chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of daptacel was administered to a patient with no reported adverse event; Initial information received on 17-Apr-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 months old male patient who was administered expired dose of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine for Prophylactic vaccination.  On 17-Apr-2024, the patient received 0.5 ml (dose 4) of expired suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine (Suspension for injection) with no reported adverse event (expired product administered) (latency: same day) (lot C5980AB) (expiry not reported) (frequency: once) (strength: standard) via unknown route in unknown administration site for Prophylactic Vaccination (Immunisation).  Reportedly, Nurse reports that the patient had no reaction and "everything is well".  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: 1.5
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given expired ActHib yesterday with no reported adverse event; Initial information received on 18-Apr-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old male patient who was given expired acthib yesterday with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Prophylactic vaccination.  On 17-Apr-2024, the patient received a dose 4 (0.5 ml) of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection lot UJ852AB, expiry- 13-Apr-2024 via intramuscular route in vastus lateralis for immunization (strength- unknown) with no reported adverse event (expired product administered) (latency same day).    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product preparation error
Clinical narrative: was diluted to 0.5 sterile water and was administered to a patient with no reported adverse event; Initial information received on 18-Apr-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient for whom DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel) was diluted to 0.5 sterile water and was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, Suspension for injection via unknown route in unknown administration site for immunization (strength, dose, batch number and expiry date- unknown) that was diluted to 0.5 sterile water and was administered to a patient with no reported adverse event (product preparation error) (latency same day). Information on the batch number was requested.   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: 61.0
Sex: F
Vaccine: RAB
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: they were administered on the buttocks with no adverse event; Initial information received on 18-Apr-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional (Patient).  This case involves a 61 years old female patient who were administered Rabies (Hdc) Vaccine [Imovax Rabies] on the buttocks with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On 17-Apr-2024, the patient received a dose 2 of suspect Rabies (Hdc) Vaccine (Powder and solvent for suspension for injection) lot number, strength, expiry date not reported via  buttocks route in unknown administration site for Prophylactic vaccination (Immunization) and they were administered on the buttocks with no adverse event (incorrect route of product administration) (latency : same day). The information on batch number was requested.   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: FLUC3
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: Patient developed SIRVA symptoms; This spontaneous case, initially received on 15-Apr-2024, was reported by a health authority and concerns an adult female patient.  Administration of company suspect drug:  On 12-Oct-2023, the patient received Flucelvax Quadrivalent (influenza vaccine inact sag 4v) for not reported indication, Route of administration: Intramuscular (IM), Anatomical Location: left arm (LA), Lot number: 944465.  No additional suspect drugs.  Adverse reactions/events and outcomes:  On 13-Oct-2023, one day after receiving Flucelvax Quadrivalent, the patient developed shoulder injury related to vaccine administration (SIRVA) symptoms.  On an unspecified date, the patient was treated with unspecified corticosteroid but symptoms persisted.  On an unspecified date, the patient visited physician's office. However, further details were not reported.  At the time of initial reporting, the patient had not recovered from the event.  Flucelvax Quadrivalent action taken: Not Applicable  Reporter's assessment: The reporter did not provide causality and seriousness assessment.; Reporter's Comments: Causality is considered as possibly related for the event due to plausible temporal relationship and anatomical plausibility.
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse event reported; male patient was inadverntly administered an expired dose of the PEDVAXHIB vaccine; This spontaneous report was received from a registered nurse and refers to a male patient of unknown age.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 04-APR-2024, the patient was vaccinated with an expired dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #U029144, expiration date: 31-MAR-2024 (expired product administered), administered for prophylaxis (strength, and route of administration were not provided).The expired dose of vaccine had no prior temperature excursions.  No additional adverse event was reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I had Covid twice; Drug ineffective; COVID-19; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant) with onset 13Feb2024, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 13Feb2024, outcome "unknown"; DISEASE RECURRENCE (medically significant) with onset 13Mar2024, outcome "not recovered", described as "I had Covid twice". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Feb2024) Positive; (13Mar2024) Positive. Clinical course: The reporter had 3 Pfizer Vaccines since Covid first started. He had Covid twice, the last one on 13Feb2024. Then, exactly one month later on 13Mar2024. He lost all sense of taste and as of 19Apr2024, he had not gotten it back. He was asking how he would get his taste back. He tried eating Ginger, taking Apple Cider Vinegar, Peanut Butter, Hot Sauce for several days and nothing had helped.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was expired, no adverse reaction noted
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Biopsy, Rash
Clinical narrative: Rash on stomach, lost hair
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site rash, Urticaria
Clinical narrative: Rash/bumps near injection site of Meningococcal vaccine, right arm.  Localized urticarial rash.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Mechanical urticaria
Clinical narrative: No issues with the 1st and 2nd dose of vaccine, but upon receiving the 3rd dose of Moderna (booster), I developed urticaria with severe itching approximately 20 days after the booster. Was finally diagnosed as dermographism and have been on treatment with antihistamines since. Was getting better, thinking it was the Moderna form of vaccine, I requested the Novavax for the 4th shot. Within 10 days of this vaccine, the dermographism worsened. I have no doubt that this exacerbation is related to the 3rd and 4th vaccine doses. Reporting to make it know.
Age: 53.0
Sex: M
Vaccine: IPV
Symptoms: Anti-thyroid antibody decreased, Anti-thyroid antibody positive, Blood cholesterol normal, Blood thyroid stimulating hormone decreased, Blood triglycerides normal
Clinical narrative: Hand tremor started about a week after (first week of November) the vaccination and lasted a week or so during which I had trouble writing with a pen. I also noticed increased heart rate, big eyes, and heat intolerance, but I did not know the reason. During my annual physical, my cholesterol, triglycerides, and LDL all came within normal range from elevated state for the past few years. My BP was also higher, even with 10 mg of lisinopril. My doctor commented on my cholesterol levels, and raised the lisinopril dose to 20 mg daily. My doctor aunt and uncle who were visiting us told me that my eyes look bulged and asked me to get my thyroid function tested.  I got tested in February and my T4 level was high (>2 ng/dL), TSH <0.01 microIU/mL. Further testing confirmed high T3 (280 ng/dL), high TRAb (30.96 IU/L), and TSI (431 % of baseline), and low TPO Ab (<1IU/mL). The diagnosis is Graves Disease along with Graves eye (Thyroid eye). I was put immediately (March 06, 2024) on methimazole (10 mg BID), stopped lisinopril, and added long acting propranolol 60 mg once daily. Baseline CBC with differential and liver function test were conducted prior to starting methimazole. ECG was done before propranolol. After one month of this treatment, my T4 and and T3 are in normal range, but TRAb is still 26 and TSI is still high (around 350). I am continuing with the medication right now. I have also been seen by my opthamologist for the thyroid eye condition. Baseline measurements have been done and I am using artificial tears for the dry eyes. I am trying to get the CT scan of my eyes done at this moment.
Age: 53.0
Sex: M
Vaccine: IPV
Symptoms: Condition aggravated, Differential white blood cell count, Dry eye, Dysgraphia, Electrocardiogram
Clinical narrative: Hand tremor started about a week after (first week of November) the vaccination and lasted a week or so during which I had trouble writing with a pen. I also noticed increased heart rate, big eyes, and heat intolerance, but I did not know the reason. During my annual physical, my cholesterol, triglycerides, and LDL all came within normal range from elevated state for the past few years. My BP was also higher, even with 10 mg of lisinopril. My doctor commented on my cholesterol levels, and raised the lisinopril dose to 20 mg daily. My doctor aunt and uncle who were visiting us told me that my eyes look bulged and asked me to get my thyroid function tested.  I got tested in February and my T4 level was high (>2 ng/dL), TSH <0.01 microIU/mL. Further testing confirmed high T3 (280 ng/dL), high TRAb (30.96 IU/L), and TSI (431 % of baseline), and low TPO Ab (<1IU/mL). The diagnosis is Graves Disease along with Graves eye (Thyroid eye). I was put immediately (March 06, 2024) on methimazole (10 mg BID), stopped lisinopril, and added long acting propranolol 60 mg once daily. Baseline CBC with differential and liver function test were conducted prior to starting methimazole. ECG was done before propranolol. After one month of this treatment, my T4 and and T3 are in normal range, but TRAb is still 26 and TSI is still high (around 350). I am continuing with the medication right now. I have also been seen by my opthamologist for the thyroid eye condition. Baseline measurements have been done and I am using artificial tears for the dry eyes. I am trying to get the CT scan of my eyes done at this moment.
Age: 53.0
Sex: M
Vaccine: IPV
Symptoms: Endocrine ophthalmopathy, Exophthalmos, Full blood count, Graves' disease, Heart rate increased
Clinical narrative: Hand tremor started about a week after (first week of November) the vaccination and lasted a week or so during which I had trouble writing with a pen. I also noticed increased heart rate, big eyes, and heat intolerance, but I did not know the reason. During my annual physical, my cholesterol, triglycerides, and LDL all came within normal range from elevated state for the past few years. My BP was also higher, even with 10 mg of lisinopril. My doctor commented on my cholesterol levels, and raised the lisinopril dose to 20 mg daily. My doctor aunt and uncle who were visiting us told me that my eyes look bulged and asked me to get my thyroid function tested.  I got tested in February and my T4 level was high (>2 ng/dL), TSH <0.01 microIU/mL. Further testing confirmed high T3 (280 ng/dL), high TRAb (30.96 IU/L), and TSI (431 % of baseline), and low TPO Ab (<1IU/mL). The diagnosis is Graves Disease along with Graves eye (Thyroid eye). I was put immediately (March 06, 2024) on methimazole (10 mg BID), stopped lisinopril, and added long acting propranolol 60 mg once daily. Baseline CBC with differential and liver function test were conducted prior to starting methimazole. ECG was done before propranolol. After one month of this treatment, my T4 and and T3 are in normal range, but TRAb is still 26 and TSI is still high (around 350). I am continuing with the medication right now. I have also been seen by my opthamologist for the thyroid eye condition. Baseline measurements have been done and I am using artificial tears for the dry eyes. I am trying to get the CT scan of my eyes done at this moment.
Age: 53.0
Sex: M
Vaccine: IPV
Symptoms: Hypertension, Liver function test, Low density lipoprotein normal, Temperature intolerance, Therapy change
Clinical narrative: Hand tremor started about a week after (first week of November) the vaccination and lasted a week or so during which I had trouble writing with a pen. I also noticed increased heart rate, big eyes, and heat intolerance, but I did not know the reason. During my annual physical, my cholesterol, triglycerides, and LDL all came within normal range from elevated state for the past few years. My BP was also higher, even with 10 mg of lisinopril. My doctor commented on my cholesterol levels, and raised the lisinopril dose to 20 mg daily. My doctor aunt and uncle who were visiting us told me that my eyes look bulged and asked me to get my thyroid function tested.  I got tested in February and my T4 level was high (>2 ng/dL), TSH <0.01 microIU/mL. Further testing confirmed high T3 (280 ng/dL), high TRAb (30.96 IU/L), and TSI (431 % of baseline), and low TPO Ab (<1IU/mL). The diagnosis is Graves Disease along with Graves eye (Thyroid eye). I was put immediately (March 06, 2024) on methimazole (10 mg BID), stopped lisinopril, and added long acting propranolol 60 mg once daily. Baseline CBC with differential and liver function test were conducted prior to starting methimazole. ECG was done before propranolol. After one month of this treatment, my T4 and and T3 are in normal range, but TRAb is still 26 and TSI is still high (around 350). I am continuing with the medication right now. I have also been seen by my opthamologist for the thyroid eye condition. Baseline measurements have been done and I am using artificial tears for the dry eyes. I am trying to get the CT scan of my eyes done at this moment.
Age: 53.0
Sex: M
Vaccine: IPV
Symptoms: Thyroid function test, Thyroid stimulating immunoglobulin increased, Thyroxine increased, Tremor, Tri-iodothyronine increased
Clinical narrative: Hand tremor started about a week after (first week of November) the vaccination and lasted a week or so during which I had trouble writing with a pen. I also noticed increased heart rate, big eyes, and heat intolerance, but I did not know the reason. During my annual physical, my cholesterol, triglycerides, and LDL all came within normal range from elevated state for the past few years. My BP was also higher, even with 10 mg of lisinopril. My doctor commented on my cholesterol levels, and raised the lisinopril dose to 20 mg daily. My doctor aunt and uncle who were visiting us told me that my eyes look bulged and asked me to get my thyroid function tested.  I got tested in February and my T4 level was high (>2 ng/dL), TSH <0.01 microIU/mL. Further testing confirmed high T3 (280 ng/dL), high TRAb (30.96 IU/L), and TSI (431 % of baseline), and low TPO Ab (<1IU/mL). The diagnosis is Graves Disease along with Graves eye (Thyroid eye). I was put immediately (March 06, 2024) on methimazole (10 mg BID), stopped lisinopril, and added long acting propranolol 60 mg once daily. Baseline CBC with differential and liver function test were conducted prior to starting methimazole. ECG was done before propranolol. After one month of this treatment, my T4 and and T3 are in normal range, but TRAb is still 26 and TSI is still high (around 350). I am continuing with the medication right now. I have also been seen by my opthamologist for the thyroid eye condition. Baseline measurements have been done and I am using artificial tears for the dry eyes. I am trying to get the CT scan of my eyes done at this moment.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Death
Clinical narrative: I am just reporting a possible adverse event. Just want a documentation made. My mom received her vaccinations on 1/27/2021 and 2/18/2021. On 3/8/2021, she experienced a major stroke and succumbed to stroke on 3/24/2021, Obviously, can not say that this was due to the vaccine but wanted to report for statistical purposes.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: This patient was accidentally administered a Covid-19 vaccine which was note age appropriate. The patient was administered a 12+ dose of Comirnaty instead of the age appropriate vaccine with the correct strength. The patient did not have any known adverse affects.  The staff who administered the vaccine has been educated and re-trained. The patient and their parents have been informed.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Rash, Rash papular
Clinical narrative: At 6 AM on 1/19/2024 4 days after pt received the vaccine woke up with a severe rash on his right butt check and lower right side of his back. Pictures attached. This looked severe and was raised. Parents reported these to pt Pediatrician who wasn't sure what was the cause but suggested it might be an immune response to the shot. 6 hours later at noon on 1/19/2024 this rash was completely gone with no sign it had been there. On 1/20/2024 at 5:45PM a new rash had appeared on both of pt shoulders, his right knee, and hit right forearm. This second rash was much less severe looking than the first one. The Pediatrician was also notified about this. Picture for both rashes are attached. By midnight that rash had also completely gone away. No rashes have been see on pt since. Throughout this he has no fever, cough, or other symptoms. The Rash didn't seem to bother him either.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: hives throughout right arm, denied sob, oral cavity swelling, n/v
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chills, Culture, Pyrexia, Vomiting
Clinical narrative: Severe shivering, fever, emesis
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient was accidentally administered a Covid-19 vaccine which was not age appropriate. The patient was administered a 12+ dose of Comirnaty instead of the age appropriate vaccine with the correct strength. The patient did not have any known adverse affects. The staff member who administered the vaccine has been educated and re-trained.  The patient and their parents have been informed.
Age: 1.25
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Rash, Rash macular, Rash papular
Clinical narrative: Disseminated, erythematous, macules and papules on the trunk during initial assessment.  10 minutes later, patient had developed similar disseminated, erythematous, macules and papules on the chin, neck, upper and lower extremities. CONSULTED WITH: Dr., Infectious Disease, who evaluated the patient and states that while the rash does appear to represent measles, it appeared in an atypical fashion starting at the trunk and then spreading outward.  The patient is afebrile and does not appear acutely ill.  She is eating, drinking, and eliminating normally.  He advised this is likely a reaction to the MMR vaccination.   TX: advised to quarantine for at least 5 days after the appearance of the rash. Follow-up if patient develops red runny eyes, elevated fever, loss of appetite, or changes in elimination patterns. REPORTED TO: Contacted, RN at Public Health. Advised of the patient reporting to the Rapid Access and concern of measles rash, without diagnosis of Measles. Testing not completed at this time. Per RN if symptoms change, Testing will need completed and a Report Form will need completed.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Choking, Cough, Immediate post-injection reaction, Swelling face, Throat tightness
Clinical narrative: Immediately started coughing/choking due to throat closing, swelling of entire face. 7.5mL of Benadryl was given at home along with 10mg of dexAMETHasone at hospital. A script for an EPI Pen was also provided
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site rash, Injection site urticaria, Rash erythematous, Urticaria
Clinical narrative: Started getting hives with red rash on right arm near injection site roughly 96 hours after injection. Took 50mg Benadryl and that helped the itching but hives continued to spread, now covering both legs, most of torso and right arm. No other recent diet, medication or environmental changes to account for this. I had received my first ever pneumonia vaccine on same day as COVID booster. I do not know specific pneumonia vaccine or manufacturer. You're authorized to get this info from pharmacy.
Age: 68.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Back pain, Blood test, Dyspnoea, Injected limb mobility decreased, Nervous system disorder
Clinical narrative: I was trembling in both hands,losing feeling in my right arm. Also severe pain my back and had difficulty breathing along with neurological episode . Still having from time to time sleeping disorder.
Age: 68.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Sleep apnoea syndrome, Sleep disorder, Tachyphrenia, Tremor
Clinical narrative: I was trembling in both hands,losing feeling in my right arm. Also severe pain my back and had difficulty breathing along with neurological episode . Still having from time to time sleeping disorder.
Age: 68.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Back pain, Dyspnoea, Hypoaesthesia, Neurological symptom, Sleep disorder
Clinical narrative: I was trembling in both hands,losing feeling in my right arm. Also severe pain my back and had difficulty breathing along with neurological episode . Still having from time to time sleeping disorder.
Age: 68.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Tremor
Clinical narrative: I was trembling in both hands,losing feeling in my right arm. Also severe pain my back and had difficulty breathing along with neurological episode . Still having from time to time sleeping disorder.
Age: 0.08
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A patients received PEDVAX HIB younger than recommended.  First patient received a dose at age 7 weeks 6 days old; No adverse event; This spontaneous report was received from a medical student and refers to a 7-week-6-days-old patient of unknown gender.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On an unknown date, the patient started therapy with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) (Inappropriate age at vaccine administration). The reporter did not have additional information regarding the patient.  No adverse event was reported.  Lot # is being requested and will be submitted if received.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2404USA010408:
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; the patient received their first dose of the ROTATEQ vaccine on 10/30/2023, the patient received their second dose of vacccine on 03/22/2024; This spontaneous report was received from other health professional and refers to a currently 32 weeks and 6 days-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 30-OCT-2023, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally (exact dose, strength, lot #, expiry date, and indication were not provided). On 22-MAR-2024, the patient received the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally (exact dose, strength, lot #, expiry date, and indication were not provided) (inappropriate schedule of product administration). The reason of the extended interval was unknown. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No AE/PQC reported; Medical assistant reporting administering PROQUAD vaccine to an adult patient. Permission to contact HCP was granted. No additional information provided. No AE/PQC reported.; This spontaneous report has been received from a medical assistant, regarding an adult patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On 19-DEC-2023, the patient was vaccinated with one dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQAUD) injection, as prophylaxis (lot number: X007358, which was determined to be valid, with an expiration date on 08-SEP-2024, therapy type rHA) (strength, dose, scheme, route and anatomical location of administration were not reported) (Product administered to patient of inappropriate age).  No additional adverse event was reported.
Age: 15.0
Sex: M
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: physician ordered Twinrix but the patient is only 15 years old/ vaccine received at wrong age; 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 15-year-old male patient who received HAB (Twinrix) (batch number H7RF2, expiry date 17-JAN-2026) for prophylaxis.   Previously administered products included Hepatitis A vaccine (already received 1 previous shot of Hepatitis A) and Hepatitis B vaccine (already received 1 previous shot of Hepatitis B).   On 02-APR-2024, the patient received the 1st dose of Twinrix. On 02-APR-2024, an unknown time after receiving Twinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: physician ordered Twinrix but the patient is only 15 years old/ vaccine received at wrong age). 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: 12-APR-2024 The medical assistant explained that a physician ordered Twinrix but the patient was only 15-years-old. It was the first and only Twinrix vaccine received by the patient, but they already received one previous shot of Hepatitis A and one shot of Hepatitis B vaccine. The vaccine administration facility was the same as primary reporter. The patient received a dose of Twinrix earlier than the recommended age, which led to an inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chills, Extra dose administered, Headache
Clinical narrative: stomach pain; shivering; headache; received 3 doses of shingrix; This serious case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix and the 2nd dose of Shingrix. In NOV-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix and less than 2 months after receiving Shingrix, the patient experienced stomach pain (Verbatim: stomach pain) (serious criteria hospitalization), shivering (Verbatim: shivering) (serious criteria hospitalization), headache (Verbatim: headache) and extra dose administered (Verbatim: received 3 doses of shingrix). The outcome of the stomach pain, shivering, headache and extra dose administered were unknown.   It was unknown if the reporter considered the stomach pain, shivering and headache to be related to Shingrix, Shingrix and Shingrix.     It was unknown if the company considered the stomach pain, shivering and headache to be related to Shingrix, Shingrix and Shingrix.   Additional Information: GSK Receipt date: 15-APR-2024 The patient self-reported this case. He received 3 doses of Shingrix, and he did not know the exact date of the first dose but thought it was in November 2023.  Patient was experiencing shivering, headache and stomach pain.  He was hospitalized in December for stomach pain and shivering. The patient received 3 doses of Shingrix which led to extra dose administered.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE QUADRIVALENT High dose described as in error and was given to a 44-year old with no reported adverse event; FLUZONE QUADRIVALENT High dose described as in error and was given to a 44-year old with no reported adverse event; Initial information received on 18-Apr-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 44 years old female patient who was administerd Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent] described as in error 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 Pneumococcal Vaccine CONJ 20V (CRM197) (Prevnar 20), HPV Vaccine and COVID-19 Vaccine for Prophylactic vaccination.  On 19-Mar-2024, the patient received 0.7 ml dose of suspect Influenza Quadrival A-B High Dose HV Vaccine described as in error with no reported adverse (product prescribing error) (latency: unknown)  (product administered to patient of inappropriate age) (latency: same day) (lot UT8072CA) (expiry not reported) (strength: high dose) (frequency: once) via intramuscular route in the left arm for Immunization.  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: 1.83
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Blood pressure decreased, Hypotonia, Lethargy, Pallor
Clinical narrative: About 5-10 minutes after she immediately threw up, went completely limp, lost all color, white lips, couldn?t hold her head up or body weight and became extremely lethargic. Her blood pressure also dropped.
Age: 1.83
Sex: F
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: About 5-10 minutes after she immediately threw up, went completely limp, lost all color, white lips, couldn?t hold her head up or body weight and became extremely lethargic. Her blood pressure also dropped.
Age: 1.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: PENTACEL was administered in which only the ACTHIB portion was given, with no reported adverse event; Initial information received on 16-Apr-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 17 months old male patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] in which only the ACTHIB portion was given, 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 pneumococcal vaccine for Immunisation.  On 22-Mar-2024, the patient received a Standard total dose 4 (0.5mL) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (strength unknown) (lot UJ981AA, expiry date- 11-FEB-2025) via intramuscular route in the left thigh for Immunisation.  On 22-MAR-2024 the patient was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, in which only the acthib portion was given, with no reported adverse event (single component of a two-component product administered) (latency- same day).  Reportedly, Caller also reporting that the ACTHIB was reconstituted with an unknown diluent. Caller asking what diluent needs to be used in order for the ACTHIB to be valid and asking if she should discard the DTAP/IPV portion.    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: 14.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered Daptacel to a patient, instead of the Adacel with no reported adverse event; administered Daptacel to 14 years old patient, instead of the Adacel with no reported adverse event; Initial information received on 17-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 14 years old male patient who was administered Diphtheria, Tetanus and Acellular Pertussis Vaccine [Daptacel], instead of the Diphtheria, Tetanus and Acellular Pertussis Vaccine [Adacel]  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 Polio Vaccine INACT 3V (Vero) (Ipol); Hepatitis A Vaccine; Hepatitis B Vaccine; Varicella Zoster Vaccine (Varicella Vaccine); and HPV Vaccine all for Prophylactic Vaccination.  On 16-Apr-2024, 14 years old patient was administered 0.5 ml of Diphtheria, Tetanus and Acellular Pertussis Vaccine (Suspension for injection) (lot 2CA77C1, expiry date: 30-Apr-2025, frequency: once, strength: standard via intramuscular route in the left deltoid instead of the adacel with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency:same day) for Immunization.   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: 14.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, No adverse event, Product storage error
Clinical narrative: Pfizer covid vaccine was improperly stored in the freezer when received at facility. There was no harm to the patient but the effectiveness of the vaccine could have been diminished. Re-vaccination is recommended by the CDC.
Age: 75.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Headache, Nausea
Clinical narrative: headache, nausea, vomiting x 1, stomachache, diarrhea, fever 100 degrees, poor appetite.
Age: 75.0
Sex: F
Vaccine: TYP
Symptoms: Pyrexia, Vomiting
Clinical narrative: headache, nausea, vomiting x 1, stomachache, diarrhea, fever 100 degrees, poor appetite.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: On arrival to clinic we pulled record.  It only showed patient ever receiving 2 covid doses.  No other vaccines.  He denies having received other vaccines.  So we gave him a Twin Rix, Shingrix and Tdap.  At the end of day another provider had entered that he received a Tdap a there facility.  I contacted the facility and confirmed that he did indeed receive a Tdap at another facility on 4/23/24 , just 30 minutes before coming to our facility, but the delayed entering into chart.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Nausea, Paraesthesia
Clinical narrative: nausea, diarrhea, pain in knees and elbows, and tingling in feet, legs, arms, and hands. Two weeks later, I'm still experiencing the tingling in feet, legs, arms, and hands.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Feeling cold, Hypersomnia, Pyrexia
Clinical narrative: Chills then shivering; fever of 99.0; vomited; couldn't get warm.  I did not eat dinner on 4/23.  Slept 12 hours under extra blankets.  On 4/24 I am still chilled but not like yesterday.  Shivering gone.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Chills then shivering; fever of 99.0; vomited; couldn't get warm.  I did not eat dinner on 4/23.  Slept 12 hours under extra blankets.  On 4/24 I am still chilled but not like yesterday.  Shivering gone.
Age: 1.08
Sex: F
Vaccine: DTAPIPVHIB, MMRV, PNC15, VARCEL
Symptoms: No adverse event, Product preparation issue
Clinical narrative: There was no adverse event as far as signs and symptoms. Unfortunately, this was the first time I administered Pentacel and I did not mix the 2 vials together so the patient did not receive the Hib part of the vaccine. The father was notified and the patient came in on 4/18 to receive the Hib part of the injection.
Age: 18.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: gave varicella 2 days early
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Neck pain, SARS-CoV-2 test
Clinical narrative: Chills, fatigue, headache, neck pain
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: bruise at injection site 2 days post, (itching 4 days post and inflammation & redness 6 days post below the injection site further down ) patient used ice to help with heat and inflammation
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine dose was expired but no adverse effects noted
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Blood test abnormal, Diplopia, Eyelid ptosis
Clinical narrative: Myasthenia Gravis - drooping eye lid, double vision, fatigue and weakness in neck, arms and legs - balance issues.  I am being treated by a Neurologist at Center.  Currently on a dosage of prednisone and Pyridostigmine Bromide. This dosage has materially improvised the issues with drooping eye lid, and muscle weakness but the double vision continues intermittently
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Magnetic resonance imaging, Muscular weakness, Myasthenia gravis
Clinical narrative: Myasthenia Gravis - drooping eye lid, double vision, fatigue and weakness in neck, arms and legs - balance issues.  I am being treated by a Neurologist at Center.  Currently on a dosage of prednisone and Pyridostigmine Bromide. This dosage has materially improvised the issues with drooping eye lid, and muscle weakness but the double vision continues intermittently
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Covid vaccine was expired but no adverse effects noted
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired but no adverse effects noted
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine dose was expired. No adverse effects.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered 12 days too soon to be a valid 2nd dose. Parent Notified
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 1.08
Sex: M
Vaccine: VARCEL, MMR
Symptoms: Immunodeficiency, Laboratory test abnormal, Rash, Skin ulcer, Streptococcal bacteraemia
Clinical narrative: Hospitalized on 3/9/24 for group A Strep bacteremia in setting of 1 week of rash consistent with chickenpox. Transferred from Medical Center after 23 day hospitalization to another Hospital for further care of probable primary immunodeficiency and skin ulcers related to chickenpox.
Age: 1.08
Sex: M
Vaccine: VARCEL, MMR
Symptoms: Varicella
Clinical narrative: Hospitalized on 3/9/24 for group A Strep bacteremia in setting of 1 week of rash consistent with chickenpox. Transferred from Medical Center after 23 day hospitalization to another Hospital for further care of probable primary immunodeficiency and skin ulcers related to chickenpox.
Age: 1.08
Sex: M
Vaccine: VARCEL, MMR
Symptoms: Disseminated varicella, Endotracheal intubation, Gene mutation identification test positive, Immunodeficiency, Morbillivirus test positive
Clinical narrative: Hospitalized on 3/9/24 for group A Strep bacteremia in setting of 1 week of rash consistent with chickenpox. Transferred from Medical Center after 23 day hospitalization to another Hospital for further care of probable primary immunodeficiency and skin ulcers related to chickenpox.