chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging heart, Myopericarditis, Postural orthostatic tachycardia syndrome
Clinical narrative: PFIZER #1 4/8/2021 PFIZER #2 4/29/2021 PFIZER #3 UNKNOWN DATE  DEVELOPED VACCINE INDUCED MYOPERICARDITIS  POTS AND RECURRENT SARS-COV-2 INFECTION TREATED WITH COLCHICINE PROPRANOLOL AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 1.83
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Induration, Skin irritation, Skin warm
Clinical narrative: Hard and red spot, hot to the touch, got bigger over night and more irritated
Age: 11.0
Sex: F
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Balance disorder, Gait disturbance, Loss of consciousness, Seizure, Somnolence
Clinical narrative: Approximately 15 minutes after administering her recommended vaccines the patient passed out. Her mother and I were able to get her on the ground gently with out further injury. She did not hit her head. She then had a seizure that lasted 15-20 seconds. She was very sleepy and hard to rise. Once she had woken completely she was alert and oriented x's 4. Vitals were taken; BP:98/60(laying down), O2 sat 97; Pulse: 59, Temp: 97.4 F. We were able to get her into a sitting position in a chair where she proceeded to vomit. She was able to drink some water. She did not lose bladder control. Since she did experience a seizure we decided to call for an ambulance to take her to the ED. Client was unsteady on her feet and needed assistance to walk. EMS took her to the ED.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Approximately 15 minutes after administering her recommended vaccines the patient passed out. Her mother and I were able to get her on the ground gently with out further injury. She did not hit her head. She then had a seizure that lasted 15-20 seconds. She was very sleepy and hard to rise. Once she had woken completely she was alert and oriented x's 4. Vitals were taken; BP:98/60(laying down), O2 sat 97; Pulse: 59, Temp: 97.4 F. We were able to get her into a sitting position in a chair where she proceeded to vomit. She was able to drink some water. She did not lose bladder control. Since she did experience a seizure we decided to call for an ambulance to take her to the ED. Client was unsteady on her feet and needed assistance to walk. EMS took her to the ED.
Age: 1.0
Sex: M
Vaccine: MMR, UNK, UNK, UNK, HEPA, MMR, PNC15, VARCEL
Symptoms: Death, Food refusal, Gait disturbance, Pyrexia, Seizure
Clinical narrative: After the MMR vaccine My child  refused to eat or walk had fever then went into a seizure and passed away
Age: 1.0
Sex: M
Vaccine: MMR, UNK, UNK, UNK, HEPA, MMR, PNC15, VARCEL
Symptoms: Death, Decreased appetite
Clinical narrative: After the MMR vaccine My child  refused to eat or walk had fever then went into a seizure and passed away
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Autopsy, Cardiomegaly, Death, Left atrial appendage closure implant
Clinical narrative: MODERNA #1 5/26/2021 MODERNA #2 6/26/2021 MODERNA #3 12/27/2021 BACKGROUND HISTORY OF ALCOHOL ABUSE DEVELOPED ATRIAL FIBRILLATION HAD LAA OCCLUDER DEVICE PLACED WAS FOUND DEAD AT HOME.  AUTOPSY REVEALED INCREASED HEART WEIGHT AND INTERSTITIAL FIBROSIS.  LUNG WEIGHT INCREASED WITH FLUID.  RELATIVE CONTACT
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocardial fibrosis, Pulmonary oedema
Clinical narrative: MODERNA #1 5/26/2021 MODERNA #2 6/26/2021 MODERNA #3 12/27/2021 BACKGROUND HISTORY OF ALCOHOL ABUSE DEVELOPED ATRIAL FIBRILLATION HAD LAA OCCLUDER DEVICE PLACED WAS FOUND DEAD AT HOME.  AUTOPSY REVEALED INCREASED HEART WEIGHT AND INTERSTITIAL FIBROSIS.  LUNG WEIGHT INCREASED WITH FLUID.  RELATIVE CONTACT
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, IPV, MENB, MMR, TDAP, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Patient without copu of Immunization records. Family in agreement to restart immunization series.  Provider placed orders for hepatitis b (engerix-B), MMR,Varicella (varivax), Hepaitits A (Havrix), Ipv (Ipol), Tdap (boostrix) and meningococcal (menveo).  The MA mistakenly interpreted Hepatitis B (HBV) for HPV, and meningococcal for Men B and inadvertedly administered Gardasil and Bexsero instead of Hep B and MCV4.   Notified error to the family. Mother agreed on HPV and understanding about Men B. The Mother requested to give Hep B and MCV4, and they were administered.   Provided anticipatory guidance about potential side effects. Patient was in obersation for 30 min and asymptomatic.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: area around the injection site became red and swollen within hours of patient receiving the DTap vaccine in her right deltoid.   She did not have an fever or complaints of pain.  Area swelled up to her shoulder area by the next day still afebrile and no c/o pain.  Today, 11/26/24 the swelling had resolved, area was  slightly pink in color and there was a lump at injection site.  Mom reports patient did complain of it hurting her only when Mom touched it otherwise patient was not bothered by the lump.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Dizziness, Pyrexia, Vomiting
Clinical narrative: Fever, Chills, vomiting, dizziness.  Patient to Coricidin 2 tablets took a total of 5 doses in 2 days.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Dizziness, Malaise, Pyrexia, Vomiting
Clinical narrative: Fever, Chills, vomiting, dizziness.  Patient to Coricidin 2 tablets took a total of 5 doses in 2 days.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event. Patient received the wrong dose
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Chills, Diarrhoea, Headache
Clinical narrative: Wheezing, nausea, vomiting, headache, arm pain, lump on injection site, feeling burning throughout my body as if I had a fever, chills, body aches, joint pain, diarrhea. The arm pain started within 15 minutes of getting the vaccine, the headache and nausea were within an hour of getting the vaccine, everything else was about 12 hours afterwards.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Wheezing, nausea, vomiting, headache, arm pain, lump on injection site, feeling burning throughout my body as if I had a fever, chills, body aches, joint pain, diarrhea. The arm pain started within 15 minutes of getting the vaccine, the headache and nausea were within an hour of getting the vaccine, everything else was about 12 hours afterwards.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, Wheezing
Clinical narrative: Wheezing, nausea, vomiting, headache, arm pain, lump on injection site, feeling burning throughout my body as if I had a fever, chills, body aches, joint pain, diarrhea. The arm pain started within 15 minutes of getting the vaccine, the headache and nausea were within an hour of getting the vaccine, everything else was about 12 hours afterwards.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse events. Patient received the wrong dose.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: no reaction to vaccine given.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Guillian Barre Syndrome followed by infusion of IV Immunoglobins (still revovering)
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19, FLU3, HPV9, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The pt was supposed to receive Flu, Tdap, HPV, Meningococcal, and Covid. Instead, the pt received Flu, Tdap, HPV, and 2 doses of Covid- an 11 yr old dose as well as a 12 yr old dose. No adverse effects were apparent in pt for the estimated 1/2 hr more they were here.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Mobility decreased
Clinical narrative: Had lower back pain, could barely move, did no heavy lifting
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Hyperhidrosis, Malaise, Nausea, Nervousness
Clinical narrative: Pt was supposed to get covid and flu vaccine, pt got the covid vaccine and was ok. When the immunizer inject the flu shot after the covid vaccine, pt immediately said she is not feeling well, nauseated and anxious. The immunizer immediately pulled out the needle without giving the vaccine. Pt was sweating, shaking and nervous. Checked blood pressure but was getting an error message. Pt said she has a history of vasovagal syncope when getting lab works. Called EMS. Spoke to pt the next day and she did not go to ER but went to her PCP.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Pt was supposed to get covid and flu vaccine, pt got the covid vaccine and was ok. When the immunizer inject the flu shot after the covid vaccine, pt immediately said she is not feeling well, nauseated and anxious. The immunizer immediately pulled out the needle without giving the vaccine. Pt was sweating, shaking and nervous. Checked blood pressure but was getting an error message. Pt said she has a history of vasovagal syncope when getting lab works. Called EMS. Spoke to pt the next day and she did not go to ER but went to her PCP.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Pain
Clinical narrative: Patient complains of "heavy soreness sensation" from the time of administration to present. Complains of discomfort with movement/use rated as a 2 to 6 (on 0 to 10 scale with 10 being worst).  Employee reported this on Nov. 22, 2024.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Condition aggravated, Epistaxis, Headache
Clinical narrative: Elevated BP (166/89), headache, spontaneous nosebleed.  No treatment.  Nosebleed stopped within 20 minutes, BP and headache subsided within 1 day.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Soreness, Muscle pain
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Vision blurred
Clinical narrative: she developed a rash; it was hot and swollen at the site; it was hot and swollen at the site; e had blurry eyes; This spontaneous report was received from a consumer and referred to her daughter, a 20-year-old female patient. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On an unknown date in July 2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered for prophylaxis (strength, dose, lot #, expiry date, anatomical site of administration and route of administration were not provided).  On an unknown date in 2024 (exactly a week to the day she got the shot), the patient developed a rash and it was hot and swollen at the site and the patient had blurry eyes but she wears glasses. No treatment was given. The consumer did contact HCP (Sought Medical Attention) who stated they "had not heard of a reaction like that a week later and recommended she delay the second shot by a couple of weeks". No other information provided. No letter sent due to caller refusing HCP notification/contact information. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not applicable. The patient's present status was reported as recovered. The reporter considered hot and swollen at the site to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (reported as "delayed site reaction to GARDASIL 9"). The causal relationship of blurry eyes, rash regarding hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.  Additional Information is not expected.
Sex: F
Vaccine: MMRV
Symptoms: Occupational exposure to product, Syringe issue
Clinical narrative: the nurse withdrawing the vaccine/diluent back into the diluent syringe was sprayed in the glasses; the nurse withdrawing the vaccine/diluent back into the diluent syringe was sprayed in the glasses; No additional AE; This spontaneous report has been received from a nurse via company representative referring to herself of unknown age. The nurse's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, when the nurse pushed the sterile diluent (0.5 mL, lot #1973304 has been verified to be a valid lot number and expiration date was 10-SEP-2026) into the vial of the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection (lot #Y010291 has been verified to be a valid lot number and expiration date was 01-DEC-2025), it sprayed out of the hub of the diluent syringe and only small amount of the diluent went into the vial. Then, the nurse withdrew the vaccine/diluent back into the diluent syringe was sprayed in the glasses (Occupational exposure to product and Accidental exposure to product). It was reported the size of needle and syringe used was 25 gauge 5/8 inch. The diluent was stored in the room temperature. The vaccine was unable to be used. It was confirmed products were not administered and there were no missed doses. No additional event was reported.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Retired Pharmacist with active license calling to get information on GARDASIL 9. Retired Pharmacist stated a female patient received at age 19 first dose of GARDASIL 9 (date was unknown), than the female patient received at age 40 2nd and 3rd dose of; No additional AE; This spontaneous report was received from a pharmacist referring to a 40-year-old female patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On an unknown date, when the patient was 19, she was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot number and expiration date not reported) for prophylaxis. On an unknown date, when the patient was 40, received the second dose of the vaccine and on 15-NOV-2024, received the third dose of the vaccine (inappropriate schedule of product administration). No adverse event was reported.
Age: 4.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hep B vaccine administered on 14-JUL-2005, 23-AUG-2005 and on 11-JAN-2006; Hep B vaccine administered on 14-JUL-2005, 23-AUG-2005 and on 11-JAN-2006; This spontaneous report has been received via a immunization records from a case in litigation for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (MARRS # 2407USA010097), concerning a currently 23-year-old female patient.  The patient's medical history, her concurrent conditions and concomitant therapies were not reported.  On 14-JUL-2005 (at the age of 4-year-old), the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) On 23-AUG-2005, the patient received second dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (inappropriate schedule of product administration), and on 11-JAN-2006, the patient recieved the third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) intramuscular injection, all administered for prophylaxis (exact dose, strength, lot #, expiry date, and route of administration were not provided for all doses).  This is one of the 4 cases received from the same reporter.; Sender's Comments:  US-009507513-2407USA010097:
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Syringe issue
Clinical narrative: Inbound from nurse who reports broken VAXNUEVANCE finger flange during administration. Nurse reports the finger flange broken during administration, nobody was injured and the patient received the full dose of vaccine product. Nurse does not want to; Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES; No additional AE/PQC reported; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE), formulation: injection, lot # Y002963, expiration date: 04-OCT-2026, 0.5 milliliter (route of administration and anatomical location were not provided) for prophylaxis.  On an unknown date, during vaccine administration, the finger flange had broken. Nobody was injured and the patient received the full dose of vaccine product (syringe issue, poor quality device used). No additional adverse event reported (no adverse event).   This case is non-valid due to lack of patient's identifiers.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Injection site pain
Clinical narrative: injection site pain; shivers; redness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-OCT-2024, the patient received Shingrix (left arm). In OCT-2024, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: injection site pain), shivers (Verbatim: shivers) and erythema (Verbatim: redness). The outcome of the injection site pain, shivers and erythema were not reported.   It was unknown if the reporter considered the injection site pain, shivers and erythema to be related to Shingrix.     It was unknown if the company considered the injection site pain, shivers and erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-OCT-2024 The reporter reported that he received a Shingrix vaccine and he had shivers and injection site pain and redness.  Vaccine administered in the left arm. No other information was provided such as dose number, date of birth, address of pharmacy, pharmacy phone number.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; got them right now inspite of the vaccine I still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got them right now inspite of the vaccine I still got it). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 12-NOV-2024 The reporter reported better get vaccines because this shingles were the worsts and painful disease ever the patient got at the time of reporting inspite of the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about details regarding  completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; she has the shingles around her eye; she has the shingles forehead and scalp; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: she has the shingles around her eye) (serious criteria GSK medically significant) and shingles (Verbatim: she has the shingles forehead and scalp). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster and shingles were not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 12-NOV-2024 This case was reported by a patient's child via social media. The patient (the reporter's mother) received both shingles vaccinations in her 70s and now (on the reporting day) she had the shingles around her eye, forehead and scalp and so these vaccinations did not prevent us from getting the shingles. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1) and Shingrix (dose 2). Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix (dose 1) and Shingrix (dose 2).
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Migraine, Pain, Post herpetic neuralgia
Clinical narrative: Suspected vaccination failure; received the shingles vaccine and still got shingles; postherpetic neuralgia/just not how painful; migraines; fatigue; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: received the shingles vaccine and still got shingles), post herpetic neuralgia (Verbatim: postherpetic neuralgia/just not how painful), migraine (Verbatim: migraines) and fatigue (Verbatim: fatigue). The outcome of the vaccination failure was not reported and the outcome of the shingles, post herpetic neuralgia, migraine and fatigue were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, migraine and fatigue to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, post herpetic neuralgia, migraine and fatigue to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-NOV-2024 This case was reported by a patient via interactive digital media. The patient had chicken pox and had received Shingles vaccine and still got shingles and now dealing with postherpetic neuralgia, migraines and fatigue.  The patient started an antiviral right away too and knew about shingles, just not how painful they could be for a long term. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure; received the shingles vaccine and still got shingles; postherpetic neuralgia/just not how painful; migraines; fatigue; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: received the shingles vaccine and still got shingles), post herpetic neuralgia (Verbatim: postherpetic neuralgia/just not how painful), migraine (Verbatim: migraines) and fatigue (Verbatim: fatigue). The outcome of the vaccination failure was not reported and the outcome of the shingles, post herpetic neuralgia, migraine and fatigue were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, migraine and fatigue to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, post herpetic neuralgia, migraine and fatigue to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-NOV-2024 This case was reported by a patient via interactive digital media. The patient had chicken pox and had received Shingles vaccine and still got shingles and now dealing with postherpetic neuralgia, migraines and fatigue.  The patient started an antiviral right away too and knew about shingles, just not how painful they could be for a long term. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: injection site pain; injection site redness; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site pain in a child patient who received DTPa (Infanrix) (batch number 47Y5M, expiry date 26-JUN-2026) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced injection site pain (Verbatim: injection site pain) and injection site erythema (Verbatim: injection site redness). The outcome of the injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Infanrix and Infanrix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain and injection site erythema to be related to Infanrix and Infanrix Pre-Filled Syringe Device.   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: 23-OCT-2024 The healthcare professional stated that two of her pediatric patients received Infanrix.  Both children had injection site redness and pain.  The parent's notified the healthcare professional of the effects a few days after vaccination.  It was not reported when the effects began or if they had resolved. Nothing else was reported.  The vaccine administration facility was the same as primary reporter. This case is linked with case US2024131885, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2024131885:Same reporter/Different patient
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Engerix-B was given instead of a third dose of Twinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 41-year-old male patient who received HBV (Engerix B) (batch number Y5X9T, expiry date 30-SEP-2026) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose in June 2022) and Twinrix (received 2nd dose in August 2022).   On 29-OCT-2024, the patient received Engerix B. On an unknown date, the patient did not receive Twinrix. On 29-OCT-2024, an unknown time after receiving Engerix B and not applicable after receiving Twinrix, the patient experienced wrong vaccine administered (Verbatim: Engerix-B was given instead of a third dose of Twinrix). The outcome of the wrong vaccine administered 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: 29-OCT-2024 The medical assistant reported that Engerix-B was given in error instead of a third dose of Twinrix on the reporting day, which led to wrong vaccine administered.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Arthralgia, Henoch-Schonlein purpura, International normalised ratio, Prothrombin time
Clinical narrative: henoch schonlein purpura; lower extremity purpuric rash; s/p knee/hip pain; This spontaneous case was reported by an other health care professional and describes the occurrence of HENOCH-SCHONLEIN PURPURA (henoch schonlein purpura), PURPURA (lower extremity purpuric rash) and ARTHRALGIA (s/p knee/hip pain) in a 7-year-old female patient who received mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (batch no. LM2045) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Sep-2024, the patient received dose of mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use) .25 milliliter. On 13-Nov-2024, the patient experienced HENOCH-SCHONLEIN PURPURA (henoch schonlein purpura), PURPURA (lower extremity purpuric rash) and ARTHRALGIA (s/p knee/hip pain). At the time of the report, HENOCH-SCHONLEIN PURPURA (henoch schonlein purpura), PURPURA (lower extremity purpuric rash) and ARTHRALGIA (s/p knee/hip pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2024, Activated partial thromboplastin time: 39.0(High). On 16-Nov-2024, International normalised ratio: 0.99. On 16-Nov-2024, Prothrombin time: 11.4.     For mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. It was reported that patient experienced lower extremity purpuric rash and s/p knee/hip pain 2.5-3 wks. ago with knee/hip pain. Diagnosed was most likely Henoch-Schonlein purpura. It was unknown if the patient experienced any additional symptoms/events. No treatment medications provided by the reporter.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Purpura
Clinical narrative: henoch schonlein purpura; lower extremity purpuric rash; s/p knee/hip pain; This spontaneous case was reported by an other health care professional and describes the occurrence of HENOCH-SCHONLEIN PURPURA (henoch schonlein purpura), PURPURA (lower extremity purpuric rash) and ARTHRALGIA (s/p knee/hip pain) in a 7-year-old female patient who received mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (batch no. LM2045) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Sep-2024, the patient received dose of mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use) .25 milliliter. On 13-Nov-2024, the patient experienced HENOCH-SCHONLEIN PURPURA (henoch schonlein purpura), PURPURA (lower extremity purpuric rash) and ARTHRALGIA (s/p knee/hip pain). At the time of the report, HENOCH-SCHONLEIN PURPURA (henoch schonlein purpura), PURPURA (lower extremity purpuric rash) and ARTHRALGIA (s/p knee/hip pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2024, Activated partial thromboplastin time: 39.0(High). On 16-Nov-2024, International normalised ratio: 0.99. On 16-Nov-2024, Prothrombin time: 11.4.     For mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. It was reported that patient experienced lower extremity purpuric rash and s/p knee/hip pain 2.5-3 wks. ago with knee/hip pain. Diagnosed was most likely Henoch-Schonlein purpura. It was unknown if the patient experienced any additional symptoms/events. No treatment medications provided by the reporter.
Age: 30.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Vaccination site inflammation
Clinical narrative: That evening, I noticed a 2-3inch diameter site of inflammation NOT centered on the injection sites. It became slightly larger the next day. The following days the redness diminished. As of 18Nov2024 I still have a small red patch that is irritated.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE INFLAMMATION (That evening, I noticed a 2-3inch diameter site of inflammation NOT centered on the injection sites. It became slightly larger the next day. The following days the redness diminished. As of 18Nov2024 I still have a small red patch that is irritated.) in a 30-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043835) for COVID-19 prophylaxis.    Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication.    On 15-Dec-2023, patient took 1st dose of Moderna Spikevax SARS-CoV-2 COVID-19 - Ages 12+ PFS vaccine with batch lot number 3032712.   On 14-Nov-2024, the patient received second dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient received dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 14-Nov-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced VACCINATION SITE INFLAMMATION (That evening, I noticed a 2-3inch diameter site of inflammation NOT centered on the injection sites. It became slightly larger the next day. The following days the redness diminished. As of 18Nov2024 I still have a small red patch that is irritated.). At the time of the report, VACCINATION SITE INFLAMMATION (That evening, I noticed a 2-3inch diameter site of inflammation NOT centered on the injection sites. It became slightly larger the next day. The following days the redness diminished. As of 18Nov2024 I still have a small red patch that is irritated.) was resolving.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  It was unknown if the patient experienced any additional symptoms/events.  Treatment medication use information was not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Syringe issue
Clinical narrative: No adverse effect; When removing the cap/seal from the vaccine syringe the hub of the syringe cracked; This spontaneous case was reported by an other health care professional and describes the occurrence of SYRINGE ISSUE (When removing the cap/seal from the vaccine syringe the hub of the syringe cracked) and NO ADVERSE EVENT (No adverse effect) in a  patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. B0005) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection (batch no. B0005) for COVID-19 prophylaxis.    No Medical History information was reported.   On 20-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 20-Nov-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced SYRINGE ISSUE (When removing the cap/seal from the vaccine syringe the hub of the syringe cracked). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse effect). At the time of the report, SYRINGE ISSUE (When removing the cap/seal from the vaccine syringe the hub of the syringe cracked) and NO ADVERSE EVENT (No adverse effect) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.  The Device Problem Information include FDA code: 2284, IMDRF code: A0204, Device problem: Device Damaged Prior to Use and FDA code: 1670, IMDRF Code: A23, Device problem: Use of Device Problem.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: I tried to reconstitute, and it is the tip broke off; need to report it as a damaged; This is a spontaneous report received from a Pharmacist from product quality group.  This report involved a rsv vaccine prot.subunit pref 2v (ABRYSVO), (Lot number: LH4511, Expiration Date: Oct2025) for immunisation. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "I tried to reconstitute, and it is the tip broke off; need to report it as a damaged".  Causality for "i tried to reconstitute, and it is the tip broke off; need to report it as a damaged" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). Additional information included: NDC number of Abrysvo: 0069-0344-05. UPC number of Abrysvo: 300690344058. The pharmacist had a Abrysvo RSV Vaccine that tried to reconstitute, and it is the tip broke off. So, report it as a damaged. The damaged vaccine was not administered to any patient, it was before pharmacist administered it. Contacted the reporter who stated she did not see any sharp edges or glass shards in/on the damaged product.
Sex: U
Vaccine: RSV
Symptoms: Device connection issue, Needle issue, Soft tissue foreign body
Clinical narrative: needle was in patient's arm, when pulled syringe back the needle stayed; needle was in patient's arm, when pulled syringe back the needle stayed; This is a spontaneous report received from a Pharmacist from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, 0.5 ml, single (Lot number: KC7884, Expiration Date: 30Sep2025) intramuscular, in left deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEEDLE ISSUE (non-serious), FOREIGN BODY (non-serious), outcome "unknown" and all described as "needle was in patient's arm, when pulled syringe back the needle stayed".  Additional information: On two occasions when administering the shot, the little adapter attached to the barrel of the syringe comes off, so the needle comes off. Confirmed issues occurred with two Abrysvo products. With first Abrysvo, the needle was in patient's arm, when pulled syringe back the needle stayed. With second Abrysvo, issue occurred when still attaching to vial and pushing diluent in, in that whole process of mixing up the little adapter on barrel of syringe came off. Still is the same part coming off, but luckily happened prior to sticking in someone's arm with the second Abrysvo that had the issue. Confirmed one patient involved, one patient was administered the first Abrysvo that had the issue. Caller does not have any patient information to provide for the patient. Confirmed no patients involved with the second Abrysvo that had the issue. Needle was in patient's arm, when pulled syringe back the needle stayed.  Causality for "needle was in patient's arm, when pulled syringe back the needle stayed" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: she was trying to reconstitute it, it broke off and it leaked; she was trying to reconstitute it, it broke off and it leaked; This is a spontaneous report received from a Pharmacist, Program ID.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HY1812, Expiration Date: Aug2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), DEVICE LEAKAGE (non-serious), outcome "unknown" and all described as "she was trying to reconstitute it, it broke off and it leaked".  Causality for "she was trying to reconstitute it, it broke off and it leaked" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: U
Vaccine: MMR, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: then received PROQUAD at 16 years old; then received PROQUAD at 16 years old making the dose of PROQUAD the child's first dose of VARIVAX.; No additional AE; This spontaneous report was received from nurse, referring to a 16-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date (at 15 months and 17 days of age), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided). On an unspecified date (at 16 years old), the patient was vaccinated with a dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided), "making the dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) the child's first dose of varicella virus vaccine live (oka/merck) (VARIVAX)".  The nurse stated, she sees a trend in which many adolescents who came to the country form others, often have not received varicella virus vaccine live (oka/merck) (VARIVAX) vaccines at all. No additional adverse events.  Lot # is being requested and will be submitted if received.
Age: 52.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional information on AE; Consumer reports she received first dose only in the GARDASIL 9 series at the age of 52 years old on 12/6/2022. No additional information on AE/No PQC.; This spontaneous report was received from a consumer and refers to a 52 year old female patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 06-DEC-2022, the patient was vaccinated with the first and only dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, lot #, expiration date, route of administration, anatomical location not provided) as prophylaxis; at the age of 52 years old (product administered to patient of inappropriate age). The patient stated she felt that was age discrimination to have the age of indicated use to stop at 45. No additional adverse event was reported.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Head injury, Hot flush, Incorrect dose administered
Clinical narrative: Got up 2am to use the rest room passing out; Hitting my head on the toilet; Hot flash an hr later; Cool chills in the middle of the night; Feeling horrible; Wrong dose administered/2.5 mL of dose was administered; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Got up 2am to use the rest room passing out) in a 36-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043153) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 2.5 milliliter. On 16-Nov-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced INCORRECT DOSE ADMINISTERED (Wrong dose administered/2.5 mL of dose was administered). On 17-Nov-2024, the patient experienced LOSS OF CONSCIOUSNESS (Got up 2am to use the rest room passing out) (seriousness criterion medically significant), HEAD INJURY (Hitting my head on the toilet), HOT FLUSH (Hot flash an hr later), CHILLS (Cool chills in the middle of the night) and FEELING ABNORMAL (Feeling horrible). On 17-Nov-2024, CHILLS (Cool chills in the middle of the night) and FEELING ABNORMAL (Feeling horrible) had resolved with sequelae. At the time of the report, LOSS OF CONSCIOUSNESS (Got up 2am to use the rest room passing out), HEAD INJURY (Hitting my head on the toilet), HOT FLUSH (Hot flash an hr later) and INCORRECT DOSE ADMINISTERED (Wrong dose administered/2.5 mL of dose was administered) outcome was unknown.        Company comment: This spontaneous case concerns a 36-year-old male patient who experienced serious (due to medically significant) unexpected event of Loss of consciousness. The event is assessed as related to vaccination due to close temporal association and known safety profile of vaccine. The patient also experienced non  serious event of Head injury, Hot flush, Chills, Feeling abnormal, Incorrect dose administered. The benefit-risk relationship of product is not affected by this report.     Concomitant medication was not provided. It was reported that, patient felt cool chills in the middle of the night and then hot flash an hour later. He got up at 2am to use the rest room and passed out and hit his head on the toilet, clawed back to bed feeling horrible. Treatment information was not reported.