chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: soreness on the arm of the injection; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness on the arm of the injection) and FATIGUE (felt tired) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Blood cholesterol abnormal and Prostate cancer.    On 12-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 VACCINATION SITE PAIN (soreness on the arm of the injection) and FATIGUE (felt tired). At the time of the report, VACCINATION SITE PAIN (soreness on the arm of the injection) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified blood pressure and cholesterol medication. No treatment information was provided. The patient is going to have a surgery on 09-APR-2021.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Scratchy Throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Scratchy Throat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (different underlying health problems and allergies). Concomitant products included MONTELUKAST, ATENOLOL, ALLOPURINOL, ACETAMINOPHEN, CALCIUM CARBONATE (TUMS 500 CALCIUM), FISH OIL, TRAMADOL, METFORMIN, AMLODIPINE, ESTRADIOL (ESTRADIOL ANTIBIOTICOS), LOTEPREDNOL ETABONATE and CITICOLINE for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced THROAT IRRITATION (Scratchy Throat). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Throat irritation, at a dose of UNK dosage form. On 28-Feb-2021, THROAT IRRITATION (Scratchy Throat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified eye drops.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Dizziness, Eating disorder, Vomiting
Clinical narrative: dizziness,dizziness is worse; can't stand up; cannot eat; very weak; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness,dizziness is worse), BALANCE DISORDER (can't stand up), EATING DISORDER (cannot eat), ASTHENIA (very weak) and VOMITING (vomiting) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    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 BALANCE DISORDER (can't stand up), EATING DISORDER (cannot eat), ASTHENIA (very weak) and VOMITING (vomiting). On an unknown date, the patient experienced DIZZINESS (dizziness,dizziness is worse). At the time of the report, DIZZINESS (dizziness,dizziness is worse), BALANCE DISORDER (can't stand up), EATING DISORDER (cannot eat) and VOMITING (vomiting) outcome was unknown and ASTHENIA (very weak) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient were not provided. Patient had experienced dizziness on 16 Mar 2021 ant the dizziness was worse on 17 Mar 2021. Treatment information was not provided.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 23-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and DOCOSAHEXAENOIC ACID (DHA) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 22-Oct-2020 and the estimated date of delivery was 02-Aug-2021. On 17-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  On 17-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. 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.   Tests done was Ultrasounds, Anatomy scan and urinalysis (test results unknown).  On 26 Nov 2020, Pregnancy test was Positive. No treatment medications reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Insomnia, Lymphadenopathy, Vaccination site pain
Clinical narrative: Loss of sleep; Lymph node swelling; Injection site pain; Aches in joints/Aches in knees; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node swelling), VACCINATION SITE PAIN (Injection site pain), ARTHRALGIA (Aches in joints/Aches in knees), CHILLS (Chills) and INSOMNIA (Loss of sleep) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included MONASCUS PURPUREUS (RED YEAST RICE), OMEPRAZOLE, LISINOPRIL, IBUPROFEN, FISH OIL and MULTIVITAMIN [VITAMINS NOS] 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 11-Mar-2021, the patient experienced LYMPHADENOPATHY (Lymph node swelling), VACCINATION SITE PAIN (Injection site pain), ARTHRALGIA (Aches in joints/Aches in knees), CHILLS (Chills) and INSOMNIA (Loss of sleep). At the time of the report, LYMPHADENOPATHY (Lymph node swelling) outcome was unknown and VACCINATION SITE PAIN (Injection site pain), ARTHRALGIA (Aches in joints/Aches in knees), CHILLS (Chills) and INSOMNIA (Loss of sleep) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included coQ10.  No treatment information was provided.  Lymph node swelling had continued for 1 week.
Sex: F
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 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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Headache, Pain in extremity
Clinical narrative: rashes on chest/ rashes on abdomen/ rashes on back/rashes on neck; Headache; chills; had a fever of 99.7; legs hurting,arms hurting; back hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (legs hurting,arms hurting), BACK PAIN (back hurting), RASH (rashes on chest/ rashes on abdomen/ rashes on back/rashes on neck), HEADACHE (Headache) and CHILLS (chills) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included PROBIOTICS NOS 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 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (legs hurting,arms hurting), BACK PAIN (back hurting), HEADACHE (Headache), CHILLS (chills) and PYREXIA (had a fever of 99.7). On 13-Mar-2021, the patient experienced RASH (rashes on chest/ rashes on abdomen/ rashes on back/rashes on neck). The patient was treated with PARACETAMOL (TYLENOL) on 12-Mar-2021 for Adverse event, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 13-Mar-2021 for Adverse event, at a dose of UNK dosage form. On 13-Mar-2021, PAIN IN EXTREMITY (legs hurting,arms hurting), BACK PAIN (back hurting), HEADACHE (Headache), CHILLS (chills) and PYREXIA (had a fever of 99.7) had resolved. On 14-Mar-2021, RASH (rashes on chest/ rashes on abdomen/ rashes on back/rashes on neck) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 99.7 (High) 99.7,Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: rashes on chest/ rashes on abdomen/ rashes on back/rashes on neck; Headache; chills; had a fever of 99.7; legs hurting,arms hurting; back hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (legs hurting,arms hurting), BACK PAIN (back hurting), RASH (rashes on chest/ rashes on abdomen/ rashes on back/rashes on neck), HEADACHE (Headache) and CHILLS (chills) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included PROBIOTICS NOS 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 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (legs hurting,arms hurting), BACK PAIN (back hurting), HEADACHE (Headache), CHILLS (chills) and PYREXIA (had a fever of 99.7). On 13-Mar-2021, the patient experienced RASH (rashes on chest/ rashes on abdomen/ rashes on back/rashes on neck). The patient was treated with PARACETAMOL (TYLENOL) on 12-Mar-2021 for Adverse event, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 13-Mar-2021 for Adverse event, at a dose of UNK dosage form. On 13-Mar-2021, PAIN IN EXTREMITY (legs hurting,arms hurting), BACK PAIN (back hurting), HEADACHE (Headache), CHILLS (chills) and PYREXIA (had a fever of 99.7) had resolved. On 14-Mar-2021, RASH (rashes on chest/ rashes on abdomen/ rashes on back/rashes on neck) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 99.7 (High) 99.7,Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received the Moderna vaccine to 17 years old patient; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the Moderna vaccine to 17 years old patient) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included No adverse event (No medical history reported).    On 14-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the Moderna vaccine to 17 years old patient). On 14-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the Moderna vaccine to 17 years old patient) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information on concomitant medication was provided.  No treatment information was provided.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pain, Pyrexia
Clinical narrative: fever; Chills; soreness; Achiness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness), PYREXIA (fever), CHILLS (Chills) and ARTHRALGIA (soreness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced PAIN (Achiness) and ARTHRALGIA (soreness). On 10-Feb-2021, the patient experienced PYREXIA (fever) and CHILLS (Chills). The patient was treated with IBUPROFEN for Fever, Chills and Ache, at a dose of 1 dosage form. On 14-Jan-2021, PAIN (Achiness) and ARTHRALGIA (soreness) had resolved. On 11-Feb-2021, PYREXIA (fever) and CHILLS (Chills) had resolved.            No concomitant medication were reported The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Insomnia, Myalgia, Nausea
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (arm hurting), insomnia (unable to sleep), chills, myalgia (muscle pain) and fatigue in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 028L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional events detailed below. No medical history information reported. On Dec 28, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 25, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 25, 2021, patient experienced pain in extremity (arm hurting), insomnia (unable to sleep), chills, myalgia (muscle pain), fatigue, nausea and pyrexia (temperature 100 degrees). The patient was treated with ibuprofen at a dose of 1 dosage form. At the time of the report, pain in extremity (arm hurting), insomnia (unable to sleep), chills, myalgia (muscle pain), fatigue, nausea and pyrexia (temperature 100 degrees) outcome: unknown. For mRNA-1273 (Moderna COVID-19 vaccine), intramuscular, the reporter did not provide any causality assessments or concomitant medication use.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (arm hurting), insomnia (unable to sleep), chills, myalgia (muscle pain) and fatigue in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 028L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional events detailed below. No medical history information reported. On Dec 28, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 25, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 25, 2021, patient experienced pain in extremity (arm hurting), insomnia (unable to sleep), chills, myalgia (muscle pain), fatigue, nausea and pyrexia (temperature 100 degrees). The patient was treated with ibuprofen at a dose of 1 dosage form. At the time of the report, pain in extremity (arm hurting), insomnia (unable to sleep), chills, myalgia (muscle pain), fatigue, nausea and pyrexia (temperature 100 degrees) outcome: unknown. For mRNA-1273 (Moderna COVID-19 vaccine), intramuscular, the reporter did not provide any causality assessments or concomitant medication use.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Fatigue, Myalgia
Clinical narrative: cough; vomiting; fatigue; nausea; Chills; muscle aches; chills; sore left arm; joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (cough), PAIN IN EXTREMITY (sore left arm), ARTHRALGIA (joint pain), VOMITING (vomiting) and MYALGIA (muscle aches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included CLOPIDOGREL for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore left arm), ARTHRALGIA (joint pain), MYALGIA (muscle aches) and CHILLS (chills). On 16-Mar-2021, the patient experienced COUGH (cough), VOMITING (vomiting), FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (Chills). The patient was treated with OMEPRAZOLE at an unspecified dose and frequency; PARACETAMOL at an unspecified dose and frequency; RIVAROXABAN at an unspecified dose and frequency; RUPATADINE at a dose of 10 mg and FLUTICASONE at a dose of 200 pg/ml twice a day. On 13-Mar-2021, PAIN IN EXTREMITY (sore left arm), ARTHRALGIA (joint pain), MYALGIA (muscle aches) and CHILLS (chills) had resolved. At the time of the report, COUGH (cough), VOMITING (vomiting), NAUSEA (nausea) and CHILLS (Chills) outcome was unknown and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Oxygen saturation: 90 or less (Low) oxygen levels went down up to 90 or less when he was standing up and 95/97 (Inconclusive) if he sits down levels go back to 95/97.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include Blood Pressure Medication Doctor advised him on not taking the 2nd dose
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Oxygen saturation, Pain in extremity, Vomiting
Clinical narrative: cough; vomiting; fatigue; nausea; Chills; muscle aches; chills; sore left arm; joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (cough), PAIN IN EXTREMITY (sore left arm), ARTHRALGIA (joint pain), VOMITING (vomiting) and MYALGIA (muscle aches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included CLOPIDOGREL for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore left arm), ARTHRALGIA (joint pain), MYALGIA (muscle aches) and CHILLS (chills). On 16-Mar-2021, the patient experienced COUGH (cough), VOMITING (vomiting), FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (Chills). The patient was treated with OMEPRAZOLE at an unspecified dose and frequency; PARACETAMOL at an unspecified dose and frequency; RIVAROXABAN at an unspecified dose and frequency; RUPATADINE at a dose of 10 mg and FLUTICASONE at a dose of 200 pg/ml twice a day. On 13-Mar-2021, PAIN IN EXTREMITY (sore left arm), ARTHRALGIA (joint pain), MYALGIA (muscle aches) and CHILLS (chills) had resolved. At the time of the report, COUGH (cough), VOMITING (vomiting), NAUSEA (nausea) and CHILLS (Chills) outcome was unknown and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Oxygen saturation: 90 or less (Low) oxygen levels went down up to 90 or less when he was standing up and 95/97 (Inconclusive) if he sits down levels go back to 95/97.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include Blood Pressure Medication Doctor advised him on not taking the 2nd dose
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: itches very bad; circular rash; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itches very bad), VACCINATION SITE PAIN (pain at injection site) and VACCINATION SITE RASH (circular rash) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). On 11-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itches very bad) and VACCINATION SITE RASH (circular rash). At the time of the report, VACCINATION SITE PRURITUS (itches very bad), VACCINATION SITE PAIN (pain at injection site) and VACCINATION SITE RASH (circular rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided  No treatment of events was reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Fatigue, Feeling cold, Oropharyngeal pain
Clinical narrative: Dizziness; Sore throat; Hot water hurt her skin; Arm is in so much pain the cannot move the arm.; Freezing cold at room temperature; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (Sore throat), BURNING SENSATION (Hot water hurt her skin), PAIN IN EXTREMITY (Arm is in so much pain the cannot move the arm.) and FEELING COLD (Freezing cold at room temperature) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-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. In March 2021, the patient experienced DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (Sore throat), BURNING SENSATION (Hot water hurt her skin), PAIN IN EXTREMITY (Arm is in so much pain the cannot move the arm.), FEELING COLD (Freezing cold at room temperature) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (Sore throat), BURNING SENSATION (Hot water hurt her skin), PAIN IN EXTREMITY (Arm is in so much pain the cannot move the arm.), FEELING COLD (Freezing cold at room temperature) and FATIGUE (Fatigue) 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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Dizziness; Sore throat; Hot water hurt her skin; Arm is in so much pain the cannot move the arm.; Freezing cold at room temperature; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (Sore throat), BURNING SENSATION (Hot water hurt her skin), PAIN IN EXTREMITY (Arm is in so much pain the cannot move the arm.) and FEELING COLD (Freezing cold at room temperature) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-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. In March 2021, the patient experienced DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (Sore throat), BURNING SENSATION (Hot water hurt her skin), PAIN IN EXTREMITY (Arm is in so much pain the cannot move the arm.), FEELING COLD (Freezing cold at room temperature) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (Sore throat), BURNING SENSATION (Hot water hurt her skin), PAIN IN EXTREMITY (Arm is in so much pain the cannot move the arm.), FEELING COLD (Freezing cold at room temperature) and FATIGUE (Fatigue) 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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Inappropriate schedule of product administration
Clinical narrative: exceed dosing interval; rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart beat) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (exceed dosing interval) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) 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 10-Feb-2021, the patient experienced HEART RATE INCREASED (rapid heart beat). On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (exceed dosing interval). At the time of the report, HEART RATE INCREASED (rapid heart beat) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (exceed dosing interval) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was mentioned.  No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Fatigue, Memory impairment
Clinical narrative: disoriented; forgetful; fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of DISORIENTATION (disoriented), MEMORY IMPAIRMENT (forgetful) and FATIGUE (fatigue) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) 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 07-Mar-2021, the patient experienced DISORIENTATION (disoriented), MEMORY IMPAIRMENT (forgetful) and FATIGUE (fatigue). At the time of the report, DISORIENTATION (disoriented), MEMORY IMPAIRMENT (forgetful) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications and treatment medications were reported.  Patient was feeling better on 09-Mar-2021.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant wife received the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant wife received the vaccine) in a female patient of an unknown age (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage (Sometime in Oct-Nov 2020.).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 10-Feb-2021 and the estimated date of delivery was 17-Nov-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant wife received the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 12-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant wife received the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Pregnancy test: positive positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Patient tested positive for pregnant on 11-MAr-2021. Prenatal case has not been established.  No treatment of events was reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Internal review on 26-JUL-2021 resulted in update of Lab data,Gravida,Birth type and fetal outcome
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain, Pain in extremity, Pruritus, Vaccination site pain, Vaccination site warmth
Clinical narrative: Hurt to move her arm; Got a little fever on it; Her arm was starting to get sore again where she got the shot; Her arm was real sore, then very painful; Her arm itched like crazy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm was real sore, then very painful), PRURITUS (Her arm itched like crazy), VACCINATION SITE WARMTH (Got a little fever on it), PAIN (Hurt to move her arm) and VACCINATION SITE PAIN (Her arm was starting to get sore again where she got the shot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Itching.    Concurrent medical conditions included Hypertension (HIgh blood pressure) and Hypercholesterolaemia (High cholesterol).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Her arm was real sore, then very painful) and PRURITUS (Her arm itched like crazy). On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Her arm was starting to get sore again where she got the shot). On 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Got a little fever on it). On 14-Mar-2021, the patient experienced PAIN (Hurt to move her arm). On 17-Mar-2021, PAIN IN EXTREMITY (Her arm was real sore, then very painful), PRURITUS (Her arm itched like crazy), VACCINATION SITE WARMTH (Got a little fever on it), PAIN (Hurt to move her arm) and VACCINATION SITE PAIN (Her arm was starting to get sore again where she got the shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used included high blood pressure medication NOS and high cholesterol medication NOS.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: heart rate of 173; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate of 173) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced HEART RATE INCREASED (heart rate of 173). At the time of the report, HEART RATE INCREASED (heart rate of 173) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Heart rate: 173 (Inconclusive) heart rate of 173.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  No treatment of events was reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Middle insomnia
Clinical narrative: she was not feeling well; she had chills which woke her up all night; she had chills which woke her up all night; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she was not feeling well), MIDDLE INSOMNIA (she had chills which woke her up all night) and CHILLS (she had chills which woke her up all night) 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 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (she was not feeling well), MIDDLE INSOMNIA (she had chills which woke her up all night) and CHILLS (she had chills which woke her up all night). On 12-Mar-2021, MALAISE (she was not feeling well), MIDDLE INSOMNIA (she had chills which woke her up all night) and CHILLS (she had chills which woke her up all night) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable. Treatment medicines were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-048160, MOD-2021-041860, MOD-2021-054920 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Follow up received on 22 Mar 2021 and contains no new information and  Dates of events were reported one day earlier. Kept dates from original report; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-048160: MOD-2021-041860:Mother's Case MOD-2021-054920:Father's Case
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mobility decreased, Swelling, Vaccination site erythema, Vaccination site mass
Clinical narrative: Cannot raise her arm up due to pain; Lump the size of a golf ball at the injection site; swelling seemed to be moving down her left side; Lymph nodes started swelling under her left arm, swelling seemed to be moving her left side; Red at the injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump the size of a golf ball at the injection site), SWELLING (swelling seemed to be moving down her left side), MOBILITY DECREASED (Cannot raise her arm up due to pain), VACCINATION SITE PAIN (Sore arm) and LYMPHADENOPATHY (Lymph nodes started swelling under her left arm, swelling seemed to be moving her left side) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 14-Mar-2021, the patient experienced VACCINATION SITE MASS (Lump the size of a golf ball at the injection site), SWELLING (swelling seemed to be moving down her left side), LYMPHADENOPATHY (Lymph nodes started swelling under her left arm, swelling seemed to be moving her left side) and VACCINATION SITE ERYTHEMA (Red at the injection site). On 17-Mar-2021, the patient experienced MOBILITY DECREASED (Cannot raise her arm up due to pain). The patient was treated with IBUPROFEN on 12-Mar-2021 at a dose of UNK dosage form. At the time of the report, VACCINATION SITE MASS (Lump the size of a golf ball at the injection site) and VACCINATION SITE PAIN (Sore arm) was resolving and SWELLING (swelling seemed to be moving down her left side), MOBILITY DECREASED (Cannot raise her arm up due to pain), LYMPHADENOPATHY (Lymph nodes started swelling under her left arm, swelling seemed to be moving her left side) and VACCINATION SITE ERYTHEMA (Red at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Cannot raise her arm up due to pain; Lump the size of a golf ball at the injection site; swelling seemed to be moving down her left side; Lymph nodes started swelling under her left arm, swelling seemed to be moving her left side; Red at the injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump the size of a golf ball at the injection site), SWELLING (swelling seemed to be moving down her left side), MOBILITY DECREASED (Cannot raise her arm up due to pain), VACCINATION SITE PAIN (Sore arm) and LYMPHADENOPATHY (Lymph nodes started swelling under her left arm, swelling seemed to be moving her left side) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 14-Mar-2021, the patient experienced VACCINATION SITE MASS (Lump the size of a golf ball at the injection site), SWELLING (swelling seemed to be moving down her left side), LYMPHADENOPATHY (Lymph nodes started swelling under her left arm, swelling seemed to be moving her left side) and VACCINATION SITE ERYTHEMA (Red at the injection site). On 17-Mar-2021, the patient experienced MOBILITY DECREASED (Cannot raise her arm up due to pain). The patient was treated with IBUPROFEN on 12-Mar-2021 at a dose of UNK dosage form. At the time of the report, VACCINATION SITE MASS (Lump the size of a golf ball at the injection site) and VACCINATION SITE PAIN (Sore arm) was resolving and SWELLING (swelling seemed to be moving down her left side), MOBILITY DECREASED (Cannot raise her arm up due to pain), LYMPHADENOPATHY (Lymph nodes started swelling under her left arm, swelling seemed to be moving her left side) and VACCINATION SITE ERYTHEMA (Red at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nasal congestion, Pyrexia
Clinical narrative: stuffy nose; fever; headache; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (stuffy nose), PYREXIA (fever) and HEADACHE (headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced NASAL CONGESTION (stuffy nose), PYREXIA (fever) and HEADACHE (headache). At the time of the report, NASAL CONGESTION (stuffy nose), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 100.2 f (High) 100.2 F..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  No treatment of events was reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pain in extremity
Clinical narrative: cough; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and PAIN IN EXTREMITY (sore arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 COUGH (cough) and PAIN IN EXTREMITY (sore arm). At the time of the report, COUGH (cough) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.   Treatment information was  not reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Localised infection, Tremor, Urticaria
Clinical narrative: very Weak; Infection on the arm; Welt arm; Shaking; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very Weak), LOCALISED INFECTION (Infection on the arm), URTICARIA (Welt arm) and TREMOR (Shaking) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Infection (Infection after Chemotherapy which was resolved) in November 2020 and Chemotherapy (Not Specified) in November 2020. Concurrent medical conditions included Cancer (Not Specified) and Red rash (Red rash all over the arms prior to vaccination and still going on). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Red rash.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ASTHENIA (very Weak), LOCALISED INFECTION (Infection on the arm), URTICARIA (Welt arm) and TREMOR (Shaking). At the time of the report, ASTHENIA (very Weak), LOCALISED INFECTION (Infection on the arm), URTICARIA (Welt arm) and TREMOR (Shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Fatigue, Hypersensitivity, Peripheral swelling, Rash erythematous
Clinical narrative: arm swelled; deep red reaction that went down arm, redness is healing up on the arm but now is spreading to the middle of upper chest; started itching; she feels hazy, a little disoriented; allergic reaction; didn't feel well; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (arm swelled), RASH ERYTHEMATOUS (deep red reaction that went down arm, redness is healing up on the arm but now is spreading to the middle of upper chest), RASH PRURITIC (started itching), DISORIENTATION (she feels hazy, a little disoriented) and HYPERSENSITIVITY (allergic reaction) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030AZlA and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter. No concomitant medication reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm swelled), RASH ERYTHEMATOUS (deep red reaction that went down arm, redness is healing up on the arm but now is spreading to the middle of upper chest), RASH PRURITIC (started itching), DISORIENTATION (she feels hazy, a little disoriented) and HYPERSENSITIVITY (allergic reaction). 10-Mar-2021, the patient experienced VACCINATION COMPLICATION (didn't feel well) and FATIGUE (fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency and LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (arm swelled), RASH ERYTHEMATOUS (deep red reaction that went down arm, redness is healing up on the arm but now is spreading to the middle of upper chest), RASH PRURITIC (started itching), HYPERSENSITIVITY (allergic reaction), VACCINATION COMPLICATION (didn't feel well) and FATIGUE (fatigue) outcome was unknown and DISORIENTATION (she feels hazy, a little disoriented) had not resolved. Not Provided          Concomitant medications were not provided by the reporter.  The patient went to an urgent care on 13MAR2021. Details about the visit were not provided.