chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Pain in extremity
Clinical narrative: Blisters on Forehead; arm pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm pain) and BLISTER (Blisters on Forehead) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 10-Mar-2021, the patient experienced BLISTER (Blisters on Forehead). At the time of the report, PAIN IN EXTREMITY (arm pain) and BLISTER (Blisters on Forehead) outcome was unknown. Not applicable          No relevant concomitant medications were reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up contains second dose details.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Dyspnoea, Epistaxis, Myalgia
Clinical narrative: soreness and pain in armpit; Fever; Chills; Nausea; Severe achiness; Soreness in arm; Nose bleeds; Difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm), EPISTAXIS (Nose bleeds), DYSPNOEA (Difficulty breathing), AXILLARY PAIN (soreness and pain in armpit) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm), EPISTAXIS (Nose bleeds), DYSPNOEA (Difficulty breathing), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Severe achiness). On 09-Mar-2021, the patient experienced AXILLARY PAIN (soreness and pain in armpit). On 09-Mar-2021, DYSPNOEA (Difficulty breathing), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Severe achiness) had resolved. At the time of the report, PAIN IN EXTREMITY (Soreness in arm), EPISTAXIS (Nose bleeds), AXILLARY PAIN (soreness and pain in armpit) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: soreness and pain in armpit; Fever; Chills; Nausea; Severe achiness; Soreness in arm; Nose bleeds; Difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm), EPISTAXIS (Nose bleeds), DYSPNOEA (Difficulty breathing), AXILLARY PAIN (soreness and pain in armpit) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm), EPISTAXIS (Nose bleeds), DYSPNOEA (Difficulty breathing), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Severe achiness). On 09-Mar-2021, the patient experienced AXILLARY PAIN (soreness and pain in armpit). On 09-Mar-2021, DYSPNOEA (Difficulty breathing), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Severe achiness) had resolved. At the time of the report, PAIN IN EXTREMITY (Soreness in arm), EPISTAXIS (Nose bleeds), AXILLARY PAIN (soreness and pain in armpit) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Swell; Itchy; Red; Tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swell), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PAIN (Tender) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swell), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PAIN (Tender). At the time of the report, VACCINATION SITE SWELLING (Swell), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PAIN (Tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she takes other medications, but they weren't provided. No treatment details reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment details was not reported by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Extreme itching at the site of her vitiligo; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Extreme itching at the site of her vitiligo) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Vitiligo.    On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PRURITUS (Extreme itching at the site of her vitiligo). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, PRURITUS (Extreme itching at the site of her vitiligo) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Abdominal tenderness, Therapeutic response unexpected, Vaccination site pain
Clinical narrative: Abdominal cramping and discomfort; abdominal distension; Soreness at the injection site; Improvement in breathing; Abdominal tenderness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal cramping and discomfort), ABDOMINAL DISTENSION (abdominal distension), VACCINATION SITE PAIN (Soreness at the injection site), THERAPEUTIC RESPONSE UNEXPECTED (Improvement in breathing) and ABDOMINAL TENDERNESS (Abdominal tenderness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Gallbladder disease NOS.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ABDOMINAL PAIN (Abdominal cramping and discomfort), ABDOMINAL DISTENSION (abdominal distension), VACCINATION SITE PAIN (Soreness at the injection site), THERAPEUTIC RESPONSE UNEXPECTED (Improvement in breathing) and ABDOMINAL TENDERNESS (Abdominal tenderness). At the time of the report, ABDOMINAL PAIN (Abdominal cramping and discomfort), ABDOMINAL DISTENSION (abdominal distension), VACCINATION SITE PAIN (Soreness at the injection site), THERAPEUTIC RESPONSE UNEXPECTED (Improvement in breathing) and ABDOMINAL TENDERNESS (Abdominal tenderness) outcome was unknown.        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 provided.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Asthenia, Chills, Fatigue, Restlessness
Clinical narrative: Felt fidgety; No energy; Fells different behind her eyes; Fighting to stay awake; Exhausted; Chills; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESSNESS (Felt fidgety), ASTHENIA (No energy), ABNORMAL SENSATION IN EYE (Fells different behind her eyes), SOMNOLENCE (Fighting to stay awake) and FATIGUE (Exhausted) in a 91-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.     Concurrent medical conditions included Blood pressure high and Anxiety.    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 experienced RESTLESSNESS (Felt fidgety), ASTHENIA (No energy), ABNORMAL SENSATION IN EYE (Fells different behind her eyes), SOMNOLENCE (Fighting to stay awake), FATIGUE (Exhausted) and CHILLS (Chills). At the time of the report, RESTLESSNESS (Felt fidgety), ASTHENIA (No energy), ABNORMAL SENSATION IN EYE (Fells different behind her eyes), SOMNOLENCE (Fighting to stay awake), FATIGUE (Exhausted) and CHILLS (Chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include blood pressure and anxiety medications. No treatment details reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Followup received on 23-Jun-2021 and Patient gender updated. outcome of all events updated from unknown to recovered. Patient didn't showed any interest to answer  questions and told doesn't want any phone.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Felt fidgety; No energy; Fells different behind her eyes; Fighting to stay awake; Exhausted; Chills; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESSNESS (Felt fidgety), ASTHENIA (No energy), ABNORMAL SENSATION IN EYE (Fells different behind her eyes), SOMNOLENCE (Fighting to stay awake) and FATIGUE (Exhausted) in a 91-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.     Concurrent medical conditions included Blood pressure high and Anxiety.    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 experienced RESTLESSNESS (Felt fidgety), ASTHENIA (No energy), ABNORMAL SENSATION IN EYE (Fells different behind her eyes), SOMNOLENCE (Fighting to stay awake), FATIGUE (Exhausted) and CHILLS (Chills). At the time of the report, RESTLESSNESS (Felt fidgety), ASTHENIA (No energy), ABNORMAL SENSATION IN EYE (Fells different behind her eyes), SOMNOLENCE (Fighting to stay awake), FATIGUE (Exhausted) and CHILLS (Chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include blood pressure and anxiety medications. No treatment details reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Followup received on 23-Jun-2021 and Patient gender updated. outcome of all events updated from unknown to recovered. Patient didn't showed any interest to answer  questions and told doesn't want any phone.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Energy increased, Feeling cold, Hot flush, Ocular hyperaemia
Clinical narrative: Cold for 30 minutes after; Hot flashes for 20 minutes; Eyes turned red right after; Large burst of energy/ Another burst of energy; Energy later on drastically dropped/ Another drop of energy; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes for 20 minutes), OCULAR HYPERAEMIA (Eyes turned red right after), ENERGY INCREASED (Large burst of energy/ Another burst of energy), ASTHENIA (Energy later on drastically dropped/ Another drop of energy) and FEELING COLD (Cold for 30 minutes after) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced HOT FLUSH (Hot flashes for 20 minutes), OCULAR HYPERAEMIA (Eyes turned red right after), ENERGY INCREASED (Large burst of energy/ Another burst of energy) and ASTHENIA (Energy later on drastically dropped/ Another drop of energy). On 08-Mar-2021, the patient experienced FEELING COLD (Cold for 30 minutes after). On 07-Mar-2021, HOT FLUSH (Hot flashes for 20 minutes), OCULAR HYPERAEMIA (Eyes turned red right after), ENERGY INCREASED (Large burst of energy/ Another burst of energy) and ASTHENIA (Energy later on drastically dropped/ Another drop of energy) had resolved. On 08-Mar-2021, FEELING COLD (Cold for 30 minutes after) 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.   No treatment details reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: The reporter doesn't have a way to print the form.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: big red ring on her arm and it is hot, it went away and came back; big red ring on her arm and it is hot, it went away and came back; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (big red ring on her arm and it is hot, it went away and came back) and VACCINATION SITE ERYTHEMA (big red ring on her arm and it is hot, it went away and came back) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE WARMTH (big red ring on her arm and it is hot, it went away and came back) and VACCINATION SITE ERYTHEMA (big red ring on her arm and it is hot, it went away and came back). At the time of the report, VACCINATION SITE WARMTH (big red ring on her arm and it is hot, it went away and came back) and VACCINATION SITE ERYTHEMA (big red ring on her arm and it is hot, it went away and came back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug and treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Nausea, Pain in extremity, Peripheral coldness, Skin warm
Clinical narrative: left leg was cold and my right leg warm to the touch. I was freezing., nausea; left leg was cold and my right leg warm to the touch. I was freezing., nausea; left leg was cold and my right leg warm to the touch. I was freezing., nausea; left leg was cold and my right leg warm to the touch. I was freezing., nausea; Arm hurt really bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt really bad), PERIPHERAL COLDNESS (left leg was cold and my right leg warm to the touch. I was freezing., nausea), SKIN WARM (left leg was cold and my right leg warm to the touch. I was freezing., nausea), FEELING COLD (left leg was cold and my right leg warm to the touch. I was freezing., nausea) and NAUSEA (left leg was cold and my right leg warm to the touch. I was freezing., nausea) in a 65-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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt really bad). On 05-Mar-2021, the patient experienced PERIPHERAL COLDNESS (left leg was cold and my right leg warm to the touch. I was freezing., nausea), SKIN WARM (left leg was cold and my right leg warm to the touch. I was freezing., nausea), FEELING COLD (left leg was cold and my right leg warm to the touch. I was freezing., nausea) and NAUSEA (left leg was cold and my right leg warm to the touch. I was freezing., nausea). On 05-Mar-2021, PERIPHERAL COLDNESS (left leg was cold and my right leg warm to the touch. I was freezing., nausea), SKIN WARM (left leg was cold and my right leg warm to the touch. I was freezing., nausea), FEELING COLD (left leg was cold and my right leg warm to the touch. I was freezing., nausea) and NAUSEA (left leg was cold and my right leg warm to the touch. I was freezing., nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurt really bad) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No new significant information was provided. The reporter's contact information was updated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L30A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced HERPES ZOSTER (shingles). The patient was treated with ACYCLOVIR [ACICLOVIR] for Adverse event, at a dose of UNK dosage form. At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID 19) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID 19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID 19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Very limited information regarding this event has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: 4th Shingles flare up; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (4th Shingles flare up) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 030M20) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to vaccine (She got the second shingles vaccine last year and later got a shingles flare.). Concomitant products included AMLODIPINE for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced HERPES ZOSTER (4th Shingles flare up). The patient was treated with GABAPENTIN for Adverse event, at an unspecified dose and frequency; PREGABALIN (LYRICA) for Adverse event, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, HERPES ZOSTER (4th Shingles flare up) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: ADR Form On 05-May-2021: added concomitant drug and treatment from follow up form
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity, Tenderness
Clinical narrative: Sore arm; tender arm; sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), TENDERNESS (tender arm) and INJECTION SITE PAIN (sore at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RAMIPRIL from 10-Oct-2019 to an unknown date for Blood pressure, MULTIVITAMINES AND MINERALS from 01-Jun-1999 to an unknown date.   On 03-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 an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), TENDERNESS (tender arm) and INJECTION SITE PAIN (sore at injection site). On 30-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, TENDERNESS (tender arm) and INJECTION SITE PAIN (sore at injection site) outcome was unknown. Not Provided          No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: addition information received on 4 MAY 2021 contain information:  Patient Demographic details updated,  product tab updated and event tab updated.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness in the area around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness in the area around the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness in the area around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness in the area around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received the first dose of Moderna between February 9th and 10th and reported that they experienced redness in the area around the injection site. No further details obtained.  No Concomitant product use was reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Day 38 post first dose/trying to get 2nd dose scheduled but; A Spontaneous report was received from a consumer concerning female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and second dose scheduled but has not been successful.  / Inappropriate schedule of product administration.  The patient's medical history was not reported. Concomitant Medications were not listed.  On 30 Jan 2021, prior to the onset of events the patient received first dose of their two planned doses of mRNA-1273 (Batch N0: unknown) for prophylaxis of covid 19 infection.  On 09 Mar 2021, the patient reported that trying to get second dose scheduled but has not been successful. (Inappropriate schedule of product administration).   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event Inappropriate schedule of product administration was resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Injection site red and itchy after 1st dose; Injection site red and itchy after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site red and itchy after 1st dose) and VACCINATION SITE ERYTHEMA (Injection site red and itchy after 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site red and itchy after 1st dose) and VACCINATION SITE ERYTHEMA (Injection site red and itchy after 1st dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Injection site red and itchy after 1st dose) and VACCINATION SITE ERYTHEMA (Injection site red and itchy after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment for the events included Benadryl, which helped.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient is approaching their 42 days of the recommended interval of the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient is approaching their 42 days of the recommended interval of the 2nd dose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient is approaching their 42 days of the recommended interval of the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient is approaching their 42 days of the recommended interval of the 2nd dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medicines were not included Action taken with mRNA-1273 in response to the event was unknown; Reporter's Comments: This report refers to a case of Product omission issue(missed dose) for mRNA-1273, lot #  028L20A with no associated Adverse Events.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Headache, Pain in extremity
Clinical narrative: Sore arm; Very tired; Headache; Burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), BURNING SENSATION (Burning sensation), FATIGUE (Very tired) and HEADACHE (Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 07-Feb-2021, the patient experienced BURNING SENSATION (Burning sensation) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Very tired). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Very tired) had resolved and BURNING SENSATION (Burning sensation) and HEADACHE (Headache) outcome was unknown. Not Provided          No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: TCR received: Outcome of the event & 2nd dose was mentioned.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CILOSTAZOL for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced MYALGIA (sore arm). On 26-Feb-2021, MYALGIA (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking Cilostazol for a blockage in his right leg and was concerned about a bleeding risk. No treatment information was provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccinated a 17 year old; A spontaneous report was received from a health care professional concerning a 17-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was provided. Concomitant product use was not provided by the reporter.   On 02 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013A21A) for prophylaxis of COVID-19 infection.    On 02 Mar 2021, The patient experienced vaccinated at 17 years old. Treatment information was none.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of event vaccinated at 17 years old was considered resolved on 02 Mar 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number 013A21A) with no associated AEs reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea, Headache, Myalgia
Clinical narrative: difficulty breathing; chest discomfort; Cough; Fever; body aches; body aches , headaches , chest pains; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), CHEST DISCOMFORT (chest discomfort), COUGH (Cough), PYREXIA (Fever) and MYALGIA (body aches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DYSPNOEA (difficulty breathing), CHEST DISCOMFORT (chest discomfort), COUGH (Cough), PYREXIA (Fever), MYALGIA (body aches) and HEADACHE (body aches , headaches , chest pains). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, DYSPNOEA (difficulty breathing), CHEST DISCOMFORT (chest discomfort), COUGH (Cough), PYREXIA (Fever), MYALGIA (body aches) and HEADACHE (body aches , headaches , chest pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: difficulty breathing; chest discomfort; Cough; Fever; body aches; body aches , headaches , chest pains; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), CHEST DISCOMFORT (chest discomfort), COUGH (Cough), PYREXIA (Fever) and MYALGIA (body aches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DYSPNOEA (difficulty breathing), CHEST DISCOMFORT (chest discomfort), COUGH (Cough), PYREXIA (Fever), MYALGIA (body aches) and HEADACHE (body aches , headaches , chest pains). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, DYSPNOEA (difficulty breathing), CHEST DISCOMFORT (chest discomfort), COUGH (Cough), PYREXIA (Fever), MYALGIA (body aches) and HEADACHE (body aches , headaches , chest pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dysgeusia, Dyspepsia, Palpitations
Clinical narrative: my heart was pounding; metal taste, kind of like a fuzziness, in my tongue; heartburn; chills; random rashes on my body and it disappears in 15 minutes; felt tightness in chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (felt tightness in chest), PALPITATIONS (my heart was pounding), DYSGEUSIA (metal taste, kind of like a fuzziness, in my tongue), DYSPEPSIA (heartburn) and CHILLS (chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dermographism. Concomitant products included ATORVASTATIN, CALCIUM CITRATE, ZINC, MULTIVITAMINS [VITAMINS NOS], ALPRAZOLAM, PROBIOTICS NOS and COLECALCIFEROL (VIT D [COLECALCIFEROL]) 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 CHEST DISCOMFORT (felt tightness in chest) and RASH (random rashes on my body and it disappears in 15 minutes). On 26-Feb-2021, the patient experienced PALPITATIONS (my heart was pounding), DYSGEUSIA (metal taste, kind of like a fuzziness, in my tongue), DYSPEPSIA (heartburn) and CHILLS (chills). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at a dose of UNK dosage form. On 25-Feb-2021, CHEST DISCOMFORT (felt tightness in chest) had resolved. At the time of the report, PALPITATIONS (my heart was pounding), DYSGEUSIA (metal taste, kind of like a fuzziness, in my tongue), DYSPEPSIA (heartburn), CHILLS (chills) and RASH (random rashes on my body and it disappears in 15 minutes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Contact information & new AE added
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: my heart was pounding; metal taste, kind of like a fuzziness, in my tongue; heartburn; chills; random rashes on my body and it disappears in 15 minutes; felt tightness in chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (felt tightness in chest), PALPITATIONS (my heart was pounding), DYSGEUSIA (metal taste, kind of like a fuzziness, in my tongue), DYSPEPSIA (heartburn) and CHILLS (chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dermographism. Concomitant products included ATORVASTATIN, CALCIUM CITRATE, ZINC, MULTIVITAMINS [VITAMINS NOS], ALPRAZOLAM, PROBIOTICS NOS and COLECALCIFEROL (VIT D [COLECALCIFEROL]) 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 CHEST DISCOMFORT (felt tightness in chest) and RASH (random rashes on my body and it disappears in 15 minutes). On 26-Feb-2021, the patient experienced PALPITATIONS (my heart was pounding), DYSGEUSIA (metal taste, kind of like a fuzziness, in my tongue), DYSPEPSIA (heartburn) and CHILLS (chills). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at a dose of UNK dosage form. On 25-Feb-2021, CHEST DISCOMFORT (felt tightness in chest) had resolved. At the time of the report, PALPITATIONS (my heart was pounding), DYSGEUSIA (metal taste, kind of like a fuzziness, in my tongue), DYSPEPSIA (heartburn), CHILLS (chills) and RASH (random rashes on my body and it disappears in 15 minutes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Contact information & new AE added
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Chills, Dyspnoea, Fatigue, Nausea
Clinical narrative: Tiredness and agitation; Tiredness and agitation; nausea, chills with no fever and shortness of breath for a day; nausea, chills with no fever and shortness of breath for a day; nausea, chills with no fever and shortness of breath for a day; soreness in his arm; This spontaneous case was reported by a consumer and describes the occurrence of AGITATION (Tiredness and agitation), PAIN IN EXTREMITY (soreness in his arm), DYSPNOEA (nausea, chills with no fever and shortness of breath for a day), FATIGUE (Tiredness and agitation) and NAUSEA (nausea, chills with no fever and shortness of breath for a day) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Allergy NOS.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in his arm). On 25-Feb-2021, the patient experienced DYSPNOEA (nausea, chills with no fever and shortness of breath for a day), NAUSEA (nausea, chills with no fever and shortness of breath for a day) and CHILLS (nausea, chills with no fever and shortness of breath for a day). On 08-Mar-2021, the patient experienced AGITATION (Tiredness and agitation) and FATIGUE (Tiredness and agitation). The patient was treated with SALBUTAMOL SULFATE (VENTOLIN ACCUHALER) at a dose of 1 dosage form; LORATADINE (CLARITINE) at a dose of 1 dosage form and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form. On 15-Feb-2021, PAIN IN EXTREMITY (soreness in his arm) had resolved. On 26-Feb-2021, DYSPNOEA (nausea, chills with no fever and shortness of breath for a day), NAUSEA (nausea, chills with no fever and shortness of breath for a day) and CHILLS (nausea, chills with no fever and shortness of breath for a day) had resolved. At the time of the report, AGITATION (Tiredness and agitation) and FATIGUE (Tiredness and agitation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Tiredness and agitation; Tiredness and agitation; nausea, chills with no fever and shortness of breath for a day; nausea, chills with no fever and shortness of breath for a day; nausea, chills with no fever and shortness of breath for a day; soreness in his arm; This spontaneous case was reported by a consumer and describes the occurrence of AGITATION (Tiredness and agitation), PAIN IN EXTREMITY (soreness in his arm), DYSPNOEA (nausea, chills with no fever and shortness of breath for a day), FATIGUE (Tiredness and agitation) and NAUSEA (nausea, chills with no fever and shortness of breath for a day) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Allergy NOS.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in his arm). On 25-Feb-2021, the patient experienced DYSPNOEA (nausea, chills with no fever and shortness of breath for a day), NAUSEA (nausea, chills with no fever and shortness of breath for a day) and CHILLS (nausea, chills with no fever and shortness of breath for a day). On 08-Mar-2021, the patient experienced AGITATION (Tiredness and agitation) and FATIGUE (Tiredness and agitation). The patient was treated with SALBUTAMOL SULFATE (VENTOLIN ACCUHALER) at a dose of 1 dosage form; LORATADINE (CLARITINE) at a dose of 1 dosage form and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form. On 15-Feb-2021, PAIN IN EXTREMITY (soreness in his arm) had resolved. On 26-Feb-2021, DYSPNOEA (nausea, chills with no fever and shortness of breath for a day), NAUSEA (nausea, chills with no fever and shortness of breath for a day) and CHILLS (nausea, chills with no fever and shortness of breath for a day) had resolved. At the time of the report, AGITATION (Tiredness and agitation) and FATIGUE (Tiredness and agitation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: day after arm was red below deltoid in between bicept and tricep; itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (day after arm was red below deltoid in between bicept and tricep) and VACCINATION SITE PRURITUS (itching) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (day after arm was red below deltoid in between bicept and tricep) and VACCINATION SITE PRURITUS (itching). At the time of the report, VACCINATION SITE ERYTHEMA (day after arm was red below deltoid in between bicept and tricep) and VACCINATION SITE PRURITUS (itching) had not resolved.            Treatment included coconut oil application to injection site for itching. No concomitant medications reported.   Action taken with mRNA 1273 in response to event was not applicable.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from temperature excursion vial; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from temperature excursion vial) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029a21a and 013m20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 07-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from temperature excursion vial). On 07-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from temperature excursion vial) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 with no associated AEs.
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 female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at a dose of 1 dosage form. At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.