chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dry mouth, Fatigue, Headache
Clinical narrative: BLURRINESS; RASH; DIZZINESS; DRY MOUTH; COUGHING; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight was not reported. The patient's concurrent conditions included allergic to many medications including flu vaccination. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A22A expiry: UNKNOWN) dose was not reported, administered 1 total on 09-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that few minutes after administration she started feeling dizzy, dryness in mouth, coughing, felt like there is a cotton ball in mouth, slight rash all over and blurriness. Then she was transferred to the emergency room where they used intravenous (IV) Benadryl and Epipen and they monitored her. Ever since then she still has headaches and tiredness. Treatment medications (dates unspecified) included: Benadryl (diphenhydramine hydrochloride), and Epipen (epinephrine) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and tiredness, and the outcome of rash, dizziness, dry mouth, coughing and blurriness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-Covid-19 vaccine ad26.cov2.s-Blurring, Coughing, dizziness, dryness of mouth. These events are considered unassessable. The events 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 events. V0:-Covid-19 vaccine ad26.cov2.s-Rash. This events is labeled per RSI and is therefore considered potentially related.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vision blurred
Clinical narrative: BLURRINESS; RASH; DIZZINESS; DRY MOUTH; COUGHING; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight was not reported. The patient's concurrent conditions included allergic to many medications including flu vaccination. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A22A expiry: UNKNOWN) dose was not reported, administered 1 total on 09-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that few minutes after administration she started feeling dizzy, dryness in mouth, coughing, felt like there is a cotton ball in mouth, slight rash all over and blurriness. Then she was transferred to the emergency room where they used intravenous (IV) Benadryl and Epipen and they monitored her. Ever since then she still has headaches and tiredness. Treatment medications (dates unspecified) included: Benadryl (diphenhydramine hydrochloride), and Epipen (epinephrine) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and tiredness, and the outcome of rash, dizziness, dry mouth, coughing and blurriness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-Covid-19 vaccine ad26.cov2.s-Blurring, Coughing, dizziness, dryness of mouth. These events are considered unassessable. The events 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 events. V0:-Covid-19 vaccine ad26.cov2.s-Rash. This events is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Blood test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's 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 was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Patient have not been infected with COVID 19, which patient monitored with a blood test for Blood immunoglobulin G (IGG) and Blood immunoglobulin M (IGM). In APR-2021, laboratory data included: Blood test (NR: not provided) Blood immunoglobulin G: negative. Blood immunoglobulin M: negative and immunoglobulin Total: 0.0. The patient confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422640-covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Sensory loss
Clinical narrative: LOSS OF SENSATION IN THE WHOLE LEFT ARM REACHING HAND AND FINGERS; NUMBNESS AND TINGLING; SORE ARM; 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 pre-existing medical conditions included the patient had no known allergies and did not had medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 043A21A, expiry: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced loss of sensation in the whole left arm reaching hand and fingers. On 08-APR-2021, the subject experienced numbness and tingling. On 08-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, loss of sensation in the whole left arm reaching hand and fingers, and numbness and tingling. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Feeling abnormal, Haemorrhage
Clinical narrative: NON-STOP BLEEDING; 'FELT LIKE EVERYTHING IN BODY WAS ON FIRE; FELT LIKE - GOING TO DIE; 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 administration not reported, batch number: Unknown) dose and start therapy date were not reported, 1 total, 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 non-stop bleeding, felt like everything in body was on fire. The patient felt like patient was going to die. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for non-stop bleeding, felt like I was going to die, and felt like everything in body was on fire was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210438999-Covid-19 vaccine ad26.cov2.s-Haemorrhage. This events is considered unassessable. The events 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 events.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure systolic, Death, Dizziness, Headache, Hypertension
Clinical narrative: PASSED AWAY; HIGH BLOOD PRESSURE; DIZZINESS; THROWING UP; HEADACHE; This spontaneous report received from a consumer concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. 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, expiry: unknown) dose was not reported, 1 total  administered on 16-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that the patient received covid-19 vaccine ad26.cov2.s on 16-MAR-2021. On 17-MAR-2021, the patient's only complaint was that she experienced headache. On 14-APR-2021, she complained about dizziness and throwing up that was getting worse and high blood pressure on same day the reporter called the patient's doctor's office at 14:30 p.m. and doctor saw the patient's blood pressure was returned to normal and she underwent  laboratory data included: systolic blood pressure (NR: not provided) 113 mmHg, 170 mmHg, 190 mmHg. After few hours, 7 or 10 hours she passed away in her sleep, no pain at the time of death between 12:00 a.m. or 15:00 p.m. on 15-APR-2021. It was unspecified if an autopsy was performed. The reporter was unsure about the true time of death. The reporter did not complaint for a lawsuit as the doctor of the patient did not know if the death was correlated with the vaccine. The patient did not had no other disease, except high blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient passed away on 15-APR-2021, recovered from high blood pressure on 14-APR-2021, and headache on an unspecified date in  2021, and the outcome of dizziness and throwing up was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: - covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).   covid-19 vaccine ad26.cov2.s-High Blood pressure . 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; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: PASSED AWAY; HIGH BLOOD PRESSURE; DIZZINESS; THROWING UP; HEADACHE; This spontaneous report received from a consumer concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. 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, expiry: unknown) dose was not reported, 1 total  administered on 16-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that the patient received covid-19 vaccine ad26.cov2.s on 16-MAR-2021. On 17-MAR-2021, the patient's only complaint was that she experienced headache. On 14-APR-2021, she complained about dizziness and throwing up that was getting worse and high blood pressure on same day the reporter called the patient's doctor's office at 14:30 p.m. and doctor saw the patient's blood pressure was returned to normal and she underwent  laboratory data included: systolic blood pressure (NR: not provided) 113 mmHg, 170 mmHg, 190 mmHg. After few hours, 7 or 10 hours she passed away in her sleep, no pain at the time of death between 12:00 a.m. or 15:00 p.m. on 15-APR-2021. It was unspecified if an autopsy was performed. The reporter was unsure about the true time of death. The reporter did not complaint for a lawsuit as the doctor of the patient did not know if the death was correlated with the vaccine. The patient did not had no other disease, except high blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient passed away on 15-APR-2021, recovered from high blood pressure on 14-APR-2021, and headache on an unspecified date in  2021, and the outcome of dizziness and throwing up was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: - covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).   covid-19 vaccine ad26.cov2.s-High Blood pressure . 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; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Influenza like illness, Insomnia
Clinical narrative: DIFFICULT TO SLEEP; SHORTNESS OF BREATH; FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 60 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: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced shortness of breath. On 09-APR-2021, the subject experienced flu-like symptoms. On an unspecified date, the subject experienced difficult to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, and shortness of breath, and the outcome of difficult to sleep was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear congestion, Tinnitus
Clinical narrative: RINGING ON THE EARS; CONGESTION; DIZZINESS; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight was 147 kilograms, and height was 175 centimeters. The patient's concurrent conditions included non-smoker, and non-alcohol user, and other pre-existing medical conditions included the patient had no known allergies. The patient had not any drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced ringing on the ears, congestion and dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing on the ears, congestion, and dizziness. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Eye disorder, Hypoaesthesia oral, Lip pain, Mouth swelling
Clinical narrative: EXTREME SWELLING TO UPPER AND LOWER LIPS, LEFT MOUTH DROOP; SORENESS TO LIPS; NUMBNESS TO LIPS; TINGLING TO LIPS; EXTREME GUM TISSUE IRRITATION; LEFT EYE DROOP; SORENESS TO RIGHT ARM; FEVER; ITCHING TO RIGHT ARM; PANTING; This spontaneous report received from a patient concerned a 52 year old female. The patient's past medical history included had covid-19 on november 2nd, and aspirin, codeine, nsaids, morphine, class of erythromycins, barbiturates, sulfates, sulfonamides allergy, and concurrent conditions included hashimotos (hypothyroid), asthma, socially drinks, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient was previously treated with diphenhydramine hydrochloride for allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included formoterol fumarate for asthma.  On 11-APR-2021, the subject experienced panting. On 11-APR-2021, the subject experienced itching to right arm. On 11-APR-2021, the subject experienced soreness to right arm. On 11-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced extreme swelling to upper and lower lips, left mouth droop. On 12-APR-2021, the subject experienced soreness to lips. On 12-APR-2021, the subject experienced numbness to lips. On 12-APR-2021, the subject experienced tingling to lips. On 12-APR-2021, the subject experienced extreme gum tissue irritation. On 12-APR-2021, the subject experienced left eye droop. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme swelling to upper and lower lips, left mouth droop, panting, and itching to right arm on 11-APR-2021, left eye droop on 13-APR-2021, soreness to right arm on 14-APR-2021, and fever on 12-APR-2021, was recovering from soreness to lips, numbness to lips, and tingling to lips, and had not recovered from extreme gum tissue irritation. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia oral, Pruritus, Pyrexia, Tissue irritation
Clinical narrative: EXTREME SWELLING TO UPPER AND LOWER LIPS, LEFT MOUTH DROOP; SORENESS TO LIPS; NUMBNESS TO LIPS; TINGLING TO LIPS; EXTREME GUM TISSUE IRRITATION; LEFT EYE DROOP; SORENESS TO RIGHT ARM; FEVER; ITCHING TO RIGHT ARM; PANTING; This spontaneous report received from a patient concerned a 52 year old female. The patient's past medical history included had covid-19 on november 2nd, and aspirin, codeine, nsaids, morphine, class of erythromycins, barbiturates, sulfates, sulfonamides allergy, and concurrent conditions included hashimotos (hypothyroid), asthma, socially drinks, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient was previously treated with diphenhydramine hydrochloride for allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included formoterol fumarate for asthma.  On 11-APR-2021, the subject experienced panting. On 11-APR-2021, the subject experienced itching to right arm. On 11-APR-2021, the subject experienced soreness to right arm. On 11-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced extreme swelling to upper and lower lips, left mouth droop. On 12-APR-2021, the subject experienced soreness to lips. On 12-APR-2021, the subject experienced numbness to lips. On 12-APR-2021, the subject experienced tingling to lips. On 12-APR-2021, the subject experienced extreme gum tissue irritation. On 12-APR-2021, the subject experienced left eye droop. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme swelling to upper and lower lips, left mouth droop, panting, and itching to right arm on 11-APR-2021, left eye droop on 13-APR-2021, soreness to right arm on 14-APR-2021, and fever on 12-APR-2021, was recovering from soreness to lips, numbness to lips, and tingling to lips, and had not recovered from extreme gum tissue irritation. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, SARS-CoV-2 antibody test, Therapy non-responder, Ultrasound scan, Varicose vein
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SWELLING AROUND THE ANKLES; VARICOSE VEINS; This spontaneous report received from a patient concerned a 71 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802070 expiry: 25-MAY-2021) dose was not reported, administered on 15-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. About 2.5 weeks later, on 01-APR-2021, the patient noticed swelling around the ankles and varicose veins, for which the patient had taken acetylsalicylic acid and turmeric as recommended by his physician. Last week (APR-2021), he had a ultrasound of his lower extremities, and that came back negative. The patient also had a cardioid ultrasound as well, also coming back negative. The patient had been to vein and foot physicians. The patient mentioned that the foot physician had never seen a situation like the patient before. The patient have noticed today that his swelling and varicose veins have decreased. On 13-APR-2021,the patient got a spike protein IGG test which showed negative for antibodies. The patient was not sure if the side effects had to do the vaccine or something else. The patient would like follow-up from the safety team on what to do next regarding the negative antibody best. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling around the ankles, and varicose veins, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210440928-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Feeling abnormal, Heart rate increased, Hypoaesthesia, Influenza like illness
Clinical narrative: RAPID HEART BEAT; VERTIGO (CAN'T WALK AROUND); TINGLING IN RIGHT SIDE OF HEAD; NUMBNESS IN RIGHT SIDE OF HEAD/NUMBNESS TO THE RIGHT BODY; SEVERE MIGRAINE; BRAIN FOGGINESS/COULD NOT THINK CLEARLY/COULD NOT SPEAK CLEARLY; FLU LIKE SYMPTOMS/CHILLS/FEVER/NAUSEA; LOSS OF APPETITE; This spontaneous report received from a parent concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included 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: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced loss of appetite. On 12-APR-2021, the subject experienced flu like symptoms/chills/fever/nausea. On 13-APR-2021, the subject experienced brain fogginess/could not think clearly/could not speak clearly. On 14-APR-2021, the subject experienced vertigo (can't walk around). On 14-APR-2021, the subject experienced tingling in right side of head. On 14-APR-2021, the subject experienced numbness in right side of head/numbness to the right body. On 14-APR-2021, the subject experienced severe migraine. On 19-APR-2021, the subject experienced rapid heart beat. Laboratory data (dates unspecified) included: Heartbeats increased (NR: not provided) 70 bpm, and MRI brain (NR: not provided) Normal. Treatment medications (dates unspecified) included: vitamins nos, and metoclopramide hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe migraine, and the outcome of flu like symptoms/chills/fever/nausea, vertigo (can't walk around), brain fogginess/could not think clearly/could not speak clearly, rapid heart beat, numbness in right side of head/numbness to the right body, loss of appetite and tingling in right side of head was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Migraine, Paraesthesia, Vertigo
Clinical narrative: RAPID HEART BEAT; VERTIGO (CAN'T WALK AROUND); TINGLING IN RIGHT SIDE OF HEAD; NUMBNESS IN RIGHT SIDE OF HEAD/NUMBNESS TO THE RIGHT BODY; SEVERE MIGRAINE; BRAIN FOGGINESS/COULD NOT THINK CLEARLY/COULD NOT SPEAK CLEARLY; FLU LIKE SYMPTOMS/CHILLS/FEVER/NAUSEA; LOSS OF APPETITE; This spontaneous report received from a parent concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included 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: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced loss of appetite. On 12-APR-2021, the subject experienced flu like symptoms/chills/fever/nausea. On 13-APR-2021, the subject experienced brain fogginess/could not think clearly/could not speak clearly. On 14-APR-2021, the subject experienced vertigo (can't walk around). On 14-APR-2021, the subject experienced tingling in right side of head. On 14-APR-2021, the subject experienced numbness in right side of head/numbness to the right body. On 14-APR-2021, the subject experienced severe migraine. On 19-APR-2021, the subject experienced rapid heart beat. Laboratory data (dates unspecified) included: Heartbeats increased (NR: not provided) 70 bpm, and MRI brain (NR: not provided) Normal. Treatment medications (dates unspecified) included: vitamins nos, and metoclopramide hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe migraine, and the outcome of flu like symptoms/chills/fever/nausea, vertigo (can't walk around), brain fogginess/could not think clearly/could not speak clearly, rapid heart beat, numbness in right side of head/numbness to the right body, loss of appetite and tingling in right side of head was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: DEATHLY ILL; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced deathly ill. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of deathly ill was not reported. 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: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: BELLS PALSY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, one total, administered on 15-APR-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-APR-2021, the patient experienced numbness on left side of face, bells palsy diagnosed, was in emergency room it was direct effect from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bells palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210441515- Covid-19 vaccine ad26.cov2-Bell's palsy. 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chest discomfort, Dyspnoea
Clinical narrative: CHEST PRESSURE WHICH FELT LIKE INDIGESTION; ABDOMINAL PAIN; DIFFICULTY BREATHING; This spontaneous report received from a patient concerned a 42 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced difficulty breathing. On 13-APR-2021, the subject experienced chest pressure which felt like indigestion. On 13-APR-2021, the subject experienced abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal pain on 13-APR-2021, had not recovered from chest pressure which felt like indigestion, and the outcome of difficulty breathing was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral, Eye irritation, Vision blurred
Clinical narrative: 90% LOSS OF VISION IN ONE EYE; BURNING EYE; FOGGY VISION; This spontaneous report received from a patient concerned a 47 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, and batch number were not reported) dose, frequency 1 total, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced 90% loss of vision in one eye, burning eye, and foggy vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning eye, foggy vision and 90% loss of vision in one eye was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to. Sender's Comments: V0.- Covid-19 vaccine ad26.cov2- 90% loss of vision in one eye. 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).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Palpitations, Tachycardia
Clinical narrative: RACING HEART RATE; TACHYCARDIA; HYPERTENSION; This spontaneous report received from a health care professional via the VAERS (Vaccine Adverse Event Reporting System)  concerned a 42 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: 207A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 13:55 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced racing heart rate. On APR-2021, the subject experienced tachycardia. On APR-2021, the subject experienced hypertension. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the racing heart rate, tachycardia and hypertension was not reported. This report was non-serious. This case, from the same reporter is linked to 20210415566 and 20210441555.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Full blood count, Headache, SARS-CoV-2 test positive, Scan with contrast
Clinical narrative: WEIRD HEADACHES/COMPLICATED MENSTRUAL HEADACHE/HEADACHE BEHIND EYES; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included complicated menstrual migraine, and knee surgery, and other pre-existing medical conditions included no blood thinners, no clotting issues, been pregnant 13 times.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included ketorolac tromethamine for weird headaches/complicated menstrual headache/headache behind eyes, and naproxen for weird headaches/complicated menstrual headache/headache behind eyes. On 28-DEC-2020, Laboratory data included: COVID-19 virus test positive (NR: not provided) POSITIVE (units unspecified). On 15-APR-2021, the subject experienced weird headaches/complicated menstrual headache/headache behind eyes. On 16-APR-2021, Laboratory data included: CT scan (NR: not provided) Normal, no blood clots or tumors., Complete blood count (NR: not provided) platelets were normal. (units unspecified), and Scan with contrast (NR: not provided) Normal, no blood clots or tumors. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weird headaches/complicated menstrual headache/headache behind eyes. This report was non-serious.; Sender's Comments: V0: covid-19 vaccine ad26.cov2.s ,complicated menstrual headache, Medical assessment comment not required as per standard procedure as case assessed as non serious .
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Dyspnoea, Headache, Oxygen saturation
Clinical narrative: CONSTANT SHORTNESS OF BREATH; LOW BLOOD OXYGEN; WEIGHT LOSS; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 77 year old female. The patient's height and weight were not reported. The patient's past medical history included covid-19 positive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: unknown) dose was not reported, frequency once total, administered on left deltoid on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. After the vaccine, on 13-MAR-2021 the patient experienced chills, fever and headache. The headache goes go from the left to right side of her head. On an unspecified date, the patient experienced constant shortness of breath, low blood oxygen, and weight loss. The shortness of breath was severe and patient had to take a break every couple 100 steps for rest. On 15-MAR-2021, the patient was hospitalized. Laboratory data (dates unspecified) included: COVID-19 (nr: not provided) positive, oxygen saturation (nr: not provided) low, and weight loss (nr: not provided) 5 pounds and she is down to 86 pounds. The patient was prescribed steroids and nebulizer treatment. The patient had low blood oxygen level. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, chills, constant shortness of breath, low blood oxygen and weight loss was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210442930-covid-19 vaccine ad26.cov2.s -Constant shortness of breath/low blood oxygen/weight loss. 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pyrexia, Weight decreased
Clinical narrative: CONSTANT SHORTNESS OF BREATH; LOW BLOOD OXYGEN; WEIGHT LOSS; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 77 year old female. The patient's height and weight were not reported. The patient's past medical history included covid-19 positive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: unknown) dose was not reported, frequency once total, administered on left deltoid on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. After the vaccine, on 13-MAR-2021 the patient experienced chills, fever and headache. The headache goes go from the left to right side of her head. On an unspecified date, the patient experienced constant shortness of breath, low blood oxygen, and weight loss. The shortness of breath was severe and patient had to take a break every couple 100 steps for rest. On 15-MAR-2021, the patient was hospitalized. Laboratory data (dates unspecified) included: COVID-19 (nr: not provided) positive, oxygen saturation (nr: not provided) low, and weight loss (nr: not provided) 5 pounds and she is down to 86 pounds. The patient was prescribed steroids and nebulizer treatment. The patient had low blood oxygen level. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, chills, constant shortness of breath, low blood oxygen and weight loss was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210442930-covid-19 vaccine ad26.cov2.s -Constant shortness of breath/low blood oxygen/weight loss. 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: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Influenza like illness, Pain in extremity
Clinical narrative: CALF PAIN; ANKLE PAIN; HEADACHE; FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 21 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: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced flu like symptoms. On 07-APR-2021, the subject experienced headache. On 17-APR-2021, the subject experienced calf pain. On 17-APR-2021, the subject experienced ankle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu like symptoms, and headache, and had not recovered from ankle pain, and calf pain. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included cigarettes smoker, and concurrent conditions included birdshot uveitis, alcohol user, and seasonal allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting . The patient experienced drug allergy when treated with ketamine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 on left deltoid for prophylactic vaccination. Concomitant medications included Cellcept (mycophenolate mofetil) for birdshot uveitis. On 2021, the subject experienced confirmed immunological vaccine failure. On 08-APR-2021, 4 weeks and 1 day later after getting the Janssen Covid-19 vaccine, she got tested (semi-quantitative antibody test); as per health care professional, the result stated she did not develop antibodies/immunity. HCP stated she never was diagnosed with Covid-19. HCP stated she reported/consulted the result of her laboratory exam to CDC. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210443252-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccination failure, Drug hypersensitivity. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabelled, 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, SPECIAL SITUATIONS
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Oedema peripheral, Pyrexia
Clinical narrative: SWELLING ON HIS KNEES; JOINT PAIN; HORRIBLE CHILLS; FEVER OF 105.9 F; This spontaneous report received from a patient concerned a 46 year old male. The patient's weight was 135 pounds, and height was 173 centimeters. The patient's past medical history included marijuana use, and concurrent conditions included penicillin allergy, alcohol use, smoker, lactose intolerance, attention deficit hyperactivity disorder, and anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included clonazepam for ADHD, and anxiety, and hopantenate calcium for ADHD, and anxiety. On APR-2021, treatment medications included: ibuprofen.  On 06-APR-2021, the subject experienced swelling on his knees, joint pain, horrible chills, fever of 105.9 f. Laboratory data included: Body temperature (NR: not provided) 105.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from horrible chills on 10-APR-2021, and fever of 105.9 f on 09-APR-2021, and was recovering from joint pain, and swelling on his knees. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb mass, Pain in extremity, Peripheral swelling, Rash erythematous
Clinical narrative: HEADACHE; RED SPOTS / RASH IN LEFT ARM; KNOT/LUMP IN LEFT LEG; SWOLLEN LEFT ARM; TENDER LEFT ARM; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included deteriorating disc disease (c4 and c5 in spine), pain in hand, tingling in hand, neuropathy, and varicose veins.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 20/JUN/2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, fosinopril, ibuprofen, metformin, and simvastatin.  On APR-2021, the subject experienced knot/lump in left leg. On APR-2021, the subject experienced swollen left arm. On APR-2021, the subject experienced tender left arm. On 19-APR-2021, the subject experienced red spots / rash in left arm. On 20-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from knot/lump in left leg, tender left arm, red spots / rash in left arm, and headache on APR-2021, and had not recovered from swollen left arm. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness, Sensory disturbance
Clinical narrative: ALTERATIONS TO TASTE AND SMELL; BRAIN FOG OR  COULD NOT THINK STRAIGHT; FLU LIKE SYMPTOMS SUCH AS BODYACHE AND NAUSEA; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced alterations to taste and smell. On MAR-2021, the patient experienced brain fog or could not think straight. On MAR-2021, the patient experienced flu like symptoms such as body ache and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms such as body ache and nausea on MAR-2021, and the outcome of alterations to taste and smell and brain fog or could not think straight was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.