAIN (Sore throat), SOMNOLENCE (I slept a lot), COVID-19 (Tested positive for COVID), FEELING ABNORMAL (For about 30 years I didn't feel that bad), VACCINATION COMPLICATION (I still feel weird, one day I am ok other days feel down, and go bed), PYREXIA (Fever), MYALGIA (Body pain) and FATIGUE (Very tired) 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.   No relevant concomitant medications were reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Pain in extremity, Pyrexia, Skin burning sensation
Clinical narrative: Felt like burning my skin; Felt bad; Dry cough; Sore throat; I slept a lot; For about 30 years I didn't feel that bad; Body pain; Very tired; I still feel weird, one day I am ok other days feel down, and go bed; Tested positive for COVID; Fever; Arm pain; Arm was felling tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), LIMB DISCOMFORT (Arm was felling tired), SKIN BURNING SENSATION (Felt like burning my skin), FEELING ABNORMAL (Felt bad) and COUGH (Dry cough) in a 50-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.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and LIMB DISCOMFORT (Arm was felling tired). On 27-Apr-2021, the patient experienced PYREXIA (Fever). On 30-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID). On 21-May-2021, the patient experienced VACCINATION COMPLICATION (I still feel weird, one day I am ok other days feel down, and go bed). On an unknown date, the patient experienced SKIN BURNING SENSATION (Felt like burning my skin), FEELING ABNORMAL (Felt bad), COUGH (Dry cough), OROPHARYNGEAL PAIN (Sore throat), SOMNOLENCE (I slept a lot), FEELING ABNORMAL (For about 30 years I didn't feel that bad), MYALGIA (Body pain) and FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and KETOROLAC TROMETHAMINE (KETOROLAC ABC) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain), LIMB DISCOMFORT (Arm was felling tired), SKIN BURNING SENSATION (Felt like burning my skin), FEELING ABNORMAL (Felt bad), COUGH (Dry cough), OROPHARYNGEAL PAIN (Sore throat), SOMNOLENCE (I slept a lot), COVID-19 (Tested positive for COVID), FEELING ABNORMAL (For about 30 years I didn't feel that bad), VACCINATION COMPLICATION (I still feel weird, one day I am ok other days feel down, and go bed), PYREXIA (Fever), MYALGIA (Body pain) and FATIGUE (Very tired) 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.   No relevant concomitant medications were reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination complication
Clinical narrative: Felt like burning my skin; Felt bad; Dry cough; Sore throat; I slept a lot; For about 30 years I didn't feel that bad; Body pain; Very tired; I still feel weird, one day I am ok other days feel down, and go bed; Tested positive for COVID; Fever; Arm pain; Arm was felling tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), LIMB DISCOMFORT (Arm was felling tired), SKIN BURNING SENSATION (Felt like burning my skin), FEELING ABNORMAL (Felt bad) and COUGH (Dry cough) in a 50-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.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and LIMB DISCOMFORT (Arm was felling tired). On 27-Apr-2021, the patient experienced PYREXIA (Fever). On 30-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID). On 21-May-2021, the patient experienced VACCINATION COMPLICATION (I still feel weird, one day I am ok other days feel down, and go bed). On an unknown date, the patient experienced SKIN BURNING SENSATION (Felt like burning my skin), FEELING ABNORMAL (Felt bad), COUGH (Dry cough), OROPHARYNGEAL PAIN (Sore throat), SOMNOLENCE (I slept a lot), FEELING ABNORMAL (For about 30 years I didn't feel that bad), MYALGIA (Body pain) and FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and KETOROLAC TROMETHAMINE (KETOROLAC ABC) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain), LIMB DISCOMFORT (Arm was felling tired), SKIN BURNING SENSATION (Felt like burning my skin), FEELING ABNORMAL (Felt bad), COUGH (Dry cough), OROPHARYNGEAL PAIN (Sore throat), SOMNOLENCE (I slept a lot), COVID-19 (Tested positive for COVID), FEELING ABNORMAL (For about 30 years I didn't feel that bad), VACCINATION COMPLICATION (I still feel weird, one day I am ok other days feel down, and go bed), PYREXIA (Fever), MYALGIA (Body pain) and FATIGUE (Very tired) 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.   No relevant concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; 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 HEADACHE (headache) 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) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication and treatment information was provided.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dysuria, Musculoskeletal chest pain, Pyrexia
Clinical narrative: fever; pain when urinating; and pain underneaht their left ribs; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (pain when urinating), MUSCULOSKELETAL CHEST PAIN (and pain underneaht their left ribs) and PYREXIA (fever) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced DYSURIA (pain when urinating) and MUSCULOSKELETAL CHEST PAIN (and pain underneaht their left ribs). On 16-May-2021, the patient experienced PYREXIA (fever). The patient was treated with IBUPROFEN on 16-May-2021 for Fever, at a dose of 500 milligram twice a day. On 16-May-2021, DYSURIA (pain when urinating) and MUSCULOSKELETAL CHEST PAIN (and pain underneaht their left ribs) had resolved. At the time of the report, PYREXIA (fever) had not resolved.            No concomitant medications were reported. Action taken with mRNA-123 is not applicable.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: pain; feels warm at the injection site; swollen bigger than a quarter. It is huge; At the injection site, we have noticed that it has gotten red; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (pain), VACCINATION SITE WARMTH (feels warm at the injection site), VACCINATION SITE SWELLING (swollen bigger than a quarter. It is huge) and VACCINATION SITE ERYTHEMA (At the injection site, we have noticed that it has gotten red) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced PAIN (pain), VACCINATION SITE WARMTH (feels warm at the injection site), VACCINATION SITE SWELLING (swollen bigger than a quarter. It is huge) and VACCINATION SITE ERYTHEMA (At the injection site, we have noticed that it has gotten red). At the time of the report, PAIN (pain), VACCINATION SITE WARMTH (feels warm at the injection site), VACCINATION SITE SWELLING (swollen bigger than a quarter. It is huge) and VACCINATION SITE ERYTHEMA (At the injection site, we have noticed that it has gotten red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment details were not provided Action taken with mRNA -123 is not applicable.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blepharospasm, COVID-19, Diplopia, Eye irritation
Clinical narrative: I have also contracted COVID after receiving 2 doses of your vaccine; I have been very ill for 2 weeks; Shoulder twitching; eyes irritated very bad; eyes burnt as if I had acid or bleach in eyes; eyes swollen; eyes red; eyes twitching; Vision blurry; diplopia; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (eyes burnt as if I had acid or bleach in eyes), EYE SWELLING (eyes swollen), OCULAR HYPERAEMIA (eyes red), BLEPHAROSPASM (eyes twitching) and VISION BLURRED (Vision blurry) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), SIMVASTATIN, GABAPENTIN and FAMOTIDINE for an unknown indication.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced EYE IRRITATION (eyes burnt as if I had acid or bleach in eyes), EYE SWELLING (eyes swollen), OCULAR HYPERAEMIA (eyes red), BLEPHAROSPASM (eyes twitching), VISION BLURRED (Vision blurry), DIPLOPIA (diplopia), EYE IRRITATION (eyes irritated very bad) and ARTHRALGIA (Shoulder twitching). On an unknown date, the patient experienced COVID-19 (I have also contracted COVID after receiving 2 doses of your vaccine) and ILLNESS (I have been very ill for 2 weeks). On 20-Apr-2021, EYE IRRITATION (eyes burnt as if I had acid or bleach in eyes), EYE SWELLING (eyes swollen), OCULAR HYPERAEMIA (eyes red) and EYE IRRITATION (eyes irritated very bad) had resolved. At the time of the report, BLEPHAROSPASM (eyes twitching), VISION BLURRED (Vision blurry), DIPLOPIA (diplopia), COVID-19 (I have also contracted COVID after receiving 2 doses of your vaccine), ILLNESS (I have been very ill for 2 weeks) and ARTHRALGIA (Shoulder twitching) outcome was unknown.            No treatment medication was provided.     Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received contains significant information: Events added: COVID 19 and illness On 23-Jul-2021: Follow up received contains No New Information. On 23-Jul-2021: Follow up received contains No New Information.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Illness, Ocular hyperaemia, Vision blurred
Clinical narrative: I have also contracted COVID after receiving 2 doses of your vaccine; I have been very ill for 2 weeks; Shoulder twitching; eyes irritated very bad; eyes burnt as if I had acid or bleach in eyes; eyes swollen; eyes red; eyes twitching; Vision blurry; diplopia; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (eyes burnt as if I had acid or bleach in eyes), EYE SWELLING (eyes swollen), OCULAR HYPERAEMIA (eyes red), BLEPHAROSPASM (eyes twitching) and VISION BLURRED (Vision blurry) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), SIMVASTATIN, GABAPENTIN and FAMOTIDINE for an unknown indication.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced EYE IRRITATION (eyes burnt as if I had acid or bleach in eyes), EYE SWELLING (eyes swollen), OCULAR HYPERAEMIA (eyes red), BLEPHAROSPASM (eyes twitching), VISION BLURRED (Vision blurry), DIPLOPIA (diplopia), EYE IRRITATION (eyes irritated very bad) and ARTHRALGIA (Shoulder twitching). On an unknown date, the patient experienced COVID-19 (I have also contracted COVID after receiving 2 doses of your vaccine) and ILLNESS (I have been very ill for 2 weeks). On 20-Apr-2021, EYE IRRITATION (eyes burnt as if I had acid or bleach in eyes), EYE SWELLING (eyes swollen), OCULAR HYPERAEMIA (eyes red) and EYE IRRITATION (eyes irritated very bad) had resolved. At the time of the report, BLEPHAROSPASM (eyes twitching), VISION BLURRED (Vision blurry), DIPLOPIA (diplopia), COVID-19 (I have also contracted COVID after receiving 2 doses of your vaccine), ILLNESS (I have been very ill for 2 weeks) and ARTHRALGIA (Shoulder twitching) outcome was unknown.            No treatment medication was provided.     Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received contains significant information: Events added: COVID 19 and illness On 23-Jul-2021: Follow up received contains No New Information. On 23-Jul-2021: Follow up received contains No New Information.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: bump on the arm/swelling on the arm; 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 SITE SWELLING (bump on the arm/swelling on the arm) 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) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE SWELLING (bump on the arm/swelling on the arm). At the time of the report, VACCINATION SITE SWELLING (bump on the arm/swelling on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I received my first Moderna shot March 15th is it too late to get second dose?; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I received my first Moderna shot March 15th is it too late to get second dose?) 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 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I received my first Moderna shot March 15th is it too late to get second dose?). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I received my first Moderna shot March 15th is it too late to get second dose?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: A side effect; 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 (A side effect) 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 VACCINATION COMPLICATION (A side effect). At the time of the report, VACCINATION COMPLICATION (A side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment medication provided. The report states that the patient had a side effect after the Moderna vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain
Clinical narrative: lump is on the arm; arm soreness near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump is on the arm) and VACCINATION SITE PAIN (arm soreness near injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced VACCINATION SITE MASS (lump is on the arm) and VACCINATION SITE PAIN (arm soreness near injection site). On 07-May-2021, VACCINATION SITE MASS (lump is on the arm) had not resolved. At the time of the report, VACCINATION SITE PAIN (arm soreness near injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration
Clinical narrative: ¨Per Moderna Customer Care Agent : patient was ill after the 1st dose; Patient had to postpone and got the 2nd dose one week; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (¨Per Moderna Customer Care Agent : patient was ill after the 1st dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had to postpone and got the 2nd dose one week) 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) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (¨Per Moderna Customer Care Agent : patient was ill after the 1st dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had to postpone and got the 2nd dose one week). At the time of the report, ILLNESS (¨Per Moderna Customer Care Agent : patient was ill after the 1st dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had to postpone and got the 2nd dose one week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Breaking out all over / face; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH (Breaking out all over / face) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Breaking out all over / face). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, RASH (Breaking out all over / face) outcome was unknown.            Treatment Antibiotic Topical treatment   This case was linked to MOD-2021-162048 (Patient Link).   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 51days from first vaccination; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (51days from first vaccination) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 31-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 PRODUCT DOSE OMISSION ISSUE (51days from first vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (51days from first vaccination) had resolved.        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 history not provided. Treatment information was unknown
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Reported a side effect; 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 ADVERSE EVENT (Reported a side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided. No concomitant medication details provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ADVERSE EVENT (Reported a side effect). At the time of the report, ADVERSE EVENT (Reported a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided. No relevant concomitant medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Urticaria
Clinical narrative: hives on face from mango sap; 6 weeks and 2 days past second dose; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on face from mango sap) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (6 weeks and 2 days past second 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives on face from mango sap) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (6 weeks and 2 days past second dose). At the time of the report, URTICARIA (hives on face from mango sap) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (6 weeks and 2 days past second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment with steroids taken pertained to the events experienced.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL UNDERDOSE (Lower first dose. One drop of the vaccine fell from the needle.) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. No Medical History information was reported. On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced ACCIDENTAL UNDERDOSE (Lower first dose. One drop of the vaccine fell from the needle.). At the time of the report, ACCIDENTAL UNDERDOSE (Lower first dose. One drop of the vaccine fell from the needle.) 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. Patient takes concomitant medication, but Pharmacist didn't tell which ones and what are they for.  Treatment information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Product dose omission issue, Urticaria
Clinical narrative: Missed second dose ( Beyond Day 42); Broke out in hives; Blood Pressure very high after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke out in hives), HYPERTENSION (Blood Pressure very high after the first dose) and PRODUCT DOSE OMISSION ISSUE (Missed second dose ( Beyond Day 42)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 82028) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced URTICARIA (Broke out in hives) and HYPERTENSION (Blood Pressure very high after the first dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose ( Beyond Day 42)). On 29-Dec-2020, URTICARIA (Broke out in hives) and HYPERTENSION (Blood Pressure very high after the first dose) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose ( Beyond Day 42)) 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.   No treatment medication provided. No concomitant medication provided. Patient was referred to contact Health Care Provider whether to restart the vaccination series or continue with the second dose.