chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Lymphadenopathy, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; RIGHT SIDE GLANDS UNDER JAWLINE SWOLLEN; This spontaneous report received from a patient concerned a 46 year old. Initial information was processed along with the additional information received on 07-JAN-2022. 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 was not reported, batch number: 043A21A, expiry: Unknown) dose was not reported, 1 total administered at left arm on 07-APR-2021 for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported. On 04-JAN-2022, the patient had her throat hurted, headache, fever, and right side glands under jawline were swollen. On 05-JAN-2022, she had suspected clinical vaccination failure, suspected covid-19 infection and positive antigen test. The JnJ supplied rapid antigen test BinaxNOW, through this rapid test was performed. Laboratory data included: COVID-19 antigen test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the right side glands under jawline swollen, suspected clinical vaccination failure and suspected covid 19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220108126. This case was associated with product quality complaint: 90000210471.; Sender's Comments: V0; 20220108630-COVID-19 VACCINE AD26.COV2.S-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
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. 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: 1808980 expiry: 18-SEP-2021) dose was not reported (dose number in series 1), 01 in total, administered on 21-MAY-2021 at left arm for prophylactic vaccination. No adverse events were reported following administration of 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: 1045021A expiry: unknown) dose was not reported (dose number in series 2), 01 in total, administered on 09-DEC-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient tested positive for Covid-19 (captured as COVID-19) at home (dose number in series 2). Laboratory data (dates unspecified) included: COVID-19 virus test was positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 test positive was not reported (dose number in series 2). This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 35 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: 204B21A and expiry: UNKNOWN) dose was not reported,1 total administered on 17-AUG-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 30-DEC-2021, the patient experienced or started symptoms was sneezing, congestion nose with phlegm (confirmed covid-19 infection). On 04-JAN-2022, the patient tested covid positive, went to see walk in clinic, doctor who confirmed covid, test showed covid positive, unsure of kind of test (confirmed clinical vaccination failure). Patient fully vaccinated with janssen brand and Patient had no symptoms at present and tested covid negative today using the JNJ supplied rapid antigen binax now test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000210495.; Sender's Comments: V0.20220109765-covid-19 vaccine ad26.cov2.s -confirmed 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
Sex: M
Vaccine: COVID19
Symptoms: Illness, Influenza like illness
Clinical narrative: This spontaneous report received from a consumer concerned a 56 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUL-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 it was like the flu, and sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the it was like the flu and sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20211265856 and 20220110630.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via social media from company representative concerned a patient of unspecified age, sex, race and ethnicity. 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 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 is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter stated that, "I have a friend who was young, took the Johnson shot and died two weeks later" (Dose number in series 1). On an unspecified date, the patient died from unknown cause of death.  It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0 20220100327-COVID-19 VACCINE AD26.COV2.S-Died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID 19; This spontaneous report received from a consumer 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: Unk) 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 tested positive for covid 19. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid 19 was not reported. This report was non-serious. This case, from the same reporter is linked to 20220109542.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNKNOWN SIDE EFFECT; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced unknown side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unknown side effect was not reported. This report was non-serious. This case, from the same reporter was linked to 20220112564 and 20220112185.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Poor quality product administered, Product storage error
Clinical narrative: This spontaneous report received from a health care professional 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: 213D21A expiry: 01-JUN-2022) dose was not reported, administered on right deltoid on 29-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-DEC-2021, the patient experienced vaccine given 12-24 hours after the 6 hour window was still good (incorrectly stored vaccine administered), out of specification product use, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given 12-24 hours after the 6 hour window was still good (incorrectly stored vaccine administered), out of specification product use and off label use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness
Clinical narrative: JUST TENDER; SORE ARM; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced sore arm, and just tender. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and just tender was not reported. This report was non-serious. This case, involving the same patient is linked to 20220112632. This case, from the same reporter is linked to 20220112654 and 20220112293.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: HAVING ISSUES; 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 APR-2021 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 APR-2021, the patient experienced having issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from having issues. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, 1 total, 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 died from unknown cause of death. It was reported that "I have a relative that lost both of his parents within 2 days of the jab. They are among the official death counts attributed to the jab." It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220112398.; Sender's Comments: V0: 20220112752 -Covid-19 vaccine ad26.cov2.s- Death. 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Fatigue, Nasal congestion
Clinical narrative: NOSE CLOGGED; CHEST PAIN (DULL) LIKE THE FEELING YOU GET AFTER  YOU STUB YOUR TOE; DIARRHEA; FEELING  VERY TIRED; This spontaneous report received from a patient concerned a 51 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: abstains from alcohol, and smoker, and other pre-existing medical conditions included: Patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 expiry: UNKNOWN) dose was not reported, administered on 07-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 08-JAN-2022, the patient experienced nose clogged. On 08-JAN-2022, the patient experienced chest pain (dull) like the feeling you get after you stub your toe. On 08-JAN-2022, the patient experienced diarrhea. On 08-JAN-2022, the patient experienced feeling very tired. Treatment medications included: chlorphenamine maleate/paracetamol/phenylephrine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 08-JAN-2022, and had not recovered from nose clogged, feeling very tired, and chest pain (dull) like the feeling you get after you stub your toe. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: TINGLING IN FEET AND HANDS; This spontaneous report received from a consumer via a company representative concerned a 35 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced tingling in feet and hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tingling in feet and hands was not reported. This report was non-serious. This case, from the same reporter is linked to 20220114079, 20220114182 and 20220114533.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: HEART PALPITATIONS; This spontaneous report received from a consumer via a company representative concerned a 35 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced heart palpitations. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart palpitations was not reported. This report was non-serious. This case, from the same reporter is linked to 20220113961 and 20220114079.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID AFTER THE VACCINE; 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, 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 tested positive for covid after the vaccine. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid after the vaccine was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Headache, Illness, Mobility decreased
Clinical narrative: Base of neck feels sore; Head, base of neck, and eyes feels sore/ When the patient moves her eyes they hurt; middle of the night after booster dose patient felt sick/ feels like crap; ribs feel sore; Head feels sore; could hardly move this morning; Patient feels fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (ribs feel sore), MOBILITY DECREASED (could hardly move this morning), NECK PAIN (Base of neck feels sore), EYE PAIN (Head, base of neck, and eyes feels sore/ When the patient moves her eyes they hurt) and ILLNESS (middle of the night after booster dose patient felt sick/ feels like crap) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H219, 025A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2022, the patient experienced MOBILITY DECREASED (could hardly move this morning). 05-Jan-2022, the patient experienced FATIGUE (Patient feels fatigue). On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (ribs feel sore), NECK PAIN (Base of neck feels sore), EYE PAIN (Head, base of neck, and eyes feels sore/ When the patient moves her eyes they hurt) and HEADACHE (Head feels sore). an unknown date, the patient experienced ILLNESS (middle of the night after booster dose patient felt sick/ feels like crap). At the time of the report, MUSCULOSKELETAL CHEST PAIN (ribs feel sore), MOBILITY DECREASED (could hardly move this morning), NECK PAIN (Base of neck feels sore), EYE PAIN (Head, base of neck, and eyes feels sore/ When the patient moves her eyes they hurt), FATIGUE (Patient feels fatigue) and HEADACHE (Head feels sore) had not resolved and ILLNESS (middle of the night after booster dose patient felt sick/ feels like crap) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-441213, MOD-2022-440822 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Neck pain
Clinical narrative: Base of neck feels sore; Head, base of neck, and eyes feels sore/ When the patient moves her eyes they hurt; middle of the night after booster dose patient felt sick/ feels like crap; ribs feel sore; Head feels sore; could hardly move this morning; Patient feels fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (ribs feel sore), MOBILITY DECREASED (could hardly move this morning), NECK PAIN (Base of neck feels sore), EYE PAIN (Head, base of neck, and eyes feels sore/ When the patient moves her eyes they hurt) and ILLNESS (middle of the night after booster dose patient felt sick/ feels like crap) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H219, 025A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2022, the patient experienced MOBILITY DECREASED (could hardly move this morning). 05-Jan-2022, the patient experienced FATIGUE (Patient feels fatigue). On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (ribs feel sore), NECK PAIN (Base of neck feels sore), EYE PAIN (Head, base of neck, and eyes feels sore/ When the patient moves her eyes they hurt) and HEADACHE (Head feels sore). an unknown date, the patient experienced ILLNESS (middle of the night after booster dose patient felt sick/ feels like crap). At the time of the report, MUSCULOSKELETAL CHEST PAIN (ribs feel sore), MOBILITY DECREASED (could hardly move this morning), NECK PAIN (Base of neck feels sore), EYE PAIN (Head, base of neck, and eyes feels sore/ When the patient moves her eyes they hurt), FATIGUE (Patient feels fatigue) and HEADACHE (Head feels sore) had not resolved and ILLNESS (middle of the night after booster dose patient felt sick/ feels like crap) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-441213, MOD-2022-440822 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Very late or no menstrual cycle at all
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfur drugs) and Heart disorder. Concomitant products included DABIGATRAN ETEXILATE MESILATE (PRADAXA), METOPROLOL TARTRATE (LOPRESSOR), FUROSEMIDE (LASIX [FUROSEMIDE]), METHENAMINE HIPPURATE (HIPREX [METHENAMINE HIPPURATE]) and GABAPENTIN (NEURONTIN) for an unknown indication.    On 22-Jan-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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-393117, MOD-2021-393118 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Non-Significant Follow up received on 24-Nov-2021 which contains updated contact information. On 06-Jan-2022: Follow up received on 07-Jan-2022 included: Patient demographics, Medical history, Concomitant medications, Vaccine start date and Lot Number were updated.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Nausea, Pain in extremity
Clinical narrative: sleeping a lot; sore arm; Nauseas; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Dec-2021 and was forwarded to Moderna on 04-Dec-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (sleeping a lot), PAIN IN EXTREMITY (sore arm), NAUSEA (Nauseas) and HEADACHE (headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HYPERSOMNIA (sleeping a lot), PAIN IN EXTREMITY (sore arm), NAUSEA (Nauseas) and HEADACHE (headache). At the time of the report, HYPERSOMNIA (sleeping a lot), PAIN IN EXTREMITY (sore arm), NAUSEA (Nauseas) and HEADACHE (headache) outcome was unknown.            Concomitant medications included for Diabetes and High blood pressure medications.  Company Comment: This case concerns a 55 year-old male patient with a history of diabetes mellitus and high blood pressure who experienced the unexpected adverse event of special interest of hypersomnia which occurred at an unspecified date relative to vaccination with mRNA-1273 vaccine. The medical history of diabetes mellitus remains a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per Regulatory Authority reporting.   This case was linked to MOD-2021-404776, MOD-2021-404788 (Patient Link).; Sender's Comments: This case concerns a 55 year-old male patient with a history of diabetes mellitus and high blood pressure who experienced the unexpected adverse event of special interest of hypersomnia which occurred at an unspecified date relative to vaccination with mRNA-1273 vaccine. The medical history of diabetes mellitus remains a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per Regulatory Authority reporting.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Oral herpes, SARS-CoV-2 test
Clinical narrative: Ilost sense of smell yesterday, 3rd of December,lost sense of smell; cold sore on lip; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Ilost sense of smell yesterday, 3rd of December,lost sense of smell) and ORAL HERPES (cold sore on lip) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 041L20A and 046A21A) for COVID-19 vaccination.     The patient's past medical history included Fracture of spine. Concurrent medical conditions included Blood pressure high. Concomitant products included ENALAPRIL and CHLORTALIDONE (CHLORTHALIDONE) for Blood pressure management, POTASSIUM CHLORIDE and GABAPENTIN for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANOSMIA (Ilost sense of smell yesterday, 3rd of December,lost sense of smell). In December 2021, the patient experienced ORAL HERPES (cold sore on lip). At the time of the report, ANOSMIA (Ilost sense of smell yesterday, 3rd of December,lost sense of smell) and ORAL HERPES (cold sore on lip) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: negative (Negative) Rapid Covid-19 test negative.         Concomitant medication also include some supplements and a muscle relaxant medication because she fractured her spine, she did not remember the name but, said that it was like blexaril.  No treatment information was reported.  This case concerns a 64-year-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest, Anosmia. The event occurred approximately 2 weeks after receiving the third dose of mRNA-1273 Vaccine while the rest of the events occurred on an unknown interval. The rechallenge was not applicable since event only happened on the third dose. No clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 64-year-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest, Anosmia. The event occurred approximately 2 weeks after receiving the third dose of mRNA-1273 Vaccine while the rest of the events occurred on an unknown interval. The rechallenge was not applicable since event only happened on the third dose. No clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Haemorrhoids thrombosed, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHOIDS THROMBOSED (I developed two external hemorrhoids/ thrombosis) and RASH (I had a rash on my inner thighs which looked like a ringworm) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 HAEMORRHOIDS THROMBOSED (I developed two external hemorrhoids/ thrombosis) and RASH (I had a rash on my inner thighs which looked like a ringworm). At the time of the report, HAEMORRHOIDS THROMBOSED (I developed two external hemorrhoids/ thrombosis) and RASH (I had a rash on my inner thighs which looked like a ringworm) had not resolved.            No concomitant medication was reported. The patient reports experiencing development of two external hemorrhoids/thrombosis. The patient developed rash on the inner part of the thigh which looked at a ringworm. The symptoms are ongoing. No treatment medication use was reported. Company comment: This Spontaneous case concerns a patient of unknown age and gender, with no reported medical history, who experienced the unexpected, non-serious and AESI of Haemorrhoids thrombosed, among others. The event occurred on an unknown date after receiving a dose of mRNA-1273 vaccine, exact interval cannot be assessed as event and vaccination dates are not available. The rechallenge was not applicable, as event and vaccination dates are not available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This Spontaneous case concerns a patient of unknown age and gender, with no reported medical history, who experienced the unexpected, non-serious and AESI of Haemorrhoids thrombosed, among others. The event occurred on an unknown date after receiving a dose of mRNA-1273 vaccine, exact interval cannot be assessed as event and vaccination dates are not available. The rechallenge was not applicable, as event and vaccination dates are not available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Needs to take Diclofenac Sodium for arthritis inflammation; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Needs to take Diclofenac Sodium for arthritis inflammation) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included DICLOFENAC SODIUM for Inflammatory arthritis.   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 ARTHRITIS (Needs to take Diclofenac Sodium for arthritis inflammation). The patient was treated with DICLOFENAC SODIUM for Inflammatory arthritis, at an unspecified dose and frequency. At the time of the report, ARTHRITIS (Needs to take Diclofenac Sodium for arthritis inflammation) outcome was unknown.            Patient wanted to know if it's okay to take her medication as usual before getting the booster dose. She couldn't remember if she was taking the drug when she got the 1st and 2nd dose.  Company comment: This is a spontaneous case concerning a female patient of an unknown age with a history of arthritis, who experienced the unexpected non-serious AESI of Arthritis (needs to take Diclofenac Sodium for arthritis inflammation). The patient received two doses of vaccine and the exact temporal association between the event and vaccine administration was not reported, therefore rechallenge was not applicable. The medical history of arthritis remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with a history of arthritis, who experienced the unexpected non-serious AESI of Arthritis (needs to take Diclofenac Sodium for arthritis inflammation). The patient received two doses of vaccine and the exact temporal association between the event and vaccine administration was not reported, therefore rechallenge was not applicable. The medical history of arthritis remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Myalgia, Pain in extremity
Clinical narrative: I haven't been able to taste and smell anything; I haven't been able to taste and smell anything; soreness in my left arm; slight muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (I haven't been able to taste and smell anything), ANOSMIA (I haven't been able to taste and smell anything), PAIN IN EXTREMITY (soreness in my left arm) and MYALGIA (slight muscle ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21A, 002E21A and 023C21A) for COVID-19 immunisation.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced AGEUSIA (I haven't been able to taste and smell anything), ANOSMIA (I haven't been able to taste and smell anything), PAIN IN EXTREMITY (soreness in my left arm) and MYALGIA (slight muscle ache). At the time of the report, AGEUSIA (I haven't been able to taste and smell anything), ANOSMIA (I haven't been able to taste and smell anything), PAIN IN EXTREMITY (soreness in my left arm) and MYALGIA (slight muscle ache) had not resolved.            Patient was taken allergy pill as treatment drug for unknown indication.  These were injected IM one in the left arm and the other in the right arm.   No concomitant medication was reported.  Company comment: This is a spontaneous case concerning a female patient of unknown age, with no reported medical history, who experienced the non-serious unexpected, according RA, AESI of ageusia and anosmia. The event occurred approximately 1 day after the booster dose of mRNA-1273 vaccine. The outcome of the events was reported as not recovered. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; 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, according RA, AESI of ageusia and anosmia. The event occurred approximately 1 day after the booster dose of mRNA-1273 vaccine. The outcome of the events was reported as not recovered. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 101.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypersomnia
Clinical narrative: Slept a lot; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept a lot) and CHILLS (chills) in a 102-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-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 HYPERSOMNIA (Slept a lot) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERSOMNIA (Slept a lot) and CHILLS (chills) outcome was unknown.            Concomitant product use was not provided by the reporter.  Company comment:This is a spontaneous case concerning a 102-year-old female patient with no medical history reported, who experienced the non serious unexpected events of Hypersomnia and the expected event for Chills. Both events occurred on an unknown date, with the patient receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) on 27-Feb-2021. The rechallenge was unknown since there's no information about the first two doses. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.    This case was linked to MOD-2021-417655, MOD-2021-417678 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 102-year-old female patient with no medical history reported, who experienced the non serious unexpected events of Hypersomnia and the expected event for Chills. Both events occurred on an unknown date, with the patient receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) on 27-Feb-2021. The rechallenge was unknown since there's no information about the first two doses. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypersomnia
Clinical narrative: Slept for 9 hours after booster; light-headedness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept for 9 hours after booster) and DIZZINESS (light-headedness) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 032L20A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Vertigo (lasted two years.) from 2014 to 2016 and Surgery (8 years ago got vertigo from the surgery.) in 2014. Concurrent medical conditions included Functional neurological symptom disorder (Basically, I had a functional neurological disorder (FND)).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced HYPERSOMNIA (Slept for 9 hours after booster) and DIZZINESS (light-headedness). At the time of the report, HYPERSOMNIA (Slept for 9 hours after booster) and DIZZINESS (light-headedness) outcome was unknown.            No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-418599 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Limb injury, Mobility decreased, Musculoskeletal stiffness, Periarthritis
Clinical narrative: shoulder injury; mobility is still 75% of normal range, It is the left shoulder; frozen shoulder or adhesive capsulitis; Patient has recovered regarding the pain, it is only stiff and sore when he wakes up.; it is only stiff and sore when he wakes up; shoulder in a lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (shoulder injury), MOBILITY DECREASED (mobility is still 75% of normal range, It is the left shoulder), PERIARTHRITIS (frozen shoulder or adhesive capsulitis), MUSCULOSKELETAL STIFFNESS (Patient has recovered regarding the pain, it is only stiff and sore when he wakes up.) and ARTHRALGIA (shoulder in a lot of pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Glaucoma.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced ARTHRALGIA (shoulder in a lot of pain). On an unknown date, the patient experienced LIMB INJURY (shoulder injury), MOBILITY DECREASED (mobility is still 75% of normal range, It is the left shoulder), PERIARTHRITIS (frozen shoulder or adhesive capsulitis), MUSCULOSKELETAL STIFFNESS (Patient has recovered regarding the pain, it is only stiff and sore when he wakes up.) and ARTHRALGIA (it is only stiff and sore when he wakes up). The patient was treated with IBUPROFEN for Muscle pain, at an unspecified dose and frequency. At the time of the report, LIMB INJURY (shoulder injury) and MOBILITY DECREASED (mobility is still 75% of normal range, It is the left shoulder) had not resolved, PERIARTHRITIS (frozen shoulder or adhesive capsulitis), MUSCULOSKELETAL STIFFNESS (Patient has recovered regarding the pain, it is only stiff and sore when he wakes up.) and ARTHRALGIA (it is only stiff and sore when he wakes up) outcome was unknown and ARTHRALGIA (shoulder in a lot of pain) had resolved.            Concomitant medication included eyedrop for glaucoma. Treatment medication included topical penetrating cream for pain in the muscle.   This case was linked to MOD-2021-416933 (Patient Link).; Sender's Comments: This case concerns a patient, with medical history of glaucoma, who experienced the non-serious event(s) of limb injury, mobility decreased, periarthritis, musculoskeletal stiffness, and arthralgia. The event(s) started occurring on unknown date after the 2nd dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered NA. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Nasopharyngitis, SARS-CoV-2 test, Sneezing
Clinical narrative: Head cold; Sneezy; Slight Cough; Positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Head cold), SNEEZING (Sneezy), COUGH (Slight Cough) and COVID-19 (Positive for 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 18-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced COVID-19 (Positive for Covid). On an unknown date, the patient experienced NASOPHARYNGITIS (Head cold), SNEEZING (Sneezy) and COUGH (Slight Cough). At the time of the report, NASOPHARYNGITIS (Head cold), SNEEZING (Sneezy), COUGH (Slight Cough) and COVID-19 (Positive for Covid) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. No treatment information was reported.  It was reported that the booster dose clearly not worked.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Dec-2021: Follow-up information received included no new information. On 24-Dec-2021: Follow-up information received included no new information. Sender's Comments: This case concerns a male patient with no relevant medical history, who experienced the unexpected non-serious events of Nasopharyngitis, Sneezing, Cough, and Covid-19. Patient experienced a head cold, sneezy, and slight cough, right after (unspecified date) the booster dose of mRNA-1273 (Moderna covid-19 vaccine); and tested positive (antigen test) for Covid-19 5 days after the booster dose.  The rechallenge was not applicable as events occurred after booster dose and details of previous doses were not reported/provided. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.