chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Melaena, Myalgia, Peripheral swelling, Polymenorrhoea, Vaginal haemorrhage
Clinical narrative: MELENA; BLOOD IN STOOL; BRUISING ON THE LOWER HALF OF HER BODY; HEAVY VAGINAL BLEEDING; HEMATURIA; ABDOMINAL PAIN; DIZZINESS; HYPERTENSION; ARM SWELLING; EARLY MENSES; HEAVY MENSTRUAL FLOW; MUSCLE ACHES; FATIGUE; HEADACHE; 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 administration not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, one total, administered to the left arm on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient got the vaccine and had arm swelling, fatigue, muscle aches, and abdominal pain. The following Monday on 12-APR-2021, the patient experienced heavy vaginal bleeding which was not related to menses. Tuesday on 13-APR-2021, the patient had  bruising on the lower half of her body. On Wednesday 14-APR-2021, the patient noticed a large bruise on her thigh and experienced hematuria which was not consistent every time she uses the restroom. On the following Friday 16-APR-2021, the patient experienced blood in the stool. Additionally, following Saturday and Sunday, the patient noticed she had more bruises. On 27-APR-2021, she went to urgent care and then followed by the emergency room (ER), and got her bloodwork taken and her platelets were 345. The patient was experiencing menses early and going through 1 ultra tampon every hour. She was also having headache, dizziness, melena, and hypertension. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm swelling, and muscle aches on APR-2021, had not recovered from abdominal pain, heavy vaginal bleeding, hematuria, bruising on the lower half of her body, hypertension, and melena, and the outcome of fatigue, early menses, heavy menstrual flow, headache, dizziness and blood in stool was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210453653-covid-19 vaccine ad26.cov2.s-malena, blood in stool. 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Thrombosis, Ultrasound scan, X-ray
Clinical narrative: BLOOD CLOT WITH DYING PAIN IN RIGHT SHOULDER; This spontaneous report received from a patient concerned a 72 year old  female.  The patient's weight was 141 pounds, and height was 164 centimeters. The patient's concurrent conditions included back pain, two cysts on kidney, high blood pressure, anxiety, high cholesterol, non smoker, non alcoholic, and spine issue, and other pre-existing medical conditions included it was unknown that patient had drug abuse or illicit drug usage. she was health healthy and always doing exercises, she lifts 3kg dumbbells and walked and use indoor bicycle for exercise. 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, frequency one total administered on 15-MAR-2021 for prophylactic vaccination. Concomitant medications included citalopram for anxiety, lorazepam for anxiety, oxycodone for back pain, and spine issue, and acetylsalicylic acid for drug used for unknown indication. Patient received vaccine on March 15, 2021 at a local vaccination center. she woke up with pain and had this for several days before. somebody suggested going to the Emergency room. Patient proceeded to ER on 26-March-2021 and was seen by Doctor. Doctor suspected a blood clot and told the if its blood clot  it could moved  to lung and cause stroke. The patient reports the following tests were performed  X-ray, ultrasound and blood tests. Test results all showed blood clot that the patient describes as deep vein in the right shoulder between shoulder and neck. Patient reported that she was given a blood thinner in her tummy and then a prescription for 30 days of Eliquis 5mg. Patient reported that the pain was killing her and stated she was dying of pain. The pain was in the area of the blood clot (right shoulder). Patient was also seen by a specialist who prescribed Eliquis prescription for 1 year. she was taking baby aspirin which told to continued. she finished her 30 days prescription ,she planning to visit ER as pain had not go away. She has been told not to stop the blood thinner as it is dangerous.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot, and dying of pain s in the area of the blood clot (right shoulder). This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210453704-COVID-19 VACCINE AD26.COV2.S - BLOOD CLOT WITH DYING PAIN IN RIGHT SHOULDER. This event is considered unassessable. The event 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.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Palpitations, Ventricular extrasystoles
Clinical narrative: HEART PALPITATIONS; NUMBNESS IN THE FACE; PREMATURE VENTRICULAR CONTRACTIONS; 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, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced premature ventricular contractions. On 10-APR-2021, the subject experienced heart palpitations. On 10-APR-2021, the subject experienced numbness in the face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart palpitations, numbness in the face and premature ventricular contractions 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.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Flatulence, Malaise, Nausea
Clinical narrative: STOMACH NOT FEELING GOOD; GAS INSIDE THE STOMACH; NOT FELT GOOD AFTER VACCINATION; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. 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 stomach not feeling good, gas inside the stomach, not felt good after vaccination, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stomach not feeling good, not felt good after vaccination, nausea and gas inside the stomach was not reported. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Magnetic resonance imaging, Systemic lupus erythematosus, White blood cell count
Clinical narrative: LUPUS FLARING; This spontaneous report received from a patient via a company representative concerned a 42 year old female.  The patient's height, and weight were not reported. The patient's concurrent conditions included lupus, adrenal problems, non alcohol user, and non smoker. The patient had no known allergies and no history of drug abuse or illicit. 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: 042A21A expiry: UNKNOWN) dose was not reported, 1 in total administered at left arm on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the patient was sick for 3 weeks already and could not even get out of bed and recently had lupus flaring and adrenal issues. The patient was experienced canker sores in mouth, pain in left upper chest, diarrhea, left arm pain, bad headaches and extreme fatigue. The patient could not keep on getting pains all up and down her left side. She went to hospital twice with various tests which includes computed tomography scan, Electrocardiography, Magnetic resonance imaging, and White blood all results were normal. The patient was seeking guidance on why the adverse event are lasting so long and was concerned that she might die from after taking the vaccine shot.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lupus flaring. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210453759-covid-19 vaccine ad26.cov2.s-Lupus flaring. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Thrombosis
Clinical narrative: DEATH; BLOOD CLOT; This spontaneous report received from a consumer news/social media platform concerned a 5 decade 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient developed a rare blood clot and died within two weeks of getting the Janssen covid vaccine. On an unspecified date, the patient died from unknown cause of death. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to.; Sender's Comments: V0-covid-19 vaccine ad26.cov2.s-This case concerns with 5 decade old female. Death, Blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Asthma, Dizziness, Dyspnoea, Fatigue
Clinical narrative: SHORTNESS OF BREATH; ASTHMA ATTACK; DIZZINESS; EXPERIENCING HOT FLASHES; SORE ARM; SWEATING; PASSING OUT RIGHT AFTER VACCINATION; SLEEPY; LOW ENERGY; WEAKNESS; TIRED; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included codeine allergy, penicillin allergy, anxiety, smoker, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 on right arm for prophylactic vaccination. Concomitant medications included clonazepam for anxiety, and ibuprofen for pain/ and inflammation. On 12-APR-2021, after 5 minutes, the patient started feeling dizzy and passed out. He woke up as nurse pulling his chest hair and nurse was about to give him adrenaline shot. The patient was for his vitals until restabilized and was asked to walk around for sometime. The patient had sore arm. The patient was at facility for 2 hours. On 12-APR-2021, at night, he woke up sweating and experiencing hot flashes as if med going through his body.  On 16-APR-2021, the patient was not breathing well at night and woke up with an asthma attack which lasted for about 3 hours and the whole next day. He visited clinic for asthma attack and was prescribed with medicines. He had a week and half of low energy. On 27-APR-2021, the patient stated that he was still feeling sleepy, dizzy and tired sometimes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passing out right after vaccination on 12-APR-2021, experiencing hot flashes, shortness of breath, asthma attack, and sweating, and sore arm on 19-APR-2021, and had not recovered from dizziness, weakness, sleepy, tired, and half of low energy. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210453787-COVID vaccine-loss of consciousness. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Hyperhidrosis, Loss of consciousness, Pain in extremity, Somnolence
Clinical narrative: SHORTNESS OF BREATH; ASTHMA ATTACK; DIZZINESS; EXPERIENCING HOT FLASHES; SORE ARM; SWEATING; PASSING OUT RIGHT AFTER VACCINATION; SLEEPY; LOW ENERGY; WEAKNESS; TIRED; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included codeine allergy, penicillin allergy, anxiety, smoker, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 on right arm for prophylactic vaccination. Concomitant medications included clonazepam for anxiety, and ibuprofen for pain/ and inflammation. On 12-APR-2021, after 5 minutes, the patient started feeling dizzy and passed out. He woke up as nurse pulling his chest hair and nurse was about to give him adrenaline shot. The patient was for his vitals until restabilized and was asked to walk around for sometime. The patient had sore arm. The patient was at facility for 2 hours. On 12-APR-2021, at night, he woke up sweating and experiencing hot flashes as if med going through his body.  On 16-APR-2021, the patient was not breathing well at night and woke up with an asthma attack which lasted for about 3 hours and the whole next day. He visited clinic for asthma attack and was prescribed with medicines. He had a week and half of low energy. On 27-APR-2021, the patient stated that he was still feeling sleepy, dizzy and tired sometimes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passing out right after vaccination on 12-APR-2021, experiencing hot flashes, shortness of breath, asthma attack, and sweating, and sore arm on 19-APR-2021, and had not recovered from dizziness, weakness, sleepy, tired, and half of low energy. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210453787-COVID vaccine-loss of consciousness. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Heart rate increased, Hypokinesia, Muscular weakness
Clinical narrative: RAPID HEART RATE; DIZZINESS; UNABLE TO MOVE; MUSCLE ACHES; HEADACHE; LEGS WOBBLING; This spontaneous report received from a patient concerned an 83 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: Unknown, and batch number: 6043A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced legs wobbling. On an unspecified date, the subject experienced rapid heart rate, dizziness, unable to move, muscle aches, and headache. Laboratory data (dates unspecified) included: X-ray (NR: not provided) not related to symptoms. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle aches, dizziness, headache, rapid heart rate, legs wobbling and unable to move was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard operating procedure as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, X-ray
Clinical narrative: RAPID HEART RATE; DIZZINESS; UNABLE TO MOVE; MUSCLE ACHES; HEADACHE; LEGS WOBBLING; This spontaneous report received from a patient concerned an 83 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: Unknown, and batch number: 6043A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced legs wobbling. On an unspecified date, the subject experienced rapid heart rate, dizziness, unable to move, muscle aches, and headache. Laboratory data (dates unspecified) included: X-ray (NR: not provided) not related to symptoms. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle aches, dizziness, headache, rapid heart rate, legs wobbling and unable to move was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard operating procedure as the case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: ADVERSE EFFECT AND STILL HAVING PROBLEM; This spontaneous report received from a patient via social media concerned a patient of unspecified age and sex.   The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient reported that had a adverse effect and just got discharged from the hospital after 5 days of antibiotics and still having problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from adverse effect and still having problem. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- COVID-19 VACCINE AD26.COV2.s.adverse effect . This event is considered unassessable. The event 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.
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling cold, Groin pain, Headache, Pain in extremity
Clinical narrative: FEELING COLD; JOINT PAIN IN GROIN; LEG AND ARM PAIN; HEADACHE; STOMACH PAIN; This spontaneous report received from a patient concerned a 29 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, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, the subject experienced stomach pain. On 27-APR-2021, the subject experienced feeling cold. On 27-APR-2021, the subject experienced joint pain in groin. On 27-APR-2021, the subject experienced leg and arm pain. On 27-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 joint pain in groin, leg and arm pain, feeling cold, headache, and stomach pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: MIGRAINE HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced migraine headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of migraine headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210453792.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: INCREASED SLEEP; TIREDNESS; This spontaneous report received from a consumer concerned a 57 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: 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 MAR-2021, the subject experienced increased sleep. On MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness, and increased sleep. This report was non-serious.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Discomfort, Feeling abnormal, Lethargy
Clinical narrative: FEELING LETHARGIC; HAVEN'T BEEN FEELING GOOD EVER SINCE; OCCASIONAL SHORT FEVER MILD; SEVERE NAUSEA; STOMACH UPSET EVERY TIME WHEN EATING AND FASTING; BRAIN FOG; BLOATING AFTER EATING; DISCOMFORT; This spontaneous report received from a patient concerned a 32 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 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced stomach upset every time when eating and fasting. On 11-APR-2021, the subject experienced brain fog. On 11-APR-2021, the subject experienced bloating after eating. On 11-APR-2021, the subject experienced severe nausea. On 11-APR-2021, the subject experienced discomfort. On 11-APR-2021, the subject experienced haven't been feeling good ever since. On 11-APR-2021, the subject experienced occasional short fever mild. On 12-APR-2021, the subject experienced feeling lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from occasional short fever mild, and had not recovered from stomach upset every time when eating and fasting, discomfort, severe nausea, brain fog, bloating after eating, feeling lethargic, and haven't been feeling good ever since. 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: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pyrexia
Clinical narrative: FEELING LETHARGIC; HAVEN'T BEEN FEELING GOOD EVER SINCE; OCCASIONAL SHORT FEVER MILD; SEVERE NAUSEA; STOMACH UPSET EVERY TIME WHEN EATING AND FASTING; BRAIN FOG; BLOATING AFTER EATING; DISCOMFORT; This spontaneous report received from a patient concerned a 32 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 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced stomach upset every time when eating and fasting. On 11-APR-2021, the subject experienced brain fog. On 11-APR-2021, the subject experienced bloating after eating. On 11-APR-2021, the subject experienced severe nausea. On 11-APR-2021, the subject experienced discomfort. On 11-APR-2021, the subject experienced haven't been feeling good ever since. On 11-APR-2021, the subject experienced occasional short fever mild. On 12-APR-2021, the subject experienced feeling lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from occasional short fever mild, and had not recovered from stomach upset every time when eating and fasting, discomfort, severe nausea, brain fog, bloating after eating, feeling lethargic, and haven't been feeling good ever since. 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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue
Clinical narrative: EXHAUSTED; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 18-APR-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for ulcerative colitis, and crohn's disease. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 19-APR-2021, the subject experienced exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient recovered from exhausted on 19-APR-2021. This report was non-serious.
Age: 52.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Pulmonary thrombosis
Clinical narrative: BLOOD CLOTS IN THE LUNGS; CHEST PAIN; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 52 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, route of admin not reported, batch number: unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination in the left arm. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-APR-2021, the subject experienced chest pain and shortness of breath and was taken to the Emergency Room. The patient was hospitalized and a diagnosis of blood clots in the lungs was made. The patient was hospitalized for 4 days. Corrective treatment included blood thinners ( to be taken for 6 months) and a follow-up appointment with the pulmonologist was scheduled.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots in the lungs, chest pain and shortness of breath was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210454248-Covid-19 vaccine ad26.cov2.s-Blood clots in the lungs, chest pain and shortness of breath. 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: 52.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Chest X-ray, Chest discomfort, Chest pain, Computerised tomogram thorax abnormal
Clinical narrative: BLOOD CLOTS IN THE LUNGS; CHEST PAIN; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 52 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, route of admin not reported, batch number: unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination in the left arm. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-APR-2021, the subject experienced chest pain and shortness of breath and was taken to the Emergency Room. The patient was hospitalized and a diagnosis of blood clots in the lungs was made. The patient was hospitalized for 4 days. Corrective treatment included blood thinners ( to be taken for 6 months) and a follow-up appointment with the pulmonologist was scheduled.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots in the lungs, chest pain and shortness of breath was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210454248-Covid-19 vaccine ad26.cov2.s-Blood clots in the lungs, chest pain and shortness of breath. 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: 52.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram, Painful respiration, Pulmonary thrombosis
Clinical narrative: BLOOD CLOTS IN THE LUNGS; CHEST PAIN; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 52 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, route of admin not reported, batch number: unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination in the left arm. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-APR-2021, the subject experienced chest pain and shortness of breath and was taken to the Emergency Room. The patient was hospitalized and a diagnosis of blood clots in the lungs was made. The patient was hospitalized for 4 days. Corrective treatment included blood thinners ( to be taken for 6 months) and a follow-up appointment with the pulmonologist was scheduled.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots in the lungs, chest pain and shortness of breath was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210454248-Covid-19 vaccine ad26.cov2.s-Blood clots in the lungs, chest pain and shortness of breath. 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: 52.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: BLOOD CLOTS IN THE LUNGS; CHEST PAIN; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 52 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, route of admin not reported, batch number: unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination in the left arm. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-APR-2021, the subject experienced chest pain and shortness of breath and was taken to the Emergency Room. The patient was hospitalized and a diagnosis of blood clots in the lungs was made. The patient was hospitalized for 4 days. Corrective treatment included blood thinners ( to be taken for 6 months) and a follow-up appointment with the pulmonologist was scheduled.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots in the lungs, chest pain and shortness of breath was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210454248-Covid-19 vaccine ad26.cov2.s-Blood clots in the lungs, chest pain and shortness of breath. 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: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis
Clinical narrative: BLOOD CLOT IN BRAIN; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in brain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in brain was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210453717.; Sender's Comments: V0:20210454254-covid-19 vaccine ad26.cov2.s-blood clot in brain. This event(s) is considered related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES BLISTERS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, penicillin allergy, and shellfish allergy. The patient was previously treated with gabapentin, vitamin b12 nos, salbutamol, fluticasone propionate, meloxicam, omeprazole, rosuvastatin calcium, levothyroxine, tizanidine hydrochloride, valaciclovir hydrochloride, estradiol, nystatin, amlodipine, hyoscyamine sulfate, ketorolac tromethamine, ondansetron, loratadine, and biotin; and experienced drug allergy when treated with ciprofloxacin, and trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced shingles blisters. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from shingles blisters on 30-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Sinusitis, Thyroid pain
Clinical narrative: SINUS INFECTION; THYROID PAIN; 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: unk) 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 sinus infection. On APR-2021, the subject experienced thyroid pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sinus infection and thyroid pain 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.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Feeling jittery, Headache
Clinical narrative: RAPID HEART RATE; EXTREME DIZZINESS; SLIGHT COUGH; JITTERINESS; TIGHTNESS IN THROAT; INJECTION SITE PAIN; ON AND OFF HEADACHES; FEVER; DIFFICULTY BREATHING; 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 07-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 difficulty breathing. On APR-2021, the subject experienced tightness in throat. On APR-2021, the subject experienced injection site pain. On APR-2021, the subject experienced on and off headaches. On APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced rapid heart rate. On 08-APR-2021, the subject experienced extreme dizziness. On 08-APR-2021, the subject experienced slight cough. On 08-APR-2021, the subject experienced jitteriness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, and fever on APR-2021, and was recovering from difficulty breathing, rapid heart rate, extreme dizziness, slight cough, jitteriness, on and off headaches, and tightness in throat. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard operating procedure as the case is assessed as Non-serious
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, Injection site pain, Pyrexia, Throat tightness
Clinical narrative: RAPID HEART RATE; EXTREME DIZZINESS; SLIGHT COUGH; JITTERINESS; TIGHTNESS IN THROAT; INJECTION SITE PAIN; ON AND OFF HEADACHES; FEVER; DIFFICULTY BREATHING; 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 07-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 difficulty breathing. On APR-2021, the subject experienced tightness in throat. On APR-2021, the subject experienced injection site pain. On APR-2021, the subject experienced on and off headaches. On APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced rapid heart rate. On 08-APR-2021, the subject experienced extreme dizziness. On 08-APR-2021, the subject experienced slight cough. On 08-APR-2021, the subject experienced jitteriness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, and fever on APR-2021, and was recovering from difficulty breathing, rapid heart rate, extreme dizziness, slight cough, jitteriness, on and off headaches, and tightness in throat. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard operating procedure as the case is assessed as Non-serious
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer (source: news report) concerned a female of age under 60. 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, expiry: unknown) dose, 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. It was reported from a news story that, on an unspecified date, the patient experienced blood clots which was in investigation by an agency.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210454646.; Sender's Comments: V0:20210454446-covid-19 vaccine ad26.cov2.s- Blood clots. 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: ITCHINESS AT INJECTION SITE; INJECTION SITE ARM FEELS PAIN/SORE/HURTS; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient was previously treated with nortriptyline for antidepressant, duloxetine for antidepressant, progesterone, and estradiol. 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 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 27-APR-2021, the subject experienced itchiness at injection site. On 27-APR-2021, the subject experienced injection site arm feels pain/sore/hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site arm feels pain/sore/hurts, and itchiness at injection site. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 43 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-APR-2021, the subject experienced suspected immunological vaccine failure.  Laboratory data included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was non-serious.
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Weight decreased
Clinical narrative: WEIGHT LOSS; MALAISE; GENERALIZED JOINT PAIN; .This spontaneous report received from a parent concerned a 19 year old of unspecified sex. The patient's weight was 49.5 kilograms, and height was not reported. The patient's pre-existing medical conditions included the patient had no history of vaccine allergy and no pre-existing acute illness 30 days prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (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 APR-2021, the subject experienced weight loss. On APR-2021, the subject experienced malaise. On APR-2021, the subject experienced generalized joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the malaise, weight loss and generalized joint pain was not reported. This report was non-serious. This parent/child case is linked to.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pain, Palpitations
Clinical narrative: CAN HEAR OWN HEART BEAT IN EARS; BODY ACHES SORENESS; CHILLS; NOT STRONG WEAK; HEADACHE; .This spontaneous report received from a patient concerned a 23 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 27-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-APR-2021, the subject experienced can hear own heart beat in ears. On 27-APR-2021, the subject experienced body aches soreness. On 27-APR-2021, the subject experienced chills. On 27-APR-2021, the subject experienced not strong weak. On 27-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, headache, not strong weak, body aches soreness and can hear own heart beat in ears was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer concerned an adult 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) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot. The reporter stated that as per news report, the agency was investigating this case of blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210454446.; Sender's Comments: V0:20210454646-covid-19 vaccine ad26.cov2.s -blood clot. This event(s) is considered unassessable. The event(s) 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(s).