chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Blood creatine phosphokinase, Computerised tomogram, Rhabdomyolysis
Clinical narrative: RHABDOMYOLYSIS; ACUTE KIDNEY FAILURE; This spontaneous report was received from a health care professional via the Regulatory Authority (Vaccine Adverse Event Reporting System) ( ID: 1336145-1) and from literature Following Ad26.COV2.S. Vaccines 2021. 2021 Aug 27; 9, 9561-7. This report concerned a 37 year old female. 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, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced rhabdomyolysis, and acute kidney failure. The time for symptom onset was 17 days. The patient was hospitalized on an unspecified date. The number of days of hospitalization was not reported. The patient underwent computerised tomogram scan (CT scan) that suggested myositis in her masseter muscles and peak creatine kinase level was 744000 U/L. The patient was transferred to intensive care unit (ICU), was intubated and had renal replacement therapy (RRT). It was unknown if patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rhabdomyolysis and acute kidney failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This case, from Same Literature article is linked to 20210923039, 20210528518, 20210914711, 20210705289, 20210721677, 20210705289, 20210757800, 20210762171, 20210905291, 20210923028, 20210702722, 20210922810, 20210543394 and 20210922823.; Sender's Comments: V0: 20210923042-covid-19 vaccine ad26.cov2.s-Rhabdomyolysis, Acute kidney failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blindness, Computerised tomogram, Confusional state, Dizziness
Clinical narrative: JOINT PAIN; DEBILITATING HEADACHE; LOST PERIPHERAL VISION; 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-JUN-2021, the patient experienced lost peripheral vision. On an unspecified date, the patient experienced joint pain, and debilitating headache. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, CAT scan (NR: not provided) Unknown, and Magnetic resonance imaging (NR: not provided) Unknown. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from lost peripheral vision, and the outcome of debilitating headache and joint pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Paraesthesia, Vertigo, Vision blurred, Visual impairment
Clinical narrative: JOINT PAIN; DEBILITATING HEADACHE; LOST PERIPHERAL VISION; 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-JUN-2021, the patient experienced lost peripheral vision. On an unspecified date, the patient experienced joint pain, and debilitating headache. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, CAT scan (NR: not provided) Unknown, and Magnetic resonance imaging (NR: not provided) Unknown. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from lost peripheral vision, and the outcome of debilitating headache and joint pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Computerised tomogram, Headache, Magnetic resonance imaging
Clinical narrative: JOINT PAIN; DEBILITATING HEADACHE; LOST PERIPHERAL VISION; 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-JUN-2021, the patient experienced lost peripheral vision. On an unspecified date, the patient experienced joint pain, and debilitating headache. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, CAT scan (NR: not provided) Unknown, and Magnetic resonance imaging (NR: not provided) Unknown. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from lost peripheral vision, and the outcome of debilitating headache and joint pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Visual field defect
Clinical narrative: JOINT PAIN; DEBILITATING HEADACHE; LOST PERIPHERAL VISION; 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-JUN-2021, the patient experienced lost peripheral vision. On an unspecified date, the patient experienced joint pain, and debilitating headache. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, CAT scan (NR: not provided) Unknown, and Magnetic resonance imaging (NR: not provided) Unknown. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from lost peripheral vision, and the outcome of debilitating headache and joint pain was not reported. This report was non-serious.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: diluted vaccine in vial kept in refrigerator given over 24 hours dilute; diluted vaccine in vial kept in refrigerator given over 24 hours dilute; This is a spontaneous report from a contactable other HCP. A 12-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0217, Expiry date: 30Sep2021) via an unspecified route of administration in deltoid right on 29Jul2021 at 14:22 (at the age of 12-year-old) as dose 1, 0.3ml single for COVID-19 immunisation at physician office. Patient medical history was none. Up on follow up received 23Aug2021, patients medical history included ongoing Mixed Expressive Receptive Language Disorder since 07May2019. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported and children's gummy multivitamin. Up on follow up received 23Aug2021, concomitant medication was reported as none. The patient had not received any other vaccine within 4 weeks. On 29Jul2021 14:22, the patient administered with a diluted vaccine in vial kept in refrigerator given over 24 hours dilute which led to physician office visit. Caller reports the diluted vial was placed in the refrigerator previous day at 11:00 am and the last dose was inadvertently drawn up and given on 29Jul2021 around 02:00 pm. Medication error did not affect the patient with clinical consequences at the time of reporting. The patient did not receive treatment for adverse events. Patient took blood work at outpatient lab. The patient underwent lab tests and procedures which included SARS-CoV-2 test (SARS-CoV-2 IgG AB, Nucleocapsid Protein): negative on 16Aug2021 and blood tests: unknown result on an unspecified date in 2021. The outcome of the events was resolved.   Follow-up attempts are completed. No further information is expected.  Follow-up (23Aug2021): New information received from a contactable physician reported in response to HCP letter sent that included: updated age at vaccination, vaccination time, trade name, added relevant medical history, lab data, treatment and updated outcome of event.   Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Poor quality product administered, Product storage error, SARS-CoV-2 test
Clinical narrative: diluted vaccine in vial kept in refrigerator given over 24 hours dilute; diluted vaccine in vial kept in refrigerator given over 24 hours dilute; This is a spontaneous report from a contactable other HCP. A 12-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0217, Expiry date: 30Sep2021) via an unspecified route of administration in deltoid right on 29Jul2021 at 14:22 (at the age of 12-year-old) as dose 1, 0.3ml single for COVID-19 immunisation at physician office. Patient medical history was none. Up on follow up received 23Aug2021, patients medical history included ongoing Mixed Expressive Receptive Language Disorder since 07May2019. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported and children's gummy multivitamin. Up on follow up received 23Aug2021, concomitant medication was reported as none. The patient had not received any other vaccine within 4 weeks. On 29Jul2021 14:22, the patient administered with a diluted vaccine in vial kept in refrigerator given over 24 hours dilute which led to physician office visit. Caller reports the diluted vial was placed in the refrigerator previous day at 11:00 am and the last dose was inadvertently drawn up and given on 29Jul2021 around 02:00 pm. Medication error did not affect the patient with clinical consequences at the time of reporting. The patient did not receive treatment for adverse events. Patient took blood work at outpatient lab. The patient underwent lab tests and procedures which included SARS-CoV-2 test (SARS-CoV-2 IgG AB, Nucleocapsid Protein): negative on 16Aug2021 and blood tests: unknown result on an unspecified date in 2021. The outcome of the events was resolved.   Follow-up attempts are completed. No further information is expected.  Follow-up (23Aug2021): New information received from a contactable physician reported in response to HCP letter sent that included: updated age at vaccination, vaccination time, trade name, added relevant medical history, lab data, treatment and updated outcome of event.   Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Pharyngeal swelling
Clinical narrative: Throat feeling swollen; generalized flush; This is a spontaneous report from a contactable other healthcare professional. A 31-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0167, Expiry date: not reported), via intramuscular route of administration in left arm on 08Mar2021 14:19 (at age of 31-years-old) as dose 1, single for covid-19 immunisation. Medical history included allergy to medications, food or other products: multiple, multiple drug allergies including anaphylaxis to IV antibiotic of some kind. Other illnesses at the time of vaccination and up to one month prior were unknown. The patient's concomitant medications were not reported. Prescriptions, over-counter medications taken were unknown. Chronic or long-standing health conditions were unknown. The patient never had an adverse event following any previous vaccine. On 08Mar2021 at 14:25, the patient experienced throat feeling swollen and generalized flush. The patient received first dose of bnt162b2 vaccine at 14:19. At 14:25, complained of (c/o) throat feeling swollen and noticeable generalized flush. No SOB or wheezing, able to maintain conversation with nurse. Vital signs were stable. Notified EMS per adverse drug reaction chart. EMS arrived and transported patient to the hospital. The events resulted in emergency room visit. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Radial Nerve tingling; pain in right hand; This is a spontaneous case received from a contactable consumer (patient himself). A 21-year-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/batch number was not reported), via an unspecified route of administration in left arm on 31Jul2021 at 15:30 (age at vaccination 21-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Jul2021 16:15, the patient experienced radial nerve tingling and pain in right hand. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment taken for the events was unknown. The outcome of the events was recovering.   Follow-up attempts are completed. No further information was expected.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Radial Nerve tingling; pain in right hand; This is a spontaneous case received from a contactable consumer (patient himself). A 21-year-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/batch number was not reported), via an unspecified route of administration in left arm on 31Jul2021 at 15:30 (age at vaccination 21-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Jul2021 16:15, the patient experienced radial nerve tingling and pain in right hand. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment taken for the events was unknown. The outcome of the events was recovering.   Follow-up attempts are completed. No further information was expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Influenza like illness, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced I got very sick on an unspecified date. patient was just calling to report about after the first dose (Pfizer COVID 19 Vaccine) patient got very sick, so patient not sure if patient should, patient don't think patient should take the second dose. Patient just wanted to report the side effects. Patient doesn't have that information with him right now. patient not sure that patient will help you. No because patient not home right now. The clinical outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced I got very sick on an unspecified date. patient was just calling to report about after the first dose (Pfizer COVID 19 Vaccine) patient got very sick, so patient not sure if patient should, patient don't think patient should take the second dose. Patient just wanted to report the side effects. Patient doesn't have that information with him right now. patient not sure that patient will help you. No because patient not home right now. The clinical outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electromyogram, Facial paralysis, Guillain-Barre syndrome, Muscular weakness, Nerve conduction studies
Clinical narrative: Patient was hospitalized 8/12-8/21/2021 for Guillain-Barre. She had presented with progressive generalized myalgias, arthralgias, muscle spasms, billateral hand numbness over two weeks, just prior to admission she developed bilateral facial palsy and left sided weakness. She had been noted with positive Lyme Ab and was started on antibiotics. She had received J&J Covid-19 vaccine prior to symptomatology. MRI brain was normal. She was started on high dose steroids 8/13.  LP was done 8/16/2021 which showed elevated protein. EMG/NCV showed generalized predominantly distal demyelinating motor polyneuropathy. Findings are consistent with Guillain-Barre syndrome, however other demyelinating predominantly motor polyneuropathies could present in a similar fashion. Evidence of  acute denervation is not demonstrated on this study, which in the case of Guillain-Barre/acute inflammatory demeylinating polyneuropathy, predicts a good prognosis for rapid recover. She was then started on IVIG x5 days, finished on 8/20.  She was started on gabapentin for neuropathic pain. F/u with neurology in 4-6 weeks or sooner if needed. Patient was then hospitalized at acute rehab  8/21-9/6/2021. She has now finished steroid taper. She did have hyperglycemia while on steroids which has now resolved. She had significant difficulty with continued neuropathic pain and muscle spasms.  Neurontin was up titrated but did not control her pain and she was then changed to lyrica due to neurontin failure. Pain has significantly improved with lyrica. She was also started on baclofen for persistent muscle spasms which impaired her rehab progress. Baclofen was attempted to be weaned down but patient did not tolerate and she had to go back to current dosing of 20 mg qid. She was continued on celebrex for arthralgias which are still present but improved. She has still required some narcotic pain medication but has weaned down on dosing.  She was noted with mild neutropenia and will need to have f/u CBC as outpatient. She has significantly improved and is now ambulating and has been discharged.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody positive, Arthralgia, Borrelia test positive, CSF protein increased, Computerised tomogram head normal
Clinical narrative: Patient was hospitalized 8/12-8/21/2021 for Guillain-Barre. She had presented with progressive generalized myalgias, arthralgias, muscle spasms, billateral hand numbness over two weeks, just prior to admission she developed bilateral facial palsy and left sided weakness. She had been noted with positive Lyme Ab and was started on antibiotics. She had received J&J Covid-19 vaccine prior to symptomatology. MRI brain was normal. She was started on high dose steroids 8/13.  LP was done 8/16/2021 which showed elevated protein. EMG/NCV showed generalized predominantly distal demyelinating motor polyneuropathy. Findings are consistent with Guillain-Barre syndrome, however other demyelinating predominantly motor polyneuropathies could present in a similar fashion. Evidence of  acute denervation is not demonstrated on this study, which in the case of Guillain-Barre/acute inflammatory demeylinating polyneuropathy, predicts a good prognosis for rapid recover. She was then started on IVIG x5 days, finished on 8/20.  She was started on gabapentin for neuropathic pain. F/u with neurology in 4-6 weeks or sooner if needed. Patient was then hospitalized at acute rehab  8/21-9/6/2021. She has now finished steroid taper. She did have hyperglycemia while on steroids which has now resolved. She had significant difficulty with continued neuropathic pain and muscle spasms.  Neurontin was up titrated but did not control her pain and she was then changed to lyrica due to neurontin failure. Pain has significantly improved with lyrica. She was also started on baclofen for persistent muscle spasms which impaired her rehab progress. Baclofen was attempted to be weaned down but patient did not tolerate and she had to go back to current dosing of 20 mg qid. She was continued on celebrex for arthralgias which are still present but improved. She has still required some narcotic pain medication but has weaned down on dosing.  She was noted with mild neutropenia and will need to have f/u CBC as outpatient. She has significantly improved and is now ambulating and has been discharged.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Demyelinating polyneuropathy, Electromyogram abnormal, Facial paralysis, Guillain-Barre syndrome, Hemiparesis
Clinical narrative: Patient was hospitalized 8/12-8/21/2021 for Guillain-Barre. She had presented with progressive generalized myalgias, arthralgias, muscle spasms, billateral hand numbness over two weeks, just prior to admission she developed bilateral facial palsy and left sided weakness. She had been noted with positive Lyme Ab and was started on antibiotics. She had received J&J Covid-19 vaccine prior to symptomatology. MRI brain was normal. She was started on high dose steroids 8/13.  LP was done 8/16/2021 which showed elevated protein. EMG/NCV showed generalized predominantly distal demyelinating motor polyneuropathy. Findings are consistent with Guillain-Barre syndrome, however other demyelinating predominantly motor polyneuropathies could present in a similar fashion. Evidence of  acute denervation is not demonstrated on this study, which in the case of Guillain-Barre/acute inflammatory demeylinating polyneuropathy, predicts a good prognosis for rapid recover. She was then started on IVIG x5 days, finished on 8/20.  She was started on gabapentin for neuropathic pain. F/u with neurology in 4-6 weeks or sooner if needed. Patient was then hospitalized at acute rehab  8/21-9/6/2021. She has now finished steroid taper. She did have hyperglycemia while on steroids which has now resolved. She had significant difficulty with continued neuropathic pain and muscle spasms.  Neurontin was up titrated but did not control her pain and she was then changed to lyrica due to neurontin failure. Pain has significantly improved with lyrica. She was also started on baclofen for persistent muscle spasms which impaired her rehab progress. Baclofen was attempted to be weaned down but patient did not tolerate and she had to go back to current dosing of 20 mg qid. She was continued on celebrex for arthralgias which are still present but improved. She has still required some narcotic pain medication but has weaned down on dosing.  She was noted with mild neutropenia and will need to have f/u CBC as outpatient. She has significantly improved and is now ambulating and has been discharged.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperglycaemia, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture abnormal, Magnetic resonance imaging head normal
Clinical narrative: Patient was hospitalized 8/12-8/21/2021 for Guillain-Barre. She had presented with progressive generalized myalgias, arthralgias, muscle spasms, billateral hand numbness over two weeks, just prior to admission she developed bilateral facial palsy and left sided weakness. She had been noted with positive Lyme Ab and was started on antibiotics. She had received J&J Covid-19 vaccine prior to symptomatology. MRI brain was normal. She was started on high dose steroids 8/13.  LP was done 8/16/2021 which showed elevated protein. EMG/NCV showed generalized predominantly distal demyelinating motor polyneuropathy. Findings are consistent with Guillain-Barre syndrome, however other demyelinating predominantly motor polyneuropathies could present in a similar fashion. Evidence of  acute denervation is not demonstrated on this study, which in the case of Guillain-Barre/acute inflammatory demeylinating polyneuropathy, predicts a good prognosis for rapid recover. She was then started on IVIG x5 days, finished on 8/20.  She was started on gabapentin for neuropathic pain. F/u with neurology in 4-6 weeks or sooner if needed. Patient was then hospitalized at acute rehab  8/21-9/6/2021. She has now finished steroid taper. She did have hyperglycemia while on steroids which has now resolved. She had significant difficulty with continued neuropathic pain and muscle spasms.  Neurontin was up titrated but did not control her pain and she was then changed to lyrica due to neurontin failure. Pain has significantly improved with lyrica. She was also started on baclofen for persistent muscle spasms which impaired her rehab progress. Baclofen was attempted to be weaned down but patient did not tolerate and she had to go back to current dosing of 20 mg qid. She was continued on celebrex for arthralgias which are still present but improved. She has still required some narcotic pain medication but has weaned down on dosing.  She was noted with mild neutropenia and will need to have f/u CBC as outpatient. She has significantly improved and is now ambulating and has been discharged.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Myalgia, Nerve conduction studies abnormal, Neuralgia, Neutropenia
Clinical narrative: Patient was hospitalized 8/12-8/21/2021 for Guillain-Barre. She had presented with progressive generalized myalgias, arthralgias, muscle spasms, billateral hand numbness over two weeks, just prior to admission she developed bilateral facial palsy and left sided weakness. She had been noted with positive Lyme Ab and was started on antibiotics. She had received J&J Covid-19 vaccine prior to symptomatology. MRI brain was normal. She was started on high dose steroids 8/13.  LP was done 8/16/2021 which showed elevated protein. EMG/NCV showed generalized predominantly distal demyelinating motor polyneuropathy. Findings are consistent with Guillain-Barre syndrome, however other demyelinating predominantly motor polyneuropathies could present in a similar fashion. Evidence of  acute denervation is not demonstrated on this study, which in the case of Guillain-Barre/acute inflammatory demeylinating polyneuropathy, predicts a good prognosis for rapid recover. She was then started on IVIG x5 days, finished on 8/20.  She was started on gabapentin for neuropathic pain. F/u with neurology in 4-6 weeks or sooner if needed. Patient was then hospitalized at acute rehab  8/21-9/6/2021. She has now finished steroid taper. She did have hyperglycemia while on steroids which has now resolved. She had significant difficulty with continued neuropathic pain and muscle spasms.  Neurontin was up titrated but did not control her pain and she was then changed to lyrica due to neurontin failure. Pain has significantly improved with lyrica. She was also started on baclofen for persistent muscle spasms which impaired her rehab progress. Baclofen was attempted to be weaned down but patient did not tolerate and she had to go back to current dosing of 20 mg qid. She was continued on celebrex for arthralgias which are still present but improved. She has still required some narcotic pain medication but has weaned down on dosing.  She was noted with mild neutropenia and will need to have f/u CBC as outpatient. She has significantly improved and is now ambulating and has been discharged.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral motor neuropathy
Clinical narrative: Patient was hospitalized 8/12-8/21/2021 for Guillain-Barre. She had presented with progressive generalized myalgias, arthralgias, muscle spasms, billateral hand numbness over two weeks, just prior to admission she developed bilateral facial palsy and left sided weakness. She had been noted with positive Lyme Ab and was started on antibiotics. She had received J&J Covid-19 vaccine prior to symptomatology. MRI brain was normal. She was started on high dose steroids 8/13.  LP was done 8/16/2021 which showed elevated protein. EMG/NCV showed generalized predominantly distal demyelinating motor polyneuropathy. Findings are consistent with Guillain-Barre syndrome, however other demyelinating predominantly motor polyneuropathies could present in a similar fashion. Evidence of  acute denervation is not demonstrated on this study, which in the case of Guillain-Barre/acute inflammatory demeylinating polyneuropathy, predicts a good prognosis for rapid recover. She was then started on IVIG x5 days, finished on 8/20.  She was started on gabapentin for neuropathic pain. F/u with neurology in 4-6 weeks or sooner if needed. Patient was then hospitalized at acute rehab  8/21-9/6/2021. She has now finished steroid taper. She did have hyperglycemia while on steroids which has now resolved. She had significant difficulty with continued neuropathic pain and muscle spasms.  Neurontin was up titrated but did not control her pain and she was then changed to lyrica due to neurontin failure. Pain has significantly improved with lyrica. She was also started on baclofen for persistent muscle spasms which impaired her rehab progress. Baclofen was attempted to be weaned down but patient did not tolerate and she had to go back to current dosing of 20 mg qid. She was continued on celebrex for arthralgias which are still present but improved. She has still required some narcotic pain medication but has weaned down on dosing.  She was noted with mild neutropenia and will need to have f/u CBC as outpatient. She has significantly improved and is now ambulating and has been discharged.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial pain, Pain, Sleep disorder, Swelling face
Clinical narrative: Spoke with client, COVID vaccination given on 08-26-2021 at 5 pm.  Later that night while sleeping, she woke up to pain on right side of face.  Right side of face noted to be swollen, tender to touch, and pain with closing eye tightly.  She applied a cold pack and went back to sleep.  Was awaken again by the pain, she applied a cold pack and took Benadryl.  On Saturday 08-27-21, no improvement PMD was notified of symptoms, no change in treatment.  During this time she had SOB and had an increase in MDI use.  Swelling went down by Tuesday 08-31-21.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Eye pain, Facial pain, Swelling face, Tenderness
Clinical narrative: Spoke with client, COVID vaccination given on 08-26-2021 at 5 pm.  Later that night while sleeping, she woke up to pain on right side of face.  Right side of face noted to be swollen, tender to touch, and pain with closing eye tightly.  She applied a cold pack and went back to sleep.  Was awaken again by the pain, she applied a cold pack and took Benadryl.  On Saturday 08-27-21, no improvement PMD was notified of symptoms, no change in treatment.  During this time she had SOB and had an increase in MDI use.  Swelling went down by Tuesday 08-31-21.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Additional Details: patient reports extreme shortness of breath with pulse ox varying from 88 to the low 90's
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Additional Details: patient reports extreme shortness of breath with pulse ox varying from 88 to the low 90's
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized 9/16 due to ongoing poor oral intake and hyponatremia, SARS-CoV-2 positive 9/16/21 again, originally positive 8/28/21.  Had symptoms of COVID weeks to months prior to initial positive test.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Hyponatraemia, Hypophagia, Malaise, SARS-CoV-2 test positive
Clinical narrative: hospitalized 9/16 due to ongoing poor oral intake and hyponatremia, SARS-CoV-2 positive 9/16/21 again, originally positive 8/28/21.  Had symptoms of COVID weeks to months prior to initial positive test.
Age: 82.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: I would like to report an adverse vaccine event. On August 12 I have received 2nd injection of Shingrix. On August 19 one week after vaccination I started developing with increase severity an itching skin reaction macular popular with oozing on my neck, behind ears, on both thighs, both forearms, and abdomen. Because of increasing severity, I had to receive 8 days of Prednisone and local Clobetasol therapy. Today 5 weeks after vaccination condition improved but skin discoloration remained. without oozing and no new lesions. I do not suffer from any autoimmune conditions. I never had vaccination reactions in the past. Because of this severe reaction should I be vaccinated for 3rd Covit  and flu vaccination
Age: 82.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Skin discolouration, Skin reaction, Skin weeping
Clinical narrative: I would like to report an adverse vaccine event. On August 12 I have received 2nd injection of Shingrix. On August 19 one week after vaccination I started developing with increase severity an itching skin reaction macular popular with oozing on my neck, behind ears, on both thighs, both forearms, and abdomen. Because of increasing severity, I had to receive 8 days of Prednisone and local Clobetasol therapy. Today 5 weeks after vaccination condition improved but skin discoloration remained. without oozing and no new lesions. I do not suffer from any autoimmune conditions. I never had vaccination reactions in the past. Because of this severe reaction should I be vaccinated for 3rd Covit  and flu vaccination
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Musculoskeletal stiffness, Peripheral swelling, Rash
Clinical narrative: 30 minutes after receiving the vaccine she developed a rash and then hives as well as swelling, stiffness and numbness in her right arm. She also developed a headache behind her eyes. Was transported to ER and received prednisone and benadryl. Symptoms improved and she was prescribed oral prednisone for 4 more days along with famotidine for 10 days. Symptoms of swelling and rash improved after a few hours. She continues to have R arm paresthesia/numbness, pain at the injection site and in her R shoulder, intermittent headaches with blurry vision and decreased strength in her R arm as of today, 9/17.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: 30 minutes after receiving the vaccine she developed a rash and then hives as well as swelling, stiffness and numbness in her right arm. She also developed a headache behind her eyes. Was transported to ER and received prednisone and benadryl. Symptoms improved and she was prescribed oral prednisone for 4 more days along with famotidine for 10 days. Symptoms of swelling and rash improved after a few hours. She continues to have R arm paresthesia/numbness, pain at the injection site and in her R shoulder, intermittent headaches with blurry vision and decreased strength in her R arm as of today, 9/17.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Headache, Hypoaesthesia, Injection site pain, Musculoskeletal stiffness
Clinical narrative: 30 minutes after receiving the vaccine she developed a rash and then hives as well as swelling, stiffness and numbness in her right arm. She also developed a headache behind her eyes. Was transported to ER and received prednisone and benadryl. Symptoms improved and she was prescribed oral prednisone for 4 more days along with famotidine for 10 days. Symptoms of swelling and rash improved after a few hours. She continues to have R arm paresthesia/numbness, pain at the injection site and in her R shoulder, intermittent headaches with blurry vision and decreased strength in her R arm as of today, 9/17.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Swelling, Urticaria, Vision blurred
Clinical narrative: 30 minutes after receiving the vaccine she developed a rash and then hives as well as swelling, stiffness and numbness in her right arm. She also developed a headache behind her eyes. Was transported to ER and received prednisone and benadryl. Symptoms improved and she was prescribed oral prednisone for 4 more days along with famotidine for 10 days. Symptoms of swelling and rash improved after a few hours. She continues to have R arm paresthesia/numbness, pain at the injection site and in her R shoulder, intermittent headaches with blurry vision and decreased strength in her R arm as of today, 9/17.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Decreased appetite, Electrocardiogram, Hemiplegia
Clinical narrative: Had a stroke on her left side 4 days after taking the vaccine, few days after that had a 2nd stroke on her right side, can barely talk.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Speech disorder
Clinical narrative: Had a stroke on her left side 4 days after taking the vaccine, few days after that had a 2nd stroke on her right side, can barely talk.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Decreased appetite, Feeding disorder, Fluid intake reduced, Laboratory test
Clinical narrative: Had a stroke on her left side 4 days after taking the vaccine, few days after that had a 2nd stroke on her right side, can barely talk.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Taste disorder
Clinical narrative: Had a stroke on her left side 4 days after taking the vaccine, few days after that had a 2nd stroke on her right side, can barely talk.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Speech disorder
Clinical narrative: Had a stroke on her left side 4 days after taking the vaccine, few days after that had a 2nd stroke on her right side, can barely talk.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Cerebrovascular accident, Eating disorder, Loss of personal independence in daily activities, Malaise
Clinical narrative: Had a stroke on her left side 4 days after taking the vaccine, few days after that had a 2nd stroke on her right side, can barely talk.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Mouth injury, Pain in extremity, Speech disorder
Clinical narrative: Had a stroke on her left side 4 days after taking the vaccine, few days after that had a 2nd stroke on her right side, can barely talk.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary normal, Anticoagulant therapy, Back pain, Catheterisation cardiac, Dyspnoea
Clinical narrative: Back pain, palpitations and diagnosed with mild myocraditis.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Hypoxia, Magnetic resonance imaging heart, Myocarditis, Oedema peripheral
Clinical narrative: Back pain, palpitations and diagnosed with mild myocraditis.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Troponin, Ultrasound Doppler, Vein disorder
Clinical narrative: Back pain, palpitations and diagnosed with mild myocraditis.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Catheterisation cardiac, Computerised tomogram thorax, Myocarditis, Palpitations
Clinical narrative: Back pain, palpitations and diagnosed with mild myocraditis.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different Manu fact. initial and booster)-
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different Manu fact. initial and booster)-
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Heart rate increased, Hyperhidrosis, Loss of consciousness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: After immuniztion was given. Patient stated that she was not feeling well.  She was experiencing some difficulty breathing, lightheadness, tingling all over, sweating.  Patient never lost consciousness or fainted; however, there were moments were she couldn't keep eyes open but upon stimulation she would open them up.  Due to difficulty breathing 911 was called.  She was transported to ER.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Flushing, Hyperhidrosis, Malaise
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: After immuniztion was given. Patient stated that she was not feeling well.  She was experiencing some difficulty breathing, lightheadness, tingling all over, sweating.  Patient never lost consciousness or fainted; however, there were moments were she couldn't keep eyes open but upon stimulation she would open them up.  Due to difficulty breathing 911 was called.  She was transported to ER.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: After immuniztion was given. Patient stated that she was not feeling well.  She was experiencing some difficulty breathing, lightheadness, tingling all over, sweating.  Patient never lost consciousness or fainted; however, there were moments were she couldn't keep eyes open but upon stimulation she would open them up.  Due to difficulty breathing 911 was called.  She was transported to ER.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Rash
Clinical narrative: Systemic: Lymph Node Swelling-Mild, Additional Details: lemon size bump on left armpit on same side of injection site
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Systemic: Lymph Node Swelling-Mild, Additional Details: lemon size bump on left armpit on same side of injection site
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: FEEL LIKE FLUSH LIKE HOT; PANIC; SHAKING; CLAMMY; ACCELERATED HEART RATE; MISTAKENLY RECEIVED SECOND JANSSEN SHOT INSTEAD OF FLU VACCINE; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non-smoker, and other pre-existing medical conditions included: The Patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021, and dose was not reported, administered on 11-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-SEP-2021, the patient experienced feel like flush like hot. On 11-SEP-2021, the patient experienced panic. On 11-SEP-2021, the patient experienced shaking. On 11-SEP-2021, the patient experienced clammy. On 11-SEP-2021, the patient experienced accelerated heart rate. On 11-SEP-2021, the patient experienced mistakenly received second janssen shot instead of flu vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of the mistakenly received second janssen shot instead of flu vaccine, feel like flush like hot, panic, shaking, clammy and accelerated heart rate was not reported. This report was non-serious.