chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Oxygen saturation, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: DIAGNOSED WITH DOUBLE PNEUMONIA AS A RESULT OF COVID-19; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a (media report) patient via a company representative concerned a 56 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: Unknown, expiry- unknown) dose, frequency 1 total, 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.  After just a week receiving of vaccine patient tested positive for COVID-19 and experienced suspected covid-19 infection, she could not breath hence she was gurgling at night trying to breathe. On next day after woke up patient and her husband went to hospital and her oxygen levels were so low hence that she was immediately admitted and taken to the intensive care unit. At hospital she was diagnosed with double pneumonia as a result of COVID-19. Her lungs was tore. Laboratory data (dates unspecified) included COVID-19 virus test was positive and oxygen saturation was low. Patient was admitted in hospital for 10 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diagnosed with double pneumonia as a result of COVID-19 and suspected covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is associated with product quality complaint.; Sender's Comments: V0: 20210935146- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Diagnosed with double pneumonia as a result of COVID-19, Suspected COVID-19 infection. 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: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: SEVERE REACTION TO VACCINE; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced severe reaction to vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reaction to vaccine was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Headache, Listless, Pain, Pain in extremity
Clinical narrative: RASH (SHE HAD CONSTANT ITCHING AND SHE STARTED SCRATCHING), IT WAS HIVEY AND RED; HEADACHE; BODY ACHES; VERY LISTLESS AND DID NOT WANT TO DO ANYTHING; SORE ARM; SEVERE HEARTBURN AT NIGHT, WHILE IN BED; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included: allergy problems, and concurrent conditions included: colon cancer, and problem with kidney function. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 21-SEP-2021) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. Concomitant medications included omeprazole for colon cancer. On 14-SEP-2021, the patient experienced severe heartburn at night, while in bed. On 14-SEP-2021, the patient experienced sore arm. Treatment medications included: calcium carbonate, omeprazole, and paracetamol. On 15-SEP-2021, the patient experienced body aches. On 15-SEP-2021, the patient experienced very listless and did not want to do anything. On 15-SEP-2021, the patient experienced headache. On 16-SEP-2021, the patient experienced rash (she had constant itching and she started scratching), it was hivey and red. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe heartburn at night, while in bed on 14-SEP-2021, body aches, very listless and did not want to do anything, and headache on 16-SEP-2021, and sore arm on 15-SEP-2021, and had not recovered from rash (she had constant itching and she started scratching), it was hivey and red. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: RASH (SHE HAD CONSTANT ITCHING AND SHE STARTED SCRATCHING), IT WAS HIVEY AND RED; HEADACHE; BODY ACHES; VERY LISTLESS AND DID NOT WANT TO DO ANYTHING; SORE ARM; SEVERE HEARTBURN AT NIGHT, WHILE IN BED; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included: allergy problems, and concurrent conditions included: colon cancer, and problem with kidney function. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 21-SEP-2021) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. Concomitant medications included omeprazole for colon cancer. On 14-SEP-2021, the patient experienced severe heartburn at night, while in bed. On 14-SEP-2021, the patient experienced sore arm. Treatment medications included: calcium carbonate, omeprazole, and paracetamol. On 15-SEP-2021, the patient experienced body aches. On 15-SEP-2021, the patient experienced very listless and did not want to do anything. On 15-SEP-2021, the patient experienced headache. On 16-SEP-2021, the patient experienced rash (she had constant itching and she started scratching), it was hivey and red. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe heartburn at night, while in bed on 14-SEP-2021, body aches, very listless and did not want to do anything, and headache on 16-SEP-2021, and sore arm on 15-SEP-2021, and had not recovered from rash (she had constant itching and she started scratching), it was hivey and red. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Depressed mood, Fall, Feeling abnormal, Hyperhidrosis
Clinical narrative: WHITE/BLACK SPOT IN FRONT OF EYES; SLUMPED ON FLOOR; DRENCHED BY SWEAT; FEELING COMPLETELY DOWN; MY BODY IS FEELING PAIN AS IF IT WERE CURSED AS THAT OF GARLIC OR GINGER IN MACHINE, FROM TEMPLE (SIDE OF THE EAR BACK) SEEMS WILL GO OFF FROM MY BRAIN, NECK, SPINAL CORD, CALF ARE GETTING CRUSHED; EVERY BIT OF BONE TURNING INTO BONE POWDER; COULD NOT GET UP; LOSS OF CONSCIOUSNESS / HEAD BUMPED ON THE GLASS DOOR THEN LOST EVERYTHING; FEELING UNEASY; COULD NOT SLEEP THE WHOLE NIGHT; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, 1 total administered on 17-SEP-2021 13:30 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 17-SEP-2021 (Friday), after 18:00 the patient started feeling uneasy and could not sleep the whole night. On 18-SEP-2021, in the morning the patient tried to get up but could not get up, felt white/black spot in front of eyes. On the same day within a second or two the patient slumped on floor and experienced loss of consciousness / head bumped on the glass door then lost everything. And reported that when consciousness got back the patient was found completely drenched by sweat as if somebody poured buckets of water, the patient feeling completely down and feeling body pain as if it were cursed as that of garlic or ginger in machine, from temple (side of the ear back) seems will go off from my brain, neck, spinal cord, calf are getting crushed, and every bit of bone turning into bone powder. The action taken with covid-19 vaccine was not applicable. The patient recovered from loss of consciousness / head bumped on the glass door then lost everything on 18-SEP-2021, had not recovered from feeling completely down, and the outcome of feeling uneasy, could not sleep the whole night, could not get up, white/black spot in front of eyes, slumped on floor, drenched by sweat, my body is feeling pain as if it were cursed as that of garlic or ginger in machine, from temple (side of the ear back) seems will go off from my brain, neck, spinal cord, calf are getting crushed and every bit of bone turning into bone powder was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210936160-covid-19 vaccine Loss of consciousness/ head bumped on the glass door then lost everything. 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: U
Vaccine: COVID19
Symptoms: Hypokinesia, Insomnia, Loss of consciousness, Pain, Visual impairment
Clinical narrative: WHITE/BLACK SPOT IN FRONT OF EYES; SLUMPED ON FLOOR; DRENCHED BY SWEAT; FEELING COMPLETELY DOWN; MY BODY IS FEELING PAIN AS IF IT WERE CURSED AS THAT OF GARLIC OR GINGER IN MACHINE, FROM TEMPLE (SIDE OF THE EAR BACK) SEEMS WILL GO OFF FROM MY BRAIN, NECK, SPINAL CORD, CALF ARE GETTING CRUSHED; EVERY BIT OF BONE TURNING INTO BONE POWDER; COULD NOT GET UP; LOSS OF CONSCIOUSNESS / HEAD BUMPED ON THE GLASS DOOR THEN LOST EVERYTHING; FEELING UNEASY; COULD NOT SLEEP THE WHOLE NIGHT; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, 1 total administered on 17-SEP-2021 13:30 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 17-SEP-2021 (Friday), after 18:00 the patient started feeling uneasy and could not sleep the whole night. On 18-SEP-2021, in the morning the patient tried to get up but could not get up, felt white/black spot in front of eyes. On the same day within a second or two the patient slumped on floor and experienced loss of consciousness / head bumped on the glass door then lost everything. And reported that when consciousness got back the patient was found completely drenched by sweat as if somebody poured buckets of water, the patient feeling completely down and feeling body pain as if it were cursed as that of garlic or ginger in machine, from temple (side of the ear back) seems will go off from my brain, neck, spinal cord, calf are getting crushed, and every bit of bone turning into bone powder. The action taken with covid-19 vaccine was not applicable. The patient recovered from loss of consciousness / head bumped on the glass door then lost everything on 18-SEP-2021, had not recovered from feeling completely down, and the outcome of feeling uneasy, could not sleep the whole night, could not get up, white/black spot in front of eyes, slumped on floor, drenched by sweat, my body is feeling pain as if it were cursed as that of garlic or ginger in machine, from temple (side of the ear back) seems will go off from my brain, neck, spinal cord, calf are getting crushed and every bit of bone turning into bone powder was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210936160-covid-19 vaccine Loss of consciousness/ head bumped on the glass door then lost everything. 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: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  In SEP-2021 (last week from date of report), the patient felt flu-like symptoms which quickly resulted in what patient could only describe as the worst flu patient had ever experienced. It was confirmed through PCR (polymerase chain reaction) testing that patient was positive for COVID (confirmed clinical vaccination failure and confirmed COVID-19 infection). It was 5 consecutive days of being mostly bed-ridden with fevers, chills, and body aches. On 15-SEP-2021 was the first day that patient started to feel better, although could not smell or taste anything. The experience of catching COVID did not result in hospitalization.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed COVID-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0 20210936258-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Peripheral swelling
Clinical narrative: SEVERE CONGESTION TO THE POINT WHERE BOTH NOSTRILS WERE BLOCKED WHILE SLEEPING; SWOLLEN ARM; HEADACHE; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: unknown) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-AUG-2021, the patient experienced swollen arm. On 07-AUG-2021, the patient experienced headache. On 08-AUG-2021, the patient experienced severe congestion to the point where both nostrils were blocked while sleeping. Treatment medications (dates unspecified) included: paracetamol, cetirizine hydrochloride, and oxymetazoline. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe congestion to the point where both nostrils are blocked while sleeping, and the outcome of swollen arm and headache was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pruritus
Clinical narrative: ITCHING ALL OVER THE BODY; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 200 pounds, and height was 65 inches. The patient's past medical history included: gastric bypass, right knee replacement, two fusion done on her back, fusion on her neck, revision of right knee replacement, left knee replacement, and surgeries, and concurrent conditions included: ankylosing spondylitis, attention deficit disorder, pain, anemia, non tobacco user, abstains from alcohol, intravenous dye allergy, trees and grass allergy, bee sting allergy, sulfa drugs allergy, and fibromyalgia. The patient experienced drug allergy and itching when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1142175 expiry: UNKNOWN) 40 mg, 1 time every 2 weeks, from 18-AUG-2021 for ankylosing spondylitis. Concomitant medications included folic acid for anemia, iron for anemia, lisdexamfetamine mesilate for attention deficit disorder, duloxetine for fibromyalgia, cyclobenzaprine for muscle relaxant, and hydrocodone for pain. On 30-AUG-2021, the patient experienced itching all over the body. Treatment medications (dates unspecified) included: prednisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient recovered from itching all over the body. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Attention deficit hyperactivity disorder, Bipolar disorder, Pain, Post-traumatic stress disorder, Skin disorder
Clinical narrative: BIPOLAR DISORDER; ATTENTION DEFICIT HYPERACTIVITY DISORDER; SPOT ON LEG; PAIN ALL OVER; POST-TRAUMATIC STRESS DISORDER; This spontaneous report received from a consumer concerned a female of unspecified age, unknown race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Medical history and other relevant history was not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1143998 expiry: UNKNOWN), 1 total, dose and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced bipolar disorder, attention deficit hyperactivity disorder, spot on leg, pain all over, and post-traumatic stress disorder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the attention deficit hyperactivity disorder, spot on leg, pain all over, bipolar disorder and post-traumatic stress disorder was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210937232-covid-19 vaccine ad26.cov2.s-bipolar disorder. 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: 48.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient (Company representative) concerned a 48 year old male of unspecified ethnic origin. The patient's weight was 190 pounds and height was 70 inches. The patient's concurrent conditions included: ragweed allergy, pollen allergy, alcohol use (Occasionally), and non-smoker, 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, and batch number: 204B21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 18-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  Starting on 12-SEP-2021 (reported as Sunday night) through the week of report, the patient had stuffy nose, sneezing, loss of sense of smell, and was more tired than normal. On 16-SEP-2021, the patient was tested for COVID19, and received positive result on 17-SEP-2021 (Suspected covid-19 infection and suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with Product Quality Complaint.; Sender's Comments: V0: 20210937243-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination 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
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Hypoaesthesia
Clinical narrative: CARDIAC PROBLEMS; LEG NUMBNESS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced cardiac problems, and leg numbness. The action taken with covid-19 vaccine was not applicable. The outcome of the leg numbness and cardiac problems was not reported. This report was non-serious. This case, from the same reporter is linked to 20210937614, 20210920683 and 20210936884.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: CARDIAC PALPITATION; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. 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 cardiac palpitation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cardiac palpitation was not reported. This report was non-serious. This case, from the same reporter is linked to 20210920683, 20210936884 and 20210937248.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Pyrexia
Clinical narrative: CHILLS; FEVER/ TEMPERATURE HAS REACHED AS HIGH AS 104; WEAKNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 18-SEP-2021 17:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 18-SEP-2021, the patient experienced chills. On 18-SEP-2021, the patient experienced fever/ temperature has reached as high as 104. On 18-SEP-2021, the patient experienced weakness. Laboratory data included: Body temperature (NR: not provided) 104 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever/ temperature has reached as high as 104, and the outcome of chills and weakness was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Somnolence
Clinical narrative: LAID DOWN FOR THE REST OF DAY; SORE ARM; CHILLS; TIRED; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: Patient had no known drug allergies, 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: 18005018 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, the patient experienced sore arm. On 13-MAR-2021, the patient experienced chills. On 13-MAR-2021, the patient experienced tired. On 13-MAR-2021, the patient experienced laid down for the rest of day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, chills, tired, and laid down for the rest of day on 14-MAR-2021. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Myalgia, Paraesthesia, Pyrexia
Clinical narrative: TINGLING OF THE LOWER EXTREMITIES; WEAKNESS FELT ALL OVER THE BODY; BODY/MUSCLE ACHES; FEVER; TIREDNESS FELT ALL OVER THE BODY; This spontaneous report received from a consumer concerned a 48 year old male. 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: The patient had no medical history. The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-AUG-2021, the patient experienced tingling of the lower extremities. On 18-AUG-2021, the patient experienced weakness felt all over the body. On 18-AUG-2021, the patient experienced body/muscle aches. On 18-AUG-2021, the patient experienced fever. On 18-AUG-2021, the patient experienced tiredness felt all over the body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from weakness felt all over the body, body/muscle aches, tingling of the lower extremities, and tiredness felt all over the body. This report was non-serious. This case, from the same reporter is linked to 20210938412.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Hyperaesthesia, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: BURNING SENSATION LIKE SOMEONE SET THE INSIDE BODY ON FIRE; AWAKEN OUT SLEEP BY FUNNY FEELING THAT SOMETHING NOT RIGHT; SEVERE BODY PAIN ON TOUCH/PAIN WORSE THAN CHILD BIRTH; SKIN STILL SENSITIVE TO TOUCH; NUMBNESS IN FEET/LEGS AND HAND; TINGLING IN FEET/LEGS AND HANDS; 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 pre-existing medical conditions included: The patient had no history of previous vaccinations and did not believe in vaccination. The patient was very healthy. 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 19-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-SEP-2021, the patient experienced burning sensation like someone set the inside body on fire. On 19-SEP-2021, the patient experienced awaken out sleep by funny feeling that something not right. On 19-SEP-2021, the patient experienced severe body pain on touch/pain worse than child birth. On 19-SEP-2021, the patient experienced skin still sensitive to touch. On 19-SEP-2021, the patient experienced numbness in feet/legs and hand. On 19-SEP-2021, the patient experienced tingling in feet/legs and hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation like someone set the inside body on fire, severe body pain on touch/pain worse than child birth, skin still sensitive to touch, numbness in feet/legs and hand, and tingling in feet/legs and hands, and the outcome of awaken out sleep by funny feeling that something not right was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: BURNING SENSATION LIKE SOMEONE SET THE INSIDE BODY ON FIRE; AWAKEN OUT SLEEP BY FUNNY FEELING THAT SOMETHING NOT RIGHT; SEVERE BODY PAIN ON TOUCH/PAIN WORSE THAN CHILD BIRTH; SKIN STILL SENSITIVE TO TOUCH; NUMBNESS IN FEET/LEGS AND HAND; TINGLING IN FEET/LEGS AND HANDS; 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 pre-existing medical conditions included: The patient had no history of previous vaccinations and did not believe in vaccination. The patient was very healthy. 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 19-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-SEP-2021, the patient experienced burning sensation like someone set the inside body on fire. On 19-SEP-2021, the patient experienced awaken out sleep by funny feeling that something not right. On 19-SEP-2021, the patient experienced severe body pain on touch/pain worse than child birth. On 19-SEP-2021, the patient experienced skin still sensitive to touch. On 19-SEP-2021, the patient experienced numbness in feet/legs and hand. On 19-SEP-2021, the patient experienced tingling in feet/legs and hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation like someone set the inside body on fire, severe body pain on touch/pain worse than child birth, skin still sensitive to touch, numbness in feet/legs and hand, and tingling in feet/legs and hands, and the outcome of awaken out sleep by funny feeling that something not right was not reported. This report was non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: FEELING FEVERISH (SINCE THEN, HAD A FEVER ); HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 45 year old male. The patient's concurrent conditions included non alcohol user, non smoker. Other pre-existing medical conditions included The patient had no known allergies, no drug abuse or illicit drug usage, no medical history, and no medication. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 13-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, Laboratory data included Body temperature (not provided) 107-99.8 F. On 14-SEP-2021, the patient experienced feeling feverish. On 14-SEP-2021, the patient experienced headache. On 14-SEP-2021, the patient experienced fatigue. On 16-SEP-2021, Laboratory data included Body temperature (not provided) 101.3 F. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, headache, and fatigue. This report was non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Muscle spasms, Myalgia, Pain
Clinical narrative: CRAMPS IN LEFT LEG; FEEL DIZZY; HURT; HARD HEADACHE; MUSCLE PAIN IN BACK (COVERS WHOLE BACK); This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient did not had fever or cough. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 17-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced feel dizzy. On SEP-2021, the patient experienced hurt. On SEP-2021, the patient experienced hard headache. On SEP-2021, the patient experienced muscle pain in back (covers whole back). On 18-SEP-2021, the patient experienced cramps in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cramps in left leg, hard headache, feel dizzy, hurt and muscle pain in back (covers whole back) was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Myalgia, Pyrexia
Clinical narrative: BODY/MUSCLE ACHES; WEAKNESS; TIREDNESS; FEVER; 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 concurrent conditions included: non-smoker, and non-alcohol user, and other pre-existing medical conditions included: The patient had no known allergies and no drug abuse or illicit drug, The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-AUG-2021, the patient experienced body/muscle aches. On 18-AUG-2021, the patient experienced weakness. On 18-AUG-2021, the patient experienced tiredness. On 18-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever on 19-AUG-2021, and had not recovered from weakness, tiredness, and body/muscle aches. This report was non-serious. This case, from the same reporter is linked to 20210938329.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dysstasia, Gait disturbance, Headache, Hypoaesthesia
Clinical narrative: FINGERS TENSE UP; COULD NOT CLOSE HANDS; FINGERS FEEL NUMB FOR A FEW MINUTES; HEAD HURTS ALL THE TIME; CHEST PAIN; HAD TROUBLE WALKING; BOTH LEGS HURT; COULD NOT STAND FOR TOO LONG; This spontaneous report received from a patient concerned a 28 year old female. The patient's pre-existing medical conditions included the patient had no shortness of breath and no abdominal pain, also did not notice any swelling. The patient was not pregnant at the time of vaccination and currently not breastfeeding. The patient received covid-19 (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-AUG-2021, the patient experienced could not stand for too long. On 17-AUG-2021, the patient experienced had trouble walking. On 17-AUG-2021, the patient experienced both legs hurt. On AUG-2021, Laboratory data included Pain scale of 7/10. On 31-AUG-2021, the patient experienced chest pain. On an unspecified date, the patient experienced fingers tense up, could not close hands, fingers feel numb for a few minutes, and head hurts all the time. The action taken with covid-19 was not applicable. The patient recovered from chest pain, fingers feel numb for a few minutes, had not recovered from both legs hurt, and head hurts all the time, and the outcome of could not close hands, could not stand for too long, had trouble walking, and fingers tense up was not reported. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Musculoskeletal stiffness, Pain assessment, Pain in extremity
Clinical narrative: FINGERS TENSE UP; COULD NOT CLOSE HANDS; FINGERS FEEL NUMB FOR A FEW MINUTES; HEAD HURTS ALL THE TIME; CHEST PAIN; HAD TROUBLE WALKING; BOTH LEGS HURT; COULD NOT STAND FOR TOO LONG; This spontaneous report received from a patient concerned a 28 year old female. The patient's pre-existing medical conditions included the patient had no shortness of breath and no abdominal pain, also did not notice any swelling. The patient was not pregnant at the time of vaccination and currently not breastfeeding. The patient received covid-19 (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-AUG-2021, the patient experienced could not stand for too long. On 17-AUG-2021, the patient experienced had trouble walking. On 17-AUG-2021, the patient experienced both legs hurt. On AUG-2021, Laboratory data included Pain scale of 7/10. On 31-AUG-2021, the patient experienced chest pain. On an unspecified date, the patient experienced fingers tense up, could not close hands, fingers feel numb for a few minutes, and head hurts all the time. The action taken with covid-19 was not applicable. The patient recovered from chest pain, fingers feel numb for a few minutes, had not recovered from both legs hurt, and head hurts all the time, and the outcome of could not close hands, could not stand for too long, had trouble walking, and fingers tense up was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Vaccination error
Clinical narrative: PATIENT RECEIVED THE SECOND DOSE OF JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised, and other pre-existing medical conditions included: The patient took the second dose as patient was immunocompromised and had no known issues after having the second dose. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported, and 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 patient received the second dose of janssen covid-19 vaccine, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and patient received the second dose of janssen covid-19 vaccine was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Injection site discomfort, Injection site erythema, Injection site pruritus
Clinical narrative: FEVERISH INJECTION SITE; INJECTION SITE REALLY IRRITATED; ARMPIT SWELLING (CAN'T PUT RIGHT ARM DOWN DUE TO A HUMP IN THE ARMPIT THAT STICKS OUT WHEN ARM LIFTED UP); CONSTANT LEFT HIP PAIN/SHOOTING PAIN IN THE JOINTS; FEVERISH INSIDE; INJECTION SITE SWELLING; INJECTION SITE REDNESS (RED CIRCLE AROUND THE INJECTION SITE, THE SIZE OF A TANGERINE); ARM/HAND SHOOTING PAIN AND CONSTANT BIKINI LINE PAIN; ARMPIT MUSCLE TIGHTENED; UNABLE TO WALK; ITCHY INJECTION SITE; SLUGGISH; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: seafood allergy, and other pre-existing medical conditions included: The patient had no medical history. The patient was allergic to unspecified antibiotic. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 17-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced itchy injection site. On SEP-2021, the patient experienced sluggish. On SEP-2021, the patient experienced armpit muscle tightened. On SEP-2021, the patient experienced unable to walk. Laboratory data included: Pain scale (NR: not provided) 10/10 (units unspecified). Treatment medications included: paracetamol. On 18-SEP-2021, the patient experienced injection site really irritated. On 18-SEP-2021, the patient experienced armpit swelling (can't put right arm down due to a hump in the armpit that sticks out when arm lifted up). On 18-SEP-2021, the patient experienced arm/hand shooting pain and constant bikini line pain. On 18-SEP-2021, the patient experienced constant left hip pain/shooting pain in the joints. On 18-SEP-2021, the patient experienced feverish inside. On 18-SEP-2021, the patient experienced injection site swelling. On 18-SEP-2021, the patient experienced injection site redness (red circle around the injection site, the size of a tangerine). On 20-SEP-2021, the patient experienced feverish injection site. The action taken with covid-19 vaccine was not applicable. The patient recovered from feverish inside on 20-SEP-2021, had not recovered from injection site swelling, injection site redness (red circle around the injection site, the size of a tangerine), injection site really irritated, armpit swelling (can't put right arm down due to a hump in the armpit that sticks out when arm lifted up), constant left hip pain/shooting pain in the joints, feverish injection site, itchy injection site, and arm/hand shooting pain and constant bikini line pain, and the outcome of sluggish, armpit muscle tightened and unable to walk was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Muscle tightness, Pain, Pain assessment
Clinical narrative: FEVERISH INJECTION SITE; INJECTION SITE REALLY IRRITATED; ARMPIT SWELLING (CAN'T PUT RIGHT ARM DOWN DUE TO A HUMP IN THE ARMPIT THAT STICKS OUT WHEN ARM LIFTED UP); CONSTANT LEFT HIP PAIN/SHOOTING PAIN IN THE JOINTS; FEVERISH INSIDE; INJECTION SITE SWELLING; INJECTION SITE REDNESS (RED CIRCLE AROUND THE INJECTION SITE, THE SIZE OF A TANGERINE); ARM/HAND SHOOTING PAIN AND CONSTANT BIKINI LINE PAIN; ARMPIT MUSCLE TIGHTENED; UNABLE TO WALK; ITCHY INJECTION SITE; SLUGGISH; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: seafood allergy, and other pre-existing medical conditions included: The patient had no medical history. The patient was allergic to unspecified antibiotic. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 17-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced itchy injection site. On SEP-2021, the patient experienced sluggish. On SEP-2021, the patient experienced armpit muscle tightened. On SEP-2021, the patient experienced unable to walk. Laboratory data included: Pain scale (NR: not provided) 10/10 (units unspecified). Treatment medications included: paracetamol. On 18-SEP-2021, the patient experienced injection site really irritated. On 18-SEP-2021, the patient experienced armpit swelling (can't put right arm down due to a hump in the armpit that sticks out when arm lifted up). On 18-SEP-2021, the patient experienced arm/hand shooting pain and constant bikini line pain. On 18-SEP-2021, the patient experienced constant left hip pain/shooting pain in the joints. On 18-SEP-2021, the patient experienced feverish inside. On 18-SEP-2021, the patient experienced injection site swelling. On 18-SEP-2021, the patient experienced injection site redness (red circle around the injection site, the size of a tangerine). On 20-SEP-2021, the patient experienced feverish injection site. The action taken with covid-19 vaccine was not applicable. The patient recovered from feverish inside on 20-SEP-2021, had not recovered from injection site swelling, injection site redness (red circle around the injection site, the size of a tangerine), injection site really irritated, armpit swelling (can't put right arm down due to a hump in the armpit that sticks out when arm lifted up), constant left hip pain/shooting pain in the joints, feverish injection site, itchy injection site, and arm/hand shooting pain and constant bikini line pain, and the outcome of sluggish, armpit muscle tightened and unable to walk was not reported. This report was non-serious.