chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing, Throat irritation, Walking disability
Clinical narrative: From walking unassited and pain free to now needing crutches gain; Puffy eyes; Scratchy throat; Constant runny nose; Sneezing; Sore arm; Very painful weight bearing on my new hip/weight bering pain on hip on new hip has gotten worse; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of WALKING DISABILITY (From walking unassited and pain free to now needing crutches gain), PERIORBITAL SWELLING (Puffy eyes), THROAT IRRITATION (Scratchy throat), RHINORRHOEA (Constant runny nose) and SNEEZING (Sneezing) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21a and 038b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthroplasty of hip (Total Arthroplasty of Left Hip) on 13-Apr-2021.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, 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 experienced WALKING DISABILITY (From walking unassited and pain free to now needing crutches gain), PERIORBITAL SWELLING (Puffy eyes), THROAT IRRITATION (Scratchy throat), RHINORRHOEA (Constant runny nose), SNEEZING (Sneezing), PAIN IN EXTREMITY (Sore arm), ARTHRALGIA (Very painful weight bearing on my new hip/weight bering pain on hip on new hip has gotten worse), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, WALKING DISABILITY (From walking unassited and pain free to now needing crutches gain), PERIORBITAL SWELLING (Puffy eyes), THROAT IRRITATION (Scratchy throat), RHINORRHOEA (Constant runny nose), SNEEZING (Sneezing), PAIN IN EXTREMITY (Sore arm), ARTHRALGIA (Very painful weight bearing on my new hip/weight bering pain on hip on new hip has gotten worse), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported  No treatment medications were reported  Patient received first dose of Moderna vaccine experienced no side effects.  It was reported that the patient experienced adverse effects started approximately 16 hours after the second dose. Patient reported that the 'seasonal allergy symptoms' were constant for approximately 16 days and became intermittent.  It was reported that the patient has never suffered a single allergy symptom of any kind in the last 53 years. Patient states that the weight bearing pain on the new hip has gotten progressively worse. Patient also states that the two events are related.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient never received 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient never received 2nd dose) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-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 PRODUCT DOSE OMISSION ISSUE (Patient never received 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient never received 2nd dose) 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 considered PRODUCT DOSE OMISSION ISSUE (Patient never received 2nd dose) to be not applicable.    Treatment information was not provided.  No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea
Clinical narrative: Period cramping; This spontaneous case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Period cramping) 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 Period pains (gets cramping on period). Concomitant products included IBUPROFEN for Menstrual cramps.    On 27-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSMENORRHOEA (Period cramping). The patient was treated with PARACETAMOL (TYLENOL) for Menstrual cramps, at a dose of UNK dosage form. At the time of the report, DYSMENORRHOEA (Period cramping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that cramping was not from vaccine.   Reporter did not allow further contact
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose at day 54; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose at day 54) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 047B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLONIDINE, LISDEXAMFETAMINE MESILATE (VYVANSE), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), FLUOXETINE HYDROCHLORIDE (PROZAC) and Vistaril for an unknown indication.   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 30-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose at day 54). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose at day 54) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test
Clinical narrative: 42 days post first shot and No Second Shot yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (42 days post first shot and No Second Shot yet) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dose UNK. On 01-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (42 days post first shot and No Second Shot yet). On 01-Jun-2021, PRODUCT DOSE OMISSION ISSUE (42 days post first shot and No Second Shot yet) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.         No treatment medication were provided. No concomitant medication information was provided.   This case was linked to MOD-2021-194257 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Myalgia, Pyrexia
Clinical narrative: Was in bed for 2 days; Very horrible body aches; Had very high fever (Almost 103); This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Was in bed for 2 days), MYALGIA (Very horrible body aches) and PYREXIA (Had very high fever (Almost 103)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced BEDRIDDEN (Was in bed for 2 days), MYALGIA (Very horrible body aches) and PYREXIA (Had very high fever (Almost 103)). On 18-Feb-2021, BEDRIDDEN (Was in bed for 2 days) had resolved. On 19-Feb-2021, MYALGIA (Very horrible body aches) and PYREXIA (Had very high fever (Almost 103)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Body temperature: almost 103 (High) Almost 103.         No concomitant medication was reported.  The patient's antibody test done on an unknown date came back negative.  No treatment information was reported.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Pharmacist administered three shots from a vial left out at room temperature for roughly 20 hours; Doses administered more then 1 month apart; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist administered three shots from a vial left out at room temperature for roughly 20 hours) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses administered more then 1 month apart) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 011D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist administered three shots from a vial left out at room temperature for roughly 20 hours) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses administered more then 1 month apart). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist administered three shots from a vial left out at room temperature for roughly 20 hours) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses administered more then 1 month apart) outcome was unknown.            Concomitant medications were not provided by reporter. Treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Confusional state, Memory impairment
Clinical narrative: Confusion; problem with memory; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion) and MEMORY IMPAIRMENT (problem with memory) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (Confusion) and MEMORY IMPAIRMENT (problem with memory). At the time of the report, CONFUSIONAL STATE (Confusion) and MEMORY IMPAIRMENT (problem with memory) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was reported. No treatment medication information was reported.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer, describes the occurrence of product dose omission issue (not receiving the 2nd dose of the Moderna COVID 19 vaccine on time) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 039A21A) for COVID-19 immunization. No medical history provided. Concomitant products included vitamin 15 for an unknown indication. On Apr 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced product dose omission issue (not receiving the 2nd dose of the Moderna COVID 19 vaccine on time). At the time of the report, product dose omission issue (not receiving the 2nd dose of the Moderna COVID 19 vaccine on time) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site mass
Clinical narrative: sore arm again; knot on my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm again) and VACCINATION SITE MASS (knot on my arm) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm again) and VACCINATION SITE MASS (knot on my arm). At the time of the report, PAIN IN EXTREMITY (sore arm again) and VACCINATION SITE MASS (knot on my arm) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Cough, Dyspnoea, Ear pain
Clinical narrative: aches in her finger; she couldn't breath; earache; aches in her toes; a really bad cough; Wheezing; throaght felt like it was constricting; every single bone was hurting; muscle, joint pain all over body; joint pain all over body; she had a headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (aches in her finger), DYSPNOEA (she couldn't breath), EAR PAIN (earache), PAIN IN EXTREMITY (aches in her toes) and COUGH (a really bad cough) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had Covid in December 2020, with mild symptoms.). Concurrent medical conditions included Asthma (pulmonary embolism/ admitted into hospital) since 12-Jul-2021 and Nerve pain. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) from 2005 to an unknown date for Asthma, GABAPENTIN from 2019 to an unknown date for Nerve pain, SERTRALINE HYDROCHLORIDE (ZOLOFT), BUSPIRONE, QUETIAPINE FUMARATE (SEROQUEL), DOCUSATE SODIUM (COLACE) and HYDROCHLOROTHIAZIDE for an unknown indication.    On 30-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 PAIN IN EXTREMITY (aches in her finger), DYSPNOEA (she couldn't breath), EAR PAIN (earache), PAIN IN EXTREMITY (aches in her toes), COUGH (a really bad cough), WHEEZING (Wheezing), THROAT TIGHTNESS (throaght felt like it was constricting), BONE PAIN (every single bone was hurting), MYALGIA (muscle, joint pain all over body), ARTHRALGIA (joint pain all over body) and HEADACHE (she had a headache). At the time of the report, PAIN IN EXTREMITY (aches in her finger), DYSPNOEA (she couldn't breath), EAR PAIN (earache), PAIN IN EXTREMITY (aches in her toes), COUGH (a really bad cough), WHEEZING (Wheezing), THROAT TIGHTNESS (throaght felt like it was constricting), BONE PAIN (every single bone was hurting), MYALGIA (muscle, joint pain all over body), ARTHRALGIA (joint pain all over body) and HEADACHE (she had a headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she thought she was having a heart attack at the time of events. Treatment information included pain medicine. Patient had change in status of chronic condition pulmonary embolism/ admitted into hospital      Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Patient demographic details were updated, medical history added, concomitant medications updated, new events Muscle,Joint pain,every single bone was hurting,throuaght felt like it was constricting,wheezing.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Throat tightness, Wheezing
Clinical narrative: aches in her finger; she couldn't breath; earache; aches in her toes; a really bad cough; Wheezing; throaght felt like it was constricting; every single bone was hurting; muscle, joint pain all over body; joint pain all over body; she had a headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (aches in her finger), DYSPNOEA (she couldn't breath), EAR PAIN (earache), PAIN IN EXTREMITY (aches in her toes) and COUGH (a really bad cough) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had Covid in December 2020, with mild symptoms.). Concurrent medical conditions included Asthma (pulmonary embolism/ admitted into hospital) since 12-Jul-2021 and Nerve pain. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) from 2005 to an unknown date for Asthma, GABAPENTIN from 2019 to an unknown date for Nerve pain, SERTRALINE HYDROCHLORIDE (ZOLOFT), BUSPIRONE, QUETIAPINE FUMARATE (SEROQUEL), DOCUSATE SODIUM (COLACE) and HYDROCHLOROTHIAZIDE for an unknown indication.    On 30-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 PAIN IN EXTREMITY (aches in her finger), DYSPNOEA (she couldn't breath), EAR PAIN (earache), PAIN IN EXTREMITY (aches in her toes), COUGH (a really bad cough), WHEEZING (Wheezing), THROAT TIGHTNESS (throaght felt like it was constricting), BONE PAIN (every single bone was hurting), MYALGIA (muscle, joint pain all over body), ARTHRALGIA (joint pain all over body) and HEADACHE (she had a headache). At the time of the report, PAIN IN EXTREMITY (aches in her finger), DYSPNOEA (she couldn't breath), EAR PAIN (earache), PAIN IN EXTREMITY (aches in her toes), COUGH (a really bad cough), WHEEZING (Wheezing), THROAT TIGHTNESS (throaght felt like it was constricting), BONE PAIN (every single bone was hurting), MYALGIA (muscle, joint pain all over body), ARTHRALGIA (joint pain all over body) and HEADACHE (she had a headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she thought she was having a heart attack at the time of events. Treatment information included pain medicine. Patient had change in status of chronic condition pulmonary embolism/ admitted into hospital      Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Patient demographic details were updated, medical history added, concomitant medications updated, new events Muscle,Joint pain,every single bone was hurting,throuaght felt like it was constricting,wheezing.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of headache in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced headache. At the time of the report, headache outcome: unknown. No concomitant medications or treatment information provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination complication
Clinical narrative: was in bed for 2 days; Had very high fever (almost 103); very horrible body aches; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (was in bed for 2 days), PYREXIA (Had very high fever (almost 103)) and MYALGIA (very horrible body aches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION COMPLICATION (was in bed for 2 days), PYREXIA (Had very high fever (almost 103)) and MYALGIA (very horrible body aches). On 18-Feb-2021, VACCINATION COMPLICATION (was in bed for 2 days) had resolved. On 19-Feb-2021, PYREXIA (Had very high fever (almost 103)) and MYALGIA (very horrible body aches) had resolved.            Concomitant medications were not reported. It was reported the patient had a strong reaction after the second dose, On an unspecified date, the patient had a negative SARS-CoV-2 igG nucleocapsid antibody test. No treatment information was provided.   This case was linked to MOD-2021-019388 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Myalgia
Clinical narrative: bodyache; Joint pain; Chills; Headache; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PAIN (bodyache), HEADACHE (Headache), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 001L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced CHILLS (Chills), PAIN (bodyache), HEADACHE (Headache), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). The patient was treated with ACETAMINOPHEN (oral) on 01-Apr-2021 at a dose of 500 mg. On 03-Apr-2021, CHILLS (Chills), PAIN (bodyache), HEADACHE (Headache), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 103 (High) 103F. On 02-Apr-2021, Body temperature: 100 (High) 100F.         Concomitant medications were not provided.     This case was linked to MOD-2021-053226 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: bodyache; Joint pain; Chills; Headache; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PAIN (bodyache), HEADACHE (Headache), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 001L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced CHILLS (Chills), PAIN (bodyache), HEADACHE (Headache), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). The patient was treated with ACETAMINOPHEN (oral) on 01-Apr-2021 at a dose of 500 mg. On 03-Apr-2021, CHILLS (Chills), PAIN (bodyache), HEADACHE (Headache), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 103 (High) 103F. On 02-Apr-2021, Body temperature: 100 (High) 100F.         Concomitant medications were not provided.     This case was linked to MOD-2021-053226 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: They itch; Kind of bug bites; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Kind of bug bites) and PRURITUS (They itch) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Kind of bug bites) and PRURITUS (They itch). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Kind of bug bites) and PRURITUS (They itch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Oedema peripheral, Pain in extremity, Peripheral swelling
Clinical narrative: Left arm and arm pit swelled up to almost twice their normal size about two hours after injection.  It was very sore. Lymph nodes were swollen on that side too, on my neck and in arm pit region. I had two kids in my care and I was alone so I just waited to see if the swelling would go down. It did, two days later.   This was my second dose. My first dose I just had localized pain near the injection site.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Persistent L deltoid pain since injection
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: rapid heart rate while resting; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart rate while resting) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (rapid heart rate while resting). At the time of the report, HEART RATE INCREASED (rapid heart rate while resting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter. No concomitant medications were provided by the reporter.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity
Clinical narrative: Experienced a thrombosed hemorrhoid which lasted about a week.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site pain
Clinical narrative: left toe was swollen; Pain on the injection site; Joint pain on left toe after 2nd dose/Toe was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left toe was swollen), PAIN IN EXTREMITY (Joint pain on left toe after 2nd dose/Toe was swollen) and VACCINATION SITE PAIN (Pain on the injection site) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 002A21A) for COVID-19 vaccination.     The patient's past medical history included Squamous cell carcinoma of the tongue on 06-Jan-2004. Concurrent medical conditions included Iodine allergy (IV contrast (iodine)) and Hypertension since 02-Jan-2007. Concomitant products included TELMISARTAN from 05-Jan-2021 to an unknown date for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Joint pain on left toe after 2nd dose/Toe was swollen). On an unknown date, the patient experienced PERIPHERAL SWELLING (left toe was swollen) and VACCINATION SITE PAIN (Pain on the injection site). On 30-Apr-2021, PAIN IN EXTREMITY (Joint pain on left toe after 2nd dose/Toe was swollen) had resolved. At the time of the report, PERIPHERAL SWELLING (left toe was swollen) and VACCINATION SITE PAIN (Pain on the injection site) outcome was unknown.            Treatment medications were not provided.     This case was linked to MOD-2021-034346 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: body aches; arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and PAIN IN EXTREMITY (arm hurts) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history 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 MYALGIA (body aches) and PAIN IN EXTREMITY (arm hurts). At the time of the report, MYALGIA (body aches) and PAIN IN EXTREMITY (arm hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Sense of taste returned after being fully vaccinated, It's a good one; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Sense of taste returned after being fully vaccinated, It's a good one) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (In november).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Sense of taste returned after being fully vaccinated, It's a good one). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Sense of taste returned after being fully vaccinated, It's a good one) had resolved.            No concomitant medications were provided. Two weeks from the second dose, patient's sense of taste returned. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: a week and three days late for her second shot; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (a week and three days late for her second shot) 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 PRODUCT DOSE OMISSION ISSUE (a week and three days late for her second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (a week and three days late for her second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate irregular
Clinical narrative: rapid heart rate while resting; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (rapid heart rate while resting) 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 HEART RATE IRREGULAR (rapid heart rate while resting). At the time of the report, HEART RATE IRREGULAR (rapid heart rate while resting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of inappropriate schedule of product administration (second dose 49 days after the first one) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On May 11, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 29, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 29, 2021, patient experienced inappropriate schedule of product administration (second dose 49 days after the first one). At the time of the report, inappropriate schedule of product administration (second dose 49 days after the first one) outcome: unknown. Concomitant medication reported for diabetes. No treatment medication reported.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Peripheral swelling
Clinical narrative: Is it normal for your arm to swell a bit a couple days after getting; Hiw long will it take for my arm to stop being sore; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Is it normal for your arm to swell a bit a couple days after getting) and MYALGIA (Hiw long will it take for my arm to stop being sore) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Is it normal for your arm to swell a bit a couple days after getting) and MYALGIA (Hiw long will it take for my arm to stop being sore). At the time of the report, PERIPHERAL SWELLING (Is it normal for your arm to swell a bit a couple days after getting) and MYALGIA (Hiw long will it take for my arm to stop being sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: its been 2 months between my first and second vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (its been 2 months between my first and second vaccinations) 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) (unknown route) 1 dosage form. On an unknown date, 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 experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (its been 2 months between my first and second vaccinations). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (its been 2 months between my first and second vaccinations) outcome was unknown.            No relevant concomitant medication was reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reaction to vaccine/many problems; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction to vaccine/many problems) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction to vaccine/many problems). At the time of the report, VACCINATION COMPLICATION (Reaction to vaccine/many problems) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       There was no concomitant medication reported. There was no treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up received contains significant information, updated verbatim term to Reaction to vaccination/many problems.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: same big red rash to injection site arm with the second vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH ERYTHEMATOUS (same big red rash to injection site arm with the second vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (same big red rash to injection site arm with the second vaccine). At the time of the report, RASH ERYTHEMATOUS (same big red rash to injection site arm with the second vaccine) had resolved.            Concomitant medications included unspecified blood pressure medications.  The red rash resolved after 3-4 days.   She did not take any treatment medications for the adverse events.   This case was linked to MOD-2021-067353, MOD-2021-106494 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Outbreak of Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Outbreak of Shingles) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Outbreak of Shingles). At the time of the report, HERPES ZOSTER (Outbreak of Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.            No concomitant medication reported.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The SD attached is unable to be read.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use
Clinical narrative: Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine; Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine) and EXTRA DOSE ADMINISTERED (Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine) 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 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced OFF LABEL USE (Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine) and EXTRA DOSE ADMINISTERED (Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine). At the time of the report, OFF LABEL USE (Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine) and EXTRA DOSE ADMINISTERED (Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose given 20hrs after vial expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given 20hrs after vial expiration) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002c21 and 002c21) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included LISINOPRIL for Blood pressure management, ATORVASTATIN for Cholesterol, INSULIN GLARGINE (TOUJEO) and GLIPIZIDE for Diabetes.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given 20hrs after vial expiration). On 18-May-2021, EXPIRED PRODUCT ADMINISTERED (dose given 20hrs after vial expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-162276 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Additional information received on 30-06-2021 contain patient demographic
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Skin breakout (Patient had a very bad reaction). Concurrent medical conditions included Iodine allergy (Patient was recently been released from the hospital after taking a test in which they injected Iodine into patient for a procedure).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.            No concomitant medication was reported.  No treatment medication reported.   This case was linked to MOD-2021-098289 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: significant follow-up. event sore arm after the shot updated.