chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Syncope
Clinical narrative: Pt immediately fell after receiving both vaccinations in the right arm (1 in. apart). He fell back and hit his head on the door behind him. He had posturing and was turned to his side. He became alert and was sat in a chair for evaluation. He had sinus bradycardia (HR 44) and BP (100/70's). He was pale and stated he did not remember what happened. He had a bump on the back of his head, no laceration or blood noted, however patient also reported a headache and nausea.  One of our physicians evaluated him, he was alert and oriented x3, PERRLA, with vitals stabilizing once EMS arrived. He reports getting faint at the sight of blood, when asked if this has happened before, however he had not mentioned this during pre-screening. This likely was vasovagal syncope.
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, Fatigue
Clinical narrative: Patient incorrectly received a second dose of the Arexvy RSV vaccine on 8-15-24, after already receiving a dose on 2-15-24. Revaccination is not recommended by the vaccine manufacturer at this time. Patient, physician, and vaccine manufacturer were contacted about this event. Patient reported excess fatigue a few hours after administration but no other adverse effects.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient incorrectly received a second dose of the Arexvy RSV vaccine on 8-15-24, after already receiving a dose on 2-15-24. Revaccination is not recommended by the vaccine manufacturer at this time. Patient, physician, and vaccine manufacturer were contacted about this event. Patient did not experience any adverse effects.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea, Nausea
Clinical narrative: patient states that she has had many flu shots in the past with no real adverse events.  this flu vaccine caused severe nausea and diarrhea for since receiving the flu vaccine.  she c/o nausea and diarrhea until 08/17/2024 (time of reporting).
Age: 0.17
Sex: M
Vaccine: UNK
Symptoms: Cough, Laboratory test, Nasal congestion, Respiratory syncytial virus infection
Clinical narrative: patient started having cough and nasal congestion and did not get better ended up being tested and now has case  of  RSV
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Carotid artery stent insertion, Chest pain, Coronary artery bypass, Myocardial infarction
Clinical narrative: Had chest pain before having a heart attack on 9/06/2021.  It was 10 days after the vaccine
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Malaise, Migraine, Mobility decreased, Neck pain
Clinical narrative: The morning after the shingles vaccine I had a horrible migraine and my body ached all over.  I?m on day two and I?m still feeling sick. I?m so sick I can?t get out of bed. I have taken over the counter painkillers and no luck.  I have sweats and neck aches.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: The morning after the shingles vaccine I had a horrible migraine and my body ached all over.  I?m on day two and I?m still feeling sick. I?m so sick I can?t get out of bed. I have taken over the counter painkillers and no luck.  I have sweats and neck aches.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No complaints from patient - reporting because this was the patients second flu shot this season.
Age: 85.0
Sex: F
Vaccine: FLUA4, TDAP
Symptoms: Extra dose administered
Clinical narrative: duplicate administration of fluad on 7/26/24 and 08/17/24
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiac monitoring abnormal, Cardiac stress test, Colonoscopy, Dizziness
Clinical narrative: Upon receiving the vaccine I felt "different", and everyday after I felt slowly worse. 5 weeks post vaccine,  all these different feeling/changes in my body became more intense. I felt labored breathing upon mild exercise, along with vision changes, and then ultimately heart palpitations. I felt lethargic and with mild exercising I thought I would pass out, and I did twice. My primary doctor sent me to a Pulmonologist (which took 2 months to get in due to the covid pandemic). I did numerous tests and they concluded it wasn't a pulmonary issue. I was then sent to a Cardiologist (and again due to covid it took 5 months post vaccine to see him). They put a heart monitor on me for a week, and it was confirmed that I had a heart arrythmia. I was put on medication to help with the heart arrythmia. That March 2022, I had a MRI (6 months post beginning of symptoms) and it was found I had mild fluid around my heart suggesting I had the end stages of myocarditis.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Dyspnoea exertional, Endoscopy, Feeling abnormal, Inflammatory marker test
Clinical narrative: Upon receiving the vaccine I felt "different", and everyday after I felt slowly worse. 5 weeks post vaccine,  all these different feeling/changes in my body became more intense. I felt labored breathing upon mild exercise, along with vision changes, and then ultimately heart palpitations. I felt lethargic and with mild exercising I thought I would pass out, and I did twice. My primary doctor sent me to a Pulmonologist (which took 2 months to get in due to the covid pandemic). I did numerous tests and they concluded it wasn't a pulmonary issue. I was then sent to a Cardiologist (and again due to covid it took 5 months post vaccine to see him). They put a heart monitor on me for a week, and it was confirmed that I had a heart arrythmia. I was put on medication to help with the heart arrythmia. That March 2022, I had a MRI (6 months post beginning of symptoms) and it was found I had mild fluid around my heart suggesting I had the end stages of myocarditis.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Lethargy, Loss of consciousness, Magnetic resonance imaging, Magnetic resonance imaging heart abnormal
Clinical narrative: Upon receiving the vaccine I felt "different", and everyday after I felt slowly worse. 5 weeks post vaccine,  all these different feeling/changes in my body became more intense. I felt labored breathing upon mild exercise, along with vision changes, and then ultimately heart palpitations. I felt lethargic and with mild exercising I thought I would pass out, and I did twice. My primary doctor sent me to a Pulmonologist (which took 2 months to get in due to the covid pandemic). I did numerous tests and they concluded it wasn't a pulmonary issue. I was then sent to a Cardiologist (and again due to covid it took 5 months post vaccine to see him). They put a heart monitor on me for a week, and it was confirmed that I had a heart arrythmia. I was put on medication to help with the heart arrythmia. That March 2022, I had a MRI (6 months post beginning of symptoms) and it was found I had mild fluid around my heart suggesting I had the end stages of myocarditis.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pericardial effusion, Pulmonary function test normal, Ultrasound scan, Visual impairment
Clinical narrative: Upon receiving the vaccine I felt "different", and everyday after I felt slowly worse. 5 weeks post vaccine,  all these different feeling/changes in my body became more intense. I felt labored breathing upon mild exercise, along with vision changes, and then ultimately heart palpitations. I felt lethargic and with mild exercising I thought I would pass out, and I did twice. My primary doctor sent me to a Pulmonologist (which took 2 months to get in due to the covid pandemic). I did numerous tests and they concluded it wasn't a pulmonary issue. I was then sent to a Cardiologist (and again due to covid it took 5 months post vaccine to see him). They put a heart monitor on me for a week, and it was confirmed that I had a heart arrythmia. I was put on medication to help with the heart arrythmia. That March 2022, I had a MRI (6 months post beginning of symptoms) and it was found I had mild fluid around my heart suggesting I had the end stages of myocarditis.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Upon receiving the vaccine I felt "different", and everyday after I felt slowly worse. 5 weeks post vaccine,  all these different feeling/changes in my body became more intense. I felt labored breathing upon mild exercise, along with vision changes, and then ultimately heart palpitations. I felt lethargic and with mild exercising I thought I would pass out, and I did twice. My primary doctor sent me to a Pulmonologist (which took 2 months to get in due to the covid pandemic). I did numerous tests and they concluded it wasn't a pulmonary issue. I was then sent to a Cardiologist (and again due to covid it took 5 months post vaccine to see him). They put a heart monitor on me for a week, and it was confirmed that I had a heart arrythmia. I was put on medication to help with the heart arrythmia. That March 2022, I had a MRI (6 months post beginning of symptoms) and it was found I had mild fluid around my heart suggesting I had the end stages of myocarditis.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cervix carcinoma stage III, Detoxification, Echocardiogram, Electrocardiogram, Hysterectomy
Clinical narrative: MODERNA #1 1/5/2021 MODERNA #2 2/2/2021 MODERNA #3 1/4/2022 DEVELOPED VACCINE INDUCED RAPIDLY PROGRESSIVE STAGE 3 UTERINE CANCER REQUIRING HYSTERECTOMY, PELVIC WASHING, AND RECOMMENDATIONS FOR MULTI-DRUG CHEMOTHERAPY.   MRNA VACCINE CONSIDERED A DETERMINANT SUPPORTED BY  PATIENT ADDITIONALLY TREATED WITH PROTOCOL BASE SPIKE DETOXIFICATION AS SHE MAKES DECISIONS ON ADJUVANT CHEMOTHERAPY.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Imaging procedure abnormal, Laboratory test, Peritoneal washing cytology
Clinical narrative: MODERNA #1 1/5/2021 MODERNA #2 2/2/2021 MODERNA #3 1/4/2022 DEVELOPED VACCINE INDUCED RAPIDLY PROGRESSIVE STAGE 3 UTERINE CANCER REQUIRING HYSTERECTOMY, PELVIC WASHING, AND RECOMMENDATIONS FOR MULTI-DRUG CHEMOTHERAPY.   MRNA VACCINE CONSIDERED A DETERMINANT SUPPORTED BY  PATIENT ADDITIONALLY TREATED WITH PROTOCOL BASE SPIKE DETOXIFICATION AS SHE MAKES DECISIONS ON ADJUVANT CHEMOTHERAPY.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient received the child/adolescent dose of the vaccine rather than the adult dose.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Disturbance in attention, Echocardiogram, Electrocardiogram, Laboratory test, Malaise
Clinical narrative: PFIZER #1 4/5/2021 PFIZER #2 4/26/2021 PFIZER BIVALENT #3 9/13/2022 DEVELOPED POST EXERTIONAL MALAISE, LOSS OF MENTAL CLARITY, SMALL FIBER NEUROPATHY.  TREATED WITH NICOTINE PATCH AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Small fibre neuropathy
Clinical narrative: PFIZER #1 4/5/2021 PFIZER #2 4/26/2021 PFIZER BIVALENT #3 9/13/2022 DEVELOPED POST EXERTIONAL MALAISE, LOSS OF MENTAL CLARITY, SMALL FIBER NEUROPATHY.  TREATED WITH NICOTINE PATCH AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Dysuria, Nitrite urine absent, Protein urine present, Proteinuria, Urinary occult blood negative
Clinical narrative: proteinuria and dsyuria.  initially no treatment; monitoring for resolution.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: White blood cells urine negative
Clinical narrative: proteinuria and dsyuria.  initially no treatment; monitoring for resolution.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Apnoea, Blood glucose, Electrocardiogram, Loss of consciousness, Pallor
Clinical narrative: Very sleepy after shot 5 hours later started in with projectile vomiting then stopped breathing and passed out and turned completely gray and we couldn?t get her to wake up. She did not wake up until firefighters got to our home. She was still very pale when she woke and was just laying there very out of it. Two hours after even started in with 101 fever and has continued to have fever since the event.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Pyrexia, Skin discolouration, Somnolence, Unresponsive to stimuli, Vomiting projectile
Clinical narrative: Very sleepy after shot 5 hours later started in with projectile vomiting then stopped breathing and passed out and turned completely gray and we couldn?t get her to wake up. She did not wake up until firefighters got to our home. She was still very pale when she woke and was just laying there very out of it. Two hours after even started in with 101 fever and has continued to have fever since the event.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe tinnitus in both ears almost immediately after receiving both Covid-19 vaccines
Age: 70.0
Sex: M
Vaccine: FLUA4
Symptoms: Arthralgia, Back pain, Pain in extremity
Clinical narrative: Patient reports that the next day he experienced intense pain in his lower back and sore joints in addition to the normal sore arm. Patient reports no redness, swelling, itching, or trouble breathing. Patient used icy hot patch and took his valacyclovir and the pain decreased considerably. He reported this today three days after vaccination and is still a little sore but has improved.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Injection site pain
Clinical narrative: PATIENT REPORTED PAIN AT INJECTION SITE THAT HAS CONTINUED TO  OCCUR TO TODAY, AND SHE STATES THAT THIS PAIN NOT GOES DOWN THE ARM AND SHE HAD A FALL THAT SHE MAY ATTRIBUTE TO THIS VACCINE. SHE STATES TH TRIED AT HOME REMEDY WITH NO AVAIL. SHE STATES SHE HAS A DR APPOINTMENT THIS WEEK TO EVALUATE.
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis
Clinical narrative: Patient came in 8/18/24 and stated after she got a prevnar imz she developed cellulitis in same arm
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness transitory, Ear congestion, Pyrexia, Tinnitus
Clinical narrative: 8 hours aver the vaccine was given, I experienced deafness lasting about 8 more hours with a low-pitched and soft ringing at the same time. It felt like a stuffy nose only in my ears. I'm not sure how it's possible to be deaf yet  still hear something.  I also had a fever of 101.2F but that seemed OK.  Tylenol worked fine.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient stated today upon arriving for his 2nd dose that he broke out into a rash on both arms the night of his first dose. He stated that he was late (longer than 2 months) for the 2nd one. I suggested he call the md and he stated they often did not respond to him. I suggested that he wait until we could contact the MD on Monday (or this week) and speak with his provider. Once/If the provider ok the 2nd dose, we would call him. He still wanted to get but wife asked him to wait until we called to verify. I explained that if it were a true allergic reaction, it could be worse with the 2nd dose. He is waiting for us to contact md, they respond, and us to call him back either way. He did not state that he had to go to any clinic or any md about the rash. Simply stated that he waited longer in between the doses to completely heal. Unknown to reporter the number of days he had rash
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I developed chronic idiopathic uticaria hives I had to go on Xolair shots to get rid of them I still get hives if I don?t take my shots on time it took over my life and took months to find out my diagnosis with a proper doctor
Sex: M
Vaccine: HPV9
Symptoms: Orchitis noninfective
Clinical narrative: left testicular inflammation; This spontaneous report was received from a nurse (patient's mother) via a company representative referring a 11-year-old male patient.  Concurrent condition, medical history, and concomitant medication 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) injection, administered for prophylaxis at a clinic (strength, dose, route, lot#, and expiration date were not reported). On an unknown date, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) with 6 months apart between doses.  On an unknown date, the patient experienced left testicular inflammation. The patient had sought medical attention. The reporter called the pediatrician and he recommend going to emergency room with him to see if it could be something that had to be operated, the patient was now at hospital to assess with inflammation in the testicles. Hospitalization was reported. It was unknown if treatment was given. HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) product had been discarded and was not available for retrieval. Outcome of the event was unknow. Action taken with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not applicable.  Causality between the event and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.  Lot# is being requested and will be submitted if received.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Patient was given dose 1 of Shingrix but only given adjuvant; Patient was given dose 1 of Shingrix but only given adjuvant; This non-serious case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Patient was given dose 1 of Shingrix but only given adjuvant) and inappropriate dose of vaccine administered (Verbatim: Patient was given dose 1 of Shingrix but only given adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 07-AUG-2024 Patient was given dose 1 of Shingrix but only given adjuvant which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Patient did not receive antigen plus adjuvant. Healthcare professional stated that he would like for Shingrix to be ready to administer upon arrival and not require reconstitution (single vial or prefilled syringe).
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-AUG-2024 This case was reported by a consumer via interactive digital media. The patient got one shingles vaccine, made him/her very sick and never got the second one.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number KX3LM, expiry date 31-JUL-2025) for prophylaxis.   On 05-AUG-2024, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 05-AUG-2024 The nurse called and reported that they had a vaccine drown up on the first, it was the Menveo and it was in the prefilled syringe and it was given today (on the reporting day), which led to incorrect storage of drug. The vaccine was stored outside recommended conditions and administered to patient.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA912A, expiry date 31-MAR-2024) for prophylaxis.   Previously administered products included Menveo (1st dose received on 25-OCT-2022).   On 07-AUG-2024, the patient received the 2nd dose of Menveo. On 07-AUG-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-AUG-2024 Nurse explained they accidentally administered an expired dose of Menveo (2 vial presentation), which led expired vaccine used. The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Incorrect dose administered, Wrong product administered
Clinical narrative: Adult dose to a 16 years old; Adult dose to a 16 years old; the 4th dose of Engerix-B that the patient received; incorrectly administer Engerix-B instead of Men B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 16-year-old female patient who received HBV (Engerix B) (batch number 92NK2, expiry date 29-SEP-2026) for prophylaxis.   Previously administered products included engerix b (1st dose), engerix b (2nd dose) and engerix b (3rd dose).   On 06-AUG-2024, the patient received the 4th dose of Engerix B. On 06-AUG-2024, an unknown time after receiving Engerix B, the patient experienced adult use of a child product (Verbatim: Adult dose to a 16 years old), underdose (Verbatim: Adult dose to a 16 years old), extra dose administered (Verbatim: the 4th dose of Engerix-B that the patient received) and wrong vaccine administered (Verbatim: incorrectly administer Engerix-B instead of Men B). The outcome of the adult use of a child product, underdose, extra dose administered and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-AUG-2024 The reporter reported one of staff member give an adult Hepatitis B mistakenly to the patient, which led underdose and adult use of a child product. Due to a mistake, they administer Engerix-B instead of Men B vaccine, which led wrong vaccine administered. As they incorrectly administer Engerix-B instead of Men B, this was the 4th dose of Engerix-B that the patient received, extra dose administered. The reporter consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: concerned patients did not receive the full dose; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete dose administered in a specified number of patients who received Men B NVS (Bexsero) (batch number FH443, expiry date 30-SEP-2027) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete dose administered (Verbatim: concerned patients did not receive the full dose). The outcome of the incomplete dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 08-AUG-2024 The physician had an issue with a box of Bexsero a bubble was in each syringe and they were unable to rid the syringes of the bubble. They were concerned that the patients they administered the Bexsero to did not receive the full dose which led to incomplete dose administered. A total of 5 patients received.
Age: 7.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediarix was administered to a 7 year old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number E9Y29, expiry date 26-OCT-2024) for prophylaxis.   On 05-AUG-2024, the patient received Pediarix. On 05-AUG-2024, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: Pediarix was administered to a 7 year old). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 08-AUG-2024 CMA stated that Pediarix was administered to a 7 year old which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate Schedule of Vaccine (second dose); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) (batch number 547MC, expiry date 13-JUN-2026) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 06-AUG-2024, the patient received the 2nd dose of Shingrix. On 06-AUG-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate Schedule of Vaccine (second dose)). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 08-AUG-2024 The reporter wanted to know what to do if a Shingrix vaccine (second dose) had been administered to a patient a month early.  The reporter confirmed there was a real patient involved in that situation and this is the second dose for that patient (pharmacist did not provide detail about first dose vaccination date).  Vaccine (lot number/expiration date) and vaccination date detail were retrieved and registered in the corresponding section above.  Once demographics were asked, the pharmacist said that he/she did not have information on the patient right now. The reporter did not consent to follow-up. No further information was collected since the pharmacist was anxious and rude during the phone call. The patient received the 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: both vaccines were drawn into one syringe and administered as one injection with no reported AE; Initial information received on 09-Aug-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  The case is linked to 2024SA241435.  This case involves a 11 years old female patient who received both vaccines of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] were drawn into one syringe and administered as one injection 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 HPV Vaccine for Prophylactic vaccination.  On 09-Aug-2024, the patient received a unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (Suspension for injection) (lot 2CA56C1, Expiry date: 12-May-2025, strength was unknown) via intramuscular route in the right arm. for Immunization and both vaccines were drawn into one syringe and administered as one injection with no reported adverse event (wrong technique in product usage process) (latency : same day).  Reportedly " HCP (healthcare professional) asked if patient should receive Adacel and Menquadfi vaccines again due to having been administered in the same syringe. "  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA241435:02176249
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: an inappropriate use due to administering dose of PENTACEL giving only the liquid DTAP/IPV component, without reconstituting with the lyophilized HIB portion of the vaccine with no reported adverse event; Initial information received on 12-Aug-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 months old female patient who stated that an inappropriate use due to administering dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] giving only the liquid dtap/ipv component, without reconstituting with the lyophilized hib portion of the vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On 05-Aug-2024, the patient received a dose 1 of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Powder and suspension for suspension for injection) (lot UK019AA, Expiry date: Jun-2025, strength :standard) via intramuscular route in the right thigh for Immunization and an inappropriate use due to administering dose of pentacel giving only the liquid dtap/ipv component, without reconstituting with the lyophilized hib portion of the vaccine with no reported adverse event (Single component of a two-component product administered) (latency : same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Medication error, No adverse event, Wrong technique in product usage process
Clinical narrative: MENQUADFI & ADACEL were drawn up with the same syringe and administered separately but was given to a patient,with no reported adverse event; Initial information received on 12-Aug-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  The case is linked to 2024SA241801.  This case involves a 11 years old female patient who received Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] and adacel were drawn up with the same syringe and administered separately but was given to a patient,with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV Vaccine for Prophylactic vaccination.  On 09-Aug-2024, the patient received a unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine (Solution for injection) (lot U7827AB, expiry date: 01-Sep-2025, frequency: once, strength :standard) via intramuscular route at right arm for prophylactic vaccination (Immunization) and menquadfi & adacel were drawn up with the same syringe and administered separately but was given to a patient,with no reported adverse event (wrong technique in product usage process) (latency : same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA241801:02176249
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Extra dose administered, Medication error
Clinical narrative: inadvertently received multiple doses of both MENQUADFI (4 doses total) due to the patient having multiple accounts with no reported AE; Initial information received on 13-Aug-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case- 2024SA242611  This case involves a 16 years old female patient who inadvertently received multiple doses of both MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] (4 doses total) due to the patient having multiple accounts with no reported ae (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Jul-2018 patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection via unknown route in unknown administration site. The patient also received same vaccine on 11-Jan-2023 and  10-Jul-2023 (strength, dose, batch number and expiry date unknown). On 12-Aug-2024 she received same vaccine dose 0.5 ml Total, batch U8124AA expiry-30-Sep-2027 via intramuscular route in the left deltoid for Immunization (strength unknown) inadvertently received multiple doses of both menquadfi (4 doses total) due to the patient having multiple accounts with no reported ae (extra dose administered) (latency same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA242611:
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Only the liquid portion DTAP- IPV portion was administered to the patient.with no reported adverse event; Initial information received on 13-Aug-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient to whom only the liquid portion dtap- ipv portion was administered with no reported adverse event with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination.  On 08-Aug-2024, the patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, 0.5 ml TOTAL, Powder and suspension for suspension for injection expiry 24-Nov-2024 lot UJ982AA via intramuscular route in the left vastus lateralis for Immunization (strength unknown) only the liquid portion dtap- ipv portion was administered with no reported adverse event (single component of a two-component product administered) (latency same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administering daptacel to 11 years patient outside of the age indication in the approved product labeling with no reported adverse event; DAPTACEL was inadvertently administered to an 11-year-old instead of the intended ADACEL with no reported adverse event; Initial information received on 13-Aug-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old female patient who received Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] was inadvertently administered instead of the intended adacel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 05-Aug-2024, the patient received a dose 5 of 0.5 ml of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine (Suspension for injection) (Frequency : Total, lot 2CA77C1, Expiry date: 30-Apr-2024, strength was unknown) via intramuscular route in the left arm for prophylactic vaccination (Immunization) and administering daptacel to 11 years patient outside of the age indication in the approved product labeling with no reported adverse event (product administered to patient of inappropriate age) and daptacel was inadvertently administered to an 11-year-old instead of the intended adacel with no reported adverse event (wrong product administered)(latency : same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test abnormal, Cognitive disorder, Full blood count abnormal, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Hospitalization for over a month. Unable to move. Level 4 pitted adema, all blood counts and tests were off the charts, had to learn how to do simply motor functions, cognitive issues, loss of normal human functions, the worst experience of my life.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Motor dysfunction, Oedema
Clinical narrative: Hospitalization for over a month. Unable to move. Level 4 pitted adema, all blood counts and tests were off the charts, had to learn how to do simply motor functions, cognitive issues, loss of normal human functions, the worst experience of my life.
Age: 11.0
Sex: F
Vaccine: COVID19, IPV, MENB, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Child received Covid-19 vaccine for age 12 and above.
Age: 11.0
Sex: F
Vaccine: COVID19, IPV, MENB, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Child received Covid-19 vaccine for age 12 yrs and above.
Age: 34.0
Sex: F
Vaccine: RSV
Symptoms: Condition aggravated, Delivery, Exposure during pregnancy, Uterine contractions during pregnancy, Vaginal haemorrhage
Clinical narrative: Pregnancy history: 36 week gestation, 6/10/2024 admitted to hospital for 2 days due to vaginal bleeding and contractions (diagnosed with placenta rupture about 30%, discharged with no longer bleeding and contractions), got 2 shots of steroid into each buttock to stimulate baby lung development in case. Expected date: 07/14/2024. 06/13/2024 Obgyn still recommended Abrysvo even being aware of risk of early delivery. 06/15/2024 got Abrysvo by itself and started getting low intensity but constant contractions. 06/16/2024 experienced both low intensity but constant contractions and moderate contractions all days and at 11 pm experienced some vaginal bleeding. Got admitted this night. Delivered baby 04 lbs and 15 oz
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC20
Symptoms: Erythema, Lip swelling, Rash, Rash macular, Rash papular
Clinical narrative: 11 days after vaccines, patient woke up with diffuse erythema. 2-5mm raised blotchy disconnected spots surrounded by a white halo. It continued to spread and worsen over the next 2 days, peaking on the evening of day 12. Day 12 rash had spread head to toes, worst on trunk and feet. Swelling to jaw/lips also
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC20
Symptoms: Swelling face
Clinical narrative: 11 days after vaccines, patient woke up with diffuse erythema. 2-5mm raised blotchy disconnected spots surrounded by a white halo. It continued to spread and worsen over the next 2 days, peaking on the evening of day 12. Day 12 rash had spread head to toes, worst on trunk and feet. Swelling to jaw/lips also
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Pharyngeal hypoaesthesia
Clinical narrative: Mom brought pt to clinic so this nurse could evaluate, Left  upper arm is red and swollen and hot to the touch from just below deltoid process and right above elbow. Pt describes tonsils feeling numb on 8/1/24. Referrred to PCP 8/2/24 @9:30am. RN 8/2/24  8/2/24-Mom called clinic reports took to PCP and child was diagnosed with cellulitis in left arm and placed child on Cephalexin antibiotic. RN 8/2/24
Age: 1.75
Sex: M
Vaccine: DTAPIPVHIB, PNC15
Symptoms: No adverse event, Product preparation issue
Clinical narrative: INADVERTENLY ADMINISTERE DTAP AND POLIO DILUENT OF PENTACEL WITHOUT MIXING THE HIB POWDERED COMPONENT OF THE PENTACEL. NO ADVERSE REACTIONS NOTED OR VOICED BY PARENT.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Hypersomnia, Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: pain at injection site and all up and down her arm, also had fever for 4 days, aching all over, slept all weekend.
Age: 8.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: NONE
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Crying, Dyskinesia, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Fever, swelling and redness at site, knot for 6 days at sight, uncontrollable crying for hours since shot administered , twitching and jerking.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Muscle twitching, Pyrexia
Clinical narrative: Fever, swelling and redness at site, knot for 6 days at sight, uncontrollable crying for hours since shot administered , twitching and jerking.
Age: 17.0
Sex: M
Vaccine: HEP, HPV9, IPV, MENB, MMRV, TDAP, UNK, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: On 8/15/24 patient was scheduled to received his second Varicella and MMR based on his vaccine history, instead due to an error a Proquad and an additional varicella was administered. The teenager has no complains or had any adverse reaction during or after vaccine administration during clinic visit. Called parent on 8/16/2024 at 12:25pm no answer left voice message. Spoke to teen's mom on Monday, 8-19-24 at 9:45am, she reports the 17-year-old did not show or complained of any adverse effects up to these points. Mom stated, no fevers, no malaise, or any other s/s. Instructed mom to keep child's next vaccine appointment for middle of October.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Computerised tomogram head, Electrocardiogram normal, Hyporesponsive to stimuli, Laboratory test
Clinical narrative: Prior to administration, patient was at baseline orientation (alert and oriented x 3). Able to make needs known. Afebrile. No s/sx of infection noted and patient reports feeling well and declines any shortness of breath, cough, or feeling sick. Vaccine was administered IM to patient's left arm on 8/16. On 8/17, patient had slightly elevated temp at 99.9, patient was leaning towards the right with lessened trunk control and appeared less conversative than at baseline.  VITALS on 8/17 @3pm HR 117, BP 194/135, O2 96% RA. Patient was transferred to hospital. Patient received full work up in ED. EKG showed no abnormalities, CT of Head was negative for acute intracranial hemorrhage, hydrocephalus, or acute territorial infarction. CT did note potential for acute sinusitis. Urine and CXR negative.  Patient received 1 L of NS for hydration but has CKS stage 3b at baseline. Patient was admitted to hospital for ongoing observation as of 8/17/24.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Posture abnormal, Urine analysis normal
Clinical narrative: Prior to administration, patient was at baseline orientation (alert and oriented x 3). Able to make needs known. Afebrile. No s/sx of infection noted and patient reports feeling well and declines any shortness of breath, cough, or feeling sick. Vaccine was administered IM to patient's left arm on 8/16. On 8/17, patient had slightly elevated temp at 99.9, patient was leaning towards the right with lessened trunk control and appeared less conversative than at baseline.  VITALS on 8/17 @3pm HR 117, BP 194/135, O2 96% RA. Patient was transferred to hospital. Patient received full work up in ED. EKG showed no abnormalities, CT of Head was negative for acute intracranial hemorrhage, hydrocephalus, or acute territorial infarction. CT did note potential for acute sinusitis. Urine and CXR negative.  Patient received 1 L of NS for hydration but has CKS stage 3b at baseline. Patient was admitted to hospital for ongoing observation as of 8/17/24.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Dry mouth
Clinical narrative: She got her vaccine, after a few days or so she started having dry mouth and went to the ER on 7th or 8 for a low pulse she had during the night.  She wasn't aware if she had COVID or not, but blamed the dry mouth on other things like her medications.  She did some adjustments and this has helped a little.   She still has the dry mouth but it is not as bad, and was on some other medications and stopped them as they tend to cause dry mouth.  She is not sure if the vaccine is related to the dry mouth but feels that it could be.  She has gone to her PCP twice, went to UC and she went to an ENT doctor thinking that she may have had a blocked salivary gland.  She was recommended to go to rheumatology to see if she had Sjogren's and had testing done that was negative.  She is going to be rechecked for the antibody screening in 5 months.  This came on suddenly and that's why she feels it is related to the vaccine.