chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Cough, Fatigue, Feeling abnormal, Hyperventilation
Clinical narrative: nasal discharge; weakness/no energy; fatigue; deep breath; upper respiratory cold; feeling bad; coughing; Initial information received on 31-Oct-2022 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 45 years old female patient who experienced deep breath, upper respiratory cold, feeling bad, nasal discharge, weakness/no energy, fatigue and coughing after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Oct-2022, the patient received 0.7ml once (1X)  dose of suspect influenza quadrival A-B high dose HV vaccine (formulation, dose, lot number and expiry date not reported) via unknown route in the left arm for immunization.  On 25-OCT-2022 the next day the patient started feeling bad (feeling abnormal), upper respiratory cold (upper respiratory tract infection) and coughing (cough)  (latency; 1 day) She stated that the HCP's at Urgent Care did not really determine why she was feeling like this or any treatments at a time. She states that she did not get a chest xray that day, but is going back today to get one. On an unknown date the patient states that her symptoms were having a lot of nasal discharge (rhinorrhoea), weakness (asthenia), fatigue, having to deep breath to avoid pneumonia (hyperventilation) (unknown latency) and feeling it in the base of her lungs. The symptoms are continuing and have not improved.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Rhinorrhoea, Upper respiratory tract infection
Clinical narrative: nasal discharge; weakness/no energy; fatigue; deep breath; upper respiratory cold; feeling bad; coughing; Initial information received on 31-Oct-2022 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 45 years old female patient who experienced deep breath, upper respiratory cold, feeling bad, nasal discharge, weakness/no energy, fatigue and coughing after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Oct-2022, the patient received 0.7ml once (1X)  dose of suspect influenza quadrival A-B high dose HV vaccine (formulation, dose, lot number and expiry date not reported) via unknown route in the left arm for immunization.  On 25-OCT-2022 the next day the patient started feeling bad (feeling abnormal), upper respiratory cold (upper respiratory tract infection) and coughing (cough)  (latency; 1 day) She stated that the HCP's at Urgent Care did not really determine why she was feeling like this or any treatments at a time. She states that she did not get a chest xray that day, but is going back today to get one. On an unknown date the patient states that her symptoms were having a lot of nasal discharge (rhinorrhoea), weakness (asthenia), fatigue, having to deep breath to avoid pneumonia (hyperventilation) (unknown latency) and feeling it in the base of her lungs. The symptoms are continuing and have not improved.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Allergy; This spontaneous report was received from nurse prescriber and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced allergy (unspecified). At the time of reporting, the outcome of the event was unknown.  The causal relationship between allergy and zoster vaccine live (ZOSTAVAX) was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: upset stomach; diarrhea; This case was reported by a consumer via interactive digital media and described the occurrence of upset stomach in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. In October 2022, unknown after receiving Shingrix, the patient experienced upset stomach and diarrhea. On an unknown date, the outcome of the upset stomach and diarrhea were not recovered/not resolved.   It was unknown if the reporter considered the upset stomach and diarrhea to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-OCT-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had got the second Shingrix shot and had an upset stomach and diarrhea for four days now. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that after received Shingles vaccine he/she experienced headache.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: Not feeling good; This case was reported by a physician via sales rep and described the occurrence of feeling unwell in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (for the tolerance of the 1st dose, refer linked case US2022AMR160021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   The reporter considered the feeling unwell to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR160021   Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: Reporter was the patient. He reported not feeling good for 1 to 2 days after immunization with Shingrix. The patient was asked if reported since he was a vaccine expert, he stated that he had not and these events are expected with Shingrix vaccine. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2022AMR160021:same patient, 1st dose
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: No adverse event; some dose leaked out of the syringe; some dose leaked out of the syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of SYRINGE ISSUE (some dose leaked out of the syringe), UNDERDOSE (some dose leaked out of the syringe) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Nov-2022, the patient experienced SYRINGE ISSUE (some dose leaked out of the syringe) and UNDERDOSE (some dose leaked out of the syringe). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, SYRINGE ISSUE (some dose leaked out of the syringe), UNDERDOSE (some dose leaked out of the syringe) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for SYRINGE ISSUE (some dose leaked out of the syringe) and UNDERDOSE (some dose leaked out of the syringe).    No concomitant medications were reported. The pharmacist stated that they were trying to administer Moderna bivalent 0.5 ml, but some dose leaked out of the syringe.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Experienced 3 months of significant muscle pain; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (Experienced 3 months of significant muscle pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced MYALGIA (Experienced 3 months of significant muscle pain). At the time of the report, MYALGIA (Experienced 3 months of significant muscle pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   On 20-Oct-2022, it was reported that on an unspecified date patient received the booster dose of Moderna COVID-19 Vaccine.  Treatment medication was not provided.   Reporter did not allow further contact
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abnormal loss of weight, Anaemia, Haematocrit, Haemoglobin
Clinical narrative: new onset anemia unintentional weight loss
Age: 25.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic, Tenderness
Clinical narrative: Tender, red, itchy, swollen 4-inch diameter rash around injection site
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Anaphylactic reaction, Pruritus, Rash
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Deep vein thrombosis, Fibrin D dimer, Ultrasound Doppler
Clinical narrative: DVT onset within 5 days of injection. No prior hx of DVTs or blood clots
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Syringe issue
Clinical narrative: Error: Leaking from Syringe-
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Condition aggravated, Injection site pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Additional Details: patient already had injured shoulder and limited movement prior to the vaccine and states that vaccine made her shoulder and arm hurt even more. she had a routine appotintment with her physical therapist during which she said she would discuss the adverse event.  we reccomended to her to consult her pcp
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Mild, Systemic: Fever-Medium, Additional Details: patient thinks the reaction is from flu shot, however, appears like its actually a somewhat common reaction to the shingles vaccine
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cerebral disorder, Computerised tomogram head abnormal, Condition aggravated, Culture urine negative
Clinical narrative: Patient with2 COVID vaccines who had a positive COVID PCR on admission to hospital.  Provider d/c note:  "59 YO female with h/o intellectual disability, nonambulatory status, seizure disorder on Dilantin, anxiety admitted 10/31 for multiple seizures at assistive living facility after her years since previous seizure.  CT head showing no acute intracranial abnormality although with continued chronic findings of ventricular prominence as well as extra-axial fluid overlying left cerebellum.  Neurology consulted and increase patient's dose of Dilantin from 200 mg to 300 mg.  There were initial concerns for urinary tract infection but urine culture came back negative and antibiotics were discontinued.  Patient positive for COVID on testing on admission although had been symptomatic apparently on 10/27.  Patient never hypoxic throughout hospitalization and only symptoms noted during hospitalization were fatigue which was improved by time of discharge.  At time of discharge patient was alert and talking in simple one-word answers for short sentences and answering simple questions such as her name and appearing to be at her baseline self.  Patient discharged back to assistive living facility with follow-up with Neurology on 11/17."
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, SARS-CoV-2 test positive, Seizure
Clinical narrative: Patient with2 COVID vaccines who had a positive COVID PCR on admission to hospital.  Provider d/c note:  "59 YO female with h/o intellectual disability, nonambulatory status, seizure disorder on Dilantin, anxiety admitted 10/31 for multiple seizures at assistive living facility after her years since previous seizure.  CT head showing no acute intracranial abnormality although with continued chronic findings of ventricular prominence as well as extra-axial fluid overlying left cerebellum.  Neurology consulted and increase patient's dose of Dilantin from 200 mg to 300 mg.  There were initial concerns for urinary tract infection but urine culture came back negative and antibiotics were discontinued.  Patient positive for COVID on testing on admission although had been symptomatic apparently on 10/27.  Patient never hypoxic throughout hospitalization and only symptoms noted during hospitalization were fatigue which was improved by time of discharge.  At time of discharge patient was alert and talking in simple one-word answers for short sentences and answering simple questions such as her name and appearing to be at her baseline self.  Patient discharged back to assistive living facility with follow-up with Neurology on 11/17."
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Bradycardia, COVID-19, Cardiac telemetry abnormal, Dizziness
Clinical narrative: "Patient up to date on COVID vaccines who admitted to hospital with COVID detected PCR and hypoxia.  Provider d/c note:  ""80-year-old female with significant past medical history of Afib, CHF, COPD, DM, HTN who presented to hospital with weakness and shortness of breath.  Patient was diagnosed with COVID-19 on 10/25, completed molnupiravir therapy at home. Since her diagnosis she has increased weakness, exertional shortness of breath, generalized fatigue, and mild productive cough due to post nasal drip. Prior to admission, patient complained of significant lightheadedness without pre-syncope or syncopal event. EMS was called to her home due and found her hypoxic into the 80's. At baseline she uses home oxygen at 2 LPM due to asthma, but only uses at night. Upon arrival to the ED was found to be bradycardic into the 30's and 40's with hypotension. She was given one liter NS, with subsequent improvement in her blood pressure. In addition, she continued to require supplemental oxygen to maintain her SpO2 in the mid-90s.    Hospital Course:  The patient's home metoprolol and propafenone were held due to symptomatic bradycardia. Cardiology was consulted. Overnight there were no significant events. Patient reported significant improvement in her symptoms with improved vitals prior to discharge. Telemetry was significant for sinus bradycardia with HR 50s. Echo was not performed as patient recently completed study with outpatient Cardiologist in August 2022. Pharmacology was consulted to aid in Warfarin dosing. Cardiology recommendations included discharge with outpatient follow-up and to hold home metoprolol and propafenone until further discussion with the patient's Cardiologist. She was discharged home in stable condition.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Dyspnoea exertional, Fatigue, Hypotension, Hypoxia
Clinical narrative: "Patient up to date on COVID vaccines who admitted to hospital with COVID detected PCR and hypoxia.  Provider d/c note:  ""80-year-old female with significant past medical history of Afib, CHF, COPD, DM, HTN who presented to hospital with weakness and shortness of breath.  Patient was diagnosed with COVID-19 on 10/25, completed molnupiravir therapy at home. Since her diagnosis she has increased weakness, exertional shortness of breath, generalized fatigue, and mild productive cough due to post nasal drip. Prior to admission, patient complained of significant lightheadedness without pre-syncope or syncopal event. EMS was called to her home due and found her hypoxic into the 80's. At baseline she uses home oxygen at 2 LPM due to asthma, but only uses at night. Upon arrival to the ED was found to be bradycardic into the 30's and 40's with hypotension. She was given one liter NS, with subsequent improvement in her blood pressure. In addition, she continued to require supplemental oxygen to maintain her SpO2 in the mid-90s.    Hospital Course:  The patient's home metoprolol and propafenone were held due to symptomatic bradycardia. Cardiology was consulted. Overnight there were no significant events. Patient reported significant improvement in her symptoms with improved vitals prior to discharge. Telemetry was significant for sinus bradycardia with HR 50s. Echo was not performed as patient recently completed study with outpatient Cardiologist in August 2022. Pharmacology was consulted to aid in Warfarin dosing. Cardiology recommendations included discharge with outpatient follow-up and to hold home metoprolol and propafenone until further discussion with the patient's Cardiologist. She was discharged home in stable condition.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Productive cough, SARS-CoV-2 test positive, Sinus bradycardia, Upper-airway cough syndrome
Clinical narrative: "Patient up to date on COVID vaccines who admitted to hospital with COVID detected PCR and hypoxia.  Provider d/c note:  ""80-year-old female with significant past medical history of Afib, CHF, COPD, DM, HTN who presented to hospital with weakness and shortness of breath.  Patient was diagnosed with COVID-19 on 10/25, completed molnupiravir therapy at home. Since her diagnosis she has increased weakness, exertional shortness of breath, generalized fatigue, and mild productive cough due to post nasal drip. Prior to admission, patient complained of significant lightheadedness without pre-syncope or syncopal event. EMS was called to her home due and found her hypoxic into the 80's. At baseline she uses home oxygen at 2 LPM due to asthma, but only uses at night. Upon arrival to the ED was found to be bradycardic into the 30's and 40's with hypotension. She was given one liter NS, with subsequent improvement in her blood pressure. In addition, she continued to require supplemental oxygen to maintain her SpO2 in the mid-90s.    Hospital Course:  The patient's home metoprolol and propafenone were held due to symptomatic bradycardia. Cardiology was consulted. Overnight there were no significant events. Patient reported significant improvement in her symptoms with improved vitals prior to discharge. Telemetry was significant for sinus bradycardia with HR 50s. Echo was not performed as patient recently completed study with outpatient Cardiologist in August 2022. Pharmacology was consulted to aid in Warfarin dosing. Cardiology recommendations included discharge with outpatient follow-up and to hold home metoprolol and propafenone until further discussion with the patient's Cardiologist. She was discharged home in stable condition.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Fall, Wheelchair user
Clinical narrative: Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for vitamin d deficiency, severe COPD, malignant tumor of lung, htn, disorder of kidney, former smoker, hypercholesterolemia. Patient did present at a outside entity hospital on 5/8/21 after falling from a wheelchair. No other information from this visit available. No information regarding death available.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, MNQ, PNC13, RV5
Symptoms: Product administration error, Wrong product administered
Clinical narrative: Administration Error was reported to management, the provider and the manufacturer and instructions were given by the provider and manufacturer. Menquadfi was given in place of Hib in error. The mother was contacted and was informed of the mistake. She was scheduled to come back and recieve the Hib vaccine and was advised that the meningococcal series will need to be began as usually because due to the age of the patient he will not be fully protected by the Medquadfi.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19, CSF culture positive, CSF shunt removal, CSF valve removal
Clinical narrative: Patient with 2 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "41 YO male with h/o cerebral palsy, severe developmental delay, paraplegia, nonverbal, alpha-1 antitrypsin deficiency, emphysema, seizure disorder, chronic constipation admitted on 10/30 for fever and weakness.  Found to have COVID on admission as well as CT of head on admission showing increasing hydrocephalus.  Regarding COVID patient had fevers for a couple days but did not have any respiratory symptoms and did not require any treatments other than symptomatic care.  CT of the head demonstrating increasing hydrocephalus for which Neurosurgery was consulted and after patient is cleared for procedure from Infectious Disease perspective performed VP shunt revision on 11/03.  Also during hospitalization ID was consulted for patient's fevers and concern for possible infected VP shunt.  Lumbar puncture from 10/31 and 11/3 no growth by time of discharge and in PACS antibiotics provided during admission were changed over to patient's home life time doxycycline for suppression of previous CNS MSSA as well as patient to continue voriconazole through December 12 for previous history CSF growing mold on 08/05.  During hospitalization SLP evaluated patient and recommend that patient have a level for, nectar thick diet.  On day of discharge patient was alert but seem to be as baseline status of being nonverbal and had been afebrile for 3 days prior to discharge.  Neurosurgery and ID cleared patient for discharge and patient will follow-up with Dr. on 11/29 and has follow-up with Dr. on 11/17 for removal of staples.  I did update patient's guardian on day of discharge."
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Catheter placement, Catheter removal, Computerised tomogram head abnormal, Condition aggravated, Fungal test positive
Clinical narrative: Patient with 2 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "41 YO male with h/o cerebral palsy, severe developmental delay, paraplegia, nonverbal, alpha-1 antitrypsin deficiency, emphysema, seizure disorder, chronic constipation admitted on 10/30 for fever and weakness.  Found to have COVID on admission as well as CT of head on admission showing increasing hydrocephalus.  Regarding COVID patient had fevers for a couple days but did not have any respiratory symptoms and did not require any treatments other than symptomatic care.  CT of the head demonstrating increasing hydrocephalus for which Neurosurgery was consulted and after patient is cleared for procedure from Infectious Disease perspective performed VP shunt revision on 11/03.  Also during hospitalization ID was consulted for patient's fevers and concern for possible infected VP shunt.  Lumbar puncture from 10/31 and 11/3 no growth by time of discharge and in PACS antibiotics provided during admission were changed over to patient's home life time doxycycline for suppression of previous CNS MSSA as well as patient to continue voriconazole through December 12 for previous history CSF growing mold on 08/05.  During hospitalization SLP evaluated patient and recommend that patient have a level for, nectar thick diet.  On day of discharge patient was alert but seem to be as baseline status of being nonverbal and had been afebrile for 3 days prior to discharge.  Neurosurgery and ID cleared patient for discharge and patient will follow-up with Dr. on 11/29 and has follow-up with Dr. on 11/17 for removal of staples.  I did update patient's guardian on day of discharge."
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hydrocephalus, Lumbar puncture abnormal, Pyrexia, SARS-CoV-2 test positive, Ventriculo-peritoneal shunt
Clinical narrative: Patient with 2 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "41 YO male with h/o cerebral palsy, severe developmental delay, paraplegia, nonverbal, alpha-1 antitrypsin deficiency, emphysema, seizure disorder, chronic constipation admitted on 10/30 for fever and weakness.  Found to have COVID on admission as well as CT of head on admission showing increasing hydrocephalus.  Regarding COVID patient had fevers for a couple days but did not have any respiratory symptoms and did not require any treatments other than symptomatic care.  CT of the head demonstrating increasing hydrocephalus for which Neurosurgery was consulted and after patient is cleared for procedure from Infectious Disease perspective performed VP shunt revision on 11/03.  Also during hospitalization ID was consulted for patient's fevers and concern for possible infected VP shunt.  Lumbar puncture from 10/31 and 11/3 no growth by time of discharge and in PACS antibiotics provided during admission were changed over to patient's home life time doxycycline for suppression of previous CNS MSSA as well as patient to continue voriconazole through December 12 for previous history CSF growing mold on 08/05.  During hospitalization SLP evaluated patient and recommend that patient have a level for, nectar thick diet.  On day of discharge patient was alert but seem to be as baseline status of being nonverbal and had been afebrile for 3 days prior to discharge.  Neurosurgery and ID cleared patient for discharge and patient will follow-up with Dr. on 11/29 and has follow-up with Dr. on 11/17 for removal of staples.  I did update patient's guardian on day of discharge."
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Herpes zoster
Clinical narrative: Shingles followed by Bells Palsy.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Acute kidney injury, Biopsy colon, COVID-19, Colonoscopy abnormal
Clinical narrative: Patient with 3 COVID vaccines who admitted to hospital with positive COVID detected PCR.  Provider d/c note:  " 61 YO woman with history of diabetes type II, HLD, IBS and sigmoid colectomy in 2020 for diverticulitis, who presented to the ED for abdominal pain and multiple episodes of BRBPR in setting of COVID-19 infection. CT scan demonstrated findings of infectious/inflammatory colitis extending from the splenic flexure through the rectum, associated with leukocytosis, AKI, mild hyponatremia. She was treated with IV cipro/flagyl, IV fluids, and bowel rest. Surgery was consulted for colonoscopy. She initially had resolution of diarrhea and significant improvement in pain while on a clear liquid diet, however symptoms returned when diet was advanced. Due to recurrent symptoms, she underwent colonoscopy on 11/5. This demonstrated inflammation from the end-to-end colonic anastomosis through the sigmoid and descending colon. Biopsies were taken and pending at time of discharge. She did much better with diet advancement following the procedure. Will discharge home to complete 7 day course of antibiotics. Advised to stay well hydrated and return precautions discussed.  She will follow-up with Dr. in about 10 days and she will call her PCP tomorrow to schedule hospital follow-up as well. "
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abdomen abnormal, Diarrhoea, Hyponatraemia, Large intestine anastomosis, Large intestine infection
Clinical narrative: Patient with 3 COVID vaccines who admitted to hospital with positive COVID detected PCR.  Provider d/c note:  " 61 YO woman with history of diabetes type II, HLD, IBS and sigmoid colectomy in 2020 for diverticulitis, who presented to the ED for abdominal pain and multiple episodes of BRBPR in setting of COVID-19 infection. CT scan demonstrated findings of infectious/inflammatory colitis extending from the splenic flexure through the rectum, associated with leukocytosis, AKI, mild hyponatremia. She was treated with IV cipro/flagyl, IV fluids, and bowel rest. Surgery was consulted for colonoscopy. She initially had resolution of diarrhea and significant improvement in pain while on a clear liquid diet, however symptoms returned when diet was advanced. Due to recurrent symptoms, she underwent colonoscopy on 11/5. This demonstrated inflammation from the end-to-end colonic anastomosis through the sigmoid and descending colon. Biopsies were taken and pending at time of discharge. She did much better with diet advancement following the procedure. Will discharge home to complete 7 day course of antibiotics. Advised to stay well hydrated and return precautions discussed.  She will follow-up with Dr. in about 10 days and she will call her PCP tomorrow to schedule hospital follow-up as well. "
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Leukocytosis, Rectal haemorrhage, SARS-CoV-2 test positive
Clinical narrative: Patient with 3 COVID vaccines who admitted to hospital with positive COVID detected PCR.  Provider d/c note:  " 61 YO woman with history of diabetes type II, HLD, IBS and sigmoid colectomy in 2020 for diverticulitis, who presented to the ED for abdominal pain and multiple episodes of BRBPR in setting of COVID-19 infection. CT scan demonstrated findings of infectious/inflammatory colitis extending from the splenic flexure through the rectum, associated with leukocytosis, AKI, mild hyponatremia. She was treated with IV cipro/flagyl, IV fluids, and bowel rest. Surgery was consulted for colonoscopy. She initially had resolution of diarrhea and significant improvement in pain while on a clear liquid diet, however symptoms returned when diet was advanced. Due to recurrent symptoms, she underwent colonoscopy on 11/5. This demonstrated inflammation from the end-to-end colonic anastomosis through the sigmoid and descending colon. Biopsies were taken and pending at time of discharge. She did much better with diet advancement following the procedure. Will discharge home to complete 7 day course of antibiotics. Advised to stay well hydrated and return precautions discussed.  She will follow-up with Dr. in about 10 days and she will call her PCP tomorrow to schedule hospital follow-up as well. "
Age: 2.25
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV
Symptoms: Extra dose administered
Clinical narrative: DUE TO A CLERICAL ERROR, PATIENT RECEIVED DOSES OF DTAP, IPV, HEPATITIS A & HEPATITIS B   15 DAYS AFTER RECEIVING THE SAME VACCINES AT ANOTHER CLINIC
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, HEP, HEPA
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: DUE TO A CLERICAL ERROR, PATIENT RECEIVED DOSES OF SEASONAL INFLUENZA, IPV, HEPATITIS A,  HEPATITIS B, DTAP & POLIO 15 DAYS AFTER RECEIVING THE SAME VACCINES AT ANOTHER CLINIC
Age: 9.0
Sex: M
Vaccine: FLU4, HEP, HEPA, IPV
Symptoms: Extra dose administered
Clinical narrative: DUE TO A CLERICAL ERROR, PATIENT RECEIVED DOSES OF SEASONAL INFLUENZA, IPV, HEPATITIS A & HEPATITIS B 10 DAYS AFTER RECEIVING THE SAME VACCINES AT ANOTHER CLINIC
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Dyspnoea, Hypertension, Tachycardia, Throat tightness
Clinical narrative: Tuesday within 1-2 hours of receiving vaccination. Throat closing, difficulty breathing, O2 saturation in the 80's, Tachy and HTN. Went to UC for treatment of Anaphylactic reaction following influenza vaccine
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient tested positive prior to transfer from a HCF to another Hospital.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test negative, Blood test normal, Computerised tomogram normal, Diplopia, Dizziness
Clinical narrative: Upon awakening 11/28/21 (6 days after Covid Moderna booster administration), I experienced  intermittent double vision (Diplopia)., and diziness/haziness. Over the next couple of weeks, Diplopia became permanent. I saw my primary care doctor and my eye doctor. Lenses were administered to help correct the vision and a CT was ordered. CT showed no abnormalities. Referral was then made to a neurologist who ordered an MRI. Once again, nothing abnormal. Myasthenia Gravis (MG) was then expected as the cause, so antibody tests were conducted which showed no signs of antibodies for MG. I was then referred to another Dr who performed an optical evaluation. He did not think the cause was MG, so we ordered the blood tests again which came back showing no antibodies associated with MG. I then saw a retina specialist, and underwent a single fiber EMG test for MG. That test also shows no signs of MG. As of 11/8/2022, there is no diagnosis of why sudden onset Diplopia occurred, other than the Covid vaccine booster being administered 6 days prior to the onset.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Electromyogram normal, Magnetic resonance imaging normal, Vision blurred
Clinical narrative: Upon awakening 11/28/21 (6 days after Covid Moderna booster administration), I experienced  intermittent double vision (Diplopia)., and diziness/haziness. Over the next couple of weeks, Diplopia became permanent. I saw my primary care doctor and my eye doctor. Lenses were administered to help correct the vision and a CT was ordered. CT showed no abnormalities. Referral was then made to a neurologist who ordered an MRI. Once again, nothing abnormal. Myasthenia Gravis (MG) was then expected as the cause, so antibody tests were conducted which showed no signs of antibodies for MG. I was then referred to another Dr who performed an optical evaluation. He did not think the cause was MG, so we ordered the blood tests again which came back showing no antibodies associated with MG. I then saw a retina specialist, and underwent a single fiber EMG test for MG. That test also shows no signs of MG. As of 11/8/2022, there is no diagnosis of why sudden onset Diplopia occurred, other than the Covid vaccine booster being administered 6 days prior to the onset.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 92.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 66.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Headache, Lethargy, Nasal congestion, Rhinorrhoea
Clinical narrative: I had runny nose for the first 24 hours then became very lethargic and had headaches. That's as far as it went, I slept it off for a couple of days. I took over the counter TYLENOL and SUDAFED since it didn't get any worse I didn't need to take any antivirals. I'm a little stuffy today but feel fine and don't have any other symptoms.
Age: 66.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had runny nose for the first 24 hours then became very lethargic and had headaches. That's as far as it went, I slept it off for a couple of days. I took over the counter TYLENOL and SUDAFED since it didn't get any worse I didn't need to take any antivirals. I'm a little stuffy today but feel fine and don't have any other symptoms.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Immediate post-injection reaction, Influenza like illness
Clinical narrative: I experienced tiredness immediately after my shot, flu-like symptoms, aches all over in my joints, weakness and these symptoms lasted for 10 days.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient did not have an adverse reaction to the vaccine.  The patient had received a Janssen vaccine and a Moderna vaccine in 2021.  A monovalent was in error when a Bivalent should have been given.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Trumemba before appropriate age.
Age: 90.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reasons occurred. Resident was transferred to our facility from Hospital. She had not received any Covid vaccinations prior. The hospital was supposed to give her the first dose of the primary series. Instead they gave her a dose of the Pfizer Bivalent Booster.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient is 64 years old and received a Fluzone Quad High Dose vaccine. According to CDC: Fluzone High-Dose Quadrivalent vaccine is approved only for people 65 years and older. Fluzone High-Dose Quadrivalent is not approved for people younger than 65 years or for people of any age with a history of severe allergic reaction to any influenza vaccine or to vaccine components other than eggs. Information about vaccine ingredients is located in the manufacturer?s package insert. Manufacturer Package insert:
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: High dose vaccine given and patient is 63 years old and should have received regular dose.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine given, MD called patient to inform, no adverse reaction.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Chest X-ray normal, Chest discomfort, Heart rate increased
Clinical narrative: Chest tightness, rapid heart rate, blood pressure issues   Needed a chest X-ray
Age: 76.0
Sex: M
Vaccine: UNK
Symptoms: Wrong product administered
Clinical narrative: MD ordered HD Fluzone to be given to patient. Vaxelis was given instead.
Age: 32.0
Sex: M
Vaccine: COVID19-2
Symptoms: Herpes zoster
Clinical narrative: Shingles. Started one week after vaccination, treating with antivirals, not yet recovered.
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nausea, Vomiting
Clinical narrative: Irretracable vomiting and nausea
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Patient was here for her Bivalent booster on 11/4/2022. At the time of this appointment, she reported that after her 2nd and 3rd doses of the Pfizer vaccine, she experienced chest pain that lasted for 2 weeks. She described the chest pain as "feeling like a punch with superficial pain that was hard to pinpoint". She did not see a provider after experiencing the chest pain after either dose. There was no documentation of chest pain after the 2nd dose, so a 3rd dose was given by a paramedic at our clinic. Upon  further review with a physician in our office, we did not administer the bivalent booster to this patient.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired vaccine, MD called patient to make aware, no adverse reacitons.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 51 years old and received a Fluzone Quad High Dose vaccine. According to CDC: Fluzone High-Dose Quadrivalent vaccine is approved only for people 65 years and older. Fluzone High-Dose Quadrivalent is not approved for people younger than 65 years or for people of any age with a history of severe allergic reaction to any influenza vaccine or to vaccine components other than eggs. Information about vaccine ingredients is located in the manufacturer?s package insert.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error, Wrong product administered
Clinical narrative: ADMINISTRATION ERROR; Booster was given to patient instead of Bivalent booster.
Age: 73.0
Sex: M
Vaccine: UNK
Symptoms: Wrong product administered
Clinical narrative: MD ordered High Dose Fluzone to be given and the nurse administered Vaxelis
Age: 85.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Cough, Exposure to SARS-CoV-2, Feeling abnormal, Rhinorrhoea
Clinical narrative: I started that morning feeling bad, my daughter and grands had COVID-19. I had appointment scheduled so I tested because I wanted to make sure I didn't spread it to people. I was only having a runny nose and a scratchy throat. I took a home test and it was positive, so I called my doctors. I was told to treat the symptoms and he would call in medication (molnupiravir) was also instructed to take vitamins A-D. I still have the cough today.
Age: 85.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: SARS-CoV-2 test positive, Throat irritation
Clinical narrative: I started that morning feeling bad, my daughter and grands had COVID-19. I had appointment scheduled so I tested because I wanted to make sure I didn't spread it to people. I was only having a runny nose and a scratchy throat. I took a home test and it was positive, so I called my doctors. I was told to treat the symptoms and he would call in medication (molnupiravir) was also instructed to take vitamins A-D. I still have the cough today.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There was no adverse reaction to the flu vaccine. The patient was given a duplicate dose. The first dose was given on 11/4/22, 0.5 ml, and the second dose of 0.5 ml was given on 11/7/2022.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Exercise tolerance decreased, Limb discomfort, Muscular weakness, Pain in extremity
Clinical narrative: Had initial arm discomfort after receiving her flu vaccine in her left deltoid. Discomfort improved although 6 weeks post vaccination patient has continued experiencing on and off soreness and weakness to her left arm since receiving her vaccine, ie., unable to shoulder press 10 lbs due to arm weakness.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Given Bivalent in primary series
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Smear cervix abnormal
Clinical narrative: Pt was given Pfizer Covid monovalent and not the Covid bivalent.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: On 03/22 I noticed that my lymph nodes in my jaw neck area were swollen and tender. I took some echinacea and it helped to get the swelling down. In 07/22 the lymph nodes started swelling again, this time the echinacea did not help get the swelling to go down. I called my doctor's office and went in for a visit. They prescribed an antibiotic for me that helped to get the swelling to go down. This occurred again in 09/22, I called the doctor's office, this time we just had a telehealth visit and they called in an antibiotic prescription. My doctor did try to get me in for an ultrasound, but they were backed up and by the time they could get me in the swelling was down.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received exp vaccine
Age: 63.0
Sex: F
Vaccine: FLUR4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient verbally agreed to Influenza vaccination. After vaccine was given, she stated she received the vaccination in October. No adverse reaction noted.
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Chills, Diarrhoea
Clinical narrative: chills and achy joints    repeated again the next night without the achy joints but with diarrhea
Age: 74.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: Duplicate vaccine administered.  Patient was signed up for an offsite flu clinic.  Vaccine was administered - Was not noted until a few weeks later that patient had already received annual flu vaccine at PCP office prior to vaccine clinic.  There was no indication onsite that this was the case.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Nasal congestion, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I experienced chills, fever upper respiratory infection with nasal congestion.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Upper respiratory tract infection
Clinical narrative: I experienced chills, fever upper respiratory infection with nasal congestion.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received exp vaccine
Age: 36.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Product storage error
Clinical narrative: Vaccine likely sustained a below 2 C temp excursion.
Age: 87.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: Duplicate vaccine administered.  Patient was signed up for an offsite flu clinic.  Vaccine was administered - Was not noted until a few weeks later that patient had already received annual flu vaccine at PCP office prior to vaccine clinic.  There was no indication onsite that this was the case.
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: NO ACTUAL EVENT !!!! JUST THE PATIENT HAD RECEIVED THE FLU SHOT THE DAY BEFORE AND THEN ON 10/27/22 THE PHARMACIST (MYSELF) GAVE A FLU SHOT INSTEAD OF THE COVID 19 BOOSTER. SUBSEQUENTLY COVID SHOT GIVEN BUT THE PT DID RECEIVE 2 FLU SHOTS WITHIN 24 HRS
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Immediate swelling and hard mass to site of MMR vaccine.  Hard mass about nickel size as of 11/4/22.  Mass size has shrunk since 9/26.
Age: 0.75
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event.  Dose given too early. Was not due until 10/26/2022.