chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain
Clinical narrative: ALL OVER BODY ACHES; JOINT PAIN; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced all over body aches, joint pain, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the joint pain, all over body aches and fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID AFTER RECEIVING THE JANSSEN COVID 19 VACCINE; This spontaneous report received from a consumer concerned a 43 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 01-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced tested positive for covid after receiving the janssen covid 19 vaccine. Laboratory data (dates unspecified) included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid after receiving the janssen covid 19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: FAINTED DURING ADMINISTRATION; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced fainting during an administration of a dose of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fainted during administration was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220109514 -COVID-19 VACCINE AD26.COV2.S-  Fainted during administration. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s)
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: UNKNOWN) dose was not reported, administered on 24-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-DEC-2021, the patient experienced confirmed covid-19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) 2 time resulted Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was non-serious.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE (VIAL WAS PUNCTURED APPROXIMATELY 28-DEC-2021 AT 9:00 AND THEN DOSE WAS ADMINISTERED TO THE PATIENT ON 30-DEC-2021 AT 9:00 IN THE MORNING); This spontaneous report received from a health care professional concerned a 25 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: UNKNOWN) dose was not reported, administered on 30-DEC-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 30-DEC-2021, the patient experienced out of specification product use (vial was punctured approximately 28-dec-2021 at 9:00 and then dose was administered to the patient on 30-dec-2021 at 9:00 in the morning). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of out of specification product use (vial was punctured approximately 28-dec-2021 at 9:00 and then dose was administered to the patient on 30-dec-2021 at 9:00 in the morning) was not reported. This report was non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: 11-SEP-2021) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-JAN-2022, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 test positive. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Colonoscopy, Fatigue, Hypomenorrhoea, Magnetic resonance imaging
Clinical narrative: TWO SMALL SIZE BENIGN POLYPS; FEELING FATIGUED AND TIRED; FEELING A LITTLE BIT WEAK; HAD TWO LIGHT PERIODS AFTER RECEIVING THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included: adenoma on the liver, and celiac disease, concurrent conditions included: perimenopausal, and other pre-existing medical conditions included: Before the vaccine, the patient's last menstrual period was in APR-2021. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 13-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced had two light periods after receiving the janssen covid-19 vaccine. On 14-OCT-2021, Laboratory data included: Colonoscopy (NR: not provided) Two benign polyps. On an unspecified date, the patient experienced two small size benign polyps, feeling fatigued and tired, and feeling a little bit weak. Laboratory data (dates unspecified) included: MRI (NR: not provided) Adenoma on the liver. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from two small size benign polyps, feeling fatigued and tired, and feeling a little bit weak, and the outcome of had two light periods after receiving the janssen covid-19 vaccine was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Polyp
Clinical narrative: TWO SMALL SIZE BENIGN POLYPS; FEELING FATIGUED AND TIRED; FEELING A LITTLE BIT WEAK; HAD TWO LIGHT PERIODS AFTER RECEIVING THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included: adenoma on the liver, and celiac disease, concurrent conditions included: perimenopausal, and other pre-existing medical conditions included: Before the vaccine, the patient's last menstrual period was in APR-2021. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 13-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced had two light periods after receiving the janssen covid-19 vaccine. On 14-OCT-2021, Laboratory data included: Colonoscopy (NR: not provided) Two benign polyps. On an unspecified date, the patient experienced two small size benign polyps, feeling fatigued and tired, and feeling a little bit weak. Laboratory data (dates unspecified) included: MRI (NR: not provided) Adenoma on the liver. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from two small size benign polyps, feeling fatigued and tired, and feeling a little bit weak, and the outcome of had two light periods after receiving the janssen covid-19 vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TESTED POSITIVE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JAN-2022, the patient experienced covid-19 tested positive. Laboratory data included: Body temperature (NR: not provided) 101 F, and COVID-19 rapid POC test (NR: not provided) Positive, Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 tested positive. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: IT HAS BEEN PAINFUL TO LIFT UP THE ARM (SAME SIDE THAT WAS INJECTED); ISSUE WITH THE ARM MUSCLES (SAME SIDE THAT WAS INJECTED); This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced it has been painful to lift up the arm (same side that was injected), and issue with the arm muscles (same side that was injected). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the issue with the arm muscles (same side that was injected) and it has been painful to lift up the arm (same side that was injected) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210314164 and 20220109828.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; This spontaneous report received from a consumer concerned a 69 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no medical conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included estrogens conjugated.  On 02-APR-2021, the patient experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 02-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20220110118.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: REGULARLY DIZZY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced regularly dizzy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from regularly dizzy. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Blood test, Computerised tomogram, Constipation, Myalgia
Clinical narrative: PERSISTENT STOMACH PAIN; CONSTIPATION; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and other pre-existing medical conditions included: The patient did not taken a birth control pill. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced persistent stomach pain, constipation, muscle aches, and fever. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, CT scan (NR: not provided) Not reported, and Diagnostic ultrasound (NR: not provided) Not reported. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from persistent stomach pain, and muscle aches, and the outcome of fever and constipation was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Ultrasound scan
Clinical narrative: PERSISTENT STOMACH PAIN; CONSTIPATION; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and other pre-existing medical conditions included: The patient did not taken a birth control pill. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced persistent stomach pain, constipation, muscle aches, and fever. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, CT scan (NR: not provided) Not reported, and Diagnostic ultrasound (NR: not provided) Not reported. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from persistent stomach pain, and muscle aches, and the outcome of fever and constipation was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Blood test, Computerised tomogram abdomen abnormal, Constipation, Endoscopy normal
Clinical narrative: PERSISTENT STOMACH PAIN; CONSTIPATION; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and other pre-existing medical conditions included: The patient did not taken a birth control pill. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced persistent stomach pain, constipation, muscle aches, and fever. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, CT scan (NR: not provided) Not reported, and Diagnostic ultrasound (NR: not provided) Not reported. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from persistent stomach pain, and muscle aches, and the outcome of fever and constipation was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flatulence, Hepatic lesion, Laboratory test, Magnetic resonance imaging hepatobiliary, Ultrasound biliary tract
Clinical narrative: PERSISTENT STOMACH PAIN; CONSTIPATION; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and other pre-existing medical conditions included: The patient did not taken a birth control pill. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced persistent stomach pain, constipation, muscle aches, and fever. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, CT scan (NR: not provided) Not reported, and Diagnostic ultrasound (NR: not provided) Not reported. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from persistent stomach pain, and muscle aches, and the outcome of fever and constipation was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound ovary
Clinical narrative: PERSISTENT STOMACH PAIN; CONSTIPATION; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and other pre-existing medical conditions included: The patient did not taken a birth control pill. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced persistent stomach pain, constipation, muscle aches, and fever. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, CT scan (NR: not provided) Not reported, and Diagnostic ultrasound (NR: not provided) Not reported. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from persistent stomach pain, and muscle aches, and the outcome of fever and constipation was not reported. This report was non-serious.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Magnetic resonance imaging, Paraesthesia
Clinical narrative: DIFFICULTY WALKING; TINGLING SENSATION STARTED AT THE TOES AND CONTINUES TO SPREAD UP LEGS TOWARDS HIPS AND BUTTOCKS; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. Patient had no known previous medical conditions. Patient had no known medication usage history. The patient was an athlete. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the patient experienced difficulty walking, and tingling sensation started at the toes and continues to spread up legs towards hips and buttocks. Laboratory data included: Magnetic resonance imaging (not provided) Ruled out spinal conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tingling sensation started at the toes and continues to spread up legs towards hips and buttocks and difficulty walking was not reported. This report was non-serious. This case, from the same reporter is linked to 20220109867.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Gait inability
Clinical narrative: DIZZY; COULD NO LONGER HANDLE TAKING A WALK; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced dizzy, could no longer handle taking a walk, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy, fatigue and could no longer handle taking a walk was not reported. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: General side effects after 1st and 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (General side effects after 1st and 2nd dose) in a 27-year-old female 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 VACCINATION COMPLICATION (General side effects after 1st and 2nd dose). At the time of the report, VACCINATION COMPLICATION (General side effects after 1st and 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was provided. No treatment  was provided.   This case was linked to MOD-2022-439047, MOD-2022-439468 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: right arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (right arm hurt) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (skin on some fruits including apples, pears, plums, cherries, and artichokes (highly allergic).).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (right arm hurt). On 04-Apr-2021, VACCINATION SITE PAIN (right arm hurt) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant Medication was provided. No treatment  was provided.   This case was linked to MOD-2022-442122 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles about 2 months after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles about 2 months after vaccination) 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 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 HERPES ZOSTER (Shingles about 2 months after vaccination). At the time of the report, HERPES ZOSTER (Shingles about 2 months after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported  It was reported by reporter that her friend's husband was vaccinated with Moderna and developed shingles about 2 months after vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy, Product dose omission issue
Clinical narrative: Did not get the second dose before 36 days after the first dose; got pregnant after getting the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE and MATERNAL EXPOSURE BEFORE PREGNANCY 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In January 2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE. In January 2021, MATERNAL EXPOSURE BEFORE PREGNANCY had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.  Patient received her first Moderna COVID-19 vaccine a year ago in January 2021, before being pregnant. For whatever reason she did not catch her second dose. A few months later she was pregnant, and her doctor advised her not to get the 2nd dose. Now she was afraid of covid and her doctor told her to get the 2nd dose. She was due her pregnancy in 6 months.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Decreased appetite, Myalgia, Nausea, Pyrexia
Clinical narrative: Loss of taste; loss of appetite; Nausea; vomiting; body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA, DECREASED APPETITE, NAUSEA, VOMITING, and MYALGIA in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy to lettuce and cucumber.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced AGEUSIA, DECREASED APPETITE, NAUSEA, VOMITING, MYALGIA, and PYREXIA. At the time of the report, AGEUSIA, DECREASED APPETITE, NAUSEA, and VOMITING had not resolved and MYALGIA and PYREXIA had resolved.            It was reported that the patient had no pre-existing conditions. No concomitant medications were provided. No treatment medications were provided.  This case concerns a 32-year-old female patient with no relevant medical history who experienced non-serious unexpected events of Decreased appetite, Ageusia, and non-serious expected events of Nausea, Vomiting, Myalgia, and Pyrexia. The events occurred within a week following vaccination with the third, booster dose of mRNA-1273, however, the precise temporal relationship cannot be determined, having in mind that the exact start date of the reported events was not provided. At the time of the report, Decreased appetite, Ageusia, Nausea, and Vomiting were still ongoing whereas Myalgia and Pyrexia had resolved. No further information regarding clinical course of the events was provided at this time. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Loss of taste; loss of appetite; Nausea; vomiting; body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA, DECREASED APPETITE, NAUSEA, VOMITING, and MYALGIA in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy to lettuce and cucumber.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced AGEUSIA, DECREASED APPETITE, NAUSEA, VOMITING, MYALGIA, and PYREXIA. At the time of the report, AGEUSIA, DECREASED APPETITE, NAUSEA, and VOMITING had not resolved and MYALGIA and PYREXIA had resolved.            It was reported that the patient had no pre-existing conditions. No concomitant medications were provided. No treatment medications were provided.  This case concerns a 32-year-old female patient with no relevant medical history who experienced non-serious unexpected events of Decreased appetite, Ageusia, and non-serious expected events of Nausea, Vomiting, Myalgia, and Pyrexia. The events occurred within a week following vaccination with the third, booster dose of mRNA-1273, however, the precise temporal relationship cannot be determined, having in mind that the exact start date of the reported events was not provided. At the time of the report, Decreased appetite, Ageusia, Nausea, and Vomiting were still ongoing whereas Myalgia and Pyrexia had resolved. No further information regarding clinical course of the events was provided at this time. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: First dose administered to a 11 y/o patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose administered to a 11 y/o patient) in an 11-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose administered to a 11 y/o patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose administered to a 11 y/o patient) had resolved.        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 medication was provided by the reporter.  No treatment medication was provided by the reporter.  HCP has enquiring about a female patient of 11years who have taken first dose of Moderna 5 days before turning to 12 years,  Now, they were suggested her to go to the pharmacy to get the second dose instead of doing it themselves and enquiring whether she can get the second dose? Or should she get Pfizer instead?".
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Oropharyngeal pain, Pharyngeal swelling, Tachycardia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), PHARYNGEAL SWELLING (some swelling in his throat), DYSPNOEA (felt winded after riding a bike/rapid breathing) and TACHYCARDIA (more rapid heart rate than usual while working out) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and PHARYNGEAL SWELLING (some swelling in his throat). In March 2021, the patient experienced DYSPNOEA (felt winded after riding a bike/rapid breathing) and TACHYCARDIA (more rapid heart rate than usual while working out.). In April 2021, DYSPNOEA (felt winded after riding a bike/rapid breathing) and TACHYCARDIA (more rapid heart rate than usual while working out) had resolved. At the time of the report, OROPHARYNGEAL PAIN (sore throat) and PHARYNGEAL SWELLING (some swelling in his throat) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.  Patient had enquiring about booster dose and reported, that he had experienced events after first dose vaccination. Patient had identified himself as a cyclist who was in good physical condition.  Patient had reported that he had not diagnosed with Myocarditis or Pericarditis.  Patient had reported that he had not underwent any cardiac lab tests, and confirmed that he had never experienced symptoms like this before receiving Moderna COVID-19 vaccine, and no history of COVID-19 infection, and no record of hospitalization due to Myocarditis/Pericarditis.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Illness, Pyrexia
Clinical narrative: sick for 12 hours [after second shot]; bugging in his head; fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 12 hours [after second shot]), HEAD DISCOMFORT (bugging in his head) and PYREXIA (fever) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 007B21A) for COVID-19 vaccination.     Concomitant products included CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS (sick for 12 hours [after second shot]), HEAD DISCOMFORT (bugging in his head) and PYREXIA (fever). At the time of the report, ILLNESS (sick for 12 hours [after second shot]), HEAD DISCOMFORT (bugging in his head) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had never had a history of indigestion or problems eating, but he swung from eating a full meal and going for a run to having terrible indigestion. No medical history was reported. Patient took Moderna booster (lot 027H21B) on 20-NOV-2021. No treatment medications were reported.   This case was linked to MOD-2022-440894 (Patient Link).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Patient experienced myocarditis after receiving his 2nd dose; This spontaneous case was reported by a physician and describes the occurrence of MYOCARDITIS (Patient experienced myocarditis after receiving his 2nd dose) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Patient experienced myocarditis after receiving his 2nd dose) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Patient experienced myocarditis after receiving his 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported  Patient had taken 2nd dose 3 weeks after 1st dose. Company Comment This case concerns a 41-year-old, male patient with no relevant medical history reported, who experienced the expected event of myocarditis. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.   No Treatment medications were reported; Sender's Comments: This case concerns a 41-year-old, male patient with no relevant medical history reported, who experienced the expected event of myocarditis. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Petechiae
Clinical narrative: petechiae on breasts & right arm; bruises on breasts and now right arm; This spontaneous case was reported by a nurse and describes the occurrence of PETECHIAE (petechiae on breasts & right arm) and CONTUSION (bruises on breasts and now right arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Dec-2021, the patient experienced PETECHIAE (petechiae on breasts & right arm) and CONTUSION (bruises on breasts and now right arm). At the time of the report, PETECHIAE (petechiae on breasts & right arm) and CONTUSION (bruises on breasts and now right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient had notice few bruises and petechiae on her breasts and right arm, it was 3 in the morning and went up to 5 afterwards. Patient was not on any blood thinner medications and did not remember bumping onto anything. No treatment medications were reported.  Company comment: This spontaneous case concerns a 34-year-old female patient with no medical history of reported, who experienced the unexpected non serious events of Petechiae (AESI) and Contusion after mRNA- 1273 vaccine. The event occurred approximately 3 days after the booster dose of mRNA- 1273 vaccine. The patient noticed few bruises and petechiae on her breasts and right arm. Very limited information is available regarding clinical course, diagnostic work-up and medical assessment. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 34-year-old female patient with no medical history of reported, who experienced the unexpected non serious events of Petechiae (AESI) and Contusion after mRNA- 1273 vaccine. The event occurred approximately 3 days after the booster dose of mRNA- 1273 vaccine. The patient noticed few bruises and petechiae on her breasts and right arm. Very limited information is available regarding clinical course, diagnostic work-up and medical assessment. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired gastric emptying
Clinical narrative: [after booster dose]a bout of gastroparesis; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED GASTRIC EMPTYING ([after booster dose] bout of gastroparesis) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 040H21A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Gastroparesis (she got a bout of gastroparesis. She gets it occasionally, but it's usually triggered by the weirdest thing, like eating chicken, so she gave up eating chicken 20 years ago. Close to a week and a half ago, she had the booster, and the next day she woke up with another bout of gastroparesis.) and Ehlers-Danlos syndrome.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMPAIRED GASTRIC EMPTYING ([after booster dose] bout of gastroparesis) (seriousness criterion medically significant). At the time of the report, IMPAIRED GASTRIC EMPTYING ([after booster dose] bout of gastroparesis) outcome was unknown.            No concomitant product was provided. No treatment information was provided. Company comment: This Spontaneous case concerns a 54-year-old, female patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) event of Impaired gastric emptying. The event occurred after receiving the booster dose of mRNA-1273 vaccine, exact time interval cannot be assessed as event date is not available. Rechallenge was positive, as it was reported that the same occurred after the second dose of mRNA-1273 vaccine. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-428354 (Patient Link).; Sender's Comments: This Spontaneous case concerns a 54-year-old, female patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) event of Impaired gastric emptying. The event occurred after receiving the booster dose of mRNA-1273 vaccine, exact time interval cannot be assessed as event date is not available. Rechallenge was positive, as it was reported that the same occurred after the second dose of mRNA-1273 vaccine. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives in different part of body/hives in back area which crawl back to chin area; Itchy in armpit; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives in different part of body/hives in back area which crawl back to chin area) and PRURITUS (Itchy in armpit) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives in different part of body/hives in back area which crawl back to chin area) and PRURITUS (Itchy in armpit). At the time of the report, URTICARIA (Hives in different part of body/hives in back area which crawl back to chin area) and PRURITUS (Itchy in armpit) had not resolved.            No concomitant product use was provided. No treatment medication was provided.   This case was linked to MOD-2022-439650 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fear, Goitre, Palpitations
Clinical narrative: felt horrible; think it hit my thyroid gland and it swelled; had heart pulsation; This spontaneous case was reported by a consumer and describes the occurrence of FEAR (felt horrible), GOITRE (think it hit my thyroid gland and it swelled) and PALPITATIONS (had heart pulsation) 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 FEAR (felt horrible), GOITRE (think it hit my thyroid gland and it swelled) and PALPITATIONS (had heart pulsation). At the time of the report, FEAR (felt horrible), GOITRE (think it hit my thyroid gland and it swelled) and PALPITATIONS (had heart pulsation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication were reported. It was reported the patient felt horrible and thought it hit thyroid gland and it swelled and had all the symptoms of a thyroid. The patient had  heart pulsation now afraid to get booster but want to get it but scared.