chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reporting patient likely received VARIVAX during temperature excursion; This spontaneous report was received from a medical assistant referring to a 14-month-old (also reported as a 15-month-old) female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 28-MAR-2024, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #X018952, expiration date: 13-JUL-2025, administered subcutaneously in the left tight for prophylaxis (strength was not provided) that was improperly stored. The temperature excursion (freezer) was unknown with a time frame of 17 minutes (the most recent excursion was reported on 28-MAR-2024). The reporter stated that the patient received 1-year-old vaccines. A previous temperature excursion was reported as 14.1 degrees Celsius for 19 minutes. No additional adverse event was reported (no adverse event). No other information at that time was provided.; Sender's Comments:  US-009507513-2404USA009834: US-009507513-2405USA004944: US-009507513-2405USA004945: US-009507513-2405USA004946: US-009507513-2405USA004948:
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reporting patient likely received VARIVAX during temperature excursion; This spontaneous report was received from a medical assistant referring to a  4-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 01-APR-2024, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #X018952, expiration date: 13-JUL-2025, administered subcutaneously in the left tight for prophylaxis (strength was not provided) that was improperly stored. The temperature excursion (freezer) was unknown with a time frame of 17 minutes (the most recent excursion was reported on 28-MAR-2024). A previous temperature excursion was reported as 14.1 degrees Celsius for 19 minutes. No additional adverse event was reported (no adverse event). No other information at that time was provided.
Age: 4.0
Sex: U
Vaccine: HEP
Symptoms: Febrile convulsion
Clinical narrative: the 4year old patient had a previous reaction to RECOMBIVAX HB/child had a febrile seizure; This spontaneous report was received from a physician referring to a 4-year-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.  On 26-APR-2024, the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (dose, route of administration, lot number and expiration date not reported) for prophylaxis.         On an unknown date in 2024, the patient experienced febrile seizure (febrile convulsion).      The outcome of febrile convulsion was unknown. The causal relationship between the event and the vaccine was reported as related.
Sex: U
Vaccine: HIBV
Symptoms: Antibody test negative
Clinical narrative: no antibody titers; This spontaneous report has been received from a physician, referring to a 7-year-old patient of an unknown gender. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not reported.  On an unknown date (reported as "as a child"), the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose, route of administration, anatomical location, lot# and expiry date were not reported) for prophylaxis. The patient completed the recommended dosing series.  On an unspecified date in approximately May 2024 (reported as "currently"), the patient had no antibody titers.  At the time of reporting, the patient had not recovered from the event.  Causality assessment was not provided.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Syringe issue
Clinical narrative: No additional AE; FINGER FLANGE BROKE OFF SYRINGE BARREL; broke into pieces (the finger flange) broke off of the syringe barrel during; This spontaneous report was received from a nurse refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 21-MAY-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), formulation: injection, lot # was reported as: Y002963t, expiration date was reported as: 04-OCT-2026, 0.5 milliliter, once (route of administration and anatomical location were not provided) for prophylaxis.  On 21-MAY-2024, 1 unit of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) broke into pieces (the finger flange) broke off of the syringe barrel during administration and no one was injured and no missed or partial dose (syringe issue, poor quality device used). No additional adverse event reported (no adverse event).  Lot numer Y002963t has been verified to be a non-valid lot number for pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) and does not match any Company product.
Age: 0.42
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: hepatis B vaccine administered on 22-JUL-2003, 28-OCT-2003, and on 02-MAR-2004; hepatis B vaccine administered on 22-JUL-2003, 28-OCT-2003, and on 02-MAR-2004; This spontaneous report has been received from a physician, via medical records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (MARRS #2401USA013885), concerning a 5 months-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. The pt's historical vaccinations included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP VACCINE), hib vaccine (HIB VACCINE), poliovirus vaccine, and pneumococcal vaccine conj 7v (crm197) (PREVNAR).  Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP VACCINE), hib vaccine (HIB VACCINE) and pneumococcal vaccine conj 7v (crm197) (PREVNAR).   On 22-JUL-2003, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered as prophylaxis. Consequently, on 28-OCT-2003 (inappropriate schedule of product administration), and on 02-MAR-2004 he was vaccinated with second and third dose respectively (inappropriate schedule of product administration) (strengths, doses, lot #s, expiry dates, and routes of administration were not provided).; Sender's Comments:  US-009507513-2401USA013885: US-009507513-2401USA013885:
Age: 0.92
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: She received the third dose of varivax at 14 years old; She received the second dose at age of 9 y.o; She received Varivax at 11 m.o; This spontaneous report has been received from a physician regarding to a 11-month-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported.    On 03-JUN-2000, when the patient had 11 months (Product administered to patient of inappropriate age), she was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, then on 17-OCT-2008, she received the second dose at the age of 9 years old (Product administered to patient of inappropriate age), and 01-AUG-2013, she received the third dose at 14 years old (Extra dose administered). All administered as prophylaxis (strengths, doses, vaccination schemes, routes of administration, anatomical sites of injection, lot numbers and expiration dates were not reported).; Sender's Comments:  US-009507513-2405USA004457: US-009507513-2310USA011548:
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a parent via J&J managed social media concerned a 38 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced stroke (dose series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Cerebrovascular accident. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: F
Vaccine: COVID19
Symptoms: Coronary artery thrombosis
Clinical narrative: 11 BLOOD CLOTS WENT TO HEART; This spontaneous report received from a consumer via a company representative concerned an adult female patient (in her 40s). The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. We were unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced 11 blood clots went to heart (dose series 1) and needed a quadruple bypass. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 11 blood clots went to heart was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Coronary artery thrombosis: The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Death, Gastric cancer
Clinical narrative: LOTS OF PEOPLE DIED; STOMACH CANCER; This spontaneous report received from a consumer concerned multiple patients. Initial version was processed with additional information received on 22-MAY-2024. The patients weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. Batch number was not provided and have been requested. No concomitant medications were reported. No concomitant medications were reported. On an unspecified date, lots of people died (dose series 1), and patients experienced stomach cancer (dose series 1) after Covid 19 vaccine. The patients died from an unknown cause of death. It was not reported if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stomach cancer was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with a product quality complaint: 90000325915. The suspected product quality complaint has been confirmed to be void: this record is determined to be a follow up to complaint #90000317081 and records have been cross referenced as appropriate. this record indicates medical adverse events for additional patients with no new product quality issue identified. approval to void this duplicate complaint report. based on the PQC evaluation/investigation performed.; Sender's Comments: 000- Death, Gastric  cancer . The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: had a prescription that was written in the event got covid; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (had a prescription that was written in the event got covid) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Had covid once before and took Paxlovid, but the Covid symptoms had then were much worse.). Previously administered products included for Drug use for unknown indication: Simvastatin (Patient stopped simvastatin knowing it was contraindicated to take with Paxlovid.). Past adverse reactions to the above products included No adverse effect with Simvastatin.    In February 2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (had a prescription that was written in the event got covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 10-May-2024 for COVID-19, at a dose of 3 tablets, tid. At the time of the report, COVID-19 (had a prescription that was written in the event got covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2024, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient was little tired and congested this time when tested positive for Covid-19. Use by date of the Paxlovid was reported as 29-Feb-2024 and patient already started expired medication.
Age: 0.5
Sex: U
Vaccine: COVID19-2, DTAPIPVHIB, PNC15, RV5
Symptoms: Expired product administered, Irritability, Vaccination site bruising
Clinical narrative: Some bruising on the right thigh; Irritability; expired product administered/ patient was administered with vaccine >12 hours post puncture after receiving rotavirus vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE BRUISING (Some bruising on the right thigh), IRRITABILITY (Irritability) and EXPIRED PRODUCT ADMINISTERED (expired product administered/ patient was administered with vaccine >12(us) hours post puncture after receiving rotavirus vaccine) in a 6-month-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 immunisation.    Co-suspect products included non-company products PENTACEL for Prophylactic vaccination, PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) for Prophylactic vaccination and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.    The patient's past medical history included Cough on 06-May-2023. Concomitant products included VITAMIN D NOS for an unknown indication.   On 09-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form, third dose of PENTACEL (Intramuscular use) 1 dosage form, third dose of PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) (Intramuscular use) 1 dosage form and third dose of ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) (Oral use) 1 dosage form. On 09-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired product administered/ patient was administered with vaccine >12(us) hours post puncture after receiving rotavirus vaccine). On an unknown date, the patient experienced VACCINATION SITE BRUISING (Some bruising on the right thigh) and IRRITABILITY (Irritability). At the time of the report, VACCINATION SITE BRUISING (Some bruising on the right thigh) had resolved and IRRITABILITY (Irritability) and EXPIRED PRODUCT ADMINISTERED (expired product administered/ patient was administered with vaccine >12 hours post puncture after receiving rotavirus vaccine) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I never had COVID before. I took the two vaccines from Pfizer. This is the first time I believe; I never had COVID before. I took the two vaccines from Pfizer. This is the first time I believe; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I never had COVID before. I took the two vaccines from Pfizer. This is the first time I believe". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid as treatment.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pain, Tooth abscess, Tooth infection
Clinical narrative: Constant absesses/infections; Constant absesses/infections; Constant intense tooth/oral pains; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Oct2021 as dose 2, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Other medications in two weeks: Multi-Vitamins. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot:FE3592, Location: Left arm), administration date: 11Sep2021, when the patient was 57-year-old, for COVID-19 immunization. The patient had no known allergies, no chronic health conditions. The following information was reported: TOOTH INFECTION (medically significant), TOOTH ABSCESS (medically significant) all with onset 31Oct2022, outcome "recovering" and all described as "Constant absesses/infections"; ORAL PAIN (non-serious) with onset 31Oct2022, outcome "recovering", described as "Constant intense tooth/oral pains". The events "constant absesses/infections" and "constant intense tooth/oral pains" required physician office visit. Therapeutic measures were taken as a result of tooth infection, tooth abscess. It was unknown if therapeutic measures were taken as a result of oral pain. Clinical course: new dental experience of constant intense tooth/oral pains, abscesses/infections. The abscess/infection seems to occur every other month. (Had to extract 2 teeth so far. The patient friend's entire mouth is now toothless, without prior dental issues).  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based from limited information and plausible temporal relationship, the causal association of reported events with suspected vaccine BNT162b2 cannot be excluded. Case will be reassess pending new information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant, Pulmonary embolism, Thrombosis
Clinical narrative: Cancer; Blood clots; Pulmonary embolism; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (BNT162B2), on 08May2021 as dose 1, single (Lot number: EW0185), on 29May2021 as dose 2, single (Lot number: EW0187) and on 27Jan2022 as dose 3 (booster), single (Lot number: FL3198) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (death), outcome "fatal", described as "Cancer"; THROMBOSIS (death), outcome "fatal", described as "Blood clots"; PULMONARY EMBOLISM (death), outcome "fatal". The clinical course was reported as follows: The reporter mentioned that her father passed away in Apr2023, due to complications such as cancer, blood clots and pulmonary embolism and she was attempting to investigate cause of death. She inquired whether Pfizer was involved in an internet resource where lot numbers were identified as "toxic", and according to her after in this site two of three lot numbers of doses administered to her father were identified as "toxic". The patient date of death was Apr2024. Reported cause of death: "Cancer", "Blood clots", "Pulmonary embolism". It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Cancer; Blood clots; Pulmonary embolism
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Leukopenia, White blood cell count
Clinical narrative: leukopenia/low white blood count started after vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 42 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's hypothyroid", start date: 2009 (ongoing). Concomitant medication(s) included: SYNTHROID oral taken for hypothyroidism, start date: 2009 (ongoing). Vaccination history included: BNT162b2 (Dose 1, Arm, Batch/lot number: EP7534), administration date: 26Mar2021, when the patient was 41-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Arm, Batch/lot number: EW0162), administration date: 17Apr2021, when the patient was 41-year-old, for Covid-19 immunization, reaction(s): "Irregular menstrual cycle". The following information was reported: LEUKOPENIA (medically significant), outcome "unknown", described as "leukopenia/low white blood count started after vaccine". The patient underwent the following laboratory tests and procedures: White blood cell count: Low.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400068013 Same patient/vaccine, different dose/event;US-PFIZER INC-202400026231 Same patient/vaccine, different dose/event;
Age: 49.0
Sex: M
Vaccine: RAB
Symptoms: Tinnitus
Clinical narrative: ringing in ears; Initial information received on 21-May-2024 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a 49 years old male patient who experienced ringing in ears, after receiving vaccine Rabies (Hdc) Vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant or : no other vaccines.   On 07-May-2024, the patient received a (1 ml, 1x) dose 1 of suspect Rabies (Hdc) Vaccine, Powder and solvent for suspension for injection (strength: unknown) (lot: W1D182M, expiry date: 30-Nov-2025) via intramuscular route in right deltoid for pre-exposure/Immunization.  On 07-MAY-2024, the patient developed ringing in ears (tinnitus) (latency: same day) following the administration of Rabies (Hdc) Vaccine.  No lab data reported.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was administered IPOL and Pediarix vaccines on same day with no reported AE; Initial information received on 21-May-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 months old male patient who was administered IPV (VERO) [IPOL] and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [PEDIARIX] vaccines on same day 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) and ROTAVIRUS VACCINE both for Prophylactic vaccination and PEDIATRIX PARACETAMOL [PEDIATRIX] .  On 21-May-2024, the patient received 0.5 ml, total of suspect IPV (VERO), suspension for injection (lot W1B511M and expiry 08-SEP-2025)  via intramuscular route in the right thigh and  PEDIARIX not produced by Sanofi Pasteur  (dose, formulation, lot, expiry and admistraion site: unknown) [strength: unknown] [extra dose adminsterered, latency same day] both for Prophylactic Vaccination (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: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine administered with no adverse event; Initial information received on 22-May-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old female patient to whom expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] administered with no 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 expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, Suspension for injection via unknown route in unknown administration site for immunization (strength, dose, batch and expiry date unknown) with no adverse event (expired product administered) (latency same day).  Information on batch number and expiration date corresponding to the one at time of event occurrence 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: 67.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product prescribing issue
Clinical narrative: ACT-HIB is recommended by a physician after the patient had undergone splenectomy (with no reported adverse event); Initial information received on 17-May-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 67 years old patient of an unknown gender who had prescribed Hib (PRP/T) Vaccine [Act-Hib] by a physician after splenectomy (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 had prescribed suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection after splenectomy (strength, expiry date and lot number not reported via unknown route in unknown administration site as immunization (Product prescribing issue) (unknown latency).  Information on the batch number was requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizures
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Pneumonia, muscle pain, tiredness, fever, shivering, headache dizziness, stomach pain, nausea
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pneumonia, Pyrexia
Clinical narrative: Pneumonia, muscle pain, tiredness, fever, shivering, headache dizziness, stomach pain, nausea
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient received Moderna Covid Vaccine 0.25ml  (6month - 11yrs) on 05/09/2024.  Patient was informed and she didn't have any allergic reaction
Age: 43.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site cellulitis, Injection site erythema, Urticaria
Clinical narrative: Pt had prevnar 4 days ago, and broke out in severe hives over both upper extremeties, as well as site erythema and cellulitis that covers most of her upper arm.  Tx with steroids
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Vomiting
Clinical narrative: 6 hours after the shot, paitient started having fever , aches and chills and started to vomit once every hour .  ended up going to the er i believe she said 24 hours from the shot,. they gave her iv fluids and kept and eye on her. told her not to get a second shot. She left afterwards and was better.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT EXPERIENCED PAIN, ITCHING, REDNESS, SWELLING, AND HEAT IN THE LEFT ARM AT THE INJECTION SITE. SHE WILL TRY BENADRYL, IBUPROFEN, AND COMPRESS. WE DO NOT KNOW THE OUTCOME OF TREATMENT, AS SHE WILL START IT TODAY.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Swelling
Clinical narrative: Patient states had right neck swelling/pain - she spoke to primary care about treatment options and they told her to rest/ice/ibuprofen.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Blood test, Electrocardiogram abnormal
Clinical narrative: Afib  with VRV .  Cardiology appointment on 5/17/2024 with an EKG confirming afib;  conditions getting worse until I was admitted to Hospital on  05/21/2024; received amiodarone by IV;  was released the next day to take 400 mg  for one week the\n 200mg after that. The Afib  has not resolved
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Swollen & tender Injection site, Fever
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Scattered maculopapular rash trunk & face - most abundant upper back. Does not appear to bother him.  No treatment  Isolation thru weekend recommended. Mother reports older sister had same adverse reaction with chicken pox vaccine.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Medical Assistant called to report that a patient received her first GARDASIL 9 at 15 years of age on an unspecified date in 2019, then received her second dose on another unspecified date in 2023.; No additional AE details available; This spontaneous report was received from a medical assistance and refers to a 19-year-old female patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  In 2019 when the patient was 15-year-old, she was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), then in 2023 the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). No additional adverse events were reported.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hepatitis B second dose 27-MAR-2003, third dose 12-JAN-2004; Hepatitis B first dose 27-JUN-2002, second dose 27-MAR-2003; This spontaneous report has been received from an other health care professional via medical records from a case in litigation for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (2401USA014365), concerning a 9-months-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 27-JUN-2002, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) intramuscular injection, (strength, dosage regimen, lot #, expiry date, anatomical location, route of administration, and indication were not provided). On 27-MAR-2003, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (manufacturer unknown) intramuscular injection, (strength, dosage regimen, lot #, expiry date, anatomical location, route of administration, and indication were not provided) (Inappropriate schedule of product administration). On 12-JAN-2004, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) intramuscular injection, (strength, dosage regimen, lot #, expiry date, anatomical location, route of administration, and indication were not provided) (Inappropriate schedule of product administration).; Sender's Comments:  US-009507513-2401USA014365: US-009507513-2405USA001665:
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hib second dose 24-OCT-2002, third dose 09-JAN-2003; This spontaneous report has been received from an other health care professional via medical records from a case in litigation for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (MARRS #2401USA014365), concerning a 6-months-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 27-AUG-2002, the patient was vaccinated with the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection, (strength, dosage regimen, lot #, expiry date, anatomical location, route of administration, and indication were not provided). On 24-OCT-2002, the patient was vaccinated with the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection, (strength, dosage regimen, lot #, expiry date, anatomical location, route of administration, and indication were not provided). On 09-JAN-2003, the patient was vaccinated with the third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection, (strength, dosage regimen, lot #, expiry date, anatomical location, route of administration, and indication were not provided) (Inappropriate schedule of product administration).; Sender's Comments:  US-009507513-2401USA014365: US-009507513-2405USA001662:
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: HCP reports that a patient received her first dose of GARDASIL 9 at the age of 14 but has not received her second or third dose.; No additional AE/ no PQC.; This spontaneous report was received from a pharmacist and refers to a 23-year-old female patient.  There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  In approximately 2005 when the patient was 14-year-old, she was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 mL (route, anatomical location, lot number and expiration date were not reported) for prophylaxis. The patient had not received the second or third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), (Inappropriate schedule of product administration). No additional adverse events were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse side effects were reported; HCP called after administering VARIVAX and PROQUAD to two 12-month-old children; This spontaneous report was received from a nurse concerning a 12-month-old patient of unspecified gender.  The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On 20-MAY-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, lot #X024913, expiration date 14-APR-2025 (dosage regimen, anatomical location and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X026320, expiration date 07-NOV-2025 (dosage regimen, anatomical location and route of administration were not provided), both administered as prophylaxis (overdose).  The reporter also requested information on adverse effects. No adverse side effects were reported (no adverse event).  This was one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2405USA006252:
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: syncopal episode after administration of GARDASIL 9; This spontaneous report was received from a physician via company representative regarding to a male patient of unspecified age. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with human papilloma virus (HPV) rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, frequency, route of administration, anatomical injection site, lot number and expiration date were not provided) for prophylaxis.   On an unspecified date (also reported as "after administration of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine [yeast] [GARDASIL 9]), the patient had a syncopal episode (syncope). At the time of reporting, the outcome of the event was unknown.   The causal relationship between the vaccination with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the event was not provided.  Upon internal review, the event syncope was determined to be medically significant.  Limited information was available. Permission to contact HCP was not given. Additional information is not expected.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Blood test, Diarrhoea, Non-alcoholic fatty liver, Stool analysis
Clinical narrative: Approximately 1 week after vaccine I began to have nonstop stomach pain where anything I ate caused severe stomach pain and intense diarrhea as well as occasional vomiting.  I could eat about one piece of toast per day without spending the day in the bathroom if I ate that piece of toast over a  period of about 1 hour.  I could drink small sips of water without immediately getting Diarrhea, but if I drank quickly or in too much volume I spent the day in the bathroom.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan abnormal, Vomiting
Clinical narrative: Approximately 1 week after vaccine I began to have nonstop stomach pain where anything I ate caused severe stomach pain and intense diarrhea as well as occasional vomiting.  I could eat about one piece of toast per day without spending the day in the bathroom if I ate that piece of toast over a  period of about 1 hour.  I could drink small sips of water without immediately getting Diarrhea, but if I drank quickly or in too much volume I spent the day in the bathroom.
Age: 48.0
Sex: F
Vaccine: RAB
Symptoms: Injection site bruising, Injection site discharge, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Donor noticed three hours after the immunization was given and band aide was removed that vaccine site was leaking. Donor noticed faint bruising. Donor did not think much of this and went to sleep for the night. Donor awoke the next morning and took a shower and noticed their arm in the mirror. Donor stated she has a large bruise with a firm round ball underneath site. Donor stated there was warmth, pain, and itching to site. Donor did not call center or report any issues until 5/25/2024 0900. Donor states this is because they had a migraine on 5/24/2024 and did not feel like returning to center.  Donor massaged arm but did not apply any treatment.
Age: 48.0
Sex: F
Vaccine: RAB
Symptoms: Injection site warmth, Migraine
Clinical narrative: Donor noticed three hours after the immunization was given and band aide was removed that vaccine site was leaking. Donor noticed faint bruising. Donor did not think much of this and went to sleep for the night. Donor awoke the next morning and took a shower and noticed their arm in the mirror. Donor stated she has a large bruise with a firm round ball underneath site. Donor stated there was warmth, pain, and itching to site. Donor did not call center or report any issues until 5/25/2024 0900. Donor states this is because they had a migraine on 5/24/2024 and did not feel like returning to center.  Donor massaged arm but did not apply any treatment.
Age: 12.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Got PPSV23 booster earlier today at 11 am. Left arm.  Went back to school  Picked up at 3 pm. Noted for redness and swelling of the left upper arm. ~3 inch Also with pain, 7/10.  Cool compresses used  Given Ibuprofen, 200 mg  Seems to have helped.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Started to get red and swollen on same day in afternoon.  Next day got worse, more redand swollen. Friday morning took her to the Dr and the doctor prescribed cephALEXin, 8.3mls. 3 times a day for 7 days. She outlined the infected area and advised to follow up next day. Went for a follow up on 5/25/2024. The redness had spread some more passed the outline. Once at dr. Office she checked the infection site  and drew another line&was administered some benadryl and told to Follow up on 5/28/24. Was also told if it spread more, past the outline over the weekend, to give the doctor a call.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV, MMRV
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Started to get red and swollen on same day in afternoon.  Next day got worse, more redand swollen. Friday morning took her to the Dr and the doctor prescribed cephALEXin, 8.3mls. 3 times a day for 7 days. She outlined the infected area and advised to follow up next day. Went for a follow up on 5/25/2024. The redness had spread some more passed the outline. Once at dr. Office she checked the infection site  and drew another line&was administered some benadryl and told to Follow up on 5/28/24. Was also told if it spread more, past the outline over the weekend, to give the doctor a call.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Injection site pain, Injection site rash, Mobility decreased, Rash pruritic
Clinical narrative: 20 May 2024, an itchy rash 4 cm x 6 cm appeared in the area of the injection.  No blisters.  Rash faded in 3 days.  On 22 May 2024, I had pain in area of the in injected muscle and in the left shoulder joint, not the usual muscle soreness.  Too painful to raise arm even to shoulder height.  Loss of flexibility.  That continued 3 days and today, 25 May, it is improved.  Still some pain when shoulder is raised; however, use of the arm is much better.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure, Catheterisation cardiac, Coronary artery dissection, Echocardiogram abnormal, Ejection fraction decreased
Clinical narrative: 6 days after I received the vaccine, I had a Spontaneous Coronary Artery Dissection. I did not have any cardiac risk factors at the time. I did not have high blood pressure, high cholesterol, diabetes, vascular disease, previous coronary disease, etc. I was at rest when it happened so it was not caused by increased workload or strenuous activity. From what my doctors told me, this condition is rare & usually affects pregnant or recently postpartum women (which I am not) or persons with vascular dysplasia which I do not have. The doctors have no explanation as to why this happened to me. The only thing that occurred around that time frame was  the fact that I got the vaccine 6 days prior.  In the emergency room, an echocardiogram showed that my heart function was seriously affected. My ejection fraction was just 30-35% which meant I was at heart failure level.  I was hospitalized for 5 days. While I have improved since then, my heart function is still not back to what it was previously & my last echocardiogram is still not in the normal range.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Arteriogram carotid, Chills, Computerised tomogram, Coordination abnormal, Dizziness
Clinical narrative: Chills, dizziness, uncoordinated walking, nausea, rapid heart rate
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Heart rate increased, Magnetic resonance imaging, Nausea, Ultrasound abdomen
Clinical narrative: Chills, dizziness, uncoordinated walking, nausea, rapid heart rate
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Vomiting
Clinical narrative: Patient felt nauseated, then vomited within 15 minutes of given vaccine. Pt recovered on their own and walked out of the vaccination area feeling better after vomiting.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Child had a runny bowel movement at night the day of the injection ( Child is homebound and does not go to public places or in a school setting, all meals are homemade, no one else with symptoms at home) Child complained of nausea and vomited at 11:05am
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angiogram pulmonary normal, Chest X-ray normal, Chest pain, Electrocardiogram normal, Full blood count normal
Clinical narrative: Severe left side and back chest pain requiring ER visit to rule out heart attack or PE. Tests were negative. Discharge diagnosis: pluritic chest pain
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Metabolic function test normal, Pleuritic pain, Troponin normal
Clinical narrative: Severe left side and back chest pain requiring ER visit to rule out heart attack or PE. Tests were negative. Discharge diagnosis: pluritic chest pain
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Bursa injury, Imaging procedure, Injection site injury
Clinical narrative: Patient states her provider suspects a Bursa sac puncture. Patient is attending physical therapy.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pruritus, Pyrexia, Rash
Clinical narrative: Rash that looked like chicken pox or measles on lower abdomen, itching and singing pain on hands, tired, fever
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Rash that looked like chicken pox or measles on lower abdomen, itching and singing pain on hands, tired, fever
Age: 6.0
Sex: M
Vaccine: TYP
Symptoms: Eye swelling
Clinical narrative: around 1 hour after administration,  developed bilateral eye swelling that did not improve with 12.5mg diphenhydramine. Continued diphenhydramine 25mg every 6 hours for next 36 hours. Eye swelling improved somewhat but persisted so treated with prednisone 1mg/kg for 5 days
Age: 33.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Dermatitis bullous, Erythema
Clinical narrative: bullous rash to left posterior arm and underlying erythema