chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Circumstance or information capable of leading to medication error, Skin abrasion, Syringe issue, Underdose
Clinical narrative: the needle of the syringe to scrape the patient's leg; remaining volume of the VAQTA dose was then "squirted out of the syringe and landed on the mother's clothes; This spontaneous report was received from a Medical Assistant and refers to a 1-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 22-APR-2025, the patient received the second dose of Hepatitis A Vaccine, Inactivated (VAQTA) (lot #Y015910, expiration date: 06-Feb-2026) (0.5 mL / single or two dose series), intramuscularly, for the treatment of Hepatitis A vaccination.  The Medical Assistant stated that during the vaccination, the patient moved their leg during the attempt to administer the product, causing the needle of the syringe to scrape the patient's leg (Skin abrasion) and the remaining volume of the vaccine dose was then "squirted out of the syringe and landed on the mother's clothes" (Accidental underdose). Medical Assistant confirmed there have been no medical concerns or reactions reported regarding this event.   The patient did not seek medical attention. As treatment for the event the patient received a bandage. The patient recovered from the event of the needle of the syringe to scrape the patient's leg on an unspecified date. At the reporting time, the outcome of remaining volume of the VAQTA dose was then squirted out of the syringe and landed on the mother's clothes was unknown.   The action taken with Hepatitis A Vaccine, Inactivated was reported as not applicable.   The causal relationship between the event of the needle of the syringe to scrape the patient's leg and Hepatitis A Vaccine, Inactivated was not provided.
Sex: F
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient did not report any adverse issues or side effect from the administered dose; temperature excursion on 01/02/2025 with a "short-dated"  expiration date of 04/02/2025.; This spontaneous report was received from a medical assistant referring an approximately 5-year-old female patient.   Her medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.   On 02-Jan-2025, Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) underwent a temperature excursion of 69 degrees Fahrenheit (F) for 4 hours, 20 minutes and 0 seconds with no additional excursions.  On 04-Apr-2025, the patient inadvertently received an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), injection (batch/lot number Y014307 has been verified to be a valid batch/lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, expiration date reported as "short-dated" expiration date of 04-Apr-2025 and 18-Feb-2026, but upon internal validation established as 18-Feb-2026) 0.5 mL (dosage regimen, anatomical location and route of administration were not reported) administered as prophylaxis (product storage error), which was diluted with sterile diluent (MERCK STERILE DILUENT), 0.5 mL (expiration date, and lot # were not reported.)   The patient did not report any adverse issues or side effect from the administered dose (no adverse event.)  This was one of two reports received from the same reporter.
Vaccine: MMR, MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; HCP called to report that an extra (second) dose of MMR II was inadvertently administered to a 15 month old patient on the same day (4/21/2025), at the same office visit within 2 minutes of the first dose.  HCP stated it was not product confusion.  T; This spontaneous report was received from a registered nurse and refers to a 15-month-old patient of unknown gender.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 21-APR-2025, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (valid lot #Y014094, expiration date reported and confirmed as 19-AUG-2026) at a dose 0.5 mL as prophylaxis, reconstituted with a sterile diluent (indication, dose, expiration date, and lot # were not reported). On the same day, after 2 minutes, an extra dose of the suspect vaccine (as described above [however it was not clear of the same lot number of Y014094 corresponded to both doses]) was inadvertently administered to the patient (accidental overdose).  It was confirmed that it was not product confusion. The nurse simply picked up the wrong syringe on the tray. There were several vaccinations that were being administered to a set of twins, and the wrong one was selected from the ones that were out and prepped.  No adverse effects were reported (no adverse event).
Vaccine: HEP
Symptoms: Ear infection, Meningitis
Clinical narrative: found I had MENINGITIS within 2 weeks of hep B 2nd shot; ear infections; This serious case was reported by a consumer via interactive digital media and described the occurrence of meningitis in a patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine. On an unknown date, 2 weeks after receiving Hepatitis B vaccine, the patient experienced meningitis (Verbatim: found I had MENINGITIS within 2 weeks of hep B 2nd shot) (serious criteria GSK medically significant) and ear infection (Verbatim: ear infections). The outcome of the meningitis and ear infection were not reported.   It was unknown if the reporter considered the meningitis and ear infection to be related to Hepatitis B vaccine.     The company considered the meningitis to be unrelated to Hepatitis B vaccine. It was unknown if the company considered the ear infection to be related to Hepatitis B vaccine.   Additional Information: GSK Receipt Date: 05-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that look at records and found had meningitis within 2 weeks of hepatitis B 2nd shot.  Not to mention multiple ear infections following shots.; Sender's Comments: Meningitis is a listed event which, due to the following criteria (insufficient information on medical history, concurrent conditions, concomitant medications, age of patient, relevant lab results, investigation details) is considered unrelated to GSK Hepatitis B vaccine.
Age: 1.17
Sex: F
Vaccine: HIBV, PNC20
Symptoms: Abnormal behaviour, Dark circles under eyes, Tremor
Clinical narrative: Parents noted some tremors in the evening after vaccine (denies true seizure). No fever. Parents also report that patient had behavior change for 6-7 days after vaccine. Was not talking, had dark circles under eyes. Returned to baseline after ~1 week. Information about symptoms noted by parents not reported to provider until May 2025.
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Blood cholesterol, Dyspnoea, Influenza, Loss of personal independence in daily activities, Pulmonary pain
Clinical narrative: Day after for a week I had normal Flu symptoms, Fever etc.  A week Later, both bottom lungs had constant Pain, the following days after about 3-4 days after, I had problems breathing when doing any exerting activity, walking to far.  A week later, it became worse that when I drove in the car if it was too warm I had to open all windows so i could try breath, Showering has become and issue, the steam aggravates the breathing too.  I did go to my GP, he was not sure what was causing the issues, I however through reading about the vaccination and allergic reactions, realized I had a lot of these symptoms.
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Ventilation/perfusion scan
Clinical narrative: Day after for a week I had normal Flu symptoms, Fever etc.  A week Later, both bottom lungs had constant Pain, the following days after about 3-4 days after, I had problems breathing when doing any exerting activity, walking to far.  A week later, it became worse that when I drove in the car if it was too warm I had to open all windows so i could try breath, Showering has become and issue, the steam aggravates the breathing too.  I did go to my GP, he was not sure what was causing the issues, I however through reading about the vaccination and allergic reactions, realized I had a lot of these symptoms.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Pain in extremity, Rash erythematous
Clinical narrative: Patient received the prevnar-20 vaccine on 5/6/25 around 1:20pm.   She reported feeling achiness in the vaccinated arm around evening time.  On 5/11/25, patient developed a red rash around the  vaccinated area that is tender and warm to the touch. Redness was partially relieved with the use of a cold compress. Patient will continue to monitor rash.
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: INJECTION SITE ERYTHEMA; INJECTION SITE PRURITUS; This spontaneous report was received from FDA and refers to an 81-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 29-Jan-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Y013009, expiration date: 17-Nov-2025), dose number 1, administered by Intramuscular route in left arm for an unknown indication.  On 04-Feb-2025, the patient experienced redness (injection site erythema) and itching (injection site pruritus) at injection site. At the reporting time, the outcome of the events was unknown.    The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided.
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: HCP called stating that she gave MMR-II to a pediatric student on 4/24/2025 and the vaccine had expired 4/19/2025.; This spontaneous report was received from a nurse and refers to a pediatric student (child) patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 24-Apr-2025, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 ml, lot #X011431, with expiration date reported as and upon internal validation confirmed to be: 19-Apr-2025) (route of administration and vaccination site were not reported) administered for prophylaxis (expired product administered). The reporter was submitting a medical information request to ensure it was okay and stated "I don't have much time because I have kids coming in and out of the office. I just need to process the medical information request." and was unable to provide further information about the adverse event or patient.
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms. No additional AE; HCP reported improperly stored administered MMR II; This spontaneous report was received from a Physician Assistant (Medical assistant) and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.   On 21-APR-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Injection, 0.5 mL, administered as prophylaxis (lot number X026330 has been verified to be valid for Measles, Mumps, and Rubella [Wistar RA 27-3] Virus Vaccine, Live [M-M-R II], expiration date 07-NOV-2025; route of administration, anatomical site of injection and vaccination scheme frequency were not provided), which was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (expiration date, and lot number were not reported). The dose was administered after a temperature excursion (TE) at 8.5 degree Celsius (C) for 4 minutes, with no previous TE (Product storage error). No symptoms and no additional adverse events (AE) were reported for the patient.
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Caller reported expired vaccine administered.  No other information provided.  No additional AE/PQC reported.; This spontaneous report was received from a Medical Assistant and refers to a identifiable patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 22-APR-2025, the patient received a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X011441, which had expired on 19-APR-2025 (expired vaccine administered) for prophylaxis. The patient experienced No additional AE.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: The patient received the first and second dose but never recived her 3rd dose.; No additional AE reported.; This spontaneous report has been received from an other health professional, regarding to a 27-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On an unknown date in December 2017, the patient received the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), then on an unspecified date in March 2018, she received the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), both doses administered as prophylaxis (doses, routes of administration, anatomical sites of injection, vaccination schemes frequency, lot numbers and expiration dates were not reported). Also, it was reported that the patient never received her 3rd dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (Inappropriate schedule of product administration).  No additional adverse events were reported in the patient.
Sex: M
Vaccine: HPV9
Symptoms: Injection site irritation, Injection site nodule, Injection site pain
Clinical narrative: The caller stated that yesterday in the shower, her son noticed a "nodule" on his arm. The nodule is on the same arm (deltoid area) where the vaccine was administered; he has pain/irritation if the nodule is pressed on; he has pain/irritation if the nodule is pressed on; This spontaneous report was received from a consumer regarding a 13-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On approximately 21-APR-2025 (also reported as about 3 weeks ago), the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) administered on the deltoid area (unspecified) for prophylaxis (strength, dose, vaccination scheme, route of administration, lot number, and expiration date were not reported).  On 11-MAY-2025, the patient noticed a "nodule" on his arm. The nodule was on the same arm where the vaccine was administered (Vaccination site nodule). The patient also had pain/irritation if the nodule was pressed on (Vaccination site pain, Vaccination site irritation). The outcome of the events was unknown.   The reporter considered the events to be related to Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9).
Vaccine: HPVX, TDAP
Symptoms: Wrong product administered
Clinical narrative: During the call the clinic sister mentioned that she administered Tdap (Adacel - batch number 2CA82C2; exp date June 2026) instead of HPV vaccine (Gardasil); This spontaneous report was received from a consumer or other non-health professional, via vendor and refers to a 9-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with Diphtheria vaccine toxoid;Pertussis vaccine acellular 5-component;Tetanus vaccine toxoid (ADACEL) (lot number2CA82C2, expiration date: on an unknown date in June 2026), instead of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (dose, dose number, frequency, vaccination scheme, route of administration, anatomical location, lot number and expiration date were not reported) (Wrong product administered).
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Incomplete course of vaccination, Ophthalmic herpes zoster, Visual impairment
Clinical narrative: shingles in her eye; Blindness/ went blind in eye/woke up to shadows, like a curtain over her eye; eye is itchy; This serious case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-NOV-2023, the patient received the 1st dose of Shingrix (left arm). In NOV-2023, less than a month after receiving Shingrix, the patient experienced ophthalmic herpes zoster (Verbatim: shingles in her eye) (serious criteria GSK medically significant) and blindness (Verbatim: Blindness/ went blind in eye/woke up to shadows, like a curtain over her eye) (serious criteria GSK medically significant). On an unknown date, the patient experienced eye pruritus (Verbatim: eye is itchy). The patient was treated with valaciclovir (Valacyclovir). In NOV-2023, the outcome of the ophthalmic herpes zoster and blindness were resolved. The outcome of the eye pruritus was not resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, blindness and eye pruritus to be related to Shingrix.     The company considered the ophthalmic herpes zoster, blindness and eye pruritus to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 05-MAY-2025 and 06-MAY-2025 The reporter reported that she woke up to shadows, like a curtain over her eye, blind in her eye (unknown eye) around 18-November-2023.  The patient reported that she had shingles in her eye (unknown eye).  The patient reported that blindness lasted for a good week (no specific date provided).  The patient did see an Ophthalmologist, and received prescriptions from her pharmacy on 19-November-2023 for several eye drops (unknown products information), and Valacyclovir 500mg, 1 Tablet three times a day (might be) for 10 days, quantity 30.  The patient also reported that she never received the second dose of Shingrix because what she experienced after the first dose was scary.  The patient also reports that her eye was itchy at the time of reporting, and she thought she had shingles in her eye again. The patient reported received vaccination for shingles.  The patient went blind in eye now the repercussions were could get shingles at any time for the rest of life. The patient was 53 and company does not even take responsibility for that and why did not even pay the eye doctor bills that's ridiculous.; Sender's Comments: Ophthalmic herpes zoster, Blindness and Eye pruritus are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Discomfort, Fungal infection, Lichen sclerosus
Clinical narrative: Lichen Sclerosus Flare; Lichen Sclerosus Flare; Yeast infection; Uncomfortable; This non-serious case was reported by a consumer via call center representative and described the occurrence of lichen sclerosus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included lichen sclerosus (patient was diagnosed with Lichen Sclerosus in her genital area a year ago).   On 11-NOV-2024, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced lichen sclerosus (Verbatim: Lichen Sclerosus Flare), condition aggravated (Verbatim: Lichen Sclerosus Flare), yeast infection (Verbatim: Yeast infection) and discomfort (Verbatim: Uncomfortable). The outcome of the lichen sclerosus, condition aggravated and discomfort were not resolved and the outcome of the yeast infection was resolved.   The reporter considered the lichen sclerosus and condition aggravated to be possibly related to Shingrix. It was unknown if the reporter considered the yeast infection and discomfort to be related to Shingrix.     The company considered the lichen sclerosus and condition aggravated to be possibly related to Shingrix. It was unknown if the company considered the yeast infection and discomfort to be related to Shingrix.   Additional Information: GSK receipt date: 06-MAY-2025 The reporter was female patient that was diagnosed with Lichen Sclerosus in her genital area a year ago, pre-existing receiving the first dose of Shingrix. The patient reported that after she received the first dose of Shingrix (no specific date provided), she had a flare of her Lichen Sclerosus, and this flare had been going on for a couple of months now (no specific dates provided). The patient reported that the flare was very uncomfortable. The patient reported that after the flare of her Lichen Sclerosus occurred, she also experienced a yeast infection (no specific date provided, which had cleared up at the time of reporting. The patient reported that she used Clobetasol Ointment 0.01% topically twice a day on the rash in the area of the flare on her genitals. The patient reported that her physician told her that the Lichen Sclerosus flare could be related to receiving the first dose of Shingrix. The patient did not had a Lot/Expiry/NDC/or route of administration for the Shingrix first dose.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Vitreous floaters
Clinical narrative: floaters in his left eye; This non-serious case was reported by a nurse via call center representative and described the occurrence of eye floaters in a male patient who received Herpes zoster (Shingrix) (batch number 33473, expiry date 29-OCT-2026) for prophylaxis.   On 18-APR-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced eye floaters (Verbatim: floaters in his left eye). The outcome of the eye floaters was unknown.   It was unknown if the reporter considered the eye floaters to be related to Shingrix.     It was unknown if the company considered the eye floaters to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-MAY-2025 The reporter had been the healthcare professional (nurse) who had stated that a patient had experienced floaters in his left eye after receiving his first dose of Shingrix.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Ultrasound scan, X-ray
Clinical narrative: Received flu vaccine and within 2-3 days had intense arm pain on side of vaccine.
Age: 67.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: patient said she had rash and swelling around injection site. it was still there after a week
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Nausea
Clinical narrative: Patient reported nausea for 24 hours following immunization, soreness at injection site.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Allergy test positive, Food allergy, Hypersensitivity, Lip swelling, Swelling of eyelid
Clinical narrative: Mild reaction to first dose of vaccine- mild rash.  Second dose woke up with eyes swollen almost unable to open and lips swollen with massive hives all over body- back, belly, face etc, proceeded to then continue with allergic reactions for months until we had extensive allergy testing and discovered her new allergies to soybeans and peas and wheat! She also became sensitive to things in general including food dyes. Her vaccines were delayed on a modified schedule due to her mothers similar reaction to mmr vaccine as a child and again in nursing school.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Mild reaction to first dose of vaccine- mild rash.  Second dose woke up with eyes swollen almost unable to open and lips swollen with massive hives all over body- back, belly, face etc, proceeded to then continue with allergic reactions for months until we had extensive allergy testing and discovered her new allergies to soybeans and peas and wheat! She also became sensitive to things in general including food dyes. Her vaccines were delayed on a modified schedule due to her mothers similar reaction to mmr vaccine as a child and again in nursing school.
Age: 33.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: woke up the next day with the area red and swollen.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Brain fog, Dyspnoea, Exercise tolerance decreased, Inappropriate sinus tachycardia
Clinical narrative: Inappropriate sinus tachycardia upon standing, palpitations, brain fog, exercise intolerance, shortness of breath
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, SARS-CoV-2 antibody test
Clinical narrative: Inappropriate sinus tachycardia upon standing, palpitations, brain fog, exercise intolerance, shortness of breath
Age: 61.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the second of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Papule, Pyrexia, Rash, Rash papular, Rash pruritic
Clinical narrative: Patient developed post vaccination fever day after vaccination along with a pruritic erythematous papular rash on side of face, rash subsequently spread to other parts of face, arms and trunk and continued to have low grade fever. No other viral like symptoms developed. On exam noted to have 20-30 erythematous papules and 2 crusted over lesions.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Scab, Skin lesion, Varicella virus test
Clinical narrative: Patient developed post vaccination fever day after vaccination along with a pruritic erythematous papular rash on side of face, rash subsequently spread to other parts of face, arms and trunk and continued to have low grade fever. No other viral like symptoms developed. On exam noted to have 20-30 erythematous papules and 2 crusted over lesions.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Condition aggravated, Diabetes mellitus, Hypoaesthesia, Movement disorder
Clinical narrative: After i got the first one i went and sat for 15 mins and everything was fine and then same for the second one. After the second one i started having issues with my heart and it got worse and worse and i had trouble moving and lose feeling in my arm and it cause a TIA. but that cant be proved. I was in and out of the hospital a number of times over the heart issues and my diabetes. I was even transferred over to (redacted) because it was too packed at the hospital and after a while i finally got with the doctor i am with now and i started to get better and got me on medication that help improved everything and i am hoping that i will get to the point where i don't need to take the medication any more.
Age: 38.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
Age: 41.0
Sex: M
Vaccine: SMALL, VARZOS
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient accidentally given a dose that had expired on 5/6/25. No adverse reaction reported after dose.
Age: 41.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs or reactions reported.
Age: 39.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the second of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Nausea, Pyrexia
Clinical narrative: Nausea; Head aching; temperature; felt like a rock in her stomacht; This non-serious case was reported by a consumer via call center representative and described the occurrence of nausea in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-MAY-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 06-MAY-2025, 1 days after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea), headache (Verbatim: Head aching), fever (Verbatim: temperature) and stomach feeling heavy (Verbatim: felt like a rock in her stomacht). The outcome of the nausea, headache and fever were not resolved and the outcome of the stomach feeling heavy was unknown.   It was unknown if the reporter considered the nausea, headache, fever and stomach feeling heavy to be related to Shingrix.     It was unknown if the company considered the nausea, headache, fever and stomach feeling heavy to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-MAY-2025 and 07-MAY-2025 The consumer was the primary reporter.   The reporter stated that she received her second dose of Shingrix on in her left arm. The reporter stated that the next morning she felt like a rock was in her stomach, nausea, head aching, and a temperature of 98.9 degree Fahrenheit and her temperature usually runs around 97.6 degree Fahrenheit. On 7 May 2025, The reporter stated that she does not have the power even to say whether aspirin Tylenol or ibuprofen are contraindicated when somebody was having a headache or something like that from the shot The reporter stated it would be awfully nice if patient had at least that much authority.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction the vaccine was out of date when given.  Patient was called and had no reactions.  We have informed her to return  28 days after the 7th of May for repeat dose.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Three variances of COVID Booster with production left to one of two Manufactures.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Bacterial disease carrier, Blood brain barrier defect, Blood test, Dental operation, Depressed mood
Clinical narrative: pts mothers states a few weeks after getting the vaccine, the pt had to go get some major dental work done with Dr.. When she woke up from the anesthesia, the parents say she was a different child. She was melancholy and was never like this before. Her body was trying to fight off the immunization and the anesthesia from the dental work. Within a couple of weeks she developed strep throat. She had her tonsils taken out when she was 7 because her throat never went back to normal from strep. She was given penicillin shots. The anesthesiologist explained to the mother that she had pandas. This is when the strep in the body is displaced and it keeps your body from fighting it off the way that it should. It was the strep crossing the blood brain barrier. Something is keeping her body from being able to fight off infection. It was explained to her that her body wasn't able to fight off the immunization, and then the dental work and strep. It sent her body into hyper overdrive trying to fight off the immunization. She continues to have this melancholy behavior. She now has extensive dental issues and is a carrier of strep. She struggles daily and was not like this before getting her MMR vaccine at the age of 4.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Paediatric acute-onset neuropsychiatric syndrome, Pharyngitis streptococcal, Streptococcus test positive, Tonsillectomy, Tooth disorder
Clinical narrative: pts mothers states a few weeks after getting the vaccine, the pt had to go get some major dental work done with Dr.. When she woke up from the anesthesia, the parents say she was a different child. She was melancholy and was never like this before. Her body was trying to fight off the immunization and the anesthesia from the dental work. Within a couple of weeks she developed strep throat. She had her tonsils taken out when she was 7 because her throat never went back to normal from strep. She was given penicillin shots. The anesthesiologist explained to the mother that she had pandas. This is when the strep in the body is displaced and it keeps your body from fighting it off the way that it should. It was the strep crossing the blood brain barrier. Something is keeping her body from being able to fight off infection. It was explained to her that her body wasn't able to fight off the immunization, and then the dental work and strep. It sent her body into hyper overdrive trying to fight off the immunization. She continues to have this melancholy behavior. She now has extensive dental issues and is a carrier of strep. She struggles daily and was not like this before getting her MMR vaccine at the age of 4.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: X-ray
Clinical narrative: pts mothers states a few weeks after getting the vaccine, the pt had to go get some major dental work done with Dr.. When she woke up from the anesthesia, the parents say she was a different child. She was melancholy and was never like this before. Her body was trying to fight off the immunization and the anesthesia from the dental work. Within a couple of weeks she developed strep throat. She had her tonsils taken out when she was 7 because her throat never went back to normal from strep. She was given penicillin shots. The anesthesiologist explained to the mother that she had pandas. This is when the strep in the body is displaced and it keeps your body from fighting it off the way that it should. It was the strep crossing the blood brain barrier. Something is keeping her body from being able to fight off infection. It was explained to her that her body wasn't able to fight off the immunization, and then the dental work and strep. It sent her body into hyper overdrive trying to fight off the immunization. She continues to have this melancholy behavior. She now has extensive dental issues and is a carrier of strep. She struggles daily and was not like this before getting her MMR vaccine at the age of 4.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Depressed level of consciousness, Visual impairment
Clinical narrative: Pt began to pass out but never lost full consciousness. She was seeing black dots. We had her lie on the ground and she began to feel better. Full recovery around 45 minutes later.
Age: 57.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient received vaccine on 5/6/25, started to develop warmth and redness in the right deltoid on 5/8/25. Patient tried using cool compresses at home. After 6 days and the redness is worsening, patient called this PCP office. An appointment was scheduled.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cognitive disorder, Communication disorder, Fatigue, Impaired work ability
Clinical narrative: Fatigue, cognitive impairment affecting judgment, thought processes and communication skills, pain in muscles and joints throughout the body not explained by degenerative disc disease and a decreased ability to work--exhausted FMLA benefits and am now on short term disability due to the effects of the vaccines by Moderna. First dose was administered on or about 2/1/2021. I have used Ivermectin intermittently to help temper symptoms but it is not a long-term solution as it cannot be taken daily without significant risk of liver damage.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Judgement impaired, Myalgia, Thinking abnormal
Clinical narrative: Fatigue, cognitive impairment affecting judgment, thought processes and communication skills, pain in muscles and joints throughout the body not explained by degenerative disc disease and a decreased ability to work--exhausted FMLA benefits and am now on short term disability due to the effects of the vaccines by Moderna. First dose was administered on or about 2/1/2021. I have used Ivermectin intermittently to help temper symptoms but it is not a long-term solution as it cannot be taken daily without significant risk of liver damage.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Needle issue
Clinical narrative: I had an incident yesterday when giving a shingrix injection. I reconstituted the vaccine normally. But when I went to inject the patient, once I inserted the needle I could not push the syringe to inject the immunization. There was pressure and I couldn?t get the syringe/medicine out. So I took the needle out and reinserted and had the same issue. I then told the patient I had an issue with the needle so I switched out the needle and that worked. The new needle/ third try went smoothly.
Age: 1.25
Sex: M
Vaccine: HEPA
Symptoms: Rash, Rash maculo-papular
Clinical narrative: 2 days following administration of Havrix Ped/Adol to LVL, pt broke out in full body macular-papular rash to head and face, torso, trunk, all 4 extremities.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient received pediatric dose instead of adult dose of the hep b vaccine
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site, Sleep disorder
Clinical narrative: Injection site high up on left arm near edge of shoulder area. Pain scale 8 out of 10 for 6 days (started 1 day post vaccine). Area is tender and pain inhibits range of motion. Cannot sleep and discomfort continues even at rest.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Dizziness
Clinical narrative: Felt dizzy and had stomachache the evening of vaccine administration and next morning, motrin helped,  felt better by time of doctor's visit
Age: 47.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Vaccine: RVX
Symptoms: Muscle disorder
Clinical narrative: muscle in right leg has never been the same/it affected the muscle in right leg; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle disorder in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   In JUL-2024, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced muscle disorder (Verbatim: muscle in right leg has never been the same/it affected the muscle in right leg). The outcome of the muscle disorder was not resolved.   It was unknown if the reporter considered the muscle disorder to be related to RSV vaccine.     It was unknown if the company considered the muscle disorder to be related to RSV vaccine.   Additional Information: GSK receipt date: 03-MAY-2025 This case was reported by a patient via interactive digital media.  Patient stated that they got this vaccine last July and the muscle in right leg had never been the same. Patient indicated that they would never do it again. Also stated that they got vaccine and it affected the muscle in right leg.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Axillary pain, Pain, Pain in extremity, Tremor, Ultrasound scan abnormal
Clinical narrative: R arm/axilla pain daily since administration, > 1 year. Awakens from sleep sometimes. Mother will massage. Seen for symptoms 12/7/2024, ibuprofen recommended. Presented again 4/22/2025. Reports pain in R arm/armpit, especially when raises arm. Also R hand will shake when tries to hold something.
Age: 47.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the second of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Injectable contraception, No adverse event, Pregnancy test urine negative, Wrong product administered
Clinical narrative: pt came into the office to get her 2nd Gardasil vaccine as scheduled. Pt was given wrong injection. She was given Depo Provera (birth control) Pt did also still receive the Gardasil vaccine with no issues.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Transient global amnesia
Clinical narrative: First TGA 8 days after second injection. I?ve had 3 more since then.
Age: 11.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Asthenia, Dizziness, Fall, Head injury, Pain in extremity
Clinical narrative: pts father says he complained about having a sore arm after the vaccine. The next morning he woke up dizzy, weak, and fainted. He fell and hit his head. He feels extremely weak and was not able to attend class. The doctors office has been contacted and will get a call back from the nurse.
Age: 11.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Syncope
Clinical narrative: pts father says he complained about having a sore arm after the vaccine. The next morning he woke up dizzy, weak, and fainted. He fell and hit his head. He feels extremely weak and was not able to attend class. The doctors office has been contacted and will get a call back from the nurse.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Intensive care, Ischaemic stroke, Myocardial infarction, Thrombosis, Transient ischaemic attack
Clinical narrative: A week after the  initial Pfizer shot, I suffered an acute left ischemic stroke, a TIA 3 months later on 09/26/2022,  a heart attack 13 months later and an additional heart attack 10 months after this. My body has now been forming blood clots, despite not having high blood pressure, no diabetes, and no other contributing factors
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired on 5-9, administered on 5-13, patient not reporting any side effects since administration,
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no adverse reaction
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no adverse reaction
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pain, Pyrexia
Clinical narrative: This was #2 dose of the Shingrix vaccine. The next morning prepared myself for work. Normal hygiene felt I was older than I am. Body/muscles aches I complained of body aches similar to labor pains but all over. At work walking slower and temperature was measured, Fever was 101.0 and was sent home.   Headaches were managed alternating with Tylenol 1000mg every 6 hrs and Ibuprofen 800mg. Relief of Headache finally after 8 p.m. Drank plenty of fluids, Gatorade and rested and sleep. The next day symptoms resolved except for headache lingered.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Antibody test, Injection site reaction, Measles antibody, Mumps antibody test, Pruritus
Clinical narrative: Immunization was not given correctly and  has had a small pruritic lesion at  injection site for 1 year
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Rubella antibody test, Skin lesion, Wrong technique in product usage process
Clinical narrative: Immunization was not given correctly and  has had a small pruritic lesion at  injection site for 1 year
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site swelling, Pyrexia
Clinical narrative: Patient says he has had a fever, a bruise at the site of injection, and swelling at the site since the day he received the vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Chills, Fatigue, Injection site nodule, Oral mucosal blistering
Clinical narrative: First 24 hours felt tired, knot at site injection given (LD), chills and blisters all inside mouth and around mouth.
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: open sores on 90 percent of my body; This non-serious case was reported by a consumer via call center representative and described the occurrence of skin lesion in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 months after receiving Shingrix, the patient experienced skin lesion (Verbatim: open sores on 90 percent of my body). The outcome of the skin lesion was not reported.   It was unknown if the reporter considered the skin lesion to be related to Shingrix.     It was unknown if the company considered the skin lesion to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-MAY-2025 and 05-MAY-2025 The patient had developed open sores on 90 percent of body. These started 3 months after Shingrix vaccines.
Sex: F
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms, vaccine was past expiration date. RN spoke with MERCK and the vaccine counts as a valid dose and no revaccination is needed.
Age: 14.0
Sex: F
Vaccine: ADEN_4_7, HEP, IPV, MNQ, TDAP, VARCEL
Symptoms: Exposure during pregnancy, Ultrasound antenatal screen
Clinical narrative: Patient received vaccinations listed above at public health clinic on 4/1/2025. At the time of receiving vaccinations, it was unknown to patient and provider that she was pregnant, approximately 16 weeks gestational age. Patient later discovered pregnancy on 5/5/2025 during emergency room visit.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Eyelid ptosis, Muscular weakness, Myasthenia gravis, Nerve conduction studies abnormal, Speech disorder
Clinical narrative: Approximately 30 days after receiving the second COVID19 booster I began showing symptoms of weakness in the legs, ptosis and speech difficulties.  Initially, my PC diagnosed the condition as Bells Palsy but subsequently referred me to a neurologist who diagnosed me with Generalized Myasthenia Gravis.  Subsequent testing conformed the diagnosis.
Age: 65.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
Age: 45.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Asthenia, Blood test, Computerised tomogram head normal, Fatigue, Headache
Clinical narrative: Severe debilitating headaches for about 5 weeks, woke at 2:30am and 2:30pm with extreme headaches, extreme fatigue (slept 16-18 hours a day) lasting 10 days.  Antihistamines.  Migraine medication.  CT scan to rule out brain bleed.  Benadryl, Reglan. Allegra and Ibuprofen.
Age: 45.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: SARS-CoV-2 test negative, Sleep disorder
Clinical narrative: Severe debilitating headaches for about 5 weeks, woke at 2:30am and 2:30pm with extreme headaches, extreme fatigue (slept 16-18 hours a day) lasting 10 days.  Antihistamines.  Migraine medication.  CT scan to rule out brain bleed.  Benadryl, Reglan. Allegra and Ibuprofen.
Age: 16.0
Sex: F
Vaccine: MNP, MNP
Symptoms: Computerised tomogram abnormal, Computerised tomogram pelvis abnormal, Fatigue, Hypokalaemia, Hypomagnesaemia
Clinical narrative: Patient had fever and severe body aches/leg pain and fatigue causing her parents to take her to the ER where she received IV fluids, CT scan and was admitted for observation
Age: 16.0
Sex: F
Vaccine: MNP, MNP
Symptoms: Laboratory test abnormal, Leukocytosis, Oedema, Pain, Pain in extremity
Clinical narrative: Patient had fever and severe body aches/leg pain and fatigue causing her parents to take her to the ER where she received IV fluids, CT scan and was admitted for observation
Age: 16.0
Sex: F
Vaccine: MNP, MNP
Symptoms: Pyrexia
Clinical narrative: Patient had fever and severe body aches/leg pain and fatigue causing her parents to take her to the ER where she received IV fluids, CT scan and was admitted for observation
Age: 16.0
Sex: F
Vaccine: MNP, MNP
Symptoms: Arthralgia, Fatigue, Pain, Pyrexia
Clinical narrative: Patient had fever and severe body aches/leg pain and fatigue causing her parents to take her to the ER where she received IV fluids, CT scan and was admitted for observation
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient fainted a few minutes after getting the vaccine