chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.58
Sex: F
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: patient was administered with Pediatrix then IPOL on the same day with no reported adverse event; She stated that this was only supposed to be the patient's 3rd dose. .   Initial information was received on 02-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 19 months old female patient who was administered with pediatrix then ipv (vero) [ipol] on the same day with no reported adverse event while receiving vaccines diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (pediarix) and ipv (vero) [ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect IPV (VERO) (route intramuscular) along with PEDIARIX on same day (dose, formulation, strength, and expiry date: unknown) (extra dose administered, latency same day) in unknown administration site for prophylactic vaccination (immunization).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received the flu shot at the end of September and then 9 days later she received another dose with no reported adverse event; Initial information received on 03-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 years old female patient who received the Influenza Quadrival A-B Vaccine [Fluzone Qiv] at the end of September and then 9 days later she received another dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Covid-19 Vaccine (Covid-19 Vaccine) for Immunisation.  On 22-Sep-2023, the patient received 0.5 ml (Dose 1) of suspect Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT8091NA) (Expiry date: 30-Jun-2023) (Strength: Standard) (Frequency:  Once) via intramuscular route in the left deltoid for immunisation. On 06-Oct-2023, she also received Dose 2 of the same vaccine (lot number: UT8144KA) (Expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for immunization.  On 06-Oct-2023, patient received the Influenza Quadrival A-B Vaccine at the end of september and then 9 days later she received another dose with no reported adverse event (extra dose administered) (latency: 14 days).  It was reported, Practice manager calling regarding FLUZONE QIV NP. Caller stated that they had a patient who received the flu shot at the end of September and then 9 days later she received another dose. Caller stated that the Patient did not present any AEs. Caller would like to know if there is any information regarding patients receiving a second dose of the Flu vaccine. The practice manager reported that the error occurred due to the child was visiting the clinic to only get the COVID vaccine due to having the flu vaccine already; that on that day of 06Oct2023, the prescriber deleted the flu order on their end but the system end of the nurse who was giving he vaccine did not see the deleted order; that the nurse did verify with the parent that the child was to get the flu and COVID vaccine; that at this time when asking the parent about what the vaccines the child was screaming; that the parent said yes and the child got the COVID vaccine and then another Fluzone Quadrivalent Np dose.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: MEN
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received two doses of MENQUADFI. One at age 11 on 17Sep2022 and again yesterday 02Nov2023 at the age of 12 with no reported adverse event; Initial information received on 03-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old male patient who received two doses of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] one at age 11 on 17sep2022 and again yesterday 02nov2023 at the age of 12 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-Sep-2023, the patient received Dose 1 of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (with an unknown strength, expiry date and lot number) via unknown route in unknown administration site for immunisation. On 02-Nov-2023, he also received a Dose 2  of the same vaccine with an unknown batch number via unknown route in unknown administration site.  On 02-Nov-2023, the patient received two doses of Meningococcal A-C-Y-W135 (T Conj) Vaccine one at age 11 on 17sep2022 and again yesterday 02nov2023 at the age of 12 with no reported adverse event (extra dose administered) (latency: 1 month 16 days).   It was reported, HCP office pharmacy intern called to report a male patient received two doses of MENQUADFI. One at age 11 on 17Sep2022 and again yesterday 02Nov2023 at the age of 12. Are there any adverse side effects to look out for! Should the patient still receive the next dose at 16 years old! Caller is requesting a callback but would also like the information to be emailed, if available  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: nurse gave double dose of the ipol to the patient with no reported adverse event; Initial information was received  on 03-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who reported that nurse gave double dose of the IPV (VERO) [IMOVAX POLIO] to the patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  unknown dose of suspect ipv (VERO) (suspension for injection)(strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on batch number was requested.  On an unknown date the patient reported that nurse gave double dose of the ipol to the patient with no reported adverse event (extra dose administered) (latency: same day) following the administration of ipv (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event nurse gave double dose of the ipol to the patient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Back pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Left arm pain radiating from behind should/back, along underside of arm, at times tingling in forearm
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Facial paralysis, Fatigue, Hypoaesthesia oral, Lacrimation increased, Muscle twitching
Clinical narrative: Quivering of right upper and lower lips, numbness around lips, could not rinse correctly from a cup, right lower lid leaning towards left,  tearing of both eyes, reddened lower inside of lip, lips looked crooked started on November 6, and still remain Also extreme fatigue started next day after vaccination, slight nausea two hours after vaccination. Lip and eye situation remain the same as of November 13
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Nausea, Oral mucosal erythema
Clinical narrative: Quivering of right upper and lower lips, numbness around lips, could not rinse correctly from a cup, right lower lid leaning towards left,  tearing of both eyes, reddened lower inside of lip, lips looked crooked started on November 6, and still remain Also extreme fatigue started next day after vaccination, slight nausea two hours after vaccination. Lip and eye situation remain the same as of November 13
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Rash, Vaccination failure
Clinical narrative: I have had 3 mild shingles episodes/Suspected Vaccination Failure; I have had 3 mild shingles episodes; rash on right cheek; lower part of the butt and had 10-15 small blisters; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingles vaccine (on an unknown date received first shingles vaccine that was available on the market on 2010). Concurrent medical conditions included heart disorder. Concomitant products included cardiovascular system drugs (Heart Medication) and aciclovir (Acyclovir).   On an unknown date, the patient received the 2nd dose of Shingrix (left arm) and the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: I have had 3 mild shingles episodes/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: I have had 3 mild shingles episodes), rash (Verbatim: rash on right cheek) and blister (Verbatim: lower part of the butt and had 10-15 small blisters). The outcome of the vaccination failure, shingles and rash were unknown and the outcome of the blister was not reported.   It was unknown if the reporter considered the vaccination failure, shingles, rash and blister to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, rash and blister to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 07-NOV-2023 The patient was self-reported.  Patient reported he had a heart condition and takes medications for this condition and, he had other medical conditions, and he takes medications for these conditions as well. Patient reported he did take medications that affect his immune system, and he was given Acyclovir topical ointment. Patient reported that he got the 1st dose of Shingrix vaccine sometime during the year the vaccine came out, in 2017 and he got the 2nd dose of Shingrix on late 2017 or early 2018, he got both doses at a local pharmacy.  Patient reported since then he had 3 mild shingles episodes.  Patient reported that on all 3 cases he had the rash located at the same spot and all episodes were identical because they were located at the same spot, and it was the size of a half a dollar coin.  The rash was located at the right cheek, on the lower part of the butt and had 10-15 small blisters. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The reporter did not consent to follow-up.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via a company representative concerned a 43 year old male of unspecified race and ethnicity. 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, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 in total was administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 5 decade old. No concomitant medications were reported.  On an unspecified date, 16 days later after vaccination the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20231126772-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea at rest, Dyspnoea exertional, Musculoskeletal chest pain, Painful respiration
Clinical narrative: Dyspnoea at rest; Chest pain; Musculoskeletal chest pain; Dyspnoea exertional; Palpitations; Painful respiration; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA AT REST (Dyspnoea at rest) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Osteoporosis, Asthma, Glaucoma both eyes and Kearns-Sayre syndrome.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2023, the patient experienced DYSPNOEA AT REST (Dyspnoea at rest) (seriousness criterion medically significant), CHEST PAIN (Chest pain), MUSCULOSKELETAL CHEST PAIN (Musculoskeletal chest pain), DYSPNOEA EXERTIONAL (Dyspnoea exertional), PALPITATIONS (Palpitations) and PAINFUL RESPIRATION (Painful respiration). At the time of the report, DYSPNOEA AT REST (Dyspnoea at rest), CHEST PAIN (Chest pain), MUSCULOSKELETAL CHEST PAIN (Musculoskeletal chest pain), DYSPNOEA EXERTIONAL (Dyspnoea exertional), PALPITATIONS (Palpitations) and PAINFUL RESPIRATION (Painful respiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  Cardiac related signs and symptoms started on June 2023 and its resolved. Patient experienced symptoms like this before receiving the Moderna COVID-19 vaccine.  Treatment medication use information was not provided by reporter.  Company Comment: This is a spontaneous case concerning a 72 year-old, female patient with a history of asthma and hypertension, who experienced the serious (due to medically significant) unexpected, event of dyspnoea at rest, which occurred approximately 11 months after the fourth dose of mRNA-1273 vaccine. The outcome was reported as recovered. The mentioned medical history remains as a confounder. The company assessed the causality as not related to mRNA-1273 vaccine due to long latency and underlying medical history as risk factors. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2023-748712 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Dyspnoea at rest; Chest pain; Musculoskeletal chest pain; Dyspnoea exertional; Palpitations; Painful respiration; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA AT REST (Dyspnoea at rest) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Osteoporosis, Asthma, Glaucoma both eyes and Kearns-Sayre syndrome.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2023, the patient experienced DYSPNOEA AT REST (Dyspnoea at rest) (seriousness criterion medically significant), CHEST PAIN (Chest pain), MUSCULOSKELETAL CHEST PAIN (Musculoskeletal chest pain), DYSPNOEA EXERTIONAL (Dyspnoea exertional), PALPITATIONS (Palpitations) and PAINFUL RESPIRATION (Painful respiration). At the time of the report, DYSPNOEA AT REST (Dyspnoea at rest), CHEST PAIN (Chest pain), MUSCULOSKELETAL CHEST PAIN (Musculoskeletal chest pain), DYSPNOEA EXERTIONAL (Dyspnoea exertional), PALPITATIONS (Palpitations) and PAINFUL RESPIRATION (Painful respiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  Cardiac related signs and symptoms started on June 2023 and its resolved. Patient experienced symptoms like this before receiving the Moderna COVID-19 vaccine.  Treatment medication use information was not provided by reporter.  Company Comment: This is a spontaneous case concerning a 72 year-old, female patient with a history of asthma and hypertension, who experienced the serious (due to medically significant) unexpected, event of dyspnoea at rest, which occurred approximately 11 months after the fourth dose of mRNA-1273 vaccine. The outcome was reported as recovered. The mentioned medical history remains as a confounder. The company assessed the causality as not related to mRNA-1273 vaccine due to long latency and underlying medical history as risk factors. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2023-748712 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Limb discomfort, Pain, Pain in extremity
Clinical narrative: left arm was slightly painful; The patient reports that the patient was having difficulty picking items up with the left arm; Since that time each day the pain is getting a little worse.; tenderness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (left arm was slightly painful), LIMB DISCOMFORT (The patient reports that the patient was having difficulty picking items up with the left arm), PAIN (Since that time each day the pain is getting a little worse.) and INJECTION SITE PAIN (tenderness at the injection site) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL NIGHTTIME) tablet for an unknown indication.    No Medical History information was reported.   On 26-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL NIGHTTIME) (Oral use) 2 dosage form once a day. In October 2023, the patient experienced PAIN IN EXTREMITY (left arm was slightly painful), LIMB DISCOMFORT (The patient reports that the patient was having difficulty picking items up with the left arm), PAIN (Since that time each day the pain is getting a little worse.) and INJECTION SITE PAIN (tenderness at the injection site). In October 2023, INJECTION SITE PAIN (tenderness at the injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm was slightly painful) had not resolved and LIMB DISCOMFORT (The patient reports that the patient was having difficulty picking items up with the left arm) and PAIN (Since that time each day the pain is getting a little worse.) outcome was unknown.            No concomitant medication was reported. It was reported that the next day the patient was not wiped out. The patient felt a little tenderness at the injection site. The injection site was not red and not inflamed. The tenderness at the injection site lasted for at least 3 days. About a week later the patient noticed that the left arm was slightly painful in raising the arm and putting the clothes on. Since that time each day the pain was getting a little worse. As soon as the patient raise the arm, the patient can feel it and it was painful. The patient reports that the patient was having difficulty picking items up with the left arm. Just raising the hand with nothing in it was painful. Any kind of twisting motion like putting a jacket on hurts. The patient cannot sleep on the left side at night as it was painful. No treatment medication was reported.   This case was linked to MOD-2023-748684, MOD-2023-748682, MOD-2023-748686 (Patient Link).
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Nasopharyngitis, Upper respiratory tract infection, Vomiting
Clinical narrative: Vomiting right after and then upper respiratory cold after that. Still sick after a week
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disorientation, Foot fracture
Clinical narrative: Horrible chills that lasted over 2 hours.  Last year I had the COVID vaccine along with the flu shot; I became so disoriented that I walked into the door frame in the middle of the night and broke a toe.  I thought it was the combination of the two shots that caused this; now I'm convinced it was the COVID vaccine.  No more COVID vaccines for me!
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site pain, Injection site pruritus, Peripheral swelling, Pruritus
Clinical narrative: Soreness & itch in left arm at shot site. The following night the arm was bright red, swollen & extremely itchy.  The following morning went to the Urgent care clinic.  Was seen & examined, the arm was measured at 18cm from side to side. Was given a prescription for Cephalexin 500MG to take for 7 days.  Started pills on that day, by the 3rd day the redness was starting to fade. Completed the course of pills , the itching stopped & arm slowly went back to normal
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Computerised tomogram head, Computerised tomogram thorax, Demyelinating polyneuropathy, Electroneuromyography, Immunoglobulin therapy
Clinical narrative: Progressive weakness in limbs, diagnosed as acute inflammatory demyelinating  polyneuropathy (motor predominant), treated with immunoglobulin and physical therapy, with minor clinical improvement thus far over 1 month.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Lumbar puncture, Magnetic resonance imaging spinal, Muscular weakness, Nerve conduction studies, Scan with contrast
Clinical narrative: Progressive weakness in limbs, diagnosed as acute inflammatory demyelinating  polyneuropathy (motor predominant), treated with immunoglobulin and physical therapy, with minor clinical improvement thus far over 1 month.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Device intolerance, Dyspnoea
Clinical narrative: Came to emergency room with complaints of increasing shortness of breath for 2-3 days.  He apparently tested positive for COVID-19 1 week ago.   EMS, his oxygen saturation was 87% on room air.  Chest x-ray showed multifocal diffuse bilateral pulmonary infiltrates consistent with moderate to severe COVID type pneumonia.  Started on oxygen supplementation and received IV dexamethasone.  Within 24 hours after admission patient had significant worsening of respiratory status and had to be placed on 60 L high-flow nasal cannula oxygen via Airvo and 100% FiO2 with non-rebreather mask.  Patient tried BiPAP and was unable to tolerated. Patient stated that he did not want to be intubated and did not want resuscitation. He was started on empiric antibiotics. As per patient request, hospice care was consulted and plans were made to transfer the patient home with supportive care. Unfortunately, even as arrangements were being made for the patient to go home with oxygen and BiPAP, patient died on 10/07/2021. Time of death was at 12:09 p.m. on 10/7/2021.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fraction of inspired oxygen, Lung infiltration, Positive airway pressure therapy, Respiratory distress, SARS-CoV-2 test positive
Clinical narrative: Came to emergency room with complaints of increasing shortness of breath for 2-3 days.  He apparently tested positive for COVID-19 1 week ago.   EMS, his oxygen saturation was 87% on room air.  Chest x-ray showed multifocal diffuse bilateral pulmonary infiltrates consistent with moderate to severe COVID type pneumonia.  Started on oxygen supplementation and received IV dexamethasone.  Within 24 hours after admission patient had significant worsening of respiratory status and had to be placed on 60 L high-flow nasal cannula oxygen via Airvo and 100% FiO2 with non-rebreather mask.  Patient tried BiPAP and was unable to tolerated. Patient stated that he did not want to be intubated and did not want resuscitation. He was started on empiric antibiotics. As per patient request, hospice care was consulted and plans were made to transfer the patient home with supportive care. Unfortunately, even as arrangements were being made for the patient to go home with oxygen and BiPAP, patient died on 10/07/2021. Time of death was at 12:09 p.m. on 10/7/2021.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea
Clinical narrative: presented to ER with progressive shortness of breath. tested positive for COVID-19.Patient has acute on chronic respiratory failure with hypoxia and COPD exacerbation.   O2 requirement improved, down to 2 L nasal cannula   empiric antibiotic,  IV steroids.  home with home health.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, SARS-CoV-2 test positive
Clinical narrative: presented to ER with progressive shortness of breath. tested positive for COVID-19.Patient has acute on chronic respiratory failure with hypoxia and COPD exacerbation.   O2 requirement improved, down to 2 L nasal cannula   empiric antibiotic,  IV steroids.  home with home health.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthenia, COVID-19, Dyspnoea, Fatigue
Clinical narrative: Comes in with worsening SOB and weakness, dyspnea, fatigue. Acute respiratory failure with hypoxia (HCC) -- patient with recent COVID, however repeat COVID testing here has been negative. Continued Lovenox for positive D dimer, Patient seen for respiratory complaints and thought to have COVID.  He did require oxygen for a short while.  He was able to be weaned down and did not qualify for home oxygen.  He had mild elevation in his LFTs which improved during admission.  D-dimer was high but he was negative for blood clot.  He had a positive blood culture for a contaminant.  He was covered with antibiotics while in hospital.  Patient felt better was really wanting to go home. He was discharged on oral antibiotics
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Hypoxia, Liver function test increased, SARS-CoV-2 test negative
Clinical narrative: Comes in with worsening SOB and weakness, dyspnea, fatigue. Acute respiratory failure with hypoxia (HCC) -- patient with recent COVID, however repeat COVID testing here has been negative. Continued Lovenox for positive D dimer, Patient seen for respiratory complaints and thought to have COVID.  He did require oxygen for a short while.  He was able to be weaned down and did not qualify for home oxygen.  He had mild elevation in his LFTs which improved during admission.  D-dimer was high but he was negative for blood clot.  He had a positive blood culture for a contaminant.  He was covered with antibiotics while in hospital.  Patient felt better was really wanting to go home. He was discharged on oral antibiotics
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 64yo patient received vaccine indicated for 65yo and greater. No known adverse reaction has occurred at this time.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Crying, Dyskinesia, Electroencephalogram normal, Middle insomnia, Screaming
Clinical narrative: Pt. recieved the MMR at about 4 PM on 9-22-23. That night, while asleep, he woke up screaming and crying, slapping hands together, wringing hands, extending lower extremities, feet appearing to tremble, calling out, "Mommy, Mommy, Mommy," over and over, not fully awake but no longer asleep. He had never done anything like that before. In the following 2.5 weeks, he had similar episodes- another at night waking from sleep, and three other episodes during or shortly after waking from daytime naps. He had another episode  seven weeks later after a nap on 11-11-2023.  So far, he exhibits no abnormal behavior changes or abnormal behaviors while awake and fully conscious. With an event occurring three days prior to my filing this report, I consider the ongoing episodes unresolved.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Tremor
Clinical narrative: Pt. recieved the MMR at about 4 PM on 9-22-23. That night, while asleep, he woke up screaming and crying, slapping hands together, wringing hands, extending lower extremities, feet appearing to tremble, calling out, "Mommy, Mommy, Mommy," over and over, not fully awake but no longer asleep. He had never done anything like that before. In the following 2.5 weeks, he had similar episodes- another at night waking from sleep, and three other episodes during or shortly after waking from daytime naps. He had another episode  seven weeks later after a nap on 11-11-2023.  So far, he exhibits no abnormal behavior changes or abnormal behaviors while awake and fully conscious. With an event occurring three days prior to my filing this report, I consider the ongoing episodes unresolved.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Bradycardia, COVID-19 pneumonia, Cough, Dyspnoea
Clinical narrative: Patient presented with dyspnea, fatigue, myalgias, fatigue, nonproductive cough.  In the ER he was noted to be AFib with RVR that required Cardizem drip  And transitioned to po BB. Pt had bradycardia therefore was taken off BB and transitioned to amiodarone.   He was also noted to have a COVID pneumonia for which he was started on remdesivir, Rocephin, steroids, antibitoics,  lasix and Barcitnib. He required high flow nasal canula and was in the ICU.  He was followed by ID, pulmonology and cardiology. Discharged on home oxygen.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Intensive care, Myalgia
Clinical narrative: Patient presented with dyspnea, fatigue, myalgias, fatigue, nonproductive cough.  In the ER he was noted to be AFib with RVR that required Cardizem drip  And transitioned to po BB. Pt had bradycardia therefore was taken off BB and transitioned to amiodarone.   He was also noted to have a COVID pneumonia for which he was started on remdesivir, Rocephin, steroids, antibitoics,  lasix and Barcitnib. He required high flow nasal canula and was in the ICU.  He was followed by ID, pulmonology and cardiology. Discharged on home oxygen.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Nausea
Clinical narrative: Muscle aches, chills, nausea
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, Cardiac failure congestive, Chest X-ray abnormal, Lung infiltration
Clinical narrative: Presented with syncope, CXR with bilat infiltrates, + covid; also CHF and afib; Tx- Vit C, Vit D3, Decadron, lovenox, zinc; O2 @ 2 LPM, then down to room air by dc
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Syncope
Clinical narrative: Presented with syncope, CXR with bilat infiltrates, + covid; also CHF and afib; Tx- Vit C, Vit D3, Decadron, lovenox, zinc; O2 @ 2 LPM, then down to room air by dc
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Brain injury, COVID-19, Cardiac arrest, Cardioversion
Clinical narrative: Covid positive on admission. Woke up at home complaining of severe nausea. Patient passed out and EMS was called. EMS was called to his home after being found unresponsive, noted to be in AFib then asystole.  Was given epinephrine and shocked, intubated in route.  Remained in asystole in the ED.  Patient was coded, had return of circulation.  Cardiology was consulted, deemed too unstable for cath lab.  Patient was admitted to ICU, start heparin drip.  He remained unresponsive despite no sedation.  Patient likely with anoxic brain injury from cardiac arrest.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Endotracheal intubation, Intensive care, Loss of consciousness, Nausea, SARS-CoV-2 test positive
Clinical narrative: Covid positive on admission. Woke up at home complaining of severe nausea. Patient passed out and EMS was called. EMS was called to his home after being found unresponsive, noted to be in AFib then asystole.  Was given epinephrine and shocked, intubated in route.  Remained in asystole in the ED.  Patient was coded, had return of circulation.  Cardiology was consulted, deemed too unstable for cath lab.  Patient was admitted to ICU, start heparin drip.  He remained unresponsive despite no sedation.  Patient likely with anoxic brain injury from cardiac arrest.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Covid positive on admission. Woke up at home complaining of severe nausea. Patient passed out and EMS was called. EMS was called to his home after being found unresponsive, noted to be in AFib then asystole.  Was given epinephrine and shocked, intubated in route.  Remained in asystole in the ED.  Patient was coded, had return of circulation.  Cardiology was consulted, deemed too unstable for cath lab.  Patient was admitted to ICU, start heparin drip.  He remained unresponsive despite no sedation.  Patient likely with anoxic brain injury from cardiac arrest.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling around injection site -3" diameter, hardness, red color, hot. Painful to touch. Fever - 99 degree.  Ice pack, Neosporin with pain relief, ibuprofen
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Cardiac assistance device user, Cardiac failure acute, Cardiac failure congestive
Clinical narrative: resented with increased work of breathing and diagnosed with acute hypoxemic respiratory failure, related to fluid overload from acute combined heart failure as well as possible aspiration pneumonia.  Patient tested positive for Covid 19. Patient was intubated in the emergency room and eventually extubated.  She was treated with Remdesivir, steroids as well as antibiotics.  Patient was also treated for acute combined congestive heart failure.  Echocardiogram showed an EF of 25-30% and was diuresed.  She underwent a left and right heart catheterization 3/1 with PCI to the proximal left circumflex.  She will be fitted with a life vest and will then be able to be discharged.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Catheterisation cardiac abnormal, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased, Endotracheal intubation
Clinical narrative: resented with increased work of breathing and diagnosed with acute hypoxemic respiratory failure, related to fluid overload from acute combined heart failure as well as possible aspiration pneumonia.  Patient tested positive for Covid 19. Patient was intubated in the emergency room and eventually extubated.  She was treated with Remdesivir, steroids as well as antibiotics.  Patient was also treated for acute combined congestive heart failure.  Echocardiogram showed an EF of 25-30% and was diuresed.  She underwent a left and right heart catheterization 3/1 with PCI to the proximal left circumflex.  She will be fitted with a life vest and will then be able to be discharged.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypervolaemia, Percutaneous coronary intervention, Polyuria, SARS-CoV-2 test positive
Clinical narrative: resented with increased work of breathing and diagnosed with acute hypoxemic respiratory failure, related to fluid overload from acute combined heart failure as well as possible aspiration pneumonia.  Patient tested positive for Covid 19. Patient was intubated in the emergency room and eventually extubated.  She was treated with Remdesivir, steroids as well as antibiotics.  Patient was also treated for acute combined congestive heart failure.  Echocardiogram showed an EF of 25-30% and was diuresed.  She underwent a left and right heart catheterization 3/1 with PCI to the proximal left circumflex.  She will be fitted with a life vest and will then be able to be discharged.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Headache, SARS-CoV-2 test positive
Clinical narrative: Hospital acquired Covid. Tested negative x 2 early in the admission, tested positive on 1/20/22. Also on 1/20/22, patient went from requiring 3L O2 to 7L O2 with increased SOB, headache, started intermittently requiring hi flow oxygen,cough,
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient went to the emergency room with itching and rash on the face. Was given Benadryl and Zyrtec.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Dyspnoea, Headache, Pain, Urticaria
Clinical narrative: Patient says she experienced headaches, hives, hard time breathing, body aches, joint aches, that lasted for 3 days. Started feeling better on Tuesday 11/14/23
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Contusion, Erythema, Pain in extremity
Clinical narrative: My right arm is red and purple bruised from the shoulder to the fingertips and it is extremely painful. Bicep and tricep was very painful first, a day later it was down to the elbow, and then the forearm a few days later and now its to the tips of my fingers. Everything hurts and my doctor prescribed pain relievers and muscle relaxers and it does make it feel much better. If I don't take them, I am in excruciating pain. Nabumetone-pain reliever  Baclofen
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Contusion, Immunisation reaction, Pain in extremity, Peripheral swelling, Rash macular
Clinical narrative: My right arm is red and purple bruised from the shoulder to the fingertips and it is extremely painful. Bicep and tricep was very painful first, a day later it was down to the elbow, and then the forearm a few days later and now its to the tips of my fingers. Everything hurts and my doctor prescribed pain relievers and muscle relaxers and it does make it feel much better. If I don't take them, I am in excruciating pain. Nabumetone-pain reliever  Baclofen
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tendonitis
Clinical narrative: My right arm is red and purple bruised from the shoulder to the fingertips and it is extremely painful. Bicep and tricep was very painful first, a day later it was down to the elbow, and then the forearm a few days later and now its to the tips of my fingers. Everything hurts and my doctor prescribed pain relievers and muscle relaxers and it does make it feel much better. If I don't take them, I am in excruciating pain. Nabumetone-pain reliever  Baclofen
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Angiocardiogram, Arteriogram carotid, Blood test, Cardiac stress test, Electrocardiogram
Clinical narrative: I had gone to the doctor for a check up the week before.  I am positive I did not have high blood pressure.  A few days after the vaccine,  my nose started bleeding.  I went to two ENTS because the first cauterization did not work.  The second ENT took my blood pressure and it was 146/112.   He suggested the ER.  I tried to go home and see if it came down on its own.  After a few more days, it was still so high that I went to the ER at hospital.  I have since had a full cardiac work-up, ekg, sonograms of the caratoid artery and heart, stress test and blood work.   I do not have any other issues.  I am still following up tomorrow to see if I need blood pressure medication.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Hypertension, Vascular cauterisation
Clinical narrative: I had gone to the doctor for a check up the week before.  I am positive I did not have high blood pressure.  A few days after the vaccine,  my nose started bleeding.  I went to two ENTS because the first cauterization did not work.  The second ENT took my blood pressure and it was 146/112.   He suggested the ER.  I tried to go home and see if it came down on its own.  After a few more days, it was still so high that I went to the ER at hospital.  I have since had a full cardiac work-up, ekg, sonograms of the caratoid artery and heart, stress test and blood work.   I do not have any other issues.  I am still following up tomorrow to see if I need blood pressure medication.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, Dyspnoea, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Presented to the ED with SOB, found to be COVID positive, small PE, patient was started on empiric IV antibiotics, steroid therapy with Decadron, infection Disease consulted, he was also seen by Cardiology due to associated atrial fibrillation with RVR new onset, most likely triggered by pneumonia, patient was started on heparin anticoagulation and later switched to Eliquis with loading dose for 1 week then switch to 5 mg b.i.d.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, C-reactive protein increased, COVID-19, Fibrin D dimer increased, Mental status changes
Clinical narrative: Admitted to the hospital with nausea and AMS as well as generalized weakness and acute metabolic encephalopathy. Positive for Covid. Treated with decadron, CRP and D dimer were elevated. Discharged on eliquis as Covid VTE ppx
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic encephalopathy, Nausea, SARS-CoV-2 test positive
Clinical narrative: Admitted to the hospital with nausea and AMS as well as generalized weakness and acute metabolic encephalopathy. Positive for Covid. Treated with decadron, CRP and D dimer were elevated. Discharged on eliquis as Covid VTE ppx
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory distress syndrome, Anion gap, Blood bicarbonate decreased, Blood creatinine increased
Clinical narrative: Patient presented to the ER with worsening dyspnea and productive cough over the past five days. He was given azithromycin outpatient by pcp without improvement. Per EMS patient had spo2 70% on RA. Work up in ED showed WBC 7.51, bicarb 17, agap 16, BUN 30, SCr 2.2, lactate 6.41 -- > 3.10. CXR with bilateral pneumonia. He was found to have COVID, had worsening respiratory failure required mechanical ventilation, had worsening AKI, ultimately requiring CRRT, had worsening 3 pressor shock, severe ARDS, Ongoing d/w family, and ultiatmley decision made for DNR. Family went to speak w/ the pt's wife (who has deferred decision to the children) and the family did decide to transition to end of life care.  Patient passed away 16 minutes after life support was withdrawn.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blood lactic acid, Blood urea increased, COVID-19, Chest X-ray abnormal, Death
Clinical narrative: Patient presented to the ER with worsening dyspnea and productive cough over the past five days. He was given azithromycin outpatient by pcp without improvement. Per EMS patient had spo2 70% on RA. Work up in ED showed WBC 7.51, bicarb 17, agap 16, BUN 30, SCr 2.2, lactate 6.41 -- > 3.10. CXR with bilateral pneumonia. He was found to have COVID, had worsening respiratory failure required mechanical ventilation, had worsening AKI, ultimately requiring CRRT, had worsening 3 pressor shock, severe ARDS, Ongoing d/w family, and ultiatmley decision made for DNR. Family went to speak w/ the pt's wife (who has deferred decision to the children) and the family did decide to transition to end of life care.  Patient passed away 16 minutes after life support was withdrawn.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Haemofiltration, Mechanical ventilation, Pneumonia, Productive cough
Clinical narrative: Patient presented to the ER with worsening dyspnea and productive cough over the past five days. He was given azithromycin outpatient by pcp without improvement. Per EMS patient had spo2 70% on RA. Work up in ED showed WBC 7.51, bicarb 17, agap 16, BUN 30, SCr 2.2, lactate 6.41 -- > 3.10. CXR with bilateral pneumonia. He was found to have COVID, had worsening respiratory failure required mechanical ventilation, had worsening AKI, ultimately requiring CRRT, had worsening 3 pressor shock, severe ARDS, Ongoing d/w family, and ultiatmley decision made for DNR. Family went to speak w/ the pt's wife (who has deferred decision to the children) and the family did decide to transition to end of life care.  Patient passed away 16 minutes after life support was withdrawn.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory failure, Shock, White blood cell count normal, Withdrawal of life support
Clinical narrative: Patient presented to the ER with worsening dyspnea and productive cough over the past five days. He was given azithromycin outpatient by pcp without improvement. Per EMS patient had spo2 70% on RA. Work up in ED showed WBC 7.51, bicarb 17, agap 16, BUN 30, SCr 2.2, lactate 6.41 -- > 3.10. CXR with bilateral pneumonia. He was found to have COVID, had worsening respiratory failure required mechanical ventilation, had worsening AKI, ultimately requiring CRRT, had worsening 3 pressor shock, severe ARDS, Ongoing d/w family, and ultiatmley decision made for DNR. Family went to speak w/ the pt's wife (who has deferred decision to the children) and the family did decide to transition to end of life care.  Patient passed away 16 minutes after life support was withdrawn.