chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Axillary mass, Dyspnoea, Intentional product use issue, Pruritus
Clinical narrative: trouble breathing; rash going down inner thighs and back; Took second dose with a gap of 94 days; armpit lump; felt panicky; itching; Welt; This spontaneous case was reported by a patient and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Took second dose with a gap of 94 days), PRURITUS (itching), URTICARIA (Welt), ANXIETY (felt panicky) and DYSPNOEA (trouble breathing) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seasonal allergy since an unknown date. Concurrent medical conditions included Seafood allergy (Crab allergy was reported), Penicillin allergy (Allergic to penicillin, versed and anesthetics), Asthma (The patient reports she has slight asthma) and Anesthesia. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Depression.   On 12-Jan-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced PRURITUS (itching) and URTICARIA (Welt). On 26-Jan-2021, the patient experienced ANXIETY (felt panicky). On 03-Feb-2021, the patient experienced AXILLARY MASS (armpit lump). On 16-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Took second dose with a gap of 94 days). On an unknown date, the patient experienced DYSPNOEA (trouble breathing) and RASH (rash going down inner thighs and back). On 16-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (Took second dose with a gap of 94 days) had resolved. At the time of the report, PRURITUS (itching), URTICARIA (Welt), ANXIETY (felt panicky), DYSPNOEA (trouble breathing), AXILLARY MASS (armpit lump) and RASH (rash going down inner thighs and back) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Benadryl, Hydrocortisone cream 4 times a day was recommended treatment by Dr for itching, red, baseball size welt on 18-JAN-2021. On 25-JAN-2021 the reported began having trouble breathing, feelin panicky, in which Dr prescribed Medrol Pack, Benadryl, and Cortisone Cream.  Action taken with mRNA-1273 in response to the event was not applicable.  The patient also reports that she have O+ blood type.       Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Significant Follow up Appended - new reporter added
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: trouble breathing; rash going down inner thighs and back; Took second dose with a gap of 94 days; armpit lump; felt panicky; itching; Welt; This spontaneous case was reported by a patient and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Took second dose with a gap of 94 days), PRURITUS (itching), URTICARIA (Welt), ANXIETY (felt panicky) and DYSPNOEA (trouble breathing) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seasonal allergy since an unknown date. Concurrent medical conditions included Seafood allergy (Crab allergy was reported), Penicillin allergy (Allergic to penicillin, versed and anesthetics), Asthma (The patient reports she has slight asthma) and Anesthesia. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Depression.   On 12-Jan-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced PRURITUS (itching) and URTICARIA (Welt). On 26-Jan-2021, the patient experienced ANXIETY (felt panicky). On 03-Feb-2021, the patient experienced AXILLARY MASS (armpit lump). On 16-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Took second dose with a gap of 94 days). On an unknown date, the patient experienced DYSPNOEA (trouble breathing) and RASH (rash going down inner thighs and back). On 16-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (Took second dose with a gap of 94 days) had resolved. At the time of the report, PRURITUS (itching), URTICARIA (Welt), ANXIETY (felt panicky), DYSPNOEA (trouble breathing), AXILLARY MASS (armpit lump) and RASH (rash going down inner thighs and back) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Benadryl, Hydrocortisone cream 4 times a day was recommended treatment by Dr for itching, red, baseball size welt on 18-JAN-2021. On 25-JAN-2021 the reported began having trouble breathing, feelin panicky, in which Dr prescribed Medrol Pack, Benadryl, and Cortisone Cream.  Action taken with mRNA-1273 in response to the event was not applicable.  The patient also reports that she have O+ blood type.       Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Significant Follow up Appended - new reporter added
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: body aches; chills; fever; headache; fatigue; severe vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), CHILLS (chills), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced PAIN (body aches), CHILLS (chills), PYREXIA (fever), HEADACHE (headache), FATIGUE (fatigue) and VOMITING (severe vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (body aches), CHILLS (chills), PYREXIA (fever), HEADACHE (headache), FATIGUE (fatigue) and VOMITING (severe vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history and relevant concomitant medications weren't reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: body aches; chills; fever; headache; fatigue; severe vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), CHILLS (chills), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced PAIN (body aches), CHILLS (chills), PYREXIA (fever), HEADACHE (headache), FATIGUE (fatigue) and VOMITING (severe vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (body aches), CHILLS (chills), PYREXIA (fever), HEADACHE (headache), FATIGUE (fatigue) and VOMITING (severe vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history and relevant concomitant medications weren't reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: migratory arthralgia in right foot; This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (migratory arthralgia in right foot) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Ammoniacal dermatitis (Allergic to ammonia in Hair dye), Myasthenia gravis on 01-Jan-2012 and Lymphoma.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021 at 1:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced ARTHRALGIA (migratory arthralgia in right foot). At the time of the report, ARTHRALGIA (migratory arthralgia in right foot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's relevant concomitant medications weren't reported Treatment medication include Benadryl before and after vaccination.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left arm sore; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (left arm sore) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Sluggish thinking (Fell, Sluggish Memory). Concurrent medical conditions included Vitamin D deficiency, Sickness (relapse), Diarrhea, Multiple sclerosis (Stage 1) and Dysgraphia (Hazy Memory). Concomitant products included OCRELIZUMAB (OCREVUS), LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), VITAMIN D2, VITAMIN B12 [VITAMIN B12 NOS], FERROUS SULFATE and PARACETAMOL (TYLENOL) for an unknown indication.    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (left arm sore). At the time of the report, PAIN IN EXTREMITY (left arm sore) had not resolved.            No treatment information provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Influenza like illness, Injection site mass, Swelling
Clinical narrative: lump swelled up to size of boiled egg; flu like symptoms; lump developed in lower part of neck; redness; swelling; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), SWELLING (lump developed in lower part of neck), ERYTHEMA (redness), SWELLING (swelling) and INJECTION SITE MASS (lump swelled up to size of boiled egg) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ADALIMUMAB (HUMIRA) for Skin discomfort.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), SWELLING (lump developed in lower part of neck), ERYTHEMA (redness) and SWELLING (swelling). On an unknown date, the patient experienced INJECTION SITE MASS (lump swelled up to size of boiled egg). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), ERYTHEMA (redness) and INJECTION SITE MASS (lump swelled up to size of boiled egg) outcome was unknown and SWELLING (lump developed in lower part of neck) and SWELLING (swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia, Sleep disorder
Clinical narrative: wake in night; General malaise; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (wake in night), MALAISE (General malaise), CHILLS (Chills) and PYREXIA (Fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Ciprofloxacin), Drug allergy (Levaquin), Blood pressure high and Osteoporosis. Concomitant products included OLMESARTAN from 15-Aug-2018 to an unknown date for Blood pressure high, DENOSUMAB (PROLIA) from 01-Jun-2018 to an unknown date and CALCIUM for Osteoporosis.   On 17-Jan-2021 at 12:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021 at 12:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021 at 1:00 AM, the patient experienced SLEEP DISORDER (wake in night). 15-Feb-2021 at 1:00 AM, the patient experienced MALAISE (General malaise), CHILLS (Chills) and PYREXIA (Fever). On 16-Feb-2021, SLEEP DISORDER (wake in night), MALAISE (General malaise), CHILLS (Chills) and PYREXIA (Fever) had resolved.            The patient took Tylenol, slept and felt okay.   This case was linked to MOD-2021-025359, MOD-2021-025359 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DYSGEUSIA (Metallic taste in mouth) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Metallic taste in mouth). At the time of the report, DYSGEUSIA (Metallic taste in mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rash
Clinical narrative: Tingling of lower legs; Rash on lower leg; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA (Tingling of lower legs) and RASH (Rash on lower leg) in a 49-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PARAESTHESIA (Tingling of lower legs) and RASH (Rash on lower leg). At the time of the report, PARAESTHESIA (Tingling of lower legs) and RASH (Rash on lower leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information was provided.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Jaundice
Clinical narrative: Jaundice; This spontaneous case was reported by an other health care professional and describes the occurrence of JAUNDICE (Jaundice) in a neonate male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced JAUNDICE (Jaundice). At the time of the report, JAUNDICE (Jaundice) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-020512 (Parent-Child Link).   See case MOD-2021-020512 for details regarding the child case.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: not feel better until 16 hours after the vaccination; Fever for four hours; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (not feel better until 16 hours after the vaccination) and PYREXIA (Fever for four hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (not feel better until 16 hours after the vaccination) and PYREXIA (Fever for four hours). At the time of the report, FEELING ABNORMAL (not feel better until 16 hours after the vaccination) and PYREXIA (Fever for four hours) 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.   Concomitant product use was not provided. Treatment information were not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Oral herpes, Pain in extremity
Clinical narrative: huge cold sore; some arm soreness upon reaching; some redness & itching around injection site; some redness & itching around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (some arm soreness upon reaching), INJECTION SITE ERYTHEMA (some redness & itching around injection site), INJECTION SITE PRURITUS (some redness & itching around injection site) and ORAL HERPES (huge cold sore) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20N) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (sulfa), Iodine allergy, Drug allergy (Bacitracin), Hypothyroidism (since 1973), Psoriasis (since 1993), Paroxysmal ventricular tachycardia (since 2014), High cholesterol and Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, ATORVASTATIN for High cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, METOPROLOL for Paroxysmal ventricular tachycardia, MELATONIN for an unknown indication.    On 15-Feb-2021 at 2:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (some arm soreness upon reaching), INJECTION SITE ERYTHEMA (some redness & itching around injection site) and INJECTION SITE PRURITUS (some redness & itching around injection site). On 23-Feb-2021, the patient experienced ORAL HERPES (huge cold sore). The patient was treated with DOCOSANOL (ABREVA) in February 2021 for Oral herpes, at a dose of 1 dosage form. On 18-Feb-2021, PAIN IN EXTREMITY (some arm soreness upon reaching) had resolved. On 20-Feb-2021, INJECTION SITE ERYTHEMA (some redness & itching around injection site) had resolved. On 22-Feb-2021, INJECTION SITE PRURITUS (some redness & itching around injection site) had resolved. On 08-Mar-2021, ORAL HERPES (huge cold sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-080849 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up report included updates on patient height, weight, race, ethnicity, medical history, batch number of vaccine, concomitant medications, event outcome, treatment medication and causality.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: lost taste; lost smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost taste) and ANOSMIA (lost smell) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced AGEUSIA (lost taste) and ANOSMIA (lost smell). On 19-Mar-2021, AGEUSIA (lost taste) and ANOSMIA (lost smell) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment included acetaminophen.   This case was linked to MOD-2021-080846 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Very sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Very sore arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Very sore arm). At the time of the report, PAIN IN EXTREMITY (Very sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant Medications were not reported. Treatment information  was not reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Hypoaesthesia oral, Influenza like illness
Clinical narrative: chills; very tired; fever; body aches; itchy at the injection site; Top of her lip is numb; light headed/ dizziness; feels like blisters in the bottom of her lip; feels itchy in the bottom of her lip; felt like she had flu; hot at the injection site; injection site was swollen; sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site was swollen), VACCINATION SITE PAIN (sore at the injection site), CHILLS (chills), FATIGUE (very tired) and PYREXIA (fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE SWELLING (injection site was swollen), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE WARMTH (hot at the injection site). On 16-Apr-2021, the patient experienced CHILLS (chills), FATIGUE (very tired), PYREXIA (fever), MYALGIA (body aches), VACCINATION SITE PRURITUS (itchy at the injection site), HYPOAESTHESIA ORAL (Top of her lip is numb), DIZZINESS (light headed/ dizziness), ORAL MUCOSAL BLISTERING (feels like blisters in the bottom of her lip), PRURITUS (feels itchy in the bottom of her lip) and INFLUENZA LIKE ILLNESS (felt like she had flu). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. On 17-Apr-2021, VACCINATION SITE SWELLING (injection site was swollen), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE WARMTH (hot at the injection site) had resolved. On 18-Apr-2021, CHILLS (chills), PYREXIA (fever), MYALGIA (body aches), VACCINATION SITE PRURITUS (itchy at the injection site), HYPOAESTHESIA ORAL (Top of her lip is numb), ORAL MUCOSAL BLISTERING (feels like blisters in the bottom of her lip), PRURITUS (feels itchy in the bottom of her lip) and INFLUENZA LIKE ILLNESS (felt like she had flu) had resolved. At the time of the report, FATIGUE (very tired) and DIZZINESS (light headed/ dizziness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided .   This case was linked to MOD-2021-080834 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oral mucosal blistering, Pruritus, Pyrexia, Vaccination site pain
Clinical narrative: chills; very tired; fever; body aches; itchy at the injection site; Top of her lip is numb; light headed/ dizziness; feels like blisters in the bottom of her lip; feels itchy in the bottom of her lip; felt like she had flu; hot at the injection site; injection site was swollen; sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site was swollen), VACCINATION SITE PAIN (sore at the injection site), CHILLS (chills), FATIGUE (very tired) and PYREXIA (fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE SWELLING (injection site was swollen), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE WARMTH (hot at the injection site). On 16-Apr-2021, the patient experienced CHILLS (chills), FATIGUE (very tired), PYREXIA (fever), MYALGIA (body aches), VACCINATION SITE PRURITUS (itchy at the injection site), HYPOAESTHESIA ORAL (Top of her lip is numb), DIZZINESS (light headed/ dizziness), ORAL MUCOSAL BLISTERING (feels like blisters in the bottom of her lip), PRURITUS (feels itchy in the bottom of her lip) and INFLUENZA LIKE ILLNESS (felt like she had flu). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. On 17-Apr-2021, VACCINATION SITE SWELLING (injection site was swollen), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE WARMTH (hot at the injection site) had resolved. On 18-Apr-2021, CHILLS (chills), PYREXIA (fever), MYALGIA (body aches), VACCINATION SITE PRURITUS (itchy at the injection site), HYPOAESTHESIA ORAL (Top of her lip is numb), ORAL MUCOSAL BLISTERING (feels like blisters in the bottom of her lip), PRURITUS (feels itchy in the bottom of her lip) and INFLUENZA LIKE ILLNESS (felt like she had flu) had resolved. At the time of the report, FATIGUE (very tired) and DIZZINESS (light headed/ dizziness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided .   This case was linked to MOD-2021-080834 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: chills; very tired; fever; body aches; itchy at the injection site; Top of her lip is numb; light headed/ dizziness; feels like blisters in the bottom of her lip; feels itchy in the bottom of her lip; felt like she had flu; hot at the injection site; injection site was swollen; sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site was swollen), VACCINATION SITE PAIN (sore at the injection site), CHILLS (chills), FATIGUE (very tired) and PYREXIA (fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE SWELLING (injection site was swollen), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE WARMTH (hot at the injection site). On 16-Apr-2021, the patient experienced CHILLS (chills), FATIGUE (very tired), PYREXIA (fever), MYALGIA (body aches), VACCINATION SITE PRURITUS (itchy at the injection site), HYPOAESTHESIA ORAL (Top of her lip is numb), DIZZINESS (light headed/ dizziness), ORAL MUCOSAL BLISTERING (feels like blisters in the bottom of her lip), PRURITUS (feels itchy in the bottom of her lip) and INFLUENZA LIKE ILLNESS (felt like she had flu). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. On 17-Apr-2021, VACCINATION SITE SWELLING (injection site was swollen), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE WARMTH (hot at the injection site) had resolved. On 18-Apr-2021, CHILLS (chills), PYREXIA (fever), MYALGIA (body aches), VACCINATION SITE PRURITUS (itchy at the injection site), HYPOAESTHESIA ORAL (Top of her lip is numb), ORAL MUCOSAL BLISTERING (feels like blisters in the bottom of her lip), PRURITUS (feels itchy in the bottom of her lip) and INFLUENZA LIKE ILLNESS (felt like she had flu) had resolved. At the time of the report, FATIGUE (very tired) and DIZZINESS (light headed/ dizziness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided .   This case was linked to MOD-2021-080834 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Pyrexia, Rash
Clinical narrative: Some malaise first week; ocular migraines-brief; woke up one day with rash on breasts for 2 days; usually get with fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Some malaise first week), MIGRAINE (ocular migraines-brief), RASH (woke up one day with rash on breasts for 2 days) and PYREXIA (usually get with fever) 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 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Some malaise first week), MIGRAINE (ocular migraines-brief), RASH (woke up one day with rash on breasts for 2 days) and PYREXIA (usually get with fever). At the time of the report, MALAISE (Some malaise first week), MIGRAINE (ocular migraines-brief), RASH (woke up one day with rash on breasts for 2 days) and PYREXIA (usually get with fever) outcome was unknown.            No concomitant medications were reported. No treatment information was provided for the events.   This case was linked to MOD-2021-080820 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: itching at the site of injection; redness at the site of injection/circular 7cm top to bottom and 7cm right to left; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the site of injection) and VACCINATION SITE ERYTHEMA (redness at the site of injection/circular 7cm top to bottom and 7cm right to left) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma and Overactive bladder. Concomitant products included TIMOLOL for Glaucoma, TOLTERODINE L-TARTRATE (DETROL LA) for Overactive bladder, MULTIVITAMIN IRON for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the site of injection) and VACCINATION SITE ERYTHEMA (redness at the site of injection/circular 7cm top to bottom and 7cm right to left). At the time of the report, VACCINATION SITE PRURITUS (itching at the site of injection) and VACCINATION SITE ERYTHEMA (redness at the site of injection/circular 7cm top to bottom and 7cm right to left) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive any treatment for the event.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Nasal congestion, Oropharyngeal pain
Clinical narrative: sore throat; congested; tired; not feeling great; chills; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (not feeling great), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congested), CHILLS (chills) and FATIGUE (tired) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced CHILLS (chills). On 19-Apr-2021, the patient experienced MALAISE (not feeling great). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congested) and FATIGUE (tired). At the time of the report, MALAISE (not feeling great), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congested), CHILLS (chills) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medications included cold and flu medication.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: sweats; site pain/redness; site pain/redness; fatigue; body aches; headache; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (sweats), INJECTION SITE PAIN (site pain/redness), INJECTION SITE ERYTHEMA (site pain/redness), FATIGUE (fatigue) and MYALGIA (body aches) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039k20a and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Panic attack.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Dec-2020, the patient experienced HYPERHIDROSIS (sweats), INJECTION SITE PAIN (site pain/redness), INJECTION SITE ERYTHEMA (site pain/redness), FATIGUE (fatigue), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, HYPERHIDROSIS (sweats), INJECTION SITE PAIN (site pain/redness), INJECTION SITE ERYTHEMA (site pain/redness), FATIGUE (fatigue), MYALGIA (body aches) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-012594 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Followup  ADR attached on 25-MAY-2021: No new information
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sweats; site pain/redness; site pain/redness; fatigue; body aches; headache; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (sweats), INJECTION SITE PAIN (site pain/redness), INJECTION SITE ERYTHEMA (site pain/redness), FATIGUE (fatigue) and MYALGIA (body aches) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039k20a and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Panic attack.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Dec-2020, the patient experienced HYPERHIDROSIS (sweats), INJECTION SITE PAIN (site pain/redness), INJECTION SITE ERYTHEMA (site pain/redness), FATIGUE (fatigue), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, HYPERHIDROSIS (sweats), INJECTION SITE PAIN (site pain/redness), INJECTION SITE ERYTHEMA (site pain/redness), FATIGUE (fatigue), MYALGIA (body aches) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-012594 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Followup  ADR attached on 25-MAY-2021: No new information
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Nasal congestion, Pyrexia
Clinical narrative: Lost smell and teste; Lost smell and teste; Congested; Coughing; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Lost smell and teste), AGEUSIA (Lost smell and teste), NASAL CONGESTION (Congested), COUGH (Coughing) and VOMITING (Vomiting) in a male 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.     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 ANOSMIA (Lost smell and teste), AGEUSIA (Lost smell and teste), NASAL CONGESTION (Congested), COUGH (Coughing), VOMITING (Vomiting) and PYREXIA (Fever). At the time of the report, ANOSMIA (Lost smell and teste), AGEUSIA (Lost smell and teste), NASAL CONGESTION (Congested), COUGH (Coughing), VOMITING (Vomiting) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment information not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Lost smell and teste; Lost smell and teste; Congested; Coughing; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Lost smell and teste), AGEUSIA (Lost smell and teste), NASAL CONGESTION (Congested), COUGH (Coughing) and VOMITING (Vomiting) in a male 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.     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 ANOSMIA (Lost smell and teste), AGEUSIA (Lost smell and teste), NASAL CONGESTION (Congested), COUGH (Coughing), VOMITING (Vomiting) and PYREXIA (Fever). At the time of the report, ANOSMIA (Lost smell and teste), AGEUSIA (Lost smell and teste), NASAL CONGESTION (Congested), COUGH (Coughing), VOMITING (Vomiting) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment information not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pain, Pain in extremity, Pyrexia
Clinical narrative: arm soreness; body ache; lethargy; fever; sore throat; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (arm soreness), PAIN (body ache), LETHARGY (lethargy), PYREXIA (fever) and HEADACHE (sore throat) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 027L20A) for COVID-19 vaccination.     The patient's past medical history included Dental surgery NOS. Concurrent medical conditions included Hypothyroidism since 2019, Allergy (Septra) and Allergy to antibiotic (Septra allergy). Concomitant products included LORATADINE from 2015 to an unknown date for Allergy, LEVOTHYROXINE from 2019 to an unknown date for Hypothyroidism, ASPIRIN [ACETYLSALICYLIC ACID] from 2015 to an unknown date for Prevention, VITAMINS NOS (MVI [VITAMINS NOS]) from 2015 to an unknown date for Supplementation therapy.   On 07-Jan-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021 at 4:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), PAIN (body ache), LETHARGY (lethargy), PYREXIA (fever) and HEADACHE (sore throat). On 23-Feb-2021, PAIN IN EXTREMITY (arm soreness), PAIN (body ache), LETHARGY (lethargy), PYREXIA (fever) and HEADACHE (sore throat) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (arm soreness), PAIN (body ache), LETHARGY (lethargy), PYREXIA (fever) and HEADACHE (sore throat) to be possibly related.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Treatment information was not provided.   This case was linked to MOD-2021-012397 (Patient Link).
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old got vaccinated with both doses of Moderna; Product administered to patient of inappropriate age; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got vaccinated with both doses of Moderna) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Product administered to patient of inappropriate age) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got vaccinated with both doses of Moderna) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Product administered to patient of inappropriate age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got vaccinated with both doses of Moderna) had resolved and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Product administered to patient of inappropriate age) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant products was reported.  No treatment information was reported.  No lab data information was reported. Action taken in response to mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up document was attached on 01JUNE2021. No other new information was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hypersensitivity, Rash
Clinical narrative: Dizziness; Rash on left arm; Fatigue; Hypersensitivity reaction; This spontaneous case was reported by a nurse and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), DIZZINESS (Dizziness), RASH (Rash on left arm) and FATIGUE (Fatigue) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Drug allergy (Dilaudid allergy) and Drug allergy (Levaquin allergy).    On 08-Apr-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On 10-Apr-2021 at 11:00 PM, the patient experienced DIZZINESS (Dizziness), RASH (Rash on left arm) and FATIGUE (Fatigue). At the time of the report, HYPERSENSITIVITY (Hypersensitivity reaction), DIZZINESS (Dizziness), RASH (Rash on left arm) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DIZZINESS (Dizziness), RASH (Rash on left arm) and FATIGUE (Fatigue) to be possibly related. No further causality assessment was provided for HYPERSENSITIVITY (Hypersensitivity reaction).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up information received on 25-MAY-2021. Patient's relevant medical history, vaccination details, event details were updated. It contains significant information. On 19-Jul-2021: Follow up received:  Route of administration and event added