chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Diarrhoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea consistently everyday), DIARRHOEA (diarrhea) and CONDITION AGGRAVATED (bones continue to ache more after vax, different areas) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination.    Co-suspect product included non-company product MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    Concurrent medical conditions included Arthritis (more pain in bones) since 1985, Hypothyroidism (underactive thyroid) since 1985, Glaucoma (MILD) since 2010, Blood pressure high (MODERATE HBP) since 1985, Drug allergy (LEVOTHYROXINE) and Drug allergy (PREMARIN). Concomitant products included DICLOFENAC SODIUM, LINUM USITATISSIMUM, MENTHOL, METHYL SALICYLATE, THIOCOLCHICOSIDE (INSTAFLEX) for Arthritis, TRAVOPROST (TRAVATAN Z) and TIMOLOL for Glaucoma, LISINOPRIL for Hypertension, NAPROXEN SODIUM (ALEVE) and ACETAMINOPHEN for Pain, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroiditis, PROBIOTICS NOS for Urinary tract disorder.   On 14-Jan-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started MULTIVITAMIN [VITAMINS NOS] (Oral) 1 dosage form. On 24-Mar-2021, the patient experienced DIARRHOEA (Diarrhea consistently everyday). On 29-Jun-2021, the patient experienced DIARRHOEA (diarrhea). On an unknown date, the patient experienced CONDITION AGGRAVATED (bones continue to ache more after vax, different areas). The patient was treated with PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]) ongoing since an unknown date for Diarrhoea, at an unspecified dose and frequency. On 29-Mar-2021, DIARRHOEA (Diarrhea consistently everyday) had resolved. At the time of the report, DIARRHOEA (diarrhea) and CONDITION AGGRAVATED (bones continue to ache more after vax, different areas) outcome was unknown.            Concomitant medication included probiotic for urinary tract health and digestive health.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15 july 2021.concomitant information updated, new event added.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Vaccination site warmth; Vaccination site pruritus; Vaccination site erythema; Itching; Vaccination site pain; Red blotches; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotches), VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy (sulfa, keflex), Drug allergy (keflex), Hypertension, High cholesterol and Hypothyroidism. Concomitant products included METOPROLOL for Blood pressure management, EZETIMIBE and FISH OIL (OMEGA 3 FISH OILS) for Cholesterol, LEVOTHYROXINE for Thyroid disorder, CALCIUM for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced RASH MACULAR (Red blotches), VACCINATION SITE PAIN (Vaccination site pain) and PRURITUS (Itching). On 12-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth). On 28-Mar-2021, RASH MACULAR (Red blotches) and VACCINATION SITE PRURITUS (Vaccination site pruritus) had resolved. At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown and PRURITUS (Itching) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication was taken.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Additional adverse event  and outcome with date of recovery for two of the events  Concomitants added and 2nd dose information added, relevant history of the patient added.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Vaccination site warmth; Vaccination site pruritus; Vaccination site erythema; Itching; Vaccination site pain; Red blotches; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotches), VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy (sulfa, keflex), Drug allergy (keflex), Hypertension, High cholesterol and Hypothyroidism. Concomitant products included METOPROLOL for Blood pressure management, EZETIMIBE and FISH OIL (OMEGA 3 FISH OILS) for Cholesterol, LEVOTHYROXINE for Thyroid disorder, CALCIUM for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced RASH MACULAR (Red blotches), VACCINATION SITE PAIN (Vaccination site pain) and PRURITUS (Itching). On 12-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth). On 28-Mar-2021, RASH MACULAR (Red blotches) and VACCINATION SITE PRURITUS (Vaccination site pruritus) had resolved. At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown and PRURITUS (Itching) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication was taken.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Additional adverse event  and outcome with date of recovery for two of the events  Concomitants added and 2nd dose information added, relevant history of the patient added.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruise Below the Injection site) and VACCINATION SITE RASH (Rash Below the Injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash Below the Injection site). On 23-Mar-2021, the patient experienced VACCINATION SITE BRUISING (Bruise Below the Injection site). On 16-Mar-2021, VACCINATION SITE RASH (Rash Below the Injection site) had resolved. At the time of the report, VACCINATION SITE BRUISING (Bruise Below the Injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  No complications after the second dose of Moderna COVID-19 vaccine.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10-May-2021 included crosslinked case information, second dose details added and action taken updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: My throat got tight in the evening; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (My throat got tight in the evening) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to chemicals (Dye), Drug allergy (Codeine) and Drug allergy (steroids).    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced THROAT TIGHTNESS (My throat got tight in the evening). On 23-Feb-2021, THROAT TIGHTNESS (My throat got tight in the evening) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported The patient did not receive any treatment medication
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Influenza like illness, Nasopharyngitis, Pyrexia
Clinical narrative: Flu like symptoms; Mild reaction; Cold; Body is weak/ She does not want to go anywhere; Mild fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION COMPLICATION (Mild reaction), NASOPHARYNGITIS (Cold), ASTHENIA (Body is weak/ She does not want to go anywhere) and PYREXIA (Mild fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION COMPLICATION (Mild reaction), NASOPHARYNGITIS (Cold), ASTHENIA (Body is weak/ She does not want to go anywhere), PYREXIA (Mild fever) and FATIGUE (Tired). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION COMPLICATION (Mild reaction), NASOPHARYNGITIS (Cold), ASTHENIA (Body is weak/ She does not want to go anywhere), PYREXIA (Mild fever) and FATIGUE (Tired) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Flu like symptoms; Mild reaction; Cold; Body is weak/ She does not want to go anywhere; Mild fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION COMPLICATION (Mild reaction), NASOPHARYNGITIS (Cold), ASTHENIA (Body is weak/ She does not want to go anywhere) and PYREXIA (Mild fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION COMPLICATION (Mild reaction), NASOPHARYNGITIS (Cold), ASTHENIA (Body is weak/ She does not want to go anywhere), PYREXIA (Mild fever) and FATIGUE (Tired). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION COMPLICATION (Mild reaction), NASOPHARYNGITIS (Cold), ASTHENIA (Body is weak/ She does not want to go anywhere), PYREXIA (Mild fever) and FATIGUE (Tired) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nasal congestion, Pain in extremity, Pyrexia
Clinical narrative: body sore/ sore arm; Stuffy Nose; Chills; headcahe; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (body sore/ sore arm), NASAL CONGESTION (Stuffy Nose), CHILLS (Chills), HEADACHE (headcahe) and PYREXIA (fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (body sore/ sore arm), NASAL CONGESTION (Stuffy Nose), CHILLS (Chills), HEADACHE (headcahe) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (body sore/ sore arm), NASAL CONGESTION (Stuffy Nose), CHILLS (Chills), HEADACHE (headcahe) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Fluid intake reduced, Vaccination complication
Clinical narrative: feeling sick; could not eat or drink anything; could not eat or drink anything; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feeling sick), FEEDING DISORDER (could not eat or drink anything) and FLUID INTAKE REDUCED (could not eat or drink anything) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION COMPLICATION (feeling sick), FEEDING DISORDER (could not eat or drink anything) and FLUID INTAKE REDUCED (could not eat or drink anything). At the time of the report, VACCINATION COMPLICATION (feeling sick), FEEDING DISORDER (could not eat or drink anything) and FLUID INTAKE REDUCED (could not eat or drink anything) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  On 29-Feb-2021, the patient presented to the Emergency Room due to her symptoms.  No treatment was reported for the events.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Diarrhoea, Fatigue
Clinical narrative: experienced a full day of rapid heart beats; difficulty speaking; pain in back near the liver; fever that comes and goes; headaches in the mornings and evenings; weakness; diarrhea; fatigue; muscle pain; joint pain; chills; nausea; vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (weakness), DIARRHOEA (diarrhea), HEART RATE INCREASED (experienced a full day of rapid heart beats), SPEECH DISORDER (difficulty speaking) and PAIN (pain in back near the liver) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hepatitis C. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included UPADACITINIB (RINVOQ), PREDNISONE and CELECOXIB (CELEBREX) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced ASTHENIA (weakness), DIARRHOEA (diarrhea), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (headaches in the mornings and evenings). On an unknown date, the patient experienced HEART RATE INCREASED (experienced a full day of rapid heart beats), SPEECH DISORDER (difficulty speaking), PAIN (pain in back near the liver) and PYREXIA (fever that comes and goes). At the time of the report, ASTHENIA (weakness), DIARRHOEA (diarrhea), HEART RATE INCREASED (experienced a full day of rapid heart beats), SPEECH DISORDER (difficulty speaking), PAIN (pain in back near the liver), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever that comes and goes) and HEADACHE (headaches in the mornings and evenings) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Myalgia, Nausea, Pain
Clinical narrative: experienced a full day of rapid heart beats; difficulty speaking; pain in back near the liver; fever that comes and goes; headaches in the mornings and evenings; weakness; diarrhea; fatigue; muscle pain; joint pain; chills; nausea; vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (weakness), DIARRHOEA (diarrhea), HEART RATE INCREASED (experienced a full day of rapid heart beats), SPEECH DISORDER (difficulty speaking) and PAIN (pain in back near the liver) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hepatitis C. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included UPADACITINIB (RINVOQ), PREDNISONE and CELECOXIB (CELEBREX) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced ASTHENIA (weakness), DIARRHOEA (diarrhea), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (headaches in the mornings and evenings). On an unknown date, the patient experienced HEART RATE INCREASED (experienced a full day of rapid heart beats), SPEECH DISORDER (difficulty speaking), PAIN (pain in back near the liver) and PYREXIA (fever that comes and goes). At the time of the report, ASTHENIA (weakness), DIARRHOEA (diarrhea), HEART RATE INCREASED (experienced a full day of rapid heart beats), SPEECH DISORDER (difficulty speaking), PAIN (pain in back near the liver), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever that comes and goes) and HEADACHE (headaches in the mornings and evenings) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Speech disorder, Vomiting
Clinical narrative: experienced a full day of rapid heart beats; difficulty speaking; pain in back near the liver; fever that comes and goes; headaches in the mornings and evenings; weakness; diarrhea; fatigue; muscle pain; joint pain; chills; nausea; vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (weakness), DIARRHOEA (diarrhea), HEART RATE INCREASED (experienced a full day of rapid heart beats), SPEECH DISORDER (difficulty speaking) and PAIN (pain in back near the liver) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hepatitis C. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included UPADACITINIB (RINVOQ), PREDNISONE and CELECOXIB (CELEBREX) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced ASTHENIA (weakness), DIARRHOEA (diarrhea), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (headaches in the mornings and evenings). On an unknown date, the patient experienced HEART RATE INCREASED (experienced a full day of rapid heart beats), SPEECH DISORDER (difficulty speaking), PAIN (pain in back near the liver) and PYREXIA (fever that comes and goes). At the time of the report, ASTHENIA (weakness), DIARRHOEA (diarrhea), HEART RATE INCREASED (experienced a full day of rapid heart beats), SPEECH DISORDER (difficulty speaking), PAIN (pain in back near the liver), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever that comes and goes) and HEADACHE (headaches in the mornings and evenings) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years old received the Moderna COVID 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old received the Moderna COVID 19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old received the Moderna COVID 19 vaccine). On 19-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old received the Moderna COVID 19 vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Patient initials, action taken updated
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided. No concomitant medication were provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: arm was warm; has now knots around the injection site; Arm is red; she had chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm was warm), VACCINATION SITE INDURATION (has now knots around the injection site), VACCINATION SITE ERYTHEMA (Arm is red) and CHILLS (she had chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement on 11-Mar-2021. Concomitant products included Pain meds for an unknown indication.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE WARMTH (arm was warm), VACCINATION SITE INDURATION (has now knots around the injection site), VACCINATION SITE ERYTHEMA (Arm is red) and CHILLS (she had chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (arm was warm), VACCINATION SITE INDURATION (has now knots around the injection site), VACCINATION SITE ERYTHEMA (Arm is red) and CHILLS (she had chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that her symptoms went away for a while, however on an unreported date, she picked at the scab (on her arm) and the symptoms returned.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Rph reports that a 16 year old patient received 1st dose of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Rph reports that a 16 year old patient received 1st dose of vaccine) in a 16-year-old 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Rph reports that a 16 year old patient received 1st dose of vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Rph reports that a 16 year old patient received 1st dose of vaccine) 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.   Concomitant product use was not provided by the reporter.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Nausea
Clinical narrative: red ring at injection site site; hot and painful at injection site; tender to touch at vaccine site; hot and painful at injection site; weakness; dizziness; headache; nausea; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), VACCINATION SITE WARMTH (hot and painful at injection site), ASTHENIA (weakness), VACCINATION SITE ERYTHEMA (red ring at injection site site) and VACCINATION SITE PAIN (hot and painful at injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) 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) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced NAUSEA (nausea), CHILLS (chills) and PYREXIA (fever). On 21-Mar-2021, the patient experienced DIZZINESS (dizziness), ASTHENIA (weakness) and HEADACHE (headache). On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot and painful at injection site), VACCINATION SITE ERYTHEMA (red ring at injection site site), VACCINATION SITE PAIN (hot and painful at injection site) and VACCINATION SITE PAIN (tender to touch at vaccine site). The patient was treated with IBUPROFEN at a dose of UNK dosage form; MULTIVITAMIN [VITAMINS NOS] at a dose of UNK dosage form and VITAMIN D NOS at a dose of UNK dosage form. At the time of the report, DIZZINESS (dizziness), VACCINATION SITE WARMTH (hot and painful at injection site), ASTHENIA (weakness), VACCINATION SITE ERYTHEMA (red ring at injection site site), VACCINATION SITE PAIN (hot and painful at injection site), VACCINATION SITE PAIN (tender to touch at vaccine site), HEADACHE (headache), NAUSEA (nausea), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-155661.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: red ring at injection site site; hot and painful at injection site; tender to touch at vaccine site; hot and painful at injection site; weakness; dizziness; headache; nausea; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), VACCINATION SITE WARMTH (hot and painful at injection site), ASTHENIA (weakness), VACCINATION SITE ERYTHEMA (red ring at injection site site) and VACCINATION SITE PAIN (hot and painful at injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) 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) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced NAUSEA (nausea), CHILLS (chills) and PYREXIA (fever). On 21-Mar-2021, the patient experienced DIZZINESS (dizziness), ASTHENIA (weakness) and HEADACHE (headache). On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot and painful at injection site), VACCINATION SITE ERYTHEMA (red ring at injection site site), VACCINATION SITE PAIN (hot and painful at injection site) and VACCINATION SITE PAIN (tender to touch at vaccine site). The patient was treated with IBUPROFEN at a dose of UNK dosage form; MULTIVITAMIN [VITAMINS NOS] at a dose of UNK dosage form and VITAMIN D NOS at a dose of UNK dosage form. At the time of the report, DIZZINESS (dizziness), VACCINATION SITE WARMTH (hot and painful at injection site), ASTHENIA (weakness), VACCINATION SITE ERYTHEMA (red ring at injection site site), VACCINATION SITE PAIN (hot and painful at injection site), VACCINATION SITE PAIN (tender to touch at vaccine site), HEADACHE (headache), NAUSEA (nausea), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-155661.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swelling on her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling on her arm) 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 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swelling on her arm). At the time of the report, VACCINATION SITE SWELLING (swelling on her arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment was administered for the event at the time of the report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site pain
Clinical narrative: Vaccination site pain; fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), PYREXIA (fever) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A) and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included HIV infection, Allergy and Appetite disorder.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), PYREXIA (fever) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), PYREXIA (fever) and HEADACHE (Headache) had resolved.            Concomitant medication included medications for  blood pressure, HIV medicine, allergy pills, appetite pills, stomach pills. Action taken for Moderna COVID-19 Vaccine was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-054219 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Event resolved and Patient declined FU; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054219:First dose
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: rash all over her upper body(shoulders, chest, neck and arms); Hives; itchy and the itching is unbearable; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy and the itching is unbearable), RASH (rash all over her upper body(shoulders, chest, neck and arms)) and URTICARIA (Hives) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced PRURITUS (itchy and the itching is unbearable). On 18-Mar-2021, the patient experienced URTICARIA (Hives). On an unknown date, the patient experienced RASH (rash all over her upper body(shoulders, chest, neck and arms)). The patient was treated with CORTISONE (topical) ongoing since an unknown date for Rash and Itch, at a dose of UNK dosage form; PEPPERMINT OIL [MENTHA X PIPERITA OIL] (topical) ongoing since an unknown date for Rash and Itch, at a dose of UNK dosage form and HYDROCORTISONE ACETATE, NEOMYCIN SULFATE (HYDROCORTISONE N) at an unspecified dose and frequency. On 23-Feb-2021, PRURITUS (itchy and the itching is unbearable) had resolved. On 19-Mar-2021, URTICARIA (Hives) had resolved. At the time of the report, RASH (rash all over her upper body(shoulders, chest, neck and arms)) had resolved.            No concomitant medications were provided. The patient provided pictures of a rash which has spread over her upper body, on her shoulders, chest, neck and arms. At the time of the report, products used as treatment for the events had not provided relief of her symptoms.   This case was linked to MOD-2021-027896 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Initial additional information received on 23 Mar 2021 contains non-significant information. On 21-May-2021: Initial additional information received on 21 May 2021 contains information regarding second dose events pics and had no previous history like this. On 31-May-2021: Initial additional information received on 31 May 2021 contains  non-significant information. On 24-Jul-2021: Significant Follow-up received event and event outcome was updated
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Chills; Fever; Body aches; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body aches) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021. Concomitant products included LOSARTAN for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Chills, Myalgia and Fever, at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenopia, Body temperature, Chills, Fatigue
Clinical narrative: Stomach discomfort; headache; fever; chills; Myalgia; nauseas; fatigue; Tingling lips; Eyes heavy feeling of; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tingling lips), ASTHENOPIA (Eyes heavy feeling of), ABDOMINAL DISCOMFORT (Stomach discomfort), HEADACHE (headache) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced PARAESTHESIA ORAL (Tingling lips) and ASTHENOPIA (Eyes heavy feeling of). On 23-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach discomfort), HEADACHE (headache), PYREXIA (fever), CHILLS (chills), MYALGIA (Myalgia), NAUSEA (nauseas) and FATIGUE (fatigue). On 22-Mar-2021, PARAESTHESIA ORAL (Tingling lips) and ASTHENOPIA (Eyes heavy feeling of) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Stomach discomfort), HEADACHE (headache), PYREXIA (fever), CHILLS (chills), MYALGIA (Myalgia), NAUSEA (nauseas) and FATIGUE (fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. On 07-Feb-2021, SARS-CoV-2 antibody test: positive (Positive) Positive. On 23-Mar-2021, Body temperature: 102.6 (Inconclusive) 102.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported  that 12 hours after the injection she experienced events headache, fever of 102.6, chills, body ache, nauseas, fatigue and sick to her stomach feeling.  Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Contact Information Updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Paraesthesia oral, Pyrexia
Clinical narrative: Stomach discomfort; headache; fever; chills; Myalgia; nauseas; fatigue; Tingling lips; Eyes heavy feeling of; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tingling lips), ASTHENOPIA (Eyes heavy feeling of), ABDOMINAL DISCOMFORT (Stomach discomfort), HEADACHE (headache) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced PARAESTHESIA ORAL (Tingling lips) and ASTHENOPIA (Eyes heavy feeling of). On 23-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach discomfort), HEADACHE (headache), PYREXIA (fever), CHILLS (chills), MYALGIA (Myalgia), NAUSEA (nauseas) and FATIGUE (fatigue). On 22-Mar-2021, PARAESTHESIA ORAL (Tingling lips) and ASTHENOPIA (Eyes heavy feeling of) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Stomach discomfort), HEADACHE (headache), PYREXIA (fever), CHILLS (chills), MYALGIA (Myalgia), NAUSEA (nauseas) and FATIGUE (fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. On 07-Feb-2021, SARS-CoV-2 antibody test: positive (Positive) Positive. On 23-Mar-2021, Body temperature: 102.6 (Inconclusive) 102.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported  that 12 hours after the injection she experienced events headache, fever of 102.6, chills, body ache, nauseas, fatigue and sick to her stomach feeling.  Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Contact Information Updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Stomach discomfort; headache; fever; chills; Myalgia; nauseas; fatigue; Tingling lips; Eyes heavy feeling of; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tingling lips), ASTHENOPIA (Eyes heavy feeling of), ABDOMINAL DISCOMFORT (Stomach discomfort), HEADACHE (headache) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced PARAESTHESIA ORAL (Tingling lips) and ASTHENOPIA (Eyes heavy feeling of). On 23-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach discomfort), HEADACHE (headache), PYREXIA (fever), CHILLS (chills), MYALGIA (Myalgia), NAUSEA (nauseas) and FATIGUE (fatigue). On 22-Mar-2021, PARAESTHESIA ORAL (Tingling lips) and ASTHENOPIA (Eyes heavy feeling of) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Stomach discomfort), HEADACHE (headache), PYREXIA (fever), CHILLS (chills), MYALGIA (Myalgia), NAUSEA (nauseas) and FATIGUE (fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. On 07-Feb-2021, SARS-CoV-2 antibody test: positive (Positive) Positive. On 23-Mar-2021, Body temperature: 102.6 (Inconclusive) 102.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported  that 12 hours after the injection she experienced events headache, fever of 102.6, chills, body ache, nauseas, fatigue and sick to her stomach feeling.  Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Contact Information Updated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Vertigo
Clinical narrative: vertigo; chills; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu shot in December 2020. Concurrent medical conditions included Vertigo (due to barometer pressure changes and weather changes.) and Feeling cold.    On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VERTIGO (vertigo), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, VERTIGO (vertigo), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: severe diarrhea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIARRHOEA (severe diarrhea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack (has to take heart medication).   On 10-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) 1 dosage form. On 11-Mar-2021, the patient experienced DIARRHOEA (severe diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM A-D) for Diarrhea, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (severe diarrhea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medication included heart medication
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 immunisation.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced URTICARIA (Hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives) outcome was unknown.            No concomitant medications reported. Action taken with mRNA-1273 in response to events was not applicable.