chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: INCREASED BLOOD PRESSURE; ARM WEAK; SEVERE RINGING; MASSIVE HEADACHE; ARM NUMB; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 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 increased blood pressure, arm weak, severe ringing, massive headache, and arm numb. Laboratory data included: Blood pressure (NR: not provided) increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased blood pressure, arm weak, severe ringing, massive headache, and arm numb on DEC-2021. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a parent concerned a 4 decade 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, 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. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FELT HORRIBLE; This spontaneous report received from a consumer concerned a 59 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, 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 felt horrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt horrible was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Fatigue, Feeling abnormal, Nausea
Clinical narrative: SHORT OF BREATH ON ACTIVITY LIKE WALKING; FELT SO BAD, CHANGED SO QUICK; FEVER/LOW GRADE FEVER; TIREDNESS; NAUSEA; VOMITING; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and intensive care unit (icu). 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 29-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced short of breath on activity like walking, felt so bad, changed so quick, fever/low grade fever, tiredness, nausea, and vomiting. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever/low grade fever, and short of breath on activity like walking, and the outcome of felt so bad, changed so quick, tiredness, nausea and vomiting was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: SHORT OF BREATH ON ACTIVITY LIKE WALKING; FELT SO BAD, CHANGED SO QUICK; FEVER/LOW GRADE FEVER; TIREDNESS; NAUSEA; VOMITING; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and intensive care unit (icu). 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 29-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced short of breath on activity like walking, felt so bad, changed so quick, fever/low grade fever, tiredness, nausea, and vomiting. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever/low grade fever, and short of breath on activity like walking, and the outcome of felt so bad, changed so quick, tiredness, nausea and vomiting was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Groin pain, Lymphadenopathy, Ultrasound scan
Clinical narrative: PAIN IN GROIN AREA; SWOLLEN LYMPH NODES/STOMACH SWELLING IN GROIN AREA (THINNER BUMP LIKE A LINE); This spontaneous report received from a patient concerned a 52 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: 211021A expiry: UNKNOWN) dose was not reported, administered on 27-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On DEC-2021, the patient experienced pain in groin area, and swollen lymph nodes/stomach swelling in groin area (thinner bump like a line). On 30-DEC-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) swollen lymph node in groin area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in groin area on DEC-2021, and the outcome of swollen lymph nodes/stomach swelling in groin area (thinner bump like a line) was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Erythema, Headache, Pyrexia
Clinical narrative: BURSITIS TYPE IRRITATION; HEADACHE IN THE BACK OF THE HEAD ON THE RIGHT SIDE ON THE BASE OF THE SKULL AND FELT LIKE PULSATING PAIN; REDNESS OF FACE; FEVER; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included: bursitis, and concurrent conditions included: allergy to antibiotics, environmental allergies, and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for environmental allergies, and allergies to antibiotics. On 07-APR-2021, the patient experienced redness of face, and fever. On 08-APR-2021, the patient experienced bursitis type irritation, and headache in the back of the head on the right side on the base of the skull and felt like pulsating pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bursitis type irritation, redness of face, and fever on 07-APR-2021, and headache in the back of the head on the right side on the base of the skull and felt like pulsating pain on 08-APR-2021. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Gait disturbance, Nodule, Pain in extremity
Clinical narrative: HURTS TO WALK; BOTH FEET HURT; BOTH HANDS HURT; BOTH ANKLES HURT; BUMP UNDER AND BEHIND LEFT EAR/BUMP ON NECK HURT WHEN TOUCHED; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: autism. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211021A, and expiry: UNKNOWN) dose was not reported, administered on 27-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-DEC-2021, the patient experienced bump under and behind left ear/bump on neck hurt when touched. On 27-DEC-2021, Laboratory data included: Blood test (NR: not provided) Unknown. On 30-DEC-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Unknown. On 01-JAN-2022, the patient experienced hurts to walk, both feet hurt, both hands hurt, and both ankles hurt.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bump under and behind left ear/bump on neck hurt when touched, and the outcome of both feet hurt, both hands hurt, hurts to walk and both ankles hurt was not reported. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: HURTS TO WALK; BOTH FEET HURT; BOTH HANDS HURT; BOTH ANKLES HURT; BUMP UNDER AND BEHIND LEFT EAR/BUMP ON NECK HURT WHEN TOUCHED; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: autism. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211021A, and expiry: UNKNOWN) dose was not reported, administered on 27-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-DEC-2021, the patient experienced bump under and behind left ear/bump on neck hurt when touched. On 27-DEC-2021, Laboratory data included: Blood test (NR: not provided) Unknown. On 30-DEC-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Unknown. On 01-JAN-2022, the patient experienced hurts to walk, both feet hurt, both hands hurt, and both ankles hurt.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bump under and behind left ear/bump on neck hurt when touched, and the outcome of both feet hurt, both hands hurt, hurts to walk and both ankles hurt was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Anxiety, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: HEART RACING/RAPID HEART RATE; SHORTNESS OF BREATH; ANXIOUS FOR MAY BE GETTING A BLOOD CLOT; UNUSUAL ABDOMINAL PAIN; FEELING LIGHTHEADED; TINGLING SENSATION OF ARMS & LEGS; FLU-LIKE SYMPTOMS (CHILLS, FEELING FEVERISH, FATIGUE); This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, and non-alcohol user, and other pre-existing medical conditions included: The patient has no known allergies and does not abuse or illicit drug usage. The patient does not consume any birth control medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, and batch number: 1855835 expiry: 27-APR-2022) dose was not reported, administered on 27-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-DEC-2021, the patient experienced flu-like symptoms (chills, feeling feverish, fatigue). On 01-JAN-2022, the patient experienced heart racing/rapid heart rate, shortness of breath, anxious for may be getting a blood clot, unusual abdominal pain, feeling lightheaded, and tingling sensation of arms & legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms (chills, feeling feverish, fatigue) on 29-DEC-2021, and had not recovered from heart racing/rapid heart rate, shortness of breath, anxious for may be getting a blood clot, unusual abdominal pain, tingling sensation of arms & legs, and feeling lightheaded. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Paraesthesia
Clinical narrative: HEART RACING/RAPID HEART RATE; SHORTNESS OF BREATH; ANXIOUS FOR MAY BE GETTING A BLOOD CLOT; UNUSUAL ABDOMINAL PAIN; FEELING LIGHTHEADED; TINGLING SENSATION OF ARMS & LEGS; FLU-LIKE SYMPTOMS (CHILLS, FEELING FEVERISH, FATIGUE); This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, and non-alcohol user, and other pre-existing medical conditions included: The patient has no known allergies and does not abuse or illicit drug usage. The patient does not consume any birth control medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, and batch number: 1855835 expiry: 27-APR-2022) dose was not reported, administered on 27-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-DEC-2021, the patient experienced flu-like symptoms (chills, feeling feverish, fatigue). On 01-JAN-2022, the patient experienced heart racing/rapid heart rate, shortness of breath, anxious for may be getting a blood clot, unusual abdominal pain, feeling lightheaded, and tingling sensation of arms & legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms (chills, feeling feverish, fatigue) on 29-DEC-2021, and had not recovered from heart racing/rapid heart rate, shortness of breath, anxious for may be getting a blood clot, unusual abdominal pain, tingling sensation of arms & legs, and feeling lightheaded. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Positron emission tomogram, Pulmonary mass, X-ray
Clinical narrative: FELT STRANGE TO TAKE A DEEP  BREATH IN; NODULE IN LEFT LUNG; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: severe asthma, and non smoker. 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 felt strange to take a deep breath in, and nodule in left lung. Laboratory data (dates unspecified) included: CT scan (not provided) Not reported, Not reported, PET scan (not provided) nodule in left lung, and X-ray (not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt strange to take a deep breath in and nodule in left lung was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: LINGERING PAIN INSIDE MY SHOULDER AREA, RADIATING OUTWARD; FEVERISH; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced lingering pain inside my shoulder area, radiating outward, and feverish. Treatment medications (dates unspecified) included: origanum minutiflorum oil. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lingering pain inside my shoulder area, radiating outward, and the outcome of feverish was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, COVID-19
Clinical narrative: I had a light case of the COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I had a light case of the COVID) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (I had a light case of the COVID). At the time of the report, COVID-19 (I had a light case of the COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 2400 (High) 2400.         No Concomitant product use was reported.  The patient had two Moderna shots and then they had a light case of the COVID. When the patient cheeked their antibodies checked, they were 2400. The patient wanted to check when the antibodies had to get down to before the booster shot.  No treatment information was provided.  Company comment This is a regulatory case concerning a 76-year-old female patient with no medical history reported, who experienced the non- serious event of special interest of COVID-19. The event occurred approximately on an unknown date after the second dose of mRNA-1273 (vaccination dates unknown). The rechallenge was assessed as not applicable as the AEs occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Although referred that COVID-19 is diagnosed being fully vaccinated, the information regarding the vaccination dates is incomplete so lack of efficacy situation cannot be properly assessed.; Sender's Comments: This is a regulatory case concerning a 76-year-old female patient with no medical history reported, who experienced the non- serious event of special interest of COVID-19. The event occurred approximately on an unknown date after the second dose of mRNA-1273 (vaccination dates unknown). The rechallenge was assessed as not applicable as the AEs occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Although referred that COVID-19 is diagnosed being fully vaccinated, the information regarding the vaccination dates is incomplete so lack of efficacy situation cannot be properly assessed.
Sex: F
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: Lost vision (one eye); This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Lost vision (one eye)) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS (Lost vision (one eye)) (seriousness criteria hospitalization and medically significant). At the time of the report, BLINDNESS (Lost vision (one eye)) outcome was unknown.            Concomitant medication were not reported. Hospitalized for two weeks and had administered with steroids.  Company Comment: This case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious event of Blindness. The event occurred on an unknown date after the second dose of mRNA-1273 Vaccine which resulted in hospitalization. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-419388, MOD-2021-423152, MOD-2021-423102 (Patient Link).; Sender's Comments: This case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious event of Blindness. The event occurred on an unknown date after the second dose of mRNA-1273 Vaccine which resulted in hospitalization. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Broke out with hives; itching; Rashes, Rash occurred on 11/22/21 and continues to be a huge problem everyday for me; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke out with hives), PRURITUS (itching) and RASH (Rashes, Rash occurred on 11/22/21 and continues to be a huge problem everyday for me) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .025 ml. On 22-Nov-2021, the patient experienced RASH (Rashes, Rash occurred on 11/22/21 and continues to be a huge problem everyday for me). On an unknown date, the patient experienced URTICARIA (Broke out with hives) and PRURITUS (itching). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Rash, at an unspecified dose and frequency. At the time of the report, URTICARIA (Broke out with hives) and PRURITUS (itching) outcome was unknown and RASH (Rashes, Rash occurred on 11/22/21 and continues to be a huge problem everyday for me) had not resolved.            No relevant concomitant medications were reported. Treatment information also included steroids to control the rash.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After first vaccination caller had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After first vaccination caller had a sore arm) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 23-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (After first vaccination caller had a sore arm). At the time of the report, PAIN IN EXTREMITY (After first vaccination caller had a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   This case was linked to MOD-2022-436414 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Fatigue, Pyrexia
Clinical narrative: Cough; He had no energy; Low grade fever; was feeling fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), ASTHENIA (He had no energy), PYREXIA (Low grade fever) and FATIGUE (was feeling fatigue) 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 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced COUGH (Cough), ASTHENIA (He had no energy), PYREXIA (Low grade fever) and FATIGUE (was feeling fatigue). At the time of the report, COUGH (Cough), ASTHENIA (He had no energy), PYREXIA (Low grade fever) and FATIGUE (was feeling fatigue) outcome was unknown.            No Concomitant product use was reported.  The patient post receiving their Moderna booster was having low grade fever and cough the next day. The patient had no energy and was feeling fatigue. The patient had not been seen by a doctor although they were planning to.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral
Clinical narrative: Lost vision (one eye); This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS UNILATERAL (Lost vision (one eye)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Brain tumor and Brain tumor operation (Removed when patient was 18).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS UNILATERAL (Lost vision (one eye)) (seriousness criteria hospitalization and medically significant). At the time of the report, BLINDNESS UNILATERAL (Lost vision (one eye)) outcome was unknown.            Concomitant medications were not provided. Treatment information includes steroids.  Patient was hospitalized for couple of weeks and no doctors could point out the causes. They said they can do nothing and gave patient steroid and asked them to go home. Reporter knew some people who had experienced same issue after 3-6 months of taking second vaccination. COMPANY COMMENT: This is an spontaneous case concerning an unknown-year-old female patient with clinical history  of Brain tumor removed who experienced the unexpected event of BLINDNESS UNILATERAL  The event occurred unknown days after second dose of mRNA-1273. The rechallenge was not applicable since only information about second dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-423102, MOD-2021-423139, MOD-2021-423152 (Patient Link).; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an unknown-year-old female patient with clinical history  of Brain tumor removed who experienced the unexpected event of BLINDNESS UNILATERAL  The event occurred unknown days after second dose of mRNA-1273. The rechallenge was not applicable since only information about second dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died the next day; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died the next day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on December 2021 The patient died in December 2021. The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medications were provided. No treatment medications were reported.  The patient took the booster shot about 4 days ago and died the next day. The paramedics found the patient sitting upright dead with an oxygen mask on. This fatal spontaneous case concerns an unknown year-old, patient with no medical history  who experienced the unexpected fatal events of DEATH The event occurred unknown days after third dose of Moderna Covid 19 vaccine. The cause of death was not reported. It is unknown if an autopsy was performed.    The rechallenge is not applicable The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This fatal spontaneous case concerns an unknown year-old, patient with no medical history  who experienced the unexpected fatal events of DEATH The event occurred unknown days after third dose of Moderna Covid 19 vaccine. The cause of death was not reported. It is unknown if an autopsy was performed.    The rechallenge is not applicable The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: My first dose was taken 32 days back and COVID positive was 14 days back; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (My first dose was taken 32 days back and COVID positive was 14 days back) 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 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced COVID-19 (My first dose was taken 32 days back and COVID positive was 14 days back). At the time of the report, COVID-19 (My first dose was taken 32 days back and COVID positive was 14 days back) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive and negative (Negative) after quarantine patient tested negative..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  This is a regulatory authority case concerning  a  patient of unknown age and gender with no relevant medical history, who experienced the non-serious event Covid-19. The event occurred approximately 32 days after the first dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event was reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a regulatory authority case concerning  a  patient of unknown age and gender with no relevant medical history, who experienced the non-serious event Covid-19. The event occurred approximately 32 days after the first dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event was reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: died of the Omicron variant 2-3 weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (died of the variant 2-3 weeks ago) 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 (died of the variant 2-3 weeks ago) (seriousness criterion death). The reported cause of death was died of the variant. It is unknown if an autopsy was performed.            Concomitant medications were not reported.  It was reported that one person died of the variant  2-3 weeks ago, even after getting the vaccine. Reporter does not have more information on this person.  Treatment details were not provided.; Sender's Comments: This case concerns a patient (demographics not provided) with no relevant medical history, who experienced the unexpected event of COVID-19 (variant) and resulted in death. The event occurred at unspecified interval after a dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after a dose and resulted in death. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) in not affected by this report.; Reported Cause(s) of Death: died of the variant
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID 19) 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 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2020, the patient experienced COVID-19 (COVID 19). At the time of the report, COVID-19 (COVID 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported.  Treatment medications was not reported.  This is a regulatory authority case concerning  a  male patient of unknown age with no relevant medical history, who experienced the non-serious events of Covid-19. The events occurred approximately on the same day after the first dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The events outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a regulatory authority case concerning  a  male patient of unknown age with no relevant medical history, who experienced the non-serious events of Covid-19. The events occurred approximately on the same day after the first dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The events outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot from Moderna Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot from Moderna Vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 THROMBOSIS (blood clot from Moderna Vaccine) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blood clot from Moderna Vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This report was received as the Regulatory Authority.   Concomitant medications were not reported.  Treatment medications were  not reported.  The co- suspect included two doses of Shingles vaccine manufacturer.   The patient got twice vaccinated with the shingles vaccine.  The patient took Moderna COVID-19 vaccine and had a blood clot.  The patient reports they are not kidding about the pain from Shingles.  Company comment: This case concerns a patient of an unknown age and gender, with no reported medical history, but with co-suspect drug Shingles vaccine, who experienced the serious, unexpected AESI event of thrombosis, on unknown date after unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine). The shingles vaccine may be a confounder to the event.  The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, with no reported medical history, but with co-suspect drug Shingles vaccine, who experienced the serious, unexpected AESI event of thrombosis, on unknown date after unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine). The shingles vaccine may be a confounder to the event.  The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications details were provided. No Treatment Medications details were provided.  This is a regulatory authority case concerning  a female patient of unknown age with no relevant medical history, who experienced the non-serious events of covid-19. The events occurred approximately on an unknown day after the first dose of mRNA-1273 COVID 19 Vaccine The rechallenge was not applicable, as the event happened after the first dose. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a regulatory authority case concerning  a female patient of unknown age with no relevant medical history, who experienced the non-serious events of covid-19. The events occurred approximately on an unknown day after the first dose of mRNA-1273 COVID 19 Vaccine The rechallenge was not applicable, as the event happened after the first dose. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive to COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive to COVID 19) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced COVID-19 (tested positive to COVID 19). At the time of the report, COVID-19 (tested positive to COVID 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. No treatment medications were reported This is a spontaneous case reported by a female consumer (no other patient details reported), with no medical history, who experienced the unexpected non serious AESI of COVID-19, 2 days after the first dose of mRNA-1273 vaccine given on 13 Jan 2021 with unknown route of administration.  The subject was tested positive to COVID 19 test on 15 Jan 2021, At the time of this report no concomitant medications and no treatment medications were reported. The outcome of the event was not reported. The consumer wanted to know if she can still receive her second shot scheduled on 10 FEB2021, after this event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 31-Dec-2021: Significant follow-up included Reluctant to give information, defensive.; Sender's Comments: This is a spontaneous case reported by a female consumer (no other patient details reported), with no medical history, who experienced the unexpected non serious AESI of COVID-19, 2 days after the first dose of mRNA-1273 vaccine given on 13 Jan 2021 with unknown route of administration.  The subject was tested positive to COVID 19 test on 15 Jan 2021, At the time of this report no concomitant medications and no treatment medications were reported. The outcome of the event was not reported. The consumer wanted to know if she can still receive her second shot scheduled on 10 FEB2021, after this event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Polyarthritis
Clinical narrative: after booster shoot she started experiencing inflammation in all her joints all over the body.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Dec-2021 and was forwarded to Moderna on 26-Dec-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (after booster shoot she started experiencing inflammation in all her joints all over the body.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (after booster shoot she started experiencing inflammation in all her joints all over the body.). At the time of the report, ARTHRITIS (after booster shoot she started experiencing inflammation in all her joints all over the body.) outcome was unknown.            Reporter states that concomitant medication includes blood pressure medication for high blood medication. Reporter states that treatment medication includes steroid medication.; Sender's Comments: This is a spontaneous case received from an unknown source, reported by a consumer, concerns a 81 year old elderly female with  no relevant medical history, who experienced the unexpected non serious AESI of Polyarthritis, after the booster dose of mRNA-1273 vaccine given on 11 Nov 2021 . The route of administration, dose of the vaccine , onset date and time of the event was not reported. As per the reporter, after the booster shot, she started experiencing inflammation in all her joints all over the body. Concomitant medications included Blood pressure medications. Steroids were given as treatment medications for the event. The outcome of the event was not reported. The reporter did not provide any causality assessment for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: loss of smell; loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss of smell) and AGEUSIA (loss of taste) 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 ANOSMIA (loss of smell) and AGEUSIA (loss of taste). At the time of the report, ANOSMIA (loss of smell) and AGEUSIA (loss of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  This is a regulatory authority case concerning  a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected non-serious events of  Anosmia and Ageusia. The events occurred approximately on an unknown day after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as information about further dosing was not disclosed. The events outcome were reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a regulatory authority case concerning  a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected non-serious events of  Anosmia and Ageusia. The events occurred approximately on an unknown day after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as information about further dosing was not disclosed. The events outcome were reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Contracted COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Contracted COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Contracted COVID). At the time of the report, COVID-19 (Contracted COVID) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. The patient was scheduled for second Moderna vaccine on 10-Feb-2021.  This is a regulatory authority case concerning  a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected non-serious events of Covid-19. The events occurred approximately on an unknown day after the first dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The events were reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a regulatory authority case concerning  a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected non-serious events of Covid-19. The events occurred approximately on an unknown day after the first dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The events were reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.