chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Epilepsy
Clinical narrative: EPILEPTIC SEIZURE; This spontaneous report received from a patient concerned a 60 year old male. The patient's height and weight were not reported. Concurrent conditions included: high blood pressure and epilepsy. The patient had no known drug allergies (NKDA). The patient had been diagnosed with epilepsy back in 2016 and has been on medications for it for the past 5 years. He states he has not had a seizure since he has been on the medication for it. The patient previously received with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: unknown) dose was not reported, 1 total, administered on 10-APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following primary vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received booster of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: unknown) dose was not reported, 1 total, administered at right arm on 16-DEC-2021 for prophylactic vaccination on right arm (dose number in series 2).  The patient has high blood pressure and for which he was on two blood pressure medications.  On Saturday night of 18-DEC-2021, patient experienced an epileptic seizure (Dose number in series 2). Patient stated that, he was disoriented after the seizure but was fine afterwards and he could hear his wife after the seizure. The patient went to work Monday and Tuesday before hearing back from physician. He took Keppra (levetiracetam) 1000mg twice a day and before that he was on 750mg of Keppra twice a day. The patient stated that, due to seizure and his work he cannot be on the road for at least 3 months.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from epileptic seizure.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220107552- Covid-19 vaccine ad26.cov2.s-epileptic seizure. This event is considered unassessable. The event 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
Sex: M
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Fatigue, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: SORE THROAT; DRY COUGH; DIARRHEA; TIREDNESS; 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 previously received covid-19 vaccine ad26. cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: Unknown) dose was not reported, 1 in total, administered on 04-MAY-2021 for prophylactic vaccination on his right arm. (dose number in series 1). No adverse events were reported following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835 expiry: Unknown) dose was not reported, 1 in total, administered on 20-DEC-2021 for prophylactic vaccination on his right arm as booster dose (dose number in series 2). No concomitant medications were reported.  On 30-DEC-2021, the patient experienced sore throat, dry cough, diarrhea, and tiredness. The patient was currently having cough and sore throat, and other symptoms went away on 04-JAN-2022 (dose number in series 2). On 05-JAN-2022, Laboratory data included: COVID-19 (coronavirus disease) antigen test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and tiredness on 04-JAN-2022, and had not recovered from sore throat, and dry cough. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: This spontaneous report received from a patient via social media concerned a female of unspecified age, race, and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 in 2020. The patient received covid-19 vaccine (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total administered 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 after primary series, the patient was vaccinated with covid-19 vaccine for prophylactic vaccination (Dose number in series 2). No adverse events were reported following covid-19 vaccine (Dose number in series: 2) On an unspecified date after vaccination, the patient experienced that vaccine did not work as expected (suspected clinical vaccination failure). Patient had more symptoms (suspected covid-19 infection) than the first-time half when she had covid-19 in 2020 before vaccination (suspected clinical vaccination failure) (dose number in series 1). The reporter stated "I am contacting you to inform you that the Johnson and Johnson vaccine does not work as expected. I have 2 vaccines from Johnson and Johnson, and I got Covid 19. The problem is not that I get infected, but that the symptoms I have are more than the first-time half in 2020 without having any vaccine". The action taken with covid-19 vaccine was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority number 90000210262 and 90000209965.; Sender's Comments: V0:20220108290-COVID-19 VACCINE Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 22 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 211A21A, expiry: unknown) dose was not reported, dose number in series was 01, 01 in total was administered on 24-SEP-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 03-JAN-2022, the patient experienced dry cough, headache, nausea, light headedness, weird taste and had suspected clinical vaccination failure. On 04-JAN-2022, Laboratory data included: coronavirus disease (COVID-19) virus test (rapid) which was positive. At the time of reporting patient just had dry cough and headache (dose number in series was 01). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority. This case, from the same reporter is linked to 20220112121.; Sender's Comments: V0:20220109542-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID AFTER RECEIVING THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a consumer concerned a 44 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: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced covid after receiving the janssen covid-19 vaccine. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Had covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid after receiving the janssen covid-19 vaccine was not reported. This report was associated with product quality complaint (PQC): 90000210584 This report was non-serious The suspected product quality complaint has been confirmed to be the reported allegation could not be determined a manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Headache, Pain
Clinical narrative: BODY ACHES; KNOCKED ME ON MY BUTT; HEADACHE; 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(Dose number in series 1) (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 body aches, adverse event (knocked me on my butt), and headache.(Dose number in series 1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, headache and adverse event was not reported. This report was non-serious. This case, involving the same patient is linked to 20220112564.(Dose number in series 2 case) This case, from the same reporter is linked to 20220112253.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID; This spontaneous report received from a consumer concerned five patients of unspecified age. No past medical history or concurrent conditions were reported. The patients were previously treated with both the doses of covid-19 vaccine (unspecified manufacturer) (Dose number in series 1) ( Form of admin, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. It was unknown whether patients experienced any adverse event (Dose number in series 1). The patients received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of admin, batch number and expiration date were not reported) dose,1 total start therapy date were not reported for prophylactic vaccination (Dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, five family members who had both shots of the vaccine and the booster got covid (Dose number in series 2). Reporter did not know whether they had received the Janssen Covid-19 vaccine  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event covid was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE GIVEN AT LEAST 29 HOURS AFTER THE 6 HOUR PUNCTURE WINDOW; This spontaneous report received from a health care professional 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 not reported and batch number: 1822811 expiry: 20-MAR-2022) dose was not reported, administered on 04-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 04-JAN-2022, the patient experienced vaccine given at least 29 hours after the 6 hour puncture window. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine given at least 29 hours after the 6 hour puncture window was not reported. This report was non-serious. This case, from the same reporter is linked to 20220116755.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION; 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 was not reported, administered on 03-MAR-2021 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 allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic reaction was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: CONTRACTED COVID; This spontaneous report received from a patient 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 was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-DEC-2021, the patient experienced contracted covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of contracted covid was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000211192.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Headache, Injection site pain, Myalgia, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report received from a parent concerned a 12-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and other pre-existing medical conditions included: The patient had no known allergies. The patient was not on any medications. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 29-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-DEC-2021, the patient experienced 12-year-old female got the vaccine, vision disturbances, felt whole body was heavy, severe headaches, muscle aches, and injection site pain. Treatment medications included: sulfamethoxazole/trimethoprim. The action taken with covid-19 vaccine was not applicable. The patient recovered from vision disturbances, felt whole body was heavy, severe headaches, muscle aches, and injection site pain on 30-DEC-2021, and the outcome of 12-year-old female got the vaccine was not reported. This report was non-serious.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: This spontaneous report received from a parent concerned a 12-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and other pre-existing medical conditions included: The patient had no known allergies. The patient was not on any medications. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 29-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-DEC-2021, the patient experienced 12-year-old female got the vaccine, vision disturbances, felt whole body was heavy, severe headaches, muscle aches, and injection site pain. Treatment medications included: sulfamethoxazole/trimethoprim. The action taken with covid-19 vaccine was not applicable. The patient recovered from vision disturbances, felt whole body was heavy, severe headaches, muscle aches, and injection site pain on 30-DEC-2021, and the outcome of 12-year-old female got the vaccine was not reported. This report was non-serious.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report received from a parent concerned a 12-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and other pre-existing medical conditions included: The patient had no known allergies. The patient was not on any medications. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 29-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-DEC-2021, the patient experienced 12-year-old female got the vaccine, vision disturbances, felt whole body was heavy, severe headaches, muscle aches, and injection site pain. Treatment medications included: sulfamethoxazole/trimethoprim. The action taken with covid-19 vaccine was not applicable. The patient recovered from vision disturbances, felt whole body was heavy, severe headaches, muscle aches, and injection site pain on 30-DEC-2021, and the outcome of 12-year-old female got the vaccine was not reported. This report was non-serious.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Headache, Injection site pain, Myalgia, Product administered to patient of inappropriate age
Clinical narrative: Patient was given 0.3mls of janssen but was intended to get pfizer
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: Patient was given 0.3mls of janssen but was intended to get pfizer
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given 0.3mls of janssen but was intended to get pfizer
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-2021 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 two periods a month instead of one, longer, heavier, more frequent period, and painful period. The action taken with covid-19 vaccine was not applicable. The outcome of the two periods a month instead of one, longer, heavier, more frequent period and painful period was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood viscosity increased, COVID-19, Hepatic enzyme increased, Investigation, Palpitations
Clinical narrative: COVID-LIKE SYMPTOMS ONE WEEK AFTER VACCINATION; BLOOD THICKENING; DEVELOPED AN ENZYME IN LIVER; HEART PALPITATIONS THAT WERE PERSISTENT AND GOT WORSE; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: allergies and stuff, and other pre-existing medical conditions included: The patient had no heart issues and had great health and wellness. 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 AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On AUG-2021, the patient experienced heart palpitations that were persistent and got worse. Laboratory data included: Investigation (NR: not provided) not available. On an unspecified date, the patient experienced covid-like symptoms one week after vaccination, blood thickening, and developed an enzyme in liver. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart palpitations that were persistent and got worse, and the outcome of covid-like symptoms one week after vaccination, blood thickening and developed an enzyme in liver was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Eczema, Lymphadenitis, Mammogram
Clinical narrative: This spontaneous report received from a patient 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 25-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the patient experienced dermatitis, and eczema. On JUN-2021, the patient experienced inflammation of lymph nodes on the side of the vaccination. Laboratory data included: Mammogram (NR: not provided) Inflamed lymph nodes. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from dermatitis, and eczema, and the outcome of inflammation of lymph nodes on the side of the vaccination was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000211236.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: 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. The patient's concurrent conditions included: vitamin d supplementation. The patient received covid-19 vaccine (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 fatigue/ more tired, and mild fever. The action taken with covid-19 vaccine was not applicable. The outcome of the fatigue/ more tired and mild fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abortion, Maternal exposure during pregnancy
Clinical narrative: friends pregnant daughter lost her baby after the jab; friends pregnant daughter lost her baby after the jab; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION (friends pregnant daughter lost her baby after the jab) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION (friends pregnant daughter lost her baby after the jab) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (friends pregnant daughter lost her baby after the jab). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. lost her baby after getting the jab. At the time of the report, ABORTION (friends pregnant daughter lost her baby after the jab) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (friends pregnant daughter lost her baby after the jab) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported. Treatment information was not provided.  A friend pregnant daughter lost her baby after getting jab. COMPANY COMMENT: This is a Spontaneous case concerning an unknown-year-old female patient with no clinical history who experienced the unexpected events of  ABORTION and MATERNAL EXPOSURE DURING PREGNANCY The events occurred unknown days after a dose of mRNA-1273. The rechallenge was not applicable since only information about a dose was disclosed Authority report states the doses were given on same date (providing different lots). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    This case was linked to MOD-2022-438341 (Patient Link).; Sender's Comments: COMPANY COMMENT: This is a Spontaneous case concerning an unknown-year-old female patient with no clinical history who experienced the unexpected events of  ABORTION and MATERNAL EXPOSURE DURING PREGNANCY The events occurred unknown days after a dose of mRNA-1273. The rechallenge was not applicable since only information about a dose was disclosed Authority report states the doses were given on same date (providing different lots). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: mild sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (mild sore arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0301421B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Dec-2021, the patient experienced PAIN IN EXTREMITY (mild sore arm). On 03-Dec-2021, PAIN IN EXTREMITY (mild sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient received 2 dose of vaccine intramuscular injection on 31 DEC 2021 lot ,059H21A, expiration date unknown, No concomitant medication was provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2022-448142 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness
Clinical narrative: Ancillary health issues; Had COVID; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (Ancillary health issues) and COVID-19 (Had COVID) 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 ILLNESS (Ancillary health issues) and COVID-19 (Had COVID). At the time of the report, ILLNESS (Ancillary health issues) and COVID-19 (Had COVID) 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 medication were  reported.  Patient received monoclonal antibodies 60 days ago as he had COVID and some ancillary health issues.  Company comment: This is a spontaneous case concerning a male patient with no reported medical history, who experienced the unexpected, non-serious, AESI event of Covid-19 and unspecified ancillary health issues. The events Covid-19 and unspecified ancillary health issues occurrence unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. Patient received monoclonal antibodies for treatment of Covid-19. The outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a male patient with no reported medical history, who experienced the unexpected, non-serious, AESI event of Covid-19 and unspecified ancillary health issues. The events Covid-19 and unspecified ancillary health issues occurrence unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. Patient received monoclonal antibodies for treatment of Covid-19. The outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Had a mild case of covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Had a mild case of covid-19) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had a mild case of covid-19). At the time of the report, COVID-19 (Had a mild case of covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Had a mild case of Covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information were reported.  Company comment: This is a spontaneous case concerning a female patient of unknown age with no reported medical history, who experienced the unexpected, non-serious, AESI event of mild Covid-19. The event mild Covid-19 occurred after the unknown dose number of mRNA-1273 vaccine administration. No reported treatment information. The outcome of the event was unknown.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-419667 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no reported medical history, who experienced the unexpected, non-serious, AESI event of mild Covid-19. The event mild Covid-19 occurred after the unknown dose number of mRNA-1273 vaccine administration. No reported treatment information. The outcome of the event was unknown.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: son contracted Covid (determined by at-home testing kit); This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (son contracted Covid (determined by at-home testing kit)) 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 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 COVID-19 (son contracted Covid (determined by at-home testing kit)). At the time of the report, COVID-19 (son contracted Covid (determined by at-home testing kit)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Patient contracted COVID which was determined by at-home testing kit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. Patient did not received Booster, but he was scheduled. Company Comment: This is a spontaneous case concerning male patient of unknown age with no medical history reported, who experienced the unexpected non-serious AESI COVID-19 (determined by at-home testing). The event occurred approximately at an unknown day after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning male patient of unknown age with no medical history reported, who experienced the unexpected non-serious AESI COVID-19 (determined by at-home testing). The event occurred approximately at an unknown day after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event following immunisation
Clinical narrative: COVID symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (COVID symptoms) 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 ADVERSE EVENT FOLLOWING IMMUNISATION (COVID symptoms). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (COVID symptoms) 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  Symptoms: Patient experienced COVID symptoms after first dose of Moderna COVID-19 vaccine and was asking if it was safe to get 2nd dose and any timeline to wait for a dose.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity, Palpitations
Clinical narrative: fast heartbeat/pounding heartbeat every 4 hours/ heart pounded 5 minutes; pain in the arm; rashes; headache; chills; nausea; vomiting; fever; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (fast heartbeat/pounding heartbeat every 4 hours/ heart pounded 5 minutes), PAIN IN EXTREMITY (pain in the arm), RASH (rashes), HEADACHE (headache) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A and 033H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinusitis NOS (sinus problem causing her allergy) and Heart disease aggravated. Concomitant products included RIVAROXABAN (XARELTO) and NADOLOL for Heart disease aggravated.   On 09-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, the patient experienced PALPITATIONS (fast heartbeat/pounding heartbeat every 4 hours/ heart pounded 5 minutes), PAIN IN EXTREMITY (pain in the arm), RASH (rashes), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at an unspecified dose and frequency. On 08-Jan-2022, PAIN IN EXTREMITY (pain in the arm), RASH (rashes), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea) had resolved. At the time of the report, PALPITATIONS (fast heartbeat/pounding heartbeat every 4 hours/ heart pounded 5 minutes), VOMITING (vomiting) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient  took Ginger candy for nausea.  Patient said that sinus problem causing her allergy. Patient is taking Vitamin-D for unknown indication
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: fast heartbeat/pounding heartbeat every 4 hours/ heart pounded 5 minutes; pain in the arm; rashes; headache; chills; nausea; vomiting; fever; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (fast heartbeat/pounding heartbeat every 4 hours/ heart pounded 5 minutes), PAIN IN EXTREMITY (pain in the arm), RASH (rashes), HEADACHE (headache) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A and 033H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinusitis NOS (sinus problem causing her allergy) and Heart disease aggravated. Concomitant products included RIVAROXABAN (XARELTO) and NADOLOL for Heart disease aggravated.   On 09-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, the patient experienced PALPITATIONS (fast heartbeat/pounding heartbeat every 4 hours/ heart pounded 5 minutes), PAIN IN EXTREMITY (pain in the arm), RASH (rashes), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at an unspecified dose and frequency. On 08-Jan-2022, PAIN IN EXTREMITY (pain in the arm), RASH (rashes), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea) had resolved. At the time of the report, PALPITATIONS (fast heartbeat/pounding heartbeat every 4 hours/ heart pounded 5 minutes), VOMITING (vomiting) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient  took Ginger candy for nausea.  Patient said that sinus problem causing her allergy. Patient is taking Vitamin-D for unknown indication
Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Influenza, Nasopharyngitis
Clinical narrative: Flu Symptoms; cold symptoms; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu Symptoms), NASOPHARYNGITIS (cold symptoms) and ARTHRALGIA (Joint pain) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ENZALUTAMIDE (ENZALUTAMIDE ASTELLAS) tablet for Prostate cancer.    Concurrent medical conditions included PSA increased (Rising PSA for treatment for malignant neoplasm prostate) and Malignant neoplasm of prostate (Rising PSA for treatment for malignant neoplasm prostate).   On 07-Aug-2021, the patient started ENZALUTAMIDE (ENZALUTAMIDE ASTELLAS) (Oral) 160 mg once a day. On 08-Nov-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 INFLUENZA (Flu Symptoms), NASOPHARYNGITIS (cold symptoms) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Joint pain, at an unspecified dose and frequency. At the time of the report, INFLUENZA (Flu Symptoms) and ARTHRALGIA (Joint pain) was resolving and NASOPHARYNGITIS (cold symptoms) had resolved.            No Concomitant medications were provided.  Patient received Tylenol for joint pain which was a 3 on scale of 0.10. Patient stated that soon after woke up in the morning feeling pretty good. No lab test information was provided. The flu symptoms lasted for 36 hours, cold symptoms lasted for a couple of days  however it was reported that flu symptoms and joint pain was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Lower respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: chest congestion; This spontaneous case was reported by a physician and describes the occurrence of LOWER RESPIRATORY TRACT CONGESTION (chest congestion) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOWER RESPIRATORY TRACT CONGESTION (chest congestion). At the time of the report, LOWER RESPIRATORY TRACT CONGESTION (chest congestion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2022, SARS-CoV-2 test: negative (Negative) tested negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information was not reported.  Patient was scheduled for booster dose on the day of report but the patient experienced chest congestion in the previous week of Jan-2022.  Patient had a doubt whether still the patient could take the vaccine or not.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre type of thing; This spontaneous case was reported by a physician and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre type of thing) and LOSS OF CONTROL OF LEGS (loss control of the lower limbs) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 007H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient reports back on 01DEC2020 he got Covid) on 01-Dec-2020, Weight bearing difficulty in December 2020, Movements abnormal in December 2020 and Hospitalization (Patient reported being hospitalized 3 times due to Covid). Concurrent medical conditions included Loss of control of legs since December 2020.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre type of thing) (seriousness criterion medically significant) and LOSS OF CONTROL OF LEGS (loss control of the lower limbs) (seriousness criterion medically significant). In February 2021, GUILLAIN-BARRE SYNDROME (Guillain-Barre type of thing) and LOSS OF CONTROL OF LEGS (loss control of the lower limbs) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included about 15 unspecified medications. No treatment was received for the side effects. Company Comment This case concerns an 89-year-old, male patient with relevant medical history of COVID-19, who experienced the unexpected event of Guillain-Barre syndrome (AESI). The event occurred on and unknown number of days after the first dose of mRNA-1273. The medical history of COVID-19 remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns an 89-year-old, male patient with relevant medical history of COVID-19, who experienced the unexpected event of Guillain-Barre syndrome (AESI). The event occurred on and unknown number of days after the first dose of mRNA-1273. The medical history of COVID-19 remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Extrasystoles
Clinical narrative: Had been feeling like her heart have been skipping a beat; chest pain; This spontaneous case was reported by a consumer and describes the occurrence of EXTRASYSTOLES (Had been feeling like her heart have been skipping a beat) and CHEST PAIN (chest pain) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A and 058F21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 23-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Dec-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 EXTRASYSTOLES (Had been feeling like her heart have been skipping a beat) and CHEST PAIN (chest pain). At the time of the report, EXTRASYSTOLES (Had been feeling like her heart have been skipping a beat) and CHEST PAIN (chest pain) outcome was unknown.            No medical history was provided by the reporter. Treatment information was not provided by the reporter.  Company comment: This case concerns a 40-year-old, female patient with no medical history, who experienced the unexpected non serious events of extrasystoles and chest pain. The events occurred approximately 29 day after the second dose of mRNA-1273. As reported, patient had been feeling like her heart have been skipping a beat and also some chest pain. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-436412 (Patient Link).; Sender's Comments: This case concerns a 40-year-old, female patient with no medical history, who experienced the unexpected non serious events of extrasystoles and chest pain. The events occurred approximately 29 day after the second dose of mRNA-1273. As reported, patient had been feeling like her heart have been skipping a beat and also some chest pain. The benefit-risk relationship of mRNA-1273 is not affected by this report.