chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Pain in extremity, Rash
Clinical narrative: Allergic reaction rash; rash on both legs and on inside of both his fore arms; arm hurt for a few days; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction rash), PAIN IN EXTREMITY (arm hurt for a few days) and RASH (rash on both legs and on inside of both his fore arms) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 001A121A) for COVID-19 vaccination.     The patient's past medical history included Enlarged prostate. Concurrent medical conditions included Hypertension on 01-Jan-1999 and Asthma on 01-Mar-2019. Concomitant products included MOMETASONE FUROATE (ASMANEX) from 01-Mar-2019 to an unknown date for Asthma, ATORVASTATIN from 01-Jan-2000 to an unknown date for Blood cholesterol, FINASTERIDE from 21-Jan-2016 to an unknown date for Prostatomegaly, TAMSULOSIN from 21-Jan-2016 to an unknown date for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm hurt for a few days). On 01-Feb-2021, the patient experienced RASH (rash on both legs and on inside of both his fore arms). On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergic reaction rash). On 12-Feb-2021, ALLERGY TO VACCINE (Allergic reaction rash) and RASH (rash on both legs and on inside of both his fore arms) had resolved. At the time of the report, PAIN IN EXTREMITY (arm hurt for a few days) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Benadryl, Hydrocortisone cream, Clear Caladril   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: additional reporter information, medical history, concomitant medication ,second dose information, was added and outcome of the event was changed from unknown to resolved
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Peripheral swelling, Tenderness, Vaccination site induration
Clinical narrative: arm felt numb; arm hard to move due to pain; swollen arm; tender arm; arm hard under injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (arm felt numb), PAIN IN EXTREMITY (arm hard to move due to pain), PERIPHERAL SWELLING (swollen arm), TENDERNESS (tender arm) and VACCINATION SITE INDURATION (arm hard under injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 HYPOAESTHESIA (arm felt numb), PAIN IN EXTREMITY (arm hard to move due to pain), PERIPHERAL SWELLING (swollen arm), TENDERNESS (tender arm) and VACCINATION SITE INDURATION (arm hard under injection site). At the time of the report, HYPOAESTHESIA (arm felt numb), PAIN IN EXTREMITY (arm hard to move due to pain), PERIPHERAL SWELLING (swollen arm), TENDERNESS (tender arm) and VACCINATION SITE INDURATION (arm hard under injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Musculoskeletal stiffness, Sleep disorder, Somnolence
Clinical narrative: Stiffness over the body plus injection arm; slept for 12 straight on Friday; slept for 24 hours on Saturday; getting a little now except for sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness over the body plus injection arm), SLEEP DISORDER (slept for 12 straight on Friday), HYPERSOMNIA (slept for 24 hours on Saturday) and SOMNOLENCE (getting a little now except for sleepiness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) 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) dosage was changed to 1 dosage form. 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 MUSCULOSKELETAL STIFFNESS (Stiffness over the body plus injection arm), SLEEP DISORDER (slept for 12 straight on Friday), HYPERSOMNIA (slept for 24 hours on Saturday) and SOMNOLENCE (getting a little now except for sleepiness). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness over the body plus injection arm) was resolving and SLEEP DISORDER (slept for 12 straight on Friday), HYPERSOMNIA (slept for 24 hours on Saturday) and SOMNOLENCE (getting a little now except for sleepiness) outcome was unknown.            Patient stated that The second vaccine was not as bad as the first.  No concomitant medications were provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-264281 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Additional information was received on 22-JUL-2021 contains patient's demographics (gender and initials) and dose 2 information.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Hypoaesthesia, Lip swelling, Oral discomfort, Oropharyngeal discomfort
Clinical narrative: Face became numb; Lips began to swell; Her bottom lips was burning; Throat was scratchy; Ice tea burn as it was going down; Coughing; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Face became numb), LIP SWELLING (Lips began to swell), ORAL DISCOMFORT (Her bottom lips was burning), OROPHARYNGEAL DISCOMFORT (Throat was scratchy) and ORAL DISCOMFORT (Ice tea burn as it was going down) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Shellfish allergy.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced HYPOAESTHESIA (Face became numb), LIP SWELLING (Lips began to swell), ORAL DISCOMFORT (Her bottom lips was burning), OROPHARYNGEAL DISCOMFORT (Throat was scratchy), ORAL DISCOMFORT (Ice tea burn as it was going down) and COUGH (Coughing). At the time of the report, HYPOAESTHESIA (Face became numb), LIP SWELLING (Lips began to swell), ORAL DISCOMFORT (Her bottom lips was burning), OROPHARYNGEAL DISCOMFORT (Throat was scratchy), ORAL DISCOMFORT (Ice tea burn as it was going down) and COUGH (Coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: pretty bad Pressure in her chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (pretty bad Pressure in her chest) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 14M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Asthma, Diabetes and Allergy.    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 CHEST DISCOMFORT (pretty bad Pressure in her chest). At the time of the report, CHEST DISCOMFORT (pretty bad Pressure in her chest) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications blood pressure medications, asthma medications, sugar shots and allergy medicine. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Updated re-challenge field.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea, Sneezing
Clinical narrative: Sneezing; Runny nose; Dry cough; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing), RHINORRHOEA (Runny nose) and COUGH (Dry cough) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) 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 SNEEZING (Sneezing), RHINORRHOEA (Runny nose) and COUGH (Dry cough). At the time of the report, SNEEZING (Sneezing), RHINORRHOEA (Runny nose) and COUGH (Dry cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-029896 (E2B Linked Report).; Sender's Comments:  MOD-2021-029896:
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Feeling cold, Hypoaesthesia, Hypoaesthesia eye, Hypoaesthesia oral
Clinical narrative: face freezing; something is wrong; Face numbness and tingling; left arm numbness; neck numbness; lips numbness; eyes numbness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (face freezing), DISCOMFORT (something is wrong), HYPOAESTHESIA (Face numbness and tingling), HYPOAESTHESIA (left arm numbness) and HYPOAESTHESIA (neck numbness) in a female patient of an unknown age 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.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced FEELING COLD (face freezing), DISCOMFORT (something is wrong), HYPOAESTHESIA (Face numbness and tingling), HYPOAESTHESIA (left arm numbness), HYPOAESTHESIA (neck numbness), HYPOAESTHESIA ORAL (lips numbness) and HYPOAESTHESIA EYE (eyes numbness). At the time of the report, FEELING COLD (face freezing), DISCOMFORT (something is wrong), HYPOAESTHESIA (Face numbness and tingling), HYPOAESTHESIA (left arm numbness), HYPOAESTHESIA (neck numbness), HYPOAESTHESIA ORAL (lips numbness) and HYPOAESTHESIA EYE (eyes numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Illness, Myalgia
Clinical narrative: fatigue; headache; body aches; chills; violently sick; like covid again; smells exhaust fumes; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (violently sick), SYMPTOM RECURRENCE (like covid again), PAROSMIA (smells exhaust fumes), FATIGUE (fatigue) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included GABAPENTIN and CLOZAPINE for an unknown indication.    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 PAROSMIA (smells exhaust fumes). On 03-Feb-2021, the patient experienced ILLNESS (violently sick), SYMPTOM RECURRENCE (like covid again), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (body aches) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Feb-2021, ILLNESS (violently sick), SYMPTOM RECURRENCE (like covid again), HEADACHE (headache), MYALGIA (body aches) and CHILLS (chills) had resolved. At the time of the report, PAROSMIA (smells exhaust fumes) outcome was unknown and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Symptom recurrence
Clinical narrative: fatigue; headache; body aches; chills; violently sick; like covid again; smells exhaust fumes; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (violently sick), SYMPTOM RECURRENCE (like covid again), PAROSMIA (smells exhaust fumes), FATIGUE (fatigue) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included GABAPENTIN and CLOZAPINE for an unknown indication.    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 PAROSMIA (smells exhaust fumes). On 03-Feb-2021, the patient experienced ILLNESS (violently sick), SYMPTOM RECURRENCE (like covid again), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (body aches) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Feb-2021, ILLNESS (violently sick), SYMPTOM RECURRENCE (like covid again), HEADACHE (headache), MYALGIA (body aches) and CHILLS (chills) had resolved. At the time of the report, PAROSMIA (smells exhaust fumes) outcome was unknown and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Throat tightness
Clinical narrative: Throat closing; Joint pain in shoulder; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Throat closing) and ARTHRALGIA (Joint pain in shoulder) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple myeloma.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced THROAT TIGHTNESS (Throat closing) and ARTHRALGIA (Joint pain in shoulder). On 24-Feb-2021, THROAT TIGHTNESS (Throat closing) had resolved. On 27-Feb-2021, ARTHRALGIA (Joint pain in shoulder) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis allergic, Rash
Clinical narrative: Allergic dermatitis; Rash all over his body (looks like the rash people get from having COVID-19); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (Allergic dermatitis) and RASH (Rash all over his body (looks like the rash people get from having COVID-19)) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L204) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus. Concomitant products included INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN 30/70), GLIPIZIDE, ATORVASTATIN, CALCIUM and ALLOPURINOL for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced RASH (Rash all over his body (looks like the rash people get from having COVID-19)). On an unknown date, the patient experienced DERMATITIS ALLERGIC (Allergic dermatitis). At the time of the report, DERMATITIS ALLERGIC (Allergic dermatitis) and RASH (Rash all over his body (looks like the rash people get from having COVID-19)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Dizziness, Feeling hot, Headache
Clinical narrative: Face feels hot; Dizzy; Upset stomach; No appetite; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Face feels hot), DIZZINESS (Dizzy), ABDOMINAL DISCOMFORT (Upset stomach), DECREASED APPETITE (No appetite) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer and Breast cancer.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced FEELING HOT (Face feels hot), DIZZINESS (Dizzy), ABDOMINAL DISCOMFORT (Upset stomach), DECREASED APPETITE (No appetite) and HEADACHE (Headache). At the time of the report, FEELING HOT (Face feels hot), DIZZINESS (Dizzy), ABDOMINAL DISCOMFORT (Upset stomach), DECREASED APPETITE (No appetite) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment medication included Tylenol (paracetamol) and taking Tylenol was helping somewhat.
Sex: F
Vaccine: COVID19
Symptoms: Endodontic procedure
Clinical narrative: Root canal; This spontaneous case was reported by a consumer and describes the occurrence of ENDODONTIC PROCEDURE (Root canal) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ENDODONTIC PROCEDURE (Root canal). The patient was treated with AMOXICILLIN at an unspecified dose and frequency. On 08-Feb-2021, ENDODONTIC PROCEDURE (Root canal) had 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: visual disturbances/saw "a small elongated triangle that was orange in color"/saw "a small elongated triangle that was blue in color"; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (visual disturbances/saw "a small elongated triangle that was orange in color"/saw "a small elongated triangle that was blue in color") in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Macular degeneration ((wet, dry)), Arthritis, Asthma, Coronary artery disease, Diverticulosis, Barrett's esophagus (Barrett's esophagus III), GERD and Glaucoma (Suspected glaucoma). Concomitant products included MONTELUKAST SODIUM (SINGULAIR), AMLODIPINE BESILATE (NORVASC), EZETIMIBE (ZETIA), CELECOXIB (CELEBREX), DEXLANSOPRAZOLE (DEXILANT), ROSUVASTATIN CALCIUM (CRESTOR), FAMOTIDINE (PEPCID [FAMOTIDINE]), ASCORBIC ACID, CUPRIC OXIDE, DL-ALPHA TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (PRESERVISION AREDS 2), FISH OIL, UBIDECARENONE (CO Q-10), THIAMINE HYDROCHLORIDE (VITAMIN B-6), THIAMINE HYDROCHLORIDE (VITAMIN B-12), BRIMONIDINE TARTRATE, BRINZOLAMIDE (SIMBRINZA), DICLOFENAC (VOLTAREN [DICLOFENAC]), RANIBIZUMAB (LUCENTIS) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VISUAL IMPAIRMENT (visual disturbances/saw "a small elongated triangle that was orange in color"/saw "a small elongated triangle that was blue in color"). On 09-Feb-2021, VISUAL IMPAIRMENT (visual disturbances/saw "a small elongated triangle that was orange in color"/saw "a small elongated triangle that was blue in color") had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Pruritus, Vaccination site pain
Clinical narrative: arm was itchy; arm was warm to the touch; Aching arm; arm was red from her shoulder to her elbow; bit sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm was itchy), FEELING HOT (arm was warm to the touch), PAIN IN EXTREMITY (Aching arm), ERYTHEMA (arm was red from her shoulder to her elbow) and VACCINATION SITE PAIN (bit sore at injection site) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy and Drug allergy (Dilaudid, her throat started to close (post-surgery for hip replacement).).    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 PRURITUS (arm was itchy), FEELING HOT (arm was warm to the touch), PAIN IN EXTREMITY (Aching arm), ERYTHEMA (arm was red from her shoulder to her elbow) and VACCINATION SITE PAIN (bit sore at injection site). At the time of the report, PRURITUS (arm was itchy), FEELING HOT (arm was warm to the touch) and PAIN IN EXTREMITY (Aching arm) outcome was unknown and ERYTHEMA (arm was red from her shoulder to her elbow) and VACCINATION SITE PAIN (bit sore at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. Patients doctor immediately put her on an antibiotic in case of cellulitis
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Covid exposure after 1 dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Covid exposure after 1 dose) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025S20A) for COVID-19 vaccination.     Concomitant products included LORAZEPAM from 05-Feb-2021 to an unknown date for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Covid exposure after 1 dose). At the time of the report, EXPOSURE TO SARS-COV-2 (Covid exposure after 1 dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received on 21-JUL-2021 contains: Updated contact details- Email ID;
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Lethargy
Clinical narrative: Post nasal drip sore throat; Muscle pain; Tired and Exhausted; Fever; Headache; Chills; Feeling sick; Lethargic; Sore throat; Running nose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), LETHARGY (Lethargic), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Running nose) and UPPER-AIRWAY COUGH SYNDROME (Post nasal drip sore throat) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]), LOSARTAN, AMLODIPINE, ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), LEVOCETIRIZINE, ESCITALOPRAM OXALATE (LEXAPRO) and LAMOTRIGINE for an unknown indication.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced MALAISE (Feeling sick), LETHARGY (Lethargic), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Running nose), MYALGIA (Muscle pain), FATIGUE (Tired and Exhausted), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills). On 10-Feb-2021, the patient experienced UPPER-AIRWAY COUGH SYNDROME (Post nasal drip sore throat). At the time of the report, MALAISE (Feeling sick), LETHARGY (Lethargic), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Running nose), MYALGIA (Muscle pain), FATIGUE (Tired and Exhausted), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) was resolving and UPPER-AIRWAY COUGH SYNDROME (Post nasal drip sore throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 100.7 (High) degree Fahrenheit.         No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Post nasal drip sore throat; Muscle pain; Tired and Exhausted; Fever; Headache; Chills; Feeling sick; Lethargic; Sore throat; Running nose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), LETHARGY (Lethargic), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Running nose) and UPPER-AIRWAY COUGH SYNDROME (Post nasal drip sore throat) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]), LOSARTAN, AMLODIPINE, ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), LEVOCETIRIZINE, ESCITALOPRAM OXALATE (LEXAPRO) and LAMOTRIGINE for an unknown indication.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced MALAISE (Feeling sick), LETHARGY (Lethargic), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Running nose), MYALGIA (Muscle pain), FATIGUE (Tired and Exhausted), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills). On 10-Feb-2021, the patient experienced UPPER-AIRWAY COUGH SYNDROME (Post nasal drip sore throat). At the time of the report, MALAISE (Feeling sick), LETHARGY (Lethargic), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Running nose), MYALGIA (Muscle pain), FATIGUE (Tired and Exhausted), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) was resolving and UPPER-AIRWAY COUGH SYNDROME (Post nasal drip sore throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 100.7 (High) degree Fahrenheit.         No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome
Clinical narrative: Post nasal drip sore throat; Muscle pain; Tired and Exhausted; Fever; Headache; Chills; Feeling sick; Lethargic; Sore throat; Running nose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), LETHARGY (Lethargic), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Running nose) and UPPER-AIRWAY COUGH SYNDROME (Post nasal drip sore throat) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]), LOSARTAN, AMLODIPINE, ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), LEVOCETIRIZINE, ESCITALOPRAM OXALATE (LEXAPRO) and LAMOTRIGINE for an unknown indication.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced MALAISE (Feeling sick), LETHARGY (Lethargic), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Running nose), MYALGIA (Muscle pain), FATIGUE (Tired and Exhausted), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills). On 10-Feb-2021, the patient experienced UPPER-AIRWAY COUGH SYNDROME (Post nasal drip sore throat). At the time of the report, MALAISE (Feeling sick), LETHARGY (Lethargic), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Running nose), MYALGIA (Muscle pain), FATIGUE (Tired and Exhausted), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) was resolving and UPPER-AIRWAY COUGH SYNDROME (Post nasal drip sore throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 100.7 (High) degree Fahrenheit.         No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Erythema, Fatigue, Insomnia
Clinical narrative: hands and feet are beet red; hands and feet are swollen; not been able to sleep; severe sunburn that is very very painful and feels like she is on fire; severe sunburn that is very very painful and feels like she is on fire; severe sunburn that is very very painful and feels like she is on fire; rash hot and burning; big red rash on back that spread over entire body / rash on the back/ rash all over from stomach to legs/rash on arms/rash on chest; extremely exhausted; nervous; pain at the injection site; red at injection site; chills; shakiness /feels like has the shakes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (hands and feet are beet red), PERIPHERAL SWELLING (hands and feet are swollen), INSOMNIA (not been able to sleep), PAIN OF SKIN (severe sunburn that is very very painful and feels like she is on fire) and SUNBURN (severe sunburn that is very very painful and feels like she is on fire) in a 36-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 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red at injection site). On an unknown date, the patient experienced ERYTHEMA (hands and feet are beet red), PERIPHERAL SWELLING (hands and feet are swollen), INSOMNIA (not been able to sleep), PAIN OF SKIN (severe sunburn that is very very painful and feels like she is on fire), SUNBURN (severe sunburn that is very very painful and feels like she is on fire) and SKIN BURNING SENSATION (severe sunburn that is very very painful and feels like she is on fire). The patient was treated with ALUMINIUM HYDROXIDE, MAGNESIUM TRISILICATE, SODIUM ALGINATE (PEPCID [ALUMINIUM HYDROXIDE;MAGNESIUM TRISILICATE;SODIUM ALGINATE]) for Adverse event, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Adverse event, at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (hands and feet are beet red), PERIPHERAL SWELLING (hands and feet are swollen), INSOMNIA (not been able to sleep), PAIN OF SKIN (severe sunburn that is very very painful and feels like she is on fire), SUNBURN (severe sunburn that is very very painful and feels like she is on fire), SKIN BURNING SENSATION (severe sunburn that is very very painful and feels like she is on fire) and VACCINATION SITE ERYTHEMA (red at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: No specific follow-up information recorded.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Malaise, Vaccination site erythema
Clinical narrative: Not well; Big red circle around injection site/affected area 2.5 inches on arm/could see hole in arm; 2nd dose scheduled 45 days after the first dose; A spontaneous report was received from an 87-year-old female patient concerning herself who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced events of not well, big red circle around injection site/affected area 2.5 inches on arm/could see hole in arm, and the 2nd dose scheduled 45 days after the first dose.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, 4 days prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (Batch number: 029L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. The 2nd dose was scheduled 45 days after the first dose.   On an unknown date, the patient was not well. On an unknown date, the patient experienced big red circle around injection site. The affected area was 2.5 inches on arm. The patient stated could see hole in arm. It lasted for 6 days and went away.   The patient did not take any treatment, went away on own.   Action taken with mRNA-1273 in response to the events was unknown.  The event of 2nd dose scheduled 45 days after the first dose was considered resolved, while the outcome of the events of not well, big red circle around injection site/affected area 2.5 inches on arm/could see hole in arm was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: Developed low grade fever, of 99.5 that still persists; Sore arm, nothing major; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm, nothing major) and PYREXIA (Developed low grade fever, of 99.5 that still persists) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm, nothing major). On 01-Mar-2021, the patient experienced PYREXIA (Developed low grade fever, of 99.5 that still persists). At the time of the report, PAIN IN EXTREMITY (Sore arm, nothing major) outcome was unknown and PYREXIA (Developed low grade fever, of 99.5 that still persists) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Body temperature: 99.5 (High) Fever.         No relevant concomitant medications were reported.   No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Face was flushed; tingling in her cheeks, lips, and tongue - "that feeling you get when you apply those lip pumping lipsticks."; numbness in her cheeks, lips, and tongue - "that feeling you get when you apply those lip pumping lipsticks."; This spontaneous case was reported by a nurse and describes the occurrence of FLUSHING (Face was flushed), PARAESTHESIA ORAL (tingling in her cheeks, lips, and tongue - "that feeling you get when you apply those lip pumping lipsticks.") and HYPOAESTHESIA ORAL (numbness in her cheeks, lips, and tongue - "that feeling you get when you apply those lip pumping lipsticks.") in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 11A21A and 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 2008 and Prediabetes. Concomitant products included LISINOPRIL from an unknown date to 23-Mar-2021 and LOSARTAN from 24-Mar-2021 to an unknown date for Hypertension, METFORMIN for Prediabetes, ZINC, ASCORBIC ACID (VIT C), DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID, TOCOPHEROL (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]), METHYL B COMPLEX and ACETYLCYSTEINE (NAC [ACETYLCYSTEINE]) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced FLUSHING (Face was flushed), PARAESTHESIA ORAL (tingling in her cheeks, lips, and tongue - "that feeling you get when you apply those lip pumping lipsticks.") and HYPOAESTHESIA ORAL (numbness in her cheeks, lips, and tongue - "that feeling you get when you apply those lip pumping lipsticks."). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. On 01-Mar-2021, FLUSHING (Face was flushed) and PARAESTHESIA ORAL (tingling in her cheeks, lips, and tongue - "that feeling you get when you apply those lip pumping lipsticks.") had resolved. At the time of the report, HYPOAESTHESIA ORAL (numbness in her cheeks, lips, and tongue - "that feeling you get when you apply those lip pumping lipsticks.") was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-208021 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Other relevant history, treatment drugs, concomitant medications and event were added.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm of injection warm to touch; itchy rash of 5-6 inches high to 3-4 inches wide; arm of injection swollen; arm of injection slightly sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm of injection warm to touch), VACCINATION SITE RASH (itchy rash of 5-6 inches high to 3-4 inches wide), VACCINATION SITE SWELLING (arm of injection swollen) and MYALGIA (arm of injection slightly sore) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concomitant products included BLOOD PRESSURE MEDICINE, MELOXICAM, VITAMINS NOS, SUPPLEMENTS and ALUMINIUM SULFATE, CALCIUM ACETATE (ASTRINGENT SOLUTION) for an unknown indication.    On 03-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 WARMTH (arm of injection warm to touch), VACCINATION SITE RASH (itchy rash of 5-6 inches high to 3-4 inches wide), VACCINATION SITE SWELLING (arm of injection swollen) and MYALGIA (arm of injection slightly sore). At the time of the report, VACCINATION SITE WARMTH (arm of injection warm to touch), VACCINATION SITE RASH (itchy rash of 5-6 inches high to 3-4 inches wide), VACCINATION SITE SWELLING (arm of injection swollen) and MYALGIA (arm of injection slightly sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment for the event included asper cream (OTC) that helps with the itch.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash morbilliform, Rash pruritic
Clinical narrative: kind of looks like measles; a rash between fingers and on the backs of hands; rash.. that itches; This spontaneous case was reported by an other and describes the occurrence of RASH MORBILLIFORM (kind of looks like measles), RASH (a rash between fingers and on the backs of hands) and RASH PRURITIC (rash.. that itches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH MORBILLIFORM (kind of looks like measles), RASH (a rash between fingers and on the backs of hands) and RASH PRURITIC (rash.. that itches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and TOPICAL STEROIDS at an unspecified dose and frequency. At the time of the report, RASH MORBILLIFORM (kind of looks like measles), RASH (a rash between fingers and on the backs of hands) and RASH PRURITIC (rash. that itches) was resolving.            No relevant concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported. Treatment details included Ice Pack.    Reporter did not allow further contact
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-047108 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Body ache; soreness at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache) and VACCINATION SITE PAIN (soreness at site of injection) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced MYALGIA (Body ache) and VACCINATION SITE PAIN (soreness at site of injection). At the time of the report, MYALGIA (Body ache) and VACCINATION SITE PAIN (soreness at site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Tinnitus
Clinical narrative: difficulty swallowing without water; tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (difficulty swallowing without water) and TINNITUS (tinnitus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-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 DYSPHAGIA (difficulty swallowing without water) and TINNITUS (tinnitus). At the time of the report, DYSPHAGIA (difficulty swallowing without water) and TINNITUS (tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: There is a red circle around the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (There is a red circle around the shot) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for Headache.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (There is a red circle around the shot). At the time of the report, VACCINATION SITE ERYTHEMA (There is a red circle around the shot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.