chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer concerned two patients unspecified age and sex. This report received via social media.. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that two people died recently after the vaccine. The cause of death was unknown. It was unspecified if an autopsy was performed The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: -covid-19 vaccine ad26.cov2.s-death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Platelet count, Platelet count decreased, Spinal cord haematoma
Clinical narrative: LARGE SPINAL HEMATOMA; PLATELETS DROPPED FROM 14 TO 7; This spontaneous self-report was received from a patient who is a nurse and a 70 year old female. The patient's height and weight were not reported. The patient was not pregnant at the time of event reporting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, expiry: unknown) dose was not reported, administered on right deltoid muscle on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, the patient had a planned surgery (decompression fusion).  On 13-MAR-2021, the patient had a horrible pain and magnetic resonance imaging (MRI) scan revealed that she had large spinal hematoma. On 15-MAR-2021, hematoma was drained "(3 units of blood)". At the time of this report, the patient still had a little bump and her platelets dropped from 14 to 7. The patient was discharged on 21-MAR-2021; treatment details were not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from large spinal hematoma, and the outcome of platelets dropped from 14 to 7 was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 This report concerns a 70-year-old female patient who had a spinal hematoma, 3 days after a planned surgery and 4 days after receiving Janssen COVID-19 vaccine.  One day after vaccination, the patient had the planned decompression fusion. Three days after surgery (4 days after vaccination), the patient had a severe pain and MRI revealed a large spinal hematoma. Two days after, hematoma was drained ("3 units of blood").  Patient's platelet counts dropped from "14 to 7" (unit not specified). The patient was discharged from the hospital six days later.  Although spinal surgery is the risk factor for hematoma, based on the close temporal relationship, the causality for the events is considered plausible for vaccine. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: IDIOPATHIC THROMBOCYTOPENIC PURPURA; This spontaneous report received from a consumer/other non-health professional concerned a female patient of unspecified age. On 22-APR-2021 and on 23-APR-2021, the patient was called, unable to reach the reporter. The voicemail was left for reporter. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, frequency once total, 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, laboratory data included: Idiopathic thrombocytopenic purpura (NR: not provided) recently diagnosed with rare blood disease ITP. Reporter stated that after administration of covid-19 vaccine, she experienced rare blood disease that was idiopathic thrombocytopenic purpura.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of idiopathic thrombocytopenic purpura was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: A female patient of unspecified age experienced idiopathic thrombocytopenic purpura an unknown time after vaccine. No additional information was reported including medical history, concomitant medications, family history, or event history. There is insufficient information to make a meaningful medical assessment. Additional information has been requested including attempted contact with patient.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Blood test, Breast pain, Chest pain
Clinical narrative: WHEN TAKEN DEEP BREATH LEFT  PAIN INSIDE OF THE LEFT BREAST (CENTER OF CHEST); CHEST PAIN, SORENESS OF CHEST; LOWER BACK PAIN; SORE ARM; MILD HEADACHE; FATIGUE; MILD ABDOMINAL DISCOMFORMT (SIDE STITCH) ON LEFT SIDE TO  RIGHT; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Blood test (NR: not provided) platelets were normal. On APR-2021, treatment medications included: naproxen sodium. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced mild headache. On 09-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced lower back pain. On 17-APR-2021, the subject experienced chest pain, soreness of chest. On 17-APR-2021, the subject experienced when taken deep breath left pain inside of the left breast (center of chest). On APR-2021, the subject experienced mild abdominal discomformt (side stitch) on left side to right. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lower back pain on 10-APR-2021, when taken deep breath left pain inside of the left breast (center of chest) on 17-APR-2021, and sore arm, and mild headache on APR-2021, and had not recovered from chest pain, soreness of chest, fatigue, and mild abdominal discomformt (side stitch) on left side to right. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: WHEN TAKEN DEEP BREATH LEFT  PAIN INSIDE OF THE LEFT BREAST (CENTER OF CHEST); CHEST PAIN, SORENESS OF CHEST; LOWER BACK PAIN; SORE ARM; MILD HEADACHE; FATIGUE; MILD ABDOMINAL DISCOMFORMT (SIDE STITCH) ON LEFT SIDE TO  RIGHT; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Blood test (NR: not provided) platelets were normal. On APR-2021, treatment medications included: naproxen sodium. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced mild headache. On 09-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced lower back pain. On 17-APR-2021, the subject experienced chest pain, soreness of chest. On 17-APR-2021, the subject experienced when taken deep breath left pain inside of the left breast (center of chest). On APR-2021, the subject experienced mild abdominal discomformt (side stitch) on left side to right. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lower back pain on 10-APR-2021, when taken deep breath left pain inside of the left breast (center of chest) on 17-APR-2021, and sore arm, and mild headache on APR-2021, and had not recovered from chest pain, soreness of chest, fatigue, and mild abdominal discomformt (side stitch) on left side to right. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gastrointestinal disorder, Headache, Pain
Clinical narrative: PROBLEMS IN BOWEL AREA; BODY ACHE; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced problems in bowel area. On APR-2021, the subject experienced body ache. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, body ache, problems in bowel area and fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain
Clinical narrative: BODY ACHES; HEADACHE; FATIGUE; SORE MUSCLES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced sore muscles. On 15-APR-2021, the subject experienced body aches. On 15-APR-2021, the subject experienced headache. On 15-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore muscles on APR-2021, and had not recovered from headache, fatigue, and body aches. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abnormal faeces, Body temperature, Contusion, Decreased appetite, Erythema
Clinical narrative: VOMITING; DECREASED APPETITE; 106 DEGREE FAHRENHEIT (F) FEVER; FATIGUE; STOOL ODOUR ABNORMAL; REDNESS OF LEGS; BRUISING OF LEG; PYLORIC SPHINCTER INSUFFICIENCY; PSORIASIS; This spontaneous report received from a consumer concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe adult crohn's disease.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1139170) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. No concomitant medications were reported.  On APR-2021, the subject experienced stool odour abnormal. On APR-2021, the subject experienced redness of legs. On APR-2021, the subject experienced bruising of leg. On APR-2021, the subject experienced pyloric sphincter insufficiency. On APR-2021, the subject experienced psoriasis. On APR-2021, the subject experienced 106 degree fahrenheit (f) fever. On APR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 106 F. On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced decreased appetite.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, had not recovered from stool odour abnormal, redness of legs, bruising of leg, pyloric sphincter insufficiency, and psoriasis, and the outcome of 106 degree fever, vomiting and decreased appetite was not reported. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Psoriasis, Pyloric sphincter insufficiency, Pyrexia, Vomiting
Clinical narrative: VOMITING; DECREASED APPETITE; 106 DEGREE FAHRENHEIT (F) FEVER; FATIGUE; STOOL ODOUR ABNORMAL; REDNESS OF LEGS; BRUISING OF LEG; PYLORIC SPHINCTER INSUFFICIENCY; PSORIASIS; This spontaneous report received from a consumer concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe adult crohn's disease.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1139170) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. No concomitant medications were reported.  On APR-2021, the subject experienced stool odour abnormal. On APR-2021, the subject experienced redness of legs. On APR-2021, the subject experienced bruising of leg. On APR-2021, the subject experienced pyloric sphincter insufficiency. On APR-2021, the subject experienced psoriasis. On APR-2021, the subject experienced 106 degree fahrenheit (f) fever. On APR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 106 F. On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced decreased appetite.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, had not recovered from stool odour abnormal, redness of legs, bruising of leg, pyloric sphincter insufficiency, and psoriasis, and the outcome of 106 degree fever, vomiting and decreased appetite was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20210438448, 20210437846 and 20210438524.
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Illness
Clinical narrative: SICKNESS; BLOOD PRESSURE HIGH; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sickness, and blood pressure high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sickness and blood pressure high was not reported. This report was non-serious. This case, from the same reporter is linked to 20210436063.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dyspnoea, Wheezing
Clinical narrative: DIFFICULTY BREATHING/HARD TIME BREATHING; COUGHING; CHEST PAIN; WHEEZING; This spontaneous report received from a parent concerned a 21 year old male. The patient's weight was 180 pounds, and height was 70 inches. The patient's past medical history included untreated pneumonia during childhood, and concurrent conditions included lungs not in great shape, no alcohol use, and no smoking, and other pre-existing medical conditions included the patient had not known any drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced wheezing. On 30-MAR-2021, the subject experienced difficulty breathing/hard time breathing. On 30-MAR-2021, the subject experienced coughing. On 30-MAR-2021, the subject experienced chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty breathing/hard time breathing, wheezing, coughing, and chest pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Coronavirus test, Fatigue, Headache, Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included penicillin allergy, and concurrent conditions included hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced fatigue, headache, and flu like symptoms. Laboratory data (dates unspecified) included: Coronavirus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, headache, and flu like symptoms. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: ACHES; SHORT OF BREATH; CHILLS; HEADACHE; EXTREME FATIGUE; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced aches. On APR-2021, the subject experienced short of breath. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced extreme fatigue. Laboratory data included: Blood test (NR: not provided) NORMAL, and Scan (NR: not provided) NORMAL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the aches, headache, chills, short of breath and extreme fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Scan
Clinical narrative: ACHES; SHORT OF BREATH; CHILLS; HEADACHE; EXTREME FATIGUE; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced aches. On APR-2021, the subject experienced short of breath. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced extreme fatigue. Laboratory data included: Blood test (NR: not provided) NORMAL, and Scan (NR: not provided) NORMAL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the aches, headache, chills, short of breath and extreme fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Eye pruritus, Influenza like illness, Lacrimation increased, Oxygen saturation
Clinical narrative: LOSS OF TASTE; SORE ARM BY THE ROTATOR CUFF; FLU/ALLERGY LIKE SYMPTOMS/COUGH/HEADACHE/SORE THROAT/TIREDNESS; SNEEZING; EYE WERE RUNNING; ITCHY EYES; ITCHY EARS; SCRATCHY THROAT; POST NASAL DRIP; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included kidney stones, and covid-19 test positive, and concurrent conditions included sinusitis. The patient was previously treated with paracetamol, benzonatate for cough, zinc, and ascorbic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04121A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Oxygen saturation (NR: not provided) 97-98 %. On 12-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 20-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On APR-2021, the subject experienced flu/allergy like symptoms/cough/headache/sore throat/tiredness. On APR-2021, the subject experienced sneezing. On APR-2021, the subject experienced eye were running. On APR-2021, the subject experienced itchy eyes. On APR-2021, the subject experienced itchy ears. On APR-2021, the subject experienced scratchy throat. On APR-2021, the subject experienced post nasal drip. On 06-APR-2021, the subject experienced sore arm by the rotator cuff. On 21-APR-2021, the subject experienced loss of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm by the rotator cuff, and the outcome of loss of taste, flu/allergy like symptoms/cough/headache/sore throat/tiredness, sneezing, eye were running, itchy eyes, itchy ears, scratchy throat and post nasal drip was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, SARS-CoV-2 test, Sneezing, Throat irritation
Clinical narrative: LOSS OF TASTE; SORE ARM BY THE ROTATOR CUFF; FLU/ALLERGY LIKE SYMPTOMS/COUGH/HEADACHE/SORE THROAT/TIREDNESS; SNEEZING; EYE WERE RUNNING; ITCHY EYES; ITCHY EARS; SCRATCHY THROAT; POST NASAL DRIP; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included kidney stones, and covid-19 test positive, and concurrent conditions included sinusitis. The patient was previously treated with paracetamol, benzonatate for cough, zinc, and ascorbic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04121A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Oxygen saturation (NR: not provided) 97-98 %. On 12-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 20-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On APR-2021, the subject experienced flu/allergy like symptoms/cough/headache/sore throat/tiredness. On APR-2021, the subject experienced sneezing. On APR-2021, the subject experienced eye were running. On APR-2021, the subject experienced itchy eyes. On APR-2021, the subject experienced itchy ears. On APR-2021, the subject experienced scratchy throat. On APR-2021, the subject experienced post nasal drip. On 06-APR-2021, the subject experienced sore arm by the rotator cuff. On 21-APR-2021, the subject experienced loss of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm by the rotator cuff, and the outcome of loss of taste, flu/allergy like symptoms/cough/headache/sore throat/tiredness, sneezing, eye were running, itchy eyes, itchy ears, scratchy throat and post nasal drip was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome
Clinical narrative: LOSS OF TASTE; SORE ARM BY THE ROTATOR CUFF; FLU/ALLERGY LIKE SYMPTOMS/COUGH/HEADACHE/SORE THROAT/TIREDNESS; SNEEZING; EYE WERE RUNNING; ITCHY EYES; ITCHY EARS; SCRATCHY THROAT; POST NASAL DRIP; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included kidney stones, and covid-19 test positive, and concurrent conditions included sinusitis. The patient was previously treated with paracetamol, benzonatate for cough, zinc, and ascorbic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04121A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Oxygen saturation (NR: not provided) 97-98 %. On 12-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 20-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On APR-2021, the subject experienced flu/allergy like symptoms/cough/headache/sore throat/tiredness. On APR-2021, the subject experienced sneezing. On APR-2021, the subject experienced eye were running. On APR-2021, the subject experienced itchy eyes. On APR-2021, the subject experienced itchy ears. On APR-2021, the subject experienced scratchy throat. On APR-2021, the subject experienced post nasal drip. On 06-APR-2021, the subject experienced sore arm by the rotator cuff. On 21-APR-2021, the subject experienced loss of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm by the rotator cuff, and the outcome of loss of taste, flu/allergy like symptoms/cough/headache/sore throat/tiredness, sneezing, eye were running, itchy eyes, itchy ears, scratchy throat and post nasal drip was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Rash, Tremor
Clinical narrative: SHAKING; RASH; CRAZY CHILLS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case No concomitant medications were reported. On an unspecified date, the subject experienced shaking, rash, and crazy chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash, crazy chills and shaking was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Penile rash, Peripheral swelling, Pruritus genital, Rash pruritic
Clinical narrative: ITCHING ON PRIVATE PARTS; RASH ON ALL OVER THE PRIVATE PART; ITCHING IN BOTH HANDS, FEET AND INSIDE THIGH AREA/RASH IN BOTH HANDS, FEET AND INSIDE THIGH AREA/RASH IN THIS AREA ARE RED ITCHY; HANDS AND FEET ARE BIT SWOLLEN; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced hands and feet are bit swollen. On 19-APR-2021, the subject experienced itching on private part. On 19-APR-2021, the subject experienced rash on all over the private part. On 19-APR-2021, the subject experienced itching in both hands, feet and inside thigh area/rash in both hands, feet and inside thigh area/rash in this area are red itchy. On 20-APR-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on all over the penis, and itching in both hands, feet and inside thigh area/rash in both hands, feet and inside thigh area/rash in this area are red itchy, and the outcome of hands and feet are bit swollen and itching on penis was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Feeling abnormal, Poor quality sleep, Somnolence
Clinical narrative: SO SLEEPY; HEAVY FEELING; FITFUL NIGHT; FELT BAD; CHILLS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for  this case. No concomitant medications were reported. On 2021, the subject experienced so sleepy. On 2021, the subject experienced heavy feeling. On 2021, the subject experienced fitful night. On 2021, the subject experienced felt bad. On 2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from so sleepy, heavy feeling, fitful night, felt bad, and chills on 2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Sluggishness
Clinical narrative: SLUGGISH; POUNDING HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had unspecified underlying conditions. 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 09-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced sluggish. On 10-APR-2021, the subject experienced pounding headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pounding headache, fatigue and sluggish was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: BODY ACHES; ARM HURT FOR A WHOLE WEEK; CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, arm hurt for a whole week, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, body aches and arm hurt for a whole week was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Headache, Vomiting
Clinical narrative: VOMIT; HEADACHE; INCREASE IN BLOOD PRESSURE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included abnormal cholesterol. 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 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included fenofibrate for abnormal cholesterol.  On 11-APR-2021, the subject experienced increase in blood pressure. On 11-APR-2021, the subject experienced headache. On 18-APR-2021, the subject experienced vomit.  Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 150/110 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from increase in blood pressure, headache, and vomit. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: COMPLICATIONS SINCE  VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) 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 subject experienced complications since vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of complications since vaccine was not reported. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: CHILLS; FEVER; SEVERE HEADACHE; NAUSEA; FATIGUE; LIGHTHEADEDNESS; FEELING OF NOT HERSELF (DESCRIBED LIKE BEING IN A FISHBOWL); LEGS MUSCLE TIGHTNESS; LOSS OF APPETITE; BILATERAL LEG WEAKNESS; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known allergies and did not had any history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced lightheadedness. On APR-2021, the subject experienced feeling of not herself (described like being in a fishbowl). On APR-2021, the subject experienced legs muscle tightness. On APR-2021, the subject experienced loss of appetite. On APR-2021, the subject experienced bilateral leg weakness. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadedness, feeling of not herself (described like being in a fishbowl), nausea, and fatigue on 16-APR-2021, loss of appetite on APR-2021, chills, and fever on 11-APR-2021, and severe headache on 08-APR-2021, and was recovering from bilateral leg weakness, and legs muscle tightness. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle tightness, Muscular weakness, Nausea, Pyrexia
Clinical narrative: CHILLS; FEVER; SEVERE HEADACHE; NAUSEA; FATIGUE; LIGHTHEADEDNESS; FEELING OF NOT HERSELF (DESCRIBED LIKE BEING IN A FISHBOWL); LEGS MUSCLE TIGHTNESS; LOSS OF APPETITE; BILATERAL LEG WEAKNESS; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known allergies and did not had any history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced lightheadedness. On APR-2021, the subject experienced feeling of not herself (described like being in a fishbowl). On APR-2021, the subject experienced legs muscle tightness. On APR-2021, the subject experienced loss of appetite. On APR-2021, the subject experienced bilateral leg weakness. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadedness, feeling of not herself (described like being in a fishbowl), nausea, and fatigue on 16-APR-2021, loss of appetite on APR-2021, chills, and fever on 11-APR-2021, and severe headache on 08-APR-2021, and was recovering from bilateral leg weakness, and legs muscle tightness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Pyrexia
Clinical narrative: DIZZINESS / LIGHTHEADEDNESS; FELT OUT OF IT; CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced dizziness / lightheadedness, felt out of it, chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, headache, dizziness / lightheadedness and felt out of it was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SUFFERING SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced suffering side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suffering side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE FOR 1 DAY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced fatigue for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue for 1 day. This report was non-serious.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Heart rate increased, Intentional product use issue
Clinical narrative: postpone the second dose due to the A Fib; Atrial fibrillation; fast heartbeat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and 01H021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Chronic obstructive pulmonary disease and Shortness of breath. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, ALPRAZOLAM, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant) and HEART RATE INCREASED (fast heartbeat). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (postpone the second dose due to the A Fib). On 28-Jan-2021, HEART RATE INCREASED (fast heartbeat) had resolved. On 25-Mar-2021, INTENTIONAL PRODUCT USE ISSUE (postpone the second dose due to the A Fib) had resolved. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included "senadril," "hidrocloric," and medication for irregular heartbeat. The onset of the fast heartbeat was 1 and a half hours after the vaccine dose. Treatment medication included the medication for irregular heartbeat. 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. Additional information has been requested   This case was linked to US-MODERNATX, INC.-MOD-2021-079299 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Updated medically confirmed to yes, patient medical history, concomitant medication and events.; 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. Additional information has been requested. US-MODERNATX, INC.-MOD-2021-079299:crosslinked case
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram, Dyspnoea, Echocardiogram, Pulmonary function test
Clinical narrative: difficulty breathing; soreness after 1st dose left arm; Clot in Lung; chest pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY THROMBOSIS (Clot in Lung) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disorder.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PULMONARY THROMBOSIS (Clot in Lung) (seriousness criterion medically significant) and CHEST PAIN (chest pain). On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness after 1st dose left arm). On an unknown date, the patient experienced DYSPNOEA (difficulty breathing). On 30-Mar-2021, VACCINATION SITE PAIN (soreness after 1st dose left arm) had resolved. At the time of the report, PULMONARY THROMBOSIS (Clot in Lung), CHEST PAIN (chest pain) and DYSPNOEA (difficulty breathing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Echocardiogram: normal (normal) Normal. On an unknown date, Computerised tomogram: abnormal (abnormal) Blood clot in Lung. On an unknown date, Pulmonary function test: normal (normal) came back perfect.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 08-Mar-2021 patient had an echocardiogram (results are not provided). Concomitant medications are not reported. No Treatment for events is provided. Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded. Vaccination site pain is consistent with the known safety profile of the vaccine   This case was linked to MOD-2021-084017 (Patient Link).; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded. Vaccination site pain is consistent with the known safety profile of the vaccine