chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Seizure
Clinical narrative: Pt received her 2nd Moderna COVID 19 vaccine on 4/16/2021. She has a history of crohn's disease with ileostomy managed with over the counter vit D and immodium and chronic kidney disease. She was admitted to the hospital on 6/29/21 with a witnessed, new onset seizure. Her MRI brain and CT brain were negative. EKG normal, glucose was normal. magnesium was normal, cbc and cmp were normal. She does not use alcohol or smoke or use drugs. She had no recent illness or infection. she had no fever and normal vital signs. She was on no new medication or over the counter medication or supplements. She arrived with a lip laceration and significant bilateral tongue bruising. She was discharged home on 6/20/21 to follow up with neurology for an EEG as EEG was not available while hospitalized. She has never had a seizure in her life. Neurology was consulted and did not recommend anti seizure medication at this time.
Age: 90.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Died of COVID-19 illness on 04/11/2021
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fatigue 2 hours after vaccine  Fever 101.2 ? 6:20 am 7/9/2021
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Dyspnoea, Fatigue, SARS-CoV-2 test positive
Clinical narrative: Died of COVID-19 on 05/26/2021 Symptoms: Dyspnea (shortness of breath), Fatigue
Age: 74.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster-related conditions; shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 76-year-old patient (pt) of unknown gender. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 08-AUG-2019, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster-related conditions. The outcome of the events was not provided. The relatedness between the events and zoster vaccine live (ZOSTAVAX) was related.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Reaction to preservatives
Clinical narrative: Broke out in a rash for about 2 weeks; Dr said I was allergic to the preservative in the shot; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced rash and reaction to vaccine preservatives. On an unknown date, the outcome of the rash and reaction to vaccine preservatives were recovered/resolved.   It was unknown if the reporter considered the rash and reaction to vaccine preservatives to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The patient received Shingles vaccine and broke out in a rash for about two weeks. The patient's family doctor said that the patient was allergic to the preservative in the shot.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: given a dose of Boostrix/nonviable after a temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5E43J, expiry date 30th August 2022) for prophylaxis.   On 25th June 2021, the patient received Boostrix. On 25th June 2021, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional case details were reported as follows: The patient was given a dose of Boostrix that was deemed nonviable after a temperature excursion, which led to incorrect storage of drug.  No symptoms reported. The reporter consented to follow up. This case was 4th from 6 case reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021142813:Same reporter US-GLAXOSMITHKLINE-US2021142812:Same reporter US-GLAXOSMITHKLINE-US2021142815:Same reporter US-GLAXOSMITHKLINE-US2021142817:Same reporter US-GLAXOSMITHKLINE-US2021142818:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node on armpit; This case was reported by a consumer via call center representative and described the occurrence of axillary lymph nodes enlarged in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced axillary lymph nodes enlarged. On an unknown date, the outcome of the axillary lymph nodes enlarged was unknown.   It was unknown if the reporter considered the axillary lymph nodes enlarged to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's mother. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced swollen lymph node on armpit. The reporter did not give a consent to follow-up.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Pulmonary thrombosis, Thrombosis
Clinical narrative: BLOOD CLOTS (RIGHT HAND AND LEFT LOWER LEG); BLOOD CLOT IN THE LUNGS; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's past medical history included lung cancer, tumor removal surgery, four chemotherapy sessions, and surgery to remove the blood clots, and concurrent conditions included non-smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: unknown) dose was not reported, 1 total administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-MAY-2021, the patient developed blood clot in the lungs was reported.  On 14-MAY-2021, (three days after) the patient experienced shortness of breath was reported.  On 20-MAY-2021 went to Emergency room (ER) and was subsequently admitted to Intensive Care Unit (ICU).  On 21-MAY-2021, the patient underwent through surgery to remove the blood clots on the lungs along with this on same day patient developed swelling of left leg and right arm was reported.  On 22-MAY-2021, the patient developed blood clot right hand and left lower leg.  On 29-JUN-2021, patient underwent through laboratory test included: Computed tomography (CAT) scan revealed negative for blood clots. It was also stated that patient was on Eliquis (apixaban) for anticoagulation due to blood clots. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clot in the lungs on 21-MAY-2021, and had not recovered from blood clots (right hand and left lower leg). This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210702546-Covid 19 Vaccine ad26.cov2.s-  Blood clots in the lungs, Blood clot (right hand and left lower leg). 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: MEDICAL HISTORY
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Gastroenteritis viral, Injection site erythema, Injection site irritation, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report received from a physician concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included anaphylactic shock (black widow bite), and concurrent conditions included allergy to scallops, and allergy to insect bite. The patient had no allergies to medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported,1 total, administered on 18-MAY-2021 10:00 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 18-MAY-2021, the patient felt some redness, irritation, warmth and soreness at injection site for about an hour afterwards and also experienced a brief fever from 18:00 on the day of vaccination which disappeared by the next morning. The patient also had some intestinal flu symptoms, muscle cramps and triple urinary output for about 72 hours post vaccination and he mentioned that the muscle cramps started around injection site and moved gradually down until it reached his lower extremities. Patient also experienced narcolepsy and said that the episodes would last either 90 minutes or 3 hours and would happen periodically for about 60 hours post vaccination and patient also said narcolepsy episodes would show up without any warning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from narcolepsy, muscle cramps started around injection site and moved gradually down to lower extremities, intestinal flu symptoms, and triple urinary output on 21-MAY-2021, injection site irritation, injection site warmth, injection site soreness, and injection site redness on 18-MAY-2021, and fever on 19-MAY-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210708286-covid-19 vaccine ad26.cov2.s-narcolepsy. 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).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Narcolepsy, Pyrexia, Urine output increased
Clinical narrative: This spontaneous report received from a physician concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included anaphylactic shock (black widow bite), and concurrent conditions included allergy to scallops, and allergy to insect bite. The patient had no allergies to medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported,1 total, administered on 18-MAY-2021 10:00 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 18-MAY-2021, the patient felt some redness, irritation, warmth and soreness at injection site for about an hour afterwards and also experienced a brief fever from 18:00 on the day of vaccination which disappeared by the next morning. The patient also had some intestinal flu symptoms, muscle cramps and triple urinary output for about 72 hours post vaccination and he mentioned that the muscle cramps started around injection site and moved gradually down until it reached his lower extremities. Patient also experienced narcolepsy and said that the episodes would last either 90 minutes or 3 hours and would happen periodically for about 60 hours post vaccination and patient also said narcolepsy episodes would show up without any warning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from narcolepsy, muscle cramps started around injection site and moved gradually down to lower extremities, intestinal flu symptoms, and triple urinary output on 21-MAY-2021, injection site irritation, injection site warmth, injection site soreness, and injection site redness on 18-MAY-2021, and fever on 19-MAY-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210708286-covid-19 vaccine ad26.cov2.s-narcolepsy. 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).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Bilirubin conjugated, Blood alkaline phosphatase, Blood bilirubin
Clinical narrative: Acute hepatitis; Fatigue; Diarrhea; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HEPATITIS ACUTE (Acute hepatitis) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEPATITIS ACUTE (Acute hepatitis) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) and FATIGUE (Fatigue). At the time of the report, HEPATITIS ACUTE (Acute hepatitis) was resolving, DIARRHOEA (Diarrhea) had resolved and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2021, Alanine aminotransferase: 653 (Inconclusive) 653. On 29-Jun-2021, Aspartate aminotransferase: 283 (Inconclusive) 283. On 29-Jun-2021, Bilirubin conjugated: 0.3 (Inconclusive) 0.3. On 29-Jun-2021, Blood alkaline phosphatase: 90 (normal) 90. On 29-Jun-2021, Blood bilirubin: 1.3 (Inconclusive) Gilbert's. On 29-Jun-2021, International normalised ratio: 1.03 (Inconclusive) 1.03. On 29-Jun-2021, Ultrasound liver: abnormal (abnormal) +ANA chronic for years , low suspicion. On an unknown date, Alanine aminotransferase: high (High) 20 -> 250 -> 950. On an unknown date, Aspartate aminotransferase: high (High) 20 -> 147 -> 256. On an unknown date, Blood bilirubin: 1.2 (Inconclusive) 1.2. On an unknown date, International normalised ratio: <1.2 (Inconclusive) <1.2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other laboratory included  test for Acute hepatitis- Negative for Hep A/B/C , IgG Treatment information was not provided. The physician reported that previous labs suggest underlying Gilbert's  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Hepatitis acute, International normalised ratio, Ultrasound liver
Clinical narrative: Acute hepatitis; Fatigue; Diarrhea; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HEPATITIS ACUTE (Acute hepatitis) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEPATITIS ACUTE (Acute hepatitis) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) and FATIGUE (Fatigue). At the time of the report, HEPATITIS ACUTE (Acute hepatitis) was resolving, DIARRHOEA (Diarrhea) had resolved and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2021, Alanine aminotransferase: 653 (Inconclusive) 653. On 29-Jun-2021, Aspartate aminotransferase: 283 (Inconclusive) 283. On 29-Jun-2021, Bilirubin conjugated: 0.3 (Inconclusive) 0.3. On 29-Jun-2021, Blood alkaline phosphatase: 90 (normal) 90. On 29-Jun-2021, Blood bilirubin: 1.3 (Inconclusive) Gilbert's. On 29-Jun-2021, International normalised ratio: 1.03 (Inconclusive) 1.03. On 29-Jun-2021, Ultrasound liver: abnormal (abnormal) +ANA chronic for years , low suspicion. On an unknown date, Alanine aminotransferase: high (High) 20 -> 250 -> 950. On an unknown date, Aspartate aminotransferase: high (High) 20 -> 147 -> 256. On an unknown date, Blood bilirubin: 1.2 (Inconclusive) 1.2. On an unknown date, International normalised ratio: <1.2 (Inconclusive) <1.2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other laboratory included  test for Acute hepatitis- Negative for Hep A/B/C , IgG Treatment information was not provided. The physician reported that previous labs suggest underlying Gilbert's  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Gait disturbance, Hypogeusia, Hyposmia
Clinical narrative: Pain was so excruciating and so bad that she couldn't walk; Going from a sitting to a standing position is hard; Half way taste and smell things; Half way taste and smell things; Inappropriate schedule of vaccine administered; Left knee started to feel really bad; Fever; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Pain was so excruciating and so bad that she couldn't walk) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee arthritis and Thyroid disorder. Concomitant products included THYROID (ARMOUR THYROID) for Knee arthritis.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced ARTHRALGIA (Left knee started to feel really bad) and PYREXIA (Fever). On an unknown date, the patient experienced GAIT DISTURBANCE (Pain was so excruciating and so bad that she couldn't walk) (seriousness criterion hospitalization), MOBILITY DECREASED (Going from a sitting to a standing position is hard), HYPOGEUSIA (Half way taste and smell things), HYPOSMIA (Half way taste and smell things) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was hospitalized from 22-Jun-2021 to 23-Jun-2021 due to GAIT DISTURBANCE. At the time of the report, GAIT DISTURBANCE (Pain was so excruciating and so bad that she couldn't walk), MOBILITY DECREASED (Going from a sitting to a standing position is hard), HYPOGEUSIA (Half way taste and smell things), HYPOSMIA (Half way taste and smell things), ARTHRALGIA (Left knee started to feel really bad) and PYREXIA (Fever) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: (High) during the evening and like 99 degrees or 99 something. On an unknown date, Ultrasound scan: Inconclusive.         No treatment information was reported. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-035733 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Mobility decreased, Pyrexia, Ultrasound scan
Clinical narrative: Pain was so excruciating and so bad that she couldn't walk; Going from a sitting to a standing position is hard; Half way taste and smell things; Half way taste and smell things; Inappropriate schedule of vaccine administered; Left knee started to feel really bad; Fever; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Pain was so excruciating and so bad that she couldn't walk) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee arthritis and Thyroid disorder. Concomitant products included THYROID (ARMOUR THYROID) for Knee arthritis.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced ARTHRALGIA (Left knee started to feel really bad) and PYREXIA (Fever). On an unknown date, the patient experienced GAIT DISTURBANCE (Pain was so excruciating and so bad that she couldn't walk) (seriousness criterion hospitalization), MOBILITY DECREASED (Going from a sitting to a standing position is hard), HYPOGEUSIA (Half way taste and smell things), HYPOSMIA (Half way taste and smell things) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was hospitalized from 22-Jun-2021 to 23-Jun-2021 due to GAIT DISTURBANCE. At the time of the report, GAIT DISTURBANCE (Pain was so excruciating and so bad that she couldn't walk), MOBILITY DECREASED (Going from a sitting to a standing position is hard), HYPOGEUSIA (Half way taste and smell things), HYPOSMIA (Half way taste and smell things), ARTHRALGIA (Left knee started to feel really bad) and PYREXIA (Fever) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: (High) during the evening and like 99 degrees or 99 something. On an unknown date, Ultrasound scan: Inconclusive.         No treatment information was reported. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-035733 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Muscle spasms, Peripheral swelling, Pulmonary embolism, Thrombosis
Clinical narrative: Deep vein thrombosis leg; PULMONARY EMBOLISM; BLOOD CLOT; MUSCLE CRAMP; SWELLON LEG; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (PULMONARY EMBOLISM), THROMBOSIS (BLOOD CLOT) and DEEP VEIN THROMBOSIS (Deep vein thrombosis leg) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced MUSCLE SPASMS (MUSCLE CRAMP) and PERIPHERAL SWELLING (SWELLON LEG). On an unknown date, the patient experienced PULMONARY EMBOLISM (PULMONARY EMBOLISM) (seriousness criterion medically significant), THROMBOSIS (BLOOD CLOT) (seriousness criterion medically significant) and DEEP VEIN THROMBOSIS (Deep vein thrombosis leg) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN (XARELTO) at a dose of UNK, qd. At the time of the report, PULMONARY EMBOLISM (PULMONARY EMBOLISM), THROMBOSIS (BLOOD CLOT), DEEP VEIN THROMBOSIS (Deep vein thrombosis leg), MUSCLE SPASMS (MUSCLE CRAMP) and PERIPHERAL SWELLING (SWELLON LEG) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Influenza like illness, Myalgia, Neuralgia
Clinical narrative: progressively worsened; pins and needles in her toes/Pins and needles have traveled to her hand and progressively worsened with each week; nerve pain; complete severe inflammatory red rash all over body; Burning rash all over her face; flu-like symptoms; body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (pins and needles in her toes/Pins and needles have traveled to her hand and progressively worsened with each week), CONDITION AGGRAVATED (progressively worsened), RASH ERYTHEMATOUS (complete severe inflammatory red rash all over body) and RASH (Burning rash all over her face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), MYALGIA (body aches) and HEADACHE (Headache). On 05-May-2021, the patient experienced PARAESTHESIA (pins and needles in her toes/Pins and needles have traveled to her hand and progressively worsened with each week) (seriousness criteria hospitalization and disability), RASH ERYTHEMATOUS (complete severe inflammatory red rash all over body) (seriousness criterion disability) and RASH (Burning rash all over her face) (seriousness criterion disability). On 12-Jun-2021, the patient experienced NEURALGIA (nerve pain). On an unknown date, the patient experienced CONDITION AGGRAVATED (progressively worsened) (seriousness criterion hospitalization). The patient was treated with GABAPENTIN ongoing since an unknown date for Nerve pain, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (pins and needles in her toes/Pins and needles have traveled to her hand and progressively worsened with each week), CONDITION AGGRAVATED (progressively worsened), RASH (Burning rash all over her face), INFLUENZA LIKE ILLNESS (flu-like symptoms), NEURALGIA (nerve pain), MYALGIA (body aches) and HEADACHE (Headache) outcome was unknown and RASH ERYTHEMATOUS (complete severe inflammatory red rash all over body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rash, Rash erythematous
Clinical narrative: progressively worsened; pins and needles in her toes/Pins and needles have traveled to her hand and progressively worsened with each week; nerve pain; complete severe inflammatory red rash all over body; Burning rash all over her face; flu-like symptoms; body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (pins and needles in her toes/Pins and needles have traveled to her hand and progressively worsened with each week), CONDITION AGGRAVATED (progressively worsened), RASH ERYTHEMATOUS (complete severe inflammatory red rash all over body) and RASH (Burning rash all over her face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), MYALGIA (body aches) and HEADACHE (Headache). On 05-May-2021, the patient experienced PARAESTHESIA (pins and needles in her toes/Pins and needles have traveled to her hand and progressively worsened with each week) (seriousness criteria hospitalization and disability), RASH ERYTHEMATOUS (complete severe inflammatory red rash all over body) (seriousness criterion disability) and RASH (Burning rash all over her face) (seriousness criterion disability). On 12-Jun-2021, the patient experienced NEURALGIA (nerve pain). On an unknown date, the patient experienced CONDITION AGGRAVATED (progressively worsened) (seriousness criterion hospitalization). The patient was treated with GABAPENTIN ongoing since an unknown date for Nerve pain, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (pins and needles in her toes/Pins and needles have traveled to her hand and progressively worsened with each week), CONDITION AGGRAVATED (progressively worsened), RASH (Burning rash all over her face), INFLUENZA LIKE ILLNESS (flu-like symptoms), NEURALGIA (nerve pain), MYALGIA (body aches) and HEADACHE (Headache) outcome was unknown and RASH ERYTHEMATOUS (complete severe inflammatory red rash all over body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Afib; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (Afib) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ATRIAL FIBRILLATION (Afib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (Afib) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-244772 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Hypertensive crisis, Pericarditis
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PERICARDITIS (Seen a lot of pericarditis cases in both young and old people) and HYPERTENSIVE CRISIS (Seeing more cases of a hypertensive crisis) 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 PERICARDITIS (Seen a lot of pericarditis cases in both young and old people) (seriousness criterion medically significant) and HYPERTENSIVE CRISIS (Seeing more cases of a hypertensive crisis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (Seen a lot of pericarditis cases in both young and old people) and HYPERTENSIVE CRISIS (Seeing more cases of a hypertensive crisis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis
Clinical narrative: Died with a blood clot in her brain; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL THROMBOSIS (Died with a blood clot in her brain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBRAL THROMBOSIS (Died with a blood clot in her brain) (seriousness criteria death and medically significant). The reported cause of death was died with a blood clot in her brain. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company Comment: Very limited information on this fatal case. However, based on the current available information and  assumed temporal association between the use of the unspecified Moderna Vaccine product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Very limited information on this fatal case. However, based on the current available information and  assumed temporal association between the use of the unspecified Moderna Vaccine product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Died with a blood clot in her brain
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Dyspnoea, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Patient felt like she was going to pass out; hypotension; Patient had trouble breathing; Patient became dizzy; Patient became numb; Patient's lips turned blue and grey; Patient started to sweat; Tingling feeling in throat, tingling in body; Stabbing feelings in her throat; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Patient felt like she was going to pass out), HYPOTENSION (hypotension), DYSPNOEA (Patient had trouble breathing), DIZZINESS (Patient became dizzy) and HYPOAESTHESIA (Patient became numb) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRESYNCOPE (Patient felt like she was going to pass out), HYPOTENSION (hypotension), DYSPNOEA (Patient had trouble breathing), DIZZINESS (Patient became dizzy), HYPOAESTHESIA (Patient became numb), LIP DISCOLOURATION (Patient's lips turned blue and grey), HYPERHIDROSIS (Patient started to sweat), PARAESTHESIA (Tingling feeling in throat, tingling in body) and OROPHARYNGEAL PAIN (Stabbing feelings in her throat). At the time of the report, PRESYNCOPE (Patient felt like she was going to pass out), HYPOTENSION (hypotension), DYSPNOEA (Patient had trouble breathing), DIZZINESS (Patient became dizzy), HYPOAESTHESIA (Patient became numb), LIP DISCOLOURATION (Patient's lips turned blue and grey), HYPERHIDROSIS (Patient started to sweat), PARAESTHESIA (Tingling feeling in throat, tingling in body) and OROPHARYNGEAL PAIN (Stabbing feelings in her throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: (Low) Blood pressure dropped.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information is not expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information is not expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Lip discolouration, Oropharyngeal pain, Paraesthesia, Presyncope
Clinical narrative: Patient felt like she was going to pass out; hypotension; Patient had trouble breathing; Patient became dizzy; Patient became numb; Patient's lips turned blue and grey; Patient started to sweat; Tingling feeling in throat, tingling in body; Stabbing feelings in her throat; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Patient felt like she was going to pass out), HYPOTENSION (hypotension), DYSPNOEA (Patient had trouble breathing), DIZZINESS (Patient became dizzy) and HYPOAESTHESIA (Patient became numb) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRESYNCOPE (Patient felt like she was going to pass out), HYPOTENSION (hypotension), DYSPNOEA (Patient had trouble breathing), DIZZINESS (Patient became dizzy), HYPOAESTHESIA (Patient became numb), LIP DISCOLOURATION (Patient's lips turned blue and grey), HYPERHIDROSIS (Patient started to sweat), PARAESTHESIA (Tingling feeling in throat, tingling in body) and OROPHARYNGEAL PAIN (Stabbing feelings in her throat). At the time of the report, PRESYNCOPE (Patient felt like she was going to pass out), HYPOTENSION (hypotension), DYSPNOEA (Patient had trouble breathing), DIZZINESS (Patient became dizzy), HYPOAESTHESIA (Patient became numb), LIP DISCOLOURATION (Patient's lips turned blue and grey), HYPERHIDROSIS (Patient started to sweat), PARAESTHESIA (Tingling feeling in throat, tingling in body) and OROPHARYNGEAL PAIN (Stabbing feelings in her throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: (Low) Blood pressure dropped.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information is not expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information is not expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pemphigoid
Clinical narrative: This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of PEMPHIGOID (Bullous pemphigoid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In April 2021, the patient experienced PEMPHIGOID (Bullous pemphigoid) (seriousness criterion medically significant). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, PEMPHIGOID (Bullous pemphigoid) outcome was unknown and EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were  provided by the reporter. No treatment information was provided.  Company Comment  Very limited information regarding the events has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Product dose omission issue
Clinical narrative: Heart Problems; Has Not Received the Second Dose 6 months after First dose; This spontaneous case was reported by a pharmacist and describes the occurrence of CARDIAC DISORDER (Heart Problems) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced CARDIAC DISORDER (Heart Problems) (seriousness criterion hospitalization). On 02-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has Not Received the Second Dose 6 months after First dose). On 30-Jun-2021, CARDIAC DISORDER (Heart Problems) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has Not Received the Second Dose 6 months after First dose) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  After first dose, patient had Heart Problems and she was hospitalized. She had issues for a long time and did not receive the second shot. Pharmacist does not know the details of the heart problems.  Company comment: There is not enough information to assess the event of cardiac disorder although a temporal association exist between the event  and mRNA-1273 use as the disorder was not specified and the patient's medical history and concomitant medication details are lacking.  Additional information has been requested. The event of has not received the second dose 6 months after first dose is assessed as not applicable.; Sender's Comments: There is not enough information to assess the event of cardiac disorder although a temporal association exist between the event  and mRNA-1273 use as the disorder was not specified and the patient's medical history and concomitant medication details are lacking.  Additional information has been requested. The event of has not received the second dose 6 months after first dose is assessed as not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Myalgia
Clinical narrative: Pain in heart; Pain in left arm; This spontaneous case was reported by a patient and describes the occurrence of ANGINA PECTORIS (Pain in heart) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (Pain in heart) (seriousness criterion medically significant) and MYALGIA (Pain in left arm). At the time of the report, ANGINA PECTORIS (Pain in heart) and MYALGIA (Pain in left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient stated that he was having pain in his heart and left arm after receiving the Moderna COVID 19 vaccine. The patient declined to provide additional information.  No concomitant medication was provided by the reporter.  No treatment information was reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.