chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: she inadvertently administered a dose of Shingrix that was expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 2BR9G, expiry date 09-JUL-2024) for prophylaxis.   Previously administered products included Zostavax (previously received Zostavax).   On 05-AUG-2024, the patient received the 1st dose of Shingrix. On 05-AUG-2024, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: she inadvertently administered a dose of Shingrix that was expired). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-AUG-2024 The nurse reported that, she inadvertently administered a dose of Shingrix to a patient that was expired which led to expired vaccine used.  The vaccine administration facility was the same as primary reporter. This case was linked with US2024100359, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2024100359:Same reporter/Diffrent patient
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC20
Symptoms: Rash, Rash papular
Clinical narrative: After administration of 4 and 6 month vaccines patient developed maculo-papular facial rash within 4-5 days of administration.  Resolved initially on own, treated with hydrocortisone cream after subsequent reaction
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: The Patient has been having muscle spasms in his hands and calf muscles. Also, some cellulitis in the right calf muscle. The patient has also been having his left calf muscle lock up at random times ever since the vaccine was administered
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC20
Symptoms: Extra dose administered
Clinical narrative: Single Hep B vaccine was given to patient instead of Hib. Therefore patient received double dose of Hep B vaccination at one time since he also received Pediarix on the same day.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Vaccination site rash
Clinical narrative: parent reports that small rash started at vaccination site approx 4 hours after vaccine administration.  Rash continued to spread and parent reached out to pediatrician 8/20/2024.  Pediatrician informed patient to continue watching child for trouble breathing/swelling and recommended use of allergy medication.  Parent reports that rash has now covered patients body, despite use of allergy medication, but patient is not having any trouble with fever, breathing, eating, or daily activities.  PHN informed patient to reach back out to the pediatrician since rash has spread significantly. PHN informed patient that VAERS report was being made.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: Vaccine expired 8/10/2024.
Age: 11.0
Sex: M
Vaccine: DTAP, HPV9, MENB
Symptoms: Computerised tomogram head normal, Concussion, Contusion, Fall, Gingival injury
Clinical narrative: He fainted after he was given 3 shots. He was sitting on the examination bed and fell down head first on hard floor breaking a front tooth and injuring his lip and gums with bruises near the eye. He suffered a concussion and still complains about a light headache sometimes.
Age: 11.0
Sex: M
Vaccine: DTAP, HPV9, MENB
Symptoms: Headache, Lip injury, Syncope, Tooth fracture, Vomiting
Clinical narrative: He fainted after he was given 3 shots. He was sitting on the examination bed and fell down head first on hard floor breaking a front tooth and injuring his lip and gums with bruises near the eye. He suffered a concussion and still complains about a light headache sometimes.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Mast cell activation syndrome
Clinical narrative: Developed Mast cell activation syndrome-
Age: 4.0
Sex: F
Vaccine: DTPPVHBHPB, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Inadvertently administered Vaxelis instead of Quadracel (DTaP/IPV) to 4 yo girl as booster vaccine. DTaP/IPV omponents same but not intended as booster vaccine. Also additional HIB and hep B components, which pt likely did not need. No adverse effects for pt. Discussed with state program educator to confirm no additional doses of vaccine(s) needed for pt. Discussed with pt's father today as well to explain error and measures undertaken (planned 'timeout's in future and physical measures - separating boxes, relabeling boxes) to prevent any repetition of clinical error.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Product administration error
Clinical narrative: Patient received combination dose of MMR & Varicella, as well as the single dose of Varicella.  The staff was not aware of the error until documentation after administration. Following discussing vaccine error with provider, the patient's mother was made aware of possible adverse/side effects to be aware of. Patient was monitored for approximately 20 minutes; no adverse effects noted.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: The patient reported pain at the injection site with some swelling on 8/19 on 8/21 patient stated symptoms were resolved.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Left arm bright red, itchy, hot, hard as a rock from injection site to elbow.  Treated with ice, Tylenol and Benadryl with no relief.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Arthritis, Condition aggravated, Muscular weakness, Musculoskeletal stiffness, Neuralgia
Clinical narrative: The vaccine has caused the mild arthritis in my knees to increase such that sitting down, standing up and using stairs cause greater pain.  In addition, the vaccine has caused upper arm stiffness and weakness in both arms as well as arthritis in my hands, neither of which I have experienced before.  Occasionally, I have nerve pain in the left index finger, which I had only suffered once in my right thumb about a year ago.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, X-ray limb abnormal
Clinical narrative: The vaccine has caused the mild arthritis in my knees to increase such that sitting down, standing up and using stairs cause greater pain.  In addition, the vaccine has caused upper arm stiffness and weakness in both arms as well as arthritis in my hands, neither of which I have experienced before.  Occasionally, I have nerve pain in the left index finger, which I had only suffered once in my right thumb about a year ago.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity, Rash
Clinical narrative: received a message from mother the following morning (8/1/24)  noting son's arm had a rash from shoulder to elbow and was painful.
Age: 8.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: VACCINE ERROR.  QUADRACEL GIVEN OUT OF RECOMMENDED AGE RANGE.  NO ADVERSE EVENT
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: patient received diluent without vaccine powder mixed in
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Allergy to vaccine, Immediate post-injection reaction, Injection site pruritus, Injection site urticaria
Clinical narrative: Immediate itching following Proquad vaccine patient complained that his left thigh was itching and within ~15 minutes had a large hive to thigh (see picture below).  The hive noted below was 2 cm away from the actual injection site.  An ice pack was placed over the site and he was given 7.5 mL of Diphenhydramine HCl (12.5 mg/5 mL) oral solution.  Child was monitored in the clinic for an hour following his vaccine administration and he experienced no further hives to anywhere else on his body.  Prior to leaving the clinic this area to his thigh had reduced to approximately 6 cm in diameter. Gave parent Patient Education Handout: Hives as well as a Benadryl dosing sheet and instructed parents to continue Benadryl every 6-8 hours while he continued to have the urticaria to his thigh but would anticipate this local reaction reducing in size.  Added ProQuad to his allergy list and reassured parents that this was the first and last time he will be receiving this vaccine. Also highlighted our after hours call number and instructed parents to call for any concerns.  Advised our clinical nurse manager who placed a vaccine adverse event report.
Age: 56.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO ADVERSE REACTION -RX WAS GIVEN AT AGE 56 INSTEAD OF  RECCOMENDED AGE OF 6OYRS
Age: 9.0
Sex: M
Vaccine: DTAPIPV, HEP, HEPA, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO ADVERSE REACTION.  VACCINE ERROR.  VACCINE GIVEN OUTSIDE OF RECOMMENDED AGE RANGE
Age: 57.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt received vaccine at age 57 instead of 60 .
Age: 58.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event.  Patient received the vaccination before the allowed protocol age
Age: 59.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered 4 months prior to 60th birth date.
Age: 55.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event.  Patient received vaccination prior to allowed protocol age.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Rotavirus administered at 4 months.  This author realized vaccine error and notified nurse manager and PCP
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Cerebral endovascular aneurysm repair, Computerised tomogram head, Computerised tomogram head abnormal, Confusional state, Headache
Clinical narrative: Pt received Moderna vaccine on 03/31/2021. On 04/16/2021 she presented with confusion, H/A, N/V.  She was transferred r/t abnormal CT of head.  At ER she admitted and was dx with a Ruptured left PCOMM aneurysm.  On 04/16/2021 at 2:40 PM she had an IR Neuro Coiling Procedure completed.  Post surgical IMPRESSION: Successful endovascular coil emboilization of a ruptured right posterior communication artery aneurysm utilizing hydrogel coils. She remained in hospital until 04/26/21 when she was moved to the floor. She was discharged on 05/05/2021.  She received her 2nd Moderna on 05/16/2021, a booster on 11/23/2021 and a Moderna Bivalent vaccine on 12/19/2022.  All her COVID vaccines were provided by pharmacy. She presented to the health department on 07/22/2024  as her PCP thought she should report this event.  Her age today is 67 years.  Since the surgery she has had occasional episodes of seizure activity which her neurological provider following her post surgery indicated she may have.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Intensive care, Intracranial aneurysm, Nausea, Ruptured cerebral aneurysm, Seizure
Clinical narrative: Pt received Moderna vaccine on 03/31/2021. On 04/16/2021 she presented with confusion, H/A, N/V.  She was transferred r/t abnormal CT of head.  At ER she admitted and was dx with a Ruptured left PCOMM aneurysm.  On 04/16/2021 at 2:40 PM she had an IR Neuro Coiling Procedure completed.  Post surgical IMPRESSION: Successful endovascular coil emboilization of a ruptured right posterior communication artery aneurysm utilizing hydrogel coils. She remained in hospital until 04/26/21 when she was moved to the floor. She was discharged on 05/05/2021.  She received her 2nd Moderna on 05/16/2021, a booster on 11/23/2021 and a Moderna Bivalent vaccine on 12/19/2022.  All her COVID vaccines were provided by pharmacy. She presented to the health department on 07/22/2024  as her PCP thought she should report this event.  Her age today is 67 years.  Since the surgery she has had occasional episodes of seizure activity which her neurological provider following her post surgery indicated she may have.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Subarachnoid haemorrhage, Vomiting
Clinical narrative: Pt received Moderna vaccine on 03/31/2021. On 04/16/2021 she presented with confusion, H/A, N/V.  She was transferred r/t abnormal CT of head.  At ER she admitted and was dx with a Ruptured left PCOMM aneurysm.  On 04/16/2021 at 2:40 PM she had an IR Neuro Coiling Procedure completed.  Post surgical IMPRESSION: Successful endovascular coil emboilization of a ruptured right posterior communication artery aneurysm utilizing hydrogel coils. She remained in hospital until 04/26/21 when she was moved to the floor. She was discharged on 05/05/2021.  She received her 2nd Moderna on 05/16/2021, a booster on 11/23/2021 and a Moderna Bivalent vaccine on 12/19/2022.  All her COVID vaccines were provided by pharmacy. She presented to the health department on 07/22/2024  as her PCP thought she should report this event.  Her age today is 67 years.  Since the surgery she has had occasional episodes of seizure activity which her neurological provider following her post surgery indicated she may have.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pruritus, Rash, Rash papular, Skin exfoliation, Skin lesion
Clinical narrative: The day after vaccines, patient experienced erythematous papular rash starting on thighs and spreading anterior and posterior portions of both thighs, more scarcely distributed on trunk, upper chest, and back. Lesions are itchy, rough/scaly.  Improving on follow up 8/21. No sick symptoms as in viral exanthem and no other family members with rash as in scabies, bed bugs, etc. Less clear to me whether this is linked to vaccines or a separate process. If similar rash with any of the other vaccines has been documented, please contact me so that I can provide further guidance to family.
Age: 51.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: left arm had redness, swelling, warm to touch that went away with hydrocotrisone use in 1 weeks time , right arm has redness, swelling and hardening that is not going away with topical hydrocortisone - pt advised to seek medical attention from primary care
Age: 11.0
Sex: M
Vaccine: MNQ, UNK
Symptoms: Chills, Injection site induration, Injection site inflammation, Injection site warmth, Nausea
Clinical narrative: Reaction to injection site, left arm (Adacel): warm, inflamed hard.  Fever, chills, nausea, full body aches.
Age: 11.0
Sex: M
Vaccine: MNQ, UNK
Symptoms: Pain, Pyrexia
Clinical narrative: Reaction to injection site, left arm (Adacel): warm, inflamed hard.  Fever, chills, nausea, full body aches.
Age: 56.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The immunization was given outside of protocol based on the patient's age.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Somnolence
Clinical narrative: Pt described feeling dizzy and sleepy right after receiving vaccine and as she sat down in waiting area. She stated she had never had a similar reaction prior following a vaccination.  Upon assessment patient was pale in color but was able to state her name and where she was. She also commented that she had not ate anything for dinner last night or this morning for breakfast.  Pt was taken in a wheelchair to examination room to take down her vitals signs: BP 140/84 P: 60 R: 20 O2: 98%. Pt. was given water and a snack. She stated she was feeling better after 15 minutes of being examined and her color was back to normal. Pt was advised to set up follow-up visit with primary doctor after todays visit. Pt verbalized understanding and was in agreement. Pt left clinic accompanied by her mother.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: COVID-19, Disorientation, Loss of consciousness, SARS-CoV-2 test positive
Clinical narrative: Patient had gotten the shot at  mid after noon, the next morning at about 8 am his friend found him passed out on the floor. Patient was taken to hospital and had covid. It is unknown if the vaccine caused the passing out, or if it helped contribute. Patient had the 1st shot with no issues.  Patient was taken to the hospital and was discharged.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient did not experience any adverse reactions following vaccine. product was not indicated for 2 doses. patient received dose of Arexvy on 10/19/23 and should not have received additional dose on 1/3/24.  Pt denies side effects or adverse reactions after Pharmacist counseled patients on potential effects.
Age: 58.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patint under 60 administered vaccine, no adverse effects
Age: 78.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given same flu vaccine on 7/25/24 and then given a second on 8/20/24 in error. Patient has not had any adverse reactions.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain lower, Bedridden, Brain fog, Chills, Influenza like illness
Clinical narrative: Pt reported his arm was swollen, flu like symptom, fever, chills, body aches, bedridden for 48hrs, still on the 3rd day his arm  was swollen, pain on the scalp, lower abdominal pain, brain fog.  Pt was contacted for follow up and reported symptoms improved and he was feeling much better.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain of skin, Peripheral swelling, Pyrexia
Clinical narrative: Pt reported his arm was swollen, flu like symptom, fever, chills, body aches, bedridden for 48hrs, still on the 3rd day his arm  was swollen, pain on the scalp, lower abdominal pain, brain fog.  Pt was contacted for follow up and reported symptoms improved and he was feeling much better.
Age: 58.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine was administered prior to patient turning recommended age of 60 years. Patient was informed and guidance was provided to prevent revaccination once patient turns 60. No further action is needed.
Age: 50.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient received the vaccine outside of protocol based on patient's age. The patient reported that he didn't experience any adverse reactions.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Vaccines given on 8/19/24 without any reaction.  Mild erythema and rash developed on left arm around injection site on 8/21/24. Patient evaluated by Dr. No pain or decreased range of motion noted.  Instructed to use cold compress as needed on left arm.  For future vaccines, boosters of these vaccines will be given on different dates.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT RECIEVED EXTRA DOSE OF RSV BY MISTAKE. FIRST DOSE WAS IN APRIL 2024 THAT SHOULD HAVE BEEN ONLY DOSE BUT WAS ACCIDENTALLY GIVEN SECOND DOSE IN AUGUST 2024. RN CALLED PATIENT TO EXPLAIN SITUATION AND GO OVER POTENTIAL SIDE EFFECTS. NO CURRENT SIDE EFFECTS OTHER THAN AN UNRELATED HEADACHE THAT PATIENT HAS HAD FOR A COUPLE DAYS. PATIENT KNOWS WHAT TO LOOK OUT FOR AND WHAT TO SEEK MEDICAL TREATMENT FOR.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Erythema, Induration, Musculoskeletal stiffness
Clinical narrative: Arm stiff, red, warm to touch, throbbing, and hard from shoulder to elbow
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Skin warm
Clinical narrative: Arm stiff, red, warm to touch, throbbing, and hard from shoulder to elbow
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, and pain at immunization injection site (left Deltoid). Donor counseled on signs of symptom progression and need to contact outside medical care, verbalizing understanding.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Back pain, Body temperature increased, Headache, Monoplegia, Peripheral swelling
Clinical narrative: Developed swelling of the left arm and soreness after immunizations on 7/31/24.  Developed temp of 100.6 on 8/1/24 as well as headache and backache.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Rash, Rash pruritic
Clinical narrative: The evening of 8/15/24, the patient noticed a pinpoint, pruritic rash on her face. This rash and itching is still present, but has improved some.
Age: 56.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: N/a. Vaccine given when pt was 56. CDC recommendations in 2023 were for 60 years and older. CDC now recommends 75 for most patients and 60 and older for individuals with comorbidities
Age: 20.0
Sex: F
Vaccine: TD
Symptoms: Anxiety, Blood glucose normal, Dyspnoea, Nausea
Clinical narrative: Patient presented to Student Health Services on 8-21-24 for a tetanus booster and a physical.  The patient did not have any contractions to the vaccine.  She received the Tenivac vaccine (Lot: U8303AA; Exp: 09/2026).  After sitting for about 10 minutes, she began to feel nauseated.  Protocols were followed and patient was laid flat on back with cold compress to head and clothes loosened.  Her vitals were taken (BP:  126/83, 114/72, 132/84; Pulse: 101 and 95 (Patient chronically tachycardic); Blood glucose: 74).  Patient stated that she had not eaten today, was still nauseated, and now a little anxious and slightly short of breath. Patient was given some food, a promethazine 12.5 mg tablet, and some Benadryl, and she rested at the clinic until recovery.
Age: 53.0
Sex: F
Vaccine: HEP, HEPA, VARZOS
Symptoms: Arthralgia, Back pain, Neck pain
Clinical narrative: Aching pain from neck to lower back and hip area that started the morning after vaccination. Took ketorolac for pain without relief. Will seek care from provider if worsens.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: A hot red rash two inches in diameter appeared below the vaccination site the day after the vaccination. The rash became less red but grew to six inches in diameter over the next four days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Dtap/IPV combo vaccine was administered to pt on 8/15/24. According to the report in chart it showed that the pt was due for this vaccine. Mother gave us vaccine records for all of her children at pt's appointment. I inspected the records prior to administering the vaccine but I did not see the record pt had from another state. Upon further inspection today I found that I had missed this record when reviewing his vaccine history. According to his records pt received the vaccine on 12/28/23. The vaccine administered on 8/15/24 was a duplicate dose for this patient.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site swelling, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Vaccines on 8/16; by 8/17 Left arm  swelling, onset by morning in upper arm.  By 8/18 swelling had spread to entire arm and forearm with itchy bumps on left forearm also.  NO fever.  8/20 swelling started to decrease.  Seen in office 8/21, minimal swelling in upper arm still but marked swelling remained in left forearm approx 75% larger than right forearm but minimally tender, with excoriated approx 6 lesions ?vesicular vs papular.  Surrounding erythema and warmth.  Arm was very painful over weekend but pain improving by visit 8/21 and able to use arm. Treating with recc icing, ibuprofen and topical triamcinolone.  Plan to recheck at visit on 8/23.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash papular, Rash pruritic, Rash vesicular, Skin abrasion, Skin lesion
Clinical narrative: Vaccines on 8/16; by 8/17 Left arm  swelling, onset by morning in upper arm.  By 8/18 swelling had spread to entire arm and forearm with itchy bumps on left forearm also.  NO fever.  8/20 swelling started to decrease.  Seen in office 8/21, minimal swelling in upper arm still but marked swelling remained in left forearm approx 75% larger than right forearm but minimally tender, with excoriated approx 6 lesions ?vesicular vs papular.  Surrounding erythema and warmth.  Arm was very painful over weekend but pain improving by visit 8/21 and able to use arm. Treating with recc icing, ibuprofen and topical triamcinolone.  Plan to recheck at visit on 8/23.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Skin warm
Clinical narrative: Vaccines on 8/16; by 8/17 Left arm  swelling, onset by morning in upper arm.  By 8/18 swelling had spread to entire arm and forearm with itchy bumps on left forearm also.  NO fever.  8/20 swelling started to decrease.  Seen in office 8/21, minimal swelling in upper arm still but marked swelling remained in left forearm approx 75% larger than right forearm but minimally tender, with excoriated approx 6 lesions ?vesicular vs papular.  Surrounding erythema and warmth.  Arm was very painful over weekend but pain improving by visit 8/21 and able to use arm. Treating with recc icing, ibuprofen and topical triamcinolone.  Plan to recheck at visit on 8/23.
Age: 64.0
Sex: M
Vaccine: SMALLMNK, TYP
Symptoms: Abdominal pain upper, Diarrhoea, Injection site pain, Rectal haemorrhage
Clinical narrative: After receiving mpox and typhoid vacinnation a matter of minutes apart, I felt soreness in my upper right arm about 15-30 minutes later.  The soreness continued for almost 12 hours.  Approximately 11.5 hours later, at 0230 the following day, I woke up with a stomach ache and went to the bathroom.  Initially, my bowel movements were formed and hard.  After a couple BMs, they became soft, but firm.  After an hour or two, I had several bouts of diarrhea.  At approximately 0830, I attempted to have a BM, but a small amount of watery blood came out.  The same thing happened at approximately 1230.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse reactions occurred, a third dose was given in error
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site swelling, Rash, Rash macular
Clinical narrative: Patient has localized swelling in the site of vaccine of 2 cm in diameter indurated but not  significantly tender. Macular rash noted on the trunk and lower extremities improving since last night. Possible DTap and Hib allergy with vaccines given at 15 month wellness visit.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Arthritis, Attention deficit hyperactivity disorder, Back pain, Blood cholesterol increased
Clinical narrative: Now you show me the box? Go look at the other box.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Carpal tunnel syndrome, Limb injury, Major depression, Nightmare, Obesity
Clinical narrative: Now you show me the box? Go look at the other box.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Post-traumatic stress disorder, Rapid eye movement sleep behaviour disorder, Sleep apnoea syndrome, Tenosynovitis stenosans
Clinical narrative: Now you show me the box? Go look at the other box.
Age: 24.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Cold sweat, Confusional state, Dizziness, Fatigue
Clinical narrative: Patient stated he felt dizzy about 2 minutes after vaccine administration and lost consciousness fully for about 1 minute while sitting up in his chair. Skin cool, clammy, diaphoretic with pale lips/face. Pt initially confused when returning to consciousness. Pt normotensive w/ BP 120s/60s, tachycardic w/ pulse of 105, spo2 99%.  Pt transferred to clinic bed to raise feet up and given water and apple juice. Pt reported tingling in fingers, feeling cold/clammy, and feeling "drained" after coming to, but A&Ox4. Pt vomited x3 and reported feeling better afterwards. Pt monitored for 1 hour and medical director consulted prior to discharge with family.
Age: 24.0
Sex: M
Vaccine: HPV9
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Paraesthesia, Tachycardia
Clinical narrative: Patient stated he felt dizzy about 2 minutes after vaccine administration and lost consciousness fully for about 1 minute while sitting up in his chair. Skin cool, clammy, diaphoretic with pale lips/face. Pt initially confused when returning to consciousness. Pt normotensive w/ BP 120s/60s, tachycardic w/ pulse of 105, spo2 99%.  Pt transferred to clinic bed to raise feet up and given water and apple juice. Pt reported tingling in fingers, feeling cold/clammy, and feeling "drained" after coming to, but A&Ox4. Pt vomited x3 and reported feeling better afterwards. Pt monitored for 1 hour and medical director consulted prior to discharge with family.
Age: 24.0
Sex: M
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: Patient stated he felt dizzy about 2 minutes after vaccine administration and lost consciousness fully for about 1 minute while sitting up in his chair. Skin cool, clammy, diaphoretic with pale lips/face. Pt initially confused when returning to consciousness. Pt normotensive w/ BP 120s/60s, tachycardic w/ pulse of 105, spo2 99%.  Pt transferred to clinic bed to raise feet up and given water and apple juice. Pt reported tingling in fingers, feeling cold/clammy, and feeling "drained" after coming to, but A&Ox4. Pt vomited x3 and reported feeling better afterwards. Pt monitored for 1 hour and medical director consulted prior to discharge with family.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT HAS A BUMP AT THE SITE OF THE INJECTION AND HAS REDNESS ABOUT 3 INCHES IN DIAMETER AS WELL. ERYTHEMA IS HOT TO THE TOUCH AS WELL.  PATIENT RECEIVED ANTIBIOTICS FOR CELLULITIS.
Age: 6.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV, MMR, MNQ
Symptoms: No adverse event, Product administration error
Clinical narrative: MCV 4 was given in error, no adverse reaction noted after 15 minutes. Will follow up 8/22/24 by provider. Immunization division notified.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Pruritus, Rash, Vaccination site bruising
Clinical narrative: 08/21/2024- Patient called in to report that 5-7 days after she received dose #2 of her Heplisav B (07/31/2024 @ 2:45 pm), she began to have rash, itching, and chills. She also said that she has a bruise where the vaccine was administered. She states that she has experienced these symptoms intermittently beginning  at an unknown time 5-7 days after the vaccination. She denied having any shortness of breath or any other symptoms possibly related to allergic reaction. She was instructed to go to the nearest urgent care to be examined as she stated she would not be able to see her PCP for months. At no time did she notify this Clinic of her symptoms . She agreed to seek an exam at an urgent care. She states that the symptoms are ongoing.
Age: 5.0
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse events, Kinrix was ordered by provider and Vaxelis was given. Parents informed and told we would report error. Child doing well no issues.
Sex: F
Vaccine: HPV9
Symptoms: Intercepted product prescribing error, No adverse event
Clinical narrative: Patient did not receive their second dose of GARDASIL 9 due to being currently pregnant/was not pregnant when the first dose of GARDASIL 9 was administered.; No additional AE; This spontaneous report was received from a physician and referred to a currently 16-year-old female patient. This is a prospective report.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). The patient was not pregnant when the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered.  Administration date for second dose would have been on 24-JUL-2024 (reported as today), however, the patient did not receive her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) due to being currently pregnant (Maternal exposure before pregnancy), therefore, the doctor withheld the dose. Moreover, lot# and expiration date for the pre-filled syringe that was prepared for the patient but was discarded and not administered to the patient were reported (reported as lot# 2018414 and expiration date 11-DEC-2025). Pregnancy and fetal outcome were unknown. No further information provided. No additional adverse event (AE)/ no product quality complaint (PQC) (No adverse event).  Lot # is being requested and will be submitted if received.
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improper stored of product in use; This spontaneous report was received from a registered nurse referring to a 5-month-old male patient.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On 28-JUN-2024, the patient was vaccinated with the improperly stored of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot # 2003174, expiration date: 14-SEP-2025, the third dose, administered orally as prophylaxis (strength, and dose were not provided) (product storage error). The vaccine was exposed to 12.8 degrees Fahrenheit (F) (also reported as 12.7 F) for 76 hours 50 minutes and 0 seconds on unknown dates (reported from 28-APR-2024 to 01-JUL-2024). It was reported that vaccine was too cold for administration. There was no previous temperature excursion. No adverse event was reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2407USA000658: US-009507513-2408USA000406: US-009507513-2408USA000433: US-009507513-2408USA000547:
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improper storage of product in use; This spontaneous report was received from a registered nurse referring to an 11-year-old male patient.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.   On 28-JUN-2024, the patient was vaccinated with the improperly stored vaccine of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #X022737, expiration date: 12-APR-2026, the first dose, administered intramuscularly for prophylaxis (strength, and dose were not provided) (product storage error). The vaccine was exposed to 12.8 degrees Fahrenheit (F) (also reported as 12.7 F) for 76 hours 50 minutes and 0 seconds on unknown dates (reported as from 28-JUN-2024 to 01-JUL-2024). It was reported that vaccine was too cold for administration. There was no previous temperature excursion. No adverse event was reported (no adverse event).   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2408USA000396: US-009507513-2407USA000658: US-009507513-2408USA000406: US-009507513-2408USA000433: US-009507513-2408USA000547:
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: No adverse effects reported.; HCP calling to report 15 month old patient "moved her leg" during administration of PEDVAX HIB and likely did not get the full dose.  Per patients mother "there was alot of liquid still on her leg".  Unknown actual amount administered.; This spontaneous report was received from an other health professional (HCP) and referring to a 15-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-AUG-2024, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #X021053, expiration date reported as 15-MAY-2025, but upon internal validation established as: 15-MAY-2026, administered for prophylaxis (strength, dose and route of administration were not provided). Operator of device was health professional.  It was reported by HCP that the patient "moved her leg" during administration of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) and likely did not get the full dose (Underdose). Per patient's mother "there was a lot of liquid still on her leg". Unknown actual amount administered. No adverse effects reported (No adverse event). No other information provided.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient over the age of 20 years old received their first dose of RECOMBIVAX HB in February 2024 and would like to receive their second dose today; No additional AE; This spontaneous report was received from a pharmacist and referred to a patient over the age of 20 years old. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date in February 2024, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  The patient would like to receive the second dose today (12-AUG-2024) (Inappropriate schedule of product administration). No additional adverse event.  Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Student pharmacist calling regarding a female patient who has received her first dose of GARDASIL-9 in 2019 and has not received the subsequent doses. He is requesting information on if she needs to start the series over and if its appropriate to get; No additional AE/PQC.; This spontaneous report was received from a student pharmacist referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2019, the patient received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  She had not received the subsequent doses (Inappropriate schedule of product administration). The reporter was requesting information on if she needed to start the series over and if it was appropriate to get the second and the third dose. No additional adverse event (AE) (No adverse event).  Lot # is being requested and will be submitted if received.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE; multiple current below excursions where products were administered; This spontaneous report was received from an Other Health Professional and referred to a 12-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date, hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot #Y008285, expiration date: 24-NOV-2025) was underwent a temperature excursion of 0.9 Celsus (C) for 24 hours 40 minutes 0 seconds, and minus 1.1C for 0 hours 20 minutes 0 seconds. No previous excursions.  On 09-AUG-2024, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, strength 25/0.5 (unit not provided), lot #Y008285, expiration date: 24-NOV-2025, administered for prophylaxis (route of administration was not provided) (Product storage error). No Additional AE.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: No additional AE; Caller reported AE on behalf of an adult patient who was inadvertently administered 1 dose of PROQUAD on 8/13/2024 instead of 1 dose of MMR-II and 1 dose of VARIVAX administered separately. No symptoms reported. No additional AE details reported. Obt; Caller reported AE on behalf of an adult patient who was inadvertently administered 1 dose of PROQUAD on 8/13/2024 instead of 1 dose of MMR-II and 1 dose of VARIVAX administered separately. No symptoms reported. No additional AE details reported. Obt; This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 13-AUG-2024, the patient was inadvertently vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rhA)(PROQUAD) 0.5 mL/dose, lot # X025820 with expiration date 29-APR-2025, for prophylaxis (strength, route of administration and anatomical location were not reported), instead of 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and 1 dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration, anatomical location, Lot # and expiration date were not reported) administered separately (inappropriate schedule of product administration and wrong product administered). No additional adverse event (AE) was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; patient was accidently administered an expired dose of MMR II on Dec 15, 2020; This spontaneous report was received from an office manager on behalf of a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 15-DEC-2020, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) injection (lot#: R035704; expiration date was reported as 12-DEC-2020 but upon internal validation indicated as 09-DEC-2020; strength, dose, and route of administration were not reported) accidently by a health professional for prophylaxis (expired product administered). The vaccine had no prior temperature excursion. No additional adverse events (AE) were reported (no adverse event).  This case was received from the same reporter with the case 2408USA006174.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Blood creatinine increased, Blood urea increased, Dizziness, Injected limb mobility decreased, Injection site movement impairment
Clinical narrative: passing out; severe arm pain at the injection site; vomiting due to pain; vomiting due to pain/soreness; dizziness; limited range of motion at the injection site.; Increased creatinine; BUN; This spontaneous report was received from a registered nurse and refers to a 66-year-old female patient. The patient's medical history included: migraine. Her concomitant medications included: famotidine, ascorbic acid (VITAMIN C), fish oil, magnesium and vitamin d no otherwise specified (nos) (VITAMIN D).  Her concurrent conditions, drug reactions and allergies were not provided.  On 09-AUG-2024, the patient was vaccinated with a pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 0.5 milliliter, administered intramuscularly, lot #x023561, expiration date: 17-NOV-2025, (strength, dose#, and anatomical site of vaccination were not provided) for immunization.  On 09-AUG-2024, one hour after vaccination, the patient experienced following adverse reactions: severe arm pain at the injection site, passing out , vomiting due to pain, soreness, dizziness, and limited range of motion at the injection site. On an unspecified day in August due to the events, the she received  prednisone as a treatment of adverse events, additionally it was reported that she sought medical attention. On an unknown day in August 2024, the patient experienced blood creatinine increased, an iblood urea nitrogen (BUN) increased. On 12-AUG-2024, she had recovered from the events of: severe arm pain at the injection site, passing out , vomiting due to pain, soreness, dizziness, and limited range of motion at the injection site, whereas the outcome of the events of blood creatinine increased and blood urea nitrogen (BUN) increased was not provided.  The casual relationship between the suspect vaccine and the events was not provided, however for the events of severe arm pain at the injection site, passing out , vomiting due to pain, soreness, dizziness, and limited range of motion at the injection site was established as related per company guidelines. The casual relationship between the events of blood creatinine increased and blood urea nitrogen increased  was not provided (unknown).  Upon internal review, te event of passing out was determined to be medically significant.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Loss of consciousness, Vomiting
Clinical narrative: passing out; severe arm pain at the injection site; vomiting due to pain; vomiting due to pain/soreness; dizziness; limited range of motion at the injection site.; Increased creatinine; BUN; This spontaneous report was received from a registered nurse and refers to a 66-year-old female patient. The patient's medical history included: migraine. Her concomitant medications included: famotidine, ascorbic acid (VITAMIN C), fish oil, magnesium and vitamin d no otherwise specified (nos) (VITAMIN D).  Her concurrent conditions, drug reactions and allergies were not provided.  On 09-AUG-2024, the patient was vaccinated with a pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 0.5 milliliter, administered intramuscularly, lot #x023561, expiration date: 17-NOV-2025, (strength, dose#, and anatomical site of vaccination were not provided) for immunization.  On 09-AUG-2024, one hour after vaccination, the patient experienced following adverse reactions: severe arm pain at the injection site, passing out , vomiting due to pain, soreness, dizziness, and limited range of motion at the injection site. On an unspecified day in August due to the events, the she received  prednisone as a treatment of adverse events, additionally it was reported that she sought medical attention. On an unknown day in August 2024, the patient experienced blood creatinine increased, an iblood urea nitrogen (BUN) increased. On 12-AUG-2024, she had recovered from the events of: severe arm pain at the injection site, passing out , vomiting due to pain, soreness, dizziness, and limited range of motion at the injection site, whereas the outcome of the events of blood creatinine increased and blood urea nitrogen (BUN) increased was not provided.  The casual relationship between the suspect vaccine and the events was not provided, however for the events of severe arm pain at the injection site, passing out , vomiting due to pain, soreness, dizziness, and limited range of motion at the injection site was established as related per company guidelines. The casual relationship between the events of blood creatinine increased and blood urea nitrogen increased  was not provided (unknown).  Upon internal review, te event of passing out was determined to be medically significant.