chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-MAY-2025 This case was reported by a patient via interactive digital media. The reporter stated that bad stuff happened.  Patient got his/her shots, it helped, but it had already worked and still , he/she had it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; i got the shot and i still got shingles many times with it.; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: i got the shot and i still got shingles many times with it.). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-MAY-2025 This case was reported by a patient via interactive digital media. The patient got the shot and still got shingles many times with it.  The shingles was very tricky and the shot only last five years do your research before doing the shot.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: not feeling well after dose 1 of the vaccine; feeling rough after dose 1 of the vaccine; This non-serious case was reported by a physician via sales rep and described the occurrence of feeling unwell in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: not feeling well after dose 1 of the vaccine) and feeling abnormal (Verbatim: feeling rough after dose 1 of the vaccine). The outcome of the feeling unwell and feeling abnormal were not reported.   It was unknown if the reporter considered the feeling unwell and feeling abnormal to be related to Shingrix.     It was unknown if the company considered the feeling unwell and feeling abnormal to be related to Shingrix.   Additional Information: GSK receipt date: 29-MAY-2025 The patient was approximately 59 year old. The physician reported that he had taken first dose of Shingrix and experienced not feeling well and feeling rough. Despite this, he returned and completed the second dose. He had not described specific symptoms, and he had not stated how long the symptoms had lasted.
Vaccine: VARZOS
Symptoms: Muscular weakness
Clinical narrative: having muscle weakness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle weakness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced muscle weakness (Verbatim: having muscle weakness). The outcome of the muscle weakness was not resolved.   It was unknown if the reporter considered the muscle weakness to be related to Shingles vaccine.     It was unknown if the company considered the muscle weakness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 29-MAY-2025 This case was reported by a patient via interactive digital media. Patient was having muscle weakness and asked if that's was side effect.
Sex: M
Vaccine: COVID19
Symptoms: Autism spectrum disorder, Maternal exposure during pregnancy
Clinical narrative: took 4-5 shots while she was pregnant; Autism; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient was exposed to BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), transplacental, administration details for the mother: not provided as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The mother's relevant medical history and concomitant medications were not reported. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (medically significant), outcome "unknown", described as "took 4-5 shots while she was pregnant"; AUTISM SPECTRUM DISORDER (medically significant), outcome "unknown", described as "Autism".  Clinical flare reaction: Caller stated she (Patient's mother) was trying to learn about Autism and the screening and how to get him (patient) help/resources. Where could she get help to learn about Autism? Caller stated she was told that she might have it but was never screened and her Mom had a learning disability as well and there was a communication barrier with the Doctor. Patient's mother asking if she was still a participant in the Covid 19 Vaccine study? Caller stated she was trying to get in contact with them and also to see if they were studying the babies of the pregnant women who received the shots? Caller states she took 4-5 shots while she was pregnant with her son and he was showing signs of Autism. Caller stated her mom his Guardian and told her that she needs to sign over her rights as his parent to get him screened for autism. Caller stated her objective was not to report because she did not knew how to represent herself legally, for now she was just trying to get him services and if he had cognitive issues, get him the medical professionals to get screened and get care. Caller stated she was a willing volunteer, they didn't trick her. She stated she was just trying to get her son to get the services he needs.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500109463 Mom case;
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: experienced swelling, warmness, itching and noticed a red circle at the injection site; experienced swelling, warmness, itching and noticed a red circle at the injection site; experienced swelling, warmness, itching and noticed a red circle at the injection site; experienced swelling, warmness, itching and noticed a red circle at the injection site; This is a spontaneous report received from a Pharmacist from medical information team.  A 78-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), 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 WARMTH (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "experienced swelling, warmness, itching and noticed a red circle at the injection site".  Additional information : Patient experienced Swelling, warmness, itching and noticed a red circle at the injection site were started at day 4 or 5 after getting the vaccine. The patient would like to know if it was normal.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: severe pain in right arm, many doctor and PT visits, surgery on rotator cuff
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Pyrexia
Clinical narrative: fever for 1 day; injection site reaction for 3 days (red, hot, mild itchiness)
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: event: after receiving the third vaccine (on 5/22/25), it was discovered that the  second vaccine received on 1/22/25 (above) had expired on 1/06/2025.  patient was contacted and advised to receive additional hpv vaccine to complete series on or after aug 14 (12 weeks after vaccine given 5/22/25). no symptoms or signs experienced by patient.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events noted immediately after the administration and for the duration of the patient appointment visit.
Age: 76.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was administered the 2nd MenQuadfi dose too early. 1st MenQuadfi dose was administered on 4/2/2025 and 2nd dose was due on 5/28/2025 however, the 2nd dose was administered on 5/16 which was too early
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: HEPLISAV-BGiven at Step Step 1 of 2 Brand HEPLISAV-B Components Hepatitis B vaccine (recombinant), CpG adjuvanted Route IM Location deltoid Side L Lot No Given at Step Step 1 of 2 Brand HEPLISAV-B Components Hepatitis B vaccine (recombinant), CpG adjuvanted Route IM Location deltoid Side L Lot No 943888 Order details signed on 04/18/25 Order details signed on 04/18/25
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC20, RV5
Symptoms: Hyperhidrosis, Injection site reaction, Pain in extremity, Pyrexia, Rash
Clinical narrative: injection site reaction, rash and fever, swelling, warmth and pain both lower extremities
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC20, RV5
Symptoms: Skin warm
Clinical narrative: injection site reaction, rash and fever, swelling, warmth and pain both lower extremities
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cold sweat, Head injury, Hyperhidrosis, Hypotension, Pallor
Clinical narrative: Pt fainted 3 minutes after receiving, 3 vaccines. She was pale, clammy and sweaty, BP slightly low, pulse in 90's. She did hit her head when fainting, no open wound or concussion though. It took her 35 minutes to recover and be discharged. Provider did assess pt.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Pt fainted 3 minutes after receiving, 3 vaccines. She was pale, clammy and sweaty, BP slightly low, pulse in 90's. She did hit her head when fainting, no open wound or concussion though. It took her 35 minutes to recover and be discharged. Provider did assess pt.
Age: 63.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Feeling hot, Inflammation
Clinical narrative: Redness and inflammation, hot to the touch, two inches wide and 3 inches long. Lasted 3-4 days.
Age: 61.0
Sex: M
Vaccine: PNC21
Symptoms: Back pain, Dyspnoea, Headache, Injection site reaction, Nausea
Clinical narrative: following day, red sore injection site, headaches, back soreness, did not feel like I could take a full breath, nausea.  Day 2, sore injection site, back soreness, still not a full breath.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Limb mass, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Per patient and mother, On Thursday, left arm was more sore. On Friday morning, Left arm was sore, hot to the touch, itchy, with small lump. Per provider assessment: 2-3 cm erythematous, raised, itchy, not circular at anterior of bicep head, not over deltoid, not fluctuant, no induration. Advised cool compresses and Benadryl as needed.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Agitation, Dizziness, Dyskinesia, Eye pain, Gait disturbance
Clinical narrative: Mom got a call from the school nurse on Wednesday, April 30th at 11am stating her son was having a hard time walking, he was dizzy, nauseous, had a headache and vision was blurry.  He has a hx of migraines, so Mom thought it was that.  He then started complaining that he had severe neck pain, eye pain, jaw pain and numbness in fingers and told her that he felt like he ?was being stabbed in the brain?.  Mom took him to their PCP, and they recommended he go to hospital.  When they got to hospital, Mom said the doctor thought this was a side effect of his ADHD med, Adderall, but Mom said he had been on the med for over a year.  She told them about the vaccines he had gotten on Monday, April 28th and they said he had just probably developed a tic and that tics can develop at any time.  By this time, her son had become agitated, had the shakes and uncontrolled jaw movement.  He did not have a fever.  They sent them home and told her to give him Benedryl, Advil and take Guaifenesin at bedtime.   No CT scan or MRI were done.  Mom asked about Myasthenia Gravis and the doctor told her that he did not have this.  I did reach out to Mom on May 6th, to see how her son was doing, and she said the involuntary jaw movement lasted until Saturday, May 3rd but everything is now back to normal.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Hypoaesthesia, Nausea, Neck pain, Pain in jaw
Clinical narrative: Mom got a call from the school nurse on Wednesday, April 30th at 11am stating her son was having a hard time walking, he was dizzy, nauseous, had a headache and vision was blurry.  He has a hx of migraines, so Mom thought it was that.  He then started complaining that he had severe neck pain, eye pain, jaw pain and numbness in fingers and told her that he felt like he ?was being stabbed in the brain?.  Mom took him to their PCP, and they recommended he go to hospital.  When they got to hospital, Mom said the doctor thought this was a side effect of his ADHD med, Adderall, but Mom said he had been on the med for over a year.  She told them about the vaccines he had gotten on Monday, April 28th and they said he had just probably developed a tic and that tics can develop at any time.  By this time, her son had become agitated, had the shakes and uncontrolled jaw movement.  He did not have a fever.  They sent them home and told her to give him Benedryl, Advil and take Guaifenesin at bedtime.   No CT scan or MRI were done.  Mom asked about Myasthenia Gravis and the doctor told her that he did not have this.  I did reach out to Mom on May 6th, to see how her son was doing, and she said the involuntary jaw movement lasted until Saturday, May 3rd but everything is now back to normal.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Tic, Tremor, Vision blurred
Clinical narrative: Mom got a call from the school nurse on Wednesday, April 30th at 11am stating her son was having a hard time walking, he was dizzy, nauseous, had a headache and vision was blurry.  He has a hx of migraines, so Mom thought it was that.  He then started complaining that he had severe neck pain, eye pain, jaw pain and numbness in fingers and told her that he felt like he ?was being stabbed in the brain?.  Mom took him to their PCP, and they recommended he go to hospital.  When they got to hospital, Mom said the doctor thought this was a side effect of his ADHD med, Adderall, but Mom said he had been on the med for over a year.  She told them about the vaccines he had gotten on Monday, April 28th and they said he had just probably developed a tic and that tics can develop at any time.  By this time, her son had become agitated, had the shakes and uncontrolled jaw movement.  He did not have a fever.  They sent them home and told her to give him Benedryl, Advil and take Guaifenesin at bedtime.   No CT scan or MRI were done.  Mom asked about Myasthenia Gravis and the doctor told her that he did not have this.  I did reach out to Mom on May 6th, to see how her son was doing, and she said the involuntary jaw movement lasted until Saturday, May 3rd but everything is now back to normal.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Fall
Clinical narrative: after receiving vaccine and waiting in the clinic, patient was light headed upon exiting and fell into the wall. He did not lose consciousness
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Throat tightness
Clinical narrative: Client stated that she felt like her throat was closing post injections for just a "second.".  Client was monitored for 15 minutes with no distress noted before being  released with no labored respirations.  Mother stated that the child was a "Drama Queen."
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient reports since the injection his left arm has been feeling like he has no mobility and is having trouble using his arm. Patient prefers to defer second dose of vaccine
Age: 1.33
Sex: M
Vaccine: PNC20
Symptoms: Injection site swelling
Clinical narrative: leg swelling at the injection site with redness and warmth. Mom used benadryl cream and ice over the course of 2 days
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Asthenia, Blood sodium decreased, Chest X-ray normal, Computerised tomogram neck, Full blood count normal
Clinical narrative: Sore arm started evening of the vaccine that progressively worsened over time.  Around midnight on May 25, patient reports weakness and the inability to get out of bed to go to the bathroom.  The headache was described as the worst headache ever experienced.  Patient had nausea and vomiting and generalized weakness.  Patient admitted to ED around 8am.  Patient administered ketorolac IV one dose along with diphenhydramine which helped with headache.  Patient was discharged around noon.  Patient's headache was gone the next day but after a week from this incidence she still reports fatigue.
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Headache, International normalised ratio normal, Metabolic function test normal, Mobility decreased, Nausea
Clinical narrative: Sore arm started evening of the vaccine that progressively worsened over time.  Around midnight on May 25, patient reports weakness and the inability to get out of bed to go to the bathroom.  The headache was described as the worst headache ever experienced.  Patient had nausea and vomiting and generalized weakness.  Patient admitted to ED around 8am.  Patient administered ketorolac IV one dose along with diphenhydramine which helped with headache.  Patient was discharged around noon.  Patient's headache was gone the next day but after a week from this incidence she still reports fatigue.
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Pain in extremity, Prothrombin time normal, Troponin normal, Urine analysis normal, Vomiting
Clinical narrative: Sore arm started evening of the vaccine that progressively worsened over time.  Around midnight on May 25, patient reports weakness and the inability to get out of bed to go to the bathroom.  The headache was described as the worst headache ever experienced.  Patient had nausea and vomiting and generalized weakness.  Patient admitted to ED around 8am.  Patient administered ketorolac IV one dose along with diphenhydramine which helped with headache.  Patient was discharged around noon.  Patient's headache was gone the next day but after a week from this incidence she still reports fatigue.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: The Medical Assistant assigned to the provider accidentally administered an expired vaccine to a patient. The vaccine is ineffective, and the patient needs to get another dose of the medication.
Age: 13.0
Sex: F
Vaccine: HEP, MMRV
Symptoms: No adverse event
Clinical narrative: ProQuad vaccine was administered to patient on 05/30/2025. Patient is 13 years old, and ProQuad is not routinely recommended for this age group. No adverse reaction observed at the time. Patient will be monitored as appropriate. Provider has been informed.
Age: 41.0
Sex: F
Vaccine: HPV9, MMR, TDAP
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient called on 6/2/25 to report allergic reaction that began evening of 6/1/25 after receiving vaccines. Patient described fever, body ache, chills, sore arm. Patient states that fever has resolved at this time but body soreness is still present.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2nd dose only 2 weeks after first dose.  @nd dose invalid due to be given too soon.  Patient only stated they felt tired no other reaction noted.
Age: 8.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administered combo vaccine to an 8-year-old patient that is only indicated for ages 4-6, so he should have received DTaP and IPV as separate injections.  No adverse events or side effects reported by patient or his parents.  Steps have been taken within the office to avoid this error in the future.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired vaccines was administered to patient. vaccine expired on 5/29/2025
Age: 0.92
Sex: F
Vaccine: MMR
Symptoms: Adenoidal hypertrophy, Blood culture negative, Body temperature increased, CSF culture negative, Clonus
Clinical narrative: On 4/27/25, patient and her mom were on a plane in (redacted state) about to return to (redacted state). Mom noticed patient suddenly became lethargic with rightward gaze deviation, clonic movement of R arm, which spread to involve her full body. EMS gave two doses Versed with cessation of seizure for total duration of 20 minutes. She had a temp of 101.7F at that time. At Hospital, had L arm clonic movement, leftward gaze and intermittent twitching. Received two doses of IV lorazepam and Keppra bolus, was intubated and started on Versed drip. She was transferred to another level of care Hospital and admitted to the PICU. Started on Keppra, had continuous video EGG without seizure activity.   She remained intubated for brain MRI, which was reassuring, then extubated and weaned to room air. Transitioned from Keppra to Klonopin by discharge. Received IV ceftriaxone, vancomycin and acyclovir while blood, urine and CSF studies were pending. She had mostly returned to baseline neurologic status by discharge on 4/30/25. She has since followed up with Pediatric Neurology on 5/12/25. She had an EEG on 5/7/25 that was normal for her age.
Age: 0.92
Sex: F
Vaccine: MMR
Symptoms: Computerised tomogram head normal, Coronavirus test positive, Culture urine negative, Electroencephalogram normal, Endotracheal intubation
Clinical narrative: On 4/27/25, patient and her mom were on a plane in (redacted state) about to return to (redacted state). Mom noticed patient suddenly became lethargic with rightward gaze deviation, clonic movement of R arm, which spread to involve her full body. EMS gave two doses Versed with cessation of seizure for total duration of 20 minutes. She had a temp of 101.7F at that time. At Hospital, had L arm clonic movement, leftward gaze and intermittent twitching. Received two doses of IV lorazepam and Keppra bolus, was intubated and started on Versed drip. She was transferred to another level of care Hospital and admitted to the PICU. Started on Keppra, had continuous video EGG without seizure activity.   She remained intubated for brain MRI, which was reassuring, then extubated and weaned to room air. Transitioned from Keppra to Klonopin by discharge. Received IV ceftriaxone, vancomycin and acyclovir while blood, urine and CSF studies were pending. She had mostly returned to baseline neurologic status by discharge on 4/30/25. She has since followed up with Pediatric Neurology on 5/12/25. She had an EEG on 5/7/25 that was normal for her age.
Age: 0.92
Sex: F
Vaccine: MMR
Symptoms: Gaze palsy, HCoV-HKU1 infection, Intensive care, Lethargy, Magnetic resonance imaging head normal
Clinical narrative: On 4/27/25, patient and her mom were on a plane in (redacted state) about to return to (redacted state). Mom noticed patient suddenly became lethargic with rightward gaze deviation, clonic movement of R arm, which spread to involve her full body. EMS gave two doses Versed with cessation of seizure for total duration of 20 minutes. She had a temp of 101.7F at that time. At Hospital, had L arm clonic movement, leftward gaze and intermittent twitching. Received two doses of IV lorazepam and Keppra bolus, was intubated and started on Versed drip. She was transferred to another level of care Hospital and admitted to the PICU. Started on Keppra, had continuous video EGG without seizure activity.   She remained intubated for brain MRI, which was reassuring, then extubated and weaned to room air. Transitioned from Keppra to Klonopin by discharge. Received IV ceftriaxone, vancomycin and acyclovir while blood, urine and CSF studies were pending. She had mostly returned to baseline neurologic status by discharge on 4/30/25. She has since followed up with Pediatric Neurology on 5/12/25. She had an EEG on 5/7/25 that was normal for her age.
Age: 0.92
Sex: F
Vaccine: MMR
Symptoms: Mastoid effusion, Muscle twitching, Pharyngeal disorder, Respiratory viral panel, Seizure
Clinical narrative: On 4/27/25, patient and her mom were on a plane in (redacted state) about to return to (redacted state). Mom noticed patient suddenly became lethargic with rightward gaze deviation, clonic movement of R arm, which spread to involve her full body. EMS gave two doses Versed with cessation of seizure for total duration of 20 minutes. She had a temp of 101.7F at that time. At Hospital, had L arm clonic movement, leftward gaze and intermittent twitching. Received two doses of IV lorazepam and Keppra bolus, was intubated and started on Versed drip. She was transferred to another level of care Hospital and admitted to the PICU. Started on Keppra, had continuous video EGG without seizure activity.   She remained intubated for brain MRI, which was reassuring, then extubated and weaned to room air. Transitioned from Keppra to Klonopin by discharge. Received IV ceftriaxone, vancomycin and acyclovir while blood, urine and CSF studies were pending. She had mostly returned to baseline neurologic status by discharge on 4/30/25. She has since followed up with Pediatric Neurology on 5/12/25. She had an EEG on 5/7/25 that was normal for her age.
Age: 0.92
Sex: F
Vaccine: MMR
Symptoms: Tonsillar hypertrophy
Clinical narrative: On 4/27/25, patient and her mom were on a plane in (redacted state) about to return to (redacted state). Mom noticed patient suddenly became lethargic with rightward gaze deviation, clonic movement of R arm, which spread to involve her full body. EMS gave two doses Versed with cessation of seizure for total duration of 20 minutes. She had a temp of 101.7F at that time. At Hospital, had L arm clonic movement, leftward gaze and intermittent twitching. Received two doses of IV lorazepam and Keppra bolus, was intubated and started on Versed drip. She was transferred to another level of care Hospital and admitted to the PICU. Started on Keppra, had continuous video EGG without seizure activity.   She remained intubated for brain MRI, which was reassuring, then extubated and weaned to room air. Transitioned from Keppra to Klonopin by discharge. Received IV ceftriaxone, vancomycin and acyclovir while blood, urine and CSF studies were pending. She had mostly returned to baseline neurologic status by discharge on 4/30/25. She has since followed up with Pediatric Neurology on 5/12/25. She had an EEG on 5/7/25 that was normal for her age.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: No Adverse effects from employee.
Age: 1.67
Sex: M
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: When the Medical Assistant mixed the vaccine, the wrong sterile diluent was used.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, UNK
Symptoms: Urticaria
Clinical narrative: URTICARIA DEVELOPED WITHIN ONE HOURPOST VACCINATION WITH MMRV AND QUADRACEEL. NO ANAPHYLACTIC SYMPTOMS. TREATED WITH BENADRYL AND CETRIZINE.RESOLVED WITHIN 24 HOURS
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was given second dose of Menquadfi too early. No adverse reactions reported.
Age: 60.0
Sex: F
Vaccine: PNC21, TDAP
Symptoms: Injection site bruising, Injection site swelling, Injection site warmth
Clinical narrative: Red to purple bruising 6"x4" in diameter on LEFT upper arm, as described by patient.  Area swollen and continues to be warm to touch.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Extra dose administered
Clinical narrative: I gave a DTaP thinking it was his 4th dose of DTaP; however, it was his 5th dose of DTaP upon further determination through another source.
Age: 66.0
Sex: F
Vaccine: PNC21
Symptoms: Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Patient had injection site pain immediately following administration as she normally does after immunizations, however 2-3 hours following administration the pain began to spread to her shoulder and create stiffness. It kept getting worse for 1-2 weeks, but then stopped getting worse and has been a constant and stable pain for about three weeks. She still cannot move her arm above her shoulder.  She reached out to her PCP a couple weeks ago and his office told her to make an appointment if it did not improve. She said she has not had time to make an appointment and can't miss any more work for additional doctor's appointments. She said it does still impact her daily activity, but does not interfere with sleep (aside from it being more difficult to get out of bed).
Age: 66.0
Sex: F
Vaccine: PNC21
Symptoms: Musculoskeletal stiffness
Clinical narrative: Patient had injection site pain immediately following administration as she normally does after immunizations, however 2-3 hours following administration the pain began to spread to her shoulder and create stiffness. It kept getting worse for 1-2 weeks, but then stopped getting worse and has been a constant and stable pain for about three weeks. She still cannot move her arm above her shoulder.  She reached out to her PCP a couple weeks ago and his office told her to make an appointment if it did not improve. She said she has not had time to make an appointment and can't miss any more work for additional doctor's appointments. She said it does still impact her daily activity, but does not interfere with sleep (aside from it being more difficult to get out of bed).
Age: 6.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: No adverse event, Wrong patient
Clinical narrative: No adverse event occurred, this event was a medication/vaccine error. The pt was ordered to have Hep B and MMR but was given Varicella and Polio (ordered for sister present at time of visit). Both siblings were in the exam room.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Condition aggravated, Cough, Ear infection, Encephalitis, Hypersensitivity
Clinical narrative: Melanoma with unknown primary, encephalitis of the brain, various allergies, post nasal drip with cough, tinnitus, ear infections.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Malignant melanoma, Tinnitus, Upper-airway cough syndrome
Clinical narrative: Melanoma with unknown primary, encephalitis of the brain, various allergies, post nasal drip with cough, tinnitus, ear infections.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: States felt "unwell" day of vaccination.  No other symptoms indicated.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: the child did not have any adverse reactions to the medication, after she had left the clinic is when I realized that I had given the wrong meningococcal vaccine for the wrong age.
Age: 47.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Fatigue, Influenza like illness, Injection site erythema, Lymphadenopathy
Clinical narrative: I received the CAPVAXIVE (21-valent pneumococcal conjugate) vaccine on Saturday, May 31st around 3:00 PM at a pharmacy. The vaccine was administered as part of an immunological workup due to suspected immune dysfunction (possible CVID or MCAS), to evaluate my ability to mount an appropriate antibody response. Within 24 hours, I developed significant arm pain and redness at the injection site, which progressively worsened rather than improved. By 36?48 hours post-injection, the pain had intensified and spread from the deltoid area down into the lower bicep, with visible redness and swelling. I also experienced chills, deep fatigue, and flu-like symptoms, leading me to go to bed at 4:45 PM the following day. As of today (just under 48 hours post-vaccine), I continue to have significant fatigue, a low-grade fever, mild throat irritation, postnasal drip, and swollen lymph nodes? all localized to the left side only, corresponding with the arm where the vaccine was administered. The red area on my arm is about the size of a palm. For symptom management, I?ve used Zyrtec (cetirizine), famotidine, as well as Advil (ibuprofen) every 4?6 hours. This combination makes it possible to lift my arm, but the pain returns between doses. I plan to go to bed early again due to ongoing fatigue. No formal medical evaluation yet. Symptoms are still active at the time of this report.
Age: 47.0
Sex: F
Vaccine: PNC21
Symptoms: Myalgia, Pain in extremity, Pyrexia, Throat irritation, Upper-airway cough syndrome
Clinical narrative: I received the CAPVAXIVE (21-valent pneumococcal conjugate) vaccine on Saturday, May 31st around 3:00 PM at a pharmacy. The vaccine was administered as part of an immunological workup due to suspected immune dysfunction (possible CVID or MCAS), to evaluate my ability to mount an appropriate antibody response. Within 24 hours, I developed significant arm pain and redness at the injection site, which progressively worsened rather than improved. By 36?48 hours post-injection, the pain had intensified and spread from the deltoid area down into the lower bicep, with visible redness and swelling. I also experienced chills, deep fatigue, and flu-like symptoms, leading me to go to bed at 4:45 PM the following day. As of today (just under 48 hours post-vaccine), I continue to have significant fatigue, a low-grade fever, mild throat irritation, postnasal drip, and swollen lymph nodes? all localized to the left side only, corresponding with the arm where the vaccine was administered. The red area on my arm is about the size of a palm. For symptom management, I?ve used Zyrtec (cetirizine), famotidine, as well as Advil (ibuprofen) every 4?6 hours. This combination makes it possible to lift my arm, but the pain returns between doses. I plan to go to bed early again due to ongoing fatigue. No formal medical evaluation yet. Symptoms are still active at the time of this report.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None known
Age: 9.0
Sex: F
Vaccine: HEP, TD, VARCEL
Symptoms: Extra dose administered
Clinical narrative: I misunderstood that patient needed a 3rd Tetanus, due to no childhood doses and had only 2 tetanus at that point. It was discussed with father at the time  - because database indicated complete. He agreed to get 3rd dose for child.
Age: 66.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain, Arthralgia, Decreased appetite, Fatigue, Nausea
Clinical narrative: Six days after shot began extreme fatigue. It has continued. Days 7 to 10 systemic joint pain. I tried 2 days of Aleve but it didn't help as much as the advil I took today.  Days 8 to 10 abdominal pain, nausea, and low appetite.
Age: 0.5
Sex: M
Vaccine: FLU3, HEPA, PNC20, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Given Havrix instead of Vaxelis. Not old enough for Vaxelis.
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: RN administered the Varivax vaccine and ProQuad vaccine on the same day. RN thought that she was administering MMR instead of ProQuad, but administered ProQuad (MMRV) and Varivax together. RN spoke to MD after the event around 11:15. RN notified the pt and the pt guardian that the pt received 2 doses of Varicella. Pt was monitored for 20 min after the event. No adverse outcomes were noted. RN gave pt strict return to clinic / ED protocol if pt develops a rash, fever > 101 F, difficulty breathing, facial swelling, or other concerning symptoms.
Age: 62.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Rash
Clinical narrative: On May 7, 2025, pt received Prevnar 20 and Shingrix vaccines. On June 2, 2025, pt came to the pharmacy to report a rash that he developed 4 days after receiving the vaccines. Pt has been only using a moisturizer cream to help with the rash. Advised pt to take Zyrtec or Benadryl and use hydrocortisone cream 1% and if symptoms persist or worsen to seek medical help. Pt verbalized understanding. Pt did not report any allergies and states he is not taking any medications.
Age: 1.92
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 3 given 3 weeks after dose 2 instead of waiting the 8 weeks.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Per mom after patient recived vaccine, patients arm began to swell up. The next day mom notice patient's arm got red and itchy and the arm felt warm. Mom had been giving Motrin for pain and it looked to be helping patient per mom.
Age: 45.0
Sex: F
Vaccine: PNC20
Symptoms: Dermatitis, Injection site erythema, Injection site pain, Vasculitis
Clinical narrative: Development of pain and redness at injection site; Development of pain and redness at injection site; Development of vasculitis/dermatitis on both legs; Development of vasculitis/dermatitis on both legs; This is a spontaneous report received from a Consumer or other non HCP.  A 45-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 20May2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 45 years, in left arm for immunisation. The patient's relevant medical history included: "Lupus SLE" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Allergy to shellfish" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE, start date: 14May2025; COLCHICINE, start date: 12Feb2025. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 22May2025, outcome "recovering" and all described as "Development of pain and redness at injection site"; DERMATITIS (non-serious), VASCULITIS (non-serious) all with onset 22May2025, outcome "recovering" and all described as "Development of vasculitis/dermatitis on both legs". Therapeutic measures were taken as a result of dermatitis, vasculitis including the use of steroid ointment for legs.  Additional information: Development of pain and redness at injection site that persists over 1 week. Development of vasculitis/dermatitis on both legs 2 days after administration. The patient did not receive any other vaccines on the same date as the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: After the first vaccination she had the vaginal bleeding/ vaginal bleeding for the two years; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VAGINAL HAEMORRHAGE (medically significant), outcome "not recovered", described as "After the first vaccination she had the vaginal bleeding/ vaginal bleeding for the two years". The event "after the first vaccination she had the vaginal bleeding/ vaginal bleeding for the two years" required physician office visit. Patient mentioned route of administration as: arm, unknown if left or right side. Other Conditions/ products mentioned as No; Investigations mentioned as: No. Calling about Covid Vaccination, Pfizer Covid Vaccination. The patient received the vaccine 2 years ago. Patient also been bleeding since got the vaccination. She has been having vaginal bleeding for the two years. Have been seen by several specialist not just one.  When attempted to clarify if there was a specific one to provide she stated her primary doctor she just moved. Other Conditions: At the time took the vaccination was a very health woman. Was not taking any medications. The patient did not receive any other vaccines on the same date as the Pfizer vaccine. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. Confirmed had the bleeding with the first vaccination. After the first vaccination she had the vaginal bleeding, but she was not aware why she was going through it. The patient was not allergic to any previous vaccination, medications, food or other products.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500111472 same patient, reporter, vaccine/ different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had covid; had covid; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: has long Covid symptoms; has long Covid symptoms; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NOV25-00368 (Novavax).  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "has long Covid symptoms".  Clinical course: Reporter stated she was trying to find a Novavax vaccine for her daughter before she was travelling to (redacted). She stated her daughter "needs to get the Novavax because she reacted very badly to Pfizer and everything". She did not mention if daughter has had any Novavax Covid-19 vaccine previously. She also stated that her daughter "has long Covid symptoms and can't have the other two vaccines.  No follow-up attempts are possible. Batch/Lot number is not provided, and it cannot be obtained
Age: 9.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inappropriate use due to administering Pentacel when the same patient was 7 and 9 years old with no reported adverse event; Initial information received on 30-May-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9 years old female patient who was inappropriately use administered with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] when the patient was 7 and 9 years old with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis a vaccine (Hepatitis a vaccine) and Varicella zoster vaccine live (Oka/Merck) (Varivax) for Immunisation.  On 24-Feb-2025, the patient received 0.5mL (dose 1) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection ((lot UK168AA, expiry date 31-Oct-2025) via intramuscular route in the deltoid NOS (not other specified) and on 11-Apr-2023 she also received 0.5mL (dose 2) of vaccine (lot UJ807AA, expiry date 01-Oct-2023)  (frequency once and strength standard) via intramuscular route in the deltoid NOS for Immunisation.  On 24-Feb-2025, the patient was inappropriately administered with pentacel when the same patient was 7 and 9 years old with no reported adverse event (product administered to patient of inappropriate age) (latency same day).  Reportedly, the reporter called to ask a question regarding the administration of Pentacel. She mentioned that the patient came from another country and she was behind her routine vaccines. Patient needed DTAP, IPV, and HIB. Pentacel was first given when the patient was 7 years old and now that she's 9 years old. Reporter asked if it was okay or if the patient needs to be re-vaccinated.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Proquad given within 28 days after Flumist vaccine
Age: 32.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: PATIENT WAS GIVEN PEDIATRIC DOSE AS OPPOSED TO ADULT DOSE OF HEPATITIS A VACCINATION