chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: sore arm; fatigue; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and HEADACHE (headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient was not immunocompromised. The patient had no allergies and no COVID positive test or diagnosis.  The patient did not receive any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Tinnitus (Started 10 years ago and no recent change in status: it was about the same) since 2012.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.   It was reported that, the patient did not have any vertigo, nystagmus, neurological effects, dizziness, sinus effects, or nausea or vomiting. She was not sick and she did not have the flu.  No treatment details were reported.   This case was linked to MOD-2022-571129, MOD-2022-571130, MOD-2022-571131 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear pain
Clinical narrative: sore arm; fatigue; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and HEADACHE (headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient was not immunocompromised. The patient had no allergies and no COVID positive test or diagnosis.  The patient did not receive any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Tinnitus (Started 10 years ago and no recent change in status: it was about the same) since 2012.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.   It was reported that, the patient did not have any vertigo, nystagmus, neurological effects, dizziness, sinus effects, or nausea or vomiting. She was not sick and she did not have the flu.  No treatment details were reported.   This case was linked to MOD-2022-571129, MOD-2022-571130, MOD-2022-571131 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Accidental overdose, Fatigue, Headache, Pain in extremity
Clinical narrative: bilateral ear pain/It started off with a dull ache and pain this morning in both ears/ear infection; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (bilateral ear pain/It started off with a dull ache and pain this morning in both ears/ear infection) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049L21A, 012F21A, 028L20A and 039K20A) for COVID-19 vaccination.     The patient had no known allergy. The patient had never diagnosed or tested positive for Covid-19. The patient was not immunocompromised.  Concurrent medical conditions included Tinnitus (It was started 10 years ago, change in status such as improvement or reported as about the same).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 19-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EAR PAIN (bilateral ear pain/It started off with a dull ache and pain this morning in both ears/ear infection). The patient was treated with PARACETAMOL (TYLENOL) in May 2022 at an unspecified dose and frequency and HYDROGEN PEROXIDE in May 2022 at a dose of flushed the ear. At the time of the report, EAR PAIN (bilateral ear pain/It started off with a dull ache and pain this morning in both ears/ear infection) had not resolved.            Patient's height was reported as height: 5 feet 7 inches.  No concomitant medications were reported.  The patient took Tylenol to see if that would help. Patient also flushed the ear with hydrogen peroxide thinking that she was getting an ear infection. Patient never experienced ear pain like this before.   It was reported that, the onset was quick. Patient did not have any vertigo, nystagmus, neurological effects, dizziness, sinus effects, or nausea or vomiting. Patient was not sick and did not have the flu.  The patient did not experienced a similar event in the past.  It was reported that bilateral ear pain worse in the last 2 hours and started on 19 May 2022 about six hours ago.   This case was linked to MOD-2022-571116, MOD-2022-571129, MOD-2022-571130 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: bilateral ear pain/It started off with a dull ache and pain this morning in both ears/ear infection; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (bilateral ear pain/It started off with a dull ache and pain this morning in both ears/ear infection) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049L21A, 012F21A, 028L20A and 039K20A) for COVID-19 vaccination.     The patient had no known allergy. The patient had never diagnosed or tested positive for Covid-19. The patient was not immunocompromised.  Concurrent medical conditions included Tinnitus (It was started 10 years ago, change in status such as improvement or reported as about the same).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 19-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EAR PAIN (bilateral ear pain/It started off with a dull ache and pain this morning in both ears/ear infection). The patient was treated with PARACETAMOL (TYLENOL) in May 2022 at an unspecified dose and frequency and HYDROGEN PEROXIDE in May 2022 at a dose of flushed the ear. At the time of the report, EAR PAIN (bilateral ear pain/It started off with a dull ache and pain this morning in both ears/ear infection) had not resolved.            Patient's height was reported as height: 5 feet 7 inches.  No concomitant medications were reported.  The patient took Tylenol to see if that would help. Patient also flushed the ear with hydrogen peroxide thinking that she was getting an ear infection. Patient never experienced ear pain like this before.   It was reported that, the onset was quick. Patient did not have any vertigo, nystagmus, neurological effects, dizziness, sinus effects, or nausea or vomiting. Patient was not sick and did not have the flu.  The patient did not experienced a similar event in the past.  It was reported that bilateral ear pain worse in the last 2 hours and started on 19 May 2022 about six hours ago.   This case was linked to MOD-2022-571116, MOD-2022-571129, MOD-2022-571130 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear pain
Clinical narrative: bilateral ear pain/It started off with a dull ache and pain this morning in both ears/ear infection; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (bilateral ear pain/It started off with a dull ache and pain this morning in both ears/ear infection) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049L21A, 012F21A, 028L20A and 039K20A) for COVID-19 vaccination.     The patient had no known allergy. The patient had never diagnosed or tested positive for Covid-19. The patient was not immunocompromised.  Concurrent medical conditions included Tinnitus (It was started 10 years ago, change in status such as improvement or reported as about the same).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 19-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EAR PAIN (bilateral ear pain/It started off with a dull ache and pain this morning in both ears/ear infection). The patient was treated with PARACETAMOL (TYLENOL) in May 2022 at an unspecified dose and frequency and HYDROGEN PEROXIDE in May 2022 at a dose of flushed the ear. At the time of the report, EAR PAIN (bilateral ear pain/It started off with a dull ache and pain this morning in both ears/ear infection) had not resolved.            Patient's height was reported as height: 5 feet 7 inches.  No concomitant medications were reported.  The patient took Tylenol to see if that would help. Patient also flushed the ear with hydrogen peroxide thinking that she was getting an ear infection. Patient never experienced ear pain like this before.   It was reported that, the onset was quick. Patient did not have any vertigo, nystagmus, neurological effects, dizziness, sinus effects, or nausea or vomiting. Patient was not sick and did not have the flu.  The patient did not experienced a similar event in the past.  It was reported that bilateral ear pain worse in the last 2 hours and started on 19 May 2022 about six hours ago.   This case was linked to MOD-2022-571116, MOD-2022-571129, MOD-2022-571130 (Patient Link).
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age, Product administration error
Clinical narrative: No adverse effects reported but an administration error- the adult dose was given to an 11 year old patient
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Glomerulonephritis, Haematuria, Hypertension, Protein urine present, Red blood cells urine positive
Clinical narrative: Received immunization at Pharmacy, was treated at the Hospital. Developed Glomerulonephritic, self resolving after 49 hours. Initial gross hematuria and proteinurea.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: Received immunization at Pharmacy, was treated at the Hospital. Developed Glomerulonephritic, self resolving after 49 hours. Initial gross hematuria and proteinurea.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test, Computerised tomogram abdomen abnormal, Scan with contrast abnormal, Vasculitis gastrointestinal
Clinical narrative: Patient in excellent health with no medical conditions or comorbidities was admitted to hospital with severe abdominal pain; diagnosed by CT w/contrast, with rare abdominal vasculitis; treated with Prednisone 60 mg.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, COVID-19, Laboratory test abnormal, Type 2 diabetes mellitus
Clinical narrative: I have developed Type 2 diabetes with no previous indications.  I was sent to the emergency room on the evening of 5/19/2022 as a result of lab tests earlier that day that showed my blood sugar level at 544. This condition may be more likely due to my infection with the COVID-19 virus in March of 2020, than due to the booster shot.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Loss of consciousness, Vomiting
Clinical narrative: Administered Covid 19 vaccine to patient informed mother to have a seat and wait 15 minutes as a precaution. After a few minutes gets my attention and states her daughter is not feeling good I went outside of the pharmacy and noticed patient looking dazed asked patient how she is feeling she said she felt dizzy I asked if she had any shortness of breath and she said no and lost consciousness for less than a minute asked her again if she was having any trouble breathing she said no then called 911. Before paramedics arrived patient vomited. Paramedics arrived and left with child and mother
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Type 2 diabetes mellitus
Clinical narrative: 105 degree fever and bodily aches. Lasted about 12 hours. A few months later Type 2 Diabetes diagnosis.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Herpes zoster, Swelling, Swelling face
Clinical narrative: Swelling and blisters on face, neck & behind head Diagnosed with Shingles and treatment started with antiviral drug
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Colonoscopy, Computerised tomogram, Endoscopy, Hypersomnia
Clinical narrative: My body/blood became anemic, crash my red blood cell counts.  Cause me to have to sleep over 12 hours a day, miss and delay work.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Infusion, Laboratory test, Red blood cell count decreased, X-ray
Clinical narrative: My body/blood became anemic, crash my red blood cell counts.  Cause me to have to sleep over 12 hours a day, miss and delay work.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Severe pain when trying to move the arm under it's own power, especially laterally. Almost painless when the arm is just resting on the side.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Medication error, Urinary tract infection
Clinical narrative: Urinary tract infection due to medication error, had consult with doctor by telephone, received prescription for Cephalexin 500mg twice a day for five days. I do not believe this event was related to the COVID vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Mother reports warmth, redness, swelling that started on Saturday, the day after injection to dtap site. Then on Sunday night (5/22/22) small vesicles formed around injection site.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No aditional AE; Nurse reporting patient administered dose of VAQTA after labeled expiration date.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On 25-APR-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, strength: 25 U/0.5mL, at a dose of 0.5ml/once, lot #t034003, expiration date reported as 25-MAR-2022, but upon internal validation established as 28-MAR-2022, administered for prophylaxis (route and site of administration were not provided) after labeled expiration date (expired product administered). It was stated that the vaccine did not experience any temperature excursion. No additional adverse event was reported (no adverse event).
Age: 19.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Pyrexia, Rash
Clinical narrative: Spent 3 days in bed after receiving shingles vaccine; This spontaneous report was received from a health professional referring to a 19 year old female patient. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not provided.   40 years ago, almost 50 Years, the patient had the original measles vaccine (manufacturer unknown) (strength, dose detail, route lot # and expiration date were not provided) for prophylaxis.  The day after the vaccine, the patient had a rash and fever for 3 weeks. The outcome of the events was not provided.  Causality assessment was not provided.  This case is non-valid due to measles vaccine (manufacturer unknown) as one of the active components of a vaccine are classified.  Follow-up information has been received from the patient via telephone call on 18-MAY-2022.   The patient informed that on an unspecified date, she received vaccination with zoster vaccine live (manufacturer unknown) (reported as an unspecified shingles vaccine) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   On an unspecified date, after getting vaccinated, the patient spent three days in bed (adverse event).   At the time of reporting, the outcome of spending three days in bed was unknown.   The causal relationship between the vaccination with zoster vaccine live (manufacturer unknown) was not provided.   This case was previously considered as non-valid as the initial report mentioned measles vaccine (considered as class of product).
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC reported; expired dose of GARDASIL 9 administered; This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 24-APR-2022, the patient was vaccinated with an expired dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml, lot # S026372, expiration date 01-APR-2022; strength and anatomical location were not reported) intramuscularly (IM) for prophylaxis (expired product administered). No additional adverse events (AEs) or product quality complaint (PQC) was reported.
Sex: U
Vaccine: HPV9, MEN
Symptoms: No adverse event, Wrong product administered
Clinical narrative: some child may have received 2 doses of NIMENRIX instead of GARDASIL 9; no additional AE reported; This spontaneous report was received from a consumer and refers to a child patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On an unknown dates, the patient may have been vaccinated with two doses of meningococcal vaccine A/C/Y/W conj (TET TOX) (NIMENRIX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) instead of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot #, expiration date were not provided) for prophylaxis (wrong product administered). There was no additional adverse event reported.  This is one of two reports from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical assistant reporting PROQUAD was administered after experiencing supported temperature excursion.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's pertinent medical history, current conditions, drug reactions or allergies, and concomitant therapies were not reported.  On 28-APR-2022, the patient was vaccinated after a temperature excursion (product storage error) with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) subcutaneous injection, 0.5ml/once, lot #U031562 has been verified to be valid, expiration date: 06-APR-2023 as prophylaxis (strength, and route of administration were not provided). Timeframe and temperature were not reported.  No additional adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; patient received possibly improperly stored vaccine due to lack of temperature readings; This spontaneous report was received from a healthcare worker and refers to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 06-JAN-2022, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot # T028582, expiration date: 04-MAR-2023, administered for prophylaxis (strength, dose, and route of administration were not provided).   The reporter informed that the administered vaccine had been possibly improperly stored due to lack of temperature readings (product storage error). The refrigerator and freezer temperatures were not recorded since 10-JAN-2022 and temperature was unknown to the reporter. There was no previous temperature excursion. No adverse events (AE) were reported, and no further information was provided.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2205USA000560: US-009507513-2205USA000503: US-009507513-2205USA000524: US-009507513-2205USA000533: US-009507513-2205USA000464: US-009507513-2205USA000467: US-009507513-2205USA000503: US-009507513-2205USA000540: US-009507513-2205USA000553: US-009507513-2205USA000544: US-009507513-2205USA000545:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported; Nurse reports the administration of expired GARDASIL 9 and inquiring viability information pertaining to administered dose.; This spontaneous report was received from a registered nurse referring to a patient of unspecified age and gender. Information regarding the patient's concomitant medications, pertinent medical history, concurrent conditions and previous drug reactions or allergies was not provided.   On 02-MAY-2022, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliters (mL) for prophylaxis (route of administration, anatomical site of vaccination and vaccine scheme were not reported; lot number T007035 has been verified to be valid, expiration date reported and established as 01-MAY-2022) (expired product administered).   The reporter inquired viability information pertaining to administered dose. No additional adverse event reported (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; One dose of ROTATEQ was administered to the patient on 3 MAY 2022, after the excursion occured.; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender. Information regarding the patient's concomitant medications, pertinent medical history, concurrent conditions and previous drug reactions or allergies was not provided.  On 03-MAY-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliters (ml) for prophylaxis (route of administration, anatomical site of vaccination and vaccine scheme were not reported; lot number 1742421 has been verified to be valid, expiration date reported and established as 07-DEC-2022).   It was reported that the dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was exposed to a temperature excursion of 33.6 Fahrenheit degrees (F) during a time frame of 7 hours and 45 minutes (product storage error). Moreover, there was a previous temperature excursion of 48 Fahrenheit degrees (F) for 30 minutes. No additional adverse event was reported (no adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Limb injury, No adverse event, Poor quality product administered, Product delivery mechanism issue, Syringe issue
Clinical narrative: LPN was administering a dose of GARDASIL9 to a patient on 5/5/2022 when the finger flange shattered and the LPN cut her finger on the broken device.; This spontaneous report has been received form a medical assistant, regarding a female patient of unknow age (license practitioner nurse (LPN)). The patient's medical history, current conditions, drug reaction or allergies and concomitant medications were not reported.  On 05-MAY-2022, the LPN was administering a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) to a patient (this patient mentioned presented syringe issue, product delivery mechanism issue, no adverse event and poor-quality product administered, which were captured in MARRS # US-009507513-2205USA002063) when the finger flange shattered, and the LPN cut her finger on the broken device (Limb injury). Reporter stated the LPN was wearing gloves at the time the flange shattered and she sought medical attention after the incident. The outcome of the event was not reported.   The causal relationship between the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the event limb injury was not reported.  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2205USA002063:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; patient was administered a dose of GARDASIL 9 after the labeled expiration date; This spontaneous report was received from a license vocational nurse and refers to a patient of unknown age and gender.The patient's medical history and concurrent conditions were not reported. On 09-MAY-2022, the patient was administered a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) after the labeled expiration date (lot # S028738, expiration date reported as 22-MAR-2022, but confirmed to be 03-APR-2022 upon internal validation) (dose and route not reported). The vaccine experienced no temperature excursions.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse events reported; Expired MMR II vaccine given; This spontaneous report has been received from a medical assistant (also reported as "office manager") via Agency concerning a 57-month-old (also reported as "4 year and 9 month old") male patient.  The patient's concurrent conditions, concomitant medication, historical drugs, and pertinent medical history were not provided.  On 09-MAY-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) (rHA) 0.5 milliliter (lot number T013724 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II), expiration date reported and confirmed as 21-APR-2022) (route of administration was not provided) administered into his right arm as prophylaxis. After the vaccine was given it was discovered that it was expired (Expired product administered). The vaccine did not experience any temperature excursions. No additional adverse events were reported.
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Interchange of vaccine products, No adverse event, Wrong product administered
Clinical narrative: No additional AE information provided; HCP states that she would like information on what to do if a patient received a series of three GARDASIL 4 as a teen, and then were accidentally administered one dose of GARDASIL 9 at age 22. HCP states that; HCP states that she would like information on what to do if a patient received a series of three GARDASIL 4 as a teen, and then were accidentally administered one dose of GARDASIL 9 at age 22. HCP states that; This spontaneous report was received from a nurse and refers to a 22-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2009, the patient received two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (also reported as "GARDASIL 4")  (strength, dose, lot #, expiration date, and route of administration were not provided) for prophylaxis. The third dose was received in 2010.   On an unknown date in March 2022, the patient (at age 22) was accidentally administered one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter (single dose), lot number 1637442 (was not valid) (strength, expiration date, and route of administration were not provided) for prophylaxis. No additional adverse event provided (interchange of vaccine products, wrong product administered). Lot number 1637442 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Lot number 1637442  does not match any Company product as confirmed by Lot Verification team.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; administration of an expired MMR II; This spontaneous report was received from a medical assistant and refers to a patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 13-MAY-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #T016198, expiration date: 11-MAY-2022, administered for prophylaxis (strength, and route of administration were not provided). The reporter confirmed the vaccine was stored within the recommended storage range until administration. Also, the reporter was provided with the appropriate disclaimer per the post expiry memo. There was no additional adverse event (AE) reported.
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Cardiovascular disorder, Herpes zoster, Nervous system disorder, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; cardiovascular event; balance problems; serious neurological problems; herpes zoster; Information has been received from a lawyer regarding a case in litigation which referred to a patient (pt) of unknown gender and age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster) and as routine health maintenance (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Afterwards, on an unknown date (reported as after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered herpes zoster, postherpetic neuralgia, cardiovascular event, balance problems, and other serious neurological problems. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. In addition, the pt sustained severe and permanent personal injuries. Further, the pt had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster, postherpetic neuralgia, cardiovascular event (cardiovascular disorder), balance problems (balance disorder), and other serious neurological problems (nervous system disorder) were considered as disabling events by the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: while giving a VARIVAX to a young child, they moved and a very small amount of VARIVAX dripped out instead of going in the patient.; No additional AE information; This spontaneous report was received from a nurse and refers to a young child patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. There was no information regarding the patient's allergies or drug reactions.   On an unknown date while a varicella virus vaccine live (oka/merck) (VARIVAX) (strength, exact dose, dose number, route and site of administration , lot# and expiration date were not reported) was giving to the patient for prophylaxis, they moved and a very small amount of varicella virus vaccine live (oka/merck) (VARIVAX) dripped out instead of going in the patient (incorrect dose administered). The nurse stated that she was knew it was not enough to matter but the parent was concerned. No additional adverse event was reported (no adverse event).
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event
Clinical narrative: side effects experienced (if any): none; 1999 and 2002; This spontaneous report has been received from a lawyer via Plaintiff Fact Sheet (FS), from a physician via medical records (MR) and from registered pharmacist via immunization records (IR), from a case in litigation for zoster vaccine live (ZOSTAVAX) (# 1803USA001102), concerning currently an 81-year-old female patient, whose age at a time of the pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was at least 61-year-old. Her medical history included disability: neck injury (for 1 year, from 1986 tp 1987). Historical vaccines included influenza ("flu") vaccine administered annually (since 1996). Concurrent conditions included cigarettes: 1 pack daily (since 1953), alcohol use: less than 5 drinks a month (since 1958), primary care physician treatment (unspecified, since 1996), and chronic obstructive pulmonary disease (COPD). Concomitant therapies included fluticasone propionate (+) salmeterol xinafoate (ADVAIR) for COPD.  On an unknown date in 1999, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (provided as "pneumonia" vaccine (dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis. On an unspecified date in 2002, she received another dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (product use issue) (in MR there was reported pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX), however it could not be confirmed when the patient was administered that vaccine. In immunization records (IR) there was information included numbers provided as "J013211", "5-16", however it was not specified if it pertained to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX): nothing indicated that this vaccine was administered according to this document). Side effects after pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) were reported as none (no adverse event).  All available medical records will be provided upon request.  This is one of 2 linked reports regarding the same patient (cross referenced with the case # 1803USA001102).; Sender's Comments:  US-009507513-1803USA001102:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: recd. vaccinations over a year ago, had at least 8 outbreaks/suspected vaccination failure; 8 Shingles outbreaks; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with tofacitinib citrate (Xeljanz). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's comment: The case was reported by the patient. The patient received Shingrix vaccinations over a year prior to the reporting. The patient had at least 8 outbreaks. Since then the patient was taking Xeljanz. The patient asked if there was anything patient could do to stop outbreaks. Also the patient wanted to add that the patient had two surgeries cancelled due to physicians not wanting to operate and the patient was in a bind. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Lethargy, Pain
Clinical narrative: Side effects of lethargic; Body aches; Headache; Awful for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of lethargy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced lethargy, general body pain, headache and feels awful. On an unknown date, the outcome of the lethargy, general body pain, headache and feels awful were recovered/resolved.   It was unknown if the reporter considered the lethargy, general body pain, headache and feels awful to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced side effects of lethargic, body aches, headache and awful for 3 days.  The patient stated that after he/she was seeing people suffer from shingles it was totally worth it. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm hurt for a day; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 15th May 2022, the patient received the 1st dose of Shingles vaccine. In May 2022, less than a day after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine yesterday (day before reporting) and experienced his/her arm hurt for a day. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort
Clinical narrative: My arm is killing me; This case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16th May 2022, the patient received Shingles vaccine. On 16th May 2022, less than a day after receiving Shingles vaccine, the patient experienced arm discomfort. On an unknown date, the outcome of the arm discomfort was unknown.   It was unknown if the reporter considered the arm discomfort to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine today (day of reporting) and felt his/her arm was killing him/her. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, FLU4, HEP
Symptoms: Product storage error
Clinical narrative: 17 patients, were inadvertently administered vaccines, deemed to be nonviable from excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a child patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis, flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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-17-MAY-2022 Reporters comment- The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371. Registered nurse manager called in to inquire about the time interval for repeat dose and if it was safe. The reporter was unable to provide any vaccine or patient details. The reporter consented to follow up. Additional supportive information: The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371, which led to incorrect storage of drug. This was one of 17 linked cases reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: vaccinated with both doses. mild case of shingrix today/suspected vaccination failure; mild case of shingles today; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 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 17th May 2022, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's Comment: The patient was vaccinated with both doses of Shingrix but presented with a mild case of Shingles at the time of reporting. The reporter did not agreed to follow up from GlaxoSmithKline. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shots, I keep getting shingles/Suspected vaccination failure; I keep getting shingles; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had the shots and they did not work. The patient got it repeatedly. Asked was there any suggestions as patient keep getting shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Sore on the injection site for a few days; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient just got his/her shingles shot two weeks ago.  Then he/she would go back in June for the 2nd one.  The shot was not bad, it just was sore on the injection site for a few days and not bad reactions to the vaccine. Additional Supportive Information: The follow up would not possible as no contact details were available.