chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test, Cold sweat, Computerised tomogram, Dizziness
Clinical narrative: LEG PAIN, ONE WORSE THAN THE OTHER; HEART BEATING FAST; COLD SWEAT; THROAT CLOSING UP; HANDS AND FEET SWOLLEN; BLOOD PRESSURE UP A LOT; BODY ACHE; DIZZY; FELT VERY BAD; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, batch number: 202A21A, and expiry: 31-DEC-2069) dose was not reported, 1 total, administered on 12-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 12-APR-2021, the patient experienced heart beating fast, cold sweat, throat closing up, hands and feet swollen, blood pressure up a lot, body ache, dizzy and felt very bad shortly after vaccination approximately within 5 to 10 minutes. In the 15 minutes of post vaccine observation, emergency services were called and the ambulance/EMTs came and helped stabilize the patient. The patient conveyed when she had arrived home that day after receiving emergency services she did not felt well at all and felt very bad. The patient was still had same symptoms at home that experienced shortly after vaccination, the symptoms did not resolve. The symptoms had lasted for two weeks. On 19-APR-2021, the only symptom patient had was strong leg pain in both legs, one worse than the other and was hospitalized (date unspecified). The patient's legs get swollen still and the pain remained to be intense. The patient's HCP was aware and was monitoring the patient. On 04-MAY-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Results pending to rule out blood clots in the leg. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Cleared, CT scan (NR: not provided) Cyst, but she complained no pain there and Urinalysis (NR: not provided) Cleared. The patient was told to go to clinic and the patient had followed up with clinic, then the patient was told to visit hospital as no appointment. The patient needed to be seen at a hospital and that was when she returned back to hospital a couple days after. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart beating fast, cold sweat, throat closing up, blood pressure up a lot, and dizzy on 19-APR-2021, and body ache on APR-2021, had not recovered from leg pain, one worse than the other, and hands and feet swollen, and the outcome of felt very bad was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210513962 -covid-19 vaccine ad26.cov2.s-Pain in extremity. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate increased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: LEG PAIN, ONE WORSE THAN THE OTHER; HEART BEATING FAST; COLD SWEAT; THROAT CLOSING UP; HANDS AND FEET SWOLLEN; BLOOD PRESSURE UP A LOT; BODY ACHE; DIZZY; FELT VERY BAD; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, batch number: 202A21A, and expiry: 31-DEC-2069) dose was not reported, 1 total, administered on 12-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 12-APR-2021, the patient experienced heart beating fast, cold sweat, throat closing up, hands and feet swollen, blood pressure up a lot, body ache, dizzy and felt very bad shortly after vaccination approximately within 5 to 10 minutes. In the 15 minutes of post vaccine observation, emergency services were called and the ambulance/EMTs came and helped stabilize the patient. The patient conveyed when she had arrived home that day after receiving emergency services she did not felt well at all and felt very bad. The patient was still had same symptoms at home that experienced shortly after vaccination, the symptoms did not resolve. The symptoms had lasted for two weeks. On 19-APR-2021, the only symptom patient had was strong leg pain in both legs, one worse than the other and was hospitalized (date unspecified). The patient's legs get swollen still and the pain remained to be intense. The patient's HCP was aware and was monitoring the patient. On 04-MAY-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Results pending to rule out blood clots in the leg. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Cleared, CT scan (NR: not provided) Cyst, but she complained no pain there and Urinalysis (NR: not provided) Cleared. The patient was told to go to clinic and the patient had followed up with clinic, then the patient was told to visit hospital as no appointment. The patient needed to be seen at a hospital and that was when she returned back to hospital a couple days after. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart beating fast, cold sweat, throat closing up, blood pressure up a lot, and dizzy on 19-APR-2021, and body ache on APR-2021, had not recovered from leg pain, one worse than the other, and hands and feet swollen, and the outcome of felt very bad was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210513962 -covid-19 vaccine ad26.cov2.s-Pain in extremity. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Ultrasound scan, Urine analysis
Clinical narrative: LEG PAIN, ONE WORSE THAN THE OTHER; HEART BEATING FAST; COLD SWEAT; THROAT CLOSING UP; HANDS AND FEET SWOLLEN; BLOOD PRESSURE UP A LOT; BODY ACHE; DIZZY; FELT VERY BAD; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, batch number: 202A21A, and expiry: 31-DEC-2069) dose was not reported, 1 total, administered on 12-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 12-APR-2021, the patient experienced heart beating fast, cold sweat, throat closing up, hands and feet swollen, blood pressure up a lot, body ache, dizzy and felt very bad shortly after vaccination approximately within 5 to 10 minutes. In the 15 minutes of post vaccine observation, emergency services were called and the ambulance/EMTs came and helped stabilize the patient. The patient conveyed when she had arrived home that day after receiving emergency services she did not felt well at all and felt very bad. The patient was still had same symptoms at home that experienced shortly after vaccination, the symptoms did not resolve. The symptoms had lasted for two weeks. On 19-APR-2021, the only symptom patient had was strong leg pain in both legs, one worse than the other and was hospitalized (date unspecified). The patient's legs get swollen still and the pain remained to be intense. The patient's HCP was aware and was monitoring the patient. On 04-MAY-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Results pending to rule out blood clots in the leg. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Cleared, CT scan (NR: not provided) Cyst, but she complained no pain there and Urinalysis (NR: not provided) Cleared. The patient was told to go to clinic and the patient had followed up with clinic, then the patient was told to visit hospital as no appointment. The patient needed to be seen at a hospital and that was when she returned back to hospital a couple days after. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart beating fast, cold sweat, throat closing up, blood pressure up a lot, and dizzy on 19-APR-2021, and body ache on APR-2021, had not recovered from leg pain, one worse than the other, and hands and feet swollen, and the outcome of felt very bad was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210513962 -covid-19 vaccine ad26.cov2.s-Pain in extremity. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Injection site erythema, Injection site warmth, Neck pain
Clinical narrative: STREAKS OF BLOOD COMING OUT OF IT UNDER THE SKIN; EXCRUCIATING PAIN/SORENESS IN NECK MUSCLE UPTO EAR; BRUISED AT LEFT ARM; WARM TO TOUCH; LEFT ARM SORE; REDNESS AT THE INJECTION SITE; HEADACHE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included psoriasis, non alcohol user, non smoker, morphine allergy, penicillin allergy, and sulpha allergy. The patient experienced drug allergy when treated with rabeprazole sodium, cefaclor, ciprofloxacin, erythromycin, meloxicam, nabumetone, and administration reaction to vaccine when treated with tetanus vaccine.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 09-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced streaks of blood coming out of it under the skin. On 07-MAY-2021, the subject experienced excruciating pain/soreness in neck muscle upto ear. On 07-MAY-2021, the subject experienced bruised at left arm. On 07-MAY-2021, the subject experienced warm to touch. On 07-MAY-2021, the subject experienced left arm sore. On 07-MAY-2021, the subject experienced redness at the injection site. On 07-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from redness at the injection site, headache, bruised at left arm, excruciating pain/soreness in neck muscle upto ear, left arm sore, streaks of blood coming out of it under the skin, and warm to touch. This report was non-serious.; Sender's Comments: V0-  Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin haemorrhage
Clinical narrative: STREAKS OF BLOOD COMING OUT OF IT UNDER THE SKIN; EXCRUCIATING PAIN/SORENESS IN NECK MUSCLE UPTO EAR; BRUISED AT LEFT ARM; WARM TO TOUCH; LEFT ARM SORE; REDNESS AT THE INJECTION SITE; HEADACHE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included psoriasis, non alcohol user, non smoker, morphine allergy, penicillin allergy, and sulpha allergy. The patient experienced drug allergy when treated with rabeprazole sodium, cefaclor, ciprofloxacin, erythromycin, meloxicam, nabumetone, and administration reaction to vaccine when treated with tetanus vaccine.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 09-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced streaks of blood coming out of it under the skin. On 07-MAY-2021, the subject experienced excruciating pain/soreness in neck muscle upto ear. On 07-MAY-2021, the subject experienced bruised at left arm. On 07-MAY-2021, the subject experienced warm to touch. On 07-MAY-2021, the subject experienced left arm sore. On 07-MAY-2021, the subject experienced redness at the injection site. On 07-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from redness at the injection site, headache, bruised at left arm, excruciating pain/soreness in neck muscle upto ear, left arm sore, streaks of blood coming out of it under the skin, and warm to touch. This report was non-serious.; Sender's Comments: V0-  Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Contusion, Dehydration, Dysphonia, Headache
Clinical narrative: CONSTANT URINATION; DEHYDRATION; SENSITIVE TO TOUCH; BODY IS BRUISED; SCALP AND HAIR HURTS; EXTREME ACHE LIKE HIT BY BUS AND RUN OVER BY BUS; MUSCLE ACHE ON INJECTION ARM OTHER ARM AND THE WHOLE BODY; FEVER; SEVERE HEADACHE FELT LIKE PRESSURE FROM THE INSIDE OUT; RUNNY NOSE; VOICE HOARSENESS; EARS RINGING; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included migraine headaches, and allergy to mixed nuts, and other pre-existing medical conditions included no known previous medical conditions. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced runny nose. On MAY-2021, the subject experienced voice hoarseness. On MAY-2021, the subject experienced ears ringing. On 06-MAY-2021, the subject experienced severe headache felt like pressure from the inside out. Laboratory data included: Body temperature (NR: not provided) 100 F. On 06-MAY-2021 17:00, the subject experienced muscle ache on injection arm other arm and the whole body. On 06-MAY-2021 17:00, the subject experienced fever. On 06-MAY-2021 20:00, the subject experienced extreme ache like hit by bus and run over by bus. On 07-MAY-2021, the subject experienced constant urination. On 07-MAY-2021, the subject experienced dehydration. On 07-MAY-2021, the subject experienced sensitive to touch. On 07-MAY-2021, the subject experienced body is bruised. On 07-MAY-2021, the subject experienced scalp and hair hurts. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from muscle ache on injection arm other arm and the whole body, and severe headache felt like pressure from the inside out, and the outcome of fever, runny nose, voice hoarseness, ears ringing, constant urination, dehydration, sensitive to touch, body is bruised, scalp and hair hurts and extreme ache like hit by bus and run over by bus was not reported. This report was non-serious. This report was associated with product quality complaint: 90000178841 The suspected product quality complaint has been confirmed to be management approval - confirmed nothing  was identified within the reported complaint reported. complaint is approved for void based on the evaluation/investigation performed..
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Myalgia, Pain, Pain of skin, Pollakiuria
Clinical narrative: CONSTANT URINATION; DEHYDRATION; SENSITIVE TO TOUCH; BODY IS BRUISED; SCALP AND HAIR HURTS; EXTREME ACHE LIKE HIT BY BUS AND RUN OVER BY BUS; MUSCLE ACHE ON INJECTION ARM OTHER ARM AND THE WHOLE BODY; FEVER; SEVERE HEADACHE FELT LIKE PRESSURE FROM THE INSIDE OUT; RUNNY NOSE; VOICE HOARSENESS; EARS RINGING; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included migraine headaches, and allergy to mixed nuts, and other pre-existing medical conditions included no known previous medical conditions. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced runny nose. On MAY-2021, the subject experienced voice hoarseness. On MAY-2021, the subject experienced ears ringing. On 06-MAY-2021, the subject experienced severe headache felt like pressure from the inside out. Laboratory data included: Body temperature (NR: not provided) 100 F. On 06-MAY-2021 17:00, the subject experienced muscle ache on injection arm other arm and the whole body. On 06-MAY-2021 17:00, the subject experienced fever. On 06-MAY-2021 20:00, the subject experienced extreme ache like hit by bus and run over by bus. On 07-MAY-2021, the subject experienced constant urination. On 07-MAY-2021, the subject experienced dehydration. On 07-MAY-2021, the subject experienced sensitive to touch. On 07-MAY-2021, the subject experienced body is bruised. On 07-MAY-2021, the subject experienced scalp and hair hurts. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from muscle ache on injection arm other arm and the whole body, and severe headache felt like pressure from the inside out, and the outcome of fever, runny nose, voice hoarseness, ears ringing, constant urination, dehydration, sensitive to touch, body is bruised, scalp and hair hurts and extreme ache like hit by bus and run over by bus was not reported. This report was non-serious. This report was associated with product quality complaint: 90000178841 The suspected product quality complaint has been confirmed to be management approval - confirmed nothing  was identified within the reported complaint reported. complaint is approved for void based on the evaluation/investigation performed..
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, Tinnitus
Clinical narrative: CONSTANT URINATION; DEHYDRATION; SENSITIVE TO TOUCH; BODY IS BRUISED; SCALP AND HAIR HURTS; EXTREME ACHE LIKE HIT BY BUS AND RUN OVER BY BUS; MUSCLE ACHE ON INJECTION ARM OTHER ARM AND THE WHOLE BODY; FEVER; SEVERE HEADACHE FELT LIKE PRESSURE FROM THE INSIDE OUT; RUNNY NOSE; VOICE HOARSENESS; EARS RINGING; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included migraine headaches, and allergy to mixed nuts, and other pre-existing medical conditions included no known previous medical conditions. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced runny nose. On MAY-2021, the subject experienced voice hoarseness. On MAY-2021, the subject experienced ears ringing. On 06-MAY-2021, the subject experienced severe headache felt like pressure from the inside out. Laboratory data included: Body temperature (NR: not provided) 100 F. On 06-MAY-2021 17:00, the subject experienced muscle ache on injection arm other arm and the whole body. On 06-MAY-2021 17:00, the subject experienced fever. On 06-MAY-2021 20:00, the subject experienced extreme ache like hit by bus and run over by bus. On 07-MAY-2021, the subject experienced constant urination. On 07-MAY-2021, the subject experienced dehydration. On 07-MAY-2021, the subject experienced sensitive to touch. On 07-MAY-2021, the subject experienced body is bruised. On 07-MAY-2021, the subject experienced scalp and hair hurts. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from muscle ache on injection arm other arm and the whole body, and severe headache felt like pressure from the inside out, and the outcome of fever, runny nose, voice hoarseness, ears ringing, constant urination, dehydration, sensitive to touch, body is bruised, scalp and hair hurts and extreme ache like hit by bus and run over by bus was not reported. This report was non-serious. This report was associated with product quality complaint: 90000178841 The suspected product quality complaint has been confirmed to be management approval - confirmed nothing  was identified within the reported complaint reported. complaint is approved for void based on the evaluation/investigation performed..
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Antibody test, Colitis, Decreased immune responsiveness
Clinical narrative: FLU SYMPTOMS; DIARRHEA; COLITIS ATTACH; VOMITING; LOSS OF TASTE; LOSS OF SMELL; RASH; SORE ARM; MYALGIA; IMMUNITY DOWN; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included alcohol allergy, and codeine allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced immunity down. Laboratory data included: Antibody test (NR: not provided) Positive. On 03-MAY-2021, the subject experienced flu symptoms. On 03-MAY-2021, the subject experienced diarrhea. On 03-MAY-2021, the subject experienced colitis attach. On 03-MAY-2021, the subject experienced vomiting. On 03-MAY-2021, the subject experienced loss of taste. On 03-MAY-2021, the subject experienced loss of smell. On 03-MAY-2021, the subject experienced rash. On 03-MAY-2021, the subject experienced sore arm. On 03-MAY-2021, the subject experienced myalgia. The action taken with covid-19 vaccine was not applicable. The patient recovered from rash on 04-MAY-2021, was recovering from flu symptoms, colitis attach, vomiting, and myalgia, had not recovered from diarrhea, sore arm, loss of taste, and loss of smell, and the outcome of immunity down was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Influenza, Myalgia, Pain in extremity, Rash
Clinical narrative: FLU SYMPTOMS; DIARRHEA; COLITIS ATTACH; VOMITING; LOSS OF TASTE; LOSS OF SMELL; RASH; SORE ARM; MYALGIA; IMMUNITY DOWN; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included alcohol allergy, and codeine allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced immunity down. Laboratory data included: Antibody test (NR: not provided) Positive. On 03-MAY-2021, the subject experienced flu symptoms. On 03-MAY-2021, the subject experienced diarrhea. On 03-MAY-2021, the subject experienced colitis attach. On 03-MAY-2021, the subject experienced vomiting. On 03-MAY-2021, the subject experienced loss of taste. On 03-MAY-2021, the subject experienced loss of smell. On 03-MAY-2021, the subject experienced rash. On 03-MAY-2021, the subject experienced sore arm. On 03-MAY-2021, the subject experienced myalgia. The action taken with covid-19 vaccine was not applicable. The patient recovered from rash on 04-MAY-2021, was recovering from flu symptoms, colitis attach, vomiting, and myalgia, had not recovered from diarrhea, sore arm, loss of taste, and loss of smell, and the outcome of immunity down was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: FLU SYMPTOMS; DIARRHEA; COLITIS ATTACH; VOMITING; LOSS OF TASTE; LOSS OF SMELL; RASH; SORE ARM; MYALGIA; IMMUNITY DOWN; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included alcohol allergy, and codeine allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced immunity down. Laboratory data included: Antibody test (NR: not provided) Positive. On 03-MAY-2021, the subject experienced flu symptoms. On 03-MAY-2021, the subject experienced diarrhea. On 03-MAY-2021, the subject experienced colitis attach. On 03-MAY-2021, the subject experienced vomiting. On 03-MAY-2021, the subject experienced loss of taste. On 03-MAY-2021, the subject experienced loss of smell. On 03-MAY-2021, the subject experienced rash. On 03-MAY-2021, the subject experienced sore arm. On 03-MAY-2021, the subject experienced myalgia. The action taken with covid-19 vaccine was not applicable. The patient recovered from rash on 04-MAY-2021, was recovering from flu symptoms, colitis attach, vomiting, and myalgia, had not recovered from diarrhea, sore arm, loss of taste, and loss of smell, and the outcome of immunity down was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Flatulence
Clinical narrative: DIARRHEA; STOMACH CRAMPS/SEVER STOMACH PROBLEM; GAS; 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(suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced diarrhea. On 2021, the subject experienced stomach cramps/sever stomach problem. On 2021, the subject experienced gas. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from diarrhea, stomach cramps/sever stomach problem, and gas. This report was non-serious. This case, from the same reporter is linked to 20210516975.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Confusional state, Dizziness, Hypothermia
Clinical narrative: BODY TEMPERATURE OF 79 DEGREES F; MENTALLY CONFUSED; CRAMPING UP; DIZZY; CHILLS; This spontaneous report received from a consumer concerned a 33 year old male of an unknown ethnicity and race. 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 and expiry: Unknown) dose was not reported, 1 total administered on 08-MAY-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 08-MAY-2021 (after vaccination), patient experienced chills, fever at 102.5 degrees F, cramping up and dizzy. It was reported that patient at the first had body temperature of 79 degrees F and later had 103 degrees F body temperature. On the same day, the patient was mentally confused, did not remember that had been married for five years. At the time of reporting the patient was being taken to the emergency room. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, body temperature of 79 degrees F, cramping up, dizzy, and mentally confused. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210516895-COVID-19 VACCINE AD26.COV2.S-Body Temperature of 79 Degrees F. 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: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: BODY TEMPERATURE OF 79 DEGREES F; MENTALLY CONFUSED; CRAMPING UP; DIZZY; CHILLS; This spontaneous report received from a consumer concerned a 33 year old male of an unknown ethnicity and race. 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 and expiry: Unknown) dose was not reported, 1 total administered on 08-MAY-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 08-MAY-2021 (after vaccination), patient experienced chills, fever at 102.5 degrees F, cramping up and dizzy. It was reported that patient at the first had body temperature of 79 degrees F and later had 103 degrees F body temperature. On the same day, the patient was mentally confused, did not remember that had been married for five years. At the time of reporting the patient was being taken to the emergency room. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, body temperature of 79 degrees F, cramping up, dizzy, and mentally confused. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210516895-COVID-19 VACCINE AD26.COV2.S-Body Temperature of 79 Degrees F. 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).
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; CHILLS; SEVERE HEADACHES; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced suspected immunological vaccine failure. On 2021, the subject experienced chills. On 2021, the subject experienced severe headaches. On APR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) positive for antibodies. On 29-APR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) negative for antibodies. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The outcome of the severe headaches, chills and suspected immunological vaccine failure was not reported. This report was non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Peripheral swelling, Rash pustular
Clinical narrative: BUBBLES ON BOTH LEGS; LEGS WERE SWOLLEN; BUBBLES POPPED UP AND LEAKED YELLOW LIQUID; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included sulfa allergy, allergy to lyrica, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient did not had drug abuse or illicit drug use and had no fever, no cough, no asthma, no sob. The patient received Covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced bubbles popped up and leaked yellow liquid. On 13-APR-2021, the subject experienced bubbles on both legs. On 13-APR-2021, the subject experienced legs were swollen. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from bubbles on both legs, and legs were swollen, and the outcome of bubbles popped up and leaked yellow liquid was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 53-year-old female. The patient's height, and weight were not reported. The patient's current conditions included penicillin allergy. The patient experienced drug allergy when treated with ciprofloxacin, and vancomycin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: unknown) dose was 0.5 ml, 1 total administered on 06-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported.  On 04-MAY-2021, the patient experienced confirmed clinical vaccination failure  and confirmed COVID-19 infection. Laboratory data included: Rapid test and antibody testing for COVID-19 (NR: not provided) was positive for antibodies, and COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed clinical vaccination failure  and confirmed COVID-19 infection.  This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000179016.  The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified.  Additional live follow up information was received from Product Quality Vigilance on 11-MAY-2021.; Sender's Comments: V0: 20210518529-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19, UNK
Symptoms: Malaise
Clinical narrative: NOT FEELING WELL; 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 ustekinumab (solution for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced not feeling well. The action taken with covid-19 vaccine  was not applicable; and action taken with ustekinumab was not reported. The outcome of not feeling well was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Cough, Dry throat, Dysphonia, Hyperhidrosis
Clinical narrative: BONE PAIN; SWEATING; NASAL PROBLEMS; CONGESTION; VERY DRY THROAT; VOICE PROBLEM; COUGH; ARM PAIN; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included mold allergy, and dust allergy, and other pre-existing medical conditions included patient is mostly bedridden and does not go out due to bad allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. Concomitant medications included dexamethasone for mold allergies, and dust allergy, and diphenhydramine hydrochloride for mold allergy, and dust allergy. On an unspecified date, the subject experienced bone pain, sweating, nasal problems, congestion, very dry throat, voice problem, cough, arm pain, and fever. The action taken with covid-19 vaccine  was not applicable. The outcome of the arm pain, bone pain, fever, sweating, nasal problems, congestion, very dry throat, voice problem and cough was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nasal disorder, Pain in extremity, Pyrexia, Unevaluable event
Clinical narrative: BONE PAIN; SWEATING; NASAL PROBLEMS; CONGESTION; VERY DRY THROAT; VOICE PROBLEM; COUGH; ARM PAIN; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included mold allergy, and dust allergy, and other pre-existing medical conditions included patient is mostly bedridden and does not go out due to bad allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. Concomitant medications included dexamethasone for mold allergies, and dust allergy, and diphenhydramine hydrochloride for mold allergy, and dust allergy. On an unspecified date, the subject experienced bone pain, sweating, nasal problems, congestion, very dry throat, voice problem, cough, arm pain, and fever. The action taken with covid-19 vaccine  was not applicable. The outcome of the arm pain, bone pain, fever, sweating, nasal problems, congestion, very dry throat, voice problem and cough was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood creatine phosphokinase, C-reactive protein, Chest pain, Electrocardiogram
Clinical narrative: CONFIRMED IMMUNUNOLOGICAL VACCINATION FAILURE; CHEST PAIN TOWARDS THE LEFT; LEFT SHOULDER PAIN/ PROLONGED JOINT ACHES; FATIGUE; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight was 133 pounds, and height was 66 centimeters. The patient's concurrent conditions included alcohol use (occasional glass of wine), and non-smoker. The patient was not pregnant at the time of reporting. The patient had no known allergies/no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: 21-JUN-2021) dose was not reported, 1 total administered in left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAY-2021, the subject experienced confirmed immunological vaccination failure. On 08-APR-2021, the patient experienced left shoulder pain/ prolonged joint aches, chest pain towards the left, and fatigue. On 06-MAY-2021 laboratory data included: C-reactive protein (NR: not provided) normal, CPK (NR: not provided) normal, Electrocardiogram (NR: not provided) normal, Erythrocyte sedimentation rate (NR: not provided) normal, Fibrin D dimer (NR: not provided) normal, and SARS-CoV-2 antibody test (NR: not provided) less than 1 which was negative. On 08-MAY-2021, the patient recovered from prolonged joint aches. The patient had an emergency room visit for left shoulder pain and chest pain towards the left. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 29-APR-2021, was recovering from chest pain towards the left, had not recovered from left shoulder pain, and the outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210519849-covid-19 vaccine ad26.cov2.s- confirmed immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20210519849-covid-19 vaccine ad26.cov2.s-  left shoulder pain/ prolonged joint aches, fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Fibrin D dimer, Red blood cell sedimentation rate, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNUNOLOGICAL VACCINATION FAILURE; CHEST PAIN TOWARDS THE LEFT; LEFT SHOULDER PAIN/ PROLONGED JOINT ACHES; FATIGUE; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight was 133 pounds, and height was 66 centimeters. The patient's concurrent conditions included alcohol use (occasional glass of wine), and non-smoker. The patient was not pregnant at the time of reporting. The patient had no known allergies/no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: 21-JUN-2021) dose was not reported, 1 total administered in left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAY-2021, the subject experienced confirmed immunological vaccination failure. On 08-APR-2021, the patient experienced left shoulder pain/ prolonged joint aches, chest pain towards the left, and fatigue. On 06-MAY-2021 laboratory data included: C-reactive protein (NR: not provided) normal, CPK (NR: not provided) normal, Electrocardiogram (NR: not provided) normal, Erythrocyte sedimentation rate (NR: not provided) normal, Fibrin D dimer (NR: not provided) normal, and SARS-CoV-2 antibody test (NR: not provided) less than 1 which was negative. On 08-MAY-2021, the patient recovered from prolonged joint aches. The patient had an emergency room visit for left shoulder pain and chest pain towards the left. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 29-APR-2021, was recovering from chest pain towards the left, had not recovered from left shoulder pain, and the outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210519849-covid-19 vaccine ad26.cov2.s- confirmed immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20210519849-covid-19 vaccine ad26.cov2.s-  left shoulder pain/ prolonged joint aches, fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; 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 autoimmune disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  batch number: 1805029 and expiry: UNKNOWN) 0.5 ml, 1 total, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On 10-MAY-2021, after two months of vaccination the patient underwent a laboratory tests immunoglobulin G (IgG) and immunoglobulin M (IgM) for which reports were negative and had confirmed immunological vaccine failure. Then patient stated that his antibody was lower than normal (for a vaccinated person) and was very disappointed with it. The matter just made worse for him and he did not know what to do. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000179130 The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210520075- covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED DOSE; This spontaneous report received from a health care professional concerned a 19 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808978 expiry: 07-MAY-2021) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced administered expired dose. The action taken with covid-19 vaccine  was not applicable. The outcome of administered expired dose was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: RECEIVED A VACCINE THAT WAS LEFT OUT AT ROOM TEMPERATURE FOR UP TO 4 HOURS; This spontaneous report received from a pharmacist concerned a 22 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced received a vaccine that was left out at room temperature for up to 4 hours. The action taken with covid-19 vaccine  was not applicable. The outcome of received a vaccine that was left out at room temperature for up to 4 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210521658.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Adverse reaction
Clinical narrative: BAD REACTION; 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 (suspension for injection, intramuscular) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  Non-company suspect drugs included: diphenhydramine hydrochloride (tablet, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for drug used for unknown indication.  No concomitant medications were reported.  On an unspecified date, the subject experienced bad reaction. The action taken with covid-19 vaccine  was not applicable. The outcome of bad reaction was not reported. This report was non-serious.