chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract oedema, Suffocation feeling, Urticaria
Clinical narrative: SWELLING OF AIRWAY; FEELING OF SUFFOCATION; SWELLING OF ENTIRE BODY; SHORTNESS OF BREATH; RASHES THROUGHOUT BODY; HIVES THROUGHOUT  BODY; WATER RETENTION; GI PAIN; This spontaneous report received from a consumer concerned a female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, non-smoker, and seasonal allergy, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 (vaccinated at left deltoid) for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the Patient experienced water retention, gi pain, rashes throughout body and hives throughout body. On 20-MAR-2021, the patient experienced swelling of airway, feeling of suffocation, swelling of entire body and shortness of breath. Treatment medications included: epinephrine and antihistamines. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of airway, and feeling of suffocation, had not recovered from swelling of entire body, water retention, gi pain, rashes throughout body, and hives throughout body, and the outcome of shortness of breath was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210350470-covid-19 vaccine ad26.cov2.s- Rashes throughout body, Hives throughout body. This events are labeled and is therefore considered potentially related.  20210350470-covid-19 vaccine ad26.cov2.s-Swelling of airway, Shortness of breath ,Swelling of entire body ,Feeling of suffocation, Water retention ,GI Pain. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: VACCINE IS GIVEN TO A 17 YEARS OLD AND 6 MONTHS PATIENT; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 17 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: Unk) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-MAR-2021, the vaccine was given to a 17 years old and 6 months patient (coded as off label use and drug administered to patient of inappropriate age). Nurse wanted to know if there was anything she need to do from their end. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine is given to a 17 years old and 6 months patient and off label use was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210350675-COVID-19 VACCINE AD26.COV2.S -Vaccine Is Given To A 17 Years Old And 6 Months Patient, Off Label Use. This events are considered not related. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: SPECIAL SITUATIONS
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Delirium, Gait disturbance, Headache, Nausea, Peripheral coldness
Clinical narrative: DELIRIUM; PAIN IN HEART; DIFFICULTY IN WALKING; COLD EXTREMETIES; BODYACHE; VASCILLATE BETWEEN HOT AND CHILLS; HEADACHE; NAUSEA; FEVER; 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 concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known allergies,no drug abuse. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, intramuscular, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered in left arm on 24-MAR-2021 at 19:30 for prophylactic vaccination. Concomitant medications included paracetamol for drug used for unknown indication.  On 25-MAR-2021, the patient experienced nausea, difficulty in walking, fever , cold extremities , delirium ,vascillate between hot and chills, pain in heart ,headache body ache . The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from delirium, and pain in heart on 25-MAR-2021, and had not recovered from nausea, difficulty in walking, fever, cold extremeties, vascillate between hot and chills, headache, and bodyache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210350740-COVID-19 VACCINE AD26.COV2.S - Delirium. 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: DELIRIUM; PAIN IN HEART; DIFFICULTY IN WALKING; COLD EXTREMETIES; BODYACHE; VASCILLATE BETWEEN HOT AND CHILLS; HEADACHE; NAUSEA; FEVER; 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 concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known allergies,no drug abuse. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, intramuscular, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered in left arm on 24-MAR-2021 at 19:30 for prophylactic vaccination. Concomitant medications included paracetamol for drug used for unknown indication.  On 25-MAR-2021, the patient experienced nausea, difficulty in walking, fever , cold extremities , delirium ,vascillate between hot and chills, pain in heart ,headache body ache . The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from delirium, and pain in heart on 25-MAR-2021, and had not recovered from nausea, difficulty in walking, fever, cold extremeties, vascillate between hot and chills, headache, and bodyache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210350740-COVID-19 VACCINE AD26.COV2.S - Delirium. 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood pressure increased, Hyperacusis, Hypoaesthesia, Paraesthesia
Clinical narrative: ANAPHYLACTIC REACTION, NAUSEA, VOMITING, DIARRHEA, PAIN, DISTRESS AND HEADACHE.; BLOOD PRESSURE ESCALATED; TINNITUS AND RINGING; NUMBNESS; TINGLING OF THE EARS; HYPERSENSITIVE TO SOUNDS; This spontaneous report received from a physician and concerned a 54 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 was not reported, administered on 24-MAR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On an unspecified date, the patient experienced anaphylactic reaction, tingling of the ears, numbness and tingling of ears, blood pressure escalated, hypersensitive to sounds, pain/distress, diarrhea, vomiting, tinnitus, headache, and nausea. Treatment medications (dates unspecified) included: epinephrine, triamcinolone acetonide, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling of the ears, numbness and tingling of ears, and vomiting, had not recovered from headache, nausea, diarrhea, and tinnitus, and the outcome of anaphylactic reaction, blood pressure escalated, hypersensitive to sounds and pain/distress was not reported. Initial information was processed along with the additional information received on 27-mar-2021. additional event of tinnitus was added. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210350839-Covid-19 vaccine ad26.cov2.s-Anaphylactic reaction. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.  V0: 20210350839-Covid-19 vaccine ad26.cov2.s-Blood pressure escalated, tingling of ear, numbness, hypersensitive to sound, tinnitus. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ANAPHYLACTIC REACTION, NAUSEA, VOMITING, DIARRHEA, PAIN, DISTRESS AND HEADACHE.; BLOOD PRESSURE ESCALATED; TINNITUS AND RINGING; NUMBNESS; TINGLING OF THE EARS; HYPERSENSITIVE TO SOUNDS; This spontaneous report received from a physician and concerned a 54 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 was not reported, administered on 24-MAR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On an unspecified date, the patient experienced anaphylactic reaction, tingling of the ears, numbness and tingling of ears, blood pressure escalated, hypersensitive to sounds, pain/distress, diarrhea, vomiting, tinnitus, headache, and nausea. Treatment medications (dates unspecified) included: epinephrine, triamcinolone acetonide, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling of the ears, numbness and tingling of ears, and vomiting, had not recovered from headache, nausea, diarrhea, and tinnitus, and the outcome of anaphylactic reaction, blood pressure escalated, hypersensitive to sounds and pain/distress was not reported. Initial information was processed along with the additional information received on 27-mar-2021. additional event of tinnitus was added. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210350839-Covid-19 vaccine ad26.cov2.s-Anaphylactic reaction. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.  V0: 20210350839-Covid-19 vaccine ad26.cov2.s-Blood pressure escalated, tingling of ear, numbness, hypersensitive to sound, tinnitus. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Headache, Musculoskeletal chest pain, Pain
Clinical narrative: RIB PAIN; SEVERE GENERAL BODY PAIN; FEELING HOT AND COLD; BODY CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned an female of unspecified age. The patient's weight, height, and medical history were not reported. The patient initiated treatment with COVID-19 vaccine AD26.COV2.s (suspension for injection, route of administration was not reported, batch number: 1808609, expiry date: unknown) dose was not reported, on 25-MAR-2021 at 15:00, for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, about 19:00, she experienced severe side effects that included rib pain, severe general body pain, felt hot and cold, had body chills, headache and fever. On 26-MAR-2021, at 1:00, she was admitted to the hospital. In the emergency room, she received treatment with ketorolac and sodium chloride intravenously and was instructed to purchase Motrin for home use. On 27-Mar-2021, at 4:00, she was discharged. Number of days of hospitalization was 1. At the time of discharge, around 4:00, she felt better with some improvement of pain but, the symptoms started again. The action taken with COVID-19 vaccine AD26.COV2.s was not applicable. The patient had not recovered from body chills, fever, rib pain, severe general body pain, headache, and feeling hot and cold. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210351965-Covid-19 vaccine ad26.cov2.s-Rib pain, Severe general body pain, Feeling hot and cold, Body chills. 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). 20210351965-Covid-19 vaccine ad26.cov2.s-Headache, Fever. This event(s) is labeled and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: RIB PAIN; SEVERE GENERAL BODY PAIN; FEELING HOT AND COLD; BODY CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned an female of unspecified age. The patient's weight, height, and medical history were not reported. The patient initiated treatment with COVID-19 vaccine AD26.COV2.s (suspension for injection, route of administration was not reported, batch number: 1808609, expiry date: unknown) dose was not reported, on 25-MAR-2021 at 15:00, for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, about 19:00, she experienced severe side effects that included rib pain, severe general body pain, felt hot and cold, had body chills, headache and fever. On 26-MAR-2021, at 1:00, she was admitted to the hospital. In the emergency room, she received treatment with ketorolac and sodium chloride intravenously and was instructed to purchase Motrin for home use. On 27-Mar-2021, at 4:00, she was discharged. Number of days of hospitalization was 1. At the time of discharge, around 4:00, she felt better with some improvement of pain but, the symptoms started again. The action taken with COVID-19 vaccine AD26.COV2.s was not applicable. The patient had not recovered from body chills, fever, rib pain, severe general body pain, headache, and feeling hot and cold. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210351965-Covid-19 vaccine ad26.cov2.s-Rib pain, Severe general body pain, Feeling hot and cold, Body chills. 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). 20210351965-Covid-19 vaccine ad26.cov2.s-Headache, Fever. This event(s) is labeled and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Contusion, Diarrhoea, Gastrointestinal sounds abnormal
Clinical narrative: PAIN IN ARM/MINOR PAIN IN RIGHT ARM (BOTH SIDES) NEAR ELBOW; PAIN IN TOE/MEDIUM PAIN IN BOTH TOES AND SECOND TOE ON LEFT FOOT; HOT/HOT FLUSH; BRUISE ON LEFT ARM; HEADACHE; FAINT; PAIN IN PELVIC AREA; ABDOMINAL PAIN; BUBBLING SENSATION AS IF THERE WAS A VIRAL INFECTION OR STOMACH FLU; DIARRHEA; VOMITING; SWEATING; SLIGHTLY WEAK; VEINS PROTRUDING FROM LEGS AND ARMS MORE THAN USUAL; Throbbing pain in knuckle of right hand; This spontaneous report received from a patient of unspecified age and sex reporting on self. 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: 1085031 and expiry: unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced minor side effects the day of minor pain in right arm (both sides) near elbow (pain in arm), medium pain in both toes and second toe on left foot (pain in toe). The toe pain continued for a few days. On 23-MAR-2021 (mentioned as next week), the patient noticed veins protruding from legs and arms more than usual (dilated veins). The patient mentioned no pain, however and throbbing pain in knuckle of right hand (throbbing pain). On 24-MAR-2021 and 25-MAR-2021 (also mentioned as next week), the patient had pain in pelvic area (pelvic pain), abdominal pain (bubbling sensation as if there was a viral infection or stomach flu (abdominal noises)), diarrhea, some vomiting, hot/hot flush and sweating, slightly weak (weakness) and faint all symptoms on same day. The patient took Pedialyte to help with vomiting and to restore energy. On next day, 26-MAR- 2021, the patient was feeling much better. Most symptoms were gone. But there continues to be hot flashes as had been all along (but this may be due to hormones). On 26-MAR-2021, headache continued as well.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hot flashes, and headache, and the outcome of pain in arm/minor pain in right arm (both sides) near elbow, pain in toe/medium pain in both toes and second toe on left foot, veins protruding from legs and arms more than usual, throbbing pain in knuckle of right hand, pain in pelvic area, abdominal pain, bubbling sensation as if there was a viral infection or stomach flu, diarrhea, vomiting, hot/hot flush and sweating, slightly weak, faint and bruise on left arm was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210352411-covid-19 vaccine ad26.cov2.s-Faint. 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: U
Vaccine: COVID19
Symptoms: Headache, Hot flush, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: PAIN IN ARM/MINOR PAIN IN RIGHT ARM (BOTH SIDES) NEAR ELBOW; PAIN IN TOE/MEDIUM PAIN IN BOTH TOES AND SECOND TOE ON LEFT FOOT; HOT/HOT FLUSH; BRUISE ON LEFT ARM; HEADACHE; FAINT; PAIN IN PELVIC AREA; ABDOMINAL PAIN; BUBBLING SENSATION AS IF THERE WAS A VIRAL INFECTION OR STOMACH FLU; DIARRHEA; VOMITING; SWEATING; SLIGHTLY WEAK; VEINS PROTRUDING FROM LEGS AND ARMS MORE THAN USUAL; Throbbing pain in knuckle of right hand; This spontaneous report received from a patient of unspecified age and sex reporting on self. 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: 1085031 and expiry: unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced minor side effects the day of minor pain in right arm (both sides) near elbow (pain in arm), medium pain in both toes and second toe on left foot (pain in toe). The toe pain continued for a few days. On 23-MAR-2021 (mentioned as next week), the patient noticed veins protruding from legs and arms more than usual (dilated veins). The patient mentioned no pain, however and throbbing pain in knuckle of right hand (throbbing pain). On 24-MAR-2021 and 25-MAR-2021 (also mentioned as next week), the patient had pain in pelvic area (pelvic pain), abdominal pain (bubbling sensation as if there was a viral infection or stomach flu (abdominal noises)), diarrhea, some vomiting, hot/hot flush and sweating, slightly weak (weakness) and faint all symptoms on same day. The patient took Pedialyte to help with vomiting and to restore energy. On next day, 26-MAR- 2021, the patient was feeling much better. Most symptoms were gone. But there continues to be hot flashes as had been all along (but this may be due to hormones). On 26-MAR-2021, headache continued as well.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hot flashes, and headache, and the outcome of pain in arm/minor pain in right arm (both sides) near elbow, pain in toe/medium pain in both toes and second toe on left foot, veins protruding from legs and arms more than usual, throbbing pain in knuckle of right hand, pain in pelvic area, abdominal pain, bubbling sensation as if there was a viral infection or stomach flu, diarrhea, vomiting, hot/hot flush and sweating, slightly weak, faint and bruise on left arm was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210352411-covid-19 vaccine ad26.cov2.s-Faint. 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: U
Vaccine: COVID19
Symptoms: Pelvic pain, Syncope, Vasodilatation, Vomiting
Clinical narrative: PAIN IN ARM/MINOR PAIN IN RIGHT ARM (BOTH SIDES) NEAR ELBOW; PAIN IN TOE/MEDIUM PAIN IN BOTH TOES AND SECOND TOE ON LEFT FOOT; HOT/HOT FLUSH; BRUISE ON LEFT ARM; HEADACHE; FAINT; PAIN IN PELVIC AREA; ABDOMINAL PAIN; BUBBLING SENSATION AS IF THERE WAS A VIRAL INFECTION OR STOMACH FLU; DIARRHEA; VOMITING; SWEATING; SLIGHTLY WEAK; VEINS PROTRUDING FROM LEGS AND ARMS MORE THAN USUAL; Throbbing pain in knuckle of right hand; This spontaneous report received from a patient of unspecified age and sex reporting on self. 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: 1085031 and expiry: unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced minor side effects the day of minor pain in right arm (both sides) near elbow (pain in arm), medium pain in both toes and second toe on left foot (pain in toe). The toe pain continued for a few days. On 23-MAR-2021 (mentioned as next week), the patient noticed veins protruding from legs and arms more than usual (dilated veins). The patient mentioned no pain, however and throbbing pain in knuckle of right hand (throbbing pain). On 24-MAR-2021 and 25-MAR-2021 (also mentioned as next week), the patient had pain in pelvic area (pelvic pain), abdominal pain (bubbling sensation as if there was a viral infection or stomach flu (abdominal noises)), diarrhea, some vomiting, hot/hot flush and sweating, slightly weak (weakness) and faint all symptoms on same day. The patient took Pedialyte to help with vomiting and to restore energy. On next day, 26-MAR- 2021, the patient was feeling much better. Most symptoms were gone. But there continues to be hot flashes as had been all along (but this may be due to hormones). On 26-MAR-2021, headache continued as well.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hot flashes, and headache, and the outcome of pain in arm/minor pain in right arm (both sides) near elbow, pain in toe/medium pain in both toes and second toe on left foot, veins protruding from legs and arms more than usual, throbbing pain in knuckle of right hand, pain in pelvic area, abdominal pain, bubbling sensation as if there was a viral infection or stomach flu, diarrhea, vomiting, hot/hot flush and sweating, slightly weak, faint and bruise on left arm was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210352411-covid-19 vaccine ad26.cov2.s-Faint. 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: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Hyperpyrexia
Clinical narrative: FEVER OF 110 DEGREE; FELT BAD (FELT LIKE DEATH); 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 was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 26-MAR-2021, reporter stated that the patient "felt bad" felt like death. Reporter also stated that patient had a fever of 110 degrees and wanted to know could give patient aspirin. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 110 degree, and felt bad (felt like death). This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210353896-covid-19 vaccine ad26.cov2.s-fever of 110 degrees. 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Burning sensation, Fatigue, Feeling hot, Hallucination
Clinical narrative: PANIC ATTACK; NOT ABLE TO SLEEP LAST NIGHT; BURNING FACE; DRUMMING IN HER RIGHT EAR; POSSIBLY HALLUCINATING; TIREDNESS; ANXIETY WENT UP; ARM NUMBNESS; MORE FOCUSED THAN USUAL; ARM SORENESS; HOT FLASHES; ARM, HEAD, FEELING HOT; FACE TINGLING; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included polycystic ovarian syndrome, diabetes, attention deficit hyperactivity disorder, and anxiety.  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 left arm on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included amitriptyline, and medroxyprogesterone acetate.  On MAR-2021, the patient had ongoing arm soreness like a knot and being more focused than usual since receiving the vaccine. On 27-MAR-2021, the patient experienced a panic/anxiety attack. It was reported that, the patient's face was burning and tingling and her anxiety went up. The patient's head and her arm also felt hot during this experience. On MAR-2021, the patient also experienced hot flashes and arm numbness. The patient jumped out of bed and went to the bathroom and felt blurry around her face. The patient saw that her face was red in the mirror, then back to normal, then red again. The patient believed that she was possibly hallucinating during this episode on the night of 27-MAR-2021. On 27-MAR-2021, the patient's left arm had felt like it did not have circulation and felt drumming in her right ear. The patient also had tiredness and was not able to sleep on the night of 27-MAR-2021 because of this experience.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm soreness, and the outcome of anxiety went up, panic attack, possibly hallucinating, more focused than usual, tiredness, not able to sleep last night, arm, head, feeling hot, face tingling, arm numbness, drumming in her right ear, hot flashes and burning face was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210353962-Covid-19 vaccine ad26.cov2.s-HALLUCINATION. 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: CONMEDS-OTHER SUSPECT DRUGS, UNDERLYING DISEASE.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Hypoaesthesia, Insomnia, Pain in extremity, Panic attack
Clinical narrative: PANIC ATTACK; NOT ABLE TO SLEEP LAST NIGHT; BURNING FACE; DRUMMING IN HER RIGHT EAR; POSSIBLY HALLUCINATING; TIREDNESS; ANXIETY WENT UP; ARM NUMBNESS; MORE FOCUSED THAN USUAL; ARM SORENESS; HOT FLASHES; ARM, HEAD, FEELING HOT; FACE TINGLING; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included polycystic ovarian syndrome, diabetes, attention deficit hyperactivity disorder, and anxiety.  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 left arm on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included amitriptyline, and medroxyprogesterone acetate.  On MAR-2021, the patient had ongoing arm soreness like a knot and being more focused than usual since receiving the vaccine. On 27-MAR-2021, the patient experienced a panic/anxiety attack. It was reported that, the patient's face was burning and tingling and her anxiety went up. The patient's head and her arm also felt hot during this experience. On MAR-2021, the patient also experienced hot flashes and arm numbness. The patient jumped out of bed and went to the bathroom and felt blurry around her face. The patient saw that her face was red in the mirror, then back to normal, then red again. The patient believed that she was possibly hallucinating during this episode on the night of 27-MAR-2021. On 27-MAR-2021, the patient's left arm had felt like it did not have circulation and felt drumming in her right ear. The patient also had tiredness and was not able to sleep on the night of 27-MAR-2021 because of this experience.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm soreness, and the outcome of anxiety went up, panic attack, possibly hallucinating, more focused than usual, tiredness, not able to sleep last night, arm, head, feeling hot, face tingling, arm numbness, drumming in her right ear, hot flashes and burning face was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210353962-Covid-19 vaccine ad26.cov2.s-HALLUCINATION. 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: CONMEDS-OTHER SUSPECT DRUGS, UNDERLYING DISEASE.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Therapeutic response unexpected, Tinnitus
Clinical narrative: PANIC ATTACK; NOT ABLE TO SLEEP LAST NIGHT; BURNING FACE; DRUMMING IN HER RIGHT EAR; POSSIBLY HALLUCINATING; TIREDNESS; ANXIETY WENT UP; ARM NUMBNESS; MORE FOCUSED THAN USUAL; ARM SORENESS; HOT FLASHES; ARM, HEAD, FEELING HOT; FACE TINGLING; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included polycystic ovarian syndrome, diabetes, attention deficit hyperactivity disorder, and anxiety.  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 left arm on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included amitriptyline, and medroxyprogesterone acetate.  On MAR-2021, the patient had ongoing arm soreness like a knot and being more focused than usual since receiving the vaccine. On 27-MAR-2021, the patient experienced a panic/anxiety attack. It was reported that, the patient's face was burning and tingling and her anxiety went up. The patient's head and her arm also felt hot during this experience. On MAR-2021, the patient also experienced hot flashes and arm numbness. The patient jumped out of bed and went to the bathroom and felt blurry around her face. The patient saw that her face was red in the mirror, then back to normal, then red again. The patient believed that she was possibly hallucinating during this episode on the night of 27-MAR-2021. On 27-MAR-2021, the patient's left arm had felt like it did not have circulation and felt drumming in her right ear. The patient also had tiredness and was not able to sleep on the night of 27-MAR-2021 because of this experience.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm soreness, and the outcome of anxiety went up, panic attack, possibly hallucinating, more focused than usual, tiredness, not able to sleep last night, arm, head, feeling hot, face tingling, arm numbness, drumming in her right ear, hot flashes and burning face was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210353962-Covid-19 vaccine ad26.cov2.s-HALLUCINATION. 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: CONMEDS-OTHER SUSPECT DRUGS, UNDERLYING DISEASE.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE AS A RESULT OF RECEIVING THE J&J VACCINE; 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 JNJ78436735 (Ad26.COV2.S) (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination at unknown site. 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 experienced stroke as a result of receiving the j&j vaccine. The action taken with JNJ78436735 (Ad26.COV2.S) was not applicable. The outcome of stroke as a result of receiving the j&j vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210353970 - COVID-19 VACCINE AD26.COV2.S - Stroke. 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: Asthenia, Disability, Fear, Motor dysfunction, Movement disorder
Clinical narrative: FEVER; LOSS OF BODY FUNCTION; CANNOT MOVE RIGHT ARM; RIGHT LEG ISN'T FUNCTIONING PROPERLY; INCAPACITATED; CANNOT TALK; DEBILITATING THROUGHOUT THE BODY; TERRIFIED; This spontaneous report received from a consumer concerned a 58 year old not 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 on right arm for prophylactic vaccination. Concomitant medications included paracetamol. The patient was expecting the side effects to last for a "couple of days" but it has been a week and 1 day since the vaccination. On 19-Mar-2021, the patient has experienced "debilitation" throughout the body, that started on the right arm, side of vaccination. This then moved to the neck and now the whole body. It was still persisting. The patient "cannot move her right arm" and the "right leg isn't functioning properly" and she was "incapacitated" and "cannot talk".  On 26-MAR-2021, the subject experienced fever. The patient has stated that she has received the paracetamol. after vaccination and it was also not helping. When referred to seek HCP's attention, caller said they are in between HCPs and therefore cannot see one. Agent referred to the ER, but caller states the patient was terrified of the ER and that she "might die" there. Caller confirmed that the patient was stable and not in any medical emergency. Reminded to seek medical attention as soon as possible if condition changes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, debilitating throughout the body, loss of body function, incapacitated, cannot talk, terrified, right leg isn't functioning properly, and cannot move right arm. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210354095-Covid-19 vaccine ad26.cov2.s -INCAPACITATED. 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: NATURE OF EVENT
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, Pyrexia, Speech disorder
Clinical narrative: FEVER; LOSS OF BODY FUNCTION; CANNOT MOVE RIGHT ARM; RIGHT LEG ISN'T FUNCTIONING PROPERLY; INCAPACITATED; CANNOT TALK; DEBILITATING THROUGHOUT THE BODY; TERRIFIED; This spontaneous report received from a consumer concerned a 58 year old not 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 on right arm for prophylactic vaccination. Concomitant medications included paracetamol. The patient was expecting the side effects to last for a "couple of days" but it has been a week and 1 day since the vaccination. On 19-Mar-2021, the patient has experienced "debilitation" throughout the body, that started on the right arm, side of vaccination. This then moved to the neck and now the whole body. It was still persisting. The patient "cannot move her right arm" and the "right leg isn't functioning properly" and she was "incapacitated" and "cannot talk".  On 26-MAR-2021, the subject experienced fever. The patient has stated that she has received the paracetamol. after vaccination and it was also not helping. When referred to seek HCP's attention, caller said they are in between HCPs and therefore cannot see one. Agent referred to the ER, but caller states the patient was terrified of the ER and that she "might die" there. Caller confirmed that the patient was stable and not in any medical emergency. Reminded to seek medical attention as soon as possible if condition changes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, debilitating throughout the body, loss of body function, incapacitated, cannot talk, terrified, right leg isn't functioning properly, and cannot move right arm. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210354095-Covid-19 vaccine ad26.cov2.s -INCAPACITATED. 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: NATURE OF EVENT
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: ANAPHYLACTIC REACTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included family history of anaphylaxis. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination .The batch number was not reported and has been requested . No concomitant medications were reported.  On an unspecified date, the patient experienced anaphylactic reaction. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylactic reaction was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210354170-COVID-19 VACCINE AD26.COV2.S -Anaphylactic reaction. This event(s) is considered not related. The event(s) has an unknown/unclear 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: U
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: IN THE HOSPITAL; A potential AE sent comment to the account from a vaccine recipient. Text: "Patient my friend is in the hospital after getting the shot! Was on oxygen 20 days and then headed back to the ER!!" The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, 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 was in the hospital after getting vaccine, was on oxygen 20 days and then headed back to the ER. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event in the hospital was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210354346-covid-19 vaccine ad26.cov2.s- in the hospital. 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: Depressed level of consciousness
Clinical narrative: DECREASED LEVEL OF CONSCIOUSNESS AND HARD TO AROUSE; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included dementia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the patient got a temperature, experienced decreased level of consciousness and was hard to arouse.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the decreased level of consciousness and hard to arouse, fever was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210354631-COVID-19 VACCINE AD26.COV2.S-Decreased level of consciousness and Hard to arouse. 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: Blood glucose abnormal, Blood glucose increased
Clinical narrative: INCREASED BLOOD SUGARS; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808609 expiry: 09-JUN-2021) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination on Left arm. No concomitant medications were reported. On 26-MAR-2021, the subject experienced increased blood sugars. Laboratory data (dates unspecified) included: Blood sugar abnormal (NR: not provided) fluctuating between 300 to 400 currently at 326. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from increased blood sugars. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210354739-Covid-19 vaccine ad26.cov2.s- increased blood sugars. 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: UNDERLYING DISEASE
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Dizziness, Fall, Injury
Clinical narrative: DIZZINESS; FELL; HURT HIMSELF; SOME DAMAGE TO HIS KIDNEYS IN THE PROCESS (BLOOD CLOT); SOME DAMAGE TO HIS KIDNEYS IN THE PROCESS (BLOOD CLOT); CONFIRMED COVID-19 POSITIVE; 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 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 15-MAR-2021, the patient became ill with COVID like symptoms, and got tested for COVID on 22-Mar-2021 and received results that he was COVID positive on 25-Mar-2021 and was running high temperatures (fevers over 103), On 27-MAR-2021, the patient became dizzy, fell and hurt himself, was rushed to the hospital and was admitted same day. He did some damage to his kidneys in the process. On 25-MAR-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On 25-MAR-2021, Laboratory data included: Body temperature (NR: not provided) Over 103. Laboratory data included: Oxygen consumption decreased (NR: not provided) 87.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 positive, dizziness, fell, injury to kidney, hurt himself and blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition) This report was associated with product quality complaint : 90000174591.; Sender's Comments: V0: 20210355610- Covid-19 Vaccine Ad26.Cov2.S-Confirmed Covid-19 Positive. 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. 20210355610- Covid-19 Vaccine Ad26.Cov2.S - Dizziness, Fell, Hurt himself, Some damage to his kidneys in the process (blood clot). This events are considered Unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.