chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Visual impairment
Clinical narrative: Weird visual; Tingling in left leg; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in left leg) and VISUAL IMPAIRMENT (Weird visual) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Neuropathy.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PARAESTHESIA (Tingling in left leg). On 13-Feb-2021, the patient experienced VISUAL IMPAIRMENT (Weird visual). On 13-Feb-2021, VISUAL IMPAIRMENT (Weird visual) outcome was unknown. At the time of the report, PARAESTHESIA (Tingling in left leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear pain, Musculoskeletal chest pain, Suspected COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Ear pain), ARTHRALGIA (joint pain), MUSCULOSKELETAL CHEST PAIN (chest wall pain) and SUSPECTED COVID-19 (COVID 19 like symptoms) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced EAR PAIN (Ear pain), ARTHRALGIA (joint pain), MUSCULOSKELETAL CHEST PAIN (chest wall pain) and SUSPECTED COVID-19 (COVID 19 like symptoms). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at an unspecified dose and frequency. At the time of the report, EAR PAIN (Ear pain), ARTHRALGIA (joint pain), MUSCULOSKELETAL CHEST PAIN (chest wall pain) and SUSPECTED COVID-19 (COVID 19 like symptoms) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Ear pain), ARTHRALGIA (joint pain), MUSCULOSKELETAL CHEST PAIN (chest wall pain) and SUSPECTED COVID-19 (COVID 19 like symptoms) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced EAR PAIN (Ear pain), ARTHRALGIA (joint pain), MUSCULOSKELETAL CHEST PAIN (chest wall pain) and SUSPECTED COVID-19 (COVID 19 like symptoms). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at an unspecified dose and frequency. At the time of the report, EAR PAIN (Ear pain), ARTHRALGIA (joint pain), MUSCULOSKELETAL CHEST PAIN (chest wall pain) and SUSPECTED COVID-19 (COVID 19 like symptoms) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain
Clinical narrative: headache; muscle pain; felt exhausted; body hurt; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (muscle pain), FATIGUE (felt exhausted) and PAIN (body hurt) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M201A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced HEADACHE (headache), MYALGIA (muscle pain), FATIGUE (felt exhausted) and PAIN (body hurt). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), MYALGIA (muscle pain), FATIGUE (felt exhausted) and PAIN (body hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (muscle pain), FATIGUE (felt exhausted) and PAIN (body hurt) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M201A and 001A21A) for COVID-19 vaccination.  Concomitant medication include Birth control medicines    The patient's past medical history included No adverse event. Concomitant products included ORAL CONTRACEPTIVES for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced HEADACHE (headache), MYALGIA (muscle pain), FATIGUE (felt exhausted) and PAIN (body hurt). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), MYALGIA (muscle pain), FATIGUE (felt exhausted) and PAIN (body hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, Somnolence
Clinical narrative: Very sleepy; Achy everywhere; Chills; Slight fever; Threw up; Headaches; This spontaneous case was reported by a health care professional and describes the occurrence of MYALGIA (Achy everywhere), SOMNOLENCE (Very sleepy), HEADACHE (Headaches), CHILLS (Chills) and PYREXIA (Slight fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cholesterol since an unknown date. Concomitant products included ATORVASTATIN (LIPTOR [ATORVASTATIN]) for Cholesterol.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced HEADACHE (Headaches). On 01-Mar-2021, the patient experienced MYALGIA (Achy everywhere), SOMNOLENCE (Very sleepy), CHILLS (Chills), PYREXIA (Slight fever) and VOMITING (Threw up). On 01-Mar-2021, MYALGIA (Achy everywhere), SOMNOLENCE (Very sleepy), CHILLS (Chills), PYREXIA (Slight fever) and VOMITING (Threw up) had resolved. At the time of the report, HEADACHE (Headaches) had not 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.   Treatment information included nausea pill.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Very sleepy; Achy everywhere; Chills; Slight fever; Threw up; Headaches; This spontaneous case was reported by a health care professional and describes the occurrence of MYALGIA (Achy everywhere), SOMNOLENCE (Very sleepy), HEADACHE (Headaches), CHILLS (Chills) and PYREXIA (Slight fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cholesterol since an unknown date. Concomitant products included ATORVASTATIN (LIPTOR [ATORVASTATIN]) for Cholesterol.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced HEADACHE (Headaches). On 01-Mar-2021, the patient experienced MYALGIA (Achy everywhere), SOMNOLENCE (Very sleepy), CHILLS (Chills), PYREXIA (Slight fever) and VOMITING (Threw up). On 01-Mar-2021, MYALGIA (Achy everywhere), SOMNOLENCE (Very sleepy), CHILLS (Chills), PYREXIA (Slight fever) and VOMITING (Threw up) had resolved. At the time of the report, HEADACHE (Headaches) had not 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.   Treatment information included nausea pill.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort
Clinical narrative: Problems with the eyes; A spontaneous report  was received from a Consumer concerning a 78 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Ocular discomfort. The patient's medical history was provided as the Patient had cataracts surgery less than a year ago. Relevant concomitant medications were reported as Xanax, Corlanor, Toprol XL, baby aspirin, Lipitor 10, Dexona 60, Synthroid 75, Klor-Con and Furosemide, apart from Calcium 600 with vitamin D.  On 24 FEB 2021, prior to the onset of the event, the patient received their first dose of two planned doses of mRNA-1273 (lot/batch: 012A21A) for prophylaxis of COVID-19 infection.   On 24 FEB 2021, the patient experienced Ocular discomfort.  Laboratory details was not provided.  Treatment information was provided as Retain (eye drops).   Action taken with mRNA-1273 in response to the events was not reported. At the of this report, the outcome of the event's Ocular discomfort was considered as unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Ongoing arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Ongoing arm soreness) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-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 SITE PAIN (Ongoing arm soreness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Ongoing arm soreness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included, Advil.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 28-May-2021. On 27-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 24-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.            The patient's medical history was not provided Relevant concomitant medications were not reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Tongue blistering
Clinical narrative: Developed blisters along the the edge of the tongue; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE BLISTERING (Developed blisters along the the edge of the tongue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included SODIUM BICARBONATE, SODIUM CHLORIDE (NEILMED SINUS RINSE) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TONGUE BLISTERING (Developed blisters along the the edge of the tongue). At the time of the report, TONGUE BLISTERING (Developed blisters along the the edge of the tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included salt water and used oral gel. No medical history was reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Additional information was received and processed with initial report. Reporter Contact details were updated. Patient details were updated
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Diarrhea; soreness; Pink rash; chills; Fever; Nausea; fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN (soreness), RASH (Pink rash), CHILLS (chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy, Drug allergy (NSAID's) and Allergy to antibiotic (Cipro, Amoxicillin.). Concomitant products included LEVOTHYROXINE, DILTIAZEM and HYDROCHLOROTHIAZIDE (THIAZIDE) for an unknown indication.    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 DIARRHOEA (Diarrhea), PAIN (soreness), RASH (Pink rash), CHILLS (chills), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (fatigue) and HEADACHE (Headache). At the time of the report, DIARRHOEA (Diarrhea), PAIN (soreness), RASH (Pink rash), CHILLS (chills), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (fatigue) and HEADACHE (Headache) outcome was unknown.            No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Non-Significant follow up: Reporters contact details updated.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Diarrhea; soreness; Pink rash; chills; Fever; Nausea; fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN (soreness), RASH (Pink rash), CHILLS (chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy, Drug allergy (NSAID's) and Allergy to antibiotic (Cipro, Amoxicillin.). Concomitant products included LEVOTHYROXINE, DILTIAZEM and HYDROCHLOROTHIAZIDE (THIAZIDE) for an unknown indication.    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 DIARRHOEA (Diarrhea), PAIN (soreness), RASH (Pink rash), CHILLS (chills), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (fatigue) and HEADACHE (Headache). At the time of the report, DIARRHOEA (Diarrhea), PAIN (soreness), RASH (Pink rash), CHILLS (chills), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (fatigue) and HEADACHE (Headache) outcome was unknown.            No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Non-Significant follow up: Reporters contact details updated.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Eye pain, Headache, Hyperhidrosis
Clinical narrative: MIgraine; Ear pain/Pain in right ear; Can't open eyes due to migraine/Pain in right eye; Pain on right side of throat, when swallow; Headache; Chills; Felt very painful like all over; Face swollen/Body swollen, like couldn't put rings around finger; Feeling very bad; Woke up full of sweat; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), MYALGIA (Felt very painful like all over), SWELLING (Face swollen/Body swollen, like couldn't put rings around finger) and MALAISE (Feeling very bad) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included NAPROXEN SODIUM (ALEVE), MIRABEGRON, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and COLECALCIFEROL (VITAMIN D 3).   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 20-Feb-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills), MYALGIA (Felt very painful like all over), SWELLING (Face swollen/Body swollen, like couldn't put rings around finger), MALAISE (Feeling very bad) and HYPERHIDROSIS (Woke up full of sweat). On 01-Mar-2021, the patient experienced MIGRAINE (MIgraine), EAR PAIN (Ear pain/Pain in right ear), EYE PAIN (Can't open eyes due to migraine/Pain in right eye) and OROPHARYNGEAL PAIN (Pain on right side of throat, when swallow). At the time of the report, HEADACHE (Headache), CHILLS (Chills), MYALGIA (Felt very painful like all over), SWELLING (Face swollen/Body swollen, like couldn't put rings around finger), MALAISE (Feeling very bad), HYPERHIDROSIS (Woke up full of sweat), MIGRAINE (MIgraine), EAR PAIN (Ear pain/Pain in right ear), EYE PAIN (Can't open eyes due to migraine/Pain in right eye) and OROPHARYNGEAL PAIN (Pain on right side of throat, when swallow) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included Aprezin and Tylenol.   This case was linked to MOD-2021-031896 (Patient Link).   Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Myalgia, Oropharyngeal pain, Swelling
Clinical narrative: MIgraine; Ear pain/Pain in right ear; Can't open eyes due to migraine/Pain in right eye; Pain on right side of throat, when swallow; Headache; Chills; Felt very painful like all over; Face swollen/Body swollen, like couldn't put rings around finger; Feeling very bad; Woke up full of sweat; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), MYALGIA (Felt very painful like all over), SWELLING (Face swollen/Body swollen, like couldn't put rings around finger) and MALAISE (Feeling very bad) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included NAPROXEN SODIUM (ALEVE), MIRABEGRON, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and COLECALCIFEROL (VITAMIN D 3).   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 20-Feb-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills), MYALGIA (Felt very painful like all over), SWELLING (Face swollen/Body swollen, like couldn't put rings around finger), MALAISE (Feeling very bad) and HYPERHIDROSIS (Woke up full of sweat). On 01-Mar-2021, the patient experienced MIGRAINE (MIgraine), EAR PAIN (Ear pain/Pain in right ear), EYE PAIN (Can't open eyes due to migraine/Pain in right eye) and OROPHARYNGEAL PAIN (Pain on right side of throat, when swallow). At the time of the report, HEADACHE (Headache), CHILLS (Chills), MYALGIA (Felt very painful like all over), SWELLING (Face swollen/Body swollen, like couldn't put rings around finger), MALAISE (Feeling very bad), HYPERHIDROSIS (Woke up full of sweat), MIGRAINE (MIgraine), EAR PAIN (Ear pain/Pain in right ear), EYE PAIN (Can't open eyes due to migraine/Pain in right eye) and OROPHARYNGEAL PAIN (Pain on right side of throat, when swallow) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included Aprezin and Tylenol.   This case was linked to MOD-2021-031896 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery, Pain in extremity
Clinical narrative: Felt jittery; sore left arm; This spontaneous case was reported by a nurse and describes the occurrence of FEELING JITTERY (Felt jittery) and PAIN IN EXTREMITY (sore left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included ESTRADIOL (ESTROGEL) for an unknown indication.    On 26-Feb-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 FEELING JITTERY (Felt jittery) and PAIN IN EXTREMITY (sore left arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 28-Feb-2021 for Pain in extremity, at an unspecified dose and frequency. At the time of the report, FEELING JITTERY (Felt jittery) and PAIN IN EXTREMITY (sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   .   This case was linked to MOD21-041846, MOD21-041948 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up information received on 26-MAY-2021 contains non-significant information.; Sender's Comments:  MOD21-041846:same reporter MOD21-041948:same reporter
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery
Clinical narrative: Felt jittery; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING JITTERY (Felt jittery) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced FEELING JITTERY (Felt jittery). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, FEELING JITTERY (Felt jittery) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator   This case was linked to MOD21-041846, MOD21-041951 (E2B Linked Report).; Sender's Comments:  MOD21-041846:same reporter MOD21-041951:same reporter
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: got sick to their stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (got sick to their stomach) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (got sick to their stomach). At the time of the report, ABDOMINAL DISCOMFORT (got sick to their stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. List of concomitant medication were not given.   This case was linked to MOD-2021-031835, MOD-2021-031857, MOD-2021-031928 (Linked Report).; Sender's Comments:  MOD-2021-031835: MOD-2021-031857: MOD-2021-031928:
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Myalgia, Pain in extremity
Clinical narrative: arthritis; pain in her hands; pain in her body; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (arthritis), PAIN IN EXTREMITY (pain in her hands) and MYALGIA (pain in her body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ARTHRITIS (arthritis), PAIN IN EXTREMITY (pain in her hands) and MYALGIA (pain in her body). At the time of the report, ARTHRITIS (arthritis), PAIN IN EXTREMITY (pain in her hands) and MYALGIA (pain in her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment included Prednisone
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Recurring and intermittent abdominal pains; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Recurring and intermittent abdominal pains) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021 at 7:49 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (Recurring and intermittent abdominal pains). At the time of the report, ABDOMINAL PAIN (Recurring and intermittent abdominal pains) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash (injection site) and is swollen and itchy; Rash (injection site) and is swollen and itchy; Rash (injection site) and is swollen and itchy; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PRURITUS (Rash (injection site) and is swollen and itchy), VACCINATION SITE RASH (Rash (injection site) and is swollen and itchy) and VACCINATION SITE SWELLING (Rash (injection site) and is swollen and itchy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Rash (injection site) and is swollen and itchy), VACCINATION SITE RASH (Rash (injection site) and is swollen and itchy) and VACCINATION SITE SWELLING (Rash (injection site) and is swollen and itchy). At the time of the report, VACCINATION SITE PRURITUS (Rash (injection site) and is swollen and itchy), VACCINATION SITE RASH (Rash (injection site) and is swollen and itchy) and VACCINATION SITE SWELLING (Rash (injection site) and is swollen and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported Treatment medications was not provided    This case was linked to MOD21-042633 (E2B Linked Report).; Sender's Comments:  MOD21-042633:Crosslinked
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: got sick after second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (got sick after second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to vaccine (allergies to other vaccines).    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 (got sick after second shot). At the time of the report, VACCINATION COMPLICATION (got sick after second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Slight soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Slight soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (Slight soreness). At the time of the report, PAIN (Slight soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown. The patient was scheduled for a mammogram.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Skin swelling
Clinical narrative: Her skin was a little puffy around the area for about a day; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SKIN SWELLING (Her skin was a little puffy around the area for about a day) and HEADACHE (Headache) in an 82-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 23-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced HEADACHE (Headache). On 23-Feb-2021, the patient experienced SKIN SWELLING (Her skin was a little puffy around the area for about a day). On 24-Feb-2021, SKIN SWELLING (Her skin was a little puffy around the area for about a day) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.            This case was linked to MOD-2021-032157 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Tremor
Clinical narrative: Shaking; Dizziness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), DIZZINESS (Dizziness) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) 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 CHILLS (Chills). On an unknown date, the patient experienced TREMOR (Shaking) and DIZZINESS (Dizziness). The patient was treated with NAPROXEN SODIUM (ALEVE) for Chills, at a dose of 1 dosage form. At the time of the report, TREMOR (Shaking), DIZZINESS (Dizziness) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dyspnoea, Dyspnoea exertional, Pyrexia
Clinical narrative: Couldn't get air in real good; Couldn't eat; Still is real weak; Hard to breath with exertion; Felt like she has COVID again; Threw up all night; Had fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Couldn't get air in real good), DECREASED APPETITE (Couldn't eat), ASTHENIA (Still is real weak), DYSPNOEA EXERTIONAL (Hard to breath with exertion) and SUSPECTED COVID-19 (Felt like she has COVID again) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 31-Dec-2020.    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 PYREXIA (Had fever). On an unknown date, the patient experienced DYSPNOEA (Couldn't get air in real good), DECREASED APPETITE (Couldn't eat), ASTHENIA (Still is real weak), DYSPNOEA EXERTIONAL (Hard to breath with exertion), SUSPECTED COVID-19 (Felt like she has COVID again) and VOMITING (Threw up all night). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of UNK dosage form. On 01-Mar-2021, PYREXIA (Had fever) had resolved. On 02-Mar-2021, DECREASED APPETITE (Couldn't eat) had resolved. At the time of the report, DYSPNOEA (Couldn't get air in real good), ASTHENIA (Still is real weak), DYSPNOEA EXERTIONAL (Hard to breath with exertion), SUSPECTED COVID-19 (Felt like she has COVID again) and VOMITING (Threw up all night) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up information received and contains significant information- Event outcome updated for the events Dyspnoea, Suspected COVID-19 and  Vomiting from Unknown to Recovered/ Resolved, and for the events Asthenia and Dyspnoea exertional  outcome updated from Not recovered / Not resolved to Recovered/ Resolved.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vomiting
Clinical narrative: Couldn't get air in real good; Couldn't eat; Still is real weak; Hard to breath with exertion; Felt like she has COVID again; Threw up all night; Had fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Couldn't get air in real good), DECREASED APPETITE (Couldn't eat), ASTHENIA (Still is real weak), DYSPNOEA EXERTIONAL (Hard to breath with exertion) and SUSPECTED COVID-19 (Felt like she has COVID again) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 31-Dec-2020.    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 PYREXIA (Had fever). On an unknown date, the patient experienced DYSPNOEA (Couldn't get air in real good), DECREASED APPETITE (Couldn't eat), ASTHENIA (Still is real weak), DYSPNOEA EXERTIONAL (Hard to breath with exertion), SUSPECTED COVID-19 (Felt like she has COVID again) and VOMITING (Threw up all night). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of UNK dosage form. On 01-Mar-2021, PYREXIA (Had fever) had resolved. On 02-Mar-2021, DECREASED APPETITE (Couldn't eat) had resolved. At the time of the report, DYSPNOEA (Couldn't get air in real good), ASTHENIA (Still is real weak), DYSPNOEA EXERTIONAL (Hard to breath with exertion), SUSPECTED COVID-19 (Felt like she has COVID again) and VOMITING (Threw up all night) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up information received and contains significant information- Event outcome updated for the events Dyspnoea, Suspected COVID-19 and  Vomiting from Unknown to Recovered/ Resolved, and for the events Asthenia and Dyspnoea exertional  outcome updated from Not recovered / Not resolved to Recovered/ Resolved.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain and soreness on the right side of his body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain and soreness on the right side of his body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced PAIN (pain and soreness on the right side of his body). In February 2021, PAIN (pain and soreness on the right side of his body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.    This case was linked to MOD-2021-033433 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 31-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02C1A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (twice weekly) from 11-Feb-2010 to 11-Apr-2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Sep-2020 to an unknown date for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 30-Sep-2020 and the estimated date of delivery was 07-Jul-2021. On 02-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy. The vaginal delivery occurred on 09-Jul-2021.  On 02-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2020, Pregnancy test: positive (Positive) positive. On 03-Mar-2021, Ultrasound scan: (normal) Routine ultrasound was reported.. On 25-Mar-2021, Blood glucose: normal (normal) Normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  The patient had live full term birth.   This case was linked to MOD-2021-270945 (Parent-Child Link).   See case MOD-2021-270945 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: significant follow up appended: Pregnancy outcome were reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Body aches; headaches; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), HEADACHE (headaches), PYREXIA (Fever) and CHILLS (Chills) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Chronic obstructive pulmonary disease and Immunodeficiency.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (Body aches), HEADACHE (headaches), PYREXIA (Fever) and CHILLS (Chills). On 05-Mar-2021, PAIN (Body aches), HEADACHE (headaches), PYREXIA (Fever) and CHILLS (Chills) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not reported.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Updated Batch/Lot number. Reporter information updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Developed a bad sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Developed a bad sinus infection) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced SINUSITIS (Developed a bad sinus infection). At the time of the report, SINUSITIS (Developed a bad sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Candida infection, Chapped lips, Dry mouth, Dysphagia, Gingival swelling
Clinical narrative: Dry mouth; Treated for thrush; Tonsils were swollen; Chapped lips; Gums swelled; Half of upper tongue are numb; Lips are numb; Difficult to swallow food; This spontaneous case was reported by a consumer and describes the occurrence of CANDIDA INFECTION (Treated for thrush), TONSILLAR HYPERTROPHY (Tonsils were swollen), CHAPPED LIPS (Chapped lips), GINGIVAL SWELLING (Gums swelled) and HYPOAESTHESIA ORAL (Half of upper tongue are numb) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced CANDIDA INFECTION (Treated for thrush), TONSILLAR HYPERTROPHY (Tonsils were swollen), CHAPPED LIPS (Chapped lips), GINGIVAL SWELLING (Gums swelled), HYPOAESTHESIA ORAL (Half of upper tongue are numb), HYPOAESTHESIA ORAL (Lips are numb) and DYSPHAGIA (Difficult to swallow food). On an unknown date, the patient experienced DRY MOUTH (Dry mouth). The patient was treated with FLUCONAZOLE from 18-Feb-2021 to 20-Feb-2021 at an unspecified dose and frequency; NYSTATIN from 18-Feb-2021 to 20-Feb-2021 at an unspecified dose and frequency and LIDOCAINE from 18-Feb-2021 to 20-Feb-2021 at an unspecified dose and frequency. At the time of the report, CANDIDA INFECTION (Treated for thrush), TONSILLAR HYPERTROPHY (Tonsils were swollen), CHAPPED LIPS (Chapped lips), GINGIVAL SWELLING (Gums swelled), HYPOAESTHESIA ORAL (Half of upper tongue are numb), HYPOAESTHESIA ORAL (Lips are numb), DYSPHAGIA (Difficult to swallow food) and DRY MOUTH (Dry mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient used CPAP 3 months prior to vaccine but unable to use it as she had dry mouth.  .   This case was linked to US-MODERNATX, INC.-MOD-2021-099506 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-099506:Wife case
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Tonsillar hypertrophy
Clinical narrative: Dry mouth; Treated for thrush; Tonsils were swollen; Chapped lips; Gums swelled; Half of upper tongue are numb; Lips are numb; Difficult to swallow food; This spontaneous case was reported by a consumer and describes the occurrence of CANDIDA INFECTION (Treated for thrush), TONSILLAR HYPERTROPHY (Tonsils were swollen), CHAPPED LIPS (Chapped lips), GINGIVAL SWELLING (Gums swelled) and HYPOAESTHESIA ORAL (Half of upper tongue are numb) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced CANDIDA INFECTION (Treated for thrush), TONSILLAR HYPERTROPHY (Tonsils were swollen), CHAPPED LIPS (Chapped lips), GINGIVAL SWELLING (Gums swelled), HYPOAESTHESIA ORAL (Half of upper tongue are numb), HYPOAESTHESIA ORAL (Lips are numb) and DYSPHAGIA (Difficult to swallow food). On an unknown date, the patient experienced DRY MOUTH (Dry mouth). The patient was treated with FLUCONAZOLE from 18-Feb-2021 to 20-Feb-2021 at an unspecified dose and frequency; NYSTATIN from 18-Feb-2021 to 20-Feb-2021 at an unspecified dose and frequency and LIDOCAINE from 18-Feb-2021 to 20-Feb-2021 at an unspecified dose and frequency. At the time of the report, CANDIDA INFECTION (Treated for thrush), TONSILLAR HYPERTROPHY (Tonsils were swollen), CHAPPED LIPS (Chapped lips), GINGIVAL SWELLING (Gums swelled), HYPOAESTHESIA ORAL (Half of upper tongue are numb), HYPOAESTHESIA ORAL (Lips are numb), DYSPHAGIA (Difficult to swallow food) and DRY MOUTH (Dry mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient used CPAP 3 months prior to vaccine but unable to use it as she had dry mouth.  .   This case was linked to US-MODERNATX, INC.-MOD-2021-099506 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-099506:Wife case