chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea
Clinical narrative: fatigue; Nausea; body aches.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), NAUSEA (Nausea) and MYALGIA (body aches.) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced FATIGUE (fatigue), NAUSEA (Nausea) and MYALGIA (body aches.). On 31-Mar-2021, FATIGUE (fatigue), NAUSEA (Nausea) and MYALGIA (body aches.) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-090372, MOD-2021-090372 (Patient Link).   Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling hot, Headache
Clinical narrative: arm hot to touch; a big blotchy rash; Itchy; Dizziness; nausea; Muscle aches; CHILLS; FEVER; was a little tired; headache/stronger headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), DIZZINESS (Dizziness), FEELING HOT (arm hot to touch), RASH (a big blotchy rash) and FATIGUE (was a little tired) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Allergic reaction to antibiotics and Tooth extraction on 16-Apr-2021. Concomitant products included AMOXICILLIN, CLINDAMYCIN, VALACYCLOVIR [VALACICLOVIR], IBUPROFEN and TRAMADOL for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced FATIGUE (was a little tired) and HEADACHE (headache/stronger headache). On 23-Apr-2021, the patient experienced DIZZINESS (Dizziness), NAUSEA (nausea), MYALGIA (Muscle aches), CHILLS (CHILLS) and PYREXIA (FEVER). On 25-Apr-2021, the patient experienced PRURITUS (Itchy), FEELING HOT (arm hot to touch) and RASH (a big blotchy rash). At the time of the report, PRURITUS (Itchy), FEELING HOT (arm hot to touch), RASH (a big blotchy rash), FATIGUE (was a little tired), HEADACHE (headache/stronger headache) and MYALGIA (Muscle aches) had not resolved and DIZZINESS (Dizziness), NAUSEA (nausea), CHILLS (CHILLS) and PYREXIA (FEVER) outcome was unknown.            The patient treatment data was not provided.   This case was linked to MOD-2021-090293 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pruritus, Pyrexia, Rash
Clinical narrative: arm hot to touch; a big blotchy rash; Itchy; Dizziness; nausea; Muscle aches; CHILLS; FEVER; was a little tired; headache/stronger headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), DIZZINESS (Dizziness), FEELING HOT (arm hot to touch), RASH (a big blotchy rash) and FATIGUE (was a little tired) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Allergic reaction to antibiotics and Tooth extraction on 16-Apr-2021. Concomitant products included AMOXICILLIN, CLINDAMYCIN, VALACYCLOVIR [VALACICLOVIR], IBUPROFEN and TRAMADOL for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced FATIGUE (was a little tired) and HEADACHE (headache/stronger headache). On 23-Apr-2021, the patient experienced DIZZINESS (Dizziness), NAUSEA (nausea), MYALGIA (Muscle aches), CHILLS (CHILLS) and PYREXIA (FEVER). On 25-Apr-2021, the patient experienced PRURITUS (Itchy), FEELING HOT (arm hot to touch) and RASH (a big blotchy rash). At the time of the report, PRURITUS (Itchy), FEELING HOT (arm hot to touch), RASH (a big blotchy rash), FATIGUE (was a little tired), HEADACHE (headache/stronger headache) and MYALGIA (Muscle aches) had not resolved and DIZZINESS (Dizziness), NAUSEA (nausea), CHILLS (CHILLS) and PYREXIA (FEVER) outcome was unknown.            The patient treatment data was not provided.   This case was linked to MOD-2021-090293 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Myalgia, Vaccination site erythema
Clinical narrative: The injection site is red, but not hurting; Up most of the night last night because of her headache.; bad headache; general body aches all over; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Up most of the night last night because of her headache.), HEADACHE (bad headache), MYALGIA (general body aches all over) and VACCINATION SITE ERYTHEMA (The injection site is red, but not hurting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced INSOMNIA (Up most of the night last night because of her headache.), HEADACHE (bad headache) and MYALGIA (general body aches all over). On 26-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (The injection site is red, but not hurting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INSOMNIA (Up most of the night last night because of her headache.), HEADACHE (bad headache), MYALGIA (general body aches all over) and VACCINATION SITE ERYTHEMA (The injection site is red, but not hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment with Tylenol was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: TCR form is added.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Pain in extremity, Vaccination site erythema, Vaccination site induration
Clinical narrative: Arm/Shoulder pain; Arm/Shoulder pain; Redness at injection site; Burning at injection site; Hardness at injection site; Itchy at injection site; Breathing issues; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathing issues), PAIN IN EXTREMITY (Arm/Shoulder pain), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and ARTHRALGIA (Arm/Shoulder pain) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced DYSPNOEA (Breathing issues), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Burning at injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm/Shoulder pain) and ARTHRALGIA (Arm/Shoulder pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Breathing issues), PAIN IN EXTREMITY (Arm/Shoulder pain), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE PRURITUS (Itchy at injection site), ARTHRALGIA (Arm/Shoulder pain), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Burning at injection site) outcome was unknown. Not Provided          Patient used Benadryl as concomitant and treatment medication.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Patient declined further follow up.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Arm/Shoulder pain; Arm/Shoulder pain; Redness at injection site; Burning at injection site; Hardness at injection site; Itchy at injection site; Breathing issues; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathing issues), PAIN IN EXTREMITY (Arm/Shoulder pain), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and ARTHRALGIA (Arm/Shoulder pain) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced DYSPNOEA (Breathing issues), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Burning at injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm/Shoulder pain) and ARTHRALGIA (Arm/Shoulder pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Breathing issues), PAIN IN EXTREMITY (Arm/Shoulder pain), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE PRURITUS (Itchy at injection site), ARTHRALGIA (Arm/Shoulder pain), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Burning at injection site) outcome was unknown. Not Provided          Patient used Benadryl as concomitant and treatment medication.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Patient declined further follow up.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Neck pain, Visual impairment
Clinical narrative: occasional stabbing pain at the back of the neck; occasional stabbing pain when bending over; excruciating pain on the lest side of my head; my vision went white; severe headache; fatigue - slept for 15 hours; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache), NECK PAIN (occasional stabbing pain at the back of the neck), VISUAL IMPAIRMENT (my vision went white), BACK PAIN (occasional stabbing pain when bending over) and HEADACHE (excruciating pain on the lest side of my head) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced FATIGUE (fatigue - slept for 15 hours). On 19-Apr-2021, the patient experienced HEADACHE (severe headache). On 22-Apr-2021, the patient experienced VISUAL IMPAIRMENT (my vision went white) and HEADACHE (excruciating pain on the lest side of my head). On 26-Apr-2021, the patient experienced NECK PAIN (occasional stabbing pain at the back of the neck) and BACK PAIN (occasional stabbing pain when bending over). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form; IBUPROFEN at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and METOCLOPRAMIDE HYDROCHLORIDE (ANTI NAUSEA) at a dose of 1 dosage form. On 16-Apr-2021, FATIGUE (fatigue - slept for 15 hours) had resolved. At the time of the report, HEADACHE (severe headache), NECK PAIN (occasional stabbing pain at the back of the neck), VISUAL IMPAIRMENT (my vision went white), BACK PAIN (occasional stabbing pain when bending over) and HEADACHE (excruciating pain on the lest side of my head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: unable to sleep; I could barely see out of eyes"; uncontrollable shaking; "I was so sick, It was so bad."; "I had the chills so bad, I was uncontrollable shaking"; severe fatigue; muscle pain; joint pain; Severe Headache; fever was 102.5 for two days; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (unable to sleep), VISION BLURRED (I could barely see out of eyes"), TREMOR (uncontrollable shaking), ILLNESS ("I was so sick, It was so bad.") and CHILLS ("I had the chills so bad, I was uncontrollable shaking") in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced INSOMNIA (unable to sleep), VISION BLURRED (I could barely see out of eyes"), TREMOR (uncontrollable shaking), ILLNESS ("I was so sick, It was so bad."), CHILLS ("I had the chills so bad, I was uncontrollable shaking"), FATIGUE (severe fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (Severe Headache) and PYREXIA (fever was 102.5 for two days). On 24-Apr-2021, INSOMNIA (unable to sleep), VISION BLURRED (I could barely see out of eyes"), TREMOR (uncontrollable shaking), ILLNESS ("I was so sick, It was so bad."), CHILLS ("I had the chills so bad, I was uncontrollable shaking"), FATIGUE (severe fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (Severe Headache) and PYREXIA (fever was 102.5 for two days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2021, Body temperature: 102.5 High.         No concomitant medication were reported. Treatment medication included Tylenol and Advil to help relieve side effects.   This case was linked to MOD-2021-090359 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Insomnia, Myalgia, Pyrexia, Tremor
Clinical narrative: unable to sleep; I could barely see out of eyes"; uncontrollable shaking; "I was so sick, It was so bad."; "I had the chills so bad, I was uncontrollable shaking"; severe fatigue; muscle pain; joint pain; Severe Headache; fever was 102.5 for two days; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (unable to sleep), VISION BLURRED (I could barely see out of eyes"), TREMOR (uncontrollable shaking), ILLNESS ("I was so sick, It was so bad.") and CHILLS ("I had the chills so bad, I was uncontrollable shaking") in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced INSOMNIA (unable to sleep), VISION BLURRED (I could barely see out of eyes"), TREMOR (uncontrollable shaking), ILLNESS ("I was so sick, It was so bad."), CHILLS ("I had the chills so bad, I was uncontrollable shaking"), FATIGUE (severe fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (Severe Headache) and PYREXIA (fever was 102.5 for two days). On 24-Apr-2021, INSOMNIA (unable to sleep), VISION BLURRED (I could barely see out of eyes"), TREMOR (uncontrollable shaking), ILLNESS ("I was so sick, It was so bad."), CHILLS ("I had the chills so bad, I was uncontrollable shaking"), FATIGUE (severe fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (Severe Headache) and PYREXIA (fever was 102.5 for two days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2021, Body temperature: 102.5 High.         No concomitant medication were reported. Treatment medication included Tylenol and Advil to help relieve side effects.   This case was linked to MOD-2021-090359 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: unable to sleep; I could barely see out of eyes"; uncontrollable shaking; "I was so sick, It was so bad."; "I had the chills so bad, I was uncontrollable shaking"; severe fatigue; muscle pain; joint pain; Severe Headache; fever was 102.5 for two days; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (unable to sleep), VISION BLURRED (I could barely see out of eyes"), TREMOR (uncontrollable shaking), ILLNESS ("I was so sick, It was so bad.") and CHILLS ("I had the chills so bad, I was uncontrollable shaking") in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced INSOMNIA (unable to sleep), VISION BLURRED (I could barely see out of eyes"), TREMOR (uncontrollable shaking), ILLNESS ("I was so sick, It was so bad."), CHILLS ("I had the chills so bad, I was uncontrollable shaking"), FATIGUE (severe fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (Severe Headache) and PYREXIA (fever was 102.5 for two days). On 24-Apr-2021, INSOMNIA (unable to sleep), VISION BLURRED (I could barely see out of eyes"), TREMOR (uncontrollable shaking), ILLNESS ("I was so sick, It was so bad."), CHILLS ("I had the chills so bad, I was uncontrollable shaking"), FATIGUE (severe fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (Severe Headache) and PYREXIA (fever was 102.5 for two days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2021, Body temperature: 102.5 High.         No concomitant medication were reported. Treatment medication included Tylenol and Advil to help relieve side effects.   This case was linked to MOD-2021-090359 (Patient Link).
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: tiredness; headache; fever; inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered), PYREXIA (fever), FATIGUE (tiredness) and HEADACHE (headache) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 23-Apr-2021, the patient experienced PYREXIA (fever). On 26-Apr-2021, the patient experienced FATIGUE (tiredness) and HEADACHE (headache). On 02-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. On 25-Apr-2021, PYREXIA (fever) had resolved. At the time of the report, FATIGUE (tiredness) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Body temperature: 104 High.         No concomitant medications were reported. The patient had acetaminophen 600 mg for fever.   This case was linked to MODERNATX, INC.-MOD-2021-090443, MODERNATX, INC.-MOD-2021-090451 (E2B Linked Report).; Sender's Comments: MODERNATX, INC.-MOD-2021-090451:Mother's case dose 2 MODERNATX, INC.-MOD-2021-090443:Mother's case dose 1
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Pain
Clinical narrative: Nausea; Fatigue; Muscle pain; body aches; Fatigue; nausea; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), the second episode of FATIGUE (Fatigue), MYALGIA (Muscle pain), PAIN (body aches) and the first episode of FATIGUE (Fatigue) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced the first episode of FATIGUE (Fatigue), NAUSEA (nausea) and MYALGIA (Myalgia). On 21-Apr-2021, the patient experienced NAUSEA (Nausea), the second episode of FATIGUE (Fatigue), MYALGIA (Muscle pain) and PAIN (body aches). On 31-Mar-2021, NAUSEA (nausea) and MYALGIA (Myalgia) had resolved. At the time of the report, NAUSEA (Nausea), the last episode of FATIGUE (Fatigue), MYALGIA (Muscle pain) and PAIN (body aches) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided by the reporter. No concomitant medication was provided by the reporter. No lab data was provided by the reporter.   This case was linked to MOD-2021-090364, MOD-2021-090364 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Excessive hair fall; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Excessive hair fall) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-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 ALOPECIA (Excessive hair fall). At the time of the report, ALOPECIA (Excessive hair fall) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information were reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Lethargy
Clinical narrative: Lethargic; Weak; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), ASTHENIA (Weak) and FATIGUE (Tiredness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included Flu vaccination (she has reacting to flu vaccine). Concurrent medical conditions included Chronic kidney disease (she was born with only one functioning kidney). Concomitant products included ATORVASTATIN for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced LETHARGY (Lethargic), ASTHENIA (Weak) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Mar-2021, LETHARGY (Lethargic), ASTHENIA (Weak) and FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treat   This case was linked to MOD-2021-090383 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed the second dose (more than 8 weeks since first dose); This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the second dose (more than 8 weeks since first dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second dose (more than 8 weeks since first dose)). On 26-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Missed the second dose (more than 8 weeks since first dose)) 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.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: form, Reporter responding to FU attempt 1
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inappropriate schedule of vaccine administered; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 027B21A) for COVID-19 immunisation.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), AMLODIPINE, OLANZAPINE, METHIMAZOLE, HYDROXYZINE and ESCITALOPRAM for an unknown indication.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 22-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Cerumen removal, Hypoacusis, Product dose omission issue, Tinnitus
Clinical narrative: Remove the wax in her ears; mild hearing loss at 8 khz; ringing in her ears, high pitched & constant, it's in both ears/ongoing; Canceled second dose appointment; Had a pretty hard lump; It had a pretty hard lump, which was warm to touch; hard lump; It had a pretty hard lump, which was tender; It had a pretty hard lump, which was itchy; some swelling in injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Had a pretty hard lump), VACCINATION SITE WARMTH (It had a pretty hard lump, which was warm to touch), TINNITUS (ringing in her ears, high pitched & constant, it's in both ears/ongoing), CERUMEN REMOVAL (Remove the wax in her ears) and PRODUCT DOSE OMISSION ISSUE (Canceled second dose appointment) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE MASS (Had a pretty hard lump), VACCINATION SITE WARMTH (It had a pretty hard lump, which was warm to touch), VACCINATION SITE INDURATION (hard lump), VACCINATION SITE PAIN (It had a pretty hard lump, which was tender), VACCINATION SITE PRURITUS (It had a pretty hard lump, which was itchy) and VACCINATION SITE SWELLING (some swelling in injection site arm). On 24-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Canceled second dose appointment). On 26-Apr-2021, the patient experienced TINNITUS (ringing in her ears, high pitched & constant, it's in both ears/ongoing). On an unknown date, the patient experienced CERUMEN REMOVAL (Remove the wax in her ears) and HYPOACUSIS (mild hearing loss at 8 khz). At the time of the report, VACCINATION SITE MASS (Had a pretty hard lump), VACCINATION SITE WARMTH (It had a pretty hard lump, which was warm to touch), TINNITUS (ringing in her ears, high pitched & constant, it's in both ears/ongoing), CERUMEN REMOVAL (Remove the wax in her ears), PRODUCT DOSE OMISSION ISSUE (Canceled second dose appointment), HYPOACUSIS (mild hearing loss at 8 khz), VACCINATION SITE INDURATION (hard lump), VACCINATION SITE PAIN (It had a pretty hard lump, which was tender), VACCINATION SITE PRURITUS (It had a pretty hard lump, which was itchy) and VACCINATION SITE SWELLING (some swelling in injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Acoustic stimulation tests: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported.  Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: VAER form appended
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Remove the wax in her ears; mild hearing loss at 8 khz; ringing in her ears, high pitched & constant, it's in both ears/ongoing; Canceled second dose appointment; Had a pretty hard lump; It had a pretty hard lump, which was warm to touch; hard lump; It had a pretty hard lump, which was tender; It had a pretty hard lump, which was itchy; some swelling in injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Had a pretty hard lump), VACCINATION SITE WARMTH (It had a pretty hard lump, which was warm to touch), TINNITUS (ringing in her ears, high pitched & constant, it's in both ears/ongoing), CERUMEN REMOVAL (Remove the wax in her ears) and PRODUCT DOSE OMISSION ISSUE (Canceled second dose appointment) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE MASS (Had a pretty hard lump), VACCINATION SITE WARMTH (It had a pretty hard lump, which was warm to touch), VACCINATION SITE INDURATION (hard lump), VACCINATION SITE PAIN (It had a pretty hard lump, which was tender), VACCINATION SITE PRURITUS (It had a pretty hard lump, which was itchy) and VACCINATION SITE SWELLING (some swelling in injection site arm). On 24-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Canceled second dose appointment). On 26-Apr-2021, the patient experienced TINNITUS (ringing in her ears, high pitched & constant, it's in both ears/ongoing). On an unknown date, the patient experienced CERUMEN REMOVAL (Remove the wax in her ears) and HYPOACUSIS (mild hearing loss at 8 khz). At the time of the report, VACCINATION SITE MASS (Had a pretty hard lump), VACCINATION SITE WARMTH (It had a pretty hard lump, which was warm to touch), TINNITUS (ringing in her ears, high pitched & constant, it's in both ears/ongoing), CERUMEN REMOVAL (Remove the wax in her ears), PRODUCT DOSE OMISSION ISSUE (Canceled second dose appointment), HYPOACUSIS (mild hearing loss at 8 khz), VACCINATION SITE INDURATION (hard lump), VACCINATION SITE PAIN (It had a pretty hard lump, which was tender), VACCINATION SITE PRURITUS (It had a pretty hard lump, which was itchy) and VACCINATION SITE SWELLING (some swelling in injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Acoustic stimulation tests: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported.  Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: VAER form appended
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Asthenia, Headache, Nausea
Clinical narrative: No taste of food; Weak; Body ache; Headache as of Migraine; Nausea; Joint pains; Arm swollen with itching and hurting; Arm swollen with itching and hurting; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (No taste of food), ASTHENIA (Weak), PAIN (Body ache), HEADACHE (Headache as of Migraine) and NAUSEA (Nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Arm swollen with itching and hurting). On an unknown date, the patient experienced AGEUSIA (No taste of food), ASTHENIA (Weak), PAIN (Body ache), HEADACHE (Headache as of Migraine), NAUSEA (Nausea), ARTHRALGIA (Joint pains) and VACCINATION SITE SWELLING (Arm swollen with itching and hurting). The patient was treated with TRAMADOL for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, AGEUSIA (No taste of food), ASTHENIA (Weak), PAIN (Body ache), HEADACHE (Headache as of Migraine), NAUSEA (Nausea), ARTHRALGIA (Joint pains), VACCINATION SITE SWELLING (Arm swollen with itching and hurting) and VACCINATION SITE PRURITUS (Arm swollen with itching and hurting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: No taste of food; Weak; Body ache; Headache as of Migraine; Nausea; Joint pains; Arm swollen with itching and hurting; Arm swollen with itching and hurting; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (No taste of food), ASTHENIA (Weak), PAIN (Body ache), HEADACHE (Headache as of Migraine) and NAUSEA (Nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Arm swollen with itching and hurting). On an unknown date, the patient experienced AGEUSIA (No taste of food), ASTHENIA (Weak), PAIN (Body ache), HEADACHE (Headache as of Migraine), NAUSEA (Nausea), ARTHRALGIA (Joint pains) and VACCINATION SITE SWELLING (Arm swollen with itching and hurting). The patient was treated with TRAMADOL for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, AGEUSIA (No taste of food), ASTHENIA (Weak), PAIN (Body ache), HEADACHE (Headache as of Migraine), NAUSEA (Nausea), ARTHRALGIA (Joint pains), VACCINATION SITE SWELLING (Arm swollen with itching and hurting) and VACCINATION SITE PRURITUS (Arm swollen with itching and hurting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Limb discomfort, Nausea
Clinical narrative: couldn't move her arm; dizziness; headache; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (couldn't move her arm), DIZZINESS (dizziness), HEADACHE (headache) and NAUSEA (nausea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (couldn't move her arm), DIZZINESS (dizziness), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, LIMB DISCOMFORT (couldn't move her arm), DIZZINESS (dizziness), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. No treatment information was provided by reporter.   This case was linked to MOD-2021-090121 (E2B Linked Report).; Sender's Comments:  MOD-2021-090121:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Vaccination site lymphadenopathy
Clinical narrative: lump in the under arm/armpit region that is tender and on the same side she received the injection.; lump in the under arm/armpit region that is tender and on the same side she received the injection.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (lump in the under arm/armpit region that is tender and on the same side she received the injection.) and AXILLARY PAIN (lump in the under arm/armpit region that is tender and on the same side she received the injection.) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (lump in the under arm/armpit region that is tender and on the same side she received the injection.) and AXILLARY PAIN (lump in the under arm/armpit region that is tender and on the same side she received the injection.). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (lump in the under arm/armpit region that is tender and on the same side she received the injection.) and AXILLARY PAIN (lump in the under arm/armpit region that is tender and on the same side she received the injection.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Hyperhidrosis, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; sweating; Feeling tired; Low grade fever; She slept a lot; her face was hot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (She slept a lot), FEELING HOT (her face was hot), HYPERHIDROSIS (sweating) and FATIGUE (Feeling tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU. Concurrent medical conditions included Chronic kidney disease.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced SOMNOLENCE (She slept a lot), FEELING HOT (her face was hot), FATIGUE (Feeling tired) and PYREXIA (Low grade fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and HYPERHIDROSIS (sweating). At the time of the report, PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (She slept a lot), FEELING HOT (her face was hot), HYPERHIDROSIS (sweating), FATIGUE (Feeling tired) and PYREXIA (Low grade fever) outcome was unknown.            patient was treated with Tylenol.   This case was linked to MOD-2021-090374 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Sore arm; sweating; Feeling tired; Low grade fever; She slept a lot; her face was hot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (She slept a lot), FEELING HOT (her face was hot), HYPERHIDROSIS (sweating) and FATIGUE (Feeling tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU. Concurrent medical conditions included Chronic kidney disease.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced SOMNOLENCE (She slept a lot), FEELING HOT (her face was hot), FATIGUE (Feeling tired) and PYREXIA (Low grade fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and HYPERHIDROSIS (sweating). At the time of the report, PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (She slept a lot), FEELING HOT (her face was hot), HYPERHIDROSIS (sweating), FATIGUE (Feeling tired) and PYREXIA (Low grade fever) outcome was unknown.            patient was treated with Tylenol.   This case was linked to MOD-2021-090374 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: got the second dose on 23/Apr/2021 (day 108); tested positive for COVID-19 11 days after receiving the first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19 11 days after receiving the first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the second dose on 23/Apr/2021 (day 108)) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced COVID-19 (tested positive for COVID-19 11 days after receiving the first dose). On 23-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the second dose on 23/Apr/2021 (day 108)). The patient was treated with BAMLANIVIMAB at a dose of 1 dosage form. On 23-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the second dose on 23/Apr/2021 (day 108)) had resolved. At the time of the report, COVID-19 (tested positive for COVID-19 11 days after receiving the first dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, SARS-CoV-2 test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal
Clinical narrative: cough that will not go away and is aggravating; feeling miserable; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough that will not go away and is aggravating) and FEELING ABNORMAL (feeling miserable) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    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 COUGH (cough that will not go away and is aggravating) and FEELING ABNORMAL (feeling miserable). At the time of the report, COUGH (cough that will not go away and is aggravating) and FEELING ABNORMAL (feeling miserable) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-090264, US-MODERNATX, INC.-MOD-2021-090279 (E2B Linked Report). This case was linked to MOD-2021-090392 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090264:Husband Dose 1 case US-MODERNATX, INC.-MOD-2021-090279:Husband dose 2 case