chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: F
Vaccine: DTPPVHBHPB, FLU4, PNC13, DTPPVHBHPB, FLU4, PNC13
Symptoms: Adenovirus infection, Decreased appetite, Diarrhoea, Ear infection, Gastroenteritis
Clinical narrative: A man called and identified himself as the father on 5/23/23 and stated that had to take the child to the ER for vomiting / diarrhea and decreased PO intake.  Was concerned that the immunizations may of caused the s/s.  He was a poor historian on the phone, was unsure of the discharge instructions from the ED, states had no MD to take the child to.  Reviewed needed to take the child to the nearest pediatric clinic for follow up after ED visit.  Obtained ED visit, Medical decision making:  Vital signs were reviewed and were acceptable.  Patient was seen in ED, had taken a few sips of Pedialtye while in the ED.  Child was treated for for an ear infection and given an IM injection of IM antibiotic per family request.  Was given Rocephin and was recommended to follow up with pediatritrician.  The child was suspected to have adenoviral gastroenteritis and told to follow up in ED for significant worsening of symptoms.  Patient was discharged home in good stable condition.  Sent home with amoxicillin, Q 12 hrs.
Age: 1.25
Sex: F
Vaccine: DTPPVHBHPB, FLU4, PNC13, DTPPVHBHPB, FLU4, PNC13
Symptoms: Vomiting
Clinical narrative: A man called and identified himself as the father on 5/23/23 and stated that had to take the child to the ER for vomiting / diarrhea and decreased PO intake.  Was concerned that the immunizations may of caused the s/s.  He was a poor historian on the phone, was unsure of the discharge instructions from the ED, states had no MD to take the child to.  Reviewed needed to take the child to the nearest pediatric clinic for follow up after ED visit.  Obtained ED visit, Medical decision making:  Vital signs were reviewed and were acceptable.  Patient was seen in ED, had taken a few sips of Pedialtye while in the ED.  Child was treated for for an ear infection and given an IM injection of IM antibiotic per family request.  Was given Rocephin and was recommended to follow up with pediatritrician.  The child was suspected to have adenoviral gastroenteritis and told to follow up in ED for significant worsening of symptoms.  Patient was discharged home in good stable condition.  Sent home with amoxicillin, Q 12 hrs.
Age: 1.0
Sex: F
Vaccine: COVID19-2, HEPA, MMR, PNC13, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt inadvertently received wrong COVID vaccine; no signs or symptoms of adverse reaction
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy kidney, Blindness unilateral, Computerised tomogram thorax, Decreased appetite, Dysphonia
Clinical narrative: Begin to have massive headaches and loss of appetite. My voice started to sound raspy. By December of that year 2021, I wound up in the hospital:     I was diagnose with Vasculitis, Kidney failure, loss sight to my right eye, neuropathy on 2 fingers of my right hand,  and  peripheral neuropathy on the balls of my feet.  A hematologist, Dr. had me do a lab that revealed the presence of a particular gene mutation called: MTHFR MUTATION (HOMOZYGOUS), a blood clotting gene as I understand it.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Gene mutation identification test positive, Headache, Laboratory test abnormal, Magnetic resonance imaging, Methylenetetrahydrofolate reductase gene mutation
Clinical narrative: Begin to have massive headaches and loss of appetite. My voice started to sound raspy. By December of that year 2021, I wound up in the hospital:     I was diagnose with Vasculitis, Kidney failure, loss sight to my right eye, neuropathy on 2 fingers of my right hand,  and  peripheral neuropathy on the balls of my feet.  A hematologist, Dr. had me do a lab that revealed the presence of a particular gene mutation called: MTHFR MUTATION (HOMOZYGOUS), a blood clotting gene as I understand it.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Renal failure, Vasculitis
Clinical narrative: Begin to have massive headaches and loss of appetite. My voice started to sound raspy. By December of that year 2021, I wound up in the hospital:     I was diagnose with Vasculitis, Kidney failure, loss sight to my right eye, neuropathy on 2 fingers of my right hand,  and  peripheral neuropathy on the balls of my feet.  A hematologist, Dr. had me do a lab that revealed the presence of a particular gene mutation called: MTHFR MUTATION (HOMOZYGOUS), a blood clotting gene as I understand it.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Unevaluable event
Clinical narrative: none
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: none
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: I had my vaccination on 09/21/2022. I started to have a scratchy throat on 05/16/2023. I tested COVID-19 Positive on 05/18/2023. I was not provided a course of treatment. I was told to treat for aches and pains and fever. I am presently still experiencing congestion and coughing on 05/24/2023. These symptoms are becoming less and less each day.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Throat irritation
Clinical narrative: I had my vaccination on 09/21/2022. I started to have a scratchy throat on 05/16/2023. I tested COVID-19 Positive on 05/18/2023. I was not provided a course of treatment. I was told to treat for aches and pains and fever. I am presently still experiencing congestion and coughing on 05/24/2023. These symptoms are becoming less and less each day.
Age: 0.83
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Underdose
Clinical narrative: Received smaller dose of bivalent covid vaccine as second primary shot
Age: 0.5
Sex: F
Vaccine: COVID19, DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Underdose
Clinical narrative: Received smaller dose of bivalent covid vaccine as first primary dose
Age: 13.0
Sex: M
Vaccine: COVID19-2, HPV9
Symptoms: Dizziness, Fall
Clinical narrative: PATIENT IN WAITING ROOM AFTER VACCINES ADMINSTRATION. PATIENT FELT DIZZY WHILE HE GOT UP TO GO DRINK WATER FROM THE WATER FOUNTAIN. PT FELL TO FLOOR SIDE WAYS. MOM AND PATIENT DENIED HEAD INJURY, MOM WITNESSED INCIDENT AND STATED PATIENT,. NO SEIZURES.  MOM WANTED PATIENT TO BE EVALUATED IN THE ER. 911 CALL AND PATIENT WAS TRANSPORTED TO ER VIA PARAMEDICS
Age: 0.58
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pentacel ordered, but Vaxelis given by staff. Patient without adverse reaction or issues.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Diarrhoea, Injection site pain, Nausea, Pain
Clinical narrative: Around 2 am on 5/9 I woke up with chills and body aches. About 2:30 I got diarrhea, and then about 6AM I was throwing up green bile. The vomiting lasted only about half an hour, but the diarrhea lasted 2 full days during that same time I was nauseous. I saw my PCP who put me on dexamethasone on 5/10. I had prior proscriptions for Zofran and Lomotil which helped with the symptoms. Symptoms tapered off to 5/13 and by 5/15 I felt fully recovered. I was also sore at the injection site for about 3 days.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vomiting
Clinical narrative: Around 2 am on 5/9 I woke up with chills and body aches. About 2:30 I got diarrhea, and then about 6AM I was throwing up green bile. The vomiting lasted only about half an hour, but the diarrhea lasted 2 full days during that same time I was nauseous. I saw my PCP who put me on dexamethasone on 5/10. I had prior proscriptions for Zofran and Lomotil which helped with the symptoms. Symptoms tapered off to 5/13 and by 5/15 I felt fully recovered. I was also sore at the injection site for about 3 days.
Age: 64.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19-2, COVID19-2, COVID19-2, COVID19-2, COVID19-2, COVID19-2
Symptoms: Ear infection, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Loss of personal independence in daily activities
Clinical narrative: After each Covid-19 injection, I experienced terrible pain in both arms, that eventually went to a soreness in my upper arm muscles that never went away. Around November 2022, I could hardly use my right shoulder or move my arm. This had happened earlier that year in my left shoulder/arm, somehow subsided. Not knowing what to do, as no one I knew or heard about was experiencing this continued pain after the vaccine injections. I was in so much pain with the right shoulder and arm that I went to Dr., Orthopedic, who diagnosed me with Frozen Shoulder after taking an x ray (11/10/22), of my right shoulder. He ordered me an MRI to confirm Bursitis, but I became claustrophobic and could not do the test. I saw Dr., Orthopedic who gave me a cortisone shot in my right shoulder on 12/16/2022, which did not appear to help, other than place me back several months to pain again.  When that went away about 5 days later, I went back to the progress I had already been making in physical theraphy. PA ordered Physical Therapy which I did from 12/06/2022 to 03/20/2023.  I had to stop the theraphy because I began hearing a wind noise in my head, went to PA, diagnosed with a double ear infection, which I have never had in my life. Although I continue to do my daily exercises, my arms and shoulders remain sore, and I do not have full range of motion. This has been a life changer for me, feeling like an invalid getting dressed, undressed, & showered.  The swishing noise continues in my ears even though the ear infections are gone.  I was always pretty healthy.
Age: 64.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19-2, COVID19-2, COVID19-2, COVID19-2, COVID19-2, COVID19-2
Symptoms: Myalgia, Pain in extremity, Periarthritis, Tinnitus, X-ray limb abnormal
Clinical narrative: After each Covid-19 injection, I experienced terrible pain in both arms, that eventually went to a soreness in my upper arm muscles that never went away. Around November 2022, I could hardly use my right shoulder or move my arm. This had happened earlier that year in my left shoulder/arm, somehow subsided. Not knowing what to do, as no one I knew or heard about was experiencing this continued pain after the vaccine injections. I was in so much pain with the right shoulder and arm that I went to Dr., Orthopedic, who diagnosed me with Frozen Shoulder after taking an x ray (11/10/22), of my right shoulder. He ordered me an MRI to confirm Bursitis, but I became claustrophobic and could not do the test. I saw Dr., Orthopedic who gave me a cortisone shot in my right shoulder on 12/16/2022, which did not appear to help, other than place me back several months to pain again.  When that went away about 5 days later, I went back to the progress I had already been making in physical theraphy. PA ordered Physical Therapy which I did from 12/06/2022 to 03/20/2023.  I had to stop the theraphy because I began hearing a wind noise in my head, went to PA, diagnosed with a double ear infection, which I have never had in my life. Although I continue to do my daily exercises, my arms and shoulders remain sore, and I do not have full range of motion. This has been a life changer for me, feeling like an invalid getting dressed, undressed, & showered.  The swishing noise continues in my ears even though the ear infections are gone.  I was always pretty healthy.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Hypotension, Hypoxia, Respiratory failure
Clinical narrative: HYPOTENSION 2/5/2023 ARTHRITIS  HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/16/2023 ARTHRITIS  HYPOXEMIA 12/5/2022 ARTHRITIS
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Acquired oesophageal web, Acute respiratory failure, Hyponatraemia, Hypoxia, Lymphadenopathy mediastinal
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/7/2022 HYPONATREMIA R09.02 HYPOXIA 9/7/2022 HYPONATREMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/7/2022 ACQUIRED SCHATZKIS RING R09.02 HYPOXIA 9/7/2022 ACQUIRED SCHATZKIS RING J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/7/2022 MEDIASTINAL LYMPHADENOPATHY R09.02 HYPOXIA 9/7/2022 MEDIASTINAL LYMPHADENOPATHY J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/7/2022 HYPONATREMIA R09.02 HYPOXIA 9/7/2022 HYPONATREMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/7/2022 HYPONATREMIA R09.02 HYPOXIA 9/7/2022 HYPONATREMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/7/2022 MELENA R09.02 HYPOXIA 9/7/2022 MELENA
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Melaena
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/7/2022 HYPONATREMIA R09.02 HYPOXIA 9/7/2022 HYPONATREMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/7/2022 ACQUIRED SCHATZKIS RING R09.02 HYPOXIA 9/7/2022 ACQUIRED SCHATZKIS RING J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/7/2022 MEDIASTINAL LYMPHADENOPATHY R09.02 HYPOXIA 9/7/2022 MEDIASTINAL LYMPHADENOPATHY J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/7/2022 HYPONATREMIA R09.02 HYPOXIA 9/7/2022 HYPONATREMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/7/2022 HYPONATREMIA R09.02 HYPOXIA 9/7/2022 HYPONATREMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/7/2022 MELENA R09.02 HYPOXIA 9/7/2022 MELENA
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The medical assistant is reporting that a patient received improperly stored vaccine; This spontaneous report was received from a medical assistant and referred to a patient with unknown age and gender. The patient's concurrent conditions, concomitant medication, pertinent medical history and drug reactions/ allergies were not provided.  The hepatitis a vaccine, inactivated (VAQTA) was improperly stored during a temperature excursion. Temperature was 46.74 Fahrenheit degree (F). Time frame was 2 minutes. Previous temperature excursion did not occur. On 17-MAY-2023, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (0.5 milliliter (ml), lot # was reported as X004813, expiration date was reported as 28-JUL-2024, route and anatomical location were not provided) for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).
Age: 1.42
Sex: U
Vaccine: VARCEL
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No additional AE; 17month old moved when receiving VARIVAX and did not get the full dose. MIR on case: 02392526. No additional AE/No PQC.; This spontaneous report was received from medical assistant and referred to a 17-month-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 19-MAY-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, anatomical site of injection and route of administration, lot #, expiration date and indication were not provided). The patient moved when receiving varicella virus vaccine live (oka/merck) (VARIVAX) and did not get the full dose (Accidental underdose). No additional adverse event was reported (No adverse event).
Sex: F
Vaccine: HPV4, HPV9
Symptoms: No adverse event, Product lot number issue, Product storage error
Clinical narrative: Product Lot numer issue; No Adverse Event; HBP called to Report that ROTATEQ and GARDASIL 9 were administered to patients after being improperly stored. TE case with supported outcome 02386121. HBP is not aware of patient demographics or dates of administration.  Permission to contact granted; This spontaneous report was received from a consumer refers to a 11-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-MAY-2023, the patient was vaccinated with the second dose of improper storage quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot # reported as W013388 with expiration date reported as 16-DEC-2024, however the reported lot # occurred non-valid for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), but valid for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration were not reported) in right deltoid, for prophylaxis (product lot number issue).   Administered dose of vaccine was exposed to the temperature excursion of 47.5 degrees Fahrenheit for 1 hour. The previous temperature excursion occurred (61.7 degrees Fahrenheit  for 35 minutes) (product storage error). No additional adverse event reported (no adverse event).  This is one of several reprts received from the same reporter. ; Sender's Comments:  US-009507513-2305USA003089:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Facial pain, Herpes zoster, Paraesthesia, Vaccination failure
Clinical narrative: Got shingles this year on her forehead / Suspected vaccination failure; Got shingles this year on her forehead; Blister; Tingling pain down her face; Tingling pain down her face; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included covid-19.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Got shingles this year on her forehead / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got shingles this year on her forehead), blister (Verbatim: Blister), facial pain (Verbatim: Tingling pain down her face) and tingling (Verbatim: Tingling pain down her face). The outcome of the vaccination failure was unknown and the outcome of the shingles, blister, facial pain and tingling were resolved (duration 3 weeks).   It was unknown if the reporter considered the vaccination failure, shingles, blister, facial pain and tingling to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, blister, facial pain and tingling to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 22-May-2023 The physician gave the Shingrix vaccine during Covid, and then got shingles this year on her forehead.  The physician reporter that the patient had mild with only two blisters and had slight tingling pain down her face.  The physician reporter events only lasted about 3 weeks.  The physician thought it would have been way worse if she not gotten Shingrix. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: UNK
Symptoms: Myositis
Clinical narrative: Myosistis; This non-serious case was reported by a nurse and described the occurrence of myositis in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced myositis (Verbatim: Myosistis). The outcome of the myositis was not reported.   It was unknown if the reporter considered the myositis to be related to Arexvy.     It was unknown if the company considered the myositis to be related to Arexvy.   Additional Information: GSK Receipt Date: 15-May-2023  The reporter's aunt was in the clinical trials for Arexvy.  She reported that her aunt developed myosistis (muscle inflammation) during the clinical trial. The reporter did not know if this report had been previously captured during the clinical trials. She did not administer the vaccine and the patient was her aunt.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: patient experienced a rash that was like that of Shingles; This non-serious case was reported by a physician via sales rep and described the occurrence of vesicular rash in a 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 vesicular rash (Verbatim: patient experienced a rash that was like that of Shingles). The outcome of the vesicular rash was not reported.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.     It was unknown if the company considered the vesicular rash to be related to Shingrix.   Additional Information: GSK receipt date: 19-May-2023 The patient had experienced a rash that was like that of Shingles following a dose of Shingrix. The reporter did not consent to follow-up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: she developed a fever for about 2 days after getting both vaccines; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes virus infection. Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received in August 2022, refer case US2023072495) and valacyclovir.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: she developed a fever for about 2 days after getting both vaccines). Rechallenge with Shingrix was positive. The outcome of the fever was resolved (duration 2 days).   It was unknown if the reporter considered the fever to be related to Shingrix.     It was unknown if the company considered the fever to be related to Shingrix.   Additional Information: GSK receipt date: 22-MAY-2023 The patient stated that her second Shingrix vaccine within the 2 to 6 month range, between September and December 2022.   She reported that she developed a fever for about 2 days after getting both vaccines.   The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2023072495:1st dose
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate Schedule of Vaccine; This non-serious case was reported by a consumer and described the occurrence of drug dose administration interval too long in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2nd May 2018).   On 09-MAR-2019, the patient received the 2nd dose of Shingrix (unknown arm). On 09-MAR-2019, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 15-MAY-2023. The reporter was patient, she and her husband received the first and second dose of Shingrix in an unknown arm. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. This case had been linked with US2019GSK043866 due to same reporter and different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019GSK043866:Husband case
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Overdose
Clinical narrative: administered a patient both Kinrix and Pediarix on 16/05/2023; Extra dose administered; Kinrix received as 2nd dose; This non-serious case was reported by a physician via call center representative and described the occurrence of overdose in a 5-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number M7HL3) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) (batch number 3K54FL) for prophylaxis.   Previously administered products included hepatitis B vaccine (the patient received at birth), hepatitis B vaccine (the patient received at 4 months of age), IPV (the patient received at 4 months of age) and DTAP (the patient received at 4 months of age).   On 16-MAY-2023, the patient received the 2nd dose of Pediarix and the 2nd dose of Kinrix. On 16-MAY-2023, an unknown time after receiving Pediarix and Kinrix, the patient experienced overdose (Verbatim: administered a patient both Kinrix and Pediarix on 16/05/2023), extra dose administered (Verbatim: Extra dose administered) and inappropriate schedule of vaccine administered (Verbatim: Kinrix received as 2nd dose). The outcome of the overdose, extra dose administered and inappropriate schedule of 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: 16-MAY-2023 The vaccine, patient and event information was provided.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The reporter called and stated that a nurse administered a patient both Kinrix and Pediarix at the time of reporting, which led to overdose and inappropriate schedule of vaccine administered. The patient 2nd dose of Kinrix, which led to extra dose administered.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 18 month old received the adult 1 ml dose of Havrix; 18 month old received the adult 1 ml dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 18-month-old female patient who received HAV (Havrix adult) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   Previously administered products included Havrix (1st dose received on an unknown date).   On 16-MAY-2023, the patient received the 2nd dose of Havrix adult 1 ml. On 16-MAY-2023, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: 18 month old received the adult 1 ml dose of Havrix) and inappropriate age at vaccine administration (Verbatim: 18 month old received the adult 1 ml dose of Havrix). The outcome of the overdose and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-MAY-2023 The reporter reported that the 18 months old child patient received the adult 1 ml dose of Havrix vaccine. No reactions reported. The vaccine administration facility was the same as primary reporter. Did not consent to follow-up. The patient administered the Havrix adult vaccine to infant which led to inappropriate age at vaccine administration and overdose.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Late 2nd dose Shingrix; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received a dose of Shingrix on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Late 2nd dose Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 18-May-2023 The reporter reported that if it had been more than 6 months since a patient received the first dose of Shingrix. The reporter asked that the patient did need to restart the series or could still get the second dose as soon as was feasible. The medical information did not speak with the health care provider, so please follow up with the sales representative for more information. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: If it's been longer than 6 months for the 2nd dose of Shingrix, will they have to start the series again; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received a dose of Shingrix on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: If it's been longer than 6 months for the 2nd dose of Shingrix, will they have to start the series again). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 18-May-2023 The reporter asked that if it was been longer then 6 months for the 2nd dose Shingrix, would they have to start the series again. The medical information did not speak with the health care provider, so please follow up with the sales representative for more information. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Pain; Shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (a mild case of shingles the year before).   On 11-FEB-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 13-FEB-2023, 2 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). On 22-FEB-2023, the patient experienced pain (Verbatim: Pain). The patient was treated with valaciclovir (Valacyclovir) and gabapentin (Gabapentine). The outcome of the shingles was unknown and the outcome of the pain was resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.     It was unknown if the company considered the shingles and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-MAY-2023 The patient received 1st dose and she came down with a pretty bad cases of Shingles, which she diagnosed herself as she was the registered nurse and had a mild case of shingles the year before (no specific date was provided). The patient went to doctor the next day on February 14, 20232, and was put on Valacyclovir (no further information) that day. The patient reported started of having shingles pain (no specified location) and about a week later on February 22, 2023, and went for physician checkup. On March 6, 2023, she was put on Gabapentin (no further information), for about two weeks, but that did not work. The patient went to clinic on March 20, 2023 and gave her a prescription for something else (unknown product), that she did pick up from the pharmacy, but never took. The pain of the shingles was recovered on mid-April (no specific date provided). The reporter consented to follow up with the health care professionals.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Post herpetic neuralgia, Rash, Rash vesicular, Skin lesion
Clinical narrative: Pain; Shingles like lesions; Painful lesions on the ear, scalp, temple; Post herpetic neuralgia; This serious case was reported by a nurse via sales rep and described the occurrence of vesicular rash in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On an unknown date, 1 day after receiving Shingrix, the patient experienced vesicular rash (Verbatim: Shingles like lesions) (serious criteria hospitalization), painful rash (Verbatim: Painful lesions on the ear, scalp, temple) (serious criteria hospitalization), pain (Verbatim: Pain) (serious criteria hospitalization) and post herpetic neuralgia (Verbatim: Post herpetic neuralgia). The patient was treated with valaciclovir hydrochloride (Valtrex), prednisone, antivirals nos and gabapentin. The outcome of the vesicular rash was unknown and the outcome of the painful rash was not reported and the outcome of the pain and post herpetic neuralgia were not resolved.   It was unknown if the reporter considered the vesicular rash, painful rash, pain and post herpetic neuralgia to be related to Shingrix.     It was unknown if the company considered the vesicular rash, painful rash, pain and post herpetic neuralgia to be related to Shingrix.   Additional Information: GSK receipt date: 19-MAY-2023 The reporter stated that one day after the Shingrix vaccination the patient developed one lesion on her right arm. On an unknown day, the patient developed painful lesions on the ear, scalp, temple and nose in a trigeminal pattern.  The patient was treated with Valtrex and prednisone. Twelve days post vaccination, the patient was admitted to the hospital for 2 days to receive IV antivirals. Two months after receiving vaccination, the patient had post herpetic neuralgia and was being treated with gabapentin. Nothing else was reported. The reporter consented to follow up.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administration of expired dose of Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received HBV (Engerix B) (batch number LM992, expiry date 13-DEC-2022) for prophylaxis.   On 19-MAY-2023, the patient received Engerix B. On 19-MAY-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: administration of expired dose of Engerix-B). The outcome of the expired vaccine used 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: 22-MAY-2023 The reporter consented to follow up. The patient administered expired dose of Engerix-B, which led to expired vaccine used.
Age: 1.33
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 16 month old child was administered Boostrix instead of Infanrix.; 16 month old child was administered Boostrix instead of Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 16-month-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 19-MAY-2023, the patient received Boostrix. On 19-MAY-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: 16 month old child was administered Boostrix instead of Infanrix.) and inappropriate age at vaccine administration (Verbatim: 16 month old child was administered Boostrix instead of Infanrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 22-MAY-2023 The reporter reported that a 16 month old child was administered Boostrix instead of Infanrix. The vaccine administration facility was the same as primary reporter. The reporter declined to provide any additional adverse event details at this time, did give consent for safety team follow up. The reporter reported that a 16 month old child was administered Boostrix instead of Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received her first Shingrix vaccine in February 2022, in unknown arm and her second Shingrix vaccine on 1-14-2023, in unknown arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 0.5ml in February 2022 in an unknown arm intramuscularly).   On 14-JAN-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown arm) .5 ml. On 14-JAN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received her first Shingrix vaccine in February 2022, in unknown arm and her second Shingrix vaccine on 1-14-2023, in unknown arm). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 22-MAY-2023 The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Paraesthesia oral
Clinical narrative: her upper lip started to tingle; her upper lip started to swell and then her bottom lip started to swell; This non-serious case was reported by a consumer via call center representative and described the occurrence of tingling lips in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-MAY-2023, the patient received the 1st dose of Shingrix (left arm). On 19-MAY-2023, 1 days after receiving Shingrix, the patient experienced tingling lips (Verbatim: her upper lip started to tingle) and lip swelling (Verbatim: her upper lip started to swell and then her bottom lip started to swell). The outcome of the tingling lips was not reported and the outcome of the lip swelling was not resolved.   It was unknown if the reporter considered the tingling lips and lip swelling to be related to Shingrix.     It was unknown if the company considered the tingling lips and lip swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-MAY-2023 The patient received the dose vaccine and on following day, Friday, her lips started to tingle and on Saturday, her upper lips started to swell and then her bottom lip started to swell. At the time of reporting she stated that, swelling was still present, but had not gotten any worse. The reporter consented to follow up with the health care professionals (HCP).
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This serious case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a adult female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced anaphylactic reaction (Verbatim: anaphylactic reaction) (serious criteria GSK medically significant). The outcome of the anaphylactic reaction was resolved.   The reporter considered the anaphylactic reaction to be related to Influenza vaccine.     The company considered the anaphylactic reaction to be related to Influenza vaccine.   Additional Information: GSK Receipt Date: 22-MAY-2023 The pharmacist reported that 15 years ago from reporting date, a patient had a severe anaphylactic reaction to an unspecified influenza (flu) shot and had no further information. The manufacturer of suspect vaccine was unknown. The reporter consented to follow up.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Kinrix was expired on May 7th 2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 22-MAY-2023, the patient received Kinrix. On 22-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Kinrix was expired on May 7th 2023). The outcome of the expired vaccine used 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: 22-MAY-2023 The reporter was medical assistant. The reporter consented to follow up via email. The patient received an expired dose of Kinrix, which led to expired vaccine used. The case had been linked to US2023072490, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023072490:Linked case for twin's patient
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Kinrix was expired on May 7th 2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 22-MAY-2023, the patient received Kinrix. On 22-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Kinrix was expired on May 7th 2023). The outcome of the expired vaccine used 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: 22-May-2023  Medical assistant reported that 2 twin patents received an expired dose of Kinrix on 22nd May 2023.  Kinrix was expired on 7th May 2023. The reporter consented to follow up. Follow up preferred via email.; Sender's Comments:  US-GSK-US2023072485:Linked case for twin's patient
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique; Inappropriate Reconstitution Technique; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA912A, expiry date 28-FEB-2025) for prophylaxis.   On 20-MAY-2023, the patient received Menveo. On 20-MAY-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-MAY-2023 Nurse Manager stated that a medical assistant administered only the liquid component of Menveo to a patient. Lot number provided was that of the diluent (which was not found in the batch identifier but was repeated and confirmed with HCP). The vaccine administration facility was the same as primary reporter. Consented to follow up via postal.
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: RN reported they inadvertently administered Boostrix (Tdap) dose to a 2 hour old infant yesterday on 5/21/23 in the left thigh. RN mentioned they were trying to administer a vitamin K dose but instead grabbed the Tdap; RN reported they inadvertently administered Boostrix (Tdap) dose to a 2 hour old infant yesterday on 5/21/23 in the left thigh. RN mentioned they were trying to administer a vitamin K dose but instead grabbed the Tdap; 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 male patient who received DTPa (Reduced antigen) (Boostrix) (batch number C3SB5, expiry date 09-MAY-2025) for prophylaxis.   On 21-MAY-2023, the patient received Boostrix (left thigh). On 21-MAY-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: RN reported they inadvertently administered Boostrix (Tdap) dose to a 2 hour old infant yesterday on 5/21/23 in the left thigh. RN mentioned they were trying to administer a vitamin K dose but instead grabbed the Tdap) and wrong vaccine administered (Verbatim: RN reported they inadvertently administered Boostrix (Tdap) dose to a 2 hour old infant yesterday on 5/21/23 in the left thigh. RN mentioned they were trying to administer a vitamin K dose but instead grabbed the Tdap). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-May-2023  Registered Nurse (RN) reported they inadvertently administered Boostrix (Tdap) dose to a 2-hour old infant the day before reporting in the left thigh. RN mentioned they were trying to administer a vitamin K dose but instead grabbed the Tdap. RN stated the patient did not have a first name yet but had a last name initial. The reporter consented to follow up. Registered Nurse called to inquire what to look for in the patient.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, Herpes virus infection, Pyrexia
Clinical narrative: got an outbreak of herpes; she got COVID; she developed a fever for about 2 days after getting both vaccines; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes virus infection. Previously administered products included valacyclovir.   In AUG-2022, the patient received the 1st dose of Shingrix (left arm). In SEP-2022, less than 2 months after receiving Shingrix, the patient experienced covid-19 (Verbatim: she got COVID). On an unknown date, the patient experienced fever (Verbatim: she developed a fever for about 2 days after getting both vaccines) and herpes virus infection (Verbatim: got an outbreak of herpes). The outcome of the fever was resolved (duration 2 days) and the outcome of the covid-19 and herpes virus infection were resolved.   It was unknown if the reporter considered the fever, covid-19 and herpes virus infection to be related to Shingrix.     It was unknown if the company considered the fever, covid-19 and herpes virus infection to be related to Shingrix.   Additional Information: GSK receipt date: 22-MAY-2023 The patient stated that she got her first Shingrix vaccine and she developed a fever for about 2 days. She also stated that she got COVID after she had gotten the first vaccine but prior to having the second vaccine. In addition, she had a history of herpes that she took valacyclovir (confirmed generic) for continuously.  She stated that she also got an outbreak of herpes between the first and second shingrix vaccine, but she believed that she had stopped taking her valacyclovir. The reporter did not consent to follow-up. For tolerance to 2nd dose, refer case US2023AMR073462; Sender's Comments:  US-GSK-US2023AMR073462:1st dose