chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site lymphadenopathy, Vaccination site swelling
Clinical narrative: Pain is radiating down left arm; Site of injection is swelling; Swelling of the lymph nodes in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain is radiating down left arm), VACCINATION SITE SWELLING (Site of injection is swelling) and VACCINATION SITE LYMPHADENOPATHY (Swelling of the lymph nodes in the arm of the injection) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Site of injection is swelling) and VACCINATION SITE LYMPHADENOPATHY (Swelling of the lymph nodes in the arm of the injection). On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain is radiating down left arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain is radiating down left arm), VACCINATION SITE SWELLING (Site of injection is swelling) and VACCINATION SITE LYMPHADENOPATHY (Swelling of the lymph nodes in the arm of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Vaccination site pain
Clinical narrative: Injection arm collapses; Injection arm pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Injection arm collapses) and VACCINATION SITE PAIN (Injection arm pain) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced MUSCULAR WEAKNESS (Injection arm collapses) and VACCINATION SITE PAIN (Injection arm pain). At the time of the report, MUSCULAR WEAKNESS (Injection arm collapses) and VACCINATION SITE PAIN (Injection arm pain) 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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram, Pain
Clinical narrative: Minor pain; Lymph node swelling (left); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Minor pain) and LYMPHADENOPATHY (Lymph node swelling (left)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (esophageal).    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced LYMPHADENOPATHY (Lymph node swelling (left)). On 15-Mar-2021, the patient experienced PAIN (Minor pain). At the time of the report, PAIN (Minor pain) and LYMPHADENOPATHY (Lymph node swelling (left)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: inconclusive (Inconclusive) had annual mammogram and radiologist recommended the she receive the second Moderna vaccine in the opposite arm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) 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) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-046015 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pyrexia, Sinus headache, Vomiting
Clinical narrative: Felt better but still felt dragged out, just didn't feel right; Felt nauseas, wrenching, and threw up; Spiked a temperature of 101 and felt nauseas and threw up some yellow stuff; She had a bad sinus headache; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (She had a bad sinus headache), FEELING ABNORMAL (Felt better but still felt dragged out, just didn't feel right), VOMITING (Felt nauseas, wrenching, and threw up) and PYREXIA (Spiked a temperature of 101 and felt nauseas and threw up some yellow stuff) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced SINUS HEADACHE (She had a bad sinus headache) and PYREXIA (Spiked a temperature of 101 and felt nauseas and threw up some yellow stuff). On 12-Mar-2021, the patient experienced VOMITING (Felt nauseas, wrenching, and threw up). On 13-Mar-2021, the patient experienced FEELING ABNORMAL (Felt better but still felt dragged out, just didn't feel right). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SINUS HEADACHE (She had a bad sinus headache), FEELING ABNORMAL (Felt better but still felt dragged out, just didn't feel right), VOMITING (Felt nauseas, wrenching, and threw up) and PYREXIA (Spiked a temperature of 101 and felt nauseas and threw up some yellow stuff) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 101 (High) high.         Concomitant medication list was not provided. Action taken with mRNA-1273 in response to the event was not applicable.     This case was linked to MOD-2021-045997 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-May-2021 contains non-significant information.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Rhinorrhoea, Vomiting
Clinical narrative: Not able to talk; Snotty nose; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of APHASIA (Not able to talk), RHINORRHOEA (Snotty nose) and VOMITING (Throwing up) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Down's syndrome.    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 APHASIA (Not able to talk), RHINORRHOEA (Snotty nose) and VOMITING (Throwing up). At the time of the report, APHASIA (Not able to talk), RHINORRHOEA (Snotty nose) and VOMITING (Throwing up) 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.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Muscular weakness
Clinical narrative: Felt weak in her legs/ Legs are still weak; "Was speaking like she took a sleeping pill"; Dizzy for 2 weeks; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Felt weak in her legs/ Legs are still weak), FEELING ABNORMAL ("Was speaking like she took a sleeping pill"), DIZZINESS (Dizzy for 2 weeks) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced MUSCULAR WEAKNESS (Felt weak in her legs/ Legs are still weak), FEELING ABNORMAL ("Was speaking like she took a sleeping pill"), DIZZINESS (Dizzy for 2 weeks) and CHILLS (Chills). At the time of the report, MUSCULAR WEAKNESS (Felt weak in her legs/ Legs are still weak) had not resolved and FEELING ABNORMAL ("Was speaking like she took a sleeping pill"), DIZZINESS (Dizzy for 2 weeks) and CHILLS (Chills) outcome was unknown. Not Provided      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.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Myalgia, Pyrexia
Clinical narrative: Only slept 2 hours at night; Sore arm at the injection site; Headache; Fever; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Only slept 2 hours at night), VACCINATION SITE PAIN (Sore arm at the injection site), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced INSOMNIA (Only slept 2 hours at night), VACCINATION SITE PAIN (Sore arm at the injection site), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, INSOMNIA (Only slept 2 hours at night), VACCINATION SITE PAIN (Sore arm at the injection site), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Only slept 2 hours at night; Sore arm at the injection site; Headache; Fever; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Only slept 2 hours at night), VACCINATION SITE PAIN (Sore arm at the injection site), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced INSOMNIA (Only slept 2 hours at night), VACCINATION SITE PAIN (Sore arm at the injection site), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, INSOMNIA (Only slept 2 hours at night), VACCINATION SITE PAIN (Sore arm at the injection site), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Night sweats
Clinical narrative: Severe chest pain (severe weight on chest); Night sweats after second shot; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Severe chest pain (severe weight on chest)) and NIGHT SWEATS (Night sweats after second shot) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), LISINOPRIL, LEVOTHYROXINE, VITAMIN C [ASCORBIC ACID], MAGNESIUM, CALCIUM and MELATONIN for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced CHEST PAIN (Severe chest pain (severe weight on chest)) and NIGHT SWEATS (Night sweats after second shot). On 14-Mar-2021, NIGHT SWEATS (Night sweats after second shot) had resolved. On 15-Mar-2021, CHEST PAIN (Severe chest pain (severe weight on chest)) had resolved.            Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.     This case was linked to MOD-2021-045999 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes, Vaccination site mass, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Cold sores around his lip and nose), VACCINATION SITE MASS (Sizable bump at the injection site) and VACCINATION SITE RASH (Rash at the injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002a21a) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Diabetes mellitus. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE MASS (Sizable bump at the injection site) and VACCINATION SITE RASH (Rash at the injection site). On 08-Mar-2021, the patient experienced ORAL HERPES (Cold sores around his lip and nose). At the time of the report, ORAL HERPES (Cold sores around his lip and nose), VACCINATION SITE MASS (Sizable bump at the injection site) and VACCINATION SITE RASH (Rash at the injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Concomitant medication included blood pressure and diabetic medications. The patient stated he had his second dose since then with no adverse events. Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Event outcomes were updated to recovered/resolved and second dose taken added in I narrative.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) 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) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.    This case was linked to MOD-2021-046006 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Muscular weakness
Clinical narrative: Muscle weakness; She was able to stand up with walker and move to other chair. Her ability to do this has decreased by 50% to 75%; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakness) and MOBILITY DECREASED (She was able to stand up with walker and move to other chair. Her ability to do this has decreased by 50% to 75%) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Muscular dystrophy and Walker user (uses a walker from one chair to another).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness) and MOBILITY DECREASED (She was able to stand up with walker and move to other chair. Her ability to do this has decreased by 50% to 75%). At the time of the report, MUSCULAR WEAKNESS (Muscle weakness) and MOBILITY DECREASED (She was able to stand up with walker and move to other chair. Her ability to do this has decreased by 50% to 75%) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Facial nerve disorder, Fatigue, Feeling abnormal, Gingival pain, Pain
Clinical narrative: vaccine has attack a nerve in his face; I experienced soreness in my lower right jaw; It felt like someone had pulled out all my teeth simultaneously and poured acid into the cavities in my jaw; arm soreness; fatigue; slight fever; bad gum pain; achiness; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL NERVE DISORDER (vaccine has attack a nerve in his face), GINGIVAL PAIN (bad gum pain), PAIN (achiness), PAIN IN JAW (I experienced soreness in my lower right jaw) and FEELING ABNORMAL (It felt like someone had pulled out all my teeth simultaneously and poured acid into the cavities in my jaw) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0011321A and 029LZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer (does not have any vocal chords due to previous bout with cancer.), Blood pressure high and Cardiac discomfort. Concomitant products included OMEPRAZOLE (OMEPRAZOL A) for Acid reflux (oesophageal), AMLODIPINE BESILATE (AMLODIPINE (ALS BESILAAT) SANDOZ) for Blood pressure high, DIPHENHYDRAMINE HCL for Runny nose.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced GINGIVAL PAIN (bad gum pain), PAIN (achiness), PAIN IN EXTREMITY (arm soreness), FATIGUE (fatigue) and PYREXIA (slight fever). On an unknown date, the patient experienced FACIAL NERVE DISORDER (vaccine has attack a nerve in his face), PAIN IN JAW (I experienced soreness in my lower right jaw) and FEELING ABNORMAL (It felt like someone had pulled out all my teeth simultaneously and poured acid into the cavities in my jaw). The patient was treated with GABAPENTIN at a dose of 1000 mg three times a day; AMOXICILLIN, CLAVULANATE POTASSIUM (AUGMENTINE SR) at an unspecified dose and frequency; CHLORHEXIDINE at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, FACIAL NERVE DISORDER (vaccine has attack a nerve in his face) outcome was unknown and GINGIVAL PAIN (bad gum pain), PAIN (achiness), PAIN IN JAW (I experienced soreness in my lower right jaw), FEELING ABNORMAL (It felt like someone had pulled out all my teeth simultaneously and poured acid into the cavities in my jaw), PAIN IN EXTREMITY (arm soreness), FATIGUE (fatigue) and PYREXIA (slight fever) had not resolved.            The patient had done EKG Physician has scheduled him a MRI of the Brain   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Follow up received contains significant information: event was updated. On 25-Jul-2021: Follow up received contains significant information: events ,lab details and concomitant medication provided, patient information was added
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pain in jaw, Pyrexia
Clinical narrative: vaccine has attack a nerve in his face; I experienced soreness in my lower right jaw; It felt like someone had pulled out all my teeth simultaneously and poured acid into the cavities in my jaw; arm soreness; fatigue; slight fever; bad gum pain; achiness; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL NERVE DISORDER (vaccine has attack a nerve in his face), GINGIVAL PAIN (bad gum pain), PAIN (achiness), PAIN IN JAW (I experienced soreness in my lower right jaw) and FEELING ABNORMAL (It felt like someone had pulled out all my teeth simultaneously and poured acid into the cavities in my jaw) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0011321A and 029LZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer (does not have any vocal chords due to previous bout with cancer.), Blood pressure high and Cardiac discomfort. Concomitant products included OMEPRAZOLE (OMEPRAZOL A) for Acid reflux (oesophageal), AMLODIPINE BESILATE (AMLODIPINE (ALS BESILAAT) SANDOZ) for Blood pressure high, DIPHENHYDRAMINE HCL for Runny nose.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced GINGIVAL PAIN (bad gum pain), PAIN (achiness), PAIN IN EXTREMITY (arm soreness), FATIGUE (fatigue) and PYREXIA (slight fever). On an unknown date, the patient experienced FACIAL NERVE DISORDER (vaccine has attack a nerve in his face), PAIN IN JAW (I experienced soreness in my lower right jaw) and FEELING ABNORMAL (It felt like someone had pulled out all my teeth simultaneously and poured acid into the cavities in my jaw). The patient was treated with GABAPENTIN at a dose of 1000 mg three times a day; AMOXICILLIN, CLAVULANATE POTASSIUM (AUGMENTINE SR) at an unspecified dose and frequency; CHLORHEXIDINE at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, FACIAL NERVE DISORDER (vaccine has attack a nerve in his face) outcome was unknown and GINGIVAL PAIN (bad gum pain), PAIN (achiness), PAIN IN JAW (I experienced soreness in my lower right jaw), FEELING ABNORMAL (It felt like someone had pulled out all my teeth simultaneously and poured acid into the cavities in my jaw), PAIN IN EXTREMITY (arm soreness), FATIGUE (fatigue) and PYREXIA (slight fever) had not resolved.            The patient had done EKG Physician has scheduled him a MRI of the Brain   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Follow up received contains significant information: event was updated. On 25-Jul-2021: Follow up received contains significant information: events ,lab details and concomitant medication provided, patient information was added
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Myalgia, Rhinalgia, SARS-CoV-2 antibody test
Clinical narrative: body aches; cough; big sore in my nose; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), COUGH (cough), RHINALGIA (big sore in my nose) and CHILLS (chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D14M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 26-Apr-2020. Concurrent medical conditions included Hypertension and High cholesterol.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced MYALGIA (body aches), COUGH (cough), RHINALGIA (big sore in my nose) and CHILLS (chills). At the time of the report, MYALGIA (body aches), COUGH (cough), RHINALGIA (big sore in my nose) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2020, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included high blood pressure medicine and cholesterol medicine.  Treatment information in response to events was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Non-significant information received on 23-JUL-2021. reporter email updated.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Gait disturbance, Headache, Muscle spasms
Clinical narrative: major cramps; whole body aches; headache; joint pain; leg drag; both arms, severe pain; stomach cramps; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (leg drag), ABDOMINAL PAIN UPPER (stomach cramps), MUSCLE SPASMS (major cramps), PAIN IN EXTREMITY (both arms, severe pain) and HEADACHE (Headache) in a 23-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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (leg drag), ABDOMINAL PAIN UPPER (stomach cramps), MUSCLE SPASMS (major cramps), PAIN IN EXTREMITY (both arms, severe pain), HEADACHE (Headache), PAIN (whole body aches) and ARTHRALGIA (joint pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (leg drag), ABDOMINAL PAIN UPPER (stomach cramps), MUSCLE SPASMS (major cramps), PAIN IN EXTREMITY (both arms, severe pain), HEADACHE (Headache), PAIN (whole body aches) and ARTHRALGIA (joint pain) outcome was unknown.            No relevant concomitant medications reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: major cramps; whole body aches; headache; joint pain; leg drag; both arms, severe pain; stomach cramps; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (leg drag), ABDOMINAL PAIN UPPER (stomach cramps), MUSCLE SPASMS (major cramps), PAIN IN EXTREMITY (both arms, severe pain) and HEADACHE (Headache) in a 23-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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (leg drag), ABDOMINAL PAIN UPPER (stomach cramps), MUSCLE SPASMS (major cramps), PAIN IN EXTREMITY (both arms, severe pain), HEADACHE (Headache), PAIN (whole body aches) and ARTHRALGIA (joint pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (leg drag), ABDOMINAL PAIN UPPER (stomach cramps), MUSCLE SPASMS (major cramps), PAIN IN EXTREMITY (both arms, severe pain), HEADACHE (Headache), PAIN (whole body aches) and ARTHRALGIA (joint pain) outcome was unknown.            No relevant concomitant medications reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 006M20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, CLOPIDOGREL, LISINOPRIL, ATORVASTATIN, TAMSULOSIN, AMLODIPINE, VITAMIN C [ASCORBIC ACID] and IRON for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had not resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Concomitant medications included centrum. Treatment information was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash red spot on arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced RASH PRURITIC. At the time of the report, RASH PRURITIC had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-221115.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Back pain, Eating disorder, Insomnia, Myalgia
Clinical narrative: he lost 18 pounds; back problem; thought the pain from arthritis increased from his ankles to his neck after first dose; muscle pain for a little over three weeks; Not sleeping; Not eating; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Not sleeping), EATING DISORDER (Not eating), WEIGHT DECREASED (he lost 18 pounds), BACK PAIN (back problem) and ARTHRITIS (thought the pain from arthritis increased from his ankles to his neck after first dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seizures (Hasn't had a seizure in ten years while on medication) and Arthritis. Concomitant products included SODIUM CHLORIDE for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INSOMNIA (Not sleeping). 02-Mar-2021, the patient experienced EATING DISORDER (Not eating). On an unknown date, the patient experienced WEIGHT DECREASED (he lost 18 pounds), BACK PAIN (back problem), ARTHRITIS (thought the pain from arthritis increased from his ankles to his neck after first dose) and MYALGIA (muscle pain for a little over three weeks). The patient was treated with IBUPROFEN (oral) at a dose of unknown and PARACETAMOL (TYLENOL) (oral) at a dose of unknown. At the time of the report, INSOMNIA (Not sleeping), EATING DISORDER (Not eating), WEIGHT DECREASED (he lost 18 pounds), ARTHRITIS (thought the pain from arthritis increased from his ankles to his neck after first dose) and MYALGIA (muscle pain for a little over three weeks) had resolved and BACK PAIN (back problem) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Unspecified concomitant medications for control of high blood pressure, pulse rate, seizures, allergies, itching, temper, and an antacid, were reported.   This case was linked to MOD-2021-046048, MOD-2021-026103 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant FU contains AE outcome , events added.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: he lost 18 pounds; back problem; thought the pain from arthritis increased from his ankles to his neck after first dose; muscle pain for a little over three weeks; Not sleeping; Not eating; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Not sleeping), EATING DISORDER (Not eating), WEIGHT DECREASED (he lost 18 pounds), BACK PAIN (back problem) and ARTHRITIS (thought the pain from arthritis increased from his ankles to his neck after first dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seizures (Hasn't had a seizure in ten years while on medication) and Arthritis. Concomitant products included SODIUM CHLORIDE for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INSOMNIA (Not sleeping). 02-Mar-2021, the patient experienced EATING DISORDER (Not eating). On an unknown date, the patient experienced WEIGHT DECREASED (he lost 18 pounds), BACK PAIN (back problem), ARTHRITIS (thought the pain from arthritis increased from his ankles to his neck after first dose) and MYALGIA (muscle pain for a little over three weeks). The patient was treated with IBUPROFEN (oral) at a dose of unknown and PARACETAMOL (TYLENOL) (oral) at a dose of unknown. At the time of the report, INSOMNIA (Not sleeping), EATING DISORDER (Not eating), WEIGHT DECREASED (he lost 18 pounds), ARTHRITIS (thought the pain from arthritis increased from his ankles to his neck after first dose) and MYALGIA (muscle pain for a little over three weeks) had resolved and BACK PAIN (back problem) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Unspecified concomitant medications for control of high blood pressure, pulse rate, seizures, allergies, itching, temper, and an antacid, were reported.   This case was linked to MOD-2021-046048, MOD-2021-026103 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant FU contains AE outcome , events added.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Pain in extremity
Clinical narrative: soar arm; Not convinced their was any vaccine in her shot / forgot to ask to see the vile because she was so nervous; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soar arm) and NERVOUSNESS (Not convinced their was any vaccine in her shot / forgot to ask to see the vile because she was so nervous) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (soar arm) and NERVOUSNESS (Not convinced their was any vaccine in her shot / forgot to ask to see the vile because she was so nervous). At the time of the report, PAIN IN EXTREMITY (soar arm) and NERVOUSNESS (Not convinced their was any vaccine in her shot / forgot to ask to see the vile because she was so nervous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Product dose omission issue, Pyrexia
Clinical narrative: Cough; COVID-19; Temperature of 99.4F; missed second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second dose of vaccine), COVID-19 (COVID-19), COUGH (Cough) and PYREXIA (Temperature of 99.4F) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.  On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second dose of vaccine), COVID-19 (COVID-19), COUGH (Cough) and PYREXIA (Temperature of 99.4F). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed second dose of vaccine) had resolved and COVID-19 (COVID-19), COUGH (Cough) and PYREXIA (Temperature of 99.4F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.4 (normal) Normal. On an unknown date, SARS-CoV-2 test positive: unknown (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by the reporter.  No treatment information were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received included no new significant information. Corrections made in initial where lab data added,covid investigation removed from event tab and added event COVID-19
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Cough; COVID-19; Temperature of 99.4F; missed second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second dose of vaccine), COVID-19 (COVID-19), COUGH (Cough) and PYREXIA (Temperature of 99.4F) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.  On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second dose of vaccine), COVID-19 (COVID-19), COUGH (Cough) and PYREXIA (Temperature of 99.4F). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed second dose of vaccine) had resolved and COVID-19 (COVID-19), COUGH (Cough) and PYREXIA (Temperature of 99.4F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.4 (normal) Normal. On an unknown date, SARS-CoV-2 test positive: unknown (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by the reporter.  No treatment information were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received included no new significant information. Corrections made in initial where lab data added,covid investigation removed from event tab and added event COVID-19
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear pain, Pain in extremity
Clinical narrative: left arm was killing her; left ear pain; left shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm was killing her), EAR PAIN (left ear pain) and ARTHRALGIA (left shoulder pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (left arm was killing her), EAR PAIN (left ear pain) and ARTHRALGIA (left shoulder pain). At the time of the report, PAIN IN EXTREMITY (left arm was killing her), EAR PAIN (left ear pain) and ARTHRALGIA (left shoulder pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Top part of right arm warm to elbow; Top part of right arm red to elbow; Top part of right arm swollen to elbow; Chills; had fever; feeling bad; Top part of right arm sore to elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Top part of right arm sore to elbow), FEELING ABNORMAL (feeling bad), VACCINATION SITE WARMTH (Top part of right arm warm to elbow), VACCINATION SITE ERYTHEMA (Top part of right arm red to elbow) and VACCINATION SITE SWELLING (Top part of right arm swollen to elbow) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002821A and 015M20A) 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 METOPROLOL, ATORVASTATIN, FAMOTIDINE, COLECALCIFEROL (VIT D3), OXYBUTYNIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Top part of right arm sore to elbow) and FEELING ABNORMAL (feeling bad). On 13-Mar-2021, the patient experienced CHILLS (Chills). 13-Mar-2021, the patient experienced PYREXIA (had fever). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Top part of right arm warm to elbow), VACCINATION SITE ERYTHEMA (Top part of right arm red to elbow), VACCINATION SITE SWELLING (Top part of right arm swollen to elbow) and MYALGIA (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Mar-2021, CHILLS (Chills) and PYREXIA (had fever) had resolved. On 19-Mar-2021, VACCINATION SITE PAIN (Top part of right arm sore to elbow) had resolved. At the time of the report, FEELING ABNORMAL (feeling bad) and VACCINATION SITE SWELLING (Top part of right arm swollen to elbow) outcome was unknown and VACCINATION SITE WARMTH (Top part of right arm warm to elbow) and VACCINATION SITE ERYTHEMA (Top part of right arm red to elbow) was resolving.            Concomitant medication include shampoo for lupus in scalp Action taken with mRNA-1273 in response to the events was not applicable. Treatment include alcohol on arm       Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Updated reporter's address, updated first dose details, updated concomitant medications, updated treatment details, added two additional events Pyrexia and Feeling abnormal, updated stop date of the events and changed event outcome from recovering to recovered/resolved. On 16-Jun-2021: Follow-up information received on 16-JUN-2021 contains no new information.