chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site swelling
Clinical narrative: Pt reported sensitivity, soreness, redness, and swelling at and around the injection site on her right deltiod. Symptoms appeared on the first day after vaccination, and have subsided significantly but are still present now 48 hours post vaccination.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: sore arm (expected), exteremly stiff and sore neck lasting 3 days
Age: 70.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Headache, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Patient had nausea, vomiting, body aches, headaches and fever for hours throughout the night
Age: 15.0
Sex: F
Vaccine: UNK
Symptoms: Cold sweat, Dizziness, Feeling hot, Hypoaesthesia, Syncope
Clinical narrative: After a few minutes, patient reported faint, dizzy warm, clammy, and numbness in her joints. We provider an ice pack, fanned her, and water. Parents wanted EMS to be called, which we did. The patient started to feel better while we waited for EMS to come. Patient had no breathing issues or redness at injection site. EMS came and took over care
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling to the area where the vaccine was given.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute sinusitis, Alopecia, Aphonia, Blood pressure measurement, Blood test
Clinical narrative: positive for COVID went by 27May by end of that week; positive for COVID went by 27May by end of that week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient received BNT162b2 (BNT162B2), on 13Aug2021 as dose 1, single (Batch/Lot number: unknown), in arm and in Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "never smoked" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient drink lots of water, do not drink any alcohol never have, never smoked or anything and was very healthy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "positive for COVID went by 27May by end of that week". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Hair growth abnormal, Heart rate, Heart rate increased, Hypertension
Clinical narrative: positive for COVID went by 27May by end of that week; positive for COVID went by 27May by end of that week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient received BNT162b2 (BNT162B2), on 13Aug2021 as dose 1, single (Batch/Lot number: unknown), in arm and in Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "never smoked" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient drink lots of water, do not drink any alcohol never have, never smoked or anything and was very healthy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "positive for COVID went by 27May by end of that week". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperthyroidism, Investigation, Pain, Thyroid function test, Ultrasound scan
Clinical narrative: positive for COVID went by 27May by end of that week; positive for COVID went by 27May by end of that week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient received BNT162b2 (BNT162B2), on 13Aug2021 as dose 1, single (Batch/Lot number: unknown), in arm and in Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "never smoked" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient drink lots of water, do not drink any alcohol never have, never smoked or anything and was very healthy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "positive for COVID went by 27May by end of that week". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vocal cord disorder, Weight decreased
Clinical narrative: positive for COVID went by 27May by end of that week; positive for COVID went by 27May by end of that week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient received BNT162b2 (BNT162B2), on 13Aug2021 as dose 1, single (Batch/Lot number: unknown), in arm and in Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "never smoked" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient drink lots of water, do not drink any alcohol never have, never smoked or anything and was very healthy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "positive for COVID went by 27May by end of that week". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for COVID went by 27May by end of that week; positive for COVID went by 27May by end of that week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient received BNT162b2 (BNT162B2), on 13Aug2021 as dose 1, single (Batch/Lot number: unknown), in arm and in Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "never smoked" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient drink lots of water, do not drink any alcohol never have, never smoked or anything and was very healthy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "positive for COVID went by 27May by end of that week". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Breast cancer metastatic, Computerised tomogram, Incorrect route of product administration, Magnetic resonance imaging
Clinical narrative: Had to use Pfizer for my COVID Vaccination and I only got COVID once; Had to use Pfizer for my COVID Vaccination and I only got COVID once; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) subcutaneous, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EN6205), in arm and on 23Apr2021 as dose 2, single (Batch/Lot number: unknown), in arm, all subcutaneous for covid-19 immunisation. The patient's relevant medical history included: "stage 4 bone cancer" (unspecified if ongoing), notes: bone cancer and I have stage 4; "pain" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; BABY ASPIRIN; CLOPIDOGREL; LOVASTATIN; METFORMIN; METOPROLOL; POTASSIUM CHLORIDE; ZETIA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had to use Pfizer for my COVID Vaccination and I only got COVID once". The patient underwent the following laboratory tests and procedures: Biopsy breast: malignant breast cancer; Computerised tomogram: breast cancer; Magnetic resonance imaging: Unknown results; Positron emission tomogram: breast cancer; SARS-CoV-2 test: Negative; Unknown results; X-ray: Unknown results.  Additional information: Patient stated she had to use Pfizer for her COVID vaccination, only got COVID once and it lasted 5 days and it was over. Patient clarified she got the COVID vaccine first and she was exposed to it probably in public, she did not know but she got it and it was a very light case of COVID.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mammogram, Positron emission tomogram, Scan, X-ray
Clinical narrative: Had to use Pfizer for my COVID Vaccination and I only got COVID once; Had to use Pfizer for my COVID Vaccination and I only got COVID once; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) subcutaneous, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EN6205), in arm and on 23Apr2021 as dose 2, single (Batch/Lot number: unknown), in arm, all subcutaneous for covid-19 immunisation. The patient's relevant medical history included: "stage 4 bone cancer" (unspecified if ongoing), notes: bone cancer and I have stage 4; "pain" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; BABY ASPIRIN; CLOPIDOGREL; LOVASTATIN; METFORMIN; METOPROLOL; POTASSIUM CHLORIDE; ZETIA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had to use Pfizer for my COVID Vaccination and I only got COVID once". The patient underwent the following laboratory tests and procedures: Biopsy breast: malignant breast cancer; Computerised tomogram: breast cancer; Magnetic resonance imaging: Unknown results; Positron emission tomogram: breast cancer; SARS-CoV-2 test: Negative; Unknown results; X-ray: Unknown results.  Additional information: Patient stated she had to use Pfizer for her COVID vaccination, only got COVID once and it lasted 5 days and it was over. Patient clarified she got the COVID vaccine first and she was exposed to it probably in public, she did not know but she got it and it was a very light case of COVID.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy breast, COVID-19, Computerised tomogram, Drug ineffective, Magnetic resonance imaging
Clinical narrative: Had to use Pfizer for my COVID Vaccination and I only got COVID once; Had to use Pfizer for my COVID Vaccination and I only got COVID once; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) subcutaneous, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EN6205), in arm and on 23Apr2021 as dose 2, single (Batch/Lot number: unknown), in arm, all subcutaneous for covid-19 immunisation. The patient's relevant medical history included: "stage 4 bone cancer" (unspecified if ongoing), notes: bone cancer and I have stage 4; "pain" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; BABY ASPIRIN; CLOPIDOGREL; LOVASTATIN; METFORMIN; METOPROLOL; POTASSIUM CHLORIDE; ZETIA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had to use Pfizer for my COVID Vaccination and I only got COVID once". The patient underwent the following laboratory tests and procedures: Biopsy breast: malignant breast cancer; Computerised tomogram: breast cancer; Magnetic resonance imaging: Unknown results; Positron emission tomogram: breast cancer; SARS-CoV-2 test: Negative; Unknown results; X-ray: Unknown results.  Additional information: Patient stated she had to use Pfizer for her COVID vaccination, only got COVID once and it lasted 5 days and it was over. Patient clarified she got the COVID vaccine first and she was exposed to it probably in public, she did not know but she got it and it was a very light case of COVID.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Positron emission tomogram, SARS-CoV-2 test, X-ray
Clinical narrative: Had to use Pfizer for my COVID Vaccination and I only got COVID once; Had to use Pfizer for my COVID Vaccination and I only got COVID once; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) subcutaneous, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EN6205), in arm and on 23Apr2021 as dose 2, single (Batch/Lot number: unknown), in arm, all subcutaneous for covid-19 immunisation. The patient's relevant medical history included: "stage 4 bone cancer" (unspecified if ongoing), notes: bone cancer and I have stage 4; "pain" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; BABY ASPIRIN; CLOPIDOGREL; LOVASTATIN; METFORMIN; METOPROLOL; POTASSIUM CHLORIDE; ZETIA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had to use Pfizer for my COVID Vaccination and I only got COVID once". The patient underwent the following laboratory tests and procedures: Biopsy breast: malignant breast cancer; Computerised tomogram: breast cancer; Magnetic resonance imaging: Unknown results; Positron emission tomogram: breast cancer; SARS-CoV-2 test: Negative; Unknown results; X-ray: Unknown results.  Additional information: Patient stated she had to use Pfizer for her COVID vaccination, only got COVID once and it lasted 5 days and it was over. Patient clarified she got the COVID vaccine first and she was exposed to it probably in public, she did not know but she got it and it was a very light case of COVID.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: HEPAB
Symptoms: Electrocardiogram normal, Hyperhidrosis, Immediate post-injection reaction, Muscle contracture, Sensory disturbance
Clinical narrative: SWEATING, SENSATION OF VACCINE IN LEFT ARM, CLOSING OF LEFT HAND, AND VASOVAGAL SYNCOPE TWICE WITHIN 1 MINUTE OF EACH OTHER. ALL SYMPTOMS WERE WITHIN 30-60 SECONDS POST VACCINATION. EMS CALLED AND BLOOD PRESSURE AND EKG WERE GIVEN WITH NORMAL FINDINGS.  PATIENT WALKED BACKED TO PHARMACY WITHIN 15 MINUTES & STATED HE WAS FINE, HIS ARM FELT FINE, AND ALL PREVIOUS SYMPTOMS RESOLVED.   CHECKED IN ON PATIENT AROUND 3:00PM ON 9/3/23  AND STATED HE WAS FINE AND  FELT A LITTLE TIRED WHEN GOT HOME BUT DRANK AND EAT AS NORMAL.
Age: 68.0
Sex: M
Vaccine: HEPAB
Symptoms: Syncope
Clinical narrative: SWEATING, SENSATION OF VACCINE IN LEFT ARM, CLOSING OF LEFT HAND, AND VASOVAGAL SYNCOPE TWICE WITHIN 1 MINUTE OF EACH OTHER. ALL SYMPTOMS WERE WITHIN 30-60 SECONDS POST VACCINATION. EMS CALLED AND BLOOD PRESSURE AND EKG WERE GIVEN WITH NORMAL FINDINGS.  PATIENT WALKED BACKED TO PHARMACY WITHIN 15 MINUTES & STATED HE WAS FINE, HIS ARM FELT FINE, AND ALL PREVIOUS SYMPTOMS RESOLVED.   CHECKED IN ON PATIENT AROUND 3:00PM ON 9/3/23  AND STATED HE WAS FINE AND  FELT A LITTLE TIRED WHEN GOT HOME BUT DRANK AND EAT AS NORMAL.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysstasia, Electrocardiogram, Hyperhidrosis, Nausea
Clinical narrative: Nausea, severe sweating, unable to stand to get out of chair lasting +/- 5 min
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Erythema, Gastric disorder
Clinical narrative: Red and swelling in arm; stomach pain within 30 minutes; weakness; fast heartbeat; nausea; continual stomach issues for days; diarrhea; fever from day one and continual
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Heart rate increased, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: Red and swelling in arm; stomach pain within 30 minutes; weakness; fast heartbeat; nausea; continual stomach issues for days; diarrhea; fever from day one and continual
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID breakthrough case
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID vaccine breakthrough case
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID breakthrough case
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: incorrect vaccine given based on patient age
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Diarrhoea, Pyrexia, Rash
Clinical narrative: On 9/2 in the afternoon pt developed a fever of 100.9. The fever went away by the time she woke up on 9/3. Also on 9/2 pt. developed diarrhea. It has been slowly resolving. When she woke on on 9/3 she had a rash on her chest and stomach. It has been slowly spreading to her face, back, and butt.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: redness/swelling at injection site approximately 0.5-1in below injection for next 2-3 days patient reports day of symptoms included body aches/headache which resolved after 2 hour nap
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Headache, Rash, Rash vesicular
Clinical narrative: Shingrix GSK Y77XY left arm IM on 8/10/23 tdap 8/15/2023 GSK M4E4A  left arm IM rash bilateral antecubital fossa starting 8/19/23, progressed to entire back with diarrhea and headache. "blistered" per patient. went to UC, was given prendisone, hydroxyzine and famotidine however patient only took famotidine which did help a bit. Evaluated in my office 9/1/23, advised to add zyrtec and famotidine. Prednisone again given if not significantly improved. no wheezing or difficulty swallowing.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Large red area surrounding injection site
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Diarrhoea, Headache, Injection site erythema, Injection site inflammation
Clinical narrative: Swollen and sore arm (day 1), red, inflamed and hot to touch expanded beyond injection site by 24 hrs. Continued to spread across arm and developed rash. Fever started day 2 and stayed around 101.7 .  Fever, chills until day Day 4. Continued rash, hot to touch covering most of arm above elbow. Diarrhea started day 2 and continued through Monday (Day 5). Severe headache started day 2 and continued for 3 days.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Injection site warmth, Pain in extremity, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Swollen and sore arm (day 1), red, inflamed and hot to touch expanded beyond injection site by 24 hrs. Continued to spread across arm and developed rash. Fever started day 2 and stayed around 101.7 .  Fever, chills until day Day 4. Continued rash, hot to touch covering most of arm above elbow. Diarrhea started day 2 and continued through Monday (Day 5). Severe headache started day 2 and continued for 3 days.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Fatigue, Injection site swelling, Rash
Clinical narrative: She was super tired, running a low grade temperature, broke out in a rash, and the injection site has started to swell.  We took her to the pediatrician(for an unrelated checkup) who stated the rash could just be from a viral infection and to keep an eye on her.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Pain in extremity, Peripheral swelling, Pyrexia, Rash
Clinical narrative: rash, soreness and swelling on left arm fever general flu symptoms for about 12 hours
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Decreased appetite, Myalgia
Clinical narrative: Severe polymyalgias in large muscle groups, greatest lower back and lats, also both shoulders; decreased appetite. Symprtoms most severe 1 day post-vaccination then gradually abated over total of 4 days. treated with pain medication and heat
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Decreased appetite, Fatigue, Incorrect dose administered, Myalgia
Clinical narrative: Severe polymyalgias in large muscle groups, greatest lower back and lats, also both shoulders; decreased appetite. Symprtoms most severe 1 day post-vaccination then gradually abated over total of 4 days. treated with pain medication and heat
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash, Rash papular, Tenderness
Clinical narrative: raised rash left medial mid forearm, painful to touch. Online aprn prescribed cortisone cream, advised to seek furhter medical attention if blisters form. Also advised to cover if blisters form.
Sex: F
Vaccine: HEP, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; HBP calling regarding a medical information request. Caller stated that a female patient was administered pediatric doses of VAQTA and RECOMBIVAX HB instead of the adult doses by a newly trained medical assistant.; HBP calling regarding a medical information request. Caller stated that a female patient was administered pediatric doses of VAQTA and RECOMBIVAX HB instead of the adult doses by a newly trained medical assistant.; This spontaneous report was received from an office manager and referred to an adult female patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 09-AUG-2023, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, strength: 25/0.5 (units not reported), valid lot #1966107, expiration date: 06-FEB-2024 (dose, frequency, strength, and route of administration were not provided); and the third dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, valid lot #W038864, expiration date: 16-JUL-2025, (strength, and route of administration were not provided), both of them administered for prophylaxis. It was reported that the patient received pediatric doses of the vaccines instead of the adult doses (Product administered to patient of inappropriate age) (Wrong product administered) by a newly trained medical assistant. No symptoms were reported. No additional information was reported.
Age: 50.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; patient received an expired dose of MMR II and an expired dose of VARIVAX. The patient received both vaccines on 8/14/2023. The MMR II expired 8/4/2023 and the VARIVAX expired 8/10/2023. Caller stated the pro; This spontaneous report was received from a medical assistant and refers to a 50-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-AUG-2023, the patient was vaccinated with a first dose measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, which had a lot #U024229, with expiration date: 04-AUG-2023 (Expired drug administered), administered for prophylaxis (strength was not provided); and also vaccinated with a first dose of  varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #U024765, expiration date: 10-AUG-2023 (Expired drug administered), administered for prophylaxis (strength was not provided) both vaccines were given subcutaneously. No treatment was required for the experience. The reporter stated the vaccines had no temperature and the patient had not reported any symptoms or adverse event.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: the patient may not have received a 3rd dose because of this; whose insurance would not cover their 3rd dose of GARDASIL 9; No additional AE; This spontaneous report was received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unknown date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis. The patient's insurance would not cover the patient's third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) since the patient would be over 45 years old by that time (insurance issue). The patient had the possibility not to receive the third dose due to the insurance issue (inappropriate schedule of product administration). No additional adverse events (AE) were reported (no adverse event).
Age: 40.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Nurse called to report PROQUAD had been administered to a 40 year old patient on July 21, 2023. Nurse notes no side effects or symptoms noted.  No additional AE/no PQC.; Nurse called to report PROQUAD had been administered to a 40 year old patient on July 21, 2023. Nurse notes no side effects or symptoms noted.  No additional AE/no PQC.; This spontaneous report was received from a nurse referring to a 40-year-old patient of unknow gender. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On an unknown date, when the patient was 40-year-old, they were vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered as prophylaxis (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number W029552, with expiration date: 14-MAR-2024 and therapy type  rHA) (product administered to patient of inappropriate age). No additional adverse event was reported.
Age: 0.08
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE; HCP reported 4 week old patient received VAQTA instead of RECOMBIVAX HB; HCP reported 4 week old patient received VAQTA instead of RECOMBIVAX HB; Patient did not receive the RECOMBIVAX HB; This spontaneous report was received from a medical assistant referring to a 4-week-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 25-AUG-2023, the patient was vaccinated with Hepatitis A Vaccine, inactivated (VAQTA) intramuscular injection (strength:25/0.5, 0.5 ml, lot#: W029899, expiration date: 16-MAY-2024) intramuscularly (IM) for prophylaxis by a healthcare professional (HCP) instead of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) intramuscular injection (product administered to patient of inappropriate age and wrong product administered). The patient did not receive Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) therefore it was filed as a missed dose (product dose omission issue). No additional adverse events (AE) were reported (no adverse event).
Age: 11.0
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE reported; Inbound call from nurse who reports an additional (3rd) dose of PROQUAD was accidentally administered to a patient. Product administered 21AUG2023. Patient was 11 years old and had already received first and second dose per dosing schedule in PI. No; This spontaneous report was received from a nurse and referred to an 11-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reaction/allergies were not reported. On unknown dates, the patient had already vaccinated with the 1st, 2nd dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, administered for prophylaxis (strength, dose, lot #, expiry date and route of administration were not provided) per dosing schedule in product information (PI).  On 21-AUG-2023, an additional (3rd) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (0.5 milliliter; strength, lot #, expiry date and route of administration were not provided) was accidentally administered to the patient (Extra dose administered). No additional adverse event details available.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Overdose
Clinical narrative: No additional AE; HCP calling to report AE for PROQUAD and VARIVAX. HCP reports both vaccines were administered simultaneously to a patient on 29AUG2023. HCP reports no side effects to the patient. Both vaccines were not expired and never experienced temperature excur; This spontaneous report was received from a medical assistant and refers to an 1-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-AUG-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, unk, lot #W035460, expiration date: 06-MAY-2024, administered for prophylaxis (strength, and route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, lot #X006983, expiration date: 07-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided) (Overdose). There was no side effects to the patient. Both vaccines were not expired and never experienced temperature excursions.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No Adverse Event; Caller reported AE on behalf of an infant patient who was administered an expired dose of MMR-II (no prior TEs). No symptoms reported. Consent to contact HCP was denied. No additional AE/PQC.; This spontaneous report was received from a medical assistant refers to a infant patient of unknown gender.   The patient's medical history, concurrent conditions were not reported. The patient's concomitant therapies included STERILE DILUENT.  On 31-AUG-2023, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II) lot #U022316, expiration date: 15-JUL-2023, 0.5 milliliter (route of administration and anatomical location were not reported) for prophylaxis (expired product administered).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC; HCP called to report inadvertent administration of expired VARIVAX to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. Concomitant therapies were not reported.  On 31-AUG-2023, the patient was vaccinated inadvertent with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliters, once (lot #U026207, with an expiration date on 24-AUG-2023), administered for prophylaxis (strength, and route of administration were not provided).  No additional adverse events were reported.
Age: 31.0
Sex: U
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: HCP stated it was administered to 31-year-old patient who needed for school on 8/31/2023. No other AE reported. No PQC repo; HCP stated it was administered to 31-year-old patient who needed for school on 8/31/2023. No other AE reported. No PQC repo; This spontaneous report was received from a pharmacist referring to a 31-year-old patient of unknown gender. The patient0s concurrent conditions, medical history or concomitant therapy were not reported.  On 31-AUG-2023, the patient was vaccinated with a dose of measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection, lot# X012186, expiry date 16-JUL-2024, recombinant Human albumin (rHA) (dose and route of administration were not provided) (product administered to patient of inappropriate age).  Lot No. X012186 has been verified to be a valid lot number for measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live, expiration date reported as 19-JUL-2024, but upon internal validation established as 16-JUL-2024.  No other adverse events reported. The pharmacist also inquired if measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) could be given Intramuscular or Subcutaneous.
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Priorix admin IM instead of SQ; This non-serious case was reported by a nurse via sales rep and described the occurrence of subcutaneous injection formulation administered by other route in a male patient who received MMR (Priorix) for prophylaxis.   In AUG-2023, the patient received Priorix (intramuscular). In AUG-2023, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix admin IM instead of SQ).The outcome of the subcutaneous injection formulation administered by other route 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: 24-AUG-2023 This report was submitted via the online direct entry reporting system.  The reporter stated that Priorix administered intramuscular instead of SQ, which led to subcutaneous injection formulation administered by other route. The reporter consent to contact was not given.
Sex: F
Vaccine: MENB
Symptoms: Bacille Calmette-Guerin scar reactivation
Clinical narrative: Inflammation of BCG scar; This non-serious case was reported by a consumer and described the occurrence of bcg scar inflammation in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number Xx33P) for prophylaxis.   On 21-AUG-2023, the patient received Bexsero. On 22-AUG-2023, 1 days after receiving Bexsero, the patient experienced bcg scar inflammation (Verbatim: Inflammation of BCG scar).The outcome of the bcg scar inflammation was resolving.   It was unknown if the reporter considered the bcg scar inflammation to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   It was unknown if the company considered the bcg scar inflammation to be related to Bexsero and Bexsero 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: 25-AUG-2023 This report was submitted via the online direct entry reporting system.  The reporter was caregiver. The patient experienced inflammation of BCG scar.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted with a sterile diluent instead of the supplied AS01b diluent; reconstituted with a sterile diluent instead of the supplied AS01b diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number ZM749, expiry date 22-AUG-2025) for prophylaxis.   In AUG-2023, the patient received Shingrix. In AUG-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with a sterile diluent instead of the supplied AS01b diluent) and inappropriate dose of vaccine administered (Verbatim: reconstituted with a sterile diluent instead of the supplied AS01b diluent).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 25-AUG-2023 Clinical Operations Manager reports that a nurse administered a dose of Shingrix that was reconstituted with a sterile diluent instead of the supplied AS01b diluent, which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered.   They were not sure which patient it was that received this dose, they have it narrowed down to 4 patients.   The dose was given sometime between 05Aug2023 to 22Aug2023. At the time of reporting, no repeat doses have been administered. The reporter consented to follow up. This case has been linked to the case US2023AMR116984, US2023AMR116985 and US2023AMR116986 reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR116984:same reporter US-GSK-US2023AMR116985:same reporter US-GSK-US2023AMR116986:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: dizziness; chills; loss of appetite; vomiting; retching; fatigue; sweating profusely; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-AUG-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced dizziness (Verbatim: dizziness), chills (Verbatim: chills), appetite lost (Verbatim: loss of appetite), vomiting (Verbatim: vomiting), retching (Verbatim: retching), fatigue (Verbatim: fatigue) and sweating (Verbatim: sweating profusely).  The outcome of the dizziness, chills, appetite lost, vomiting, retching, fatigue and sweating were resolved (duration 1 week).   It was unknown if the reporter considered the dizziness, chills, appetite lost, vomiting, retching, fatigue and sweating to be related to Shingrix.     It was unknown if the company considered the dizziness, chills, appetite lost, vomiting, retching, fatigue and sweating to be related to Shingrix.   Additional Information: GSK receipt date: 25-Aug-2023 The patient never had a reaction from any vaccine which had been given.  The patient had the first vaccine and this time got the full range of dizziness, chills, loss of appetite, vomiting(retching), fatigue and sweating profusely.  It lasted for one whole week and took a week to recover.  The patient stated did not told him/her about 2 or 3 days side effect.  It was awful and unnecessary.  The patient thought you should try testing this product more and stop advertising it on tv obnoxiously. The patient will not be getting the second dose and the patient did not care.
Sex: U
Vaccine: VARZOS
Symptoms: Retching, Vomiting
Clinical narrative: dizziness; chills; loss of appetite; vomiting; retching; fatigue; sweating profusely; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-AUG-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced dizziness (Verbatim: dizziness), chills (Verbatim: chills), appetite lost (Verbatim: loss of appetite), vomiting (Verbatim: vomiting), retching (Verbatim: retching), fatigue (Verbatim: fatigue) and sweating (Verbatim: sweating profusely).  The outcome of the dizziness, chills, appetite lost, vomiting, retching, fatigue and sweating were resolved (duration 1 week).   It was unknown if the reporter considered the dizziness, chills, appetite lost, vomiting, retching, fatigue and sweating to be related to Shingrix.     It was unknown if the company considered the dizziness, chills, appetite lost, vomiting, retching, fatigue and sweating to be related to Shingrix.   Additional Information: GSK receipt date: 25-Aug-2023 The patient never had a reaction from any vaccine which had been given.  The patient had the first vaccine and this time got the full range of dizziness, chills, loss of appetite, vomiting(retching), fatigue and sweating profusely.  It lasted for one whole week and took a week to recover.  The patient stated did not told him/her about 2 or 3 days side effect.  It was awful and unnecessary.  The patient thought you should try testing this product more and stop advertising it on tv obnoxiously. The patient will not be getting the second dose and the patient did not care.
Sex: M
Vaccine: VARZOS
Symptoms: Facial pain, Hyperaesthesia, Pain
Clinical narrative: Left eye brow pain; pain that radiates from both sides of eye brow; Left eye brow sensitivity /The upper bone structure around my left eye socket has one specific spot that is sensitive and even more sensitive to pressure put on that spot; This non-serious case was reported by a consumer via call center representative and described the occurrence of eyebrow pain in a male patient who received Herpes zoster (Shingrix) (batch number 5777F, expiry date 30-MAY-2024) for prophylaxis.   On 23-MAR-2023, the patient received the 1st dose of Shingrix (right deltoid). On 18-AUG-2023, 148 days after receiving Shingrix, the patient experienced eyebrow pain (Verbatim: Left eye brow pain ), radiating pain (Verbatim: pain that radiates from both sides of eye brow) and hyperesthesia (Verbatim: Left eye brow sensitivity /The upper bone structure around my left eye socket has one specific spot that is sensitive and even more sensitive to pressure put on that spot).  The outcome of the eyebrow pain, radiating pain and hyperesthesia were not resolved.   It was unknown if the reporter considered the eyebrow pain, radiating pain and hyperesthesia to be related to Shingrix.     It was unknown if the company considered the eyebrow pain, radiating pain and hyperesthesia to be related to Shingrix.   Additional Information: GSK receipt date: 25-AUG-2023 The upper bone structure around the patient left eye socket has one specific spot that was sensitive and even more sensitive to pressure put on that spot.  The pain permeates further out when area was pressed.  The patient had left eye brow sensitivity to touch causing pain that radiates from both sides of eye brow. The left eye brow pain was not resolved. When explaining to the cardiologist in an appointment today (on the day of reporting) had and asked if had the shingrix shot.  The physician said the shingrix vaccine could affect the nerves around the eye and the bone structure around the eye. The scheduled to take 2nd dose in the next day (day after visiting the physician).  The physician did not want to recommend that I did or did not take the second dose. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: experiencing a TE, where the temperature reached 10.1 C for 59 minutes; This non-serious case was reported by a physician via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Concomitant products included diphtheria vaccine toxoid + pertussis toxoid + tetanus vaccine toxoid (Adacel).   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: experiencing a TE, where the temperature reached 10.1 C for 59 minutes).  The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 25-Aug-2023 The health care professional called to report that Adacel and Menveo administration after experiencing a temperature  excursion, where the temperature reached 10.1 Celsius for 59 minutes. No additional adverse event or product quality complaint was reported. The patient received Menveo after temperature excursion, which led to incorrect storage of drug.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: reconstituted with a sterile diluent instead of the supplied AS01b diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number ZM749, expiry date 22-AUG-2025) for prophylaxis.   In AUG-2023, the patient received Shingrix. In AUG-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with a sterile diluent instead of the supplied AS01b diluent).  The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt date: 25-AUG-2023 Clinical Operations Manager reported that a nurse administered a dose of Shingrix that was reconstituted with a sterile diluent instead of the supplied AS01b diluent, which led to wrong solution used in drug reconstitution.  They were not sure which patient it was that received this dose, they had it narrowed down to 4 patients.   The dose was given sometime between 05-Aug-2023 to 22-Aug-2023. At the time of reporting, no repeat doses have been administered. The reporter consented to follow up. This case was 1 of 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR116984:same reporter US-GSK-US2023AMR116985:same reporter US-GSK-US2023116324:same reporter