chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in March 2020 didn´t get the 2nd dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable to this report. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient asked should he/she get his/her second dose now or start over again with the first.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster oticus, Pain, Vaccination failure
Clinical narrative: gets the vaccination, shingles in her ear/Suspected vaccination failure; shingles in her ear; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 81-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster oticus (serious criteria GSK medically significant) and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the herpes zoster oticus and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, herpes zoster oticus and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's mother. The patient got the vaccination and unfortunately, a couple months before the date of reporting, the she got shingles in her ear. The patient was in lot of pain. The reporter stated she was okay at the time of reporting. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirmation for shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: received menveo with sterile water; received menveo with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA591A, expiry date 31st August 2022) for prophylaxis.   On 21st March 2022, the patient received Menveo. On 21st March 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The health care professional (HCP) reported that on the day of reporting, the patient received the lyophilized portion of Menveo with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No reactions reported. The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up by email.
Sex: M
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Extra dose administered, Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: no protective antibody levels; received a fourth dose; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 66-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B, the 3rd dose of Engerix B, the 2nd dose of Engerix B and the 1st dose of Engerix B. On an unknown date, 3 years after receiving Engerix B and unknown after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapy non-responder and extra dose administered. On an unknown date, the outcome of the therapy non-responder and extra dose administered were unknown.  Additional information was provided as follows: The age at vaccination was not reported. The patient received three doses of Engerix-B (unspecified date) and in 2017 a fourth booster dose. This patient was tested for protective antibodies three years after the booster dose and the results came back as no protective antibody levels. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered adjuvant without active component; administered adjuvant without active component; This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient was administered the Shingrix adjuvant in unknown arm without the active component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2022051810, US2022051806, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022051810:Same reporter. US-GLAXOSMITHKLINE-US2022051806:Same reporter.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia
Clinical narrative: tingling (like pin pricks) throughout body; pain throughout body; This case was reported by a consumer via call center representative and described the occurrence of pins and needles in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 3527M, expiry date 3rd June 2023) for prophylaxis.   On 9th March 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th March 2022, immediately after receiving Shingrix, the patient experienced pins and needles and general body pain. On an unknown date, the outcome of the pins and needles and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the pins and needles and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix intramuscularly into her right arm and began immediately experiencing tingling and pain (like pin pricks) throughout her body after the injection which had still not resolved. The patient did not want GlaxoSmithKline to contact her current PCP (primary care physician) but she will call back with the phone number of her neurologist. No further information reported. The reporter consented to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: They would be in the fridge about 1-3 days; Administered moderna vaccine beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccine beyond the use date and/or expired) and PRODUCT STORAGE ERROR (They would be in the fridge about 1-3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccine beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They would be in the fridge about 1-3 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccine beyond the use date and/or expired) and PRODUCT STORAGE ERROR (They would be in the fridge about 1-3 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccines are kept frozen until they are ready for adminstration which means they would be in the fridege about 1 to 3 days; Moderna vaccine beyond the use date and or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine beyond the use date and or expired) and PRODUCT STORAGE ERROR (vaccines are kept frozen until they are ready for adminstration which means they would be in the fridege about 1 to 3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine beyond the use date and or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines are kept frozen until they are ready for adminstration which means they would be in the fridege about 1 to 3 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine beyond the use date and or expired) and PRODUCT STORAGE ERROR (vaccines are kept frozen until they are ready for adminstration which means they would be in the fridege about 1 to 3 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines are kept frozen in fridge about1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated; Some of our sites administered Moderna vaccines beyond the use date and or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some of our sites administered Moderna vaccines beyond the use date and or expired) and PRODUCT STORAGE ERROR (Vaccines are kept frozen in fridge about1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some of our sites administered Moderna vaccines beyond the use date and or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines are kept frozen in fridge about1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some of our sites administered Moderna vaccines beyond the use date and or expired) and PRODUCT STORAGE ERROR (Vaccines are kept frozen in fridge about1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines are kept frozen until they were ready for administration, in fridge about 1-3 days; Admnistered Moderna vaccines beyond use date or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Admnistered Moderna vaccines beyond use date or expired) and PRODUCT STORAGE ERROR (Vaccines are kept frozen until they were ready for administration, in fridge about 1-3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Admnistered Moderna vaccines beyond use date or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines are kept frozen until they were ready for administration, in fridge about 1-3 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Admnistered Moderna vaccines beyond use date or expired) and PRODUCT STORAGE ERROR (Vaccines are kept frozen until they were ready for administration, in fridge about 1-3 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported.  Vaccines were kept frozen until they were ready for administration which meant they would be in the fridge about 1 to 3 days. They tend to store 1 to 3 bottles in the fridge to thaw out and was ready for the patients when needed. At worst case scenario they would have been in the fridge for about week if no one came in to be vaccinated.  No Treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days; administered moderna vaccines beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vaccines were tend to store with 1 to 3 bottles in the fridge to thaw out and to be ready for the patients when needed and at worst scenarios vaccines would have been in the fridge for about a week if no one came in to be vaccinated.  No treatment medication information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccines are kept frozen in fridge about1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated; Vaccine administered beyond use date or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date or expired) and PRODUCT STORAGE ERROR (vaccines are kept frozen in fridge about1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines are kept frozen in fridge about1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date or expired) and PRODUCT STORAGE ERROR (vaccines are kept frozen in fridge about1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days; Administered moderna vaccines beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccines beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Products were reported.  The vaccines were tend to store with 1 to 3 bottles in the fridge to thaw out and to be ready for the patients when needed and at worst scenarios vaccines would have been in the fridge for about a week if no one came in to be vaccinated.  No Treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days; administered moderna vaccines beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Vaccines were kept frozen until they were ready for administration which meant they would be in the fridge about 1 to 3 days. They tend to store 1 to 3 bottles in the fridge to thaw out and was ready for the patients when needed. At worst case scenario they would have been in the fridge for about week if no one came in to be vaccinated.  No treatment information was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: and the vial had been refrigerated since 11Aug2021; They administered a booster dose of the Moderna Covid-19 Vaccine on 26Nov2021 to a patient from a vial that was 4 days past its expiration date of 22Nov2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They administered a booster dose of the Moderna Covid-19 Vaccine on 26Nov2021 to a patient from a vial that was 4 days past its expiration date of 22Nov2021) and PRODUCT STORAGE ERROR (and the vial had been refrigerated since 11Aug2021) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They administered a booster dose of the Moderna Covid-19 Vaccine on 26Nov2021 to a patient from a vial that was 4 days past its expiration date of 22Nov2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (and the vial had been refrigerated since 11Aug2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They administered a booster dose of the Moderna Covid-19 Vaccine on 26Nov2021 to a patient from a vial that was 4 days past its expiration date of 22Nov2021) and PRODUCT STORAGE ERROR (and the vial had been refrigerated since 11Aug2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided. Date the vial was initially stored in the refrigerator was 11-Aug-2021 and the vial did not undergo any temperature excursions.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient felt dizzy towards the end of her 15 minute waiting period. Her BP was 100/65. Symptoms resolved within 10 minutes.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Flushing, Headache, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Additional Details: Patient felt the side effects for about 30 minutes and then made a full recovery.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Lethargy
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Additional Details: Patient felt the side effects for about 30 minutes and then made a full recovery.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: A few weeks after my second Moderna shot, on Feb 16, 2021 (Lot 023M20A) I began to experience dizzy spells. A few weeks after the dizziness started I noticed ringing in my ears. The ringing has been non-stop and has only increased in intensity since my third Moderna shot on Nov. 19, 2021 (LOT 013F21A).
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Discharge, Dizziness, Intracranial pressure increased, Magnetic resonance imaging abnormal
Clinical narrative: Within 1 hour of first vaccine I started with a migraine that lasted 30 days total. The migraine continued through the second vaccination.  Since I have had increased migraines. I use to have a migraine 3-4 times a year, now they are almost daily. I had to be put on medication. About one month after second vaccination I started having a lot of dizziness, drainage, vertigo, nausea. I thought it was due to weather change.  Last month I started seeing a Neurologist because I could not take the migraines and vertigo anymore. They did a MRI, my optic nerves are swollen, I have intracranial pressure. I was diagnosed with transverse sinus stenosis.  I know have to get a lumbar puncture and see a neurosurgeon.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Nausea, Papilloedema, Transverse sinus stenosis, Vertigo
Clinical narrative: Within 1 hour of first vaccine I started with a migraine that lasted 30 days total. The migraine continued through the second vaccination.  Since I have had increased migraines. I use to have a migraine 3-4 times a year, now they are almost daily. I had to be put on medication. About one month after second vaccination I started having a lot of dizziness, drainage, vertigo, nausea. I thought it was due to weather change.  Last month I started seeing a Neurologist because I could not take the migraines and vertigo anymore. They did a MRI, my optic nerves are swollen, I have intracranial pressure. I was diagnosed with transverse sinus stenosis.  I know have to get a lumbar puncture and see a neurosurgeon.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Immobile, Pain in extremity
Clinical narrative: Lower extremity pain and immobility
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Atelectasis, Bladder catheterisation, Blood pressure increased, COVID-19
Clinical narrative: Patient is 6 y.o. female with developmental delay, epilepsy (on ketogenic diet and multiple AEDs), neurogenic bladder with suprapubic catheter in place who is admitted to the PICU due to presumed septic shock and altered mental status.    Patient developed URI symptoms on day prior to presentation with subsequent development of fever and emesis today. Mother was concerned for subclinical seizures given that patient was not as active as she normally is, so administered rescue dose of ativan. Due to persistent fever and lethargy, was brought to ED for evaluation.    In the ED she was febrile and tachycardic. Labs obtained and significant for film array positive for human metapneumovirus. Procal elevated to 0.54 and UA with large LE and 46 WBCs, although this is baseline compared to previous urinalyses. Blood pressure trended down over the course of the ED stay, requiring 3 NS boluses without significant improvement. Admitted to the PICU for further monitoring.    Evaluated upon arrival to PICU. Responds appropriately to stimuli, then falls back asleep. Pupils reactive. Extremities warm and well perfused, cap refill 2-3 seconds. Abdomen soft; suprapubic catheter in place; Contractures of extremities present.     Requires admission to the PICU due to hemodynamic instability from presumed shock and possible subclinical seizure activity.    Plan as follows:    Neuro:   - NCC consulted  - Will place EEG  - Ativan bridge while NPO     CV:  - MAP goal > 55   RS: - 2L NC     FEN/GI:  - ketogenic diet  - NS IVFs  - NPO  - monitor glucoses    ID:  - blood and urine cultures pending  - Ceftazidime  Patient is a 6 y.o. 4 m.o. female with complex PMHx including of recurrent epileptic spasms and perinatal interventricular hemorrhage (requring ketogenic diet and multiple antiepileptic medications), intrauterine drug exposure, global developmental delay, G-tube dependence, and suprapubic catheter with recurrent urinary tract infection who presents today with increased lethargy, fever, vomiting x1 day. Per mother, pt was irritable at school, not tolerating feeds, felt warm. Tmax PTA 101, given tylenol/motrin and rescue ativan with single episode emesis shortly thereafter. Pt has been tired and lethargic all day, normally interactive at baseline. Recent increase in Banzel a few weeks ago. Mother denies diarrhea, rash, sick contacts. Pt had covid 5-6 weeks prior, no monoclonal antibody therapy.   In the ED, pt's blood pressure remained low with systolic pressures in the 70s despite 40cc/kg bolus. Film array positive for metaneumovirus; CBC, CXR unremarkable. Procalcitonin 0.54. Neurology consulted, recommending continuous EEG. Admitted to PICU for further management given continued soft blood pressures.   Admitted from: ED   History was provided by the parent and mother.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Capillary nail refill test, Chest X-ray abnormal, Decreased activity, Extremity contracture, Fatigue
Clinical narrative: Patient is 6 y.o. female with developmental delay, epilepsy (on ketogenic diet and multiple AEDs), neurogenic bladder with suprapubic catheter in place who is admitted to the PICU due to presumed septic shock and altered mental status.    Patient developed URI symptoms on day prior to presentation with subsequent development of fever and emesis today. Mother was concerned for subclinical seizures given that patient was not as active as she normally is, so administered rescue dose of ativan. Due to persistent fever and lethargy, was brought to ED for evaluation.    In the ED she was febrile and tachycardic. Labs obtained and significant for film array positive for human metapneumovirus. Procal elevated to 0.54 and UA with large LE and 46 WBCs, although this is baseline compared to previous urinalyses. Blood pressure trended down over the course of the ED stay, requiring 3 NS boluses without significant improvement. Admitted to the PICU for further monitoring.    Evaluated upon arrival to PICU. Responds appropriately to stimuli, then falls back asleep. Pupils reactive. Extremities warm and well perfused, cap refill 2-3 seconds. Abdomen soft; suprapubic catheter in place; Contractures of extremities present.     Requires admission to the PICU due to hemodynamic instability from presumed shock and possible subclinical seizure activity.    Plan as follows:    Neuro:   - NCC consulted  - Will place EEG  - Ativan bridge while NPO     CV:  - MAP goal > 55   RS: - 2L NC     FEN/GI:  - ketogenic diet  - NS IVFs  - NPO  - monitor glucoses    ID:  - blood and urine cultures pending  - Ceftazidime  Patient is a 6 y.o. 4 m.o. female with complex PMHx including of recurrent epileptic spasms and perinatal interventricular hemorrhage (requring ketogenic diet and multiple antiepileptic medications), intrauterine drug exposure, global developmental delay, G-tube dependence, and suprapubic catheter with recurrent urinary tract infection who presents today with increased lethargy, fever, vomiting x1 day. Per mother, pt was irritable at school, not tolerating feeds, felt warm. Tmax PTA 101, given tylenol/motrin and rescue ativan with single episode emesis shortly thereafter. Pt has been tired and lethargic all day, normally interactive at baseline. Recent increase in Banzel a few weeks ago. Mother denies diarrhea, rash, sick contacts. Pt had covid 5-6 weeks prior, no monoclonal antibody therapy.   In the ED, pt's blood pressure remained low with systolic pressures in the 70s despite 40cc/kg bolus. Film array positive for metaneumovirus; CBC, CXR unremarkable. Procalcitonin 0.54. Neurology consulted, recommending continuous EEG. Admitted to PICU for further management given continued soft blood pressures.   Admitted from: ED   History was provided by the parent and mother.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding intolerance, Full blood count normal, Haemodynamic instability, Human metapneumovirus test positive, Hypotension
Clinical narrative: Patient is 6 y.o. female with developmental delay, epilepsy (on ketogenic diet and multiple AEDs), neurogenic bladder with suprapubic catheter in place who is admitted to the PICU due to presumed septic shock and altered mental status.    Patient developed URI symptoms on day prior to presentation with subsequent development of fever and emesis today. Mother was concerned for subclinical seizures given that patient was not as active as she normally is, so administered rescue dose of ativan. Due to persistent fever and lethargy, was brought to ED for evaluation.    In the ED she was febrile and tachycardic. Labs obtained and significant for film array positive for human metapneumovirus. Procal elevated to 0.54 and UA with large LE and 46 WBCs, although this is baseline compared to previous urinalyses. Blood pressure trended down over the course of the ED stay, requiring 3 NS boluses without significant improvement. Admitted to the PICU for further monitoring.    Evaluated upon arrival to PICU. Responds appropriately to stimuli, then falls back asleep. Pupils reactive. Extremities warm and well perfused, cap refill 2-3 seconds. Abdomen soft; suprapubic catheter in place; Contractures of extremities present.     Requires admission to the PICU due to hemodynamic instability from presumed shock and possible subclinical seizure activity.    Plan as follows:    Neuro:   - NCC consulted  - Will place EEG  - Ativan bridge while NPO     CV:  - MAP goal > 55   RS: - 2L NC     FEN/GI:  - ketogenic diet  - NS IVFs  - NPO  - monitor glucoses    ID:  - blood and urine cultures pending  - Ceftazidime  Patient is a 6 y.o. 4 m.o. female with complex PMHx including of recurrent epileptic spasms and perinatal interventricular hemorrhage (requring ketogenic diet and multiple antiepileptic medications), intrauterine drug exposure, global developmental delay, G-tube dependence, and suprapubic catheter with recurrent urinary tract infection who presents today with increased lethargy, fever, vomiting x1 day. Per mother, pt was irritable at school, not tolerating feeds, felt warm. Tmax PTA 101, given tylenol/motrin and rescue ativan with single episode emesis shortly thereafter. Pt has been tired and lethargic all day, normally interactive at baseline. Recent increase in Banzel a few weeks ago. Mother denies diarrhea, rash, sick contacts. Pt had covid 5-6 weeks prior, no monoclonal antibody therapy.   In the ED, pt's blood pressure remained low with systolic pressures in the 70s despite 40cc/kg bolus. Film array positive for metaneumovirus; CBC, CXR unremarkable. Procalcitonin 0.54. Neurology consulted, recommending continuous EEG. Admitted to PICU for further management given continued soft blood pressures.   Admitted from: ED   History was provided by the parent and mother.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Intensive care, Irritability, Ketogenic diet, Kidney enlargement
Clinical narrative: Patient is 6 y.o. female with developmental delay, epilepsy (on ketogenic diet and multiple AEDs), neurogenic bladder with suprapubic catheter in place who is admitted to the PICU due to presumed septic shock and altered mental status.    Patient developed URI symptoms on day prior to presentation with subsequent development of fever and emesis today. Mother was concerned for subclinical seizures given that patient was not as active as she normally is, so administered rescue dose of ativan. Due to persistent fever and lethargy, was brought to ED for evaluation.    In the ED she was febrile and tachycardic. Labs obtained and significant for film array positive for human metapneumovirus. Procal elevated to 0.54 and UA with large LE and 46 WBCs, although this is baseline compared to previous urinalyses. Blood pressure trended down over the course of the ED stay, requiring 3 NS boluses without significant improvement. Admitted to the PICU for further monitoring.    Evaluated upon arrival to PICU. Responds appropriately to stimuli, then falls back asleep. Pupils reactive. Extremities warm and well perfused, cap refill 2-3 seconds. Abdomen soft; suprapubic catheter in place; Contractures of extremities present.     Requires admission to the PICU due to hemodynamic instability from presumed shock and possible subclinical seizure activity.    Plan as follows:    Neuro:   - NCC consulted  - Will place EEG  - Ativan bridge while NPO     CV:  - MAP goal > 55   RS: - 2L NC     FEN/GI:  - ketogenic diet  - NS IVFs  - NPO  - monitor glucoses    ID:  - blood and urine cultures pending  - Ceftazidime  Patient is a 6 y.o. 4 m.o. female with complex PMHx including of recurrent epileptic spasms and perinatal interventricular hemorrhage (requring ketogenic diet and multiple antiepileptic medications), intrauterine drug exposure, global developmental delay, G-tube dependence, and suprapubic catheter with recurrent urinary tract infection who presents today with increased lethargy, fever, vomiting x1 day. Per mother, pt was irritable at school, not tolerating feeds, felt warm. Tmax PTA 101, given tylenol/motrin and rescue ativan with single episode emesis shortly thereafter. Pt has been tired and lethargic all day, normally interactive at baseline. Recent increase in Banzel a few weeks ago. Mother denies diarrhea, rash, sick contacts. Pt had covid 5-6 weeks prior, no monoclonal antibody therapy.   In the ED, pt's blood pressure remained low with systolic pressures in the 70s despite 40cc/kg bolus. Film array positive for metaneumovirus; CBC, CXR unremarkable. Procalcitonin 0.54. Neurology consulted, recommending continuous EEG. Admitted to PICU for further management given continued soft blood pressures.   Admitted from: ED   History was provided by the parent and mother.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test abnormal, Lethargy, Lung consolidation, Lung opacity, Mental status changes
Clinical narrative: Patient is 6 y.o. female with developmental delay, epilepsy (on ketogenic diet and multiple AEDs), neurogenic bladder with suprapubic catheter in place who is admitted to the PICU due to presumed septic shock and altered mental status.    Patient developed URI symptoms on day prior to presentation with subsequent development of fever and emesis today. Mother was concerned for subclinical seizures given that patient was not as active as she normally is, so administered rescue dose of ativan. Due to persistent fever and lethargy, was brought to ED for evaluation.    In the ED she was febrile and tachycardic. Labs obtained and significant for film array positive for human metapneumovirus. Procal elevated to 0.54 and UA with large LE and 46 WBCs, although this is baseline compared to previous urinalyses. Blood pressure trended down over the course of the ED stay, requiring 3 NS boluses without significant improvement. Admitted to the PICU for further monitoring.    Evaluated upon arrival to PICU. Responds appropriately to stimuli, then falls back asleep. Pupils reactive. Extremities warm and well perfused, cap refill 2-3 seconds. Abdomen soft; suprapubic catheter in place; Contractures of extremities present.     Requires admission to the PICU due to hemodynamic instability from presumed shock and possible subclinical seizure activity.    Plan as follows:    Neuro:   - NCC consulted  - Will place EEG  - Ativan bridge while NPO     CV:  - MAP goal > 55   RS: - 2L NC     FEN/GI:  - ketogenic diet  - NS IVFs  - NPO  - monitor glucoses    ID:  - blood and urine cultures pending  - Ceftazidime  Patient is a 6 y.o. 4 m.o. female with complex PMHx including of recurrent epileptic spasms and perinatal interventricular hemorrhage (requring ketogenic diet and multiple antiepileptic medications), intrauterine drug exposure, global developmental delay, G-tube dependence, and suprapubic catheter with recurrent urinary tract infection who presents today with increased lethargy, fever, vomiting x1 day. Per mother, pt was irritable at school, not tolerating feeds, felt warm. Tmax PTA 101, given tylenol/motrin and rescue ativan with single episode emesis shortly thereafter. Pt has been tired and lethargic all day, normally interactive at baseline. Recent increase in Banzel a few weeks ago. Mother denies diarrhea, rash, sick contacts. Pt had covid 5-6 weeks prior, no monoclonal antibody therapy.   In the ED, pt's blood pressure remained low with systolic pressures in the 70s despite 40cc/kg bolus. Film array positive for metaneumovirus; CBC, CXR unremarkable. Procalcitonin 0.54. Neurology consulted, recommending continuous EEG. Admitted to PICU for further management given continued soft blood pressures.   Admitted from: ED   History was provided by the parent and mother.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Nothing by mouth order, Oxygen saturation decreased, Procalcitonin increased, Pyrexia, Respiratory symptom
Clinical narrative: Patient is 6 y.o. female with developmental delay, epilepsy (on ketogenic diet and multiple AEDs), neurogenic bladder with suprapubic catheter in place who is admitted to the PICU due to presumed septic shock and altered mental status.    Patient developed URI symptoms on day prior to presentation with subsequent development of fever and emesis today. Mother was concerned for subclinical seizures given that patient was not as active as she normally is, so administered rescue dose of ativan. Due to persistent fever and lethargy, was brought to ED for evaluation.    In the ED she was febrile and tachycardic. Labs obtained and significant for film array positive for human metapneumovirus. Procal elevated to 0.54 and UA with large LE and 46 WBCs, although this is baseline compared to previous urinalyses. Blood pressure trended down over the course of the ED stay, requiring 3 NS boluses without significant improvement. Admitted to the PICU for further monitoring.    Evaluated upon arrival to PICU. Responds appropriately to stimuli, then falls back asleep. Pupils reactive. Extremities warm and well perfused, cap refill 2-3 seconds. Abdomen soft; suprapubic catheter in place; Contractures of extremities present.     Requires admission to the PICU due to hemodynamic instability from presumed shock and possible subclinical seizure activity.    Plan as follows:    Neuro:   - NCC consulted  - Will place EEG  - Ativan bridge while NPO     CV:  - MAP goal > 55   RS: - 2L NC     FEN/GI:  - ketogenic diet  - NS IVFs  - NPO  - monitor glucoses    ID:  - blood and urine cultures pending  - Ceftazidime  Patient is a 6 y.o. 4 m.o. female with complex PMHx including of recurrent epileptic spasms and perinatal interventricular hemorrhage (requring ketogenic diet and multiple antiepileptic medications), intrauterine drug exposure, global developmental delay, G-tube dependence, and suprapubic catheter with recurrent urinary tract infection who presents today with increased lethargy, fever, vomiting x1 day. Per mother, pt was irritable at school, not tolerating feeds, felt warm. Tmax PTA 101, given tylenol/motrin and rescue ativan with single episode emesis shortly thereafter. Pt has been tired and lethargic all day, normally interactive at baseline. Recent increase in Banzel a few weeks ago. Mother denies diarrhea, rash, sick contacts. Pt had covid 5-6 weeks prior, no monoclonal antibody therapy.   In the ED, pt's blood pressure remained low with systolic pressures in the 70s despite 40cc/kg bolus. Film array positive for metaneumovirus; CBC, CXR unremarkable. Procalcitonin 0.54. Neurology consulted, recommending continuous EEG. Admitted to PICU for further management given continued soft blood pressures.   Admitted from: ED   History was provided by the parent and mother.