chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: THE VACCINE HAD LEFT A SIDE EFFECT; 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, 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 the vaccine had left a side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine has left a side effect was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain
Clinical narrative: EXCRUCIATING PAIN IN ALL JOINTS, WRISTS, ELBOWS AND KNEES AND THIS INTENSE PAIN WOKE UP THE CONSUMER FROM SLEEP, PAIN IN NECK AND DUE TO THIS PATIENT HAD A LOT OF DIFFICULTY GETTING OUT OF BED; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included erosive osteoarthritis, antibiotic allergy, egg allergy, mold allergy, chemicals (silver) allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included the pain has subsided from its severity right after getting the vaccine, but still lingers. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, treatment medications included: paracetamol. On 20-MAY-2021, the subject experienced excruciating pain in all joints, wrists, elbows and knees and this intense pain woke up the consumer from sleep, pain in neck and due to this subject had a lot of difficulty getting out of bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from excruciating pain in all joints, wrists, elbows and knees and this intense pain woke up the consumer from sleep, pain in neck and due to this patient had a lot of difficulty getting out of bed. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Head discomfort, Magnetic resonance imaging, Magnetic resonance imaging abnormal, Muscular weakness
Clinical narrative: MAGNETIC RESONANCE IMAGING ABNORMAL; RIGHT ARM WEAKNESS; STIFF NECK; HEAVY HEAD FEELING; TINGLING; This spontaneous report received from a physician concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included white matter changes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced stiff neck. On 25-JUN-2021, the subject experienced heavy head feeling. On 25-JUN-2021, the subject experienced tingling. On 25-JUN-2021, the subject experienced right arm weakness. On 05-JUL-2021, Laboratory data included: CAT scan (NR: not provided) unknown. On an unspecified date, the subject experienced magnetic resonance imaging abnormal. Laboratory data (dates unspecified) included: MRI (NR: not provided) White matter and vasculo ischemic changes, micro angiopathic ischemia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stiff neck, heavy head feeling, and right arm weakness, and the outcome of tingling and magnetic resonance imaging abnormal was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Paraesthesia
Clinical narrative: MAGNETIC RESONANCE IMAGING ABNORMAL; RIGHT ARM WEAKNESS; STIFF NECK; HEAVY HEAD FEELING; TINGLING; This spontaneous report received from a physician concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included white matter changes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced stiff neck. On 25-JUN-2021, the subject experienced heavy head feeling. On 25-JUN-2021, the subject experienced tingling. On 25-JUN-2021, the subject experienced right arm weakness. On 05-JUL-2021, Laboratory data included: CAT scan (NR: not provided) unknown. On an unspecified date, the subject experienced magnetic resonance imaging abnormal. Laboratory data (dates unspecified) included: MRI (NR: not provided) White matter and vasculo ischemic changes, micro angiopathic ischemia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stiff neck, heavy head feeling, and right arm weakness, and the outcome of tingling and magnetic resonance imaging abnormal was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Incontinence, Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: PARALYSIS; INCONTINENCE; COULD NOT SIT UP; RIGHT LEG SWELLING; EXTREME LEG PAIN (RIGHT); EXTREME WEAKNESS/OVERWHELMING WEAKNESS; LEG'S COLLAPSE; This spontaneous report received from a consumer concerned a 65 year old male 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, expiry: unknown) dose was not reported, 1 total, administered on end APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-MAY-2021 or 25-MAY-2021 the patient's legs collapsed under him. He spent 4 days on the floor prior to being able to get medical assistance. Reporter had to call fire department to get him evacuated and was transported to the hospital via ambulance. On an unspecified date, the patient experienced paralysis, incontinence, could not sit up, right leg swelling, extreme leg pain (right), and extreme weakness/overwhelming weakness.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the paralysis, extreme weakness/overwhelming weakness, incontinence, extreme leg pain (right), could not sit up, right leg swelling and leg's collapse was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210727800- covid-19 vaccine ad26.cov2.s-Paralysis. 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: M
Vaccine: COVID19
Symptoms: Paralysis, Peripheral swelling
Clinical narrative: PARALYSIS; INCONTINENCE; COULD NOT SIT UP; RIGHT LEG SWELLING; EXTREME LEG PAIN (RIGHT); EXTREME WEAKNESS/OVERWHELMING WEAKNESS; LEG'S COLLAPSE; This spontaneous report received from a consumer concerned a 65 year old male 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, expiry: unknown) dose was not reported, 1 total, administered on end APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-MAY-2021 or 25-MAY-2021 the patient's legs collapsed under him. He spent 4 days on the floor prior to being able to get medical assistance. Reporter had to call fire department to get him evacuated and was transported to the hospital via ambulance. On an unspecified date, the patient experienced paralysis, incontinence, could not sit up, right leg swelling, extreme leg pain (right), and extreme weakness/overwhelming weakness.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the paralysis, extreme weakness/overwhelming weakness, incontinence, extreme leg pain (right), could not sit up, right leg swelling and leg's collapse was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210727800- covid-19 vaccine ad26.cov2.s-Paralysis. 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1205A21A expiry: UNKNOWN) dose was not reported, administered on 12-JUL-2021 10:45 for prophylactic vaccination. No concomitant medications were reported. On 12-JUL-2021, the subject experienced sore arm. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm. This report was non-serious. This case, from the same reporter is linked to 20210728046 and 20210733974.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; 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. 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: 1805031, expiry: 10-JUL-2021) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-JUL-2021, the subject experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM SORE; This spontaneous report received from a patient 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced arm sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm sore. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diplopia, Dizziness, Fatigue, Gait disturbance
Clinical narrative: DOUBLE VISION; SLEPT THE WEEKEND AWAY; STUMBLING POST-VACCINATION; EXTREMELY TIRED/ TIREDNESS; SHAKINESS/UNSTEADINESS; LOSS OF APPETITE; DIZZY; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 115 pounds, and height was 64 inches. The patient's past medical history included emphysema, and smoker, and concurrent conditions included non-alcohol user, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 04A21A expiry: UNKNOWN) dose was not reported, administered on 08-JUL-2021 16:15 for prophylactic vaccination. No concomitant medications were reported. On 10-JUL-2021, the subject experienced shakiness/unsteadiness. On 10-JUL-2021, the subject experienced loss of appetite. On 10-JUL-2021, the subject experienced dizzy. On 10-JUL-2021, the subject experienced slept the weekend away. On 10-JUL-2021, the subject experienced stumbling post-vaccination. On 10-JUL-2021, the subject experienced extremely tired/ tiredness. On 13-JUL-2021, the subject experienced double vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from double vision, and had not recovered from extremely tired/ tiredness, shakiness/unsteadiness, loss of appetite, dizzy, slept the weekend away, and stumbling post-vaccination. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Tremor
Clinical narrative: DOUBLE VISION; SLEPT THE WEEKEND AWAY; STUMBLING POST-VACCINATION; EXTREMELY TIRED/ TIREDNESS; SHAKINESS/UNSTEADINESS; LOSS OF APPETITE; DIZZY; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 115 pounds, and height was 64 inches. The patient's past medical history included emphysema, and smoker, and concurrent conditions included non-alcohol user, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 04A21A expiry: UNKNOWN) dose was not reported, administered on 08-JUL-2021 16:15 for prophylactic vaccination. No concomitant medications were reported. On 10-JUL-2021, the subject experienced shakiness/unsteadiness. On 10-JUL-2021, the subject experienced loss of appetite. On 10-JUL-2021, the subject experienced dizzy. On 10-JUL-2021, the subject experienced slept the weekend away. On 10-JUL-2021, the subject experienced stumbling post-vaccination. On 10-JUL-2021, the subject experienced extremely tired/ tiredness. On 13-JUL-2021, the subject experienced double vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from double vision, and had not recovered from extremely tired/ tiredness, shakiness/unsteadiness, loss of appetite, dizzy, slept the weekend away, and stumbling post-vaccination. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase increased, Pain, Peripheral swelling
Clinical narrative: SEVERE LEVELS OF CREATINE KINASE; PAIN; ARMS SWOLLEN; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included stomach pain. 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 25-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  On Thursday 08-JUL-2021, patient was hospitalized due to severe levels of creatine kinase and she experienced pain and her arm was swollen. The doctors was shocked to see such high levels of creatine kinase and they have been running tests of all sorts. The Laboratory data included: Creatine kinase high (NR: not provided), patient stated that all the tests were done and it showed no problems with her heart, nerves, chest. The treatment medications (dates unspecified) included hydrocortisone/Cortizone ,IV, antibiotics for stomach relief from all treatment medication. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe levels of creatine kinase, pain and arms swollen was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210727837- covid-19 vaccine ad26.cov2.s-Severe levels of creatine kinase, pain, arms swollen. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain
Clinical narrative: PAIN; SICK; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced pain, and sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pains and sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20210728450.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthroscopy, Asthenia, Computerised tomogram, Fatigue, Muscular weakness
Clinical narrative: KIDNEY STONE; WEAKNESS IN BOTH LEGS, LOWER BACK AND PELVIC AREA; MORE FATIGUE/TIRED; MORE WEAKNESS; 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 right hip replacement, and concurrent conditions included hypertension, penicillin allergy, and sulfur allergy, weakness and fatigue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: Unknown) dose was not reported, 1 total, administered on 27-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 2020, Laboratory data included: Arthroscopy (NR: not provided) Not reported. The patient stated that she had been experiencing more weakness and fatigue than usual since Apr-2021 three weeks after taking vaccine. Further, the patient reported that in APR-2021, the pain intensified along with the weakness in both legs, pelvic area, and lower back 2-3 weeks after vaccination. On 20-MAY-2021, she went to emergency room for kidney stone. The patient was referred to pain specialist and stated that she felt about the same and wanted her leg to work. The patient was tired and fatigued. Laboratory data included: CAT scan (NR: not provided) Kidney stone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from more fatigue/tired, weakness in both legs, lower back and pelvic area, and more weakness, and the outcome of kidney stone was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210727924-Ccovid-19 vaccine ad26.cov2.s-kidney stone. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nephrolithiasis
Clinical narrative: KIDNEY STONE; WEAKNESS IN BOTH LEGS, LOWER BACK AND PELVIC AREA; MORE FATIGUE/TIRED; MORE WEAKNESS; 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 right hip replacement, and concurrent conditions included hypertension, penicillin allergy, and sulfur allergy, weakness and fatigue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: Unknown) dose was not reported, 1 total, administered on 27-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 2020, Laboratory data included: Arthroscopy (NR: not provided) Not reported. The patient stated that she had been experiencing more weakness and fatigue than usual since Apr-2021 three weeks after taking vaccine. Further, the patient reported that in APR-2021, the pain intensified along with the weakness in both legs, pelvic area, and lower back 2-3 weeks after vaccination. On 20-MAY-2021, she went to emergency room for kidney stone. The patient was referred to pain specialist and stated that she felt about the same and wanted her leg to work. The patient was tired and fatigued. Laboratory data included: CAT scan (NR: not provided) Kidney stone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from more fatigue/tired, weakness in both legs, lower back and pelvic area, and more weakness, and the outcome of kidney stone was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210727924-Ccovid-19 vaccine ad26.cov2.s-kidney stone. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Taste disorder, Therapeutic response unexpected
Clinical narrative: PAIN IN THE LEFT LEG; IMPROVEMENT FROM FIBROMYALGIA PAIN, MUSCLE ACHES AND PAIN WITH 80 TO 90% RELIEF; SOAPY TASTE IN THE MOUTH; MILD NAUSEA WITH ON AND OFF; 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 past medical history included blood clot in the left leg at the age of 18, and concurrent conditions included asthma, fibromyalgia pain, muscle aches, and pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 05-AUG-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced soapy taste in the mouth. On 02-APR-2021, the subject experienced mild nausea with on and off. On 05-APR-2021, the subject experienced improvement from fibromyalgia pain, muscle aches and pain with 80 to 90% relief. On 06-APR-2021, the subject experienced pain in the left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in the left leg on JUN-2021, and mild nausea with on and off, had not recovered from soapy taste in the mouth, and the outcome of improvement from fibromyalgia pain, muscle aches and pain with 80 to 90% relief was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back disorder, Blood test, Dizziness, Hypokinesia, Influenza like illness
Clinical narrative: MENOPAUSAL SYMPTOMS; DELAYED CRAMPS; COULD NOT BEND DOWN IN A SQUAT; DIZZINESS; BACK ISSUE; ACHY LIKE FLU SYMPTOMS; TINGLING IN LEGS; This spontaneous report received from a female patient of an unspecified age. Race and ethnicity not reported. Local reference number EZR20210104013. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was reported that the patient works and has children and is a busy person. The patient has a new puppy in house.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  At some timepoint after vaccination, the patient experienced dizziness. About 6-8 weeks after vaccination in late MAY-2021, the patient began to experience tingling in her legs. She initially proceeded with an urgent care visit and then primary care provider to have blood work done. The primary care provider attributed the tingling in her legs to restless leg syndromes. Later the patient saw a neurologist who advised her that she did not have restless leg syndrome but attributed her events to an issue with her back because she could not bend down and squat when at work without holding onto something to get back up. The patient returned back to her primary care provider who attributed her events to menopause as she reported delayed cramping. The patient reported that she must grab a hold of something to go over the puppy gate. The patient reported that affected areas were back and hands but not arms. As of 13-JUL-2021, the patient felt achy-like flu symptoms which she feels are related to to her immune system being affected from vaccine and that she may have Guillain-Barre since her events are in time with potential onset of Guillain-Barre. The patient wants to reach out to her care provided and get tested for Guillain-Barre and/or for Covid-19 infection.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from achy like flu symptoms, and the outcome of tingling in legs, back issue, menopausal symptoms, delayed cramps, could not bend down in a squat and dizziness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Menopausal symptoms, Muscle spasms, Paraesthesia
Clinical narrative: MENOPAUSAL SYMPTOMS; DELAYED CRAMPS; COULD NOT BEND DOWN IN A SQUAT; DIZZINESS; BACK ISSUE; ACHY LIKE FLU SYMPTOMS; TINGLING IN LEGS; This spontaneous report received from a female patient of an unspecified age. Race and ethnicity not reported. Local reference number EZR20210104013. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was reported that the patient works and has children and is a busy person. The patient has a new puppy in house.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  At some timepoint after vaccination, the patient experienced dizziness. About 6-8 weeks after vaccination in late MAY-2021, the patient began to experience tingling in her legs. She initially proceeded with an urgent care visit and then primary care provider to have blood work done. The primary care provider attributed the tingling in her legs to restless leg syndromes. Later the patient saw a neurologist who advised her that she did not have restless leg syndrome but attributed her events to an issue with her back because she could not bend down and squat when at work without holding onto something to get back up. The patient returned back to her primary care provider who attributed her events to menopause as she reported delayed cramping. The patient reported that she must grab a hold of something to go over the puppy gate. The patient reported that affected areas were back and hands but not arms. As of 13-JUL-2021, the patient felt achy-like flu symptoms which she feels are related to to her immune system being affected from vaccine and that she may have Guillain-Barre since her events are in time with potential onset of Guillain-Barre. The patient wants to reach out to her care provided and get tested for Guillain-Barre and/or for Covid-19 infection.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from achy like flu symptoms, and the outcome of tingling in legs, back issue, menopausal symptoms, delayed cramps, could not bend down in a squat and dizziness was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electroencephalogram, Pain in extremity, Restlessness, Tremor
Clinical narrative: RESLTESSNESS IN ALL OVER BODY; TREMORS  ALL OVER THE BODY; SHOOTING PAIN  IN LEGS; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included car accident, surgery for disk infusion c 4 5 6 7, left foot surgery for neurological issue, and right foot surgery for neurological issue, and other pre-existing medical conditions included on an unknown date in feb-2021, after surgery, left arm started to lose muscle tone, muscles started to get smaller and weaker and on left hand he felt tremors and weakness.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027 expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced resltessness in all over body. On 09-JUN-2021, the subject experienced tremors all over the body. On 09-JUN-2021, the subject experienced shooting pain in legs. Laboratory data (dates unspecified) included: Blood test (NR: not provided) No Parkinson, no other disease, and EEG (NR: not provided) No Parkinson, no other disease. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the resltessness in all over body, tremors all over the body and shooting pain in legs was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypokinesia, Nerve injury
Clinical narrative: LOOSING USE OF RIGHT HAND; EXTREME NERVE DAMAGE; HANDS WERE LIKE NUMB/NUMBNESS IN RIGHT HAND; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included back injuries, and right shoulder surgeries. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 1820096 expiry: UNKNOWN) dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced extreme nerve damage. On JUN-2021, the subject experienced hands were like numb/numbness in right hand. On an unspecified date, the subject experienced loosing use of right hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme nerve damage, and hands were like numb/numbness in right hand, and the outcome of loosing use of right hand was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Hyperventilation, Nervousness
Clinical narrative: NERVOUSNESS; TINGLING SENSATION IN BODY/TINGLING IN THE ARMS AND FEET; FELT FAINT; HYPERVENTILATION; SHORTNESS OF BREATH; HEAD FELT COMPLETELY SWOLLEN; TACHYCARDIA; PAIN IN ARM; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no any medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced tingling sensation in body/tingling in the arms and feet. On 2021, the subject experienced felt faint. On 2021, the subject experienced hyperventilation. On 2021, the subject experienced shortness of breath. On 2021, the subject experienced head felt completely swollen. On 2021, the subject experienced tachycardia. On 2021, the subject experienced pain in arm. On 2021, the subject experienced headache. On 13-JUL-2021, the subject experienced nervousness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in arm, tingling sensation in body/tingling in the arms and feet, headache, felt faint, hyperventilation, shortness of breath, tachycardia, and head felt completely swollen, and had not recovered from nervousness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Swelling, Tachycardia
Clinical narrative: NERVOUSNESS; TINGLING SENSATION IN BODY/TINGLING IN THE ARMS AND FEET; FELT FAINT; HYPERVENTILATION; SHORTNESS OF BREATH; HEAD FELT COMPLETELY SWOLLEN; TACHYCARDIA; PAIN IN ARM; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no any medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced tingling sensation in body/tingling in the arms and feet. On 2021, the subject experienced felt faint. On 2021, the subject experienced hyperventilation. On 2021, the subject experienced shortness of breath. On 2021, the subject experienced head felt completely swollen. On 2021, the subject experienced tachycardia. On 2021, the subject experienced pain in arm. On 2021, the subject experienced headache. On 13-JUL-2021, the subject experienced nervousness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in arm, tingling sensation in body/tingling in the arms and feet, headache, felt faint, hyperventilation, shortness of breath, tachycardia, and head felt completely swollen, and had not recovered from nervousness. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, SARS-CoV-2 test
Clinical narrative: PAINFUL SORE ARM; BAD HEADACHE; FATIGUE; This spontaneous report received from a consumer concerned a 57 year old male. 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: 025A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-JUL-2021 10:45 for prophylactic vaccination. No concomitant medications were reported.  On DEC-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive.  On 12-JUL-2021, the subject experienced painful sore arm. On 12-JUL-2021, the subject experienced fatigue. On 12-JUL-2021, the subject experienced bad headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bad headache, fatigue, and painful sore arm. This report was non-serious.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Anhedonia, Asthma, Blood test, Cardiovascular evaluation, Diarrhoea
Clinical narrative: FEELING OF ALMOST PASSING OUT; ROEMHELD SYNDROME; ANHEDONIA; WEIGHT LOSS AROUND 10 POUNDS/ LOST 40 POUNDS; SEVERE GAS; DIARRHEA; LIGHT ASTHMA; This spontaneous report received from a patient concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included childhood asthma, caffeine allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with prednisone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced light asthma. On 29-MAR-2021, the subject experienced anhedonia. On 29-MAR-2021, the subject experienced weight loss around 10 pounds/ lost 40 pounds. On 29-MAR-2021, the subject experienced severe gas. On 29-MAR-2021, the subject experienced diarrhea. On 18-MAY-2021, the subject experienced roemheld syndrome. On an unspecified date, the subject experienced feeling of almost passing out. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, Cardiovascular evaluation (NR: not provided) Not reported, Helicobacter pylori infection (NR: not provided) Negative, and Psychiatric evaluation (NR: not provided) Not reported. Treatment medications (dates unspecified) included: macrogol 3350, and omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anhedonia on 05-APR-2021, and light asthma on 25-MAR-2021, had not recovered from diarrhea, roemheld syndrome, severe gas, and weight loss around 10 pounds/ lost 40 pounds, and the outcome of feeling of almost passing out was not reported. This report was non-serious.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Flatulence, Gastrocardiac syndrome, Helicobacter infection, Presyncope, Psychiatric evaluation
Clinical narrative: FEELING OF ALMOST PASSING OUT; ROEMHELD SYNDROME; ANHEDONIA; WEIGHT LOSS AROUND 10 POUNDS/ LOST 40 POUNDS; SEVERE GAS; DIARRHEA; LIGHT ASTHMA; This spontaneous report received from a patient concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included childhood asthma, caffeine allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with prednisone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced light asthma. On 29-MAR-2021, the subject experienced anhedonia. On 29-MAR-2021, the subject experienced weight loss around 10 pounds/ lost 40 pounds. On 29-MAR-2021, the subject experienced severe gas. On 29-MAR-2021, the subject experienced diarrhea. On 18-MAY-2021, the subject experienced roemheld syndrome. On an unspecified date, the subject experienced feeling of almost passing out. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, Cardiovascular evaluation (NR: not provided) Not reported, Helicobacter pylori infection (NR: not provided) Negative, and Psychiatric evaluation (NR: not provided) Not reported. Treatment medications (dates unspecified) included: macrogol 3350, and omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anhedonia on 05-APR-2021, and light asthma on 25-MAR-2021, had not recovered from diarrhea, roemheld syndrome, severe gas, and weight loss around 10 pounds/ lost 40 pounds, and the outcome of feeling of almost passing out was not reported. This report was non-serious.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: FEELING OF ALMOST PASSING OUT; ROEMHELD SYNDROME; ANHEDONIA; WEIGHT LOSS AROUND 10 POUNDS/ LOST 40 POUNDS; SEVERE GAS; DIARRHEA; LIGHT ASTHMA; This spontaneous report received from a patient concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included childhood asthma, caffeine allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with prednisone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced light asthma. On 29-MAR-2021, the subject experienced anhedonia. On 29-MAR-2021, the subject experienced weight loss around 10 pounds/ lost 40 pounds. On 29-MAR-2021, the subject experienced severe gas. On 29-MAR-2021, the subject experienced diarrhea. On 18-MAY-2021, the subject experienced roemheld syndrome. On an unspecified date, the subject experienced feeling of almost passing out. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, Cardiovascular evaluation (NR: not provided) Not reported, Helicobacter pylori infection (NR: not provided) Negative, and Psychiatric evaluation (NR: not provided) Not reported. Treatment medications (dates unspecified) included: macrogol 3350, and omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anhedonia on 05-APR-2021, and light asthma on 25-MAR-2021, had not recovered from diarrhea, roemheld syndrome, severe gas, and weight loss around 10 pounds/ lost 40 pounds, and the outcome of feeling of almost passing out was not reported. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear congestion, Headache, Malaise, Maternal exposure during pregnancy
Clinical narrative: MATERNAL EXPOSURE DURING PREGNANCY; STUFFY EARS; VOMITING; FEELING UNWELL; CHILLS; FEVER; HEADACHE; NAUSEA; This solicited pregnancy report received from a patient concerned a 27 year old female. The patient was enrolled in a non-company sponsored study C-VIPER: COVID 19 Vaccines International Pregnancy Exposure Registry number: C00243). The patient's weight was 77.1 kilograms, and height was not reported. The patient's pre-existing medical conditions included the patient had multigravida. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ascorbic acid/calcium pantothenate/cyanocobalamin/ergocalciferol/nicotinamide/pyridoxine hydrochloride/retinol palmitate/riboflavin/thiamine mononitrate.  On 09-APR-2021, the patient experienced maternal exposure during pregnancy. On 09-APR-2021, the patient experienced stuffy ears. On 09-APR-2021, the patient experienced vomiting. On 09-APR-2021, the patient experienced feeling unwell. On 09-APR-2021, the patient experienced chills. On 09-APR-2021, the patient experienced fever. On 09-APR-2021, the patient experienced headache. On 09-APR-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stuffy ears, vomiting, feeling unwell, fever, headache, nausea, chills and maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and stuffy ears, vomiting, feeling unwell, chills, fever, headache, and nausea was related.  This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: MATERNAL EXPOSURE DURING PREGNANCY; STUFFY EARS; VOMITING; FEELING UNWELL; CHILLS; FEVER; HEADACHE; NAUSEA; This solicited pregnancy report received from a patient concerned a 27 year old female. The patient was enrolled in a non-company sponsored study C-VIPER: COVID 19 Vaccines International Pregnancy Exposure Registry number: C00243). The patient's weight was 77.1 kilograms, and height was not reported. The patient's pre-existing medical conditions included the patient had multigravida. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ascorbic acid/calcium pantothenate/cyanocobalamin/ergocalciferol/nicotinamide/pyridoxine hydrochloride/retinol palmitate/riboflavin/thiamine mononitrate.  On 09-APR-2021, the patient experienced maternal exposure during pregnancy. On 09-APR-2021, the patient experienced stuffy ears. On 09-APR-2021, the patient experienced vomiting. On 09-APR-2021, the patient experienced feeling unwell. On 09-APR-2021, the patient experienced chills. On 09-APR-2021, the patient experienced fever. On 09-APR-2021, the patient experienced headache. On 09-APR-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stuffy ears, vomiting, feeling unwell, fever, headache, nausea, chills and maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and stuffy ears, vomiting, feeling unwell, chills, fever, headache, and nausea was related.  This report was non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: MUSCLE WEAKNESS RIGHT LEG; MUSCLE WEAKNESS ARMS; TINGLING ON RIGHT LEG; TINGLING ON BACK; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included guillian barre syndrome, transverse myelitis, non-alcoholic, non-smoker, beesting allergy, and left leg paralysis, and other pre-existing medical conditions included no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported batch number: 1821288 expiry: 15-SEP-2021) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-JUL-2021, the subject experienced tingling on right leg. On 04-JUL-2021, the subject experienced tingling on back. On 11-JUL-2021, the subject experienced muscle weakness right leg. On 11-JUL-2021, the subject experienced muscle weakness arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling on right leg, tingling on back, muscle weakness right leg, and muscle weakness arms. This report was non-serious.