chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Pharyngeal swelling, Vomiting
Clinical narrative: throat is swelling; shortness of breath; feeling like I need to vomit; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (throat is swelling), DYSPNOEA (shortness of breath) and VOMITING (feeling like I need to vomit) 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 04-Sep-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 PHARYNGEAL SWELLING (throat is swelling), DYSPNOEA (shortness of breath) and VOMITING (feeling like I need to vomit). At the time of the report, PHARYNGEAL SWELLING (throat is swelling), DYSPNOEA (shortness of breath) and VOMITING (feeling like I need to vomit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: or has a little cold/he's a little cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (or has a little cold/he's a little cold) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (or has a little cold/he's a little cold). At the time of the report, NASOPHARYNGITIS (or has a little cold/he's a little cold) outcome was unknown.            No Concomitant drugs were reported.  No Treatment information  were reported.  The patient reported that, He doesn't know if he's immunocompromised and said he's a little bit immunocompromised   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Minimal side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Minimal side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 (Minimal side effects). At the time of the report, VACCINATION COMPLICATION (Minimal side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications was provided.  No Treatment medications was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Oral discomfort, Product dose omission issue, Pruritus
Clinical narrative: Chronic pain in her neck which went away for a couple of weeks; 2nd shot not yet administered; Itching all over all over  for a couple of days; Her lip looked wierd; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over all over  for a couple of days), ORAL DISCOMFORT (Her lip looked wierd), NECK PAIN (Chronic pain in her neck which went away for a couple of weeks) and PRODUCT DOSE OMISSION ISSUE (2nd shot not yet administered) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PRURITUS (Itching all over all over  for a couple of days) and ORAL DISCOMFORT (Her lip looked wierd). On an unknown date, the patient experienced NECK PAIN (Chronic pain in her neck which went away for a couple of weeks) and PRODUCT DOSE OMISSION ISSUE (2nd shot not yet administered). On 01-Mar-2021, PRURITUS (Itching all over all over  for a couple of days) outcome was unknown. At the time of the report, ORAL DISCOMFORT (Her lip looked wierd) and NECK PAIN (Chronic pain in her neck which went away for a couple of weeks) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (2nd shot not yet administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information was reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Experienced brain fog; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Experienced brain fog) 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 FEELING ABNORMAL (Experienced brain fog). At the time of the report, FEELING ABNORMAL (Experienced brain fog) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  It was reported that patient experienced brain fog four months ago.  The treatment information was  not provided.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest pain, Pericarditis
Clinical narrative: pericarditis; chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) and PERICARDITIS (pericarditis) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 pneumonia (Patient was hospitalized for 2 nights starting 26-Nov-2020. ) on 15-Nov-2020 and Diverticulitis in November 2020. Concomitant products included FINASTERIDE for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced PERICARDITIS (pericarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 06-Apr-2021 due to CHEST PAIN. The patient was treated with DILTIAZEM for Adverse event, at a dose of 60 mg; OMEPRAZOLE for Adverse event, at a dose of 40 mg; MULTIVITAMIN [VITAMINS NOS] for Adverse event, at an unspecified dose and frequency; CALCIUM for Adverse event, at an unspecified dose and frequency; ACETYLSALICYLIC ACID (ASPIRIN 81) for Adverse event, at a dose of 81 mg and ROSUVASTATIN for Adverse event, at a dose of 20 mg. At the time of the report, CHEST PAIN (chest pain) had not resolved and PERICARDITIS (pericarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: increased (High) increased.         Company Comment:  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.   Reporter did not allow further contact; 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: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: could not make a fist with the right hand; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (could not make a fist with the right hand) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced MOBILITY DECREASED (could not make a fist with the right hand). At the time of the report, MOBILITY DECREASED (could not make a fist with the right hand) had not resolved.            No relevant concomitant medications were reported. Treatment information was unknown.  Reporter stated that if he exercised the right hand he was able to make a fist but if he did not use the right hand for a few minutes, he could not make a fist.   This case was linked to MOD-2021-313220 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Myalgia, Off label use
Clinical narrative: headache; achiness; chills; a mild fever; received her booster or the 3rd dose of Moderna COVID 19 vaccine, She said she's not immunocompromised; some flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (some flu-like symptoms), HEADACHE (headache), MYALGIA (achiness), CHILLS (chills) and PYREXIA (a mild fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Asthma.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (some flu-like symptoms) and OFF LABEL USE (received her booster or the 3rd dose of Moderna COVID 19 vaccine, She said she's not immunocompromised). On an unknown date, the patient experienced HEADACHE (headache), MYALGIA (achiness), CHILLS (chills) and PYREXIA (a mild fever). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. On 31-Aug-2021, OFF LABEL USE (received her booster or the 3rd dose of Moderna COVID 19 vaccine, She said she's not immunocompromised) had resolved. On 01-Sep-2021, INFLUENZA LIKE ILLNESS (some flu-like symptoms) had resolved. At the time of the report, HEADACHE (headache), MYALGIA (achiness), CHILLS (chills) and PYREXIA (a mild fever) outcome was unknown.            Patient mentioned that her doctor's office did not say anything to her when they gave her the 3rd dose. She had some flu-like symptoms right after the 3rd dose. They lasted 24 hours and went away. She had the typical headache, achiness, chills, and a mild fever. She could not tell for sure if she had a fever since she did not have a thermometer. She slept and took acetaminophen.   For 3rd dose lot number provided as 062E214 or 062E219.  No concomitant medication was reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache; achiness; chills; a mild fever; received her booster or the 3rd dose of Moderna COVID 19 vaccine, She said she's not immunocompromised; some flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (some flu-like symptoms), HEADACHE (headache), MYALGIA (achiness), CHILLS (chills) and PYREXIA (a mild fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Asthma.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (some flu-like symptoms) and OFF LABEL USE (received her booster or the 3rd dose of Moderna COVID 19 vaccine, She said she's not immunocompromised). On an unknown date, the patient experienced HEADACHE (headache), MYALGIA (achiness), CHILLS (chills) and PYREXIA (a mild fever). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. On 31-Aug-2021, OFF LABEL USE (received her booster or the 3rd dose of Moderna COVID 19 vaccine, She said she's not immunocompromised) had resolved. On 01-Sep-2021, INFLUENZA LIKE ILLNESS (some flu-like symptoms) had resolved. At the time of the report, HEADACHE (headache), MYALGIA (achiness), CHILLS (chills) and PYREXIA (a mild fever) outcome was unknown.            Patient mentioned that her doctor's office did not say anything to her when they gave her the 3rd dose. She had some flu-like symptoms right after the 3rd dose. They lasted 24 hours and went away. She had the typical headache, achiness, chills, and a mild fever. She could not tell for sure if she had a fever since she did not have a thermometer. She slept and took acetaminophen.   For 3rd dose lot number provided as 062E214 or 062E219.  No concomitant medication was reported.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Erythema, Fatigue, Headache
Clinical narrative: Pain in both arms/ pain in legs; Pain in upper and mid back; Pain in neck; Redness in left arm; Swelling in left arm; Pain in upper shoulder; Muscle pain over entire body; Strong fatigue; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in both arms/ pain in legs), BACK PAIN (Pain in upper and mid back), NECK PAIN (Pain in neck), ERYTHEMA (Redness in left arm) and PERIPHERAL SWELLING (Swelling in left arm) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Aspirin), Drug allergy (Ibuprofen), Drug allergy (Hydrocloroquine), Drug allergy (Chloroquine) and Drug allergy (Hydroxychloroquine). Concomitant products included VITAMIN D [VITAMIN D NOS] and IRON for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced PAIN IN EXTREMITY (Pain in both arms/ pain in legs), BACK PAIN (Pain in upper and mid back), NECK PAIN (Pain in neck), ERYTHEMA (Redness in left arm), PERIPHERAL SWELLING (Swelling in left arm), ARTHRALGIA (Pain in upper shoulder), MYALGIA (Muscle pain over entire body), FATIGUE (Strong fatigue), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) on 30-May-2021 for Adverse event, at a dose of 1 dosage form and MENTHOL, METHYL SALICYLATE (BENGAY [MENTHOL;METHYL SALICYLATE]) for Pain, at an unspecified dose and frequency. On 13-Jun-2021, HEADACHE (Headache) and NAUSEA (Nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in both arms/ pain in legs), BACK PAIN (Pain in upper and mid back), NECK PAIN (Pain in neck), ERYTHEMA (Redness in left arm), PERIPHERAL SWELLING (Swelling in left arm), ARTHRALGIA (Pain in upper shoulder), MYALGIA (Muscle pain over entire body) and FATIGUE (Strong fatigue) outcome was unknown.            Treatment include : hot compresses, ice.  In July, patient went to urgent care and then her primary care physician, who switched her low dose of ibuprofen.   This case was linked to (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Pain in both arms/ pain in legs; Pain in upper and mid back; Pain in neck; Redness in left arm; Swelling in left arm; Pain in upper shoulder; Muscle pain over entire body; Strong fatigue; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in both arms/ pain in legs), BACK PAIN (Pain in upper and mid back), NECK PAIN (Pain in neck), ERYTHEMA (Redness in left arm) and PERIPHERAL SWELLING (Swelling in left arm) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Aspirin), Drug allergy (Ibuprofen), Drug allergy (Hydrocloroquine), Drug allergy (Chloroquine) and Drug allergy (Hydroxychloroquine). Concomitant products included VITAMIN D [VITAMIN D NOS] and IRON for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced PAIN IN EXTREMITY (Pain in both arms/ pain in legs), BACK PAIN (Pain in upper and mid back), NECK PAIN (Pain in neck), ERYTHEMA (Redness in left arm), PERIPHERAL SWELLING (Swelling in left arm), ARTHRALGIA (Pain in upper shoulder), MYALGIA (Muscle pain over entire body), FATIGUE (Strong fatigue), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) on 30-May-2021 for Adverse event, at a dose of 1 dosage form and MENTHOL, METHYL SALICYLATE (BENGAY [MENTHOL;METHYL SALICYLATE]) for Pain, at an unspecified dose and frequency. On 13-Jun-2021, HEADACHE (Headache) and NAUSEA (Nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in both arms/ pain in legs), BACK PAIN (Pain in upper and mid back), NECK PAIN (Pain in neck), ERYTHEMA (Redness in left arm), PERIPHERAL SWELLING (Swelling in left arm), ARTHRALGIA (Pain in upper shoulder), MYALGIA (Muscle pain over entire body) and FATIGUE (Strong fatigue) outcome was unknown.            Treatment include : hot compresses, ice.  In July, patient went to urgent care and then her primary care physician, who switched her low dose of ibuprofen.   This case was linked to (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arm is really sore; extremely exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is really sore) and FATIGUE (extremely exhausted) 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 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced PAIN IN EXTREMITY (arm is really sore) and FATIGUE (extremely exhausted). At the time of the report, PAIN IN EXTREMITY (arm is really sore) and FATIGUE (extremely exhausted) had not resolved.            no concomitant medications are provided. treatment to the events not reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Hyperhidrosis, Migraine, Nasopharyngitis
Clinical narrative: Left side of face swelled; Cough; Cold; Migraine; Chills; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), SWELLING FACE (Left side of face swelled), COUGH (Cough), NASOPHARYNGITIS (Cold) and CHILLS (Chills) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced HYPERHIDROSIS (Sweating), COUGH (Cough), NASOPHARYNGITIS (Cold), CHILLS (Chills) and MIGRAINE (Migraine). On 03-Sep-2021, the patient experienced SWELLING FACE (Left side of face swelled). On 06-Sep-2021, MIGRAINE (Migraine) had resolved. At the time of the report, HYPERHIDROSIS (Sweating), SWELLING FACE (Left side of face swelled), COUGH (Cough), NASOPHARYNGITIS (Cold) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter denied pregnancy  No concomitant medications reported.  No treatment information was reported by reporter.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Left side of face swelled; Cough; Cold; Migraine; Chills; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), SWELLING FACE (Left side of face swelled), COUGH (Cough), NASOPHARYNGITIS (Cold) and CHILLS (Chills) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced HYPERHIDROSIS (Sweating), COUGH (Cough), NASOPHARYNGITIS (Cold), CHILLS (Chills) and MIGRAINE (Migraine). On 03-Sep-2021, the patient experienced SWELLING FACE (Left side of face swelled). On 06-Sep-2021, MIGRAINE (Migraine) had resolved. At the time of the report, HYPERHIDROSIS (Sweating), SWELLING FACE (Left side of face swelled), COUGH (Cough), NASOPHARYNGITIS (Cold) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter denied pregnancy  No concomitant medications reported.  No treatment information was reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: became blind; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (became blind) 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 BLINDNESS (became blind) (seriousness criterion medically significant). At the time of the report, BLINDNESS (became blind) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: Received the Moderna vaccines who tested positive for covid; Got sick; 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 COVID-19 (Received the Moderna vaccines who tested positive for covid) and ILLNESS (Got sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  In December 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Received the Moderna vaccines who tested positive for covid) and ILLNESS (Got sick). At the time of the report, COVID-19 (Received the Moderna vaccines who tested positive for covid) and ILLNESS (Got sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Acne pustular, Rash
Clinical narrative: Large puss filled pimples; Skin rashes; 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 ACNE PUSTULAR (Large puss filled pimples) and RASH (Skin rashes) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACNE PUSTULAR (Large puss filled pimples) and RASH (Skin rashes). At the time of the report, ACNE PUSTULAR (Large puss filled pimples) and RASH (Skin rashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment information was reported by reporter.   Reporter did not allow further contact
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Bone pain, Dizziness, Feeling abnormal
Clinical narrative: Feels kind of hung over/ feels like he's getting over the flu; All his broken bones hurt like hell now/bone aches; Lightheaded; Left arm is really sore more than the first time; Headache; Body aches / lower back has been really achy; Horribly sick/really sic/feeling sick; Sick to his stomach/still feel poopy; Low energy/still in bed; Couldn't sleep last night; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Horribly sick/really sic/feeling sick), ABDOMINAL DISCOMFORT (Sick to his stomach/still feel poopy), ASTHENIA (Low energy/still in bed), INSOMNIA (Couldn't sleep last night) and FEELING ABNORMAL (Feels kind of hung over/ feels like he's getting over the flu) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ankle reconstruction (Reconstructive surgeries on ankle and knee). Concurrent medical conditions included Thyroid disorder NOS and Back pain.    On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced ILLNESS (Horribly sick/really sic/feeling sick), ABDOMINAL DISCOMFORT (Sick to his stomach/still feel poopy), BONE PAIN (All his broken bones hurt like hell now/bone aches), DIZZINESS (Lightheaded), HEADACHE (Headache) and MYALGIA (Body aches / lower back has been really achy). 07-Sep-2021, the patient experienced ASTHENIA (Low energy/still in bed), INSOMNIA (Couldn't sleep last night) and PAIN IN EXTREMITY (Left arm is really sore more than the first time). On 08-Sep-2021, the patient experienced FEELING ABNORMAL (Feels kind of hung over/ feels like he's getting over the flu). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency and TRAMADOL ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, ILLNESS (Horribly sick/really sic/feeling sick), ABDOMINAL DISCOMFORT (Sick to his stomach/still feel poopy), ASTHENIA (Low energy/still in bed), INSOMNIA (Couldn't sleep last night), FEELING ABNORMAL (Feels kind of hung over/ feels like he's getting over the flu), BONE PAIN (All his broken bones hurt like hell now/bone aches), DIZZINESS (Lightheaded), PAIN IN EXTREMITY (Left arm is really sore more than the first time), HEADACHE (Headache) and MYALGIA (Body aches / lower back has been really achy) outcome was unknown.            Concomitant medication provided include thyroid medication and tramadol for mild narcotic for pain in back.  Patient took half of a marihuana brownie for his symptoms.   This case was linked to MOD-2021-313212 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow-up was received on 9-SEP-2021 and Updated relevant medical history, added treatment medication, added event; lightheaded, updated event verbatim.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness, Insomnia, Myalgia, Pain in extremity
Clinical narrative: Feels kind of hung over/ feels like he's getting over the flu; All his broken bones hurt like hell now/bone aches; Lightheaded; Left arm is really sore more than the first time; Headache; Body aches / lower back has been really achy; Horribly sick/really sic/feeling sick; Sick to his stomach/still feel poopy; Low energy/still in bed; Couldn't sleep last night; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Horribly sick/really sic/feeling sick), ABDOMINAL DISCOMFORT (Sick to his stomach/still feel poopy), ASTHENIA (Low energy/still in bed), INSOMNIA (Couldn't sleep last night) and FEELING ABNORMAL (Feels kind of hung over/ feels like he's getting over the flu) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ankle reconstruction (Reconstructive surgeries on ankle and knee). Concurrent medical conditions included Thyroid disorder NOS and Back pain.    On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced ILLNESS (Horribly sick/really sic/feeling sick), ABDOMINAL DISCOMFORT (Sick to his stomach/still feel poopy), BONE PAIN (All his broken bones hurt like hell now/bone aches), DIZZINESS (Lightheaded), HEADACHE (Headache) and MYALGIA (Body aches / lower back has been really achy). 07-Sep-2021, the patient experienced ASTHENIA (Low energy/still in bed), INSOMNIA (Couldn't sleep last night) and PAIN IN EXTREMITY (Left arm is really sore more than the first time). On 08-Sep-2021, the patient experienced FEELING ABNORMAL (Feels kind of hung over/ feels like he's getting over the flu). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency and TRAMADOL ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, ILLNESS (Horribly sick/really sic/feeling sick), ABDOMINAL DISCOMFORT (Sick to his stomach/still feel poopy), ASTHENIA (Low energy/still in bed), INSOMNIA (Couldn't sleep last night), FEELING ABNORMAL (Feels kind of hung over/ feels like he's getting over the flu), BONE PAIN (All his broken bones hurt like hell now/bone aches), DIZZINESS (Lightheaded), PAIN IN EXTREMITY (Left arm is really sore more than the first time), HEADACHE (Headache) and MYALGIA (Body aches / lower back has been really achy) outcome was unknown.            Concomitant medication provided include thyroid medication and tramadol for mild narcotic for pain in back.  Patient took half of a marihuana brownie for his symptoms.   This case was linked to MOD-2021-313212 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow-up was received on 9-SEP-2021 and Updated relevant medical history, added treatment medication, added event; lightheaded, updated event verbatim.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Dysstasia, Neck pain, Pyrexia
Clinical narrative: Horrible neck pain; Lower back pain; Can't even stand; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Horrible neck pain), BACK PAIN (Lower back pain), DYSSTASIA (Can't even stand), PYREXIA (Fever) and CHILLS (Chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035N21A and 035N21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-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 NECK PAIN (Horrible neck pain), BACK PAIN (Lower back pain), DYSSTASIA (Can't even stand), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, NECK PAIN (Horrible neck pain), BACK PAIN (Lower back pain), DYSSTASIA (Can't even stand), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Broke out with a case of shingles 3 days after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Broke out with a case of shingles 3 days after 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 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HERPES ZOSTER (Broke out with a case of shingles 3 days after vaccine) (seriousness criterion medically significant). At the time of the report, HERPES ZOSTER (Broke out with a case of shingles 3 days after vaccine) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Feeling abnormal
Clinical narrative: She didn't feel so great; Sick with a stomach situation; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She didn't feel so great) and ABDOMINAL DISCOMFORT (Sick with a stomach situation) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (She didn't feel so great) and ABDOMINAL DISCOMFORT (Sick with a stomach situation). At the time of the report, FEELING ABNORMAL (She didn't feel so great) and ABDOMINAL DISCOMFORT (Sick with a stomach situation) outcome was unknown.            No concomitant medications were reported by reporter  Treatment information was not provided    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects/they went away; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects/they went away) 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 (side effects/they went away). At the time of the report, VACCINATION COMPLICATION (side effects/they went away) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Lymphadenopathy, Muscle tightness, Swelling
Clinical narrative: Swelling on neck; All the shoulder area down to her breasts/swelling all around; All muscles feel tight or something; It's not comfortable; Can feel 2 or 3 lymph nodes swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling on neck), SWELLING (All the shoulder area down to her breasts/swelling all around), MUSCLE TIGHTNESS (All muscles feel tight or something), DISCOMFORT (It's not comfortable) and LYMPHADENOPATHY (Can feel 2 or 3 lymph nodes swollen) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020821A and 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included AMITRIPTYLINE and PROPRANOLOL for Migraine, FLUOXETINE HYDROCHLORIDE (PROZAC) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced SWELLING (Swelling on neck), SWELLING (All the shoulder area down to her breasts/swelling all around), MUSCLE TIGHTNESS (All muscles feel tight or something), DISCOMFORT (It's not comfortable) and LYMPHADENOPATHY (Can feel 2 or 3 lymph nodes swollen). At the time of the report, SWELLING (Swelling on neck), SWELLING (All the shoulder area down to her breasts/swelling all around), MUSCLE TIGHTNESS (All muscles feel tight or something), DISCOMFORT (It's not comfortable) and LYMPHADENOPATHY (Can feel 2 or 3 lymph nodes swollen) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-313305 (Patient Link).
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939893) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-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 MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment information was reported by reporter.   This case was linked to MOD-2021-313350 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received her 1st dose of the Moderna Covid-19 vaccine in January 2021. She's here to get her 2nd dose today.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her 1st dose of the Moderna Covid-19 vaccine in January 2021. She's here to get her 2nd dose today.) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her 1st dose of the Moderna Covid-19 vaccine in January 2021. She's here to get her 2nd dose today.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her 1st dose of the Moderna Covid-19 vaccine in January 2021. She's here to get her 2nd dose today.) 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.   No concomitant medications were reported by reporter Treatment information was not provided
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: She has been having a spinal migraine on and off; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (She has been having a spinal migraine on and off) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE (She has been having a spinal migraine on and off). At the time of the report, MIGRAINE (She has been having a spinal migraine on and off) outcome was unknown.            Relevant concomitant medications were not reported.  The treatment information was  not provided.  Action taken with the drug in response to events was not applicable.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Neck pain
Clinical narrative: this week my neck rings from time to time; neck pain\my left side woke up sore; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (neck pain\my left side woke up sore) and MUSCULOSKELETAL DISCOMFORT (this week my neck rings from time to time) 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) at an unspecified dose. On 07-Sep-2021, the patient experienced NECK PAIN (neck pain\my left side woke up sore). On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (this week my neck rings from time to time). At the time of the report, NECK PAIN (neck pain\my left side woke up sore) and MUSCULOSKELETAL DISCOMFORT (this week my neck rings from time to time) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Expired product administered, Gait inability, Pain in extremity, Pruritus
Clinical narrative: Could not walk; Stomach was hurting so bad; Arm was hurting; Itching; Expired vaccine administered to patient/Vaccine was out of the refrigerator by days; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Could not walk), ABDOMINAL PAIN UPPER (Stomach was hurting so bad), PAIN IN EXTREMITY (Arm was hurting), PRURITUS (Itching) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient/Vaccine was out of the refrigerator by days) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The Medical history information was not provided by the reporter.  Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (Could not walk), ABDOMINAL PAIN UPPER (Stomach was hurting so bad), PAIN IN EXTREMITY (Arm was hurting), PRURITUS (Itching) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient/Vaccine was out of the refrigerator by days). At the time of the report, GAIT INABILITY (Could not walk), ABDOMINAL PAIN UPPER (Stomach was hurting so bad), PAIN IN EXTREMITY (Arm was hurting), PRURITUS (Itching) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient/Vaccine was out of the refrigerator by days) 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 was received by patient.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Malaise, Vaccination complication
Clinical narrative: Mild reaction; Not feeling that well overall; Mild flu like symptoms; Some fatigue for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Mild reaction), MALAISE (Not feeling that well overall), INFLUENZA LIKE ILLNESS (Mild flu like symptoms) and FATIGUE (Some fatigue for a couple of days) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Mild reaction), MALAISE (Not feeling that well overall), INFLUENZA LIKE ILLNESS (Mild flu like symptoms) and FATIGUE (Some fatigue for a couple of days). At the time of the report, VACCINATION COMPLICATION (Mild reaction), MALAISE (Not feeling that well overall), INFLUENZA LIKE ILLNESS (Mild flu like symptoms) and FATIGUE (Some fatigue for a couple of days) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient had no history of COVID-19. No concomitant product information was provided. Treatment information was not provided.      This case was linked to MOD-2021-313524 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reaction to the second injection a week after; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction to the second injection a week after) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction to the second injection a week after). At the time of the report, VACCINATION COMPLICATION (reaction to the second injection a week after) outcome was unknown. Not Provided          No Concomitant medications was provided.  No Treatment medications was provided.