chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion: negative disposition with human error max/low temperature reached: 8.5 °c to 8.8, duration: 30 minutes with no reported adverse event; Fluzone was administered to patient post excursion with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid non-serious case received from a Nurse.  This case is linked to cases- US-SA-2025SA113850, US-SA-2025SA113376, US-SA-2025SA113846, US-SA-2025SA113257, US-SA-2025SA113835, US-SA-2025SA113170, US-SA-2025SA113172, US-SA-2025SA112035, US-SA-2025SA113179, US-SA-2025SA113850.  This case involves a 36 years old female patient who was exposed to temperature excursion: negative disposition with human error max/low temperature reached: 8.5 °c to 8.8, duration: 30 minutes with no reported adverse event and influenza usp trival a-b subvirion vaccine [Fluzone] was administered to patient post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Apr-2025, the patient received 0.5 ml dose of suspect influenza usp trival a-b subvirion vaccine Suspension for injection lstrength- standard) (lot U8442BA and expiry date- 20-JUN-2025)  via intramuscular route in the right deltoid for Influenza (Influenza immunization) and temperature excursion: negative disposition with human error max/low temperature reached: 8.5 °c to 8.8, duration: 30 minutes with no reported adverse event (product storage error) and fluzone was administered to patient post excursion with no reported adverse event (poor quality product administered) (latency- same day).  Treatment: None given. No adverse events were reported  Action taken- not applicable.  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.; Sender's Comments:  US-SA-2025SA114290: US-SA-2025SA113179: US-SA-2025SA113850: US-SA-2025SA113376: US-SA-2025SA113846: US-SA-2025SA113257: US-SA-2025SA113835: US-SA-2025SA113170: US-SA-2025SA113172: US-SA-2025SA112035: US-SA-2025SA113257:
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered act-hib to a 15-month-old patient and it was already expired on 31mar2025 with no reported adverse event; Initial information received on 17-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old female patient for whom HIB (PRP/T) vaccine [ACT-HIB], administered already expired on 31-Mar-2025 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 a vaccine and pneumococcal vaccine both for Immunisation.  On 17-Apr-2025, the patient received an unknown dose of (0.5ml) of suspect HIB (PRP/T) vaccine; Powder and solvent for solution for injection (lot UK025AA with expiry date 31-MAR-2025) via intramuscular route in the thigh NOS (Not Otherwise Specified) for Immunization, administered already expired on 31-Mar-2025 with no reported adverse event (expired product administered).  Action taken was not applicable.  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.
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: inappropriate use due to administration of expired vaccine with no reported adverse event; Initial information received on 18-Apr-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and gender patient to whom received administration of expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On ana unknown date In 2025, the patient received a expired unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength: unknown, expired date: 31-Mar-2025 and lot UK025AA via unknown route in unknown administration site as immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.   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.
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired ACT-HIB vaccine was administered to a patient with no reported adverse event; Initial information received on 18-Apr-2025 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and unknown gender patient to whom expired HIB (PRP/T) Vaccine [ACT-HIB] was administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in 2025, the patient received unknown expired dose of suspect HIB (PRP/T) VACCINE (lot- UK010AA and expiry date- 28-Feb-2025) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (latency- same day).  Action taken- not applicable.  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: 50.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Erythema, Injection site pain, Pyrexia, Skin warm, Swelling
Clinical narrative: PATIENT STATED SHE STILL HAD FEVER, SWELLING, REDNESS, AND ARM HOT TO TOUCH POST 72 HOURS VACCINATION. PATIENT WAS ADVISED TO CONTINUE OTC TYLENOL, IBUPROFEN AND ALSO ADVISED TO ADD COLD COMPRESS AND START OTC ANTIHISTAMINE LIKE BENADRYL OR CLARITIN. PATIENT WAS FOLLOWING UP WITH PCP TODAY SINCE THE PAIN AT THE INJECTION SITE WAS NOT GOING AWAY AND THE REDNESS AND SWELLING WAS NOT EITHER AND BECAUSE ARM WAS STILL HOT TO THE TOUCH.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rosacea
Clinical narrative: Roseacea on cheeks burning sensation (like sunburn but I am wearing sunblock). Slight temperatures 98.9.  No other illness symptoms
Age: 69.0
Sex: F
Vaccine: PNC21
Symptoms: Inflammation, Pruritus
Clinical narrative: after 5 days of getting vaccine, she had inflammation of they arm and itching, lasting over 2 weeks
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: PATIENT RECIEVED 3 DOSES OF SHINGRIX VACCINE ON 09/14/2023,11/27/2023 AND 02/07/2025
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received 3 doses of Shingrix vaccines 09/14/2023,11/27/2023 and 02/074/2025
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Rash, Swelling, Type III immune complex mediated reaction, Urticaria
Clinical narrative: Arthus Reaction including Fever. Treatment in Urgent Care with OTC medication for Fever. Decadron injection for rash/hives/swelling with the following recommendations: You were seen today for a probable reaction to the Tdap vaccine you received last week.   You were given a steroid injection in the clinic and prescribed an oral steroid to take daily. Take the medication exactly as directed and be sure to finish the full course, even if your symptoms start to improve. You should also take Benadryl around the clock for the next two days. After that, you may take over-the-counter Benadryl as needed.    To help your skin heal, place cool, wet cloths on the affected areas. Avoid scratching, as this can worsen the irritation or cause an infection. Try not to rub or put pressure on the rash. Stay away from soaps, perfumes, dyes, or any products with added fragrances, as these can further irritate the skin. Use lukewarm water when bathing, as hot water can dry out your skin and make the rash worse.   We will report this reaction to the Vaccine Adverse Event Reporting System (VAERS) on your behalf.   Keep your scheduled appointment with your primary care provider tomorrow. You should also follow up again after you complete the steroid treatment to make sure all of your symptoms have resolved.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered
Age: 0.83
Sex: M
Vaccine: MMRV
Symptoms: Injection site pain, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: This child was given the MMRV at 10 months instead of waiting until a year. There were no adverse reactions. Had normal reaction of low grade fever and soreness at the injection site. No other s/s per parent. Merck Co to be contacted 4/22/2025.
Age: 62.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Pruritus, Rash, Swelling of eyelid
Clinical narrative: 3 days after receiving vaccine, patient developed a rash on her forehead.   The rash progressively got bigger and dry.  Her left eye swollen shut.  Daughter reported the reaction and stated that the patient has not reported to the doctor and is trying to wait it out.  Patient had been taking Benadryl 4-5 days ago and applied OTC Hydrocortisone on the rash for the itchiness.
Age: 1.25
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given the wrong vaccine. Was not supposed to get MMR + Varcella again until 2027 but was administered at 15 month check up, 3 months after his first dose. Appointment was at 9AM, vaccine administered around 10AM. Around 5 PM, Patient developed a red, raised rash on the tops of both feet. It spread up his entire right leg and all over his buttocks.
Age: 1.25
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Inappropriate schedule of product administration, Injection site reaction, Rash, Rash erythematous, Rash papular
Clinical narrative: Patient was given the wrong vaccine. Was not supposed to get MMR + Varcella again until 2027 but was administered at 15 month check up, 3 months after his first dose. Appointment was at 9AM, vaccine administered around 10AM. Around 5 PM, Patient developed a red, raised rash on the tops of both feet. It spread up his entire right leg and all over his buttocks.
Age: 1.25
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Wrong product administered
Clinical narrative: Patient was given the wrong vaccine. Was not supposed to get MMR + Varcella again until 2027 but was administered at 15 month check up, 3 months after his first dose. Appointment was at 9AM, vaccine administered around 10AM. Around 5 PM, Patient developed a red, raised rash on the tops of both feet. It spread up his entire right leg and all over his buttocks.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive 2nd dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 01-OCT-2024).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not receive 2nd dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 15-APR-2025 This case was reported by a patient via (Shingrix Chatbot) interactive digital media. The patient received his/her first Shingrix injection and wanted to know was it too late to receive his/her second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: only the liquid component was given to the patient with no adverse event; Initial information received on 17-Apr-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who was administered with only the liquid component of  Diphtheria/Tetanus/5 hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine CONJ 7V (CRM197) (PREVNAR) for Immunisation; and Rotavirus vaccine for Immunisation.  On 17-Apr-2025, the patient received an unknown dose only the liquid component of suspect Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine strength-0.5ml (formulation, expiry date-unknown) (lot UK225AB) via intramuscular route in the left thigh for Immunization with no adverse event (single component of a two-component product administered) (latency-same day).  Reportedly- The lyophilized component was not reconstituted with the liquid component and only the liquid component was given to the patient. They wanted to know if they can give the Hib component by itself or if they need to repeat the PENTACEL.  Action taken was not applicable.   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: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: injected the diluent, instead of reconstitute it; injected the diluent, instead of reconstitute it; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis.   On 09-APR-2025, the patient received Priorix. On 09-APR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: injected the diluent, instead of reconstitute it) and inappropriate dose of vaccine administered (Verbatim: injected the diluent, instead of reconstitute it). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   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: 15-APR-2025 and 17-APR-2025 On 15th April 2025, Pharmacist called and reported that he/she was using the Priorix, the MMR vaccine, and realized that he/she had just injected the diluent instead of reconstituting it, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: adminsitered post excursion with no adverse event; temperature excursion of fluzone Max/low temperature reached: 8.5 °C to 8.8 °C Duration: 30minutes with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to cases- US-SA-2025SA113850, US-SA-2025SA113376, US-SA-2025SA113846, US-SA-2025SA113257, US-SA-2025SA113179, US-SA-2025SA113835, US-SA-2025SA113170, US-SA-2025SA113172, US-SA-2025SA114282, US-SA-2025SA112035  This case involves a 25 years old male patient who was administered INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE]  post excursion with no adverse event and temperature excursion of fluzone max/low temperature reached: 8.5 °c to 8.8 °c duration: 30minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-APR-2025 temperature excursion of fluzone max/low temperature reached: 8.5 °c to 8.8 °c duration: 30minutes with no reported adverse event (product storage error) (unknown latency).  On 10-Apr-2025, the patient received INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE Suspension for injection (strength standard) dose 0.5 ml1x(once) lot U8442BA expiry date-20-Jun-2025 via intramuscular route in the left deltoid for influenza adminsitered post excursion with no adverse event (poor quality product administered) (latency same day).  Cause of excursion-Human error (Reason: Monthly cycle count, inventory checking)  Action taken: not applicable.   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.; Sender's Comments:  US-SA-2025SA112035: US-SA-2025SA114282: US-SA-2025SA113172: US-SA-2025SA113170: US-SA-2025SA113835: US-SA-2025SA113179: US-SA-2025SA113257: US-SA-2025SA113846: US-SA-2025SA113376: US-SA-2025SA113850:
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: giving the Pentacel and gave the diluent only and not the actual vaccine with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old female patient who was receiving  Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] but received the diluent only and not the actual vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was receiving Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection, (unknown strength) lot UK199AA and expiry date 30-Apr-2026, via unknown route in unknown administration site for prophylactic vaccination (immunisation), but received the diluent only and not the actual vaccine with no reported adverse event (single component of a two-component product administered) (latency same day)   Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: F
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 2 year old receiving IPOL which was due again at age 4 years with no reported adverse event; Initial information received on 17-Apr-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old female patient who recieved IPV (VERO) [IPOL] which was due again at age 4 years 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 Measles vaccine, Mumps vaccine, Rubella vaccine and Varicella zoster vaccine for Immunisation.  On an unknown date, the patient received an unknown dose of suspect IPV (VERO), Suspension for injection (unknown strength, expiry date and lot number not reported,) via unknown route in unknown administration site for immunization  On 17-Apr-2025, the patient received 0.5  dose of suspect IPV (VERO), Suspension for injection, lot X1C891M, Strength = standard, Frequency = once, expiry date:31-Oct-2026, via intramuscular route in the left thigh for immunization which was due again at age 4 years with no reported adverse event (extra dose administered) (latency: same day).   Action taken was not applicable.  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.; Sender's Comments:  US-SA-2025SA113400:IPOL
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, PNC15
Symptoms: Pyrexia, Seizure like phenomena
Clinical narrative: Pt came to clinic on 4/16 to get caught up on vaccines. He received HIB, DTAP, & PCV. He started running fever around 2320 that same evening followed by seizure like activity for 3-5 min. He was brought to ER where he was cleared.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema
Clinical narrative: Rt arm 5cm red area Lt arm 2-5 cm red area.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Brain fog, Dizziness, Fatigue, Syncope
Clinical narrative: I received the vaccine and fainted on the spot and still continue to have fainting spells, fatigue dizziness and brain fog.
Age: 0.08
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Extra dose administered
Clinical narrative: patient received Vaxelis twice due to vaccine not being documented the first time
Age: 0.08
Sex: M
Vaccine: RV1
Symptoms: Abdominal pain upper, Infant irritability, Vomiting
Clinical narrative: Vomiting, stomach pain and irritability
Age: 48.0
Sex: F
Vaccine: PNC21
Symptoms: Dizziness, Dyspnoea, Headache, Hot flush, Injection site cellulitis
Clinical narrative: Cellulitis of the left upper extremity surrounding the injection site.  Reports headaches, dizziness, lightheadedness, blurred vision, shortness of breath and a feeling of getting flushed. Reports symptoms began Saturday 4/12/25 in the morning with a severe headache (7-8/10) on pain scale. Prescribed doxycycline 100 mg BID for 10 days for cellulitis. Continue with Tylenol PRN for headaches. Advised patient to go to the ED if headaches worsen or become more frequent, or if symptoms worsen or fail to improve.
Age: 48.0
Sex: F
Vaccine: PNC21
Symptoms: Vision blurred
Clinical narrative: Cellulitis of the left upper extremity surrounding the injection site.  Reports headaches, dizziness, lightheadedness, blurred vision, shortness of breath and a feeling of getting flushed. Reports symptoms began Saturday 4/12/25 in the morning with a severe headache (7-8/10) on pain scale. Prescribed doxycycline 100 mg BID for 10 days for cellulitis. Continue with Tylenol PRN for headaches. Advised patient to go to the ED if headaches worsen or become more frequent, or if symptoms worsen or fail to improve.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported an onset of erythema, warmth and swelling at the site on 4/19/25. Patient was afebrile. RN consulted with virtual MD on call. Erythema border was traced with scheduled follow up in 24 hours. Patient was advised to take OTC Tylenol or OTC Ibuprofen, self monitor symptoms and seek emergency treatment if symptoms worsened per the instruction of MD.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient had mentioned he has fainted in the past with testing. After administering his vaccines, I stood in front of him for a moment and he fainted. I laid him down and the provider Dr elevated his legs, he came too very quickly, and we kept him in a laying down position and gave him juice. He was then able to sit up and recovered after a few minutes, the provider examined him and determined he was okay to leave with his mother as he felt better.
Vaccine: DTAP, HIBV
Symptoms: Contraindicated product administered
Clinical narrative: Our clinic was instructed by our Sanofi Representative in early 2012 that we could use Dtap (Daptacel) to reconstitute the ActHIB powder instead of using the provided diluent for ActHIB. These two vaccines were given as combined vaccines to a large number of our patients from March 2012 to April 2025. We have been made aware by our VFC representative and the CDC that these vaccines cannot be combined in this manner and any doses that have been administered as a combined injection should be revaccinated according to the CDC's Catch up Immunization Schedule.  This combination of Daptacel and ActHib vaccines was primarily utilized for the 15 month vaccines (dose 4 of Dtap and dose 3 or 4 of Hib). All vaccines given in in this manner are currently being invalidated and patients who are eligible for revaccination are being contacted. Our reports show that approximately 2, 626 patients have been effected by this error. A full report of the patient's names, DOB, date of vaccination and lot numbers can be provided as an uploaded PDF or by email if desired.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site discomfort, Pain in extremity
Clinical narrative: Vaccine reconstituted per protocol. IM injection administered, Z-track used to pt's L deltoid. Pt did note at the time of injection that she felt the injection of the fluid. Pt departed the office with no further complaints. At approximately 2:15pm the patient called stating her Larm was very painful and that she was unable to move it d/t pain. PCP notified and pt was contacted by myself and they by PCP for more detailed input. Pt was instructed to move her to help alleviate pain and contacted the office the next date with an update.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain, redness and swelling to the injection site.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Electroencephalogram, Fatigue, Seizure, Tremor, Ultrasound head
Clinical narrative: Three days following the injections, patient began to have minor convulsions and tremors while breast-feeding. He will have full body shaking that will last anywhere from 10 to 45 seconds at a time. These  tremors can take place once in a day or multiple times in a day. They follow exhaustion and settling while nursing.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site discomfort, Pain in extremity
Clinical narrative: Vaccine reconstituted per protocol, administer IM to L deltoid using Z track method. pt noted that they felt the fluid being injected (0.5ml). pt departed with no further issues. patient called office at approx 1345 hrs c/o pain in her left shoulder, arm, and hand. PCP received the message and forwarded to me for follow-up. I spoke with the patient and reported pain in her left arm equal to a 7.  She reported to me that she had taken 3 advil recently. She denied any redness, swelling, just an ache from her left shoulder blade to her left hand. Pt recommended to apply ice to the area and update us if her symptoms worsened.
Age: 38.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Extra dose administered, Headache, Oedema peripheral, Pain in extremity
Clinical narrative: The Flu vaccine is administered to the patient , the patient already has received the Flu vaccine.  The patient states the she has edema and pain in the arm, pain in the leg and a headache.  The patient was told that if she experience complication should go to the nearest hospital.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Computerised tomogram, Electrocardiogram, Heart rate increased, Joint noise
Clinical narrative: Rapid heart rate muscle locked up and joints popped upon getting out of bed - heart would shock at night upon sleeping and too this day still have symptoms. I am now wearing oxygen at night too help control symptoms
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness, Sleep study, X-ray
Clinical narrative: Rapid heart rate muscle locked up and joints popped upon getting out of bed - heart would shock at night upon sleeping and too this day still have symptoms. I am now wearing oxygen at night too help control symptoms
Age: 3.0
Sex: F
Vaccine: HEPA, HIBV, PNC20
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: localized swelling and redness at injection site
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Asthenia, Injection site pain, Mobility decreased, Myalgia
Clinical narrative: I had a very sore arm at the injection site at first .  Starting a couple of nights after the injection.  Extreme aching of muscles and joints (especially at night, could hardly move or turn over ).    The extreme pain has become less but I still have continued soreness , pain and weakness  in my joints.
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain, redness and swelling below the injection site
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Sleep disorder, Tenderness
Clinical narrative: severe stomach cramps or contractions, like gas pains except worse.  Doubled over in pain,  stomach was sore and tender. first started 4:30 in afternoon got better with Gas X, Tylenol, heating pad and massage after about 1 hour 30 minutes.  started back about 9:30 at night. more severe and lasted longer.  ate a light supper was fine then except for stomach feeling sore and tender to touch.  took more gas x and ibuprofen, heating pad and massage.  able to go to sleep around 1:00 am. woke up at 4:30 am and pain was gone and stomach tenderness was gone also.  no other symptoms except slight soreness in arm.   called pharmacist to report symptoms. If it had been daytime I would have went to my family doctor.  It was severe pain.
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: mild redness and swelling around the injection site
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event
Clinical narrative: No symptoms have been reported yet.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever of 104 degrees the day after vaccine was given
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hyperventilation, Muscle tightness, Paraesthesia
Clinical narrative: Approx 4h after vaccines pt reported numbness, tingling in face, jaw tightnening and hyperventilating
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: Diagnosed with Poly Myalgia Rheumitica on 4/11/2025
Age: 76.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Biopsy skin, Chest pain, Dry skin, Herpes zoster, Rash
Clinical narrative: diagnosis   shingles; rash on upper body, left side and around the back, rash appeared in a wide stripe with rough skin; deep pain in the front left chest area
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dyspepsia, Erythema multiforme, Fatigue, Insomnia
Clinical narrative: started day of vaccination, Feb 24 with aches, chills, mild fever, day 2 aches were so painful I could not lay down, no sleep, fever and chills got worse.    same symptoms day 3, very fatigued but noticed a bright red rash when I laid down at 7 pm to try and go to bed.    day 4, skin mostly covered with very itchy inflamed red rash.... my primary care Dr was out of the country, so I got a quick appt with my Dermatologist who is my neighbor on the afternoon of Feb 27th.  Initially he thought it may be folliculitis from my spa.  the next day I told him it was worsening and came by my house and was concerned when he saw that I had red bumps in many areas like my palms where there are no hair follicles.  Next day Saturday morning rash was worse, still having chills, aches  and fever so he opened his office and called in a nurse to do a biopsy.  He diagnosed it as erythema multiforme minor and prescribed Prednisone for 18 days.  Symptoms continued to worsen for a few days as the rash spread to everywhere but my face and groin.  I have pictures of this.  After time the rash started to recede and by the end of march was mostly gone.  Was very fatigued during this time, had to have a nap every day and experienced insomnia most nights and severe indigestion.   Still fatigued at this time, hard to sleep, and have indigestion.  My skin has cleared up and I do not itch anymore.  I'm very concerned about a reemergence of the rash in the future and potential long term consequences
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Rash, Rash erythematous, Sleep disorder
Clinical narrative: started day of vaccination, Feb 24 with aches, chills, mild fever, day 2 aches were so painful I could not lay down, no sleep, fever and chills got worse.    same symptoms day 3, very fatigued but noticed a bright red rash when I laid down at 7 pm to try and go to bed.    day 4, skin mostly covered with very itchy inflamed red rash.... my primary care Dr was out of the country, so I got a quick appt with my Dermatologist who is my neighbor on the afternoon of Feb 27th.  Initially he thought it may be folliculitis from my spa.  the next day I told him it was worsening and came by my house and was concerned when he saw that I had red bumps in many areas like my palms where there are no hair follicles.  Next day Saturday morning rash was worse, still having chills, aches  and fever so he opened his office and called in a nurse to do a biopsy.  He diagnosed it as erythema multiforme minor and prescribed Prednisone for 18 days.  Symptoms continued to worsen for a few days as the rash spread to everywhere but my face and groin.  I have pictures of this.  After time the rash started to recede and by the end of march was mostly gone.  Was very fatigued during this time, had to have a nap every day and experienced insomnia most nights and severe indigestion.   Still fatigued at this time, hard to sleep, and have indigestion.  My skin has cleared up and I do not itch anymore.  I'm very concerned about a reemergence of the rash in the future and potential long term consequences
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Somnolence
Clinical narrative: started day of vaccination, Feb 24 with aches, chills, mild fever, day 2 aches were so painful I could not lay down, no sleep, fever and chills got worse.    same symptoms day 3, very fatigued but noticed a bright red rash when I laid down at 7 pm to try and go to bed.    day 4, skin mostly covered with very itchy inflamed red rash.... my primary care Dr was out of the country, so I got a quick appt with my Dermatologist who is my neighbor on the afternoon of Feb 27th.  Initially he thought it may be folliculitis from my spa.  the next day I told him it was worsening and came by my house and was concerned when he saw that I had red bumps in many areas like my palms where there are no hair follicles.  Next day Saturday morning rash was worse, still having chills, aches  and fever so he opened his office and called in a nurse to do a biopsy.  He diagnosed it as erythema multiforme minor and prescribed Prednisone for 18 days.  Symptoms continued to worsen for a few days as the rash spread to everywhere but my face and groin.  I have pictures of this.  After time the rash started to recede and by the end of march was mostly gone.  Was very fatigued during this time, had to have a nap every day and experienced insomnia most nights and severe indigestion.   Still fatigued at this time, hard to sleep, and have indigestion.  My skin has cleared up and I do not itch anymore.  I'm very concerned about a reemergence of the rash in the future and potential long term consequences
Age: 95.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: She was already vaccinated with the seasonal dose (November 2024) and was vaccinated again.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: She was already vaccinated with the seasonal dose (November 2024) and was vaccinated again.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: She was already vaccinated with the seasonal dose (November 2024) and was vaccinated again.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patient during routine office visit. Expired vaccine was comingled in office vaccine storage. Expired vaccine was administered before expiration was realized.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Daptacel was given to 11 years old when a Tdap was suppose to be given
Age: 47.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Injection site vesicles
Clinical narrative: ~48 hours after receiving the first dose of jynneos vaccine, a "blister" appeared at the injection site, the approximate size of the initial bleb (~8mm). The blister appears to be fluid filled, raised ~3mm
Age: 65.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient had swelling, redness, hot to the touch, and soreness in both arms. Cellulitis occured, treated with Cephalexin Oral Capsule 500 MG 4 times daily.
Age: 76.0
Sex: F
Vaccine: TYP
Symptoms: Unevaluable event
Clinical narrative: Patient took Benadryl and stopped taking the vaccine.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: Dizziness, nausea, vomiting,  and fever
Age: 74.0
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was due to receive this Bexsero dose on 6/27/2025 but was administered the dose on 4/21/2025
Age: 70.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Injection site rash, Pain
Clinical narrative: Patient had local reaction of a rash below injection site that was also sore, the day before patient had sore body but was feeling better today
Age: 52.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site rash
Clinical narrative: left deltoid rash ~7x 8 cm at vaccine administration site, patient noticed 4 days after vaccine given increasing size
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Patient received COVID vaccine on 04/17/2025.  On the morning of 04/18/2025 patient developed generalized joint and muscle aches affecting the knees, and neck.  No fever, no chills, no sweats.  No joint swelling.  No rash.  Patient has been trying to keep hydrated and active.  Recommendations included Tylenol 1000 mg up to 3 times daily, if there are still issues, consider Aleve 440 mg twice daily.  Expect symptoms to dissipate within the next 3-5 days.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Per Dr.'s office visit note from 4/21/25: Patient received a vaccination for COVID-19 (Spikevax 12) on 9/17/2024 in his right shoulder during one of our vaccine clinics.  Patient states that it was the single most painful immunization he has ever received.  He states that ever since then, he has decreased range of motion of his right shoulder," has a classic frozen right shoulder".  In fact, patient does demonstrate decreased range of motion of the right shoulder although no clicking or locking is felt.  He is he is able to feed himself with his right hand.  There is no numbness or tingling.  Patient reports no prior injury to the right shoulder.  I will have to do some investigating into this vaccine and his complaint.  Also, if I cannot find any direct link or any solution, we will go ahead and order PT and proceed from there to an MRI and Ortho consult as needed
Age: 71.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Blood potassium decreased, Dizziness, Fall, Pallor, Unresponsive to stimuli
Clinical narrative: After receiving the immunizations, client started walking towards the door with his rolling walker and son helping him.  He said he felt dizzy and began to fall.  Son and this nurse were able to support him and lower him into a chair.  He was unresponsive and pale for 30 seconds-1 minute.  He began to rouse.  Vital signs were assessed.  BP 110/68  O2 86% on 5L of O2, HR 145  EMS was called and arrived shortly after.  Wife and son bedside.  Patient agreed to transport to ED after paramedics assessed him.   After follow up on 4/22/25, patient reports that he was "low in potassium"; He was given prescription for potassium and released home on 4/21/25
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Decreased eye contact, Developmental regression, Jaundice, Poor feeding infant, Screaming
Clinical narrative: Child began losing his development after this series.  He would scream in his crib for hours at a time, a purple screamer and couldn't be consoled.   He wouldn't make eye contact. Regressed on his feedings, wouldn't eat and couldn't handle his feedings would often throw up after feeding.  He started to become jaundiced.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Vomiting
Clinical narrative: Child began losing his development after this series.  He would scream in his crib for hours at a time, a purple screamer and couldn't be consoled.   He wouldn't make eye contact. Regressed on his feedings, wouldn't eat and couldn't handle his feedings would often throw up after feeding.  He started to become jaundiced.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Pt came to pharmacy on 4/22/25 to report swollen lump at site of injection from flu shot given 1/23/25.  Said the bump has been there for 3 months and she has soreness in her arm and up to her neck.  It did not look red or warm to the touch.
Age: 20.0
Sex: F
Vaccine: MENB, PNC20
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm red, warm, and swollen.  Patient reports started same evening as vaccination.  Seen in clinic the next day and patient reports very painful.  Advised patient to apply cool compresses and may use ibuprofen, Tylenol, and/or Benadryl as needed for symptom management.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Back pain, Cough, Fatigue, Headache
Clinical narrative: Patient reports pain in the neck area (left side), pain radiating down left shoulder, pain down back , hip and knee. Lasted for about 12 days. Bruising on the injection site. Looks  better today. Sudden random coughing. Headche and fatigue
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Neck pain, Pain
Clinical narrative: Patient reports pain in the neck area (left side), pain radiating down left shoulder, pain down back , hip and knee. Lasted for about 12 days. Bruising on the injection site. Looks  better today. Sudden random coughing. Headche and fatigue
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash, Rash erythematous, Somnolence
Clinical narrative: After I had my vaccine, I went home and felt so tired that I had to take a nap.  I never nap during the day.  The next morning, as I was getting into the shower, I noticed a bright red rash on the trunk of my body (chest, abdomen, back and lower back).  I felt extremely tired in spite of getting over 8 hours of sleep the night before.  I ended up sleeping most of the day.  The rash continued to spread up to my neck and into my arm pits.  Before I went to bed, I took a Benadryl tablet, hoping it would clear up the rash.  The next morning, the rash was even worse.  Bright red, like a sunburn.  I took Benadryl that night and the following night.  On the 4th day after my vaccine, the rash started to subside.  It is now completely gone.    I have always kept current with covid vaccines, getting boosters every six months.  Most of my prior vaccines were manufactured by Pfizer.  I got the Spikevax vaccine because the FDA says it is the most effective for people my age.  I'm afraid to get another Spikevax vaccine.
Age: 0.67
Sex: M
Vaccine: HEP, PNC13
Symptoms: Abnormal behaviour, Balance disorder, Crying, Developmental delay, Ear infection
Clinical narrative: Child began to lose a lot of his intended motor function.  He lost his ability to roll over and would 'crappy flop' on the floor when he tried to roll over.  He started exhibiting new hand biting behaviors.  He was having feeding issues and biting the breast while nursing which got much worse after this round.  Repetitive hand motions and hand flapping began to get really obvious after this.  His eyes would start to intermittently cross and he would then lose his balance and fall over if he was in the sitting position.  He was inconsolable many nights and a lot during the daytime.  Shortly after he got ear and eye infection that would require drops.  He hasn't reached many developmental milestones since this last round.
Age: 0.67
Sex: M
Vaccine: HEP, PNC13
Symptoms: Eye infection, Fall, Mobility decreased, Motor dysfunction, Strabismus
Clinical narrative: Child began to lose a lot of his intended motor function.  He lost his ability to roll over and would 'crappy flop' on the floor when he tried to roll over.  He started exhibiting new hand biting behaviors.  He was having feeding issues and biting the breast while nursing which got much worse after this round.  Repetitive hand motions and hand flapping began to get really obvious after this.  His eyes would start to intermittently cross and he would then lose his balance and fall over if he was in the sitting position.  He was inconsolable many nights and a lot during the daytime.  Shortly after he got ear and eye infection that would require drops.  He hasn't reached many developmental milestones since this last round.