chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: U
Vaccine: PNC15, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaxneuvance Vaccine administerd after multiple temperature excursion; Varivax and Vaxneuvance Vaccines administerd after multiple temperature excursion; This spontaneous report was received from a nurse practitioner referring to a 2-year-old patient (gender unknown).  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 19-OCT-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) were exposed to the temperature excursion of 49.5 degrees Fahrenheit for 2 minutes (refrigerated vaccines); and total time in the range from -14 to -10 degrees Celsius for 27 minutes. On 04-DEC-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) were exposed to the temperature excursion at total time in the range from -14 to -10 degrees Celsius for 28 minutes. On 04-DEC-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection,  lot #X012267, expiration date: 30-APR-2025, administered subcutaneously for prophylaxis (strength was not provided) that underwent in a temperature excursion. On 06-DEC-2023, administered doses of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) were exposed to the temperature excursion at total time in the range from -14 to -10 degrees Celsius for 15 minutes. On 18-DEC-2023, the patient started therapy with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot #X019438, expiration date: 07-NOV-2025, administered intramuscularly for prophylaxis (strength was not provided) that underwent in a temperature excursion. The temperature excursion occurred because of a reading from the Digital Data Logger in the vaccines' storage in clinical practice. There was no adverse event. It was noted that the vaccines were reported as right to use.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2401USA016206: US-009507513-2403USA005243:MSD US-009507513-2403USA005252:MSD US-009507513-2403USA005253:MSD US-009507513-2403USA005254:MSD US-009507513-2403USA005255:MSD US-009507513-2403USA005256:MSD US-009507513-2403USA005257:MSD US-009507513-2403USA005258:MSD US-009507513-2403USA005259:MSD US-009507513-2403USA005260:MSD US-009507513-2403USA005261:MSD US-009507513-2403USA005262:MSD US-009507513-2403USA005263:MSD US-009507513-2403USA005265:MSD US-009507513-2403USA005266:MSD US-009507513-2403USA005267:MSD US-009507513-2403USA005268:MSD US-009507513-2403USA005269:MSD US-009507513-2403USA005270:MSD
Age: 4.0
Sex: U
Vaccine: PNC15, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administerd after multiple temperature excursion; Vaxneuvance administered to a patient of 4 year-old; This spontaneous report was received from a nurse practitioner referring to a 4-year-old (gender unknown).  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 19-OCT-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) were exposed to the temperature excursion of 49.5 degrees Fahrenheit for 2 minutes (refrigerated vaccines); and total time in the range from -14 to -10 degrees Celsius for 27 minutes. On 04-DEC-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) were exposed to the temperature excursion at a total time in the range from -14 to -10 degrees Celsius for 28 minutes. On 06-DEC-2023, administered doses of vaccines were exposed to the temperature excursion at a total time in the range from -14 to -10 degrees Celsius for 15 minutes. On 10-JAN-2024, administered doses of vaccines were exposed to the temperature excursion at a total time in the range from -14 to -10 degrees Celsius for 24 minutes. On 27-DEC-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #X012267, expiration date: 30-APR-2025, administered subcutaneously for prophylaxis (strength was not provided); and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection,  lot #X019438, expiration date: 07-NOV-2025, administered intramuscularly for prophylaxis (strength was not provided) that underwent in a temperature excursion. The temperature excursion occurred because of a reading from the Digital Data Logger in the vaccines' storage in clinical practice. There was no adverse event. It was noted that the vaccines were reported as right to use.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2401USA016206: US-009507513-2403USA005243:MSD US-009507513-2403USA005252:MSD US-009507513-2403USA005253:MSD US-009507513-2403USA005254:MSD US-009507513-2403USA005255:MSD US-009507513-2403USA005256:MSD US-009507513-2403USA005257:MSD US-009507513-2403USA005258:MSD US-009507513-2403USA005259:MSD US-009507513-2403USA005260:MSD US-009507513-2403USA005261:MSD US-009507513-2403USA005262:MSD US-009507513-2403USA005263:MSD US-009507513-2403USA005264:MSD US-009507513-2403USA005265:MSD US-009507513-2403USA005266:MSD US-009507513-2403USA005268:MSD US-009507513-2403USA005269:MSD US-009507513-2403USA005270:MSD
Age: 4.0
Sex: U
Vaccine: HIBV, PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was vaccinated with improper storage dose of LIQUID PEDVAXHIB and VAXNEUVANCE; This spontaneous report was received from a nurse practitioner and refers to a 4-year-old patient of unknown gender with no illness at the time of vaccination. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported.  On 19-OCT-2023, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) were exposed to the temperature excursion of 49.5 degrees Fahrenheit for 2 minutes (refrigerated vaccines); and total time in the range from -14 to -10 degrees Celsius for 27 minutes.  On 20-NOV-2023, the patient was vaccinated with an improperly storage dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), intramuscularly, lot # X003664, expiration date 10-NOV-2025 (also reported as 12-NOV-2025),  and improperly storage dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), intramuscularly, lot # X019438, expiration date 07-NOV-2025 (also reported as 30-AUG-2025), both vaccines for prophylaxis (product storage error). The temperature excursion occurred because of a reading from Digital Data Logger in the vaccines' storage in clinical practice. There was no adverse event.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2403USA004981: US-009507513-2403USA004979: US-009507513-2403USA004978: US-009507513-2403USA004977: US-009507513-2403USA004976: US-009507513-2403USA004975: US-009507513-2403USA004974: US-009507513-2403USA004980: US-009507513-2403USA004999: US-009507513-2403USA004998: US-009507513-2403USA004997: US-009507513-2403USA004996: US-009507513-2403USA004995: US-009507513-2403USA004994: US-009507513-2403USA004993: US-009507513-2403USA004986: US-009507513-2403USA004992: US-009507513-2403USA004991: US-009507513-2401USA016206: US-009507513-2403USA004989: US-009507513-2403USA004988: US-009507513-2403USA005000: US-009507513-2403USA004987: US-009507513-2403USA004990: US-009507513-2403USA005310: US-009507513-2403USA005309: US-009507513-2403USA005308: US-009507513-2403USA005307: US-009507513-2403USA005305: US-009507513-2403USA005311:
Sex: F
Vaccine: HPV9
Symptoms: Nasopharyngitis
Clinical narrative: exposure to cold symptoms; This spontaneous report was received from a consumer's mom and referring to a female patient of unknown age. The patient's concomitant drugs included an unspecified influenza vaccine. The patient's medical history, concurrent conditions, and past drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, lot #, expiry date, and route of administration were not provided) prophylaxis which was administered at the same time with the unspecified flu vaccine.  Seven days after the vaccination in 2023, the patient was exposed to cold symptoms. At the time of reporting, the symptoms had not gone away, and it's been a year. The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.  Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: The patient did not experience any adverse issue or side effect; A HCP (MA and paramedic) called to inquire about the validity of a dose of PROQUAD that was administered to a patient too early.  The caller stated the first dose administered on 01/30/2024, and second dose inadvertently administered on 03/19/2024 in; Second dose of Proquad inadvertently administered instead of MMR; This spontaneous report was received from a medical assistant and refers to a 5 year old male patient. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. Concomitant medications included sterile diluent.   On 30-JAN-2024, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 mL (lot #, expiration date, route of administration, anatomical location not provided) as prophylaxis. On 19-MAR-2024, the patient was inadvertently vaccinated with a second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 mL, lot # X021126, expiration date: 12-FEB-2025, albumin status validated as rHA (route of administration, anatomical location not provided)  instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (inappropriate schedule of product administration, wrong product administered). It was reported that the patient did not experienced any adverse issue or side effects from the administered doses.
Sex: U
Vaccine: PNC20
Symptoms: Syringe issue
Clinical narrative: Syringes has a broken tip/not administered; This is a spontaneous report received from an Other HCP from product quality group.  A patient (age and gender not provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, 0.5ml single (Lot number: HE6175, Expiration Date: Mar2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "Syringes has a broken tip/not administered".  Additional information: An office manager called in regard the Prevnar 20 vaccines they received from Pfizer back in December for which they saw that one of the syringes has a broken tip. they are calling to get the replacement in case. It was also reported that the broken syringe tip vaccine was not administered to any patient. The sample of product was confirmed to be available to be returned. It was also confirmed that the packaging was sealed and intact.   Causality for "syringes has a broken tip/not administered" was determined associated to device constituent of pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein).
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: punctured IPOL has been administered post the excursion with no reported adverse event; Initial information received on 15-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old male patient who received punctured IPV (VERO) [IPOL post the excursion 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 VACCINE), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TD VACCINE) for Prophylactic vaccination.  On 13-Mar-2024, the patient received a Dose 2 of suspect IPV (VERO), suspension for injection (lot W1A191M) (dose, strength and expiry: unknown) post the excursion with no reported adverse event (poor quality product administered) (latency same day) in the left deltoid for Prophylactic Vaccination (immunization).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 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: 9.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a dose of DAPTACEL was inadvertently administered to a 9-year-old patient with no reported adverse event; Initial information received on 20-Mar-2024 regarding an unsolicited valid  non-serious case received from a Other Health Care Professional.  This case involves a 9 years old male patient who was inadvertently administered a dose of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Mar-2024, the patient received a 0.5 ml (dose 1) of Daptacel (Diphtheria-15/Tetanus/5 AC Pertussis Vaccine) (Suspension for injection) (lot C6013AA, expiry date: 05-Jul-2024, strength not reported) via intramuscular route in the right deltoid for Immunization was inadvertently administered to a 9-year-old patient with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It was reported that "she didn't realize that the approved age was only through 6 years of age, and they were trying to use the product since it has an upcoming expiration.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: vaccine was just given earlier this morning intramuscularly instead of subcutaneously, with no reported adverse event; Initial information received on 19-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient (unknown age and gender) who was just given Yellow Fever Vaccine - [YF-Vax] earlier this morning intramuscularly instead of subcutaneously, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Mar-2024, the patient received 0.5 ml dose of Yellow Fever Vaccine - (Solution for injection) (lot, strength, expiry date not reported) in unknown administration site for Prophylactic vaccination was just given earlier this morning intramuscularly instead of subcutaneously with no reported adverse event (incorrect route of product administration) (latency: same day).  Information regarding batch number will be requested in this case.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Patient got the shot and got shingles/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Patient got the shot and got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she got the shot and got the shingles it was horrific. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: shingles/ suspected vaccination failure; got the shot and got the shingles; pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got the shot and got the shingles) and pain (Verbatim: pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-Mar-2024 This case was reported by a patient via interactive digital media. Patient got the shot and got the shingles.  Patient still had the pain for 6 months now (at the time of reporting). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles twice/ suspected vaccination failure; shingles twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: shingles twice/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles twice). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 16-Mar-2024 This case was reported by a patient via interactive digital media. Patient have had both vaccines and still had gotten shingles twice.  This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure
Clinical narrative: still has the shingles / suspected vaccination failure; still has the shingles; bad part is she is 38; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 38-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: still has the shingles / suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: still has the shingles) and inappropriate age at vaccine administration (Verbatim: bad part is she is 38). The outcome of the vaccination failure and inappropriate age at vaccine administration were unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 16-Mar-2024 This case was reported by a consumer via interactive digital media. The reporter knew a person that had gotten the 2 shots and still had the shingles.  The bad part was she was 38. The patient received 2 shots of Shingrix below the recommended age, which led to inappropriate age at vaccine administration. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: I have it for the third time; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced extra dose administered (Verbatim: I have it for the third time). The outcome of the extra dose administered was unknown.   Additional Information: GSK received date: 07-Mar-2024 This case was reported by a patient via interactive digital media. Patient got the vaccine and patient had it for the third time. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Second dose administered.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2KJ34, expiry date 03-JUL-2025) for prophylaxis.   Concomitant products included RSV vaccine prot. subunit PreF3 (Arexvy).   On 18-JAN-2024, the patient received the 2nd dose of Arexvy. On 18-JAN-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Second dose administered.). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 13-MAR-2024 The pharmacist called to inform the following that they had a patient who had two doses of Arexvy, which led to Extra dose administered. The reporter did not consent to follow-up.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient given DTAP outside of the manufacturer and CDC guidelines.  Patient is 7 years and 5 months.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Injection site cellulitis, Injection site pain, Injection site warmth
Clinical narrative: Cellulitis like skin reaction @ site of injection and extending down arm - warm and mildly tender to touch
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Bilirubin urine, Blood calcium decreased, Blood creatinine decreased, Blood glucose normal, Blood potassium normal
Clinical narrative: Pt is a 7mo male here for a follow visit after receiving his vaccines he had 2 seizures. He was seen at clinic. 7 months old male who had 2 generalized seizures during a febrile episode last week. Mom states that early in the evening the day he received schedule vaccine for age of Pentacel, Rotateq and Prevnar, he developed a generalized tonic posture followed by generalized tremors, unresponsive to stimuli lasting for 2-3 minutes. No cyanosis no vomiting. EMTs were called and found the patient with a low-grade fever (unspecified) and took him to Medical Center's emergency room. Patient was diagnosed with simple febrile seizure. Discharge home with antipyretics recommendation. Mom states that within 6 hours that night patient was noticed to have a second similar episode lasting for a few minutes and was taken directly to the same emergency room. Reevaluation showed patient with a temperature of 38.7 degrees C, basic laboratory tests like a CBC , comprehensive metabolic test and a urinalysis were basically normal, patient was observed for a few hours and remained alert afebrile looking as baseline behavior and was dischatged home with a follow-up with is primary care provider. Patient has been asymptomatic since then ,afebrile, tolerating his usual diet, mom denies any differences or asymmetries in movements and behavior. Family history of paternal aunt with a  seizure disorder. Parents denied the use of toxic substances in the house.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Blood sodium decreased, Blood urea decreased, Blood urine present, Carbon dioxide decreased, Febrile convulsion
Clinical narrative: Pt is a 7mo male here for a follow visit after receiving his vaccines he had 2 seizures. He was seen at clinic. 7 months old male who had 2 generalized seizures during a febrile episode last week. Mom states that early in the evening the day he received schedule vaccine for age of Pentacel, Rotateq and Prevnar, he developed a generalized tonic posture followed by generalized tremors, unresponsive to stimuli lasting for 2-3 minutes. No cyanosis no vomiting. EMTs were called and found the patient with a low-grade fever (unspecified) and took him to Medical Center's emergency room. Patient was diagnosed with simple febrile seizure. Discharge home with antipyretics recommendation. Mom states that within 6 hours that night patient was noticed to have a second similar episode lasting for a few minutes and was taken directly to the same emergency room. Reevaluation showed patient with a temperature of 38.7 degrees C, basic laboratory tests like a CBC , comprehensive metabolic test and a urinalysis were basically normal, patient was observed for a few hours and remained alert afebrile looking as baseline behavior and was dischatged home with a follow-up with is primary care provider. Patient has been asymptomatic since then ,afebrile, tolerating his usual diet, mom denies any differences or asymmetries in movements and behavior. Family history of paternal aunt with a  seizure disorder. Parents denied the use of toxic substances in the house.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Glucose urine absent, Haematocrit decreased, Haemoglobin decreased, Nitrite urine absent, Protein urine absent
Clinical narrative: Pt is a 7mo male here for a follow visit after receiving his vaccines he had 2 seizures. He was seen at clinic. 7 months old male who had 2 generalized seizures during a febrile episode last week. Mom states that early in the evening the day he received schedule vaccine for age of Pentacel, Rotateq and Prevnar, he developed a generalized tonic posture followed by generalized tremors, unresponsive to stimuli lasting for 2-3 minutes. No cyanosis no vomiting. EMTs were called and found the patient with a low-grade fever (unspecified) and took him to Medical Center's emergency room. Patient was diagnosed with simple febrile seizure. Discharge home with antipyretics recommendation. Mom states that within 6 hours that night patient was noticed to have a second similar episode lasting for a few minutes and was taken directly to the same emergency room. Reevaluation showed patient with a temperature of 38.7 degrees C, basic laboratory tests like a CBC , comprehensive metabolic test and a urinalysis were basically normal, patient was observed for a few hours and remained alert afebrile looking as baseline behavior and was dischatged home with a follow-up with is primary care provider. Patient has been asymptomatic since then ,afebrile, tolerating his usual diet, mom denies any differences or asymmetries in movements and behavior. Family history of paternal aunt with a  seizure disorder. Parents denied the use of toxic substances in the house.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Pyrexia, Specific gravity urine normal, Tonic posturing, Tremor, Unresponsive to stimuli
Clinical narrative: Pt is a 7mo male here for a follow visit after receiving his vaccines he had 2 seizures. He was seen at clinic. 7 months old male who had 2 generalized seizures during a febrile episode last week. Mom states that early in the evening the day he received schedule vaccine for age of Pentacel, Rotateq and Prevnar, he developed a generalized tonic posture followed by generalized tremors, unresponsive to stimuli lasting for 2-3 minutes. No cyanosis no vomiting. EMTs were called and found the patient with a low-grade fever (unspecified) and took him to Medical Center's emergency room. Patient was diagnosed with simple febrile seizure. Discharge home with antipyretics recommendation. Mom states that within 6 hours that night patient was noticed to have a second similar episode lasting for a few minutes and was taken directly to the same emergency room. Reevaluation showed patient with a temperature of 38.7 degrees C, basic laboratory tests like a CBC , comprehensive metabolic test and a urinalysis were basically normal, patient was observed for a few hours and remained alert afebrile looking as baseline behavior and was dischatged home with a follow-up with is primary care provider. Patient has been asymptomatic since then ,afebrile, tolerating his usual diet, mom denies any differences or asymmetries in movements and behavior. Family history of paternal aunt with a  seizure disorder. Parents denied the use of toxic substances in the house.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Urine ketone body present, White blood cell count increased, White blood cells urine negative, pH urine
Clinical narrative: Pt is a 7mo male here for a follow visit after receiving his vaccines he had 2 seizures. He was seen at clinic. 7 months old male who had 2 generalized seizures during a febrile episode last week. Mom states that early in the evening the day he received schedule vaccine for age of Pentacel, Rotateq and Prevnar, he developed a generalized tonic posture followed by generalized tremors, unresponsive to stimuli lasting for 2-3 minutes. No cyanosis no vomiting. EMTs were called and found the patient with a low-grade fever (unspecified) and took him to Medical Center's emergency room. Patient was diagnosed with simple febrile seizure. Discharge home with antipyretics recommendation. Mom states that within 6 hours that night patient was noticed to have a second similar episode lasting for a few minutes and was taken directly to the same emergency room. Reevaluation showed patient with a temperature of 38.7 degrees C, basic laboratory tests like a CBC , comprehensive metabolic test and a urinalysis were basically normal, patient was observed for a few hours and remained alert afebrile looking as baseline behavior and was dischatged home with a follow-up with is primary care provider. Patient has been asymptomatic since then ,afebrile, tolerating his usual diet, mom denies any differences or asymmetries in movements and behavior. Family history of paternal aunt with a  seizure disorder. Parents denied the use of toxic substances in the house.
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered at inappropriate site
Clinical narrative: Given too high
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Comirnaty vaccine was administered to the patient past its beyond use date.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Comirnaty vaccine was administered to the patient past its beyond use date.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Comirnaty vaccine was administered to the patient past its beyond use date.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Comirnaty vaccine was administered to the patient past its beyond use date.
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Erythema, Nausea, Peripheral swelling, Pharyngeal swelling, Tenderness
Clinical narrative: Employee states that on 03/21/2024 his arm began to have swelling, redness, and tenderness. Employee then woke up on 03/22/2024 having nausea, vomiting, and states that throat is slightly swollen.
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Employee states that on 03/21/2024 his arm began to have swelling, redness, and tenderness. Employee then woke up on 03/22/2024 having nausea, vomiting, and states that throat is slightly swollen.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Diarrhoea, Dizziness, Peripheral swelling
Clinical narrative: Localized swelling of left upper extremity, dizziness, and diarrhea. Doctor suggested for patient to use warm compresses on area where vaccine was administered. Advised to do gradual change in position. Discussed importance of hydration and to f/up if not better.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient Called this morning 3/22/24 mentioned soreness and some redness/hard/tender at injection site. Recommended to use cold compress and Ibuprofen or Naproxen, she mentioned she applied alcohol and cortisone to it and it wasn't improving. Advised her to pause that treatment and try my recommendation and call us tomorrow if not improving.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Per our immunization records he was missing and parents gave me immunization records after given and were okey with it , they had gone to beforehand . NO reaction and told  parents and were okey with accident they said he will be more protected
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Headache, Influenza, Influenza A virus test positive, Pain
Clinical narrative: Lack of effect.  Fever 102.4, cough, severe headache.     Symptoms improved after 4 days, but cough persists at Day 8.   Prescribed doxycycline for secondary respiratory bacterial  infection, Medrol Dosepak for wheezing, Tessalon Pearls for coughing, Delsym for coughing, acetaminophen for fever and aches.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Respiratory tract infection bacterial, Vaccination failure
Clinical narrative: Lack of effect.  Fever 102.4, cough, severe headache.     Symptoms improved after 4 days, but cough persists at Day 8.   Prescribed doxycycline for secondary respiratory bacterial  infection, Medrol Dosepak for wheezing, Tessalon Pearls for coughing, Delsym for coughing, acetaminophen for fever and aches.
Age: 31.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Product administration error
Clinical narrative: Patient is a 31 year old female G4P1021, at 11 weeks, 0 days, EDD,  10-11-2024 w/ no other significant PMHx who present to Health Center to update her Tetanus vaccine and to have immune titers drawn.   The medical assistant mistook the need for immunization instead of the need for immune titers to be drawn.  The patient was vaccinated with MMR-II, Varicella and Hep B  instead of having blood drawn for immune titers.  There we no ill effects of the administration documented in the EHR
Age: 1.75
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine on 3/4/2024 and vaccine expired on 3/3/2024. Provider has been informed of incident and will be reaching out to guardian to inform of incident.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy bone marrow, Blood culture negative, COVID-19, Dysphonia, Haemoglobin decreased
Clinical narrative: Admit date: 3/8/2024  Discharge date: 3/20/20/24  Admitting Physician: DO   Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD Reason for Admission: Fever in the setting of neutropenia  Hospital Course: Patient is a 79-year-old male with a significant past medical history of AML with CNS involvement, type 2 diabetes, hypertension, who was admitted for fever in the setting of neutropenia.  Patient was started on cefepime and prophylactic fluconazole, acyclovir, Bactrim.  Patient had positive for COVID, and suspect this was the etiology of his fever.  Supportive care was given.  Due to patient condition, patient was placed on severe respiratory isolation until March 22, 2024.  Blood cultures were negative.  Daily labs were ordered to monitor blood counts.  Hemoglobin and platelets have been low, patient has needed multiple transfusions of red blood cells and platelets during his hospital stay.  Oncology consulted informally and recommended Filgastrim 480 mcg daily until ANC of 1, and restarting fluconazole prophylaxis due to ANC less than 1, can discontinue once ANC is above 1 for 2 days.  ANC eventually improved and both medications were discontinued.  Oncology also recommended bone marrow biopsy which was done on March 12, 2024.  Dietitian was also consulted for severe protein calorie malnutrition and vitamin-D insufficiency. Patient has clinically shown improvement along with his lab results. Patient was accepted and will be discharged to facility for comprehensive rehab.  Follow-up with primary care provider for post hospital discharge, medication reconciliation and refills, consider outpatient ENT referral if hoarseness of voice is persistent.  Follow-up with Oncology regarding ALL, blood count monitoring, and as-needed transfusions, follow-up results for bone marrow biopsy done on March 12, 2024   Discharged to Rehab Facility
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Malnutrition, Neutropenia, Neutrophil count decreased, Platelet count decreased, Platelet transfusion
Clinical narrative: Admit date: 3/8/2024  Discharge date: 3/20/20/24  Admitting Physician: DO   Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD Reason for Admission: Fever in the setting of neutropenia  Hospital Course: Patient is a 79-year-old male with a significant past medical history of AML with CNS involvement, type 2 diabetes, hypertension, who was admitted for fever in the setting of neutropenia.  Patient was started on cefepime and prophylactic fluconazole, acyclovir, Bactrim.  Patient had positive for COVID, and suspect this was the etiology of his fever.  Supportive care was given.  Due to patient condition, patient was placed on severe respiratory isolation until March 22, 2024.  Blood cultures were negative.  Daily labs were ordered to monitor blood counts.  Hemoglobin and platelets have been low, patient has needed multiple transfusions of red blood cells and platelets during his hospital stay.  Oncology consulted informally and recommended Filgastrim 480 mcg daily until ANC of 1, and restarting fluconazole prophylaxis due to ANC less than 1, can discontinue once ANC is above 1 for 2 days.  ANC eventually improved and both medications were discontinued.  Oncology also recommended bone marrow biopsy which was done on March 12, 2024.  Dietitian was also consulted for severe protein calorie malnutrition and vitamin-D insufficiency. Patient has clinically shown improvement along with his lab results. Patient was accepted and will be discharged to facility for comprehensive rehab.  Follow-up with primary care provider for post hospital discharge, medication reconciliation and refills, consider outpatient ENT referral if hoarseness of voice is persistent.  Follow-up with Oncology regarding ALL, blood count monitoring, and as-needed transfusions, follow-up results for bone marrow biopsy done on March 12, 2024   Discharged to Rehab Facility
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Red blood cell transfusion, SARS-CoV-2 test positive, Vitamin D deficiency
Clinical narrative: Admit date: 3/8/2024  Discharge date: 3/20/20/24  Admitting Physician: DO   Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD Reason for Admission: Fever in the setting of neutropenia  Hospital Course: Patient is a 79-year-old male with a significant past medical history of AML with CNS involvement, type 2 diabetes, hypertension, who was admitted for fever in the setting of neutropenia.  Patient was started on cefepime and prophylactic fluconazole, acyclovir, Bactrim.  Patient had positive for COVID, and suspect this was the etiology of his fever.  Supportive care was given.  Due to patient condition, patient was placed on severe respiratory isolation until March 22, 2024.  Blood cultures were negative.  Daily labs were ordered to monitor blood counts.  Hemoglobin and platelets have been low, patient has needed multiple transfusions of red blood cells and platelets during his hospital stay.  Oncology consulted informally and recommended Filgastrim 480 mcg daily until ANC of 1, and restarting fluconazole prophylaxis due to ANC less than 1, can discontinue once ANC is above 1 for 2 days.  ANC eventually improved and both medications were discontinued.  Oncology also recommended bone marrow biopsy which was done on March 12, 2024.  Dietitian was also consulted for severe protein calorie malnutrition and vitamin-D insufficiency. Patient has clinically shown improvement along with his lab results. Patient was accepted and will be discharged to facility for comprehensive rehab.  Follow-up with primary care provider for post hospital discharge, medication reconciliation and refills, consider outpatient ENT referral if hoarseness of voice is persistent.  Follow-up with Oncology regarding ALL, blood count monitoring, and as-needed transfusions, follow-up results for bone marrow biopsy done on March 12, 2024   Discharged to Rehab Facility
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Comirnaty vaccine was administered to the patient past its beyond use date.
Sex: F
Vaccine: TDAP, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient @ 6 days of age was getting 2 vaccines on date of service 2/14/24. RSV (Beyfortis) and Hepatitis B. The Hepatitis B was not given. Tdap (Boostrix) was given mistakenly instead. Both Mother and Father were contacted regarding the error. No side effect or adverse event was reported by the parents. They denied any redness or reaction around injection site.
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient inadvertently received a second shot, patient was informed and not adverse outcomes reported
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Almost 24hrs after the injection, patient returned to clinic due to swelling, redness, and warmth at the injection site. Patient was unable to move her arm bc of the symptoms. Patient was evaluated by provider and was prescribed steroids to help decrease symptoms, which it did.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood magnesium decreased, Chest discomfort, Dizziness, Dyspnoea, Hypokalaemia
Clinical narrative: Hospitalized 11/7/22-11/9/22 Tachycardia, SOB, productive cough, palpitations, dizziness, chest discomfort, hypokalemia, low magnesium, elevated troponin,
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Productive cough, Tachycardia, Troponin increased
Clinical narrative: Hospitalized 11/7/22-11/9/22 Tachycardia, SOB, productive cough, palpitations, dizziness, chest discomfort, hypokalemia, low magnesium, elevated troponin,
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received .5 ML of Moderna 6m-11yr vaccine instead of .25 ML.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Hypoaesthesia, Laboratory test, Nerve conduction studies, Pain
Clinical narrative: On 8/10/23 I woke up with swelling on both my feet and than started having tingling, numbness, and shooting pains. Then the next day my hands did the same thing bilateral. Then progressed to pariorbital, 2 bands around my chest and abdomen. I called the pharmacy and they referred me to the ER. Dr. (nurologist) Appt was 3/6/2024 next visit is 6/6/2024
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia, Periorbital pain, Periorbital swelling, Peripheral swelling
Clinical narrative: On 8/10/23 I woke up with swelling on both my feet and than started having tingling, numbness, and shooting pains. Then the next day my hands did the same thing bilateral. Then progressed to pariorbital, 2 bands around my chest and abdomen. I called the pharmacy and they referred me to the ER. Dr. (nurologist) Appt was 3/6/2024 next visit is 6/6/2024
Age: 1.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient developes redness and a bump to the site of injection as well as a fever of 102F
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, Injection site irritation, Pain in extremity
Clinical narrative: Patient received a second RSV vaccine at the pharmacy when she had a dose in October 2023.  Patient reports no adverse events. Only reported she had sore arm as a normal injection site irritation when given vaccine.
Age: 0.83
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Kinrix was administered instead of the required individual vaccines of Dtap & Polio. Doctor was informed at the time of discovery. Glaxo on-call representative was called and spoke with the physician. Mother of patient was informed within the hour. Mother denied any adverse symptoms or concerns. Mother has not contacted office since appointment.