chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Dyspnoea, Echocardiogram normal, Electrocardiogram normal, Grunting, Malaise
Clinical narrative: Patient received the 2nd dose of his HPV vaccine on Tuesday 1/14/2025 morning (he received his 1st dose without issues). He woke up at 6-7 PM with chills, shivering, and temp 100.2F so mom gave him ibuprofen with relief. On Wednesday 1/15/2025, he began to complain about his chest "feeling weird" at 6-7PM, after which mom gave him his newly prescribed albuterol inhaler with relief. On Thursday 1/16/2025, he called mom from school at 11AM to ask if she can bring his inhaler because now he was having sternal chest pain (no radiation). He was fine until 9PM that evening when his sternal chest pain returned with associated shortness of breath, grunting, and "not feeling good", thus prompting presentation to Hospital. Found to have and treated for myopericarditis. Will follow up outpatient with Cardiology.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Myopericarditis, Troponin increased
Clinical narrative: Patient received the 2nd dose of his HPV vaccine on Tuesday 1/14/2025 morning (he received his 1st dose without issues). He woke up at 6-7 PM with chills, shivering, and temp 100.2F so mom gave him ibuprofen with relief. On Wednesday 1/15/2025, he began to complain about his chest "feeling weird" at 6-7PM, after which mom gave him his newly prescribed albuterol inhaler with relief. On Thursday 1/16/2025, he called mom from school at 11AM to ask if she can bring his inhaler because now he was having sternal chest pain (no radiation). He was fine until 9PM that evening when his sternal chest pain returned with associated shortness of breath, grunting, and "not feeling good", thus prompting presentation to Hospital. Found to have and treated for myopericarditis. Will follow up outpatient with Cardiology.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Chest pain, Laboratory test, Myocarditis, Pyrexia
Clinical narrative: Patient received the 2nd dose of his HPV vaccine on Tuesday 1/14/2025 morning (he received his 1st dose without issues). He woke up at 6-7 PM with chills, shivering, and temp 100.2F so mom gave him ibuprofen with relief. On Wednesday 1/15/2025, he began to complain about his chest "feeling weird" at 6-7PM, after which mom gave him his newly prescribed albuterol inhaler with relief. On Thursday 1/16/2025, he called mom from school at 11AM to ask if she can bring his inhaler because now he was having sternal chest pain (no radiation). He was fine until 9PM that evening when his sternal chest pain returned with associated shortness of breath, grunting, and "not feeling good", thus prompting presentation to Hospital. Found to have and treated for myopericarditis. Will follow up outpatient with Cardiology.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Red patch where vaccine was administered
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Rash erythematous, Skin warm
Clinical narrative: Rash; Rash on injection site; Swelling on injection site; Rash was red and hot; Rash was red; This spontaneous case, initially received on 07-Jan-2025, was reported by a health authority via Vaccine Adverse Event Reporting System (VAERS) (Reference number 2813911-1) and concerns an adult female patient.  Past medical history included Percutaneous Nephrostomy. At the time of the event the patient had Migraines, allergy to sulfa.  Concomitant medication: refer to appropriate report section.  Administration of company suspect drug: On 07-Nov-2024, the patient received Flucelvax (TIV) for indication not reported, Dosage regimen: 1 dosage, Route of administration: not reported, Anatomical location: left arm. Lot number: AW3225B.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 08-Nov-2024, the patient experienced Rash (outcome: Recovered / Resolved), Rash on injection site (outcome: Recovered / Resolved), Swelling on injection site (outcome: Recovered / Resolved), Rash was red and hot (outcome: Recovered / Resolved), Rash was red (outcome: Recovered / Resolved).  Rash and swelling on injection site L deltoid, rash was red and hot, went halfway down upper arm. Very sore and swollen, felt like there was a ball in arm. Last 4 days.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter assessed the event as non-serious and did not provide the causality assessment.; Reporter's Comments: The events assessed related
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, DTPPVHBHPB, DTAPIPVHIB, DTPPVHBHPB
Symptoms: Extra dose administered
Clinical narrative: administration of pentacel and vaxelis at the same time with no reported adverse event; Initial information received on 15-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old male patient who was administered both pentacel and vaxelis at the same time with no reported adverse event while receiving Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] and Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), HIB Vaccine CONJ (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid [Vaxelis].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant -no other vaccines.  On 08-Jan-2025, the patient received 0.5 ml (once) dose of (standard) suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Suspension for injection in left leg (lot UK017AA, expiry date: 30-Jun-2025) via intramuscular route (latency-same day) and Vaxelis not produced by Sanofi Pasteur (latency unknown) (unknown strength, batch number, expiry date, and route) via unknown administration site for Immunization at the same time with no reported adverse event (extra dose administered).  Information on the batch number for Vaxelis was requested corresponding to the one at time of event occurrence.  Reportedly, HCP (Heath care professional) wanted to report the incident and inquire if there are any known side effects associated with the patient receiving the two vaccines at the same time.   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: M
Vaccine: DTAPIPVHIB, DTPPVHBHPB, DTAPIPVHIB, DTPPVHBHPB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: administration of pentacel and vaxelis at the same time with no reported adverse event; Initial information received on 15-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old male patient who was administered both pentacel and vaxelis at the same time with no reported adverse event while receiving Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] and Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), HIB Vaccine CONJ (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid [Vaxelis].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant -no other vaccines.  On 08-Jan-2025, the patient received 0.5 ml (once) dose of (standard) suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Suspension for injection in left leg (lot UK017AA, expiry date: 30-Jun-2025) via intramuscular route (latency-same day) and Vaxelis not produced by Sanofi Pasteur (latency unknown) (unknown strength, batch number, expiry date, and route) via unknown administration site for Immunization at the same time with no reported adverse event (extra dose administered).  Information on the batch number for Vaxelis was requested corresponding to the one at time of event occurrence.  Reportedly, HCP (Heath care professional) wanted to report the incident and inquire if there are any known side effects associated with the patient receiving the two vaccines at the same time.   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: HPV4, HPV9
Symptoms: Autoimmune thyroiditis, Impaired work ability, Memory impairment, Psoriasis
Clinical narrative: Hashimoto's thyroiditis; her memory recall has not been good since the HPV vaccine; Psoriasis; health issues; Patient was not able to confirm if the vaccine she received was the GARDASIL or GARDASIL 9; This spontaneous report was received from a female patient of unknown age concerning herself. Patient did not have pertinent medical history or concurrent conditions. Concomitant medications included vitamin C.   On an unknown date (also reported as a while ago), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (reported as HPV vaccine) route of administration reported as injection, for prevention (strength, dose, frequency, anatomical location, lot number and expiration date were not provided) (product origin unknown).   On an unknown date, the patient's memory recall and was not good since HPV vaccination. After the vaccination the patient experienced psoriasis and Hashimoto's thyroiditis. She went to a natural doctor and was being treated with some of the treatment that involved circulation with vitamin C and an unknown product. The patient mentioned that her life crippled and cannot advance in her career due to her health issues. At the time of this report, the patient had not recovered from the events.  The causal relationship between the vaccine and the events was not provided.  Upon internal review, Hashimoto's thyroiditis was determined to be a medically significant event.
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Pyrexia
Clinical narrative: fatigue; fever; This is a spontaneous report received from a Pharmacist.  An 89-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 14Jan2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Restless leg syndrome" (unspecified if ongoing); "depression" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "CHF" (unspecified if ongoing); "CAD" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN; ASCORBIC ACID; ASPIRIN (E.C.); CETIRIZINE; VIT D3; DULOXETINE; FUROSEMIDE; LACTOBACILLUS ACIDOPHILUS; LEVOTHYROXINE; MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]; OLOPATADINE; OMEGA 3 FISH OIL [FISH OIL]; OMEPRAZOLE; POLYETHYLENE GLYCOL COMPOUND; KCL oral; ROPINIROLE; ROSUVASTATIN; TROSPIUM. Past drug history included: No, reaction(s): "Hypersensitivity". The following information was reported: FATIGUE (non-serious) with onset 15Jan2025, outcome "recovered" (15Jan2025); PYREXIA (non-serious) with onset 15Jan2025, outcome "recovered" (15Jan2025), described as "fever". Therapeutic measures were taken as a result of fatigue, pyrexia.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: rash at the injection site/it is red and it is warm; rash at the injection site/it is red and it is warm; rash at the injection site/it is red and it is warm; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jan2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset Jan2025, outcome "unknown" and all described as "rash at the injection site/it is red and it is warm". Additional information: The patient was calling "today" (17Jan2025) about the Prevnar 20 vaccine and she stated she had this shot exactly one week ago "today" (Jan2025). she had a rash at the injection site, it was red and it was warm but it did not hurt or anything and she just wanted to call to find out if the rash was normal.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: This situation is pre-assessed as a medication error/an inappropriate use due to ACT-HIB was reconstituted with sterile water.  with no reported adverse event; Initial information received on 15-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves, this situation is pre-assessed as a medication error/an inappropriate use due to a 1 year old female patient received HIB (PRP/T) Vaccine [ACT-HIB] that was reconstituted with sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (DTAP); RSV Vaccine and Pneumococcal Vaccine CONJ for Immunization.  On 09-Jan-2025, this situation is pre-assessed as a medication error/an inappropriate use due to the patient received 0.25 ml to 2 ml (once) dose of suspect (standard) HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot UJ992AA, expiry date: 28-Feb-2025) (unknown strength) via intramuscular route in left thigh for Immunization that was reconstituted with sterile water with no reported adverse event (product preparation error) (latency-same day).  Reportedly, Medical assistant reported that she used sterile water instead. She asks if the dose is still valid or do they need to re-administer the dose.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administration of only the liquid DTAP-IPV portion of PENTACEL, the dose administered did not include the ACTHIB portion with no reported adverse event; Initial information received on 14-Jan-2025 regarding an unsolicited non-valid non-serious case received from a other health professional.  This case involves, the unknown age and gender patient who was administration of only the liquid DTAP-IPV portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel], the dose administered did not include the ACT HIB portion with no reported adverse.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient administration of only the liquid DTAP-IPV portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine (lot UK043AA, expiry date: 31-Aug-2025), the dose administered did not include the ACT HIB portion with no reported adverse event (single component of a two-component product administered) (unknown latency).  Reportedly, Caller did not have specific details or patient specific information available at the time of the call. No other details were available in regards to this situation.    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: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Insomnia, Pain in extremity, Rash
Clinical narrative: bumps; can not sleep at night; pain from shoulder to hand on same side as FLUZONE HD injection site; Initial information received on 15-Jan-2025 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 91 years old female patient who experienced bumps, can not sleep at night and pain from shoulder to hand on same side after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Jul-2024, the patient received a unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (expiry date: 30-Jun-2025 and lot U8527AA) via unknown route in unknown administration site as immunization.  On an unknown date in 2024 the patient developed bumps (swelling), can not sleep at night (sleep disorder) and pain from shoulder to hand on same side as fluzone hd injection site (pain in extremity) (latency: few days approximately).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all events.  At time of reporting, the outcome was Unknown for all events.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: they have an opened vial that has been left outside for 12 hours , with no reported adverse event; Initial information received on 16-Jan-2025 regarding an unsolicited non-valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient and reporter stated that they have an opened IPV (VERO) [IPOL] vial that has been left outside for 12 hours, with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.   On an unknown date, the suspect opened IPV (VERO) Suspension for injection (Unknown strength, lot and expiry date) for immunisation, vial that has been left outside for 12 hours, with no reported adverse event (product storage error).   Pharmacist called to ask regarding multidose vials of IPOL. They wanted to know what the expiration date was for punctured vials. They said that they have an opened vial that has been left outside for 12 hours that they were going to dispose of anyway and wanted the information for reference. Pharmacist declined to report about the aforementioned IPOL. They were asking because they could not agree with their partner if they should be disposing these vials by the expiration date or after 28 days.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given expired dose of vaccine with no reported adverse event; Initial information received on 16-Jan-2025 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and unknown gender patient who was given expired dose of HIB (PRP/T) Vaccine [ACT-HIB] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Jan-2025, the patient received an expired dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot- uk007ab and expiry- 01-Dec-2024) via unknown route in unknown administration site for immunization (dose, strength: not provided) with no reported adverse event (expired product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This non-serious case was reported by a consumer via patient support programs and described the occurrence of swollen lymph nodes in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-DEC-2024, the patient received Shingrix. On 20-DEC-2024, 1 days after receiving Shingrix, the patient experienced swollen lymph nodes (Verbatim: Swollen lymph nodes). The outcome of the swollen lymph nodes was not resolved.   It was unknown if the reporter considered the swollen lymph nodes to be related to Shingrix.     It was unknown if the company considered the swollen lymph nodes to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-DEC-2024 The patient self-reported this case for himself. The patient experienced swollen lymph nodes which was ongoing. The patient did not receive other products. No symptoms were treated.
Age: 0.42
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The Kinrix was the 2nd in the series; Kinrix was administered to a 5 month old; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   Concomitant products included Pediarix.   On 15-NOV-2024, the patient received the 2nd dose of Kinrix. On 15-NOV-2024, an unknown time after receiving Kinrix and an unknown time after receiving Pediarix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: The Kinrix was the 2nd in the series) and inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 5 month old). The outcome of the inappropriate schedule of vaccine administered and inappropriate age at vaccine administration were 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: 26-DEC-2024 Nurse reported that Kinrix was administered to a 5 month old on November 15, 2024.  Patient has had no issues.  1st dose of Pediarix on August 23, 2024.  The Kinrix was the 2nd in the series which led to Inappropriate schedule of vaccine administered and Inappropriate age at vaccine administration.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: A pregnant woman on her 3rd trimester received a dose of Arexvy.; A pregnant woman on her 3rd trimester received a dose of Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: A pregnant woman on her 3rd trimester received a dose of Arexvy.) and drug use in unapproved population (Verbatim: A pregnant woman on her 3rd trimester received a dose of Arexvy). The outcome of the vaccine exposure during pregnancy and drug use in unapproved population were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 10-JAN-2025 The pharmacist reported that they administered a dose of Arexvy to a pregnant woman which led to drug use in unapproved population.  The patient was on her 3rd trimester of pregnancy and she was in her mid 30's of age.  The pharmacist asked safety information about this.
Age: 0.67
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Cough, Cyanosis, Decreased appetite, Injection site erythema, Injection site swelling
Clinical narrative: Within 24 hours: decreased feeding, within 48 hours, cough/congestion, within 72 hours, peripheral cyanosis of bilateral lower extremities and injection site swelling/redness.
Age: 0.67
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Respiratory tract congestion
Clinical narrative: Within 24 hours: decreased feeding, within 48 hours, cough/congestion, within 72 hours, peripheral cyanosis of bilateral lower extremities and injection site swelling/redness.
Sex: M
Vaccine: HPV9
Symptoms: Pityriasis rosea, Rash, Rash pruritic
Clinical narrative: Itchy Rash on back, chest & abdomen  consistent with pityriasis rosea (Herald lesion on (R) shoulder blade)
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: none, vaccine was administered past the 10 week EAU expiration date.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: SUDDEN AND TEMPORARY LOSS OF CONSCIOUSNESS, DIZZINESS
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There were no adverse reactions to this vaccination.  The patient got 2  vaccinations  instead of one
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC15, RV5, DTAPIPVHIB, HEP, PNC15, RV5
Symptoms: Crying, Erythema, Infant irritability, Joint swelling, Rash
Clinical narrative: MOC REPORTS THAT PATIENT HAD A FEVER  (99.6 F) ON WEDNESDAY , 1/1/2025.  SHE GAVE THE PATIENT INFANT TYLENOL EVERY 4 HOURS FOR  3 DOSES UNTIL THERE IS WAS NO MORE FEVER.  ON THURSDAY, 1/2/2025, MOC REPORTS THAT PATIENT WAS DOING BETTER.  ON FRIDAY, 1/3/2025, MOC TOOK PATIENT  TO THE PRIMARY PROVIDER  TO GET VACCINES.   ON SATURDAY, 1/4/2025, MOC NOTICED THAT PATIENT BECAME  VERY FUSSY  AND CRIED A LOT, HOWEVER, SHE WAS CONSOLABLE.  ON SUNDAY, 1/5/2025, IN THE MORNING MOC REPORTS THAT PATIENT WAS STILL FUSSY, BUT NOW HAD A RASH ON HER. IT WAS ON BOTH ELBOWS, LEFT PINKIE AND MIDDLE FINGER, RIGHT RING FINGER AND LEFT FOOT AND KNEE WERE RED, HOT AND SWOLLEN.   PARENTS TOOK PATINENT TO THE ER  FOR FURTHER EVALUATION.  MOC REPORTS THAT SHE TOLD THEM THAT PATIENT HAD SHOTS A COUPLE OF DAYS AGO.  ER  DIAGNOSED PATIENT WITH URTICARIA AND WAS PRESCRIBED  PRENISOLONE 15MG/5ML SOLUTION  - IN A STEP DOWN REGIMEN  FOR 6 DAYS.  MOC RPORTS THAT SHE WAS ADVISED TO FOLLOW-UP WITH PATIENT'S PRIMARY PROVIDER.  WHEN SHE WENT PATIENT WAS REFERRED TO AN ALLERGIST FOR FURTHER EVALUATION.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC15, RV5, DTAPIPVHIB, HEP, PNC15, RV5
Symptoms: Skin warm, Urticaria
Clinical narrative: MOC REPORTS THAT PATIENT HAD A FEVER  (99.6 F) ON WEDNESDAY , 1/1/2025.  SHE GAVE THE PATIENT INFANT TYLENOL EVERY 4 HOURS FOR  3 DOSES UNTIL THERE IS WAS NO MORE FEVER.  ON THURSDAY, 1/2/2025, MOC REPORTS THAT PATIENT WAS DOING BETTER.  ON FRIDAY, 1/3/2025, MOC TOOK PATIENT  TO THE PRIMARY PROVIDER  TO GET VACCINES.   ON SATURDAY, 1/4/2025, MOC NOTICED THAT PATIENT BECAME  VERY FUSSY  AND CRIED A LOT, HOWEVER, SHE WAS CONSOLABLE.  ON SUNDAY, 1/5/2025, IN THE MORNING MOC REPORTS THAT PATIENT WAS STILL FUSSY, BUT NOW HAD A RASH ON HER. IT WAS ON BOTH ELBOWS, LEFT PINKIE AND MIDDLE FINGER, RIGHT RING FINGER AND LEFT FOOT AND KNEE WERE RED, HOT AND SWOLLEN.   PARENTS TOOK PATINENT TO THE ER  FOR FURTHER EVALUATION.  MOC REPORTS THAT SHE TOLD THEM THAT PATIENT HAD SHOTS A COUPLE OF DAYS AGO.  ER  DIAGNOSED PATIENT WITH URTICARIA AND WAS PRESCRIBED  PRENISOLONE 15MG/5ML SOLUTION  - IN A STEP DOWN REGIMEN  FOR 6 DAYS.  MOC RPORTS THAT SHE WAS ADVISED TO FOLLOW-UP WITH PATIENT'S PRIMARY PROVIDER.  WHEN SHE WENT PATIENT WAS REFERRED TO AN ALLERGIST FOR FURTHER EVALUATION.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC15, RV5, DTAPIPVHIB, HEP, PNC15, RV5
Symptoms: Crying, Infant irritability, Rash, Urticaria
Clinical narrative: MOC REPORTS THAT PATIENT HAD A FEVER  (99.6 F) ON WEDNESDAY , 1/1/2025.  SHE GAVE THE PATIENT INFANT TYLENOL EVERY 4 HOURS FOR  3 DOSES UNTIL THERE IS WAS NO MORE FEVER.  ON THURSDAY, 1/2/2025, MOC REPORTS THAT PATIENT WAS DOING BETTER.  ON FRIDAY, 1/3/2025, MOC TOOK PATIENT  TO THE PRIMARY PROVIDER  TO GET VACCINES.   ON SATURDAY, 1/4/2025, MOC NOTICED THAT PATIENT BECAME  VERY FUSSY  AND CRIED A LOT, HOWEVER, SHE WAS CONSOLABLE.  ON SUNDAY, 1/5/2025, IN THE MORNING MOC REPORTS THAT PATIENT WAS STILL FUSSY, BUT NOW HAD A RASH ON HER. IT WAS ON BOTH ELBOWS, LEFT PINKIE AND MIDDLE FINGER, RIGHT RING FINGER AND LEFT FOOT AND KNEE WERE RED, HOT AND SWOLLEN.   PARENTS TOOK PATINENT TO THE ER  FOR FURTHER EVALUATION.  MOC REPORTS THAT SHE TOLD THEM THAT PATIENT HAD SHOTS A COUPLE OF DAYS AGO.  ER  DIAGNOSED PATIENT WITH URTICARIA AND WAS PRESCRIBED  PRENISOLONE 15MG/5ML SOLUTION  - IN A STEP DOWN REGIMEN  FOR 6 DAYS.  MOC RPORTS THAT SHE WAS ADVISED TO FOLLOW-UP WITH PATIENT'S PRIMARY PROVIDER.  WHEN SHE WENT PATIENT WAS REFERRED TO AN ALLERGIST FOR FURTHER EVALUATION.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Bradykinesia, Chills, Dizziness
Clinical narrative: Per patient: I came in Friday 01/17/2025 for my second shot almost exactly 3 months from the  first shot which I also received the Flu shot for veterans over 65 had  absolutely no reaction to these but the shot I received Friday 01/17/2024 time  was approximately 16:15 pm I had extreme negative reaction accelerated heart  above 100 moving slowly extreme head pain, nausea, extreme, ringing of ears,  aches and pains joint, legs, arms, un controlled shivering, very dizzy, no  elevated temperature absolutely miserable Friday, Saturday, Sunday general  weakness of complete body, some relief Monday and today 01/21/2025
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Heart rate increased, Nausea, Pain in extremity
Clinical narrative: Per patient: I came in Friday 01/17/2025 for my second shot almost exactly 3 months from the  first shot which I also received the Flu shot for veterans over 65 had  absolutely no reaction to these but the shot I received Friday 01/17/2024 time  was approximately 16:15 pm I had extreme negative reaction accelerated heart  above 100 moving slowly extreme head pain, nausea, extreme, ringing of ears,  aches and pains joint, legs, arms, un controlled shivering, very dizzy, no  elevated temperature absolutely miserable Friday, Saturday, Sunday general  weakness of complete body, some relief Monday and today 01/21/2025
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Per patient: I came in Friday 01/17/2025 for my second shot almost exactly 3 months from the  first shot which I also received the Flu shot for veterans over 65 had  absolutely no reaction to these but the shot I received Friday 01/17/2024 time  was approximately 16:15 pm I had extreme negative reaction accelerated heart  above 100 moving slowly extreme head pain, nausea, extreme, ringing of ears,  aches and pains joint, legs, arms, un controlled shivering, very dizzy, no  elevated temperature absolutely miserable Friday, Saturday, Sunday general  weakness of complete body, some relief Monday and today 01/21/2025
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: No known adverse reaction.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Muscle pain, joint pain, malaise, weakness, chills, fever, headache, watery eyes, pain in hair and nails, sleepiness, tiredness.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Lacrimation increased, Malaise, Myalgia, Onychalgia, Pain
Clinical narrative: Muscle pain, joint pain, malaise, weakness, chills, fever, headache, watery eyes, pain in hair and nails, sleepiness, tiredness.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: Muscle pain, joint pain, malaise, weakness, chills, fever, headache, watery eyes, pain in hair and nails, sleepiness, tiredness.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reports localized swelling, redness and tenderness at injection site that she first noticed the morning after her injection.  Patient first reported the symptoms to the clinic on 1/22/25.  At this time the symptoms have improved.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia
Clinical narrative: Insomnia for night after injection.
Age: 6.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Tdap (adacel) 3CA22C1 0.5 mL was given on 12/18/24 to client. Client was 6 years old when dose was given. Error was discovered on 01/16/25 when RN had patient again and discovered that wrong vaccine was given. RN notified nurse manager of error and per review of CDC and immunize.org as well as standing orders no harm could come of giving this dose. RN started correct series with Dtap on 1/16/25 and educated client and FOC of client of error and new plan for restarting Dtap series. FOC and client stated understanding and were okay with plan going forward
Age: 11.0
Sex: F
Vaccine: HPV9, FLU3, HPV9, MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient already received dose 1 and 2 at ages 9 and 10 respectively. 3rd dose given at 11 incorrectly.
Age: 11.0
Sex: F
Vaccine: HPV9, FLU3, HPV9, MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: 3rd dose of Gardasil 9 given when not needed.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient given vaccine 1/22/25, Use by date for vaccine was 1/21/2025
Age: 50.0
Sex: M
Vaccine: HPV9, RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt was order to be given HPV by provider. Age limit for HPV is 45 and pt is currently 50 years old. No adverse effects noted at this time.
Age: 50.0
Sex: M
Vaccine: HPV9, RSV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt was order to be given HPV by provider. Age limit for HPV is 45 and pt is currently 50 years old. No adverse effects noted at this time.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: Client came in to receive REV vaccine per prescription from provider and following guidance for pregnancy during RSV season. Per review of chart RN noticed Flu, COVID and HPV were available to give. RN did not review standing order for HPV at time of vaccination and due to being newer was not thinking about the fact that HPV is not recommended during pregnancy. RN did report to manager after reflecting on vaccines given yesterday on 1/22/2025. Per review of Ask the experts at immunize.org and CDC guidance for HPV vaccination during pregnancy no action is required however due to standing order VAERS is required to be submitted.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Urinary incontinence
Clinical narrative: Loss of control of legs and urine - lasting about 2 hours.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, FLU3, HEP, HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix given to a 3 year old
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Embolic stroke, Multisystem inflammatory syndrome in adults
Clinical narrative: 1 week after vaccination I developed full body eczema. Now treated by a dermatologist. Now 3 years later I had an embolic stroke at 39 years old likely from multisystem inflammatory syndrome.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event
Clinical narrative: no adverse effects noted
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Large area redness, swelling, itching, hives, starting five days after injection as baseball-diameter area around injection site and traveling down left arm. Some itching relief with topical Cortizone-10 but redness and hives persisted. Some response to Benadryl, but merely temporary; redness/itching continued to spread down the arm for 2 days. Consistent Benadryl use for 6 days showed a response and reaction has abated. Still monitoring for recurrence.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 3 doses of MMR vaccine instead of 2. Patient has not reported any adverse events at this time.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Patient received second dose of Moderna 2024-2025 vaccine outside of ACIP protocol (not having immunocompromised state). Patient did not report any S/Es outside of soreness at the injection site.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Incorrect dose administered
Clinical narrative: Pt had received Hep B series as an infant, recently had titers drawn that showed no immunity.  An adult Hep B was administered inadvertently instead of a pediatric dose.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Dizziness, Headache, Malaise, Pain
Clinical narrative: Donor reports fever of 101.8 F, Chills, body aches, malaise, dizziness and severe headache. Admits to self admin of Ibuprofen x3. Reports S/S persisted x4 days.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Donor reports fever of 101.8 F, Chills, body aches, malaise, dizziness and severe headache. Admits to self admin of Ibuprofen x3. Reports S/S persisted x4 days.
Age: 53.0
Sex: F
Vaccine: HEPAB, TDAP, VARZOS
Symptoms: Axillary pain, Pain, Pain in extremity
Clinical narrative: Shingrix vaccine given on left arm, feel underarm pain running down to elbow.  Pain intensifies when lifting left arm up.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Prevnar 20 only approved as a single one time dose. Patient received one dose on 03/11/2023, and another on 01/21/2025. Patient hasn't reported any side effects but dose was given outside series recommendation.
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Patient was due 15 month old immunizations. Dtap/IPV was ordered and given rather than DTAP/Hib
Age: 18.0
Sex: F
Vaccine: COVID19, HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This report is to provide notification of a medication error only. The 18 y/o client was inadvertently given Havrix vaccine indicated for adults 19 years old ad above. The patient did not experience any adverse effects. The client was monitored post vaccination, without consequence, and notified of the error.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Varicella immunization expired on 1/9/25 and given in error to patient on 1/14/25. No adverse reactions noted.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Ventricular extrasystoles
Clinical narrative: PVC
Age: 52.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Neck mass, Oedema peripheral
Clinical narrative: Left armpit swelling (tennis ball size) and hard lump on collarbone
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: The Employee Health Nurse administered a Hep B first dose, vaccine today that has an expiration date of 1/4/2025. No adverse events noted at this time.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Impaired work ability, Seizure
Clinical narrative: None stated.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was given wrong does. No adverse affects. Patient was given the 5-11yo dose.
Age: 0.17
Sex: F
Vaccine: VARCEL
Symptoms: Wrong product administered
Clinical narrative: None, wrong vaccine given.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Skin warm
Clinical narrative: RED ARM & WARM TO TOUCH A FEW DAYS AFTER SHOT ADMINISTERED
Age: 68.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Underdose
Clinical narrative: Prior to lunch time, NCMA had asked me to administer vaccines for her last patient so she could go to lunch on time. She gave me the sheet with the list of immunizations needed and advised that patient had the consent forms. I verified the insurance with her and went to get the vaccines from the fridge. The sheet said patient was a 63-year-old female. I had  LPN verify my vaccines. Flublok was not available, so Vaccine coordinator advised it was ok to use Fluzone. However, after administering COVID and flu vaccines, I entered them in the system and saw it was a different patient listed on the consent forms (68-year-old male). Although patient received the vaccines that he needed, he should have received Fluzone High-                          I learned that I need to bring all forms with me including consent sheets whenever I verify vaccines and check the names on the sheets given to me to ensure it is the correct patient.
Age: 11.0
Sex: M
Vaccine: IPV, MNQ, TDAP, VARCEL
Symptoms: Dizziness
Clinical narrative: Patient became dizzy per parent lowered to the floor, monitored in office for about 15 minutes, dizziness resolved prior to leaving the Pediatrician office.
Age: 59.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash that showed up 6 days later
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Hypoaesthesia, Pain in extremity, Peripheral coldness, Peripheral swelling
Clinical narrative: L arm numb, swollen, cold and achy- Start Medrol (Pak) 4 mg tablets in a dose pack taper per pack instructions Start cephALEXin 500 mg capsule 1 capsule every 6 hours for 5 days
Age: 84.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Headache, Nausea, Pruritus
Clinical narrative: itching, headache, nausea
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No reported adverse events per patient, patient received a third dose of this vaccine.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Disturbance in attention, Eye movement disorder, Hypotonia, Pallor
Clinical narrative: 10 hours after vaccination, patient went limp, eyes rolled back in his head and his color left him, even his lips were white. His eyes seemed unfocused at this time. He laid very still for about 10 minutes. After 10-15 minutes his color slowly returned and he returned to his "normal self." Parents contacted the doctor's office to report the adverse event after it was over.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Disturbance in attention, Eye movement disorder, Hypotonia, Mydriasis, Pallor
Clinical narrative: Patient had a spell starting at about 14:30pm on the day of vaccination. He was very limp and still and mom thought he was sleeping at first, but then his color started leaving. His lips became white. His eyes rolled back in his head and then seemed unfocused. His eyes did dilate when his parents checked them. He laid very still for about 10-15 minutes and then his color and movement started to return, and he returned to his normal self. The doctor's office was contacted after the incident and parent's were instructed continue watching him.
Age: 51.0
Sex: M
Vaccine: HEP, IPV, TDAP
Symptoms: Extra dose administered, Injection site discomfort
Clinical narrative: Patient received a Tdap vaccine 1/21/25, but was found to have recently received a Tdap vaccine on 1/15/25 at a different clinic. Follow-up call with the patient the next day 1/22/25 and patient reports injection site discomfort of both arms, but worse on left.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Neck mass
Clinical narrative: Small lump above collarbone on left side
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Feeling hot, Nausea, Somnolence
Clinical narrative: Mom gives history that  about  10 minutes after the vaccine was given, child complained of being hot , nauseous, got up the exam table and then fell down on the floor. Mother started screaming and medical assistant and myself rushed into the room, Child was on the floor, looked drowsy but was able to answer all questions. EMS was called before I went in , paramedics came and assessed. No recommendations were made to take her to ER by them. BP was normal- 109/75, Heart rate 99, o2 sat was 99. Child was observed for 30 minutes, water was given. Then discharged home. Child has had Flu shots before in another state from where had moved in August 2024 and never had any reaction to any vaccines
Sex: U
Vaccine: HPV9
Symptoms: Incorrect dose administered
Clinical narrative: No additional AEs were reported; Pharmacist reported that a patient received first dose of GARDASIL 9 about 5 years ago and second dose on 1/14/2025; This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On an unknown date in 2020 (reported as "about 5 years ago"), the patient was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection. On 14-JAN-2025, the patient received the 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (Inappropriate schedule of product administration). Both doses were administered as prophylaxis and exact dosage, lot numbers, expiration dates, routes of administration, and anatomical locations were not provided.  No additional adverse events (AEs) were reported and no further information was provided.  Lot # is being requested and will be submitted if received.