chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Warm/hot rash; Itchy rash; pink/red rash; Triangular 5.5x5" rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warm/hot rash), VACCINATION SITE PRURITUS (Itchy rash), VACCINATION SITE ERYTHEMA (pink/red rash) and VACCINATION SITE RASH (Triangular 5.5x5" rash) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Immunization: Shingrix. Past adverse reactions to the above products included Local reaction with Shingrix.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm/hot rash), VACCINATION SITE PRURITUS (Itchy rash), VACCINATION SITE ERYTHEMA (pink/red rash) and VACCINATION SITE RASH (Triangular 5.5x5" rash). At the time of the report, VACCINATION SITE WARMTH (Warm/hot rash), VACCINATION SITE PRURITUS (Itchy rash) and VACCINATION SITE ERYTHEMA (pink/red rash) outcome was unknown and VACCINATION SITE RASH (Triangular 5.5x5" rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchy on injection site; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy on injection site) and VACCINATION SITE ERYTHEMA (Redness) 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 VACCINATION SITE PRURITUS (Itchy on injection site) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE PRURITUS (Itchy on injection site) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable Treatment medicines were not reported   Reporter did not allow further contact
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment products reported.   This case was linked to MOD-2021-051866 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Injection site warmth, Pruritus, Swelling
Clinical narrative: Itching as crazy; Swelling; Very hot to the touch; Sort of redness; Warm to the touch injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to the touch injection site), PRURITUS (Itching as crazy), SWELLING (Swelling), FEELING HOT (Very hot to the touch) and ERYTHEMA (Sort of redness ) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013K21A) for COVID-19 vaccination.     The patient's past medical history included Diverticulitis (Mild). Concurrent medical conditions included Drug allergy (Amoxicillin), Diabetes and Bronchiectasis (Mild). Concomitant products included METFORMIN for Diabetes.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INJECTION SITE WARMTH (Warm to the touch injection site) and ERYTHEMA (Sort of redness ). On 11-Mar-2021, the patient experienced PRURITUS (Itching as crazy), SWELLING (Swelling) and FEELING HOT (Very hot to the touch). At the time of the report, INJECTION SITE WARMTH (Warm to the touch injection site), PRURITUS (Itching as crazy), SWELLING (Swelling), FEELING HOT (Very hot to the touch) and ERYTHEMA (Sort of redness ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included several medications for an unknown indication. Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain, Swelling
Clinical narrative: Hard lump; Pain; Swelling; This spontaneous case was reported by a patient and describes the occurrence of MASS (Hard lump), PAIN (Pain) and SWELLING (Swelling) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) 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) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced MASS (Hard lump), PAIN (Pain) and SWELLING (Swelling). At the time of the report, MASS (Hard lump), PAIN (Pain) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information were not provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Pain
Clinical narrative: body aches; At times it has been debilitating; general exhaustion; joint pain especially in the knees; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), ASTHENIA (At times it has been debilitating), FATIGUE (general exhaustion) and ARTHRALGIA (joint pain especially in the knees) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Demyelinating polyneuropathy. Concomitant products included IMMUNOGLOBULIN HUMAN NORMAL (GAMMAGARD) for Demyelinating polyneuropathy.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), ASTHENIA (At times it has been debilitating), FATIGUE (general exhaustion) and ARTHRALGIA (joint pain especially in the knees). At the time of the report, PAIN (body aches), ASTHENIA (At times it has been debilitating), FATIGUE (general exhaustion) and ARTHRALGIA (joint pain especially in the knees) outcome was unknown.            No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Followup received on 14-JUL-2021 & added a new event as At times it has been debilitating
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A spontaneous report was received from a consumer, a female patient (age not provided), who received Moderna's COVID-19 vaccine (mRNA-1273) and reported second dose of vaccine was 20 March, but it was cancelled and would be rescheduled on 31 March 2021 (inappropriate schedule of vaccine administration). The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the events was not provided. On 19 Feb 2021, the patient received her first of the two planned vaccine doses of mRNA-1273 (Lot number: 029L20A) intramuscularly (unknown site) for prophylaxis of COVID-19 infection. The patient was supposed to get the second dose of vaccine, but it was cancelled and rescheduled on 31 Mar 2021. Treatment was not reported. Action taken with mRNA-1273 in response to the events was unknown. The outcome of event was recovered.; Reporter's Comments: This report refers to a case of Inappropriate schedule of vaccine administration, for mRNA-1273, lot #: 029L20A, with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Vaccination site reaction
Clinical narrative: mild symptoms; COVID arm; This spontaneous case was reported by a nurse and describes the occurrence of ADVERSE EVENT (mild symptoms) and PAIN IN EXTREMITY (COVID arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 ADVERSE EVENT (mild symptoms) and PAIN IN EXTREMITY (COVID arm). At the time of the report, ADVERSE EVENT (mild symptoms) and PAIN IN EXTREMITY (COVID arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided treatment was not provided
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose is scheduled 18 days post first dose; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose is scheduled 18 days post first dose) 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 Hypercholesterolemia (On cholesterol medicine.) and Blood pressure (Currently evaluated to see if she needs BP medication.).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose is scheduled 18 days post first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose is scheduled 18 days post first dose) outcome was unknown. Not Provided      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 medication included: Cholesterol medication, Potential BP medication.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: 014M20A) with no associated AEs.
Age: 92.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: started itching very bad from shoulder to elbow; arm got a little bit swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (started itching very bad from shoulder to elbow) and VACCINATION SITE SWELLING (arm got a little bit swollen) in a 92-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0015214) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included LYSINE, FLUOROMETHOLONE, LATANOPROST, BROMOCRIPTINE MESILATE (BROMIDINE), LISINOPRIL, COLECALCIFEROL (VITAMIN D), BIOTIN and ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication.   On 11-Mar-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) at an unspecified dose. On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (started itching very bad from shoulder to elbow) and VACCINATION SITE SWELLING (arm got a little bit swollen). At the time of the report, VACCINATION SITE PRURITUS (started itching very bad from shoulder to elbow) and VACCINATION SITE SWELLING (arm got a little bit swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.  Other Concomitant mediation included: Samciclovir, Timnol, amoidaodine and Water pill.  Treatment: Alcohol.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Ultrasound Doppler
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The patient's past medical history included Alcohol addiction (1-2 drinks, 3 times per week) on 22-Jun-2020. Concurrent medical conditions included Hypothyroidism and Penicillin allergy. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for GERD, LEVOTHYROXINE for Hypothyroidism, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Vitamin supplementation. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in June 2020 and the estimated date of delivery was 12-Apr-2021. On 03-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The cesarean delivery occurred on 02-Apr-2021, which was reported as Premature. For neonate 1, the birth weight was 2268 grams (5lbs). The outcome was reported as Pre-Term Birth NOS. Baby was conceived through IVF, Low AMH is culprit of infertility. Water broke and chose to do a C-section. Live, pre-term birth. Length - 18 inches. Pregnancy related complication was Baby was measuring small- labeled as IUGR. On 03-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound Doppler: normal (normal) Good chances for having early delivery. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. LMP was reported as JUN-2020, Date of positive pregnancy test was 06-JUN-2020. Relevant Lab test included: weekly NST and result was normal. Patient reported there is no adverse event for first dose. This case was linked to MOD-2021-256756, MOD-2021-269190, MOD-2021-269190 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Significant follow up received on 14-JUL-2021: Patient demographics, ethnic group, Race , pregnancy details were  added. Historical condition was added. Concomitant medication, new event were  added. On 28-Jul-2021: Significant FU - Narrative updated.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Red Rash on Bilateral Legs and Forearm; This spontaneous case was reported by a health care professional and describes the occurrence of RASH ERYTHEMATOUS (Red Rash on Bilateral Legs and Forearm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red Rash on Bilateral Legs and Forearm). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red Rash on Bilateral Legs and Forearm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) 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 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication was not reported. Treatment medication was not reported.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Inappropriate schedule of product administration, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Outside dosing interval invalid dose; COVID positive; Sinitus; Loss of efficacy; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside dosing interval invalid dose), SARS-COV-2 TEST POSITIVE (COVID positive), SINUSITIS (Sinitus), DRUG INEFFECTIVE (Loss of efficacy) and PYREXIA (Fever) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ERYTHROMYCIN and AZELASTINE 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 06-Feb-2021, the patient experienced PYREXIA (Fever). On 09-Feb-2021, the patient experienced DRUG INEFFECTIVE (Loss of efficacy). On 27-Feb-2021, the patient experienced SINUSITIS (Sinitus). On 01-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID positive). On 19-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside dosing interval invalid dose). On 07-Feb-2021, PYREXIA (Fever) had resolved. On 19-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside dosing interval invalid dose) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (COVID positive), SINUSITIS (Sinitus) and DRUG INEFFECTIVE (Loss of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, SARS-CoV-2 test: positive Positive. On 17-Mar-2021, SARS-CoV-2 test: positive (Positive) Doctor prescribed antibodies and performed PCR test (second test).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       prescribed antibodies and performed PCR test   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Outside dosing interval invalid dose; COVID positive; Sinitus; Loss of efficacy; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside dosing interval invalid dose), SARS-COV-2 TEST POSITIVE (COVID positive), SINUSITIS (Sinitus), DRUG INEFFECTIVE (Loss of efficacy) and PYREXIA (Fever) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ERYTHROMYCIN and AZELASTINE 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 06-Feb-2021, the patient experienced PYREXIA (Fever). On 09-Feb-2021, the patient experienced DRUG INEFFECTIVE (Loss of efficacy). On 27-Feb-2021, the patient experienced SINUSITIS (Sinitus). On 01-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID positive). On 19-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside dosing interval invalid dose). On 07-Feb-2021, PYREXIA (Fever) had resolved. On 19-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside dosing interval invalid dose) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (COVID positive), SINUSITIS (Sinitus) and DRUG INEFFECTIVE (Loss of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, SARS-CoV-2 test: positive Positive. On 17-Mar-2021, SARS-CoV-2 test: positive (Positive) Doctor prescribed antibodies and performed PCR test (second test).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       prescribed antibodies and performed PCR test   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Seasonal allergy, ACETAMINOPHEN for Symptomatic treatment.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced MYALGIA (muscle pain). At the time of the report, MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Pyrexia
Clinical narrative: Diarrhea; Fever(101.00F to 102.5F); This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA and PYREXIA (Fever(101.00F to 102.5F)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.   No Medical History information was reported.   On 17-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 DIARRHOEA (Diarrhea) and PYREXIA (Fever(101.00F to 102.5F)). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Fever and Diarrhea, at an unspecified dose and frequency. On 19-Mar-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, PYREXIA (Fever(101.00F to 102.5F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 101 f (High) 101.00 F to 102.5 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache which come and go on regular basis; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache which come and go on regular basis) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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 10-Mar-2021, the patient experienced HEADACHE (Headache which come and go on regular basis). At the time of the report, HEADACHE (Headache which come and go on regular basis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication  was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Chest discomfort
Clinical narrative: Tightness in her chest; Sensation of her heart pounding; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness in her chest) and CARDIAC DISCOMFORT (Sensation of her heart pounding) 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 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 CHEST DISCOMFORT (Tightness in her chest) and CARDIAC DISCOMFORT (Sensation of her heart pounding). On 26-Feb-2021, CHEST DISCOMFORT (Tightness in her chest) and CARDIAC DISCOMFORT (Sensation of her heart pounding) had resolved. Not Provided      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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Rash, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INFECTION (infection), VACCINATION SITE WARMTH (warm at injection site), RASH (rash), VACCINATION SITE PRURITUS (itching, itching, itching at injection site) and VACCINATION SITE SWELLING (swollen at injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included GABAPENTIN, ROSUVASTATIN, METOPROLOL, VENLAFAXINE, LOSARTAN, DICLOFENAC SODIUM and RANOLAZINE for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced INFECTION (infection), VACCINATION SITE WARMTH (warm at injection site), RASH (rash), VACCINATION SITE PRURITUS (itching, itching, itching at injection site), VACCINATION SITE SWELLING (swollen at injection site) and VACCINATION SITE ERYTHEMA (red at injection site). On 07-Mar-2021, RASH (rash) outcome was unknown. At the time of the report, INFECTION (infection), VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PRURITUS (itching, itching, itching at injection site), VACCINATION SITE SWELLING (swollen at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) 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.   Treatment given for infection at the site of injection was antibiotics which the patient ahs not started taking yet.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INFECTION (infection), VACCINATION SITE WARMTH (warm at injection site), RASH (rash), VACCINATION SITE PRURITUS (itching, itching, itching at injection site) and VACCINATION SITE SWELLING (swollen at injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included GABAPENTIN, ROSUVASTATIN, METOPROLOL, VENLAFAXINE, LOSARTAN, DICLOFENAC SODIUM and RANOLAZINE for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced INFECTION (infection), VACCINATION SITE WARMTH (warm at injection site), RASH (rash), VACCINATION SITE PRURITUS (itching, itching, itching at injection site), VACCINATION SITE SWELLING (swollen at injection site) and VACCINATION SITE ERYTHEMA (red at injection site). On 07-Mar-2021, RASH (rash) outcome was unknown. At the time of the report, INFECTION (infection), VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PRURITUS (itching, itching, itching at injection site), VACCINATION SITE SWELLING (swollen at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) 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.   Treatment given for infection at the site of injection was antibiotics which the patient ahs not started taking yet.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation abnormal
Clinical narrative: Wide range of fluctuations in oxygen; This spontaneous case was reported by a patient family member or friend and describes the occurrence of OXYGEN SATURATION ABNORMAL (Wide range of fluctuations in oxygen) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced OXYGEN SATURATION ABNORMAL (Wide range of fluctuations in oxygen). At the time of the report, OXYGEN SATURATION ABNORMAL (Wide range of fluctuations in oxygen) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cluster headache, Headache, Migraine
Clinical narrative: Severe migraine; Like cluster headaches; Severe headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (Severe migraine), CLUSTER HEADACHE (Like cluster headaches) and HEADACHE (Severe headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Cluster headache (Patient mentioned that she had cluster headaches when she was younger wherein it was debilitating and she couldn't look through light,she has not experienced this for 20 years until she received the vaccine). Concurrent medical conditions included Seasonal allergy and Blood pressure. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for Blood pressure management, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Seasonal allergy, MOMETASONE FUROATE (NASONEX) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MIGRAINE (Severe migraine), CLUSTER HEADACHE (Like cluster headaches) and HEADACHE (Severe headache). The patient was treated with SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Pain, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Severe migraine), CLUSTER HEADACHE (Like cluster headaches) and HEADACHE (Severe headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that as a treatment she had an ice pack on head
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 145/101 (High) 145/101 and 113/89 (Inconclusive) 113/89.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details included pill for hypertension. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-051827 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of his arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0131921a) for COVID-19 vaccination.     Concomitant products included LORATADINE (DESOLIN), ATORVASTATIN and PROBIOTICS NOS for an unknown indication.    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 PAIN IN EXTREMITY (Soreness of his arm). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of 2 tylenol. At the time of the report, PAIN IN EXTREMITY (Soreness of his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Scheduled for his 2nd dose on 22Mar2021, only 20 days from his 1st dose.; This spontaneous case was reported by a consumer and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Scheduled for his 2nd dose on 22Mar2021, only 20 days from his 1st dose.) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Scheduled for his 2nd dose on 22Mar2021, only 20 days from his 1st dose.). On 19-Mar-2021, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Scheduled for his 2nd dose on 22Mar2021, only 20 days from his 1st dose.) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache after the first dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache after the first dose). At the time of the report, HEADACHE (Headache after the first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.    This case was linked to MOD-2021-063828 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash, Rash papular, Rash pruritic, SARS-CoV-2 test
Clinical narrative: feeling achy; (rash) swollen; (rash) raised; (rash) itchy; developed a rash on her lower arm, from mid cuff and down, in both arms, and also in lower leg; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (feeling achy), SWELLING ((rash) swollen), RASH PAPULAR ((rash) raised), RASH PRURITIC ((rash) itchy) and RASH (developed a rash on her lower arm, from mid cuff and down, in both arms, and also in lower leg) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (feeling achy), SWELLING ((rash) swollen), RASH PAPULAR ((rash) raised), RASH PRURITIC ((rash) itchy) and RASH (developed a rash on her lower arm, from mid cuff and down, in both arms, and also in lower leg). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN (feeling achy), SWELLING ((rash) swollen), RASH PAPULAR ((rash) raised), RASH PRURITIC ((rash) itchy) and RASH (developed a rash on her lower arm, from mid cuff and down, in both arms, and also in lower leg) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     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 medications was not provided by the reporter.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: feeling achy; (rash) swollen; (rash) raised; (rash) itchy; developed a rash on her lower arm, from mid cuff and down, in both arms, and also in lower leg; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (feeling achy), SWELLING ((rash) swollen), RASH PAPULAR ((rash) raised), RASH PRURITIC ((rash) itchy) and RASH (developed a rash on her lower arm, from mid cuff and down, in both arms, and also in lower leg) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (feeling achy), SWELLING ((rash) swollen), RASH PAPULAR ((rash) raised), RASH PRURITIC ((rash) itchy) and RASH (developed a rash on her lower arm, from mid cuff and down, in both arms, and also in lower leg). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN (feeling achy), SWELLING ((rash) swollen), RASH PAPULAR ((rash) raised), RASH PRURITIC ((rash) itchy) and RASH (developed a rash on her lower arm, from mid cuff and down, in both arms, and also in lower leg) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     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 medications was not provided by the reporter.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus.    On 18-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021 at 10:00 AM, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Initial additional. Added race, ethnicity, relevant history, route of administration of vaccine, event start time. Reporter, Nursing Director stated that Parent were aware and verbalized that there have been no side effects or reactions. Parent requests client be put in pediatric trial and wants client to have the second dose to be administered when due. Nursing Director declined and referred them to Moderna. On 16-Jul-2021: Follow up received on 16 Jul 2021 included no new information.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (12 year old male) for mRNA-1273 (lot number 048A21A)  with no associated AEs reported. FU1 does not change company comment or causality.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Both of his hands itched like crazy; This spontaneous case was reported by a health care professional and describes the occurrence of PRURITUS (Both of his hands itched like crazy) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PRURITUS (Both of his hands itched like crazy). At the time of the report, PRURITUS (Both of his hands itched like crazy) 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 was not provided by the reporter.  Treatment for the events included a steroid shot, steroid dose pack, steroid cream, and antihistamine.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up received contains non-significant information of updated Email.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hordeolum, Hyperhidrosis, Pyrexia, Rash erythematous, Rash vesicular
Clinical narrative: Began to sweat profusely; Fever of 99.8F; Blistery rash on stomach, upper thigh which ran out towards hip area; Redness from rash took a few days to go away; Mucus came out of the stye; Developed a stye on right lower eyelid; This spontaneous case was reported by a consumer and describes the occurrence of HORDEOLUM (Mucus came out of the stye), HORDEOLUM (Developed a stye on right lower eyelid), RASH VESICULAR (Blistery rash on stomach, upper thigh which ran out towards hip area), HYPERHIDROSIS (Began to sweat profusely) and RASH ERYTHEMATOUS (Redness from rash took a few days to go away) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included ATORVASTATIN, OMEPRAZOLE, METFORMIN, CELECOXIB (CELEBREX), ASCORBIC ACID (VITAMIN C FLAVOUR), CALTRATE + D PLUS, VITAMIN B1 NOS;VITAMIN B12 NOS and SENNA ALEXANDRINA (SENNA-GEN) for an unknown indication.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HORDEOLUM (Mucus came out of the stye) and HORDEOLUM (Developed a stye on right lower eyelid). On 08-Mar-2021, the patient experienced RASH VESICULAR (Blistery rash on stomach, upper thigh which ran out towards hip area) and RASH ERYTHEMATOUS (Redness from rash took a few days to go away). On 10-Mar-2021, the patient experienced HYPERHIDROSIS (Began to sweat profusely) and PYREXIA (Fever of 99.8F). On 05-Mar-2021, HORDEOLUM (Mucus came out of the stye) had resolved. On 08-Mar-2021, HORDEOLUM (Developed a stye on right lower eyelid) had resolved. On 10-Mar-2021, HYPERHIDROSIS (Began to sweat profusely) and PYREXIA (Fever of 99.8F) had resolved. At the time of the report, RASH VESICULAR (Blistery rash on stomach, upper thigh which ran out towards hip area) and RASH ERYTHEMATOUS (Redness from rash took a few days to go away) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Triamcinolone.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient developed COVID-19 four days after the 1st Dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient developed COVID-19 four days after the 1st Dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced COVID-19 (Patient developed COVID-19 four days after the 1st Dose). At the time of the report, COVID-19 (Patient developed COVID-19 four days after the 1st Dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. On 02-Mar-2021, SARS-CoV-2 test: positive (Positive) Still tested positive on 04-Mar-2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.  .   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: TCR document was attached. No new information was reported.