chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: HPV9, TD, HPV9, TD
Symptoms: Asthenia, Balance disorder, Dyspnoea, Lethargy
Clinical narrative: Patient received HPV9 and TD on 4/11/24. Patient developed acute hypoxic respiratory failure and anaphylaxis. Patient was admitted to hospital. Patient initially itubated for respiratory arrest. Extubated and received epinephrine. Patient management HI, H@ blocker, steroids and IV fluids. Patient discharged on 4/13/2024
Age: 19.0
Sex: F
Vaccine: HPV9, TD, HPV9, TD
Symptoms: Acute respiratory failure, Anaphylactic reaction, Anaphylaxis treatment, Angiogram pulmonary, Blood potassium decreased
Clinical narrative: Patient received HPV9 and TD on 4/11/24. Patient developed acute hypoxic respiratory failure and anaphylaxis. Patient was admitted to hospital. Patient initially itubated for respiratory arrest. Extubated and received epinephrine. Patient management HI, H@ blocker, steroids and IV fluids. Patient discharged on 4/13/2024
Age: 19.0
Sex: F
Vaccine: HPV9, TD, HPV9, TD
Symptoms: Chest X-ray, Computerised tomogram head, Endotracheal intubation, Fall, Hypoxia
Clinical narrative: Patient received HPV9 and TD on 4/11/24. Patient developed acute hypoxic respiratory failure and anaphylaxis. Patient was admitted to hospital. Patient initially itubated for respiratory arrest. Extubated and received epinephrine. Patient management HI, H@ blocker, steroids and IV fluids. Patient discharged on 4/13/2024
Age: 19.0
Sex: F
Vaccine: HPV9, TD, HPV9, TD
Symptoms: Lymphocyte count increased, Monocyte count increased, Respiratory arrest
Clinical narrative: Patient received HPV9 and TD on 4/11/24. Patient developed acute hypoxic respiratory failure and anaphylaxis. Patient was admitted to hospital. Patient initially itubated for respiratory arrest. Extubated and received epinephrine. Patient management HI, H@ blocker, steroids and IV fluids. Patient discharged on 4/13/2024
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling, warm to touch, and itching. Treated with Keflex, Benadryl and cool compresses
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV, MMRV
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, swelling, warm to touch, and itching. Treated with Keflex, Benadryl and cool compresses
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A patient who received an expired dose of PROQUAD; This spontaneous report was received from a medical assistant referring to a 5-year-old patient of unknown gender.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 16-MAY-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (rHA), 0.5 milliliters, lot #W026327 that expired on 18-FEB-2024, administered for prophylaxis (strength and route of administration were not provided).  It was noted that no temperature excursions were reported. No symptoms were reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Inadvertent administration of expired ROTATEQ to a patient. ROTATEQ expired on 12-APR-2024 and was administered on 17-MAY-2024; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 17-MAY-2024, the patient was inadvertently vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1932235, that expired on 12-APR-2024, administered for prophylaxis (strength and route of administration were not provided). No additional adverse event was reported.
Age: 33.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A patient was inadvertently administered a dose of MMR II on 17-MAY-2024 that expired on 15-APR-2024; This spontaneous report was received from a registered nurse and refers to a 33-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT) (manufacturer unknown).   On 17-MAY-2024, the patient was inadvertently vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #W022640 that expired on 15-APR-2024, administered for prophylaxis (strength and route of administration were not provided). It was reported by the registered nurse that the patient was notified of the error and had not experienced any adverse issues or side effects from the expired dose. Additionally, the patient was scheduled to return to the clinic in 28 days to repeat titers and the doctor would evaluate whether to re-administer the dose if the patient's immunity is low.  The affected and administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) had not been exposed to any temperature excursions.
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No additional AE; 34-year-old patient received GARDASIL 9 while pregnant (second trimester) in OCT 2023. Patient was on birth control and did not know that they were pregnant at time of administration.; This spontaneous prospective pregnancy report was received from a nurse refers to a 34-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.    On an unknown day in October 2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), formulation: injection (strength, exact dose, dosage regimen, route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis.   On unknown day, the patient became pregnant. The Last menstrual period (LMP) and estimated due date (EDD) was not provided. The pregnancy outcome and the fetal outcome was unknown.   It was reported that, on an unknown day in October 2023, the patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) while pregnant in the second trimester (maternal exposure during pregnancy). Patient was on birth control and did not know that she was pregnant at time of administration. No symptoms or additional adverse event reported (no adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient who has had 6 doses of GARDASIL 9 over a 4 year period/ The reporter did not know exactly when the first extra dose was administered; No adverse effects were reported/ No additional AE; This spontaneous report has been received from a Pharmacist, referring a female patient of an unknown age.   The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  It was stated that the patient received 6 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, over a 4 year period starting on 28-JUN-2019 and ending on 25-SEP-2023; at a dose of 0.5 milliliter (mL), administered as prophylaxis (strength, exact dose, route, anatomical location of administration, lot #, and expiration date were not provided). No adverse effects were reported. The reporter did not know exactly when the first extra dose was administered (extra dose administered). No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia, Chest discomfort, Myocarditis, Tachycardia
Clinical narrative: Rapid heartbeat; Rapid hearbeat; Inflammation of the heart muscle (myocarditis); Cardiac arrhythmia; Heaviness in the heart muscle area; This serious initial Spontaneous safety report was received by Novavax on 21-May-2024 and 23-May-2024 from a Consumer or other non health professional (Reference number: 2024-0001223).  An individual of an unspecified age and gender was vaccinated with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula)(Intramuscular) (Lot number was requested but was unknown to the reporter. | Lot number was not provided in the report.) 3 months ago, on an unspecified date.  No medical history was reported.  No concomitant medications were reported.  On an unspecified date after vaccination the patient experienced Inflammation of the heart muscle (myocarditis)(Myocarditis)(Serious: Other Medically Important Condition), On an unspecified date after vaccination the patient experienced Cardiac arrhythmia(Arrhythmia)(Serious: Other Medically Important Condition), On an unspecified date after vaccination the patient experienced Rapid heartbeat(Tachycardia) and On an unspecified date after vaccination the patient experienced Heaviness in the heart muscle area(Chest discomfort).  At the time of reporting, the event outcome of Myocarditis was Unknown, Arrhythmia was Unknown, Tachycardia was Unknown and Chest discomfort was Unknown.; Sender's Comments: This individual of an unspecified age and sex experienced Myocarditis, Arrhythmia, Tachycardia and Chest discomfort after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula).  The event Myocarditis was reported as serious.  The event Arrhythmia was reported as serious.  The event Tachycardia was reported as non-serious.  The event Chest discomfort was reported as non-serious.   Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Myocarditis, Arrhythmia, Tachycardia and Chest discomfort is considered Possible.
Age: 48.0
Sex: F
Vaccine: PNC20
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Nausea
Clinical narrative: Severe pain at site, unable to move arm, headache, nausea
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Pyrexia
Clinical narrative: 103 fever, chills. Ibuprofen around 3AM, hopefully resolves by morning
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine was given intramuscular and not subcutaneous; This non-serious case was reported by a nurse via sales rep and described the occurrence of subcutaneous injection formulation administered by other route in a child patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Vaccine was given intramuscular and not subcutaneous). The outcome of the subcutaneous injection formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-MAY-2024 This report was submitted via the online direct entry reporting system. The nurse reported that the patient received the Priorix vaccine via intramuscular and not subcutaneous, which led to subcutaneous injection formulation administered by other route.
Age: 81.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site discolouration, Injection site haemorrhage, Injection site pain, Injection site vesicles
Clinical narrative: patient arm bled and 5 days later still sore yellow skin around injection site  and little blood blisters, recommended patient to have MD look at it
Age: 60.0
Sex: M
Vaccine: HEPAB, TDAP, VARZOS
Symptoms: Headache
Clinical narrative: pt received twinrx, boostix and shingrix vaccinations on 5/10/24, has been experiencing constant headaches since. spoke with pt on 5/28/24, said headaches were intense for first 3 days,  have waned in intensity, but continues to experience persistent headaches (average score 5 on pain scale 1-10). pt has been self medicating with acetaminophen 1500mg typically once daily, sometimes up to twice daily if needed. pt has not sought medical advice, but I advised to notify pcp as soon as possible. I contacted his prescriber and gave aforementioned information to the nurse, who also encouraged pt to establish an appointment for further assessment.
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash, Urticaria
Clinical narrative: LLT CODES: 10037844:RASH, 10046735:URTICARIA | Narrative: | Narrative2: | OtherRelevantHx: | OtherRelevantHx2: | OtherText: URTICARIA on stomach | OtherOutcomeText: | RelevantTestsLabs: | RelevantTestsLabs2:
Age: 11.0
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: Syncope
Clinical narrative: Syncopal episode after Gardasil vaccination
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: My wife and I both had the first dose of the Shingles vaccine Shinrex. We both experienced symptoms within 8 hrs after receiving the intramuscular injections. Fatigue, headache, muscle pain at the injection site, joint aches, overall body aches. Sleeping was poor the first night because moving in bed was painful and the pain would wake us up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Poor quality sleep, Sleep disorder
Clinical narrative: My wife and I both had the first dose of the Shingles vaccine Shinrex. We both experienced symptoms within 8 hrs after receiving the intramuscular injections. Fatigue, headache, muscle pain at the injection site, joint aches, overall body aches. Sleeping was poor the first night because moving in bed was painful and the pain would wake us up.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Cough, Dysphagia, Dysphonia, Intensive care
Clinical narrative: LLT CODES: 10002424:ANGIOEDEMA, 10011232:COUGHING, 10020200:HOARSE VOICE, 10024570:LIP SWELLING, 10042645:SWALLOWING DIFFICULT, 10043984:TONGUE SWELLING NON-SPECIFIC | Narrative: presented to the ED on 2/16/2024 with acute onset facial swelling. He noticed swelling to the left side of his face, which was not painful and did not affect his breathing. He was discharged from the emergency department and his family drove him home ~1:30pm. He noticed worsening swelling since returning home and called his family to bring him back to the ED around 6pm. His family reports that his entire face was swollen, including his lips and tongue.  He has a crab allergy and many years ago reacted to crab but he had generalized swelling not localized like this. He states this feels different to him. He did receive his sixth booster COVID vaccination 2 days ago with the Pfizer COVID-vaccine. He takes lisinopril but states that his dose was recently lowered to 5 mg twice a day from 10 as his blood pressure had been improved.  In the ED, he received solumedrol x2, benadryl, famotidine, epinephrine, and icatibant with some clinical improvement. He was admitted to MICU for further management. | Narrative2: | OtherRelevantHx : | OtherRelevantHx2: | OtherText: lip and tongue swelling, difficulty swallowing, hoarse voice | OtherOutcomeText: | RelevantTestsLabs: | RelevantTestsLabs2:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face, Swollen tongue
Clinical narrative: LLT CODES: 10002424:ANGIOEDEMA, 10011232:COUGHING, 10020200:HOARSE VOICE, 10024570:LIP SWELLING, 10042645:SWALLOWING DIFFICULT, 10043984:TONGUE SWELLING NON-SPECIFIC | Narrative: presented to the ED on 2/16/2024 with acute onset facial swelling. He noticed swelling to the left side of his face, which was not painful and did not affect his breathing. He was discharged from the emergency department and his family drove him home ~1:30pm. He noticed worsening swelling since returning home and called his family to bring him back to the ED around 6pm. His family reports that his entire face was swollen, including his lips and tongue.  He has a crab allergy and many years ago reacted to crab but he had generalized swelling not localized like this. He states this feels different to him. He did receive his sixth booster COVID vaccination 2 days ago with the Pfizer COVID-vaccine. He takes lisinopril but states that his dose was recently lowered to 5 mg twice a day from 10 as his blood pressure had been improved.  In the ED, he received solumedrol x2, benadryl, famotidine, epinephrine, and icatibant with some clinical improvement. He was admitted to MICU for further management. | Narrative2: | OtherRelevantHx : | OtherRelevantHx2: | OtherText: lip and tongue swelling, difficulty swallowing, hoarse voice | OtherOutcomeText: | RelevantTestsLabs: | RelevantTestsLabs2:
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: None reported
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: None reported
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: none reported
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: none reported
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: Other; This spontaneous report has been downloaded from a Surveillance System (SS), referring to an adult female patient of an unspecified age (age group reported as 55-59). No information regarding the patient's medical history, concurrent conditions, and concomitant medications was provided.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported).  On an unknown date in 2016, the patient experienced pneumococcal infection. On an unknown date in 2016, Streptococcus pneumoniae serotyping was performed (results not available). The outcome of the event was not reported.  The causal relationship between the event and suspected vaccine was not reported.  Upon internal review, the event of pneumococcal infection was determined to be medically significant.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Musculoskeletal stiffness, Seizure
Clinical narrative: Prior to administration of vaccines, pt was a little nervous. pt denied any feelings of dizziness or feeling like he was going to pass out.  Pt was administered MCV4 vaccine (menveo) in the R Deltoid and then administered Tdap (Boostrix) in the L Deltoid. Almost immediately following administration of Tdap pt stated that he felt like he was going to pass out.  Due to previous nervous feelings, LPN with the help of mom attempted to adjust patient from a sitting position to a supine position with his knees elevated for potential vasovagal syncopal reaction. At this time pt stiffened up and started to convulse. convulsions lasted 15-30 seconds. Pt was immediately arousable with no recollection of event.  MD consulted. vitals taken after event as follows: 100% O2 sat, 55bpm which increased to 82 bpm after a minute, BP sitting: 112/66, BG:143. Pt was referred to local ER d/t reaction at this time.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: high fever, rapid heart rate
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Provider ordered Prevnar23. Medical assistant administered Prevnar 20. Patient previously administered Prevnar 20 in 8/2022. No adverse reactions.
Age: 1.0
Sex: F
Vaccine: HEPA, HPV9, MMR, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reactions noted at time of vaccination or next day. Pt was given HPV instead of Prevnar.
Age: 1.75
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: none
Age: 46.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: gave full vial of vaccine which contained 3 doses. no adverse reaction
Age: 42.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Blister, Feeling hot, Injection site discomfort, Injection site erythema, Injection site pain
Clinical narrative: female presents to the clinic on Day 6 of post vaccine dermal reaction following Jynneos vaccine.  She reports that her reaction worsened after she was seen in clinic the following day (Thursday 5/23) to include a spreading regional erythema which encompassed the entire back of her upper arm, tactile warmth, site discomfort, and subjective perception of a mild core temperature elevation.  The SX persisted through post vaccine day 3, at which point the erythema began to abate, and the pain transformed into a mild pruritus, with the taut bullae remaining.  She presents 5/28 with bullae still present with only mild pruritus, but with decreased turgor.
Age: 42.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: female presents to the clinic on Day 6 of post vaccine dermal reaction following Jynneos vaccine.  She reports that her reaction worsened after she was seen in clinic the following day (Thursday 5/23) to include a spreading regional erythema which encompassed the entire back of her upper arm, tactile warmth, site discomfort, and subjective perception of a mild core temperature elevation.  The SX persisted through post vaccine day 3, at which point the erythema began to abate, and the pain transformed into a mild pruritus, with the taut bullae remaining.  She presents 5/28 with bullae still present with only mild pruritus, but with decreased turgor.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling of left arm.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Rash, Respiratory viral panel, Viral test negative, Vomiting
Clinical narrative: Received vaccines at 9:30 am on 5/22/24. Mom fed him eggs for the first time around 11 am. He woke from nap with a rash. They went to urgent care, where they recommended the ER. He had the rash and vomiting. Epi Pen and benadryl were administered at urgent care.  He was admitted for further evaluation and treatment. He was discharged with pepcid and orapred.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Fatigue, Rash, Throat tightness
Clinical narrative: Severe rash over upper torso, face and back of neck. Had some tightness in chest and throat. Fatigued and run down for a few days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Extra dose administered
Clinical narrative: Patient did not exhibit  any adverse s/s from vaccination.  Adverse event reported is due to receiving an extra dose of Hep A. Father of patient provided shot card to have recent vaccination transcribed and upon review of shot card, patient received 2nd dose of Hep A on 12 Jul 2023. Vaccination was not transcribed in system like patient's other vaccinations and additional records were not brought to clinic for transcription, and technician was not notified of additional record until after vaccination was administered. When Father of patient was told the vaccinations that would be administered today, parent had no onjections.
Age: 9.0
Sex: M
Vaccine: HPV9, MMR, TDAP, VARCEL
Symptoms: Product storage error
Clinical narrative: On January 9, 2024 the vaccines in the clinic were moved to Health Department due to a power outage. The power came back on around 9:30a.m. when I arrived to work but I was advised by my supervisor to move the vaccine still in case it took a while for the refrigerator to return to the proper temperature. Vaccines were packed with ice packs and bubble wrap and transported by CRNP. The vaccine was transported back to Health Department that afternoon. A temperature excursion was noted on the digital data logger. Once returned to clinic the data logger was found to be beside the ice packs instead of by the vaccine. The vaccine manufacturers of the affected vaccine were notified and made aware of the temperature excursion. I notified the companies that the vaccine reached a temperature of 1.8 degrees Celsius. The max temperature that the vaccine reached during transport was 12.0 degrees Celsius. Per the vaccine companies, the only vaccine that was not recommended to use was the opened vial of IPOL and the opened MDV of Fluzone. They were discarded per the vaccine companies? recommendations.  Moving forward to April 10, 2024. The vaccine was transported again to Health Department due to inclement weather that day. Vaccine was transported by my supervisor and returned on April 12, 2024. Another temperature excursion occurred when the vaccine was transported back to the clinic. The vaccine companies were again contacted for recommendations on viability of the vaccine. When contacting the vaccine companies, I was asked if any of the vaccines had undergone a previous temperature excursion. It was then when I pulled my documentation from the previous excursion that I realized I had read the temperature log incorrectly and that the vaccine had reached a temperature of negative 1.8 degrees Celsius instead of what I reported to the vaccine companies of a +1.8 Degrees Celsius. Therefore, in fact there were two 2 temp excursions one on January 9, 2024 and the other on April 12th, 2024.  A list of all patients that received vaccines between January 9-April 12th was compiled. The list was sorted through as to what patients received the affected vaccine. Patients were notified of questionable viability of vaccines and were offered and recommended to be revaccinated if desired. Notes were added into system for outside providers.  The process of packing vaccine during transport during emergencies had been reviewed by all staff to include packaging with conditioned water bottles instead of frozen ice packs. HPV9 and Tdap given on 01/23/2024 underwent a temperature excursion; therefore, needs repeating. Phonecall and letter to patient on 05/09/2024. As of 05/29/2024 no response from patient. Chart is flagged to counsel and repeat upon return to clinic. Patient has an appointment that is scheduled for July 23, 2024 which was previously scheduled.
Age: 4.0
Sex: M
Vaccine: UNK, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reactions, wrong vaccine administered. Was supposed to administered Quadracel, instead administered Pentacel. Provider notified and internal reporting completed.
Age: 8.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: On January 9, 2024 the vaccines in the clinic were moved to Health Department due to a power outage. The power came back on around 9:30a.m. when I arrived to work but I was advised by my supervisor to move the vaccine still in case it took a while for the refrigerator to return to the proper temperature. Vaccines were packed with ice packs and bubble wrap and transported by CRNP. The vaccine was transported back to Health Department that afternoon. A temperature excursion was noted on the digital data logger. Once returned to clinic the data logger was found to be beside the ice packs instead of by the vaccine. The vaccine manufacturers of the affected vaccine were notified and made aware of the temperature excursion. I notified the companies that the vaccine reached a temperature of 1.8 degrees Celsius. The max temperature that the vaccine reached during transport was 12.0 degrees Celsius. Per the vaccine companies, the only vaccine that was not recommended to use was the opened vial of IPOL and the opened MDV of Fluzone. They were discarded per the vaccine companies? recommendations.  Moving forward to April 10, 2024. The vaccine was transported again to Health Department due to inclement weather that day. Vaccine was transported by my supervisor and returned on April 12, 2024. Another temperature excursion occurred when the vaccine was transported back to the clinic. The vaccine companies were again contacted for recommendations on viability of the vaccine. When contacting the vaccine companies, I was asked if any of the vaccines had undergone a previous temperature excursion. It was then when I pulled my documentation from the previous excursion that I realized I had read the temperature log incorrectly and that the vaccine had reached a temperature of negative 1.8 degrees Celsius instead of what I reported to the vaccine companies of a +1.8 Degrees Celsius. Therefore, in fact there were two 2 temp excursions one on January 9, 2024 and the other on April 12th, 2024.  A list of all patients that received vaccines between January 9-April 12th was compiled. The list was sorted through as to what patients received the affected vaccine. Patients were notified of questionable viability of vaccines and were offered and recommended to be revaccinated if desired. Notes were added into system for outside providers.  The process of packing vaccine during transport during emergencies had been reviewed by all staff to include packaging with conditioned water bottles instead of frozen ice packs. 04/30/2024-Letter was mailed. No response back. Chart is flagged needs repeat Tdap. Upon return to clinic will counsel.
Age: 73.0
Sex: M
Vaccine: PNC20
Symptoms: Asthenia, Loss of personal independence in daily activities, Mobility decreased, Muscle disorder
Clinical narrative: Patient's wife called on 5/29/24 and said that her husband has been having problems with his muscles for the past couple of days and was not able to get out of bed by himself or go to the bathroom by himself and that he is very weak. She said he is very adamant that the issues will resolve on their own, but I advised following up with a doctor as soon as possible. I educated her about the very rare possibility of Guillain-Barre Syndrome. At this time, patient has not informed us that they have followed up with any providers yet. The wife just called us this morning, so I am documenting everything I know up until now.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: On January 9, 2024 the vaccines in the clinic were moved to Health Department due to a power outage. The power came back on around 9:30a.m. when I arrived to work but I was advised by my supervisor to move the vaccine still in case it took a while for the refrigerator to return to the proper temperature. Vaccines were packed with ice packs and bubble wrap and transported by CRNP. The vaccine was transported back to Health Department that afternoon. A temperature excursion was noted on the digital data logger. Once returned to clinic the data logger was found to be beside the ice packs instead of by the vaccine. The vaccine manufacturers of the affected vaccine were notified and made aware of the temperature excursion. I notified the companies that the vaccine reached a temperature of 1.8 degrees Celsius. The max temperature that the vaccine reached during transport was 12.0 degrees Celsius. Per the vaccine companies, the only vaccine that was not recommended to use was the opened vial of IPOL and the opened MDV of Fluzone. They were discarded per the vaccine companies? recommendations.  Moving forward to April 10, 2024. The vaccine was transported again to Health Department due to inclement weather that day. Vaccine was transported by my supervisor and returned on April 12, 2024. Another temperature excursion occurred when the vaccine was transported back to the clinic. The vaccine companies were again contacted for recommendations on viability of the vaccine. When contacting the vaccine companies, I was asked if any of the vaccines had undergone a previous temperature excursion. It was then when I pulled my documentation from the previous excursion that I realized I had read the temperature log incorrectly and that the vaccine had reached a temperature of negative 1.8 degrees Celsius instead of what I reported to the vaccine companies of a +1.8 Degrees Celsius. Therefore, in fact there were two 2 temp excursions one on January 9, 2024 and the other on April 12th, 2024.  A list of all patients that received vaccines between January 9-April 12th was compiled. The list was sorted through as to what patients received the affected vaccine. Patients were notified of questionable viability of vaccines and were offered and recommended to be revaccinated if desired. Notes were added into system for outside providers.  The process of packing vaccine during transport during emergencies had been reviewed by all staff to include packaging with conditioned water bottles instead of frozen ice packs. Kinrix given underwent a temperature excursion ;therefore, recommended dose be repeated. Attempted phoncall and no answer. Letter mailed 04/30/2024. Chart remains flagged needs repeat DTAP-IPV
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Approx 5 hrs after vaccine, severe nausea and vomiting followed by fever 101 degrees, extreme fatigue since then, as well as vomiting again starting 4 days post-vaccination.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Deafness neurosensory, Otoscopy normal, Sudden hearing loss, Treatment failure
Clinical narrative: Sudden sensorineural hearing loss, 1. Audiology results indicated an asymmetrical minimal to moderate sensorineural hearing loss above 3000 Hz in the right ear and severe rising to moderate sensorineural hearing loss in the left ear.  Speech responses were in agreement with other results obtained with excellent (100%) word recognition scores in the right ear and poor 0% in the left ear. 2. Otoscopy revealed ear canals clear of cerumen bilaterally. 3. Tympanometry revealed: Normal ear drum mobility bilaterally
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tympanometry normal
Clinical narrative: Sudden sensorineural hearing loss, 1. Audiology results indicated an asymmetrical minimal to moderate sensorineural hearing loss above 3000 Hz in the right ear and severe rising to moderate sensorineural hearing loss in the left ear.  Speech responses were in agreement with other results obtained with excellent (100%) word recognition scores in the right ear and poor 0% in the left ear. 2. Otoscopy revealed ear canals clear of cerumen bilaterally. 3. Tympanometry revealed: Normal ear drum mobility bilaterally
Age: 71.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Fall, Loss of personal independence in daily activities, Paralysis
Clinical narrative: complete paralysis accept his fingers.  Was not able to move any other part of body.  Pt fell over could not get up.  Called EMS.  symptoms lasted for 2 days
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: With in the month after my Third COVID Moderna injection (Booster Shot), I started to notice more and more a ringing in my left ear.  So much so that i went to see an Ear Specialist to have a hearing test done and discuss with them.  This was before I was aware that the COVID vaccinations have caused ringing in ears as a symptom.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Product storage error
Clinical narrative: On January 9, 2024 the vaccines in the clinic were moved to Health Department due to a power outage. The power came back on around 9:30a.m. when I arrived to work but I was advised by my supervisor to move the vaccine still in case it took a while for the refrigerator to return to the proper temperature. Vaccines were packed with ice packs and bubble wrap and transported by CRNP. The vaccine was transported back to Health Department that afternoon. A temperature excursion was noted on the digital data logger. Once returned to clinic the data logger was found to be beside the ice packs instead of by the vaccine. The vaccine manufacturers of the affected vaccine were notified and made aware of the temperature excursion. I notified the companies that the vaccine reached a temperature of 1.8 degrees Celsius. The max temperature that the vaccine reached during transport was 12.0 degrees Celsius. Per the vaccine companies, the only vaccine that was not recommended to use was the opened vial of IPOL and the opened MDV of Fluzone. They were discarded per the vaccine companies? recommendations.  Moving forward to April 10, 2024. The vaccine was transported again to Health Department due to inclement weather that day. Vaccine was transported by my supervisor and returned on April 12, 2024. Another temperature excursion occurred when the vaccine was transported back to the clinic. The vaccine companies were again contacted for recommendations on viability of the vaccine. When contacting the vaccine companies, I was asked if any of the vaccines had undergone a previous temperature excursion. It was then when I pulled my documentation from the previous excursion that I realized I had read the temperature log incorrectly and that the vaccine had reached a temperature of negative 1.8 degrees Celsius instead of what I reported to the vaccine companies of a +1.8 Degrees Celsius. Therefore, in fact there were two 2 temp excursions one on January 9, 2024 and the other on April 12th, 2024.  A list of all patients that received vaccines between January 9-April 12th was compiled. The list was sorted through as to what patients received the affected vaccine. Patients were notified of questionable viability of vaccines and were offered and recommended to be revaccinated if desired. Notes were added into system for outside providers.  The process of packing vaccine during transport during emergencies had been reviewed by all staff to include packaging with conditioned water bottles instead of frozen ice packs. Menquadfi and Bexsero need to be repeated due to vaccines underwent a temperature excursion. 05/03/2024-Phonecall to patient with no answer. Letter mailed 05/03/2024. No response back from patient. Chart is flagged to counsel upon return to clinic.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Injection site reaction, Injection site urticaria, Rash erythematous, Rash pruritic
Clinical narrative: Hives Pt developed red itchy bumps around vaccine site immediately afterward then later that night developed hives on both arms and upper chest
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Hives Pt developed red itchy bumps around vaccine site immediately afterward then later that night developed hives on both arms and upper chest
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Woke up with severe chills, no fever.  Injection site red , warm to touch with swelling and itching extending to the elbow that lasted 5 days.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: After getting the second dose of the shingles vaccine, I developed fever and strong chills about 15 hours after the vaccination. Still have fever, mild headache, and body aches 24 hours after.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reactions were reported. This is being filled out because the vaccine was expired (expiration was 2/25/2024) when given.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: VACCINE WAS GIVEN TWO DAYS EARLY FROM 28 DAY WINDOW FROM LAST LIVE VACCINE.  MMR WAS GIVEN ON 5/3/2024.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Insomnia, Myalgia
Clinical narrative: Muscle Pain, fatigue, feel cold--nit shivering, but have space heater directly on me and coat, insomnia, unsure about fever
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Product storage error
Clinical narrative: On January 9, 2024 the vaccines in the clinic were moved to County Health Department due to a power outage. The power came back on around 9:30a.m. when I arrived to work but I was advised by my supervisor to move the vaccine still in case it took a while for the refrigerator to return to the proper temperature. Vaccines were packed with ice packs and bubble wrap and transported by, CRNP. The vaccine was transported back to County Health Department that afternoon. A temperature excursion was noted on the digital data logger. Once returned to clinic the data logger was found to be beside the ice packs instead of by the vaccine. The vaccine manufacturers of the affected vaccine were notified and made aware of the temperature excursion. I notified the companies that the vaccine reached a temperature of 1.8 degrees Celsius. The max temperature that the vaccine reached during transport was 12.0 degrees Celsius. Per the vaccine companies, the only vaccine that was not recommended to use was the opened vial of IPOL and the opened MDV of Fluzone. They were discarded per the vaccine companies recommendations.  Moving forward to April 10, 2024. The vaccine was transported again to County Health Department due to inclement weather that day. Vaccine was transported by my supervisor and returned on April 12, 2024. Another temperature excursion occurred when the vaccine was transported back to the clinic. The vaccine companies were again contacted for recommendations on viability of the vaccine. When contacting the vaccine companies, I was asked if any of the vaccines had undergone a previous temperature excursion. It was then when I pulled my documentation from the previous excursion that I realized I had read the temperature log incorrectly and that the vaccine had reached a temperature of negative 1.8 degrees Celsius instead of what I reported to the vaccine companies of a +1.8 Degrees Celsius. Therefore, in fact there were two 2 temp excursions one on January 9, 2024 and the other on April 12th, 2024.  A list of all patients that received vaccines between January 9-April 12th was compiled. The list was sorted through as to what patients received the affected vaccine. Patients were notified of questionable viability of vaccines and were offered and recommended to be revaccinated if desired. Notes were added into immprint for outside providers.  The process of packing vaccine during transport during emergencies had been reviewed by all staff to include packaging with conditioned water bottles instead of frozen ice packs. 04/30/2024-Mother was contacted by phone. Notified of need to have vaccines repeated due to vaccines going through a temperature excursion. She reported she would call back and schedule and appointment 05/29/2024-No appointment has been made. Chart is flagged that child needs vaccines given DTAP-IPV-HIB,Hep B,and PCV13 repeated.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: On January 9, 2024 the vaccines in the clinic were moved to Health Department due to a power outage. The power came back on around 9:30a.m. when I arrived to work but I was advised by my supervisor to move the vaccine still in case it took a while for the refrigerator to return to the proper temperature. Vaccines were packed with ice packs and bubble wrap and transported by CRNP. The vaccine was transported back to Health Department that afternoon. A temperature excursion was noted on the digital data logger. Once returned to clinic the data logger was found to be beside the ice packs instead of by the vaccine. The vaccine manufacturers of the affected vaccine were notified and made aware of the temperature excursion. I notified the companies that the vaccine reached a temperature of 1.8 degrees Celsius. The max temperature that the vaccine reached during transport was 12.0 degrees Celsius. Per the vaccine companies, the only vaccine that was not recommended to use was the opened vial of IPOL and the opened MDV of Fluzone. They were discarded per the vaccine companies? recommendations.  Moving forward to April 10, 2024. The vaccine was transported again to Health Department due to inclement weather that day. Vaccine was transported by my supervisor and returned on April 12, 2024. Another temperature excursion occurred when the vaccine was transported back to the clinic. The vaccine companies were again contacted for recommendations on viability of the vaccine. When contacting the vaccine companies, I was asked if any of the vaccines had undergone a previous temperature excursion. It was then when I pulled my documentation from the previous excursion that I realized I had read the temperature log incorrectly and that the vaccine had reached a temperature of negative 1.8 degrees Celsius instead of what I reported to the vaccine companies of a +1.8 Degrees Celsius. Therefore, in fact there were two 2 temp excursions one on January 9, 2024 and the other on April 12th, 2024.  A list of all patients that received vaccines between January 9-April 12th was compiled. The list was sorted through as to what patients received the affected vaccine. Patients were notified of questionable viability of vaccines and were offered and recommended to be revaccinated if desired. Notes were added into system for outside providers.  The process of packing vaccine during transport during emergencies had been reviewed by all staff to include packaging with conditioned water bottles instead of frozen ice packs. 04/30/2024-Mom was contacted by phone. Scheduled appointment to have child revaccinated for May 7th. Appointment was rescheduled to May 21. Patient no showed on May 21 2024. Chart remains flagged that child needs vaccines repeated.
Age: 11.0
Sex: F
Vaccine: COVID19, FLU4, HPV9, MNQ, TDAP
Symptoms: Dizziness, Hypotonia, Vision blurred
Clinical narrative: Patient slumped into chair in lobby and slid to floor. Patient reports dizziness and blurred vision after receiving multiple vaccinations. Medical provider called to lobby to assist. Patient was placed in trendelenburg, laying on floor with legs up on chair and symptoms quickly improved. BP 110/70, HR 78bpm, O2 98%. Patient was returned to a clinic room with parent and situation and recommendations reviewed with parent. Encouraged to hydrate well with water, have future blood draws supine, and sit for at least 15 minutes after future vaccinations.