chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal, Venogram
Clinical narrative: STROKE; This spontaneous report received from a consumer concerned a 75year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1476806 expiry: 21-JUN-2021) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-APR-2021, the patient experienced stroke. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210517403-COVID-19 VACCINE AD26.COV2.S-Stroke. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a consumer concerned a 75year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1476806 expiry: 21-JUN-2021) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-APR-2021, the patient experienced stroke. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210517403-COVID-19 VACCINE AD26.COV2.S-Stroke. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: At approx. 0200 - 0230 on 5/7/21, pt in bed on her computer when she experienced rapid onset numbness/tingling b/l in feet. This sensation progressed up towards her calves then started in both hands. Pt stated she was in severe pain. At this point patient called her mother to come into her room for assistance as she could no longer feel her lower extremities. Sensory loss eventually ascended up to Chest level by the afternoon. Pt lost ability to walk, was paralyzed in both feet from (including) ankle down. Motor was weak throughout lower and upper extremities, equal bilaterally. Pt described severe pain ("I feel like I need to stretch but nothing stretches. I guess it's not pain but it's like my muscle needs to be stretched and it's stuck pulling against my bone")l find it there. Pt was originally diagnosed with Guillain-Barre however; neurologists became suspicious for transverse myelitis. Labs pending for final diagnosis. 1 week later, pt has been discharged. Pt is recovering however is still experiencing numbness/tingling on occasion and extreme weakness.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Gait inability, Gait spastic, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: At approx. 0200 - 0230 on 5/7/21, pt in bed on her computer when she experienced rapid onset numbness/tingling b/l in feet. This sensation progressed up towards her calves then started in both hands. Pt stated she was in severe pain. At this point patient called her mother to come into her room for assistance as she could no longer feel her lower extremities. Sensory loss eventually ascended up to Chest level by the afternoon. Pt lost ability to walk, was paralyzed in both feet from (including) ankle down. Motor was weak throughout lower and upper extremities, equal bilaterally. Pt described severe pain ("I feel like I need to stretch but nothing stretches. I guess it's not pain but it's like my muscle needs to be stretched and it's stuck pulling against my bone")l find it there. Pt was originally diagnosed with Guillain-Barre however; neurologists became suspicious for transverse myelitis. Labs pending for final diagnosis. 1 week later, pt has been discharged. Pt is recovering however is still experiencing numbness/tingling on occasion and extreme weakness.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Motor dysfunction, Myelitis transverse, Pain, Paraesthesia
Clinical narrative: At approx. 0200 - 0230 on 5/7/21, pt in bed on her computer when she experienced rapid onset numbness/tingling b/l in feet. This sensation progressed up towards her calves then started in both hands. Pt stated she was in severe pain. At this point patient called her mother to come into her room for assistance as she could no longer feel her lower extremities. Sensory loss eventually ascended up to Chest level by the afternoon. Pt lost ability to walk, was paralyzed in both feet from (including) ankle down. Motor was weak throughout lower and upper extremities, equal bilaterally. Pt described severe pain ("I feel like I need to stretch but nothing stretches. I guess it's not pain but it's like my muscle needs to be stretched and it's stuck pulling against my bone")l find it there. Pt was originally diagnosed with Guillain-Barre however; neurologists became suspicious for transverse myelitis. Labs pending for final diagnosis. 1 week later, pt has been discharged. Pt is recovering however is still experiencing numbness/tingling on occasion and extreme weakness.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensory loss
Clinical narrative: At approx. 0200 - 0230 on 5/7/21, pt in bed on her computer when she experienced rapid onset numbness/tingling b/l in feet. This sensation progressed up towards her calves then started in both hands. Pt stated she was in severe pain. At this point patient called her mother to come into her room for assistance as she could no longer feel her lower extremities. Sensory loss eventually ascended up to Chest level by the afternoon. Pt lost ability to walk, was paralyzed in both feet from (including) ankle down. Motor was weak throughout lower and upper extremities, equal bilaterally. Pt described severe pain ("I feel like I need to stretch but nothing stretches. I guess it's not pain but it's like my muscle needs to be stretched and it's stuck pulling against my bone")l find it there. Pt was originally diagnosed with Guillain-Barre however; neurologists became suspicious for transverse myelitis. Labs pending for final diagnosis. 1 week later, pt has been discharged. Pt is recovering however is still experiencing numbness/tingling on occasion and extreme weakness.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash papular
Clinical narrative: SKIN PEELING/SKIN FLUFFING; SEVERE RED RAISED LARGE PAPULAR RASH ON UPPER TORSO AND UPPER ARM; RASH ON BILATERAL INNER THIGHS; EAR LOBES SWELLED UP; UPPER NECK SWELLED UP; NECK DOWN RED; ITCHY SKIN; This spontaneous report received from a consumer concerned a 66 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 20A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced ear lobes swelled up. On MAY-2021, the subject experienced upper neck swelled up. On MAY-2021, the subject experienced neck down red. On MAY-2021, the subject experienced itchy skin. On 08-MAY-2021, the subject experienced severe red raised large papular rash on upper torso and upper arm. On 08-MAY-2021, the subject experienced rash on bilateral inner thighs. On 09-MAY-2021, treatment medications included: diphenhydramine hydrochloride. On 10-MAY-2021, the subject experienced skin peeling/skin fluffing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe red raised large papular rash on upper torso and upper arm, upper neck swelled up, itchy skin, and rash on bilateral inner thighs on MAY-2021, and skin peeling/skin fluffing on 12-MAY-2021, and was recovering from ear lobes swelled up, and neck down red. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear swelling, Erythema, Pruritus, Rash, Rash papular
Clinical narrative: SKIN PEELING/SKIN FLUFFING; SEVERE RED RAISED LARGE PAPULAR RASH ON UPPER TORSO AND UPPER ARM; RASH ON BILATERAL INNER THIGHS; EAR LOBES SWELLED UP; UPPER NECK SWELLED UP; NECK DOWN RED; ITCHY SKIN; This spontaneous report received from a consumer concerned a 66 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 20A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced ear lobes swelled up. On MAY-2021, the subject experienced upper neck swelled up. On MAY-2021, the subject experienced neck down red. On MAY-2021, the subject experienced itchy skin. On 08-MAY-2021, the subject experienced severe red raised large papular rash on upper torso and upper arm. On 08-MAY-2021, the subject experienced rash on bilateral inner thighs. On 09-MAY-2021, treatment medications included: diphenhydramine hydrochloride. On 10-MAY-2021, the subject experienced skin peeling/skin fluffing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe red raised large papular rash on upper torso and upper arm, upper neck swelled up, itchy skin, and rash on bilateral inner thighs on MAY-2021, and skin peeling/skin fluffing on 12-MAY-2021, and was recovering from ear lobes swelled up, and neck down red. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin exfoliation, Swelling
Clinical narrative: SKIN PEELING/SKIN FLUFFING; SEVERE RED RAISED LARGE PAPULAR RASH ON UPPER TORSO AND UPPER ARM; RASH ON BILATERAL INNER THIGHS; EAR LOBES SWELLED UP; UPPER NECK SWELLED UP; NECK DOWN RED; ITCHY SKIN; This spontaneous report received from a consumer concerned a 66 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 20A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced ear lobes swelled up. On MAY-2021, the subject experienced upper neck swelled up. On MAY-2021, the subject experienced neck down red. On MAY-2021, the subject experienced itchy skin. On 08-MAY-2021, the subject experienced severe red raised large papular rash on upper torso and upper arm. On 08-MAY-2021, the subject experienced rash on bilateral inner thighs. On 09-MAY-2021, treatment medications included: diphenhydramine hydrochloride. On 10-MAY-2021, the subject experienced skin peeling/skin fluffing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe red raised large papular rash on upper torso and upper arm, upper neck swelled up, itchy skin, and rash on bilateral inner thighs on MAY-2021, and skin peeling/skin fluffing on 12-MAY-2021, and was recovering from ear lobes swelled up, and neck down red. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE ADMINISTERED OUTSIDE OF EXPIRY SAFETY GUIDELINES; VACCINE REMOVED FROM FRIDGE AT 09:40 , EXPIRED 15:40H AND VACCINE RECEIVED IN ERROR BETWEEN 16:40-17:00H; DOSE WAS ADMINISTERED BEYOND STABILITY STORAGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1821286 expiry: 23-JUL-2021) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced vaccine administered outside of expiry safety guidelines. On 10-MAY-2021, the subject experienced vaccine removed from fridge at 0940 expired 1540h and vaccine received in error between 1640-1700h. On 10-MAY-2021, the subject experienced dose was administered beyond stability storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered outside of expiry safety guidelines, vaccine removed from fridge at 0940 expired 1540h and vaccine received in error between 1640-1700h and dose was administered beyond stability storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210518205 and 20210518106.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED OUTSIDE OF EXPIRY SAFETY GUIDELINES; VACCINE REMOVED FROM FRIDGE AT 09:40 , EXPIRED 15:40H AND VACCINE RECEIVED IN ERROR BETWEEN 16:40-17:00H; DOSE WAS ADMINISTERED BEYOND STABILITY STORAGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1821286 expiry: 23-JUL-2021) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced vaccine administered outside of expiry safety guidelines. On 10-MAY-2021, the subject experienced vaccine removed from fridge at 0940 expired 1540h and vaccine received in error between 1640-1700h. On 10-MAY-2021, the subject experienced dose was administered beyond stability storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered outside of expiry safety guidelines, vaccine removed from fridge at 0940 expired 1540h and vaccine received in error between 1640-1700h and dose was administered beyond stability storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210518205 and 20210518106.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: POTENTIALLY EXPIRED DOSE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 1821286, and expiry: 23-JUL-2021) dose was not reported, administered on 10-MAY-2021 16:54 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced potentially expired dose administered. The action taken with covid-19 vaccine  was not applicable. The outcome of potentially expired dose administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210518106 and 20210519934. This case, from the Others is linked to 20210518812.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: POTENTIALLY EXPIRED DOSE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 1821286, and expiry: 23-JUL-2021) dose was not reported, administered on 10-MAY-2021 16:54 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced potentially expired dose administered. The action taken with covid-19 vaccine  was not applicable. The outcome of potentially expired dose administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210518106 and 20210519934. This case, from the Others is linked to 20210518812.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Bursitis, Injected limb mobility decreased, Injection site pain
Clinical narrative: Shoulder Injury related to vaccine administration , Pain in shoulder area,Treated with Nsaids
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Shoulder injury related to vaccine administration
Clinical narrative: Shoulder Injury related to vaccine administration , Pain in shoulder area,Treated with Nsaids
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: CSF protein increased, Facial paralysis, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Pt received J and J vaccine 4/9/21 On April 28, pt developed headache On 4/29-30, pt developed progressive weakness on L side of face On 5/1, pt was seen in urgent care and ER and diagnosed w/ Bell's Palsy.  No imaging was done.  He was prescribed 1 week of prednisone and valacyclovir. On 5/3, the L side of face continued to weaken and he also started developing weakness of R side of face  On 5/4, I saw pt in my office and he had bilateral facial nerve palsy, left greater than right, and otherwise normal neurologic exam Out of concern for development of atypical GBS, an MRI was ordered and pt instructed to report to ER with any progression of symptoms. On 5/4, he returned to ER with progression of facial weakness and had MRI that showed enhancement of bilateral facial nerves and no other significant abnormalities. On 5/7 I saw him in the office again and he had started to have improvement in L facial nerve palsy and progression of R facial nerve palsy, but no other symptoms.  Labs including Lyme IgG, HIV, RPR, CMV titers were normal.  EBV titers suggestive of current or past infection. On 5/7 in the evening he developed paresthesias in the R foot that progressed up to the R groin over the following 2 days, and also developed paresthesias in L foot/leg and bilateral hands. He presented to the ER again on 5/9 and was admitted for evaluation for Guillain Barre syndrome CT chest was unremarkable.  He had lumbar puncture showing albuminocytologic dissociation consistent with GBS. He was seen by neurology in the hospital who confirmed diagnosis of Guillain-Barre variant. His parethesias and facial nerve palsy improved while hospitalized and decision was made not to give IVIG as he was likely past the nadir.  He was discharged 5/11. I saw him in the office 5/13 and facial nerve palsy continues to improve with only trace remaining L sided weakness and resolution of paresthesias.  He has normal reflexes and normal peak flow. He will follow up with neuromuscular clinic in the coming weeks
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiotensin converting enzyme, Antibody test negative, Antinuclear antibody negative, Bell's palsy, Blood creatine phosphokinase normal
Clinical narrative: Pt received J and J vaccine 4/9/21 On April 28, pt developed headache On 4/29-30, pt developed progressive weakness on L side of face On 5/1, pt was seen in urgent care and ER and diagnosed w/ Bell's Palsy.  No imaging was done.  He was prescribed 1 week of prednisone and valacyclovir. On 5/3, the L side of face continued to weaken and he also started developing weakness of R side of face  On 5/4, I saw pt in my office and he had bilateral facial nerve palsy, left greater than right, and otherwise normal neurologic exam Out of concern for development of atypical GBS, an MRI was ordered and pt instructed to report to ER with any progression of symptoms. On 5/4, he returned to ER with progression of facial weakness and had MRI that showed enhancement of bilateral facial nerves and no other significant abnormalities. On 5/7 I saw him in the office again and he had started to have improvement in L facial nerve palsy and progression of R facial nerve palsy, but no other symptoms.  Labs including Lyme IgG, HIV, RPR, CMV titers were normal.  EBV titers suggestive of current or past infection. On 5/7 in the evening he developed paresthesias in the R foot that progressed up to the R groin over the following 2 days, and also developed paresthesias in L foot/leg and bilateral hands. He presented to the ER again on 5/9 and was admitted for evaluation for Guillain Barre syndrome CT chest was unremarkable.  He had lumbar puncture showing albuminocytologic dissociation consistent with GBS. He was seen by neurology in the hospital who confirmed diagnosis of Guillain-Barre variant. His parethesias and facial nerve palsy improved while hospitalized and decision was made not to give IVIG as he was likely past the nadir.  He was discharged 5/11. I saw him in the office 5/13 and facial nerve palsy continues to improve with only trace remaining L sided weakness and resolution of paresthesias.  He has normal reflexes and normal peak flow. He will follow up with neuromuscular clinic in the coming weeks
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone normal, Borrelia test negative, C-reactive protein normal, CSF glucose normal, CSF protein increased
Clinical narrative: Pt received J and J vaccine 4/9/21 On April 28, pt developed headache On 4/29-30, pt developed progressive weakness on L side of face On 5/1, pt was seen in urgent care and ER and diagnosed w/ Bell's Palsy.  No imaging was done.  He was prescribed 1 week of prednisone and valacyclovir. On 5/3, the L side of face continued to weaken and he also started developing weakness of R side of face  On 5/4, I saw pt in my office and he had bilateral facial nerve palsy, left greater than right, and otherwise normal neurologic exam Out of concern for development of atypical GBS, an MRI was ordered and pt instructed to report to ER with any progression of symptoms. On 5/4, he returned to ER with progression of facial weakness and had MRI that showed enhancement of bilateral facial nerves and no other significant abnormalities. On 5/7 I saw him in the office again and he had started to have improvement in L facial nerve palsy and progression of R facial nerve palsy, but no other symptoms.  Labs including Lyme IgG, HIV, RPR, CMV titers were normal.  EBV titers suggestive of current or past infection. On 5/7 in the evening he developed paresthesias in the R foot that progressed up to the R groin over the following 2 days, and also developed paresthesias in L foot/leg and bilateral hands. He presented to the ER again on 5/9 and was admitted for evaluation for Guillain Barre syndrome CT chest was unremarkable.  He had lumbar puncture showing albuminocytologic dissociation consistent with GBS. He was seen by neurology in the hospital who confirmed diagnosis of Guillain-Barre variant. His parethesias and facial nerve palsy improved while hospitalized and decision was made not to give IVIG as he was likely past the nadir.  He was discharged 5/11. I saw him in the office 5/13 and facial nerve palsy continues to improve with only trace remaining L sided weakness and resolution of paresthesias.  He has normal reflexes and normal peak flow. He will follow up with neuromuscular clinic in the coming weeks
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: CSF white blood cell count positive, Computerised tomogram thorax normal, Cytomegalovirus test negative, Differential white blood cell count normal, Epstein-Barr virus antibody positive
Clinical narrative: Pt received J and J vaccine 4/9/21 On April 28, pt developed headache On 4/29-30, pt developed progressive weakness on L side of face On 5/1, pt was seen in urgent care and ER and diagnosed w/ Bell's Palsy.  No imaging was done.  He was prescribed 1 week of prednisone and valacyclovir. On 5/3, the L side of face continued to weaken and he also started developing weakness of R side of face  On 5/4, I saw pt in my office and he had bilateral facial nerve palsy, left greater than right, and otherwise normal neurologic exam Out of concern for development of atypical GBS, an MRI was ordered and pt instructed to report to ER with any progression of symptoms. On 5/4, he returned to ER with progression of facial weakness and had MRI that showed enhancement of bilateral facial nerves and no other significant abnormalities. On 5/7 I saw him in the office again and he had started to have improvement in L facial nerve palsy and progression of R facial nerve palsy, but no other symptoms.  Labs including Lyme IgG, HIV, RPR, CMV titers were normal.  EBV titers suggestive of current or past infection. On 5/7 in the evening he developed paresthesias in the R foot that progressed up to the R groin over the following 2 days, and also developed paresthesias in L foot/leg and bilateral hands. He presented to the ER again on 5/9 and was admitted for evaluation for Guillain Barre syndrome CT chest was unremarkable.  He had lumbar puncture showing albuminocytologic dissociation consistent with GBS. He was seen by neurology in the hospital who confirmed diagnosis of Guillain-Barre variant. His parethesias and facial nerve palsy improved while hospitalized and decision was made not to give IVIG as he was likely past the nadir.  He was discharged 5/11. I saw him in the office 5/13 and facial nerve palsy continues to improve with only trace remaining L sided weakness and resolution of paresthesias.  He has normal reflexes and normal peak flow. He will follow up with neuromuscular clinic in the coming weeks
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Facial paresis, Full blood count normal, Guillain-Barre syndrome, HIV test negative
Clinical narrative: Pt received J and J vaccine 4/9/21 On April 28, pt developed headache On 4/29-30, pt developed progressive weakness on L side of face On 5/1, pt was seen in urgent care and ER and diagnosed w/ Bell's Palsy.  No imaging was done.  He was prescribed 1 week of prednisone and valacyclovir. On 5/3, the L side of face continued to weaken and he also started developing weakness of R side of face  On 5/4, I saw pt in my office and he had bilateral facial nerve palsy, left greater than right, and otherwise normal neurologic exam Out of concern for development of atypical GBS, an MRI was ordered and pt instructed to report to ER with any progression of symptoms. On 5/4, he returned to ER with progression of facial weakness and had MRI that showed enhancement of bilateral facial nerves and no other significant abnormalities. On 5/7 I saw him in the office again and he had started to have improvement in L facial nerve palsy and progression of R facial nerve palsy, but no other symptoms.  Labs including Lyme IgG, HIV, RPR, CMV titers were normal.  EBV titers suggestive of current or past infection. On 5/7 in the evening he developed paresthesias in the R foot that progressed up to the R groin over the following 2 days, and also developed paresthesias in L foot/leg and bilateral hands. He presented to the ER again on 5/9 and was admitted for evaluation for Guillain Barre syndrome CT chest was unremarkable.  He had lumbar puncture showing albuminocytologic dissociation consistent with GBS. He was seen by neurology in the hospital who confirmed diagnosis of Guillain-Barre variant. His parethesias and facial nerve palsy improved while hospitalized and decision was made not to give IVIG as he was likely past the nadir.  He was discharged 5/11. I saw him in the office 5/13 and facial nerve palsy continues to improve with only trace remaining L sided weakness and resolution of paresthesias.  He has normal reflexes and normal peak flow. He will follow up with neuromuscular clinic in the coming weeks
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Hemiparesis, Lumbar puncture abnormal, Magnetic resonance imaging abnormal, Metabolic function test normal
Clinical narrative: Pt received J and J vaccine 4/9/21 On April 28, pt developed headache On 4/29-30, pt developed progressive weakness on L side of face On 5/1, pt was seen in urgent care and ER and diagnosed w/ Bell's Palsy.  No imaging was done.  He was prescribed 1 week of prednisone and valacyclovir. On 5/3, the L side of face continued to weaken and he also started developing weakness of R side of face  On 5/4, I saw pt in my office and he had bilateral facial nerve palsy, left greater than right, and otherwise normal neurologic exam Out of concern for development of atypical GBS, an MRI was ordered and pt instructed to report to ER with any progression of symptoms. On 5/4, he returned to ER with progression of facial weakness and had MRI that showed enhancement of bilateral facial nerves and no other significant abnormalities. On 5/7 I saw him in the office again and he had started to have improvement in L facial nerve palsy and progression of R facial nerve palsy, but no other symptoms.  Labs including Lyme IgG, HIV, RPR, CMV titers were normal.  EBV titers suggestive of current or past infection. On 5/7 in the evening he developed paresthesias in the R foot that progressed up to the R groin over the following 2 days, and also developed paresthesias in L foot/leg and bilateral hands. He presented to the ER again on 5/9 and was admitted for evaluation for Guillain Barre syndrome CT chest was unremarkable.  He had lumbar puncture showing albuminocytologic dissociation consistent with GBS. He was seen by neurology in the hospital who confirmed diagnosis of Guillain-Barre variant. His parethesias and facial nerve palsy improved while hospitalized and decision was made not to give IVIG as he was likely past the nadir.  He was discharged 5/11. I saw him in the office 5/13 and facial nerve palsy continues to improve with only trace remaining L sided weakness and resolution of paresthesias.  He has normal reflexes and normal peak flow. He will follow up with neuromuscular clinic in the coming weeks
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Thyroxine free normal, Treponema test negative, Vitamin B12 normal
Clinical narrative: Pt received J and J vaccine 4/9/21 On April 28, pt developed headache On 4/29-30, pt developed progressive weakness on L side of face On 5/1, pt was seen in urgent care and ER and diagnosed w/ Bell's Palsy.  No imaging was done.  He was prescribed 1 week of prednisone and valacyclovir. On 5/3, the L side of face continued to weaken and he also started developing weakness of R side of face  On 5/4, I saw pt in my office and he had bilateral facial nerve palsy, left greater than right, and otherwise normal neurologic exam Out of concern for development of atypical GBS, an MRI was ordered and pt instructed to report to ER with any progression of symptoms. On 5/4, he returned to ER with progression of facial weakness and had MRI that showed enhancement of bilateral facial nerves and no other significant abnormalities. On 5/7 I saw him in the office again and he had started to have improvement in L facial nerve palsy and progression of R facial nerve palsy, but no other symptoms.  Labs including Lyme IgG, HIV, RPR, CMV titers were normal.  EBV titers suggestive of current or past infection. On 5/7 in the evening he developed paresthesias in the R foot that progressed up to the R groin over the following 2 days, and also developed paresthesias in L foot/leg and bilateral hands. He presented to the ER again on 5/9 and was admitted for evaluation for Guillain Barre syndrome CT chest was unremarkable.  He had lumbar puncture showing albuminocytologic dissociation consistent with GBS. He was seen by neurology in the hospital who confirmed diagnosis of Guillain-Barre variant. His parethesias and facial nerve palsy improved while hospitalized and decision was made not to give IVIG as he was likely past the nadir.  He was discharged 5/11. I saw him in the office 5/13 and facial nerve palsy continues to improve with only trace remaining L sided weakness and resolution of paresthesias.  He has normal reflexes and normal peak flow. He will follow up with neuromuscular clinic in the coming weeks
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Insomnia, Rash, Rash pruritic
Clinical narrative: ALLERGY ON NECK, BACK AND LOWER WAIST; BUMP AND ITCHING; ITCHING ALL OVER THE BODY; THE ALLERGY AS  VERY BIG RED COLOR; HARD BUMP; This spontaneous report received from a patient concerned a 74 year old female. The patient's weight, height, and medical history were not reported . The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for allergy.  On 04-MAY-2021, the subject experienced hard bump. On an unspecified date, the subject experienced allergy on neck, back and lower waist, bump and itching, itching all over the body, and the allergy as very big red color. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from allergy on neck, back and lower waist, the allergy as very big red color, hard bump, itching all over the body, and bump and itching. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dermatitis allergic, Hypersensitivity, Pruritus, Rash pruritic, Skin mass
Clinical narrative: ALLERGY ON NECK, BACK AND LOWER WAIST; BUMP AND ITCHING; ITCHING ALL OVER THE BODY; THE ALLERGY AS  VERY BIG RED COLOR; HARD BUMP; This spontaneous report received from a patient concerned a 74 year old female. The patient's weight, height, and medical history were not reported . The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for allergy.  On 04-MAY-2021, the subject experienced hard bump. On an unspecified date, the subject experienced allergy on neck, back and lower waist, bump and itching, itching all over the body, and the allergy as very big red color. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from allergy on neck, back and lower waist, the allergy as very big red color, hard bump, itching all over the body, and bump and itching. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: L arm pain and parasthesias after noting LAD in L axillar.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: L arm pain and parasthesias after noting LAD in L axillar.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Dizziness, Headache, Heart rate increased
Clinical narrative: Within a few minutes of Receiving my second dose I started to feel nauseous, fast heart rate, tightness in chest, throat closing,  limbs tingling and numb, legs shaking, head felt swollen to the point of my eyes hurting,  seeing black spots. Ambulance was called within minutes and took me to ER.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Nausea
Clinical narrative: Within a few minutes of Receiving my second dose I started to feel nauseous, fast heart rate, tightness in chest, throat closing,  limbs tingling and numb, legs shaking, head felt swollen to the point of my eyes hurting,  seeing black spots. Ambulance was called within minutes and took me to ER.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Chest discomfort, Electrocardiogram normal, Eye pain, Heart rate increased
Clinical narrative: Within a few minutes of Receiving my second dose I started to feel nauseous, fast heart rate, tightness in chest, throat closing,  limbs tingling and numb, legs shaking, head felt swollen to the point of my eyes hurting,  seeing black spots. Ambulance was called within minutes and took me to ER.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Hypoaesthesia, Nausea, Paraesthesia, Swelling
Clinical narrative: Within a few minutes of Receiving my second dose I started to feel nauseous, fast heart rate, tightness in chest, throat closing,  limbs tingling and numb, legs shaking, head felt swollen to the point of my eyes hurting,  seeing black spots. Ambulance was called within minutes and took me to ER.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness, Tremor, Urine analysis, Visual impairment
Clinical narrative: Within a few minutes of Receiving my second dose I started to feel nauseous, fast heart rate, tightness in chest, throat closing,  limbs tingling and numb, legs shaking, head felt swollen to the point of my eyes hurting,  seeing black spots. Ambulance was called within minutes and took me to ER.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Crying, Dizziness, Dyspnoea, Inappropriate affect, Tearfulness
Clinical narrative: Anaphylaxis. Trouble breathing, dizzy, feeling faint, tingling hands and lips.  Epi-pen injection at clinic site.  Transport to hospital via ambulance.   IV Benadryl and Pepcid. Blood work, EKG and monitoring.  Not admitted.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood test, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: Anaphylaxis. Trouble breathing, dizzy, feeling faint, tingling hands and lips.  Epi-pen injection at clinic site.  Transport to hospital via ambulance.   IV Benadryl and Pepcid. Blood work, EKG and monitoring.  Not admitted.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Anaphylaxis. Trouble breathing, dizzy, feeling faint, tingling hands and lips.  Epi-pen injection at clinic site.  Transport to hospital via ambulance.   IV Benadryl and Pepcid. Blood work, EKG and monitoring.  Not admitted.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Electrocardiogram normal, Heart rate increased, Hypoaesthesia, Laboratory test normal
Clinical narrative: RAPID HEART RATE; GENERALIZED MUSCLE CRAMPING; PINS AND NEEDLES IN FEET THAT MOVED UPWARD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced rapid heart rate. On APR-2021, the subject experienced generalized muscle cramping. On APR-2021, the subject experienced pins and needles in feet that moved upward. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from generalized muscle cramping, pins and needles in feet that moved upward, and rapid heart rate. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Myalgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: RAPID HEART RATE; GENERALIZED MUSCLE CRAMPING; PINS AND NEEDLES IN FEET THAT MOVED UPWARD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced rapid heart rate. On APR-2021, the subject experienced generalized muscle cramping. On APR-2021, the subject experienced pins and needles in feet that moved upward. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from generalized muscle cramping, pins and needles in feet that moved upward, and rapid heart rate. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: RAPID HEART RATE; GENERALIZED MUSCLE CRAMPING; PINS AND NEEDLES IN FEET THAT MOVED UPWARD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced rapid heart rate. On APR-2021, the subject experienced generalized muscle cramping. On APR-2021, the subject experienced pins and needles in feet that moved upward. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from generalized muscle cramping, pins and needles in feet that moved upward, and rapid heart rate. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Muscle spasms, Paraesthesia
Clinical narrative: RAPID HEART RATE; GENERALIZED MUSCLE CRAMPING; PINS AND NEEDLES IN FEET THAT MOVED UPWARD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced rapid heart rate. On APR-2021, the subject experienced generalized muscle cramping. On APR-2021, the subject experienced pins and needles in feet that moved upward. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from generalized muscle cramping, pins and needles in feet that moved upward, and rapid heart rate. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Dyspnoea, Hyperventilation, Hypopnoea, Muscle contractions involuntary
Clinical narrative: Pt called pharmacy and complained about uncontrolled muscle contractions as well as hyperventilation. He feels better now, however he wanted the pharmacy know. I told him to seek immediate attention if he started to feel worse. He stated he was fine at the time.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain, Tremor
Clinical narrative: Pt called pharmacy and complained about uncontrolled muscle contractions as well as hyperventilation. He feels better now, however he wanted the pharmacy know. I told him to seek immediate attention if he started to feel worse. He stated he was fine at the time.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperventilation, Muscle contracture
Clinical narrative: Pt called pharmacy and complained about uncontrolled muscle contractions as well as hyperventilation. He feels better now, however he wanted the pharmacy know. I told him to seek immediate attention if he started to feel worse. He stated he was fine at the time.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Pt. received the first COVID vaccine (Pfizer, lot # EW0182 and use by date is 05/13/21 at 0930am) around 1123am.  LVN, administered the Pfizer vaccine and approximately 10 seconds after the vaccine was administered, the patient became pale and the patient loss consciousness for approximately 4 seconds. LVN ensured that the patient did not fall off the chair while RN (and Co-Lead), RN (Lead Vaccinator), and EMT observer, immediately ran to assist LVN with assisting the patient to the ground. The patient was alert and oriented when the nurses assisted him to the floor and had him lie in a supine position with his legs elevated.  The patient was alert and oriented to person, place, time, and situation. Vital signs were immediately taken at 1124 when the patient was supine on the ground with his legs elevated: blood pressure of 112/58 (right arm, supine) , heart rate of 48 beats per minute, respiratory rate of 16 breaths per minute, and 100% oxygen saturation at room air. The patient denied any headache, nausea, or dizziness. The patient was moved to the gravity chair and was placed in Fowler's position. The patient was given Gatorade, as the patient did not eat or drink anything prior to being vaccinated. Vitals were taken at 1131: BP 114/78 (Right arm, sitting) , 66 beats per minute, 16 breaths per minute, and 100% oxygen saturation at room air. Alert and oriented to person, place, time, and situation. Denied any history of fainting . Denied taking any medications or having any chronic medical conditions. The patient continued drinking Gatorade and was offered a granola bar, the patient did not have any known allergies to medications, foods, or dust. At 1141, vitals were retaken, BP 122/87 (Right arm, sitting), HR 63, RR 16, and 100% oxygen saturation at room air. The patient denied any chest pain, shortness of breath, lightheadedness, dizziness, or headache. The patient ate a breakfast biscuit at 1148. At 1153 the patient was positioned from a Fowler's position to sitting upright in the gravity chair. Instructed the patient to have a friend or family member drive him home, the patient then called a friend to transport him home. RN, went over the V-Safe app with the patient and instructed him to eat breakfast and drink fluids the next time he arrived for his 2nd Pfizer vaccine. RN also instructed him to inform the vaccinator the next time he is vaccinated (for his second dose), to inform him/her about his history of fainting with his first dose. The patient's vitals were taken  at 1158 when he was sitting upright, BP: 138/80 (right arm), HR 67, RR 15, and oxygen saturation at 99%. RN instructed the patient about ER precautions and to follow up with his primary care provider. The patient's vital signs were taken a final time at 1210, BP 122/78, RR 16, HR 67, and 100% oxygen saturation at room air. The patient's ride arrived on site around 1215, and the patient had a steady and even gait when ambulating to the vehicle, where he was driven home by a friend.