chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RSV, RSV
Symptoms: Extra dose administered, Malaise
Clinical narrative: Sick; I got 2 RSV shots in 14 months; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 76-year-old patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Arexvy and the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy and Arexvy, the patient experienced sickness (Verbatim: Sick) and extra dose administered (Verbatim: I got 2 RSV shots in 14 months). The outcome of the sickness was not reported and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the sickness to be related to Arexvy and Arexvy.     It was unknown if the company considered the sickness to be related to Arexvy and Arexvy.   Additional Information: GSK Receipt Date: 14-DEC-2024 This case was reported by patient itself. The patient accidently got two Arexvy shots in 14 months, which led extra dose administered. The patient reporter the Arexvy shots made terribly sick.
Sex: F
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Ill pass! Had it once in my life and it was the only time Ive had the flu; Initial information received on 06-Dec-2024 regarding an unsolicited valid non-serious social media case received from a patient.  This case involves Adult female patient who reported I ll pass! had it once in my life and it was the only time ive had the flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) (strength, form, dose, batch and expiry date unknown). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On an unknown date the patient reported ill pass! had it once in my life and it was the only time ive had the flu (influenza) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got my flu shot, yet I have been "sick" ever since; Initial information received on 06-Dec-2024 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (patient).  This case involves Adult and unknown gender patient who had received Influenza vaccine, yet have been sick.  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 Influenza vaccine produced by unknown manufacturer (strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   On an unknown date the patient have been sick ever since (illness) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Off label use
Clinical narrative: Intentional off label prescription by HCP: Imovax is prescribed with off label diagnosis code S41.151A (with no reported adverse event); Initial information received on 06-Dec-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 5 years old male patient who received intentional off label prescription by hcp: IPV (VERO) [IMOVAX] is prescribed with off label diagnosis code s41.151a (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 intentional off label prescription by hcp for suspect IPV (VERO), Suspension for injection (dose 1 Mll) (lot, strength and expiry: unknow) diagnosis code s41.151a (with no reported adverse event) (off label use) (latency same day) via intramuscular route in unknown administration site for open bite of right upper arm, initial encounter.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: every one has made me sick for at least 10 days; Initial information received on 08-Dec-2024 regarding an unsolicited valid Social Media non-serious case received from a consumer/Non-Healthcare Professional.  This case involves Adult male patient who experienced every one has made me sick for at least 10 days after receiving vaccine INFLUENZA VACCINE.  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 INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, strength, lot, route and expiry: unknown) in unknown administration site for prophylactic vaccination.   Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On an unknown date the patient developed a non-serious every one has made me sick for at least 10 days (illness) (unknown latency)   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (every one has made me sick for at least 10 days).  At time of reporting, the outcome was Unknown for the event every one has made me sick for at least 10 days.
Age: 1.58
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ACTHIB was inadvertently given to a patient with no reported AE; Initial information received on 09-Dec-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 19 months old male patient who had received expired HIB (PRP/T) vaccine [ACT-HIB] was inadvertently given to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Dec-2024, the patient received a expired unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength: unknown, expiry date: 30-Nov-2024 and lot UJ964AD) via unknown route in unknown administration site as immunization (expired product administered) (latency: same day).   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: M
Vaccine: MEN
Symptoms: Extra dose administered, No adverse event
Clinical narrative: given an extra dose of MENQUADFI. His series was already completed with no reported AE; Initial information received on 11-Dec-2024 regarding an unsolicited non-valid non-serious case received from a physician.  This case involves, an unknown age and male patient who was given an extra dose of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] as his series was already completed 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 an extra dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (lot U8194AA, expiry date: 01-Sep-2027) (unknown strength, dosage and route) via unknown administration site for immunization as his series was already completed with no reported adverse event (extra dose administered) (unknown latency).  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: 11.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone HD were given to a patient of 11 years of age with no reported AE; Initial information received on 11-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old and unknown gender patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Dec-2024, the patient received 0.5 ml of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, Suspension for injection in pre-filled syringe (lot UT8454AA and expiry 30-Jun-2025) with no reported adverse event (product administered to patient of inappropriate age) (latency same day) via intramuscular route in unknown administration site for 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 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: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: administered just the liquid part of PENTACEL to a patient (with no reported adverse event); Initial information received on 12-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 month old male patient who had administered just the liquid part of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] to a patient (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 Hepatitis b vaccine (Hepatitis b) for Immunisation; Rotavirus vaccine (Rotavirus vaccine) for Immunisation; and Pneumococcal vaccine conj 7v (CRM197) (Prevnar) for Immunisation.  On 12-Dec-2024, the patient received a dose 3 of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) lot UK174AB, Expiry date: 31-Mar-2026, strength was unknown via intramuscular route in the right thigh for Immunization and administered just the liquid part of pentacel to a patient (with no reported adverse event) (single component of a two-component product administered) (latency : same day).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to administering only the DTaP-IPV component of PENTACEL to a patient."   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: 1.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: wrong diluent used, that 0.9% sodium chloride was given instead of the 0.4% that comes with the box with no reported adverse event; Initial information received on 12-Dec-2024 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 1 year old and unknown gender patient who received HIB (PRP/T) vaccine [ACT-HIB] with wrong diluent used, that 0.9% sodium chloride was given instead of the 0.4% that comes with the box with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (unknown strength, formulation, lot and expiry date) via unknown route in unknown administration site for immunization with wrong diluent used, that 0.9% sodium chloride was given instead of the 0.4% that comes with the box with no reported adverse event (product preparation error) (latency same day).  On an unknown date the patient developed a non-serious wrong diluent used, that 0.9% sodium chloride was given instead of the 0.4% that comes with the box with no reported adverse event (unknown latency) following the administration of HIB (PRP/T) vaccine.   Information on the batch number was requested corresponding to the one at time of event occurrence.   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: 3.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: Patient was administered with only the Hib portion of PENTACEL. Hib portion was reconstituted with sterile water with no reported adverse event; Initial information received on 12-Dec-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 3 years old male patient who was administered with only the HIB portion of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [PENTACEL (VERO)]. HIB portion was reconstituted with sterile water 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 varicella zoster vaccine (Varicella Vaccine) for Immunisation.  On 10-Dec-2024, the patient received 0.5 ml of dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection with standard strength (expiry date- Jun-2025 and lot UK038AA via intramuscular route in unknown administration site as Immunization with only the Hib portion of pentacel. Hib portion was reconstituted with sterile water with no reported adverse event (single component of a two-component product administered) (latency- same day).  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: 2.08
Sex: M
Vaccine: FLUN3
Symptoms: Expired product administered
Clinical narrative: Vaccine expired 4 days when given
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired product administered
Clinical narrative: Vaccine expired 4 days when given
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Cough, Erythema, Injection site pruritus, Swelling, Throat irritation
Clinical narrative: Patient stated to have itchy sensation on 12/13/24 on left deltoid, swelling on 12/14/24. Seen by provider on 12/16/24. Patient back to see provider again on 12/18/24 for burning sensation in throat and coughing, redness, itchiness at injection site. Treatment - Prednisone, hydroxyzine, augmentin, bactroban
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, CSF test abnormal, Electroencephalogram abnormal, Fatigue, Mobility decreased
Clinical narrative: BECAME EXTREMELY TIRED AND FELT THE NEED TO REST, WHEN AWOKEN COULD NOT MOVE LEGS BUT HAD SENSATION AFTER ABOUT 8-10 HOURS OF INJECTION. WENT TO ER. ACCUSED OF DRUG SEEKING, HAD LABS REQUESTED AND THAN TRANSFERRED FOR SPECIALTY CARE. ARRIVED AT NEW HOSPITAL, RECIEVED LUMBAR PUNCTURE, FELT PROGGRESSIVE WEAKNESS IN CHEST AND ARMS. NO TREATMENT WAS GIVEN. ELEVATED CSF AND SLOW WAVES WERE PRESENT DURING TREATMENT. RELEASED WITHOUT RESTRICTIONS AND GIVEN INSTRUCTIONS FOR PT & OT. WEAKNESS BEGUN TO SPREAD THROUGH ENTIRE BODY AFTER A FEW WEEKS LEAVING BODY TOTALLY FATIGUED FOR MONTHS.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness
Clinical narrative: BECAME EXTREMELY TIRED AND FELT THE NEED TO REST, WHEN AWOKEN COULD NOT MOVE LEGS BUT HAD SENSATION AFTER ABOUT 8-10 HOURS OF INJECTION. WENT TO ER. ACCUSED OF DRUG SEEKING, HAD LABS REQUESTED AND THAN TRANSFERRED FOR SPECIALTY CARE. ARRIVED AT NEW HOSPITAL, RECIEVED LUMBAR PUNCTURE, FELT PROGGRESSIVE WEAKNESS IN CHEST AND ARMS. NO TREATMENT WAS GIVEN. ELEVATED CSF AND SLOW WAVES WERE PRESENT DURING TREATMENT. RELEASED WITHOUT RESTRICTIONS AND GIVEN INSTRUCTIONS FOR PT & OT. WEAKNESS BEGUN TO SPREAD THROUGH ENTIRE BODY AFTER A FEW WEEKS LEAVING BODY TOTALLY FATIGUED FOR MONTHS.
Age: 1.42
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Irritability, Rash
Clinical narrative: vomiting x3 within 15 min of vaccine administration, red and warm injection site on RLE.  No facial swelling, wheezing, trouble breathing or respiratory distress. Patient remained fussy overnight at home but stable, then next morning 12/17 awoke itchy with continued red/warm injection sites and some new hive-like rash on lower abdomen.  Mom brought patient to ER for evaluation that morning 12/17 - I do not have access to these records to follow up on outcome.
Age: 1.42
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Urticaria, Vomiting
Clinical narrative: vomiting x3 within 15 min of vaccine administration, red and warm injection site on RLE.  No facial swelling, wheezing, trouble breathing or respiratory distress. Patient remained fussy overnight at home but stable, then next morning 12/17 awoke itchy with continued red/warm injection sites and some new hive-like rash on lower abdomen.  Mom brought patient to ER for evaluation that morning 12/17 - I do not have access to these records to follow up on outcome.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Fatigue, Headache
Clinical narrative: Headache, dizziness, exhaustion, upset stomach
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: To my knowledge, pt has not had an adverse effect. I am filling this out due to it being pt's 3rd flu vaccine in 1 season.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Patient was given Hep A in Error when series already complete
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dizziness, Dyspnoea
Clinical narrative: Pt was dizzy within minutes of injection, difficulty breathing, and cough EMS instructed us to give epipen
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: mother stated the baby had febrile seizures after being vaccinated and was taked to the ER for treatment. Pt was seen with the pediatrician for another medical problem and was told about the episode after being vaccinated. Nothing further done for the patient after ER visit per mother.
Age: 43.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient receiving flu shot during physical. When charting the vaccine, administering provider noted that the Tdap vaccine was given instead of the flu vaccine. Per the reporter, the storage of the boxes had been switched in the refrigerator. Event was reported to the patient, who notably was not up to date on Tdap vaccine. Patient arrived back to clinic and received intended flu vaccine.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Swollen tongue
Clinical narrative: Pt developed swelling of the right side of his tongue and difficulty talking as a result .  no shortness of breath  . He was given epi- 0.3mg IM at 10:25 , pt felt much better at 10:45 am with resolution  . EMS summoned.
Age: 1.0
Sex: M
Vaccine: FLU3, HIBV, PNC20
Symptoms: Depressed level of consciousness, Dyskinesia, Febrile convulsion, Irritability, Moaning
Clinical narrative: Low-grade fever on 11/12/2024 at around 1800   Parent administered acetaminophen per manufacturer instructions. Increasing irritability throughout the evening. The parent describes the patient as "moaning" and restless.  The parent moved the patient into the parent room to monitor due to symptoms. At around 2100, moaning sounds and restlessness seemed worse. The parent observed jerking motions that appeared to be seizure activity. Parents called 911, and paramedics responded. The parent reports seizure-like activity that lasts for around 8-10 minutes. The patient was transported to the emergency department. The parent reports that the patient had a decreased LOC and was "unresponsive" for around an hour after arriving at the emergency department. The patient was evaluated by a physician and diagnosed with febrile seizure.
Age: 1.0
Sex: M
Vaccine: FLU3, HIBV, PNC20
Symptoms: Pyrexia, Restlessness, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: Low-grade fever on 11/12/2024 at around 1800   Parent administered acetaminophen per manufacturer instructions. Increasing irritability throughout the evening. The parent describes the patient as "moaning" and restless.  The parent moved the patient into the parent room to monitor due to symptoms. At around 2100, moaning sounds and restlessness seemed worse. The parent observed jerking motions that appeared to be seizure activity. Parents called 911, and paramedics responded. The parent reports seizure-like activity that lasts for around 8-10 minutes. The patient was transported to the emergency department. The parent reports that the patient had a decreased LOC and was "unresponsive" for around an hour after arriving at the emergency department. The patient was evaluated by a physician and diagnosed with febrile seizure.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under the age of 65 and does not qualify for high dose influenza vaccine.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Acute motor axonal neuropathy, Anti-ganglioside antibody positive, Back pain, Blood creatine phosphokinase normal, Blood immunoglobulin G increased
Clinical narrative: My patient developed  Acute Motor Axonal Neuropathy (AMAN) subtype of Guillain-Barre Syndrome. Details from Hospitalization included below in full. I gave her fluad and Prevnar20  3 days before onset of symptoms.               ----------------      The patient is a 69 year old female with significant past medical history of ESRD s/p renal transplant (12/2023), hyperlipidemia, and hypertension, who presented to the hospital after developing acute weakness in all extremities.    Reports that she developed acute weakness in the early evening of 11/7/2024.  It began in her hands then involved both arms and both legs.  Denies involvement of the trunk and head.  Denies preceding factor.  She did receive both flu and pneumonia vaccine on 11/4, and states she believes the vaccines caused this.  Felt well after vaccine up until the weakness began.  Denies sensory deficits, bladder/bowel dysfunction, myalgias, chills, falls, syncope, dysphagia, blurred vision, vision abnormalities, difficulty breathing, cough, nausea, vomiting, muscle pain.  Weakness has been constant and there is no temporal feature.  Per chart review patient did see a doctor on 11/4 for 1 week of diarrhea.  No new medications or supplements.  No sick contacts.  Patient can hardly walk.  She lives with sister and nephew, is very mobile and independent.   In the ED BP 145/74 on room air.  Labs significant for HST 37.7, WBC normal, mini RPP negative, CK normal 116. EKG and chest x-ray grossly normal.   While admitted to 12W, patient was empirically started on IVIG. She had EMG which had evidence of a severe neurogenic disorder characterized by motor nerve involvement supportive of the diagnosis of Acute Motor Axonal Neuropathy (AMAN) subtype of Guillain-Barre Syndrome. She had elevated GM1 IgG and IgM. She was completed on 5 days of IVIG. She worked with PT/OT who recommended acute rehab. On 11/14 patient with two episodes of small amounts of blood in BM. She had been constipated prior and her VSS. She did not have additional episodes of bloody bowel movements. Hospital course further complicated by LUE pain. VAS Duplex revealed complex fluid collection. She underwent LUE aspiration with IR 11/20 and etiology thought to be hematoma rather than abscess but cultures collected which were thus far unremarkable however some were pending at the time of discharge. Hospital course further c/b back pain which was treated with scheduled tylenol, lidocaine patches, heat/ice packs. The renal transplant team followed her throughout the stay. Her home Tacrolimus dose was increased to 2 mg daily - confirmed with transplant service to discharge on 2 mg daily until outpatient follow-up (no further testing needed).
Age: 69.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Blood immunoglobulin M increased, Chest X-ray normal, Culture, Diagnostic aspiration, Electrocardiogram normal
Clinical narrative: My patient developed  Acute Motor Axonal Neuropathy (AMAN) subtype of Guillain-Barre Syndrome. Details from Hospitalization included below in full. I gave her fluad and Prevnar20  3 days before onset of symptoms.               ----------------      The patient is a 69 year old female with significant past medical history of ESRD s/p renal transplant (12/2023), hyperlipidemia, and hypertension, who presented to the hospital after developing acute weakness in all extremities.    Reports that she developed acute weakness in the early evening of 11/7/2024.  It began in her hands then involved both arms and both legs.  Denies involvement of the trunk and head.  Denies preceding factor.  She did receive both flu and pneumonia vaccine on 11/4, and states she believes the vaccines caused this.  Felt well after vaccine up until the weakness began.  Denies sensory deficits, bladder/bowel dysfunction, myalgias, chills, falls, syncope, dysphagia, blurred vision, vision abnormalities, difficulty breathing, cough, nausea, vomiting, muscle pain.  Weakness has been constant and there is no temporal feature.  Per chart review patient did see a doctor on 11/4 for 1 week of diarrhea.  No new medications or supplements.  No sick contacts.  Patient can hardly walk.  She lives with sister and nephew, is very mobile and independent.   In the ED BP 145/74 on room air.  Labs significant for HST 37.7, WBC normal, mini RPP negative, CK normal 116. EKG and chest x-ray grossly normal.   While admitted to 12W, patient was empirically started on IVIG. She had EMG which had evidence of a severe neurogenic disorder characterized by motor nerve involvement supportive of the diagnosis of Acute Motor Axonal Neuropathy (AMAN) subtype of Guillain-Barre Syndrome. She had elevated GM1 IgG and IgM. She was completed on 5 days of IVIG. She worked with PT/OT who recommended acute rehab. On 11/14 patient with two episodes of small amounts of blood in BM. She had been constipated prior and her VSS. She did not have additional episodes of bloody bowel movements. Hospital course further complicated by LUE pain. VAS Duplex revealed complex fluid collection. She underwent LUE aspiration with IR 11/20 and etiology thought to be hematoma rather than abscess but cultures collected which were thus far unremarkable however some were pending at the time of discharge. Hospital course further c/b back pain which was treated with scheduled tylenol, lidocaine patches, heat/ice packs. The renal transplant team followed her throughout the stay. Her home Tacrolimus dose was increased to 2 mg daily - confirmed with transplant service to discharge on 2 mg daily until outpatient follow-up (no further testing needed).
Age: 69.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Electromyogram abnormal, Gait disturbance, Haematochezia, Haematocrit normal, Immunoglobulin therapy
Clinical narrative: My patient developed  Acute Motor Axonal Neuropathy (AMAN) subtype of Guillain-Barre Syndrome. Details from Hospitalization included below in full. I gave her fluad and Prevnar20  3 days before onset of symptoms.               ----------------      The patient is a 69 year old female with significant past medical history of ESRD s/p renal transplant (12/2023), hyperlipidemia, and hypertension, who presented to the hospital after developing acute weakness in all extremities.    Reports that she developed acute weakness in the early evening of 11/7/2024.  It began in her hands then involved both arms and both legs.  Denies involvement of the trunk and head.  Denies preceding factor.  She did receive both flu and pneumonia vaccine on 11/4, and states she believes the vaccines caused this.  Felt well after vaccine up until the weakness began.  Denies sensory deficits, bladder/bowel dysfunction, myalgias, chills, falls, syncope, dysphagia, blurred vision, vision abnormalities, difficulty breathing, cough, nausea, vomiting, muscle pain.  Weakness has been constant and there is no temporal feature.  Per chart review patient did see a doctor on 11/4 for 1 week of diarrhea.  No new medications or supplements.  No sick contacts.  Patient can hardly walk.  She lives with sister and nephew, is very mobile and independent.   In the ED BP 145/74 on room air.  Labs significant for HST 37.7, WBC normal, mini RPP negative, CK normal 116. EKG and chest x-ray grossly normal.   While admitted to 12W, patient was empirically started on IVIG. She had EMG which had evidence of a severe neurogenic disorder characterized by motor nerve involvement supportive of the diagnosis of Acute Motor Axonal Neuropathy (AMAN) subtype of Guillain-Barre Syndrome. She had elevated GM1 IgG and IgM. She was completed on 5 days of IVIG. She worked with PT/OT who recommended acute rehab. On 11/14 patient with two episodes of small amounts of blood in BM. She had been constipated prior and her VSS. She did not have additional episodes of bloody bowel movements. Hospital course further complicated by LUE pain. VAS Duplex revealed complex fluid collection. She underwent LUE aspiration with IR 11/20 and etiology thought to be hematoma rather than abscess but cultures collected which were thus far unremarkable however some were pending at the time of discharge. Hospital course further c/b back pain which was treated with scheduled tylenol, lidocaine patches, heat/ice packs. The renal transplant team followed her throughout the stay. Her home Tacrolimus dose was increased to 2 mg daily - confirmed with transplant service to discharge on 2 mg daily until outpatient follow-up (no further testing needed).
Age: 69.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Muscular weakness, Oedema peripheral, Pain in extremity, Respiratory pathogen panel, Ultrasound Doppler
Clinical narrative: My patient developed  Acute Motor Axonal Neuropathy (AMAN) subtype of Guillain-Barre Syndrome. Details from Hospitalization included below in full. I gave her fluad and Prevnar20  3 days before onset of symptoms.               ----------------      The patient is a 69 year old female with significant past medical history of ESRD s/p renal transplant (12/2023), hyperlipidemia, and hypertension, who presented to the hospital after developing acute weakness in all extremities.    Reports that she developed acute weakness in the early evening of 11/7/2024.  It began in her hands then involved both arms and both legs.  Denies involvement of the trunk and head.  Denies preceding factor.  She did receive both flu and pneumonia vaccine on 11/4, and states she believes the vaccines caused this.  Felt well after vaccine up until the weakness began.  Denies sensory deficits, bladder/bowel dysfunction, myalgias, chills, falls, syncope, dysphagia, blurred vision, vision abnormalities, difficulty breathing, cough, nausea, vomiting, muscle pain.  Weakness has been constant and there is no temporal feature.  Per chart review patient did see a doctor on 11/4 for 1 week of diarrhea.  No new medications or supplements.  No sick contacts.  Patient can hardly walk.  She lives with sister and nephew, is very mobile and independent.   In the ED BP 145/74 on room air.  Labs significant for HST 37.7, WBC normal, mini RPP negative, CK normal 116. EKG and chest x-ray grossly normal.   While admitted to 12W, patient was empirically started on IVIG. She had EMG which had evidence of a severe neurogenic disorder characterized by motor nerve involvement supportive of the diagnosis of Acute Motor Axonal Neuropathy (AMAN) subtype of Guillain-Barre Syndrome. She had elevated GM1 IgG and IgM. She was completed on 5 days of IVIG. She worked with PT/OT who recommended acute rehab. On 11/14 patient with two episodes of small amounts of blood in BM. She had been constipated prior and her VSS. She did not have additional episodes of bloody bowel movements. Hospital course further complicated by LUE pain. VAS Duplex revealed complex fluid collection. She underwent LUE aspiration with IR 11/20 and etiology thought to be hematoma rather than abscess but cultures collected which were thus far unremarkable however some were pending at the time of discharge. Hospital course further c/b back pain which was treated with scheduled tylenol, lidocaine patches, heat/ice packs. The renal transplant team followed her throughout the stay. Her home Tacrolimus dose was increased to 2 mg daily - confirmed with transplant service to discharge on 2 mg daily until outpatient follow-up (no further testing needed).
Age: 69.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Ultrasound Doppler abnormal, White blood cell count normal
Clinical narrative: My patient developed  Acute Motor Axonal Neuropathy (AMAN) subtype of Guillain-Barre Syndrome. Details from Hospitalization included below in full. I gave her fluad and Prevnar20  3 days before onset of symptoms.               ----------------      The patient is a 69 year old female with significant past medical history of ESRD s/p renal transplant (12/2023), hyperlipidemia, and hypertension, who presented to the hospital after developing acute weakness in all extremities.    Reports that she developed acute weakness in the early evening of 11/7/2024.  It began in her hands then involved both arms and both legs.  Denies involvement of the trunk and head.  Denies preceding factor.  She did receive both flu and pneumonia vaccine on 11/4, and states she believes the vaccines caused this.  Felt well after vaccine up until the weakness began.  Denies sensory deficits, bladder/bowel dysfunction, myalgias, chills, falls, syncope, dysphagia, blurred vision, vision abnormalities, difficulty breathing, cough, nausea, vomiting, muscle pain.  Weakness has been constant and there is no temporal feature.  Per chart review patient did see a doctor on 11/4 for 1 week of diarrhea.  No new medications or supplements.  No sick contacts.  Patient can hardly walk.  She lives with sister and nephew, is very mobile and independent.   In the ED BP 145/74 on room air.  Labs significant for HST 37.7, WBC normal, mini RPP negative, CK normal 116. EKG and chest x-ray grossly normal.   While admitted to 12W, patient was empirically started on IVIG. She had EMG which had evidence of a severe neurogenic disorder characterized by motor nerve involvement supportive of the diagnosis of Acute Motor Axonal Neuropathy (AMAN) subtype of Guillain-Barre Syndrome. She had elevated GM1 IgG and IgM. She was completed on 5 days of IVIG. She worked with PT/OT who recommended acute rehab. On 11/14 patient with two episodes of small amounts of blood in BM. She had been constipated prior and her VSS. She did not have additional episodes of bloody bowel movements. Hospital course further complicated by LUE pain. VAS Duplex revealed complex fluid collection. She underwent LUE aspiration with IR 11/20 and etiology thought to be hematoma rather than abscess but cultures collected which were thus far unremarkable however some were pending at the time of discharge. Hospital course further c/b back pain which was treated with scheduled tylenol, lidocaine patches, heat/ice packs. The renal transplant team followed her throughout the stay. Her home Tacrolimus dose was increased to 2 mg daily - confirmed with transplant service to discharge on 2 mg daily until outpatient follow-up (no further testing needed).
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Incorrect dose given to 15 yr old. She was give the dose formulated for 5yr-11yr olds
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Reaction to Pentacel on the Left Thigh.  It is red and swollen.  Treating with Benadryl, Zyrtec and cool compresses.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Pain
Clinical narrative: sever pain had flu and shingles in left are same time
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Irritation of injection site. -Recommended the patient use cool compress at injection site.  She is unable to use NSAIDs due to Coumadin use. -Area was marked today in clinic. Education provided to monitor if redness continues to worsen and goes outside of marking. -Patient will continue to monitor for increased redness, fever, chills, or drainage.  If this occurs and she will seek further care.
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Swollen, red rash spreading below injection sites that began around 24 hours after administration
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Musculoskeletal disorder, Vaccination site pain
Clinical narrative: When shot was given by the pharmacy student, the student reported a large amount of bleeding but otherwise did not report anything else out of the ordinary.  Approximately one month later the patient returned reporting that pain was still present in the vaccination site.  Patient reported that there was indeed a lot of bleeding which she had not experienced with out vaccines, also reported that the shot was given somewhat forcefully.  She also reported that she needed to go to physical therapy to regain proper function of the arm which was important to her as she was an artist.  I apologized and asked for an approximate location where the shot was given thinking that the shot may have been given high, however patient reported an area that would be acceptable in my professional estimation.  Patient came in today saying that the function had returned after physical therapy but that pain was still present.
Age: 69.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, COVID-19, Contusion, Joint swelling, Pneumothorax
Clinical narrative: Patient requested both vaccines be given in the same arm on 12/2/2024. Patient reported adverse event 4 days later on 12/6/2024 of painful shoulder with swelling and bruising. Patient went to emergency department and was given an antibiotic and pain medication. The following Thursday 12/12/2024 patient was hospitalized for Covid and a collapsed lung.
Age: 3.0
Sex: F
Vaccine: COVID19, TD
Symptoms: Activated partial thromboplastin time prolonged, Arthralgia, Blood fibrinogen normal, Coagulation factor IX level normal, Coagulation factor XI level normal
Clinical narrative: Patient has received seasonal influenza and COVID vaccines before. This was her 5th COVID vaccine and her 4th flu vaccine (her boosters for this season). Patient developed Henoch Schonlein Purpura after this round of immunizations. She also had mild runny nose prior to getting her vaccines, so there may have been a viral trigger. The day after her vaccines, she developed a large ecchymosis on her left thigh where her flu vaccine had been given. The following day, she developed petechiae on her lower extremities and right ankle pain and swelling along with limp. She was first seen in the ED with mildly elevated APTT but normal INR and platelets. She was later seen by Pediatric Hematology who felt that Patient may have a slightly prolonged PTT at baseline, which was exacerbated by a testing error, especially given the improvement in her PTT on mixing study screen. She developed further joint pain and swelling and lower extremity petechiae and was seen by Pediatric Rheumatology who felt her presentation was consistent with HSP. She has significantly improved since starting oral steroids and NSAIDs. She has not had significant abdominal or renal involvement to date, and will need to continued periodic monitoring of her urine over the next year. She continues to follow with Pediatric Rheumatology.
Age: 3.0
Sex: F
Vaccine: COVID19, TD
Symptoms: Coagulation factor XII level normal, Factor VIII activity normal, Full blood count normal, Gait disturbance, Henoch-Schonlein purpura
Clinical narrative: Patient has received seasonal influenza and COVID vaccines before. This was her 5th COVID vaccine and her 4th flu vaccine (her boosters for this season). Patient developed Henoch Schonlein Purpura after this round of immunizations. She also had mild runny nose prior to getting her vaccines, so there may have been a viral trigger. The day after her vaccines, she developed a large ecchymosis on her left thigh where her flu vaccine had been given. The following day, she developed petechiae on her lower extremities and right ankle pain and swelling along with limp. She was first seen in the ED with mildly elevated APTT but normal INR and platelets. She was later seen by Pediatric Hematology who felt that Patient may have a slightly prolonged PTT at baseline, which was exacerbated by a testing error, especially given the improvement in her PTT on mixing study screen. She developed further joint pain and swelling and lower extremity petechiae and was seen by Pediatric Rheumatology who felt her presentation was consistent with HSP. She has significantly improved since starting oral steroids and NSAIDs. She has not had significant abdominal or renal involvement to date, and will need to continued periodic monitoring of her urine over the next year. She continues to follow with Pediatric Rheumatology.
Age: 3.0
Sex: F
Vaccine: COVID19, TD
Symptoms: Injection site haemorrhage, International normalised ratio normal, Joint swelling, Metabolic function test normal, Platelet count normal
Clinical narrative: Patient has received seasonal influenza and COVID vaccines before. This was her 5th COVID vaccine and her 4th flu vaccine (her boosters for this season). Patient developed Henoch Schonlein Purpura after this round of immunizations. She also had mild runny nose prior to getting her vaccines, so there may have been a viral trigger. The day after her vaccines, she developed a large ecchymosis on her left thigh where her flu vaccine had been given. The following day, she developed petechiae on her lower extremities and right ankle pain and swelling along with limp. She was first seen in the ED with mildly elevated APTT but normal INR and platelets. She was later seen by Pediatric Hematology who felt that Patient may have a slightly prolonged PTT at baseline, which was exacerbated by a testing error, especially given the improvement in her PTT on mixing study screen. She developed further joint pain and swelling and lower extremity petechiae and was seen by Pediatric Rheumatology who felt her presentation was consistent with HSP. She has significantly improved since starting oral steroids and NSAIDs. She has not had significant abdominal or renal involvement to date, and will need to continued periodic monitoring of her urine over the next year. She continues to follow with Pediatric Rheumatology.
Age: 3.0
Sex: F
Vaccine: COVID19, TD
Symptoms: Prothrombin time normal
Clinical narrative: Patient has received seasonal influenza and COVID vaccines before. This was her 5th COVID vaccine and her 4th flu vaccine (her boosters for this season). Patient developed Henoch Schonlein Purpura after this round of immunizations. She also had mild runny nose prior to getting her vaccines, so there may have been a viral trigger. The day after her vaccines, she developed a large ecchymosis on her left thigh where her flu vaccine had been given. The following day, she developed petechiae on her lower extremities and right ankle pain and swelling along with limp. She was first seen in the ED with mildly elevated APTT but normal INR and platelets. She was later seen by Pediatric Hematology who felt that Patient may have a slightly prolonged PTT at baseline, which was exacerbated by a testing error, especially given the improvement in her PTT on mixing study screen. She developed further joint pain and swelling and lower extremity petechiae and was seen by Pediatric Rheumatology who felt her presentation was consistent with HSP. She has significantly improved since starting oral steroids and NSAIDs. She has not had significant abdominal or renal involvement to date, and will need to continued periodic monitoring of her urine over the next year. She continues to follow with Pediatric Rheumatology.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Patient experience itching in ankles and feet 2 days after injection
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Fatigue, Oral herpes, SARS-CoV-2 test negative, Sinus congestion
Clinical narrative: Hoarse voice (ongoing for almost two weeks), sinus congestion (4+ days), oral herpes (3+ days), fatigue to the point of nearly fainting (over a week)
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Hoarse voice (ongoing for almost two weeks), sinus congestion (4+ days), oral herpes (3+ days), fatigue to the point of nearly fainting (over a week)
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Computerised tomogram head abnormal, Echocardiogram, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: felt shooting sensation up arm and into neck area during injection.  Have never felt this sensation with any injection prior.Suffered Cryptogenic Stroke on 02/11/24 resulting in hospitalization x 3 days. No prior issues that would have caused stroke and despite extensive testing no known cause. Healthcare provider feel immunization event may have led to Stroke
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Implantable cardiac monitor insertion, Magnetic resonance imaging head abnormal, Sensory disturbance
Clinical narrative: felt shooting sensation up arm and into neck area during injection.  Have never felt this sensation with any injection prior.Suffered Cryptogenic Stroke on 02/11/24 resulting in hospitalization x 3 days. No prior issues that would have caused stroke and despite extensive testing no known cause. Healthcare provider feel immunization event may have led to Stroke