chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Superficial vein thrombosis, Thrombosis
Clinical narrative: DEEP VEIN THROMBOSIS; BLOOD CLOT INDUCED; This spontaneous report received from a health care professional via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System)(VAERS ID 1831721), concerned a 20 year old female of unknow race and ethnic origin. The patient's height, and weight were not reported.  The patient's past medical history included: fibromyalgia, and concurrent conditions included: Crohn's disease. 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, 1 total administered on 06-APR-2021 for an unspecified indication. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included amitriptyline, hydroxyzine, and infliximab. On 25-MAY-2021, the patient experienced deep vein thrombosis and blood clot induced.  Laboratory data (dates unspecified) included: Pulmonary function test (NR: not provided) not reported.  On 25-MAY-2021, the patient died from deep vein thrombosis, and blood clot induced. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211149874-Covid-19 vaccine ad26.cov2.s -Deep vein thrombosis, blood clot induced. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: DEEP VEIN THROMBOSIS; BLOOD CLOT INDUCED
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Pulmonary function test, Thrombosis
Clinical narrative: DEEP VEIN THROMBOSIS; BLOOD CLOT INDUCED; This spontaneous report received from a health care professional via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System)(VAERS ID 1831721), concerned a 20 year old female of unknow race and ethnic origin. The patient's height, and weight were not reported.  The patient's past medical history included: fibromyalgia, and concurrent conditions included: Crohn's disease. 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, 1 total administered on 06-APR-2021 for an unspecified indication. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included amitriptyline, hydroxyzine, and infliximab. On 25-MAY-2021, the patient experienced deep vein thrombosis and blood clot induced.  Laboratory data (dates unspecified) included: Pulmonary function test (NR: not provided) not reported.  On 25-MAY-2021, the patient died from deep vein thrombosis, and blood clot induced. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211149874-Covid-19 vaccine ad26.cov2.s -Deep vein thrombosis, blood clot induced. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: DEEP VEIN THROMBOSIS; BLOOD CLOT INDUCED
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Chest pain, Dizziness, Erythema, Hypersensitivity
Clinical narrative: COVID-19: Vaccine Reaction   Vaccine: Moderna Dose 1   Skin reaction: body flushing/redness and swelling around mouth and cheeks   System reaction: facial swelling/tingling/numbnessa round mouth and cheeks, and nausea, and skin flushing, and sweating, chest tightness.   Reaction symptoms first appeared: within 1 minutes of vaccine administration   Vitalsstable Medication Provided:  Zyrtec: dose given 10mg dissolvable tab, route given oral, time given 9:48   At time of reaction ice packs applied to neck and forehead, offered sips of water. 09:55 pt stated "I feel better." No longer flushed/sweating. 10:07 Pt denies symptoms stating she "is ready to go sit in lobby for an hour." Observed pt in lobby. 10:35 noticed pt leaning forward with hand on her back. Pt stated "I am having bad back pain in the middle of my back." Placed pt in exam room, applied ice to back and made pt comfortable. Dr. in to exam pt at this time. See doctor and nurse's notes.     Disposition: Advised to seek emergency medical care if symptoms recur.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Paraesthesia, Swelling face, Visual impairment
Clinical narrative: COVID-19: Vaccine Reaction   Vaccine: Moderna Dose 1   Skin reaction: body flushing/redness and swelling around mouth and cheeks   System reaction: facial swelling/tingling/numbnessa round mouth and cheeks, and nausea, and skin flushing, and sweating, chest tightness.   Reaction symptoms first appeared: within 1 minutes of vaccine administration   Vitalsstable Medication Provided:  Zyrtec: dose given 10mg dissolvable tab, route given oral, time given 9:48   At time of reaction ice packs applied to neck and forehead, offered sips of water. 09:55 pt stated "I feel better." No longer flushed/sweating. 10:07 Pt denies symptoms stating she "is ready to go sit in lobby for an hour." Observed pt in lobby. 10:35 noticed pt leaning forward with hand on her back. Pt stated "I am having bad back pain in the middle of my back." Placed pt in exam room, applied ice to back and made pt comfortable. Dr. in to exam pt at this time. See doctor and nurse's notes.     Disposition: Advised to seek emergency medical care if symptoms recur.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest discomfort, Erythema, Flushing, Hyperhidrosis
Clinical narrative: COVID-19: Vaccine Reaction   Vaccine: Moderna Dose 1   Skin reaction: body flushing/redness and swelling around mouth and cheeks   System reaction: facial swelling/tingling/numbnessa round mouth and cheeks, and nausea, and skin flushing, and sweating, chest tightness.   Reaction symptoms first appeared: within 1 minutes of vaccine administration   Vitalsstable Medication Provided:  Zyrtec: dose given 10mg dissolvable tab, route given oral, time given 9:48   At time of reaction ice packs applied to neck and forehead, offered sips of water. 09:55 pt stated "I feel better." No longer flushed/sweating. 10:07 Pt denies symptoms stating she "is ready to go sit in lobby for an hour." Observed pt in lobby. 10:35 noticed pt leaning forward with hand on her back. Pt stated "I am having bad back pain in the middle of my back." Placed pt in exam room, applied ice to back and made pt comfortable. Dr. in to exam pt at this time. See doctor and nurse's notes.     Disposition: Advised to seek emergency medical care if symptoms recur.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Nausea, Oral mucosal erythema, Paraesthesia, Skin reaction
Clinical narrative: COVID-19: Vaccine Reaction   Vaccine: Moderna Dose 1   Skin reaction: body flushing/redness and swelling around mouth and cheeks   System reaction: facial swelling/tingling/numbnessa round mouth and cheeks, and nausea, and skin flushing, and sweating, chest tightness.   Reaction symptoms first appeared: within 1 minutes of vaccine administration   Vitalsstable Medication Provided:  Zyrtec: dose given 10mg dissolvable tab, route given oral, time given 9:48   At time of reaction ice packs applied to neck and forehead, offered sips of water. 09:55 pt stated "I feel better." No longer flushed/sweating. 10:07 Pt denies symptoms stating she "is ready to go sit in lobby for an hour." Observed pt in lobby. 10:35 noticed pt leaning forward with hand on her back. Pt stated "I am having bad back pain in the middle of my back." Placed pt in exam room, applied ice to back and made pt comfortable. Dr. in to exam pt at this time. See doctor and nurse's notes.     Disposition: Advised to seek emergency medical care if symptoms recur.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face
Clinical narrative: COVID-19: Vaccine Reaction   Vaccine: Moderna Dose 1   Skin reaction: body flushing/redness and swelling around mouth and cheeks   System reaction: facial swelling/tingling/numbnessa round mouth and cheeks, and nausea, and skin flushing, and sweating, chest tightness.   Reaction symptoms first appeared: within 1 minutes of vaccine administration   Vitalsstable Medication Provided:  Zyrtec: dose given 10mg dissolvable tab, route given oral, time given 9:48   At time of reaction ice packs applied to neck and forehead, offered sips of water. 09:55 pt stated "I feel better." No longer flushed/sweating. 10:07 Pt denies symptoms stating she "is ready to go sit in lobby for an hour." Observed pt in lobby. 10:35 noticed pt leaning forward with hand on her back. Pt stated "I am having bad back pain in the middle of my back." Placed pt in exam room, applied ice to back and made pt comfortable. Dr. in to exam pt at this time. See doctor and nurse's notes.     Disposition: Advised to seek emergency medical care if symptoms recur.
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, Dyspnoea, Hypoxia, Mechanical ventilation, Obesity
Clinical narrative: LInk with VAERS Form #698342, only updating with death info, pt died 11/23/21
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Pneumonia, SARS-CoV-2 test positive
Clinical narrative: LInk with VAERS Form #698342, only updating with death info, pt died 11/23/21
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Death
Clinical narrative: LInk with VAERS Form #698342, only updating with death info, pt died 11/23/21
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Lethargy
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Heart Attack-Severe
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Injection site pain, Myocardial infarction
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Heart Attack-Severe
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Electromyogram, Magnetic resonance imaging neck, Magnetic resonance imaging spinal, Muscle contractions involuntary
Clinical narrative: elevated rheumatoid factor; Guillain barre syndrome; uncontrollable muscle twitches; Muscle spasms/Spasm in neck; Muscle tightness; muscle fatigue; Muscle fasciculations; pins and needles; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 09Nov2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular administered in arm left on 23Aug2021 13:00 (at the age of 33-years-old) (Batch/Lot Number: EW0217) as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. There was no Prior vaccinations. The patient got the Pfizer COVID vaccine back on 23Aug2021 and within 1 hour she started having uncontrollable muscle twitches and thought that it was potentially Guillain Barre. Guillain Barre had been ruled out at this point but she was still having muscle twitching, muscle spasms and muscle tightness on 23Aug2021. She saw a neurologist and that office diagnosed her officially with an adverse reaction to the COVID vaccine. She also had muscle fatigue. They had all stayed about the same. The patient received the 1st dose of the Pfizer vaccine on 23Aug2021 within one hour she began experiencing muscle fasciculations, tightness, fatigue + pins and needles on 23Aug2021. This progresses from her legs all the way up to her face. The events were not serious and required visit to physician office, emergency room. These symptoms still continued today. On 25Aug2021, she went to urgent care where they feared she had the onset of Guillain barre syndrome + insisted on an emergency appointment with a neurologist. On 26Aug2021 she had an emergency neuro appointment where they sent her to the ER. Routine testing came back normal. Further testing was required. EMG testing was done on 22Sep2021 and 29Sep2021, results were inconclusive. MRI was performed on 12Oct2021 on head + spine where muscle spasm was detected, Spasm in neck found. Blood work on 12Sep2021 revealed elevated rheumatoid factor, RH factor was high. There was no specific relevant test for thromboembolic events with thrombocytopenia. Further testing was still needed to rule out Guillain Barre. The outcome of the event elevated rheumatoid factor was unknown and the outcome of the other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle fatigue, Muscle spasms, Neurological symptom, Paraesthesia, Rheumatoid factor increased
Clinical narrative: elevated rheumatoid factor; Guillain barre syndrome; uncontrollable muscle twitches; Muscle spasms/Spasm in neck; Muscle tightness; muscle fatigue; Muscle fasciculations; pins and needles; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 09Nov2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular administered in arm left on 23Aug2021 13:00 (at the age of 33-years-old) (Batch/Lot Number: EW0217) as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. There was no Prior vaccinations. The patient got the Pfizer COVID vaccine back on 23Aug2021 and within 1 hour she started having uncontrollable muscle twitches and thought that it was potentially Guillain Barre. Guillain Barre had been ruled out at this point but she was still having muscle twitching, muscle spasms and muscle tightness on 23Aug2021. She saw a neurologist and that office diagnosed her officially with an adverse reaction to the COVID vaccine. She also had muscle fatigue. They had all stayed about the same. The patient received the 1st dose of the Pfizer vaccine on 23Aug2021 within one hour she began experiencing muscle fasciculations, tightness, fatigue + pins and needles on 23Aug2021. This progresses from her legs all the way up to her face. The events were not serious and required visit to physician office, emergency room. These symptoms still continued today. On 25Aug2021, she went to urgent care where they feared she had the onset of Guillain barre syndrome + insisted on an emergency appointment with a neurologist. On 26Aug2021 she had an emergency neuro appointment where they sent her to the ER. Routine testing came back normal. Further testing was required. EMG testing was done on 22Sep2021 and 29Sep2021, results were inconclusive. MRI was performed on 12Oct2021 on head + spine where muscle spasm was detected, Spasm in neck found. Blood work on 12Sep2021 revealed elevated rheumatoid factor, RH factor was high. There was no specific relevant test for thromboembolic events with thrombocytopenia. Further testing was still needed to rule out Guillain Barre. The outcome of the event elevated rheumatoid factor was unknown and the outcome of the other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination complication
Clinical narrative: elevated rheumatoid factor; Guillain barre syndrome; uncontrollable muscle twitches; Muscle spasms/Spasm in neck; Muscle tightness; muscle fatigue; Muscle fasciculations; pins and needles; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 09Nov2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular administered in arm left on 23Aug2021 13:00 (at the age of 33-years-old) (Batch/Lot Number: EW0217) as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. There was no Prior vaccinations. The patient got the Pfizer COVID vaccine back on 23Aug2021 and within 1 hour she started having uncontrollable muscle twitches and thought that it was potentially Guillain Barre. Guillain Barre had been ruled out at this point but she was still having muscle twitching, muscle spasms and muscle tightness on 23Aug2021. She saw a neurologist and that office diagnosed her officially with an adverse reaction to the COVID vaccine. She also had muscle fatigue. They had all stayed about the same. The patient received the 1st dose of the Pfizer vaccine on 23Aug2021 within one hour she began experiencing muscle fasciculations, tightness, fatigue + pins and needles on 23Aug2021. This progresses from her legs all the way up to her face. The events were not serious and required visit to physician office, emergency room. These symptoms still continued today. On 25Aug2021, she went to urgent care where they feared she had the onset of Guillain barre syndrome + insisted on an emergency appointment with a neurologist. On 26Aug2021 she had an emergency neuro appointment where they sent her to the ER. Routine testing came back normal. Further testing was required. EMG testing was done on 22Sep2021 and 29Sep2021, results were inconclusive. MRI was performed on 12Oct2021 on head + spine where muscle spasm was detected, Spasm in neck found. Blood work on 12Sep2021 revealed elevated rheumatoid factor, RH factor was high. There was no specific relevant test for thromboembolic events with thrombocytopenia. Further testing was still needed to rule out Guillain Barre. The outcome of the event elevated rheumatoid factor was unknown and the outcome of the other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Electromyogram, Guillain-Barre syndrome, Investigation, Magnetic resonance imaging head
Clinical narrative: elevated rheumatoid factor; Guillain barre syndrome; uncontrollable muscle twitches; Muscle spasms/Spasm in neck; Muscle tightness; muscle fatigue; Muscle fasciculations; pins and needles; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 09Nov2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular administered in arm left on 23Aug2021 13:00 (at the age of 33-years-old) (Batch/Lot Number: EW0217) as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. There was no Prior vaccinations. The patient got the Pfizer COVID vaccine back on 23Aug2021 and within 1 hour she started having uncontrollable muscle twitches and thought that it was potentially Guillain Barre. Guillain Barre had been ruled out at this point but she was still having muscle twitching, muscle spasms and muscle tightness on 23Aug2021. She saw a neurologist and that office diagnosed her officially with an adverse reaction to the COVID vaccine. She also had muscle fatigue. They had all stayed about the same. The patient received the 1st dose of the Pfizer vaccine on 23Aug2021 within one hour she began experiencing muscle fasciculations, tightness, fatigue + pins and needles on 23Aug2021. This progresses from her legs all the way up to her face. The events were not serious and required visit to physician office, emergency room. These symptoms still continued today. On 25Aug2021, she went to urgent care where they feared she had the onset of Guillain barre syndrome + insisted on an emergency appointment with a neurologist. On 26Aug2021 she had an emergency neuro appointment where they sent her to the ER. Routine testing came back normal. Further testing was required. EMG testing was done on 22Sep2021 and 29Sep2021, results were inconclusive. MRI was performed on 12Oct2021 on head + spine where muscle spasm was detected, Spasm in neck found. Blood work on 12Sep2021 revealed elevated rheumatoid factor, RH factor was high. There was no specific relevant test for thromboembolic events with thrombocytopenia. Further testing was still needed to rule out Guillain Barre. The outcome of the event elevated rheumatoid factor was unknown and the outcome of the other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal, Muscle contractions involuntary, Muscle fatigue, Muscle spasms, Muscle tightness
Clinical narrative: elevated rheumatoid factor; Guillain barre syndrome; uncontrollable muscle twitches; Muscle spasms/Spasm in neck; Muscle tightness; muscle fatigue; Muscle fasciculations; pins and needles; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 09Nov2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular administered in arm left on 23Aug2021 13:00 (at the age of 33-years-old) (Batch/Lot Number: EW0217) as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. There was no Prior vaccinations. The patient got the Pfizer COVID vaccine back on 23Aug2021 and within 1 hour she started having uncontrollable muscle twitches and thought that it was potentially Guillain Barre. Guillain Barre had been ruled out at this point but she was still having muscle twitching, muscle spasms and muscle tightness on 23Aug2021. She saw a neurologist and that office diagnosed her officially with an adverse reaction to the COVID vaccine. She also had muscle fatigue. They had all stayed about the same. The patient received the 1st dose of the Pfizer vaccine on 23Aug2021 within one hour she began experiencing muscle fasciculations, tightness, fatigue + pins and needles on 23Aug2021. This progresses from her legs all the way up to her face. The events were not serious and required visit to physician office, emergency room. These symptoms still continued today. On 25Aug2021, she went to urgent care where they feared she had the onset of Guillain barre syndrome + insisted on an emergency appointment with a neurologist. On 26Aug2021 she had an emergency neuro appointment where they sent her to the ER. Routine testing came back normal. Further testing was required. EMG testing was done on 22Sep2021 and 29Sep2021, results were inconclusive. MRI was performed on 12Oct2021 on head + spine where muscle spasm was detected, Spasm in neck found. Blood work on 12Sep2021 revealed elevated rheumatoid factor, RH factor was high. There was no specific relevant test for thromboembolic events with thrombocytopenia. Further testing was still needed to rule out Guillain Barre. The outcome of the event elevated rheumatoid factor was unknown and the outcome of the other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle twitching, Paraesthesia, Rheumatoid factor increased
Clinical narrative: elevated rheumatoid factor; Guillain barre syndrome; uncontrollable muscle twitches; Muscle spasms/Spasm in neck; Muscle tightness; muscle fatigue; Muscle fasciculations; pins and needles; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 09Nov2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular administered in arm left on 23Aug2021 13:00 (at the age of 33-years-old) (Batch/Lot Number: EW0217) as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. There was no Prior vaccinations. The patient got the Pfizer COVID vaccine back on 23Aug2021 and within 1 hour she started having uncontrollable muscle twitches and thought that it was potentially Guillain Barre. Guillain Barre had been ruled out at this point but she was still having muscle twitching, muscle spasms and muscle tightness on 23Aug2021. She saw a neurologist and that office diagnosed her officially with an adverse reaction to the COVID vaccine. She also had muscle fatigue. They had all stayed about the same. The patient received the 1st dose of the Pfizer vaccine on 23Aug2021 within one hour she began experiencing muscle fasciculations, tightness, fatigue + pins and needles on 23Aug2021. This progresses from her legs all the way up to her face. The events were not serious and required visit to physician office, emergency room. These symptoms still continued today. On 25Aug2021, she went to urgent care where they feared she had the onset of Guillain barre syndrome + insisted on an emergency appointment with a neurologist. On 26Aug2021 she had an emergency neuro appointment where they sent her to the ER. Routine testing came back normal. Further testing was required. EMG testing was done on 22Sep2021 and 29Sep2021, results were inconclusive. MRI was performed on 12Oct2021 on head + spine where muscle spasm was detected, Spasm in neck found. Blood work on 12Sep2021 revealed elevated rheumatoid factor, RH factor was high. There was no specific relevant test for thromboembolic events with thrombocytopenia. Further testing was still needed to rule out Guillain Barre. The outcome of the event elevated rheumatoid factor was unknown and the outcome of the other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Flushing, Loss of consciousness, Syncope, Vision blurred
Clinical narrative: patient had a near syncopal episode post vaccine administration.  Patient refused any treatment and denied the need for an ambulance.  Patient offered to call 911 and still refused, left clinic by own means.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Presyncope
Clinical narrative: patient had a near syncopal episode post vaccine administration.  Patient refused any treatment and denied the need for an ambulance.  Patient offered to call 911 and still refused, left clinic by own means.
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Hypotension, Renal failure
Clinical narrative: LInk with VAERS Form #706690, only updating with death info, pt died 11/24/21
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Death
Clinical narrative: LInk with VAERS Form #706690, only updating with death info, pt died 11/24/21
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Full blood count normal, Gait disturbance, Synovitis, Urine analysis normal
Clinical narrative: He woke up on 11/9/21 complaining of right thigh pain and had a limp. Saw PCP that same day. CBC, US, and bilateral hip/pelvic X-rays done. Per PCP all results were normal. He was diagnosed with transient synovitis. Pain and limp improved overnight and appeared to be resolved by 11/11/21.  He began complaining of right hip pain and noticeable limp again on 11/19/21. This appeared to be resolved by 11/21/21. Saw PCP on 11/22/21. Upon entering  building for PCP appointment he vomited once. No further vomiting episode have occurred since. He was not complaining of pain and there was no noticeable limp at time of appointment however when PCP manipulated his legs and hip joints he complained of pain in the right hip but not the left. PCP recommended postponing the second covid vaccine pending orthopedic evaluation and recommendation. Ortho appointment is scheduled for 12/1/2021.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bilirubin urine, Blood urine absent, Chromaturia, Full blood count normal, Gait disturbance
Clinical narrative: He woke up on 11/9/21 complaining of right thigh pain and had a limp. Saw PCP that same day. CBC, US, and bilateral hip/pelvic X-rays done. Per PCP all results were normal. He was diagnosed with transient synovitis. Pain and limp improved overnight and appeared to be resolved by 11/11/21.  He began complaining of right hip pain and noticeable limp again on 11/19/21. This appeared to be resolved by 11/21/21. Saw PCP on 11/22/21. Upon entering  building for PCP appointment he vomited once. No further vomiting episode have occurred since. He was not complaining of pain and there was no noticeable limp at time of appointment however when PCP manipulated his legs and hip joints he complained of pain in the right hip but not the left. PCP recommended postponing the second covid vaccine pending orthopedic evaluation and recommendation. Ortho appointment is scheduled for 12/1/2021.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haematocrit normal, Haemoglobin normal, Lymphocyte count normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal
Clinical narrative: He woke up on 11/9/21 complaining of right thigh pain and had a limp. Saw PCP that same day. CBC, US, and bilateral hip/pelvic X-rays done. Per PCP all results were normal. He was diagnosed with transient synovitis. Pain and limp improved overnight and appeared to be resolved by 11/11/21.  He began complaining of right hip pain and noticeable limp again on 11/19/21. This appeared to be resolved by 11/21/21. Saw PCP on 11/22/21. Upon entering  building for PCP appointment he vomited once. No further vomiting episode have occurred since. He was not complaining of pain and there was no noticeable limp at time of appointment however when PCP manipulated his legs and hip joints he complained of pain in the right hip but not the left. PCP recommended postponing the second covid vaccine pending orthopedic evaluation and recommendation. Ortho appointment is scheduled for 12/1/2021.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Nitrite urine absent, Pain in extremity
Clinical narrative: He woke up on 11/9/21 complaining of right thigh pain and had a limp. Saw PCP that same day. CBC, US, and bilateral hip/pelvic X-rays done. Per PCP all results were normal. He was diagnosed with transient synovitis. Pain and limp improved overnight and appeared to be resolved by 11/11/21.  He began complaining of right hip pain and noticeable limp again on 11/19/21. This appeared to be resolved by 11/21/21. Saw PCP on 11/22/21. Upon entering  building for PCP appointment he vomited once. No further vomiting episode have occurred since. He was not complaining of pain and there was no noticeable limp at time of appointment however when PCP manipulated his legs and hip joints he complained of pain in the right hip but not the left. PCP recommended postponing the second covid vaccine pending orthopedic evaluation and recommendation. Ortho appointment is scheduled for 12/1/2021.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Platelet count normal, Protein urine absent, Red blood cell count normal, Red cell distribution width normal, Specific gravity urine normal
Clinical narrative: He woke up on 11/9/21 complaining of right thigh pain and had a limp. Saw PCP that same day. CBC, US, and bilateral hip/pelvic X-rays done. Per PCP all results were normal. He was diagnosed with transient synovitis. Pain and limp improved overnight and appeared to be resolved by 11/11/21.  He began complaining of right hip pain and noticeable limp again on 11/19/21. This appeared to be resolved by 11/21/21. Saw PCP on 11/22/21. Upon entering  building for PCP appointment he vomited once. No further vomiting episode have occurred since. He was not complaining of pain and there was no noticeable limp at time of appointment however when PCP manipulated his legs and hip joints he complained of pain in the right hip but not the left. PCP recommended postponing the second covid vaccine pending orthopedic evaluation and recommendation. Ortho appointment is scheduled for 12/1/2021.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Synovitis, Ultrasound scan normal, Urine analysis normal, Urine ketone body absent, Urobilinogen urine decreased
Clinical narrative: He woke up on 11/9/21 complaining of right thigh pain and had a limp. Saw PCP that same day. CBC, US, and bilateral hip/pelvic X-rays done. Per PCP all results were normal. He was diagnosed with transient synovitis. Pain and limp improved overnight and appeared to be resolved by 11/11/21.  He began complaining of right hip pain and noticeable limp again on 11/19/21. This appeared to be resolved by 11/21/21. Saw PCP on 11/22/21. Upon entering  building for PCP appointment he vomited once. No further vomiting episode have occurred since. He was not complaining of pain and there was no noticeable limp at time of appointment however when PCP manipulated his legs and hip joints he complained of pain in the right hip but not the left. PCP recommended postponing the second covid vaccine pending orthopedic evaluation and recommendation. Ortho appointment is scheduled for 12/1/2021.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting, White blood cell count normal, X-ray of pelvis and hip normal, pH urine normal
Clinical narrative: He woke up on 11/9/21 complaining of right thigh pain and had a limp. Saw PCP that same day. CBC, US, and bilateral hip/pelvic X-rays done. Per PCP all results were normal. He was diagnosed with transient synovitis. Pain and limp improved overnight and appeared to be resolved by 11/11/21.  He began complaining of right hip pain and noticeable limp again on 11/19/21. This appeared to be resolved by 11/21/21. Saw PCP on 11/22/21. Upon entering  building for PCP appointment he vomited once. No further vomiting episode have occurred since. He was not complaining of pain and there was no noticeable limp at time of appointment however when PCP manipulated his legs and hip joints he complained of pain in the right hip but not the left. PCP recommended postponing the second covid vaccine pending orthopedic evaluation and recommendation. Ortho appointment is scheduled for 12/1/2021.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Influenza A virus test negative, Influenza B virus test
Clinical narrative: Patient was fully vaccinated + booster dose of Moderna. Doses received 1/22/21, 2/17/21, and 11/3/21. Patient admitted since 11/12/21 with COVID pneumonia (cough, sputum increased, SOB)
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Influenza virus test negative, SARS-CoV-2 test positive
Clinical narrative: Patient was fully vaccinated + booster dose of Moderna. Doses received 1/22/21, 2/17/21, and 11/3/21. Patient admitted since 11/12/21 with COVID pneumonia (cough, sputum increased, SOB)
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Cough, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Patient was fully vaccinated + booster dose of Moderna. Doses received 1/22/21, 2/17/21, and 11/3/21. Patient admitted since 11/12/21 with COVID pneumonia (cough, sputum increased, SOB)
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Sputum increased
Clinical narrative: Patient was fully vaccinated + booster dose of Moderna. Doses received 1/22/21, 2/17/21, and 11/3/21. Patient admitted since 11/12/21 with COVID pneumonia (cough, sputum increased, SOB)
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Hypertension, Neurological symptom, Pyrexia
Clinical narrative: Confusion - thought my phone was the TV remote; Neurological symptoms; Could not sit up - had no control over upper body, balance severely affected, could not place body where I intended; Administration date 17Nov2021 at 14:30, dose received=3; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the third dose (booster) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the right arm on 17Nov2021 at 14:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included heart disorder, diabetes and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included finasteride (MANUFACTURER UNKNOWN), tamsulosin (MANUFACTURER UNKNOWN), oxybutynin (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if on going. The patient previously took sulfur (MANUFACTURER UNKNOWN) for unknown indication and had drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Jan2021 (at the age of 73-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Feb2021 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. On 18Nov2021 at 13:15, the patient experienced confusion- he thought that his phone was the TV remote, neurological symptoms, could not sit up-had no control over upper body, balance severely affected, could not place body where he intended. The patient was very concerned over those affects. He had no effects with first and second dose of Pfizer, but only with the booster on 17Nov2021. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events confusion- thought his phone was the TV remote, neurological symptoms and could not sit up - had no control over upper body, balance severely affected, could not place body where he intended. The clinical outcome of the events confusion- thought his phone was the TV remote, neurological symptoms and could not sit up - had no control over upper body, balance severely affected, could not place body where he intended was recovering at the time of report.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Confusional state, Immunisation, Neurological symptom
Clinical narrative: Confusion - thought my phone was the TV remote; Neurological symptoms; Could not sit up - had no control over upper body, balance severely affected, could not place body where I intended; Administration date 17Nov2021 at 14:30, dose received=3; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the third dose (booster) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the right arm on 17Nov2021 at 14:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included heart disorder, diabetes and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included finasteride (MANUFACTURER UNKNOWN), tamsulosin (MANUFACTURER UNKNOWN), oxybutynin (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if on going. The patient previously took sulfur (MANUFACTURER UNKNOWN) for unknown indication and had drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Jan2021 (at the age of 73-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Feb2021 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. On 18Nov2021 at 13:15, the patient experienced confusion- he thought that his phone was the TV remote, neurological symptoms, could not sit up-had no control over upper body, balance severely affected, could not place body where he intended. The patient was very concerned over those affects. He had no effects with first and second dose of Pfizer, but only with the booster on 17Nov2021. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events confusion- thought his phone was the TV remote, neurological symptoms and could not sit up - had no control over upper body, balance severely affected, could not place body where he intended. The clinical outcome of the events confusion- thought his phone was the TV remote, neurological symptoms and could not sit up - had no control over upper body, balance severely affected, could not place body where he intended was recovering at the time of report.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site cellulitis, Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt reports that she develop a skin infection after her vaccine
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin infection
Clinical narrative: Pt reports that she develop a skin infection after her vaccine
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Given wrong Pfizer vaccine. Patient received 20 micrograms of adult (purple cap) Pfizer vaccine
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Wrong product administered
Clinical narrative: Given wrong Pfizer vaccine. Patient received 20 micrograms of adult (purple cap) Pfizer vaccine
Age: 0.42
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE reported.; the MA administered the wrong immunization; administerd to a 5-month-old baby on 10/25/2021; This spontaneous report was received from a medical assistant and refers to a 5-month-old female patient. There was no information about the patient's concurrent conditions, allergies, drug reactions or medical history provided.  On 25-OCT-2021, the patient was inadvertently administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in dose 0.5 (units not reported) (lot # T025367 verified as valid with expiration date: 18-NOV-2022) via intramuscular route in the right vastus lateralis for prophylaxis, instead of pneumococcal vaccine (manufacturer unknown). Concomitant vaccines administered also on 25-OCT-2021 included: hepatitis b vaccine rhbsag (yeast)(ENGERIX B) and diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid(PENTACEL). On 25-OCT-2021, the wrong vaccine was administered to patient of inappropriate age. The immunizations were ordered correctly by examing provider. The medical assistant administered the wrong immunization. The patient was monitored for reactions. No reaction occurred. The outcome of the events was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: bo known side effects; administered after temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 29-SEP-2021, the patient was vaccinated with improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) lot # T025943, expiration date 30-JUL-2022 (formulation, strength, dose, anatomical location and route of administration were not reported) for prophylaxis. The patient had no known side effects (no adverse event). The reporter stated there were 2 excursions from July and they had no data information at all for temperatures during August and September. They discovered their freezer was having issues and were not aware because the alarm had accidently been turned off after having maintenance performed on freezer. Insufficient data to evaluate vaccines. The reporter stated they knew they were warmer than refrigerated temperatures but were not able to provide warmest temperature or length of time out of range.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no known side effects; temperature excursion/administered to a patient; This spontaneous report was received from a medical assistant and refers to a 22-year-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-SEP-2021, the patient was vaccinated with improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) lot # T025943, expiration date 30-JUL-2022 (formulation, strength, dose, anatomical location and route of administration were not reported) for prophylaxis. The patient had no known side effects (no adverse event). The reporter stated they discovered their freezer was having issues and were not aware because the alarm had accidently been turned off after having maintenance performed on freezer. The reporter stated there were 2 excursions in July and they have no data collection at all for temperatures during August and September. Insufficient data to evaluate vaccines. The reporter stated they knew they were warmer than refrigerated temperatures but was not able to provide warmest temperature or length of time out of range.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No addittional adverse experiences reported as a result ofthe vaccine administration; Office manager responsible for vaccines calling to report administration of expired doses of RECOMBIVAX; This spontaneous report has been received from an office manager, regarding a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications, concurrent conditions and previous drug reactions or allergies was not provided.  On 09-NOV-2021, the patient was vaccinated with am expired single dose of hepatitis B Vaccine (Recombinant) thimerosal-free (RECOMBIVAX HB) as prophylaxis (lot number S022584 valid, and expiration date reported and validated as 31-OCT-2021) (exact dose, dose number, vaccination scheme frequency, route of administration, and anatomical location of vaccination were not reported) (expired product administered); no temperature excursions, no additional adverse experiences reported as a result of the vaccine administration (no adverse event).   This is one from several reports from the same reporter. ; Sender's Comments:  US-009507513-2111USA004039: