chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: THREE PATIENT HAD HEART ISSUES AFTER VACCINE; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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 three patient had heart issues after vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from three patient had heart issues after vaccine. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, Migraine, Pain
Clinical narrative: BAD MIGRAINE; FELT LOTS OF PAIN; LUMP IN ARM; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 07-AUG-2022) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced bad migraine, felt lots of pain, and lump in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt lots of pain, and lump in arm, and had not recovered from bad migraine. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: BODY FEELS LIKE ASS; 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 (series 1). 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 body feels like ass. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of body feels like ass was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SEVERE 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 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 severe reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reaction was not reported. This report was non-serious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain
Clinical narrative: ACHINESS IN ALL BODY JOINTS/LEG JOINTS; PAIN THE INJECTION SITE; This spontaneous report received from a patient concerned a 27 year old male. The patient's weight was 180 pounds, and height was 70 inches. The patient's concurrent conditions included: alcohol user, and nonsmoker, and other pre-existing medical conditions included: No known allergies, No drug abuse or illicit drug usage, Patient not aware of any medical condition, not taking any medication. 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 11-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-DEC-2021, the patient experienced achiness in all body joints/leg joints, and pain the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain the injection site, and achiness in all body joints/leg joints. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES FOR A MONTH; 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, 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 shingles for a month. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shingles for a month. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Discomfort, Dry throat, Fatigue, Headache
Clinical narrative: PROFUSE SWEATING WHILE STANDING; NO APPETITE; DRY THROAT; NAUSEA; FATIGUE; HEADACHES; INJECTION SITE FELT HEAVY BUT NOT PAINFUL; ITCHY SPOTS ON BODY; SHARP PAIN ALONG RIBS ON BOTH RIGHT AND LEFT SIDE; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was allergic to one medication but doesn't remember the name of it. The patient was not on previous medications, and had no previous medical conditions at the time of reporting. 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 07-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On DEC-2021, the patient experienced sharp pain along ribs on both right and left side. On 07-DEC-2021, the patient experienced itchy spots on body. On 08-DEC-2021, the patient experienced injection site felt heavy but not painful. On 10-DEC-2021, the patient experienced profuse sweating while standing. On 10-DEC-2021, the patient experienced no appetite. On 10-DEC-2021, the patient experienced dry throat. On 10-DEC-2021, the patient experienced nausea. On 10-DEC-2021, the patient experienced fatigue. On 10-DEC-2021, the patient experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site felt heavy but not painful on 09-DEC-2021, and itchy spots on body on 08-DEC-2021, had not recovered from sharp pain along ribs on both right and left side, and the outcome of nausea, fatigue, headaches, profuse sweating while standing, no appetite and dry throat was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Musculoskeletal chest pain, Nausea, Pruritus
Clinical narrative: PROFUSE SWEATING WHILE STANDING; NO APPETITE; DRY THROAT; NAUSEA; FATIGUE; HEADACHES; INJECTION SITE FELT HEAVY BUT NOT PAINFUL; ITCHY SPOTS ON BODY; SHARP PAIN ALONG RIBS ON BOTH RIGHT AND LEFT SIDE; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was allergic to one medication but doesn't remember the name of it. The patient was not on previous medications, and had no previous medical conditions at the time of reporting. 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 07-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On DEC-2021, the patient experienced sharp pain along ribs on both right and left side. On 07-DEC-2021, the patient experienced itchy spots on body. On 08-DEC-2021, the patient experienced injection site felt heavy but not painful. On 10-DEC-2021, the patient experienced profuse sweating while standing. On 10-DEC-2021, the patient experienced no appetite. On 10-DEC-2021, the patient experienced dry throat. On 10-DEC-2021, the patient experienced nausea. On 10-DEC-2021, the patient experienced fatigue. On 10-DEC-2021, the patient experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site felt heavy but not painful on 09-DEC-2021, and itchy spots on body on 08-DEC-2021, had not recovered from sharp pain along ribs on both right and left side, and the outcome of nausea, fatigue, headaches, profuse sweating while standing, no appetite and dry throat was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Headache, Neuralgia, Pain of skin
Clinical narrative: SKIN PAIN; NERVE PAIN; RECURRENT PSORIASIS; CHEST HURTS; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: psoriasis. 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 NOV-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 skin pain, nerve pain, recurrent psoriasis, chest hurts, headache, and fatigue. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) tested twice it was negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, skin pain, nerve pain, fatigue, recurrent psoriasis and chest hurts was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis, SARS-CoV-2 test
Clinical narrative: SKIN PAIN; NERVE PAIN; RECURRENT PSORIASIS; CHEST HURTS; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: psoriasis. 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 NOV-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 skin pain, nerve pain, recurrent psoriasis, chest hurts, headache, and fatigue. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) tested twice it was negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, skin pain, nerve pain, fatigue, recurrent psoriasis and chest hurts was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Wrong device used
Clinical narrative: SUBCUTANEOUS NEEDLE WAS USED TO ADMINISTER INTRAMUSCULAR VACCINE; OFF LABEL USE; 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 not reported, batch number: 1855194, and expiry: UNKNOWN) dose was not reported, administered on 12-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-DEC-2021, the patient experienced subcutaneous needle was used to administer intramuscular vaccine. On 12-DEC-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the subcutaneous needle was used to administer intramuscular vaccine and off label use was not reported. This report was non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Psoriasis, Rash
Clinical narrative: psoriasis; It was totally dry skin on his legs/ It kept getting worse and worse and worse; After the second shot, he broke out in rash on his legs up to his knees/got worse on my 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (After the second shot, he broke out in rash on his legs up to his knees/got worse on my 2nd shot), DRY SKIN (It was totally dry skin on his legs/ It kept getting worse and worse and worse) and PSORIASIS (psoriasis) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A,) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery (open heart surgery over 20 years ago). Concurrent medical conditions included Penicillin allergy, Drug allergy (allergy to anything that has statin in it) and Allergy to chemicals (Allergy to anything with sulfur in it).    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced RASH (After the second shot, he broke out in rash on his legs up to his knees/got worse on my 2nd shot). On an unknown date, the patient experienced DRY SKIN (It was totally dry skin on his legs/ It kept getting worse and worse and worse) and PSORIASIS (psoriasis). The patient was treated with BETAMETHASONE DIPROPIONATE for Adverse event, at a dose of ointment 0.05% and MOMETASONE FUROATE for Adverse event, at a dose of ointment 0.1%. At the time of the report, RASH (After the second shot, he broke out in rash on his legs up to his knees/got worse on my 2nd shot), DRY SKIN (It was totally dry skin on his legs/ It kept getting worse and worse and worse) and PSORIASIS (psoriasis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The patient wants to know if anyone else in the world has experienced anything like this. The patient wants to know if there is an antidote. He states there are injections for psoriasis, but they cost seven to eight thousand dollars. He can't afford that.   This case was linked to MOD-2021-407399 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2021: Non significant follow up appended
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vails were frozen  when  received and was immediately placed in the clinic vaccine freezer. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use. Only 1 vial was used per day between the hours of 8:00am to 4:00pm. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine used; product storage error; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (product storage error) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (product storage error). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Patient with prolonged fatigue following Covid booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced FATIGUE (Patient with prolonged fatigue following Covid booster). At the time of the report, FATIGUE (Patient with prolonged fatigue following Covid booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported  Treatment information was not reported
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given.   No treatment medication was given.   The box of vials was received on 14 Oct 2021. It was frozen when it was received and was immediately placed in the clinic vaccine freezer. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use. The vials remained in the refrigerator between uses and each vial was discarded after the final appointment of the day. Only 1 vial was used per day between the hours of 8:00am to 4:00pm.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Possible AE/  if they had COVID how much should she wait before receiving a booster; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Possible AE/  if they had COVID how much should she wait before receiving a booster) 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 (Possible AE/  if they had COVID how much should she wait before receiving a booster). At the time of the report, COVID-19 (Possible AE/  if they had COVID how much should she wait before receiving a booster) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       CC: This is a spontaneous case concerning a female patient of unknown age with no reported medical history, who experienced the non-serious unexpected event of special interest COVID-19, after receiving unspecified dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.  No Concomitant product use was reported. No treatment information was provided.  The patient wanted to know if they had COVID how much should they wait before receiving a booster dose.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: Follow-up received contains no new information.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no reported medical history, who experienced the non-serious unexpected event of special interest COVID-19, after receiving unspecified dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Malaise, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (choking congestion), COUGH (coughing), OROPHARYNGEAL DISCOMFORT (tickle in her throat), MALAISE (has felt so sick) and PYREXIA (fever (highest's 100.5 F)/currently low grade fever (99.6 F)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A, 001B21A and 058H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, the patient experienced RESPIRATORY TRACT CONGESTION (choking congestion), COUGH (coughing), OROPHARYNGEAL DISCOMFORT (tickle in her throat), PYREXIA (fever (highest's 100.5 F)/currently low grade fever (99.6 F)), MYALGIA (body aches) and CHILLS (chills). 24-Nov-2021, the patient experienced MALAISE (has felt so sick). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PARACETAMOL (NYQUIL COLD & FLU) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RESPIRATORY TRACT CONGESTION (choking congestion), COUGH (coughing), OROPHARYNGEAL DISCOMFORT (tickle in her throat), MALAISE (has felt so sick), PYREXIA (fever (highest's 100.5 F)/currently low grade fever (99.6 F)), MYALGIA (body aches) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2021, Body temperature: 100.5 (High) Fever (highest's 100.5 F). On 29-Nov-2021, Body temperature: 99.6 (High) Low grade fever (99.6 F).         Concomitant medication was not provided Patient says she also used a decongestant for her adverse events.   This case was linked to MOD-2021-400255 (Patient Link).   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pyrexia, Respiratory tract congestion
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (choking congestion), COUGH (coughing), OROPHARYNGEAL DISCOMFORT (tickle in her throat), MALAISE (has felt so sick) and PYREXIA (fever (highest's 100.5 F)/currently low grade fever (99.6 F)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A, 001B21A and 058H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, the patient experienced RESPIRATORY TRACT CONGESTION (choking congestion), COUGH (coughing), OROPHARYNGEAL DISCOMFORT (tickle in her throat), PYREXIA (fever (highest's 100.5 F)/currently low grade fever (99.6 F)), MYALGIA (body aches) and CHILLS (chills). 24-Nov-2021, the patient experienced MALAISE (has felt so sick). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PARACETAMOL (NYQUIL COLD & FLU) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RESPIRATORY TRACT CONGESTION (choking congestion), COUGH (coughing), OROPHARYNGEAL DISCOMFORT (tickle in her throat), MALAISE (has felt so sick), PYREXIA (fever (highest's 100.5 F)/currently low grade fever (99.6 F)), MYALGIA (body aches) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2021, Body temperature: 100.5 (High) Fever (highest's 100.5 F). On 29-Nov-2021, Body temperature: 99.6 (High) Low grade fever (99.6 F).         Concomitant medication was not provided Patient says she also used a decongestant for her adverse events.   This case was linked to MOD-2021-400255 (Patient Link).   Reporter did not allow further contact
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Disturbance in attention, Impaired driving ability, Seizure, Speech disorder
Clinical narrative: very difficult concentrating; couldn't drive for 6 months; Confusion; hard to talk because confuses the words or have to talk slow so don't confuse the words.; 1st Seizure episode; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (1st Seizure episode) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 028A21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.  Concomitant products included GOLIMUMAB (SIMPONI) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced SEIZURE (1st Seizure episode) (seriousness criterion medically significant). On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (very difficult concentrating), IMPAIRED DRIVING ABILITY (couldn't drive for 6 months), CONFUSIONAL STATE (Confusion) and SPEECH DISORDER (hard to talk because confuses the words or have to talk slow so don't confuse the words.). At the time of the report, SEIZURE (1st Seizure episode), DISTURBANCE IN ATTENTION (very difficult concentrating), IMPAIRED DRIVING ABILITY (couldn't drive for 6 months), CONFUSIONAL STATE (Confusion) and SPEECH DISORDER (hard to talk because confuses the words or have to talk slow so don't confuse the words.) had not resolved.            Treatment for the events were not provided.  Company comment included This is a spontaneous case concerning a 36-year-old female patient with no reported medical history, who experienced the serious (medically significant) expected event of special interest seizure . The event occurred approximately 20 days after the third   dose of mRNA-1273 and repeated again 23 days later. Very limited information was provided regarding medical history and events. Further information has been requested. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-403022 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 36-year-old female patient with no reported medical history, who experienced the serious (medically significant) expected event of special interest seizure . The event occurred approximately 20 days after the third   dose of mRNA-1273 and repeated again 23 days later. Very limited information was provided regarding medical history and events. Further information has been requested. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: 3 of my friends that got shot got COVID again; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (3 of my friends that got shot got COVID again) 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 COVID-19 (3 of my friends that got shot got COVID again). At the time of the report, COVID-19 (3 of my friends that got shot got COVID again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   This spontaneous case is concerning a patient of unknown age and gender with no medical history reported, who received mRNA-1273 vaccine on an unknown date, experienced the unexpected, AESI of COVID-19. The event occurred on an unknown date after the unknown dose of mRNA-1273 vaccine.   Re challenge is not applicable as the event occurred after the unknown dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case is concerning a patient of unknown age and gender with no medical history reported, who received mRNA-1273 vaccine on an unknown date, experienced the unexpected, AESI of COVID-19. The event occurred on an unknown date after the unknown dose of mRNA-1273 vaccine.   Re challenge is not applicable as the event occurred after the unknown dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Maternal exposure during pregnancy, Thrombosis
Clinical narrative: I had dizziness; I developed a superficial blood clot on my right calf; maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of THROMBOSIS (I developed a superficial blood clot on my right calf) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.  Concomitant products included LORATADINE, NORTRIPTYLINE, PROBIOTICS NOS and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 01-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). On 14-Jun-2021, the patient experienced THROMBOSIS (I developed a superficial blood clot on my right calf) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (I had dizziness). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency. At the time of the report, THROMBOSIS (I developed a superficial blood clot on my right calf) had resolved and DIZZINESS (I had dizziness) and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This is a spontaneous pregnancy case concerning a 39-year-old female patient with no reported medical history, who experienced the serious (medically significant) unexpected event thrombosis, 42 days after receiving the second dose of mRNA-1273.  Patient reports experiencing a superficial blood clot on her right calf. Further information has been requested. Maternal exposure during pregnancy was also captured as an event. Pregnancy remains as confounder for the event thrombosis. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous pregnancy case concerning a 39-year-old female patient with no reported medical history, who experienced the serious (medically significant) unexpected event thrombosis, 42 days after receiving the second dose of mRNA-1273.  Patient reports experiencing a superficial blood clot on her right calf. Further information has been requested. Maternal exposure during pregnancy was also captured as an event. Pregnancy remains as confounder for the event thrombosis. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Thrombosis
Clinical narrative: diagnosed with a blood clot in her right leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (diagnosed with a blood clot in her right leg) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-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 THROMBOSIS (diagnosed with a blood clot in her right leg) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) for Adverse event, at an unspecified dose and frequency. In 2021, THROMBOSIS (diagnosed with a blood clot in her right leg) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Computerised tomogram: blood clot diagnosed with a blood clot in her right leg. In 2021, Blood test: cured of the blood clot.         Consumer called stated that two weeks after she went to the emergency room, got a CAT Scan and was diagnosed with a blood clot in her right leg. The ER did not keep her overnight, they referred her to her PCP doctor. The PCP referred her to a blood specialist, who started her on Eliquis for 3 to 4 months. The specialist performed blood work following the treatment and noted that she was cured of the blood clot.  Company Comment: This case concerns an 80-year-old, female patient, with no medical history reported in this case, who experienced the serious unexpected AESI event of Thrombosis. The event occurred on an unknown date after the administration of the second dose of mRNA-1273 vaccine and was reported with the seriousness criteria of Medically significant. At the time of the report, the outcome of the event was Recovered/Resolved.  The rechallenge is not applicable since the event occurred after the second dose of the of the mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns an 80-year-old, female patient, with no medical history reported in this case, who experienced the serious unexpected AESI event of Thrombosis. The event occurred on an unknown date after the administration of the second dose of mRNA-1273 vaccine and was reported with the seriousness criteria of Medically significant. At the time of the report, the outcome of the event was Recovered/Resolved.  The rechallenge is not applicable since the event occurred after the second dose of the of the mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Lymph-Node under the Left Armpit after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen Lymph-Node under the Left Armpit after 2nd shot) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A, 025B21A and 076C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jul-2021, the patient experienced LYMPHADENOPATHY (Swollen Lymph-Node under the Left Armpit after 2nd shot). At the time of the report, LYMPHADENOPATHY (Swollen Lymph-Node under the Left Armpit after 2nd shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After 2nd dose, He started having a Swollen Lymph-Node under the Left Armpit but he noticed it 2 months after second dose. After the booster, he had a small swelling under the right arm pit.   This case was linked to MOD-2021-405733 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Small swelling under the right arm pit after booster shot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Small swelling under the right arm pit after booster shot) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 025B21A and 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Small swelling under the right arm pit after booster shot). At the time of the report, PERIPHERAL SWELLING (Small swelling under the right arm pit after booster shot) outcome was unknown.            Patient is having an appointment to see the doctor on 07-Dec-2021.  No concomitant drugs were reported by reporter.  No treatment drugs were reported   This case was linked to MOD-2021-405715 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Headache, Nausea
Clinical narrative: Dizziness; Stomach ache; Nausea; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomach ache), NAUSEA (Nausea) and HEADACHE (Bad headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac disorder NOS (under several cardiac medications).   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomach ache), NAUSEA (Nausea) and HEADACHE (Bad headache). At the time of the report, DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomach ache), NAUSEA (Nausea) and HEADACHE (Bad headache) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-406404 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Cystitis interstitial, Headache, Inflammation, Myalgia
Clinical narrative: arthritis; inflammation; interstitial cystitis, been dormant since 2009 but kicked in now; fever; body aches; headache everyday; Missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (arthritis), INFLAMMATION (inflammation), CYSTITIS INTERSTITIAL (interstitial cystitis, been dormant since 2009 but kicked in now), PYREXIA (fever) and MYALGIA (body aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (arthritis), INFLAMMATION (inflammation), CYSTITIS INTERSTITIAL (interstitial cystitis, been dormant since 2009 but kicked in now), PYREXIA (fever), MYALGIA (body aches), HEADACHE (headache everyday) and PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, ARTHRITIS (arthritis), INFLAMMATION (inflammation), CYSTITIS INTERSTITIAL (interstitial cystitis, been dormant since 2009 but kicked in now), PYREXIA (fever), MYALGIA (body aches), HEADACHE (headache everyday) and PRODUCT DOSE OMISSION ISSUE (Missed second dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications were reported. No treatment medications were reported.  This spontaneous case concerning a 72-year-old, female patient with no medical history, who experienced unexpected adverse events of Arthritis, Inflammation, Cystitis interstitial, and expected non serious events of Pyrexia, Myalgia and Headache after the first dose of mRNA-1273 vaccine administration. Due to reported events patient decided not to take second dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report; Sender's Comments: This spontaneous case concerning a 72-year-old, female patient with no medical history, who experienced unexpected adverse events of Arthritis, Inflammation, Cystitis interstitial, and expected non serious events of Pyrexia, Myalgia and Headache after the first dose of mRNA-1273 vaccine administration. Due to reported events patient decided not to take second dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pyrexia
Clinical narrative: arthritis; inflammation; interstitial cystitis, been dormant since 2009 but kicked in now; fever; body aches; headache everyday; Missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (arthritis), INFLAMMATION (inflammation), CYSTITIS INTERSTITIAL (interstitial cystitis, been dormant since 2009 but kicked in now), PYREXIA (fever) and MYALGIA (body aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (arthritis), INFLAMMATION (inflammation), CYSTITIS INTERSTITIAL (interstitial cystitis, been dormant since 2009 but kicked in now), PYREXIA (fever), MYALGIA (body aches), HEADACHE (headache everyday) and PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, ARTHRITIS (arthritis), INFLAMMATION (inflammation), CYSTITIS INTERSTITIAL (interstitial cystitis, been dormant since 2009 but kicked in now), PYREXIA (fever), MYALGIA (body aches), HEADACHE (headache everyday) and PRODUCT DOSE OMISSION ISSUE (Missed second dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications were reported. No treatment medications were reported.  This spontaneous case concerning a 72-year-old, female patient with no medical history, who experienced unexpected adverse events of Arthritis, Inflammation, Cystitis interstitial, and expected non serious events of Pyrexia, Myalgia and Headache after the first dose of mRNA-1273 vaccine administration. Due to reported events patient decided not to take second dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report; Sender's Comments: This spontaneous case concerning a 72-year-old, female patient with no medical history, who experienced unexpected adverse events of Arthritis, Inflammation, Cystitis interstitial, and expected non serious events of Pyrexia, Myalgia and Headache after the first dose of mRNA-1273 vaccine administration. Due to reported events patient decided not to take second dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report