chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Thrombocytopenia
Clinical narrative: POSSIBLE THROMBOCYTOPENIA; RASH FROM KNEE TO FEET /SPOTTY RED DOTS ON LEG; SLEEPINESS; NECK ACHE; TIREDNESS; MUSCLE ACHE; HEADACHE; This spontaneous self-report concerned a 53 year old male patient. 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: 1805029 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the patient received the vaccine, waited at facility for 15 minutes, and everything was okay.  On 17-APR-2021, the patient experienced neck ache, muscle ache and felt a sense of tiredness, headache, sleepiness, which he treated with Aleve (naproxen sodium). He also noticed his feet had a rash from his knee to feet, and according to his sister (who is a healthcare professional) it looked like small micro-embolisms (thrombocytopenia). The patient went to his physician who said the spotty red dots could be petechiae caused by thrombocytopenia.  As recommended by his primary care physician, the patient has an appointment for lab work, including platelet counts, on 20-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, tiredness, neck ache, rash from knee to feet (red dots), muscle ache, and possible thrombocytopenia, and the outcome of sleepiness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This 53-year-old male patient was found to have petechiae-like rash on his knees to feet, that according to attending physician could be caused by thrombocytopenia, 2 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection. The patient underwent laboratory procedure including platelet count (results not reported).  The patient complained of neck ache, muscle ache and felt a sense of tiredness, headache, sleepiness that he treated with Aleve (naproxen sodium) on the day the petechiae-like rash appeared.  No other details reported.  The information available precludes a complete and meaningful assessment.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information as requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood test, Chills, Contusion, Fatigue
Clinical narrative: BRUISE ON BOTTOM OF RIGHT LEG; TINGLING IN LEGS; SWELLING OF LEGS; UPSET STOMACH; BODY ACHES; CHILLS; EXHAUSTION; HEADACHE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ADHD, and hay fever. 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 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. Batch number was not reported and has been requested. On 10-APR-2021, the patient experienced upset stomach. On 10-APR-2021, the patient experienced body aches. On 10-APR-2021, the patient experienced chills. On 10-APR-2021, the patient experienced exhaustion. On 10-APR-2021, the patient experienced headache. On 14-APR-2021, the patient experienced bruise on bottom of right leg. On 14-APR-2021, the patient experienced tingling in legs. On 14-APR-2021, the patient  experienced swelling of legs. Laboratory data included: Blood test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in legs, and swelling of legs, and upset stomach, body aches, chills, exhaustion, and headache on 11-APR-2021, and had not recovered from bruise on bottom of right leg. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Paraesthesia, Peripheral swelling
Clinical narrative: BRUISE ON BOTTOM OF RIGHT LEG; TINGLING IN LEGS; SWELLING OF LEGS; UPSET STOMACH; BODY ACHES; CHILLS; EXHAUSTION; HEADACHE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ADHD, and hay fever. 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 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. Batch number was not reported and has been requested. On 10-APR-2021, the patient experienced upset stomach. On 10-APR-2021, the patient experienced body aches. On 10-APR-2021, the patient experienced chills. On 10-APR-2021, the patient experienced exhaustion. On 10-APR-2021, the patient experienced headache. On 14-APR-2021, the patient experienced bruise on bottom of right leg. On 14-APR-2021, the patient experienced tingling in legs. On 14-APR-2021, the patient  experienced swelling of legs. Laboratory data included: Blood test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in legs, and swelling of legs, and upset stomach, body aches, chills, exhaustion, and headache on 11-APR-2021, and had not recovered from bruise on bottom of right leg. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Peripheral swelling, Rash
Clinical narrative: SWOLLEN LEGS; RASH; HEADACHE; 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: Unknown) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-APR-2021, the subject experienced swollen legs. On 16-APR-2021, the subject experienced rash. On 16-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash, headache and swollen legs was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Diplopia, Dysarthria, Hypertension, Influenza
Clinical narrative: HIGH BLOOD PRESSURE; FULL-BLOWN FLU (MASSIVE HEADACHES,SICK,COUGHING,WHEEZING,PAINFUL BODY ACHES); DOUBLE VISION; SLUR SPEECH; This spontaneous report received from a patient 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 was not reported, administered on 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 high blood pressure. On APR-2021, the subject experienced full-blown flu (massive headaches, sick, coughing, wheezing, painful body aches). On APR-2021, the subject experienced double vision. On APR-2021, the subject experienced slur speech. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from full-blown flu (massive headaches,sick,coughing,wheezing,painful body aches), double vision, slur speech, and high blood pressure. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: BILATERAL PULMONARY EMBOLISMS; This spontaneous report received from a pharmacist concerned an 84 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: 1805018, and expiry: 25/MAY/2021) dose was not reported, 1 total dose administered on 10-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  10-MAR-2021 After administration of vaccine on 15-APR-2021, patient had bilateral pulmonary embolisms and was hospitalized in local hospital then triaged to heart institute, Reporter also report patient will get discharged soon.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bilateral pulmonary embolisms was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This 84 year-old male patient was hospitalized for bilateral pulmonary embolisms 36 days after receiving the Janssen Covid-19 vaccine. Medical history, concomitant medications, social history, family history, diagnostic test results, corrective treatment, and outcome were not reported. Based on the limited information, the event is considered unclassifiable. Additional information is being sought.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE/PAIN IN ARM; This spontaneous report received from a patient concerned a 70 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, batch number: 1805028, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced sore/pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore/pain in arm. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Epiploic appendagitis
Clinical narrative: EPIPLOIC APPENDAGITIS; This spontaneous report received from a consumer concerned a 20 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included anti-inflammatory therapy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202a21a, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced epiploic appendagitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from epiploic appendagitis. This report was non-serious.; Sender's Comments: : V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Hypoaesthesia
Clinical narrative: FEELS LIKE DEAF ON BOTH EARS; FEELS NUMB IN HEAD; EARS FEEL NUMB; 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced feels numb in head. On APR-2021, the subject experienced ears feel numb. On 14-APR-2021, the subject experienced feels like deaf on both ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feels like deaf on both ears, feels numb in head and ears feel numb was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Ear discomfort, Eustachian tube obstruction, Fatigue
Clinical narrative: ALLERGIES /INFLAMMATION REGARDING TO EAR; LEFT EAR NOT DRAIN WELL DUE TO HER EUSTACHIAN TUBE; CHILLS; HIP ACHE; GENERAL FATIGUE; LEFT EAR CLOGGED; RUNNY NOSE; FELT FOGGY; TOP OF LIP WAS SLIGHTLY NUMB/TINGLING; FEELING OF VACCINE TRAVELING DOWN TO HER RIGHT  HIP SOCKET; RIGHT LEG SORE NEAR THE HIP AREA/RIGHT LEG HURT AND HURT THE REST OF THE NIGHT/STILL SORE,COMES AND GOES INTERMITTENTLY ,ESPECIALLY AT NIGHT; FEEL HER HEART BEAT IN HER EARS; 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 past medical history included breast cancer, and removal of 2 lymph node, and concurrent conditions included ear does not well due to eustachian tube. 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 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced general fatigue. On 03-APR-2021, the subject experienced top of lip was slightly numb/tingling. On 03-APR-2021, the subject experienced feeling of vaccine traveling down to her right hip socket. On 03-APR-2021, the subject experienced right leg sore near the hip area/right leg hurt and hurt the rest of the night/still sore, comes and goes intermittently, especially at night. On 03-APR-2021, the subject experienced hip ache. On 03-APR-2021, the subject experienced feel her heart beat in her ears. On 03-APR-2021, the subject experienced felt foggy. On 03-APR-2021, the subject experienced left ear clogged. On 03-APR-2021, the subject experienced runny nose. On 04-APR-2021, the subject experienced chills. On an unspecified date, the subject experienced allergies /inflammation regarding to ear, and left ear not drain well due to her eustachian tube. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general fatigue, top of lip was slightly numb/tingling, feeling of vaccine traveling down to her right hip socket, hip ache, feel her heart beat in her ears, felt foggy, left ear clogged, runny nose, and chills on 04-APR-2021, had not recovered from right leg sore near the hip area/right leg hurt and hurt the rest of the night/still sore, comes and goes intermittently ,especially at night, and the outcome of left ear not drain well due to her eustachian tube and allergies /inflammation regarding to ear was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia oral, Inflammation, Pain in extremity, Palpitations
Clinical narrative: ALLERGIES /INFLAMMATION REGARDING TO EAR; LEFT EAR NOT DRAIN WELL DUE TO HER EUSTACHIAN TUBE; CHILLS; HIP ACHE; GENERAL FATIGUE; LEFT EAR CLOGGED; RUNNY NOSE; FELT FOGGY; TOP OF LIP WAS SLIGHTLY NUMB/TINGLING; FEELING OF VACCINE TRAVELING DOWN TO HER RIGHT  HIP SOCKET; RIGHT LEG SORE NEAR THE HIP AREA/RIGHT LEG HURT AND HURT THE REST OF THE NIGHT/STILL SORE,COMES AND GOES INTERMITTENTLY ,ESPECIALLY AT NIGHT; FEEL HER HEART BEAT IN HER EARS; 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 past medical history included breast cancer, and removal of 2 lymph node, and concurrent conditions included ear does not well due to eustachian tube. 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 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced general fatigue. On 03-APR-2021, the subject experienced top of lip was slightly numb/tingling. On 03-APR-2021, the subject experienced feeling of vaccine traveling down to her right hip socket. On 03-APR-2021, the subject experienced right leg sore near the hip area/right leg hurt and hurt the rest of the night/still sore, comes and goes intermittently, especially at night. On 03-APR-2021, the subject experienced hip ache. On 03-APR-2021, the subject experienced feel her heart beat in her ears. On 03-APR-2021, the subject experienced felt foggy. On 03-APR-2021, the subject experienced left ear clogged. On 03-APR-2021, the subject experienced runny nose. On 04-APR-2021, the subject experienced chills. On an unspecified date, the subject experienced allergies /inflammation regarding to ear, and left ear not drain well due to her eustachian tube. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general fatigue, top of lip was slightly numb/tingling, feeling of vaccine traveling down to her right hip socket, hip ache, feel her heart beat in her ears, felt foggy, left ear clogged, runny nose, and chills on 04-APR-2021, had not recovered from right leg sore near the hip area/right leg hurt and hurt the rest of the night/still sore, comes and goes intermittently ,especially at night, and the outcome of left ear not drain well due to her eustachian tube and allergies /inflammation regarding to ear was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sensory disturbance
Clinical narrative: ALLERGIES /INFLAMMATION REGARDING TO EAR; LEFT EAR NOT DRAIN WELL DUE TO HER EUSTACHIAN TUBE; CHILLS; HIP ACHE; GENERAL FATIGUE; LEFT EAR CLOGGED; RUNNY NOSE; FELT FOGGY; TOP OF LIP WAS SLIGHTLY NUMB/TINGLING; FEELING OF VACCINE TRAVELING DOWN TO HER RIGHT  HIP SOCKET; RIGHT LEG SORE NEAR THE HIP AREA/RIGHT LEG HURT AND HURT THE REST OF THE NIGHT/STILL SORE,COMES AND GOES INTERMITTENTLY ,ESPECIALLY AT NIGHT; FEEL HER HEART BEAT IN HER EARS; 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 past medical history included breast cancer, and removal of 2 lymph node, and concurrent conditions included ear does not well due to eustachian tube. 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 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced general fatigue. On 03-APR-2021, the subject experienced top of lip was slightly numb/tingling. On 03-APR-2021, the subject experienced feeling of vaccine traveling down to her right hip socket. On 03-APR-2021, the subject experienced right leg sore near the hip area/right leg hurt and hurt the rest of the night/still sore, comes and goes intermittently, especially at night. On 03-APR-2021, the subject experienced hip ache. On 03-APR-2021, the subject experienced feel her heart beat in her ears. On 03-APR-2021, the subject experienced felt foggy. On 03-APR-2021, the subject experienced left ear clogged. On 03-APR-2021, the subject experienced runny nose. On 04-APR-2021, the subject experienced chills. On an unspecified date, the subject experienced allergies /inflammation regarding to ear, and left ear not drain well due to her eustachian tube. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general fatigue, top of lip was slightly numb/tingling, feeling of vaccine traveling down to her right hip socket, hip ache, feel her heart beat in her ears, felt foggy, left ear clogged, runny nose, and chills on 04-APR-2021, had not recovered from right leg sore near the hip area/right leg hurt and hurt the rest of the night/still sore, comes and goes intermittently ,especially at night, and the outcome of left ear not drain well due to her eustachian tube and allergies /inflammation regarding to ear was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cardiac disorder, Illness
Clinical narrative: ASTHMA; HEART PROBLEM; SICK; This spontaneous report received from a consumer 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced asthma, heart problem, and sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the asthma, heart problem and sick was not reported. This report was non-serious.; Sender's Comments: V0:As per standard protocol, MAC comment is not required for non-serious cases
Age: 46.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Vaccination complication
Clinical narrative: VACCINATION ADVERSE REACTION; This spontaneous report received from a patient concerned a 46 year old of unspecified sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: upadacitinib (oral, batch number: UNKNOWN expiry: UNKNOWN, form of admin was not reported) dose, frequency, and therapy dates were not reported for rheumatoid arthritis. 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 vaccination adverse reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaccination adverse reaction. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Headache, Malaise
Clinical narrative: MALAISE; HEADACHE; FATIGUE; 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 left rotator cuff injury, left rotator cuff surgery, right rotator cuff injury, diastolic heart failure, cervical spine fusion, fell, and shortness of breath, and concurrent conditions included pain and stiffness in all joints, problems with usual activities like laundry, problem in walking longer distances or with stairs, pulmonary hypertension, and fatigue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 07-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, subcutaneous, batch number was not reported) dose was not reported, 1 time every 2 weeks from 05-JAN-2021 to 07-APR-2021 for psoriatic arthritis. No concomitant medications were reported. On 2021, the subject experienced fatigue. On APR-2021, the subject experienced malaise. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, malaise, and headache. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Neuroendocrine tumour, Pain in extremity, Positron emission tomogram
Clinical narrative: NEUROENDOCRIME TUMOR; PAIN IN EXTREMITY; This spontaneous report received from a patient concerned a 64 years old male. The patient's weight, height, and medical history were not reported. The patient received Ibrutinib (tablet, oral, batch number: 1140389) 420 mg, every 1 day, from SEP-2020, for chronic lymphocytic leukemia.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported), start therapy date were not reported 1 total administered 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 patient experienced neuroendocrime tumor, and pain in extremity. Laboratory data (dates unspecified) included: PET scan (NR: not provided) which showed Neuro endocrine tumor. Treatment medications (dates unspecified) included: lanreotide to suppress the growth in every 28 days of tumor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ibrutinib was not changed. The patient was recovering from pain in extremity, and the outcome of neuroendocrime tumor was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-Covid-19 vaccine ad26.cov2.s-Neuroendocrine tumor. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Headache, Injection site pain, Limb discomfort
Clinical narrative: LEGS FELT "HEAVY" BILATERALLY, LEFT MORE THAN RIGHT; PAIN IN THE ARM; FEVERISH; HEADACHE; This spontaneous report received from a consumer concerned a 42 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient does not have diabetes, circulation problems, and is not overweight. she is not taking birth control pills. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced pain in the arm. On 12-APR-2021, the subject experienced feverish. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced legs felt "heavy" bilaterally, left more than right. Laboratory data included: Body temperature (NR: not provided) 100.1 (unit unspecified). Treatment medications included: paracetamol. On 14-APR-2021, Laboratory data included: Blood test (NR: not provided) UNKNOWN (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish on 16-APR-2021, had not recovered from legs felt "heavy" bilaterally, left more than right, and the outcome of pain in the arm and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425979.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: LEGS FELT "HEAVY" BILATERALLY, LEFT MORE THAN RIGHT; PAIN IN THE ARM; FEVERISH; HEADACHE; This spontaneous report received from a consumer concerned a 42 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient does not have diabetes, circulation problems, and is not overweight. she is not taking birth control pills. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced pain in the arm. On 12-APR-2021, the subject experienced feverish. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced legs felt "heavy" bilaterally, left more than right. Laboratory data included: Body temperature (NR: not provided) 100.1 (unit unspecified). Treatment medications included: paracetamol. On 14-APR-2021, Laboratory data included: Blood test (NR: not provided) UNKNOWN (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish on 16-APR-2021, had not recovered from legs felt "heavy" bilaterally, left more than right, and the outcome of pain in the arm and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425979.
Sex: F
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: CLAIMS SHE WAS HOSPITALIZED; 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 was not reported, administered on 11-APR-2021, 1 total 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.  The contact reporter mentioned that they were working on story of woman who was the patient, received the vaccine on 11-APR-2021 and was hospitalized on 13-APR-2021 with no given release date yet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of claims she was hospitalized was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: covid-19 vaccine ad26.cov2.s-Hospitalization. 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: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF-LABEL USE; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; ADVERSE REACTION; This spontaneous report received from a parent concerned a 16 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: UNKNOWN) dose was not reported, administered on 10-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 adverse reaction. On 10-APR-2021, the subject experienced off-label use. On 10-APR-2021, the subject experienced inappropriate age at vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off-label use, adverse reaction and inappropriate age at vaccine administration was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Vision blurred
Clinical narrative: BLURRY VISION; DIZZINESS; HEADACHE; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included abstains from alcohol, and non smoker, and other pre-existing medical conditions included the patient had no 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced blurry vision. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, blurry vision, and dizziness. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Headache, Impaired work ability, Injection site pain
Clinical narrative: HEAVINESS IN LEGS; MISSED WORK DUE TO THE  FEVER; PAIN AT INJECTION SITE; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 42 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no medications prior to the janssen covid-19 vaccine. the patient had no diabetes, no circulation problems, and was not overweight. the patient was not taking birth control pills. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced pain at injection site. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced heaviness in legs. On 13-APR-2021, the subject experienced missed work due to the fever. Laboratory data included: Body temperature (NR: not provided) 100.1. On 14-APR-2021, Laboratory data included: Blood test (NR: not provided) Not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from missed work due to the fever, and fever on APR-2021, had not recovered from heaviness in legs, and the outcome of pain at injection site and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425979.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pyrexia
Clinical narrative: HEAVINESS IN LEGS; MISSED WORK DUE TO THE  FEVER; PAIN AT INJECTION SITE; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 42 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no medications prior to the janssen covid-19 vaccine. the patient had no diabetes, no circulation problems, and was not overweight. the patient was not taking birth control pills. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced pain at injection site. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced heaviness in legs. On 13-APR-2021, the subject experienced missed work due to the fever. Laboratory data included: Body temperature (NR: not provided) 100.1. On 14-APR-2021, Laboratory data included: Blood test (NR: not provided) Not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from missed work due to the fever, and fever on APR-2021, had not recovered from heaviness in legs, and the outcome of pain at injection site and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425979.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Ischaemic stroke, Magnetic resonance imaging
Clinical narrative: CLOT BLOOD; ACUTE ISCHEMIC STROKE IN LEFT FRONTAL LOBE; PARTIAL LOSS OF USE IN RIGHT LEG; MUSCLE WEAKNESS; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included amoxicillin and flexeril allergy, and migraine. The patient experienced drug allergy when treated with cyclobenzaprine hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 11:30 on left arm for prophylactic vaccination. Concomitant medications included ascorbic acid, ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride, ergocalciferol, iron, and withania somnifera.  Approximately three days after the vaccine, on 11-APR-2021 08:20, the patient experienced clot blood. Which caused an acute ischemic stroke in left frontal lobe resulting in partial loss of use in right leg and muscle weakness. The patient had a blood test, CT scan, Carotid artery ultrasound, diagnostic ultrasound, electrocardiogram (EKG) and an MRI, results are unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from clot blood, acute ischemic stroke in left frontal lobe, muscle weakness, and partial loss of use in right leg. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a report of a 46 year old, female patient  who experienced a blood clot that caused an acute ischemic stroke in the left fontal lobe 3 days after receiving the covid-19 vaccine ad26.cov.2.  Patient's height and weight were not reported. Patient has migraine and allergies to amoxicillin, flexeril and cyclobenzapine hydrochloride. Concomitant medications included ascorbic acid, ascorbic acid/ ergocalciferol/folic acid/ nicotinamide/ panthenol/retinol/ riboflavin/ thiamine hydrochloride, ergocalciferol, iron, and withania somnifera.   Smoking history, drug abuse and alcohol intake were not reported. Three (3) days after receiving the vaccine, patient was noted to have a blood clot (unspecified area) that caused an acute ischemic stroke in the left frontal lobe, resulting in muscle weakness and partial loss of use of the right leg. Patient had blood tests done as well as CT Scan, carotid artery ultrasound, electrocardiogram and MRI but the results were not reported. The information provided precludes a meaningful medical assessment. Additional information requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Monoparesis, Muscular weakness, Thrombosis, Ultrasound Doppler, Ultrasound scan
Clinical narrative: CLOT BLOOD; ACUTE ISCHEMIC STROKE IN LEFT FRONTAL LOBE; PARTIAL LOSS OF USE IN RIGHT LEG; MUSCLE WEAKNESS; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included amoxicillin and flexeril allergy, and migraine. The patient experienced drug allergy when treated with cyclobenzaprine hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 11:30 on left arm for prophylactic vaccination. Concomitant medications included ascorbic acid, ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride, ergocalciferol, iron, and withania somnifera.  Approximately three days after the vaccine, on 11-APR-2021 08:20, the patient experienced clot blood. Which caused an acute ischemic stroke in left frontal lobe resulting in partial loss of use in right leg and muscle weakness. The patient had a blood test, CT scan, Carotid artery ultrasound, diagnostic ultrasound, electrocardiogram (EKG) and an MRI, results are unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from clot blood, acute ischemic stroke in left frontal lobe, muscle weakness, and partial loss of use in right leg. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a report of a 46 year old, female patient  who experienced a blood clot that caused an acute ischemic stroke in the left fontal lobe 3 days after receiving the covid-19 vaccine ad26.cov.2.  Patient's height and weight were not reported. Patient has migraine and allergies to amoxicillin, flexeril and cyclobenzapine hydrochloride. Concomitant medications included ascorbic acid, ascorbic acid/ ergocalciferol/folic acid/ nicotinamide/ panthenol/retinol/ riboflavin/ thiamine hydrochloride, ergocalciferol, iron, and withania somnifera.   Smoking history, drug abuse and alcohol intake were not reported. Three (3) days after receiving the vaccine, patient was noted to have a blood clot (unspecified area) that caused an acute ischemic stroke in the left frontal lobe, resulting in muscle weakness and partial loss of use of the right leg. Patient had blood tests done as well as CT Scan, carotid artery ultrasound, electrocardiogram and MRI but the results were not reported. The information provided precludes a meaningful medical assessment. Additional information requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Oropharyngeal pain, Pain in extremity
Clinical narrative: LOSS OF VOICE, RASPY VOICE, DIFFICULTY PROJECTING VOICE; SORE THROAT; SORE ARM; This spontaneous report received from a patient concerned a 55 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, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced sore arm. On 11-MAR-2021, the subject experienced loss of voice, raspy voice, difficulty projecting voice. On 11-MAR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of voice, raspy voice, difficulty projecting voice, and the outcome of sore arm and sore throat was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Insomnia, Tinnitus
Clinical narrative: TINNITUS; UNABLE TO EAT; UNABLE TO SLEEP; This spontaneous report received from a patient concerned a 64 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, batch number: 042A01A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 08:15 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced tinnitus. On 08-APR-2021, the subject experienced unable to eat. On 08-APR-2021, the subject experienced unable to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus, unable to eat, and unable to sleep. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Bursal fluid accumulation, Computerised tomogram, Headache
Clinical narrative: FLUID IN THE HIP AREA BELOW THE SPINE; PAIN IN BOTH LEGS; EXTREME LOWER BACK PAIN; TINGLING IN FEET; HEADACHE; 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 pre-existing medical conditions included the patient had no known allergies. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced extreme lower back pain. On 25-MAR-2021, the subject experienced tingling in feet. On 25-MAR-2021, the subject experienced pain in both legs. On 11-APR-2021, the subject experienced fluid in the hip area below the spine. Laboratory data included: Blood test (NR: not provided) No blood clot, CAT scan (NR: not provided) No blood clot but fluid below the spine, and Diagnostic ultrasound (NR: not provided) No blood clot but fluid below the spine. Treatment medications (dates unspecified) included: acetylsalicylic acid, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 21-MAR-2021, was recovering from extreme lower back pain, pain in both legs, and tingling in feet, and the outcome of fluid in the hip area below the spine was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Ultrasound scan
Clinical narrative: FLUID IN THE HIP AREA BELOW THE SPINE; PAIN IN BOTH LEGS; EXTREME LOWER BACK PAIN; TINGLING IN FEET; HEADACHE; 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 pre-existing medical conditions included the patient had no known allergies. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced extreme lower back pain. On 25-MAR-2021, the subject experienced tingling in feet. On 25-MAR-2021, the subject experienced pain in both legs. On 11-APR-2021, the subject experienced fluid in the hip area below the spine. Laboratory data included: Blood test (NR: not provided) No blood clot, CAT scan (NR: not provided) No blood clot but fluid below the spine, and Diagnostic ultrasound (NR: not provided) No blood clot but fluid below the spine. Treatment medications (dates unspecified) included: acetylsalicylic acid, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 21-MAR-2021, was recovering from extreme lower back pain, pain in both legs, and tingling in feet, and the outcome of fluid in the hip area below the spine was not reported. This report was non-serious.