chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lichen planus, Malaise, Mental disorder
Clinical narrative: Oral, Derm & Vaginal Lichen Planus; has been a nightmare financially, mentally and physically; has been a nightmare financially, mentally and physically; This is a spontaneous report received from an Other HCP.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Nov2021 as dose 2, single (Lot number: 3230BD & 301558) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LICHEN PLANUS (non-serious), outcome "not recovered", described as "Oral, Derm & Vaginal Lichen Planus"; MENTAL DISORDER (non-serious), MALAISE (non-serious), outcome "unknown" and all described as "has been a nightmare financially, mentally and physically". Therapeutic measures were taken as a result of lichen planus.  Additional information: I have a terrible case of Oral, Derm & Vaginal Lichen Planus. Have been battling it for a few years now after receiving the COVID vaccine. Specialist, lots of steroids (by mouth & topical) nothing helps this has been a nightmare financially, mentally and physically. Patient has no drug allergy.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: second Covid infection; covid; covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 70-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Aug2022, outcome "recovered" and all described as "covid"; DISEASE RECURRENCE (medically significant) with onset Nov2022, outcome "recovered", described as "second Covid infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence included Paxlovid. Clinical course: PC is on Pfizer COVID vaccine. Had always had the Pfizer vaccines. Had Covid two times. Got Covid 12Aug2022 for first time, then same year, 2022, was second Covid infection in Nov2022. Confirmed having Covid was after having received Pfizer COVID vaccine. Received all of the recommended vaccines. In Feb2021 was the first vaccines. Unknown at time of call how many total doses of the Pfizer COVID vaccine caller had. Followed recommendations, however many had, had them all.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Infectious mononucleosis
Clinical narrative: mono; This is a spontaneous report received from a Physician, Program ID.  A patient (age and gender not provided) 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. The following information was reported: INFECTIOUS MONONUCLEOSIS (non-serious), outcome "unknown", described as "mono".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test; positive COVID-19 test; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 63-year-old 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jul2024, outcome "recovering" and all described as "positive COVID-19 test". The clinical course was reported as follows: The patient had a temperature of 104.8 on 21Jul2024, with a positive COVID-19 test. The doctor gave him a prescription of nirmatrelvir, ritonavir (PAXLOVID), and it worked amazingly well (as reported), the temperature in 24 hours was normal, and the patient felt 75% better. The patient underwent the following laboratory tests and procedures as aforementioned. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: still got COVID; still got COVID; can't taste anything 3 and a half years of disgust in my mouth; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "afib" (unspecified if ongoing); "heart condition" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: AGEUSIA (non-serious) with onset 2021, outcome "unknown", described as "can't taste anything 3 and a half years of disgust in my mouth"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "still got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: still got COVID. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-long covid; Covid-long covid; This is a spontaneous report received from a Consumer or other non HCP.  A patient in their 50's received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EJ1685), in left arm and on 27Jan2021 as dose 2, single (Lot number: EN5318) at the age of 51 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Insomnia", start date: 2012 (ongoing); "Anemia", start date: 2012 (ongoing). The patient's family history included: "Factor V", start date: 2001 (ongoing). Concomitant medication(s) included: COUMADIN oral taken for factor v deficiency, start date: 2001 (ongoing); AMBIEN CR oral taken for insomnia, start date: 2012 (ongoing); FOLIC ACID oral taken for anaemia, start date: 2012 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-long covid". Clinical course: No Prior Vaccinations. Family medical history relevant to adverse events (AES): Hypertension, High Cholesterol, Lung Cancer, Factor V. There was no specific relevant test for thromboembolic events with thrombocytopenia.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300170652 same patient, different dose/event (dose 2);
Sex: U
Vaccine: COVID19
Symptoms: Lyme disease
Clinical narrative: one of her patients got Lyme Disease after receiving COVID-19 vaccine; This is a spontaneous report received from a Physician, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYME DISEASE (medically significant), outcome "unknown", described as "one of her patients got Lyme Disease after receiving COVID-19 vaccine".  Clinical course: Participant reported that one of her patients got Lyme Disease after receiving COVID-19 vaccine and another patient got mono after receiving COVID-19 vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the information currently available, the possible contribution of the administration of suspect drug BNT162B2 OMI XBB.1.5 (COMIRNATY 2023-2024 FORMULA) to the occurrence of the reported event Lyme Disease cannot be completely excluded. 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.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: vaccine was not deemed viable with no reported adverse event; Initial information received on 15-Jul-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5-year-old male patient to whom IPV (VERO) [IPOL] vaccine was administered which was not deemed viable with no reported adverse event.  The case is linked to 2024SA201338 (master case).  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 (Daptacel) for Immunization.  On 10-Jun-2024, the patient received a 0.5 ml dose of suspect IPV (VERO) Suspension for injection (lot W1C831M, expiry date, strength: not reported) via intramuscular route in the right thigh for Immunization and ipol vaccine was not deemed viable with no reported adverse event (poor quality product administered) (latency: on same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: administered after temperature excursion; therefore, ipol vaccine was not deemed viable with no reported adverse event; Initial information received on 15-Jul-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5-year-old male patient (109 cm and 20.4 kg) whom IPV (VERO) [IPOL] vaccine was administered after temperature excursion; was not deemed viable with no reported adverse event.  The case is linked to 2024SA201338 (master case).  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 (Daptacel) for Immunization.  On 10-Jun-2024, the patient received a 0.5 ml dose of suspect IPV (VERO) Suspension for injection of lot W1C831M (expiry date, strength: not reported) via intramuscular route in the right thigh as immunization and administered after temperature excursion; therefore, ipol vaccine was not deemed viable with no reported adverse event (poor quality product administered) (latency: on same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.92
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: poor quality vaccine administered with no reported adverse event; Initial information received on 15-Jul-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 months old female patient (71 cm and 4.11 kg) where poor quality IPV (VERO) [IPOL] Vaccine was administered 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 b vaccine rhbsag (yeast) (recombivax HB) for Immunization.  On 17-Jun-2024, the patient received 0.5 ml dose of suspect IPV (VERO) Suspension for injection (lot- W1C741M) via unknown route in the right thigh (strength and expiration date: not provided) for Immunisation (poor quality product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: Ipol vaccine was not deemed viable and was administered with no adverse event; Initial information received on 15-Jul-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves IPV (VERO) [IPOL] vaccine was not deemed viable and was administered to a 5-year-old male patient with no 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 (Daptacel) for Immunization.  On 19-Jun-2024, the patient received a 0.5 ml dose of suspect IPV (VERO), Suspension for injection (lot: W1C741M, expiry date: unknown) via intramuscular route in the left thigh as immunization and ipol vaccine was not deemed viable and was administered with no adverse event (poor quality product administered) (latency: same day)  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.92
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: poor quality vaccine administered with no reported adverse event; Initial information received on 15-Jul-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 months old female patient (70 cm and 8.16 kg) where poor quality IPV (VERO) [IPOL] administered 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 (Daptacel) for Immunization.  On 19-Jun-2024, the patient received 0.5 ml dose of suspect IPV (VERO) Suspension for injection (lot- W1C741M) via unknown route in the right thigh (strength and expiration date: not provided) for Immunisation (poor quality product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 3-year-old patient was given adacel with no reported adverse event; Initial information received on 16-Jul-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 years old female patient who was given diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine (hepatitis A) for Prophylactic vaccination.  On 08-Jul-2024, the patient received an unknown dose (dose 4, total, once) of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection (lot U7961AA, expiry date: unknown, strength: standard) via intramuscular route in the left thigh for Immunization (product administered to patient of inappropriate age) (Latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 12 month old received a dose of tdap with no reported adverse event; Initial information received on 16-Jul-2024 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 1-year-old female patient who received a dose of diphtheria-2/tetanus/5 AC 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 HPV VACCINE (HPV VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination (immunization).  On 15-Jul-2024, the patient received a 0.5 ml dose (dose 1) of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection of lot U7999AA and expiry date: 08-Feb-2026 Frequency: once and Strength: standard via unknown route in the left vastus lateralis  for immunization and is reported 12 month old received a dose of TDAP with no reported adverse event (product administered to patient of inappropriate age) (latency: on same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA211168:
Age: 0.33
Sex: F
Vaccine: DTAP, IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received a dose of IPOL/Daptacel ,  after the temperature excursion with no reported adverse event; Initial information received on 16-Jul-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 4 months old female patient who received a dose of Poliomyelitis Vaccine (Inactivated) (Ipol) Ipv (Vero)/ Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel],  after the temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Jun-2024, the patient received 0.5 ml total dose of suspect Poliomyelitis Vaccine (Inactivated) Suspension for injection (with an unknown strength, expiry date, lot number) via subcutaneous route in the right vastus lateralis for immunization.  On 28-Jun-2024, the patient received 0.5 ml total dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (with an unknown strength, expiry date, lot number) via intramuscular route in unknown administration site for immunization.  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested for both suspects..  On 28-JUN-2024, the patient received Poliomyelitis Vaccine (Inactivated)/ Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine,  after the temperature excursion with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly, HCP requested temperature excursion data but did not know for sure if the vaccine was actually out of temperature range, and if so, how long it was out of range. This began on 14 Jun 2024. She said that one system showed the product out of range, but another system did not show the product was out of range. They moved the product to another refrigerator, which did not give times for how long the product was out of range. HCP stated that as far as she can tell, the maximum out-of-range temperature was 51 degrees Fahrenheit, but she does not know how long the product was out of range. HCP stated they are still trying to figure it out. Reason: Refrigerator/system malfunction Max temperature reached: 51 degrees Fahrenheit, or so the reporter thinks at this time Duration out of labelled range: Unknown Human error: No Does extended stability data cover the excursion: Unknown, but have to assume no If negative advice  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: 31.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: ADULT PATIENT WAS GIVEN A PEDIATRIC DOSE OF HEP B . SPOKE WITH PATIENT WITHIN THE HOUR OF GETTING 0.5 ML PEDS DOSE VS THE ORDERED 1ML ADULT DOSE. THE HALF DOSE HAD NOT GIVEN HIM ANY SIGNS OR SYMPTOMS. THE VAERS REPORT IS PART OF  VACCINE  REPORTING.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Balance disorder, Blood test normal, Computerised tomogram normal, Electrocardiogram normal, Fall
Clinical narrative: Symptoms feet stiffen whole body stiffen then fall backwards now feet still stiffen and loose balance n leg give out tippy toe then legs shake need to grab something
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Laboratory test normal, Muscular weakness, Musculoskeletal stiffness, Tremor, X-ray normal
Clinical narrative: Symptoms feet stiffen whole body stiffen then fall backwards now feet still stiffen and loose balance n leg give out tippy toe then legs shake need to grab something
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Encephalitis, Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Fever, headache, encephalitis, red swollen injection site, pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Pyrexia
Clinical narrative: Fever, headache, encephalitis, red swollen injection site, pain.
Age: 57.0
Sex: M
Vaccine: PNC20
Symptoms: Unevaluable event
Clinical narrative: Patient was given vaccination and was too young to receive based off of recommendations.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Breast pain, Injection site bruising, Injection site pain, Nipple pain, Pain
Clinical narrative: Patient says that symptoms started 3 days after she received the vaccination.  She reports her left breast was stinging, burning, itching, and had a bumpy rash.  Also, the left nipple hurt.  After 24 hours, the symptoms in her breast went away.  She says the injection site was mildly sore with a blue bruise but the soreness went away quick.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Patient says that symptoms started 3 days after she received the vaccination.  She reports her left breast was stinging, burning, itching, and had a bumpy rash.  Also, the left nipple hurt.  After 24 hours, the symptoms in her breast went away.  She says the injection site was mildly sore with a blue bruise but the soreness went away quick.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory, Heart rate increased
Clinical narrative: Woke up an hour after going to bed  for the night with elevated heart rate up to 180 bpm fast all that night would not go under 95 bpm continuing over half the next day. Finally subsided.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Haematochezia, Vaccine positive rechallenge
Clinical narrative: patient received rotavirus vaccine 7/19. 7/24 woke up and had few flecks of blood in stool. no further episodes.
Age: 70.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event reported or known; reporting that second dose was not recommended and given in error.  When patient called pharmacy to ask if he'd had it, evidently staff only scrolled to see the more recent Rx for Arexvy that had not been filled/given.  The same insurance covered both at no cost to the patient.  There was no 'possible duplicate' checkbox for the pharmacist.  The same doctor sent both prescriptions.  The pharmacist (me) did not check the immunization registry before immunizing.  The error was discovered only when logging in to report the Arexvy given today, 7/24.  Called the patient to notify him, and he stated no adverse effects, at least as of tonight.
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis
Clinical narrative: Cellulitis,  vibramycin 100mg capsules, motrin 800 mg tablets
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Hospitalized with COVID
Age: 9.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal pain, Decreased appetite, Headache, Injection site pain, Pyrexia
Clinical narrative: The day following vaccination began to suffer from pain at the injection site that increased in severity. On day 4 after injection headache and by day 6 high fever up to 105 and continued for 10 days along with loss of appetite, abdominal pain, continued pain at injection site and disturbed sleep.
Age: 9.0
Sex: F
Vaccine: DTAP
Symptoms: Sleep disorder
Clinical narrative: The day following vaccination began to suffer from pain at the injection site that increased in severity. On day 4 after injection headache and by day 6 high fever up to 105 and continued for 10 days along with loss of appetite, abdominal pain, continued pain at injection site and disturbed sleep.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: a dose of GARDASIL 9 that was administered to a pregnant patient.; NO AE; This spontaneous report was received from a nurse and referred to a 27-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 an unknown date, the patient was pregnant. The last menstrual period (LMP) and the estimated date of delivery (EDD) were not provided.  On 05-JUN-2024, the pregnant patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #2014634, expiration date: 20-SEP-2025, administered for prophylaxis (strength, and route of administration were not provided) (Exposure during pregnancy). Operator of device was health professional. Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe was disposed and was not available for retrieval. There was no additional adverse event. Pregnancy outcome was pending. Fetal outcome was unknown.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improper storage of product in use; This spontaneous report was received from a medical assistant, referring to a 4-year-old female patient.  The patient's medical history, concurrent conditions, and drug reactions/allergies were not reported. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX). It was reported that there were no vaccine/vaccine devices received within 4 weeks prior to the administration. And there was no adverse event following a prior vaccination.  On 22-MAY-2024, the patient was vaccinated with improperly stored vaccines of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, lot #W035041, expiration date: 24-MAY-2024, the first dose, administered on the left arm as prophylaxis (strength, dose, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X018954, expiration date: 13-JUL-2025, the first dose, administered on the left arm as prophylaxis (strength, dose, and route of administration were not provided) (product storage error). The vaccines were exposed to multiple current excursions since 22-APR-2024. The temperature excursion occurred as a result of reading from a digital data logger. There was no previous temperature excursion. No adverse event was reported (no adverse event).  This is one of several reports from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in arm; This non-serious case was reported by a nurse via sales rep and described the occurrence of numbness of upper extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis.   On 12-JUL-2024, the patient received Shingrix. In JUL-2024, an unknown time after receiving Shingrix, the patient experienced numbness of upper extremities (Verbatim: Numbness in arm). The outcome of the numbness of upper extremities was not resolved.   The reporter considered the numbness of upper extremities to be unrelated to Shingrix.   The company considered the numbness of upper extremities to be unrelated to Shingrix.   Additional Information: GSK Receipt date: 15-JUL-2024 A reporter reported that a patient had numbness in arm was reported as worsened.  The reporter ruled out heart attack and stated that the patient had arthritis.
Age: 29.0
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 29-year-old female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet). The outcome of the incomplete course of vaccination 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: 15-JUL-2024 A pharmacist reported that a patient explained to her that 35 days ago, on 10 June 2024, received Twinrix first dose and her doctor told her that she had antibodies for hep B so she only needs hep A vaccine.  Till the time of reporting the patient had not received the second dose of Twinrix, which led to incomplete course of vaccination.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Blood pressure increased, Chest pain, Chills, Diarrhoea
Clinical narrative: pain at injection site; shivering; tiredness; headache; diarrhea; increased blood pressure; reflux; lower chest pain; upper stomach pain; heart racing; Inappropriate schedule of vaccine/not received 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 12-JAN-2024, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site), shivering (Verbatim: shivering), tiredness (Verbatim: tiredness), headache (Verbatim: headache), diarrhea (Verbatim: diarrhea), increased blood pressure (Verbatim: increased blood pressure), reflux gastritis (Verbatim: reflux), chest pain (Verbatim: lower chest pain), stomach pain (Verbatim: upper stomach pain), heart racing (Verbatim: heart racing) and incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine/not received 2nd dose). The outcome of the injection site pain, shivering, tiredness, headache, diarrhea, increased blood pressure, reflux gastritis, chest pain, stomach pain and heart racing were resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain, shivering, tiredness, headache, diarrhea, increased blood pressure, reflux gastritis, chest pain, stomach pain and heart racing to be related to Shingrix.     It was unknown if the company considered the injection site pain, shivering, tiredness, headache, diarrhea, increased blood pressure, reflux gastritis, chest pain, stomach pain and heart racing to be related to Shingrix.   Additional Information: GSK Receipt date: 15-JUL-2024 The patient self-reported. She received her first dose of Shingrix on 12 Jan 2024, after the first dose she experienced upper stomach pain, lower chest pain, reflux, increased blood pressure, diarrhea, pain at the injection site, headache, tiredness, shivering, and heart racing.  All symptoms have resolved, also she was currently late for her second dose.  Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Gastrooesophageal reflux disease, Headache, Incomplete course of vaccination, Injection site pain
Clinical narrative: pain at injection site; shivering; tiredness; headache; diarrhea; increased blood pressure; reflux; lower chest pain; upper stomach pain; heart racing; Inappropriate schedule of vaccine/not received 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 12-JAN-2024, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site), shivering (Verbatim: shivering), tiredness (Verbatim: tiredness), headache (Verbatim: headache), diarrhea (Verbatim: diarrhea), increased blood pressure (Verbatim: increased blood pressure), reflux gastritis (Verbatim: reflux), chest pain (Verbatim: lower chest pain), stomach pain (Verbatim: upper stomach pain), heart racing (Verbatim: heart racing) and incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine/not received 2nd dose). The outcome of the injection site pain, shivering, tiredness, headache, diarrhea, increased blood pressure, reflux gastritis, chest pain, stomach pain and heart racing were resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain, shivering, tiredness, headache, diarrhea, increased blood pressure, reflux gastritis, chest pain, stomach pain and heart racing to be related to Shingrix.     It was unknown if the company considered the injection site pain, shivering, tiredness, headache, diarrhea, increased blood pressure, reflux gastritis, chest pain, stomach pain and heart racing to be related to Shingrix.   Additional Information: GSK Receipt date: 15-JUL-2024 The patient self-reported. She received her first dose of Shingrix on 12 Jan 2024, after the first dose she experienced upper stomach pain, lower chest pain, reflux, increased blood pressure, diarrhea, pain at the injection site, headache, tiredness, shivering, and heart racing.  All symptoms have resolved, also she was currently late for her second dose.  Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Palpitations
Clinical narrative: pain at injection site; shivering; tiredness; headache; diarrhea; increased blood pressure; reflux; lower chest pain; upper stomach pain; heart racing; Inappropriate schedule of vaccine/not received 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 12-JAN-2024, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site), shivering (Verbatim: shivering), tiredness (Verbatim: tiredness), headache (Verbatim: headache), diarrhea (Verbatim: diarrhea), increased blood pressure (Verbatim: increased blood pressure), reflux gastritis (Verbatim: reflux), chest pain (Verbatim: lower chest pain), stomach pain (Verbatim: upper stomach pain), heart racing (Verbatim: heart racing) and incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine/not received 2nd dose). The outcome of the injection site pain, shivering, tiredness, headache, diarrhea, increased blood pressure, reflux gastritis, chest pain, stomach pain and heart racing were resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain, shivering, tiredness, headache, diarrhea, increased blood pressure, reflux gastritis, chest pain, stomach pain and heart racing to be related to Shingrix.     It was unknown if the company considered the injection site pain, shivering, tiredness, headache, diarrhea, increased blood pressure, reflux gastritis, chest pain, stomach pain and heart racing to be related to Shingrix.   Additional Information: GSK Receipt date: 15-JUL-2024 The patient self-reported. She received her first dose of Shingrix on 12 Jan 2024, after the first dose she experienced upper stomach pain, lower chest pain, reflux, increased blood pressure, diarrhea, pain at the injection site, headache, tiredness, shivering, and heart racing.  All symptoms have resolved, also she was currently late for her second dose.  Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 1.08
Sex: F
Vaccine: PNC20, VARCEL
Symptoms: Myoclonus
Clinical narrative: Sudden onset of myoclonus within a couple hours of receiving the vaccines. Occurring during sleep and while awake.. We have been dealing with this for 11 consecutive days. We have seen a neurologist that diagnosed her symptoms as myoclonus. Currently seeking additional treatment due to the varicella vaccine being the potential trigger.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: a patient was given an expired dose of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received HBV (Engerix B) (batch number YY2R3, expiry date 12-MAY-2024) for prophylaxis.   On 15-JUL-2024, the patient received Engerix B. On 15-JUL-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: a patient was given an expired dose of Engerix-B). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-JUL-2024 The practice manager reported that a patient was given an expired dose of Engerix-B, which led expired product used. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Imaging procedure, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Left upper arm/shoulder redness, pain and swelling. 10 cm area of erythema, induration, warmth and tenderness noted over left shoulder.  Treatment --- Bactrim twice daily for 7 days for presumed cellulitic infection.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Laboratory test
Clinical narrative: Left upper arm/shoulder redness, pain and swelling. 10 cm area of erythema, induration, warmth and tenderness noted over left shoulder.  Treatment --- Bactrim twice daily for 7 days for presumed cellulitic infection.
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no adverse event; Inbound call from lab director/medical assistant who is reporting administration of adult RECOMIBAXHB to a 17 year old female inadvertently.  Caller states patient was administered the dose on 17-JUN-2024, however there are no symptomatic adverse eve; This spontaneous report was received from a medical assistant refers to a 17-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 17-JUN-2024, the patient was vaccinated with adult dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), formulation: intramuscular injection, lot # Y006509, expiration date: 11-FEB-2027, 1 milliliter (route of administration and anatomical location were not provided) for prophylaxis (accidental overdose). No symptomatic adverse events reported (no adverse event).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: Severe body aches and chills starting in the evening getting a little better this morning.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pharyngeal paraesthesia
Clinical narrative: Patient also received B12 injection at the same time as the vaccination. 52 y/o female presenting to the clinic for post vaccine reaction. Pt obtained first dose of Shingrix vaccine about 20 minutes ago, after 10 minutes of receiving the vaccine, pt noted tingling sensation of throat, no other symptoms. Denies any chest pain or shortness of breath, denies difficulty swallowing. Denies any rashes or hives. Denies any allergic reactions to vaccines in the past. Denies any dizziness or weakness. Clinical Notes: 25mg IM Benadryl administered by RN, pt tolerated injection well without any reactions. Pt re-examined every 20 minutes with vital signs stable, 0 airway obstruction noted, pt is able to drink water without difficulty. 0 wheezing noted, 0 rashes noted, Pt monitored for 1 hr and 30 minutes, discharged in a stable condition with her husband. Discussed with patient and her husband to continue to monitor pt closely, if any swelling of throat, difficulty breathing to call EMS , otherwise, continue with benadryl every 6 to 8 hrs, scheduled pt apt tomorrow for recheck of symptoms and again advised pt and her husband if any worsening of symptoms to take pt to the Emergency room, pt and husband verbalized understanding.
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Immediate post-injection reaction, Injection site rash, Vomiting
Clinical narrative: pt arm covered in rash right after receiving vaccines. Patient also threw up 2 times following the vaccines.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Asthenia, Biopsy bone marrow, Biopsy kidney, Biopsy skin
Clinical narrative: He had very high fevers, rapid weight loss of 70lbs in 3 months, no energy, loss of muscle mass, he has Mixed connective tissue disease with MAS, lupus nephritis, dermatomysitis, arthritis, sjogrens, congestive heart failure, hospitalization several times
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cardiac failure congestive, Chest X-ray, Dermatomyositis, Haemophagocytic lymphohistiocytosis
Clinical narrative: He had very high fevers, rapid weight loss of 70lbs in 3 months, no energy, loss of muscle mass, he has Mixed connective tissue disease with MAS, lupus nephritis, dermatomysitis, arthritis, sjogrens, congestive heart failure, hospitalization several times
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Lupus nephritis, Magnetic resonance imaging heart, Mixed connective tissue disease, Muscle disorder
Clinical narrative: He had very high fevers, rapid weight loss of 70lbs in 3 months, no energy, loss of muscle mass, he has Mixed connective tissue disease with MAS, lupus nephritis, dermatomysitis, arthritis, sjogrens, congestive heart failure, hospitalization several times
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Positron emission tomogram, Pyrexia, Sjogren's syndrome, Surgery, Weight decreased
Clinical narrative: He had very high fevers, rapid weight loss of 70lbs in 3 months, no energy, loss of muscle mass, he has Mixed connective tissue disease with MAS, lupus nephritis, dermatomysitis, arthritis, sjogrens, congestive heart failure, hospitalization several times
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC20
Symptoms: Chest pain, Dyspnoea, Irritability, Rash, Urticaria
Clinical narrative: Patient developed uncontrollable irritability, chest pain, shortness of breath and trunchal rash/hives. Patient was taken to the emergency room and was given PO Benadryl and Prednisone, per mother.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Diarrhoea, Fontanelle depressed, Rotavirus test positive, Vomiting
Clinical narrative: Pt presented to local ER on 7/22/24 with Diarrhea that started 3 days prior on 7/19/24 and Vomiting on Saturday 7/20/24 with fontanelle that was sunken in. Parents deny fever. Treated with IV fluids and discharged home.  Pt presented to our clinic on 7/23/24 for ER follow up and continued to have diarrhea and was starting to keep formula down.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: unknown